# 80 FR 11266: Health and Human Services Acquisition Regulation

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-03391

## Section

- **Citation:** 80 FR 11266
- **Heading:** Health and Human Services Acquisition Regulation
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 80 / 80 FR 11266

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES 48 CFR Chapter 3 Health and Human Services Acquisition Regulation AGENCY:
Department of Health and Human Services.

ACTION:
Proposed rule.

SUMMARY:
The Department of Health and Human Services (HHS) is proposing to amend its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation (HHSAR), to update its regulation to current FAR requirements; to remove information from the HHSAR that consists of material that is internal administrative and procedural in nature; to add or revise definitions; to correct certain terminology; and to delete outdated material or material duplicative of the FAR.

DATES:
Comments are due on or before May 1, 2015.

ADDRESSES:
Submit comments in response to Health and Human Services Acquisition Regulation, parts 301 through 370 by any of the following methods:
Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “Health and Human Services Acquisition Regulation, parts 301 through 370” under the heading “Enter Keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “Health and Human Services Acquisition Regulation, parts 301 through 370.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Health and Human Services Acquisition Regulation, parts 301 through 370” on your attached document.
Fax: 202-260-4823.
Mail: HHS/ASFR/OGAPA/Division of Acquisition, ATTN: Deborah Griffin, Room 537H, Hubert Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Instructions: Please submit comments only and cite Health and Human Services Acquisition Regulation, parts 301 through 370, in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov
S/ASFR/OGAPA/Division of Acquisition, ATTN: Deborah Griffin, Room 537H, Hubert Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Instructions: Please submit comments only and cite Health and Human Services Acquisition Regulation, parts 301 through 370, in all correspondence related to this case. All comments received will be posted without change to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Deborah Griffin, Procurement Analyst, Department of Health and Human Services, Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition, Deborah.griffin@hhs.gov.

SUPPLEMENTARY INFORMATION:
I. Background
The HHS made substantive changes in its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation or HHSAR, in November 2009 (74 FR 62396 on November 27, 2009). On April 26, 2010, HHS published in the Federal Register correcting amendments at 75 FR 2150. Since then numerous changes have been made to both statutory and regulatory (FAR) framework and requirements. Some of these new requirements were included in specific appropriations acts. This proposed rule changes the HHSAR to conform to these new requirements and to align the requirements with the current FAR. In addition, the procedural materials that were deemed internal or non-regulatory in nature are moved to internal procedures. Further changes are proposed to permit the various HHS operational divisions (OPDIVs) or staff divisions (STAFFDIVs) the necessary flexibility in meeting their respective missions. OPDIV provisions and clauses were collected and are tailored for department-wide application.
The updated HHSAR includes HHS initiatives designed to change the purpose and content of the HHSAR. The objective is to improve the efficiency and effectiveness of various phases of the acquisition lifecycle, creating the framework for innovation and maximum flexibility
eeting their respective missions. OPDIV provisions and clauses were collected and are tailored for department-wide application.
The updated HHSAR includes HHS initiatives designed to change the purpose and content of the HHSAR. The objective is to improve the efficiency and effectiveness of various phases of the acquisition lifecycle, creating the framework for innovation and maximum flexibility. The updated HHSAR will contain only requirements of law, HHS policies, delegations of FAR authorities, deviations from FAR requirements, and policies/procedures that have a significant effect beyond the internal procedures of HHS or a significant cost or administrative impact on entities pursuing business opportunities with HHS. The information removed from the HHSAR consists of internal administrative and procedural information, referred to as internal procedures. In addition, the information removed does not have a significant effect beyond HHS internal operating procedures. The internal procedures will contain internal guidance, procedures, processes, and instructions but they will not be published in the Code of Federal Regulations. This framework which separates laws, policies, and other requirements impacting our industry partners from internal operating procedures will enable HHS to more rapidly convey internal administrative and procedural information to the acquisition workforce.
II. Proposed Rule
The following summarizes changes to the HHSAR.
Part 301—HHS Acquisition Regulation System
Part 301 is revised as follows:
The nomenclature of the Contracting Officer's Technical Representative (COTR) was changed to Contracting Officer's Representative (COR) throughout the HHSAR. The training requirements for both Contracting Officers and CORs were deleted. The use of the term “project officer” has been removed throughout the HHSAR. The authority citations are corrected for all HHSAR parts
301 is revised as follows:
The nomenclature of the Contracting Officer's Technical Representative (COTR) was changed to Contracting Officer's Representative (COR) throughout the HHSAR. The training requirements for both Contracting Officers and CORs were deleted. The use of the term “project officer” has been removed throughout the HHSAR. The authority citations are corrected for all HHSAR parts.
The prescription at Section 301.106(c) (Office of Management and Budget approval under the Paperwork Reduction Act) regarding the Paperwork Reduction Act was moved to Part 311 and OMB clearance numbers were updated.
Section 301.270 (Executive Committee for Acquisition) is deleted as unnecessary for the regulation and reflecting only internal procedures.
Subpart 301.4 (Deviations from the FAR) is strengthened to enforce the appropriate use of deviations.
Subsection 301.602-3 (Ratification of unauthorized commitments), paragraph (b), is modified to strengthen the language.
Subpart 301.6 (Career Development, Contracting Authority, and Responsibilities) is extensively modified to make clear that all procurement authority stems from the SPE by delegation, ultimately, from the Head of the Agency, who can delegate authority to issue warrants to a level no lower than the HCA. The internal procedures were deleted.
Part 302—Definitions of Words and Terms
Part 302 is revised as follows:
Section 302.101 (Definitions) is revised to clarify roles and responsibilities with HHS organizational changes. Definitions that already appear in the FAR were removed as duplicative.
Subparts 302.70 (Common HHSAR Acronyms and Abbreviations) and 302.71 (HHS Standard Templates and Formats) are removed as unnecessary
ed.
Part 302—Definitions of Words and Terms
Part 302 is revised as follows:
Section 302.101 (Definitions) is revised to clarify roles and responsibilities with HHS organizational changes. Definitions that already appear in the FAR were removed as duplicative.
Subparts 302.70 (Common HHSAR Acronyms and Abbreviations) and 302.71 (HHS Standard Templates and Formats) are removed as unnecessary.
Part 303—Improper Business Practices and Personal Conflicts of Interest
Part 303 is revised as follows:
Subsection 303.104-7 (Violations or possible violations of the Procurement
Section 303.203 (Reporting suspected violations of the Gratuities clause) is revised to remove internal procedures for processing a report of a suspected violation.
Section 303.303 (Reporting suspected antitrust violations) is removed as internal procedures.
Subpart 303.4 (Contingent Fees) is deleted as unnecessary.
Subpart 303.10 (Contractor Code of Business Ethics and Conduct) is added to move Section 303.1003 (Requirements) to its proper subject placement and Section 303.1003 is revised to remove internal procedures for processing a report of a suspected violation of criminal law.
Part 304—Administrative Matters
Part 304 is revised as follows:
Section 304.602 (General) is modified to remove the internal procedures regarding contract reporting.
Section 304.604 (Responsibilities) is revised to remove the internal procedures and to note the importance of accuracy and timeliness in the Federal Procurement Data System reporting.
Subsection 304.803-70 (Contract/order file organization and use of checklists) is removed as unnecessary.
Subsection 304.804-70 (Contract closeout audits) is removed as unnecessary.
Subpart 304.13 (Personal Identity Verification) is removed as unnecessary and a policy statement is added for clarification.
Subpart 304.70 (Acquisition Instrument Identification Numbering System) is revised and renumbered as 304.16 (Unique Procurement Instrument Identifiers)
of checklists) is removed as unnecessary.
Subsection 304.804-70 (Contract closeout audits) is removed as unnecessary.
Subpart 304.13 (Personal Identity Verification) is removed as unnecessary and a policy statement is added for clarification.
Subpart 304.70 (Acquisition Instrument Identification Numbering System) is revised and renumbered as 304.16 (Unique Procurement Instrument Identifiers).
Subpart 304.71 (Review and Approval of Proposed Contract Actions) and Section 304.7100 (Policy) is revised to clarify contract reviews and to remove internal procedures.
Subpart 304.72 (Affordable Care Act Prevention and Public Health Fund—Reporting Requirements) is added to address information required by the Prevention and Public Health Fund (PPHF).
Part 305—Publicizing Contract Actions
Part 305 is revised as follows:
Subpart 305.2 (Synopsis of Proposed Contract Actions) is removed as unnecessary.
Section 305.303 (Announcement of contract awards), paragraph (a), is revised to remove a separate threshold for HHS and rely on the FAR. The internal procedures are removed.
Section 305.502 (Authority) is revised to remove language redundant to the FAR and to specify that published advertisements in print media require approval above the contracting officer.
Subpart 305.70 (Publicizing Requirements Funded from the Affordable Care Act Prevention and Public Health Fund) is added.
Part 306—Competition Requirements
Part 306 is revised as follows:
Section 306.202 (Establishing or maintaining alternative sources) is revised to include reference to the HHS Department Competition Advocate.
Subsection 306.302-1 (Only one responsible source and no other supplies or services will satisfy agency requirements), paragraph (a)(2)(iv), is deleted; the information is considered internal procedures. Also, information is added for the Bioshield Program.
Subsection 306.302-7 (Public interest) is revised to clarify the procedures for the signature of the Secretary for a determination and findings for public interest
nly one responsible source and no other supplies or services will satisfy agency requirements), paragraph (a)(2)(iv), is deleted; the information is considered internal procedures. Also, information is added for the Bioshield Program.
Subsection 306.302-7 (Public interest) is revised to clarify the procedures for the signature of the Secretary for a determination and findings for public interest.
Section 306.303 (Justifications) is deleted; the information is considered internal procedures.
Section 306.304 (Approval of the justification) is deleted; the information is considered internal procedures.
Section 306.501 (Requirement) is revised to identify the HHS Department Competition Advocate.
Section 306.502 (Duties and responsibilities) is deleted; the information is considered internal procedures.
Part 307—Acquisition Planning
Part 307 is revised as follows:
Sections 307.104 (General procedures), 307.104-70 (Acquisition strategy), and 307.104-71 (Purpose and timing) are deleted.
Section 307.105 (Contents of written acquisition plans) is revised to clarify that HHS requires a written acquisition plan for all acquisitions above the simplified acquisition threshold.
Subsection 307.108-70 (Telecommuting of contractor employees) is deleted; this language is redundant; the FAR language is sufficient.
Subpart 307.70 (Considerations in Selecting an Award Instrument) is deleted; this information is considered internal procedures.
Subpart 307.71 (Acquisition Plan) is deleted; this information is considered internal procedures.
Part 308—Required Sources of Supplies and Services
Part 308 is revised as follows:
Section 308.404 (Use of Federal Supply Schedule) is deleted; the FAR language is sufficient.
Section 308.405-6 (Limited source justification and approval) is revised; information considered internal procedures is removed.
Subpart 308.8 (Acquisition of Printing and Related Supplies) is added to provide guidance on Government printing and electronic communications
rt 308 is revised as follows:
Section 308.404 (Use of Federal Supply Schedule) is deleted; the FAR language is sufficient.
Section 308.405-6 (Limited source justification and approval) is revised; information considered internal procedures is removed.
Subpart 308.8 (Acquisition of Printing and Related Supplies) is added to provide guidance on Government printing and electronic communications.
Part 309—Contractor Qualifications
Part 309 is revised as follows:
Section 309.402 (Policy) is deleted.
Section 309.403 (Definitions) is updated to provide current HHS definitions.
Section 309.404 (List of parties excluded from Federal procurement and non-procurement programs) is revised to change the title to System for Award Management (SAM) Exclusions. This revision reflects the current FAR language.
Section 309.405 (Effect of listing. Compelling Reason Determinations) is revised to change the title and updated to reflect current HHS terminology.
Sections 309.406 (Debarment) and 306.407 (Suspension) are revised.
Section 309.470 (Reporting of suspected causes for debarment or suspension or the taking of evasive actions) is revised to clarify and update the contracting officer's responsibilities to report and coordinate suspected causes for debarment or suspension or the taking of evasive actions.
Subsection 309.470-1 (Situations where reports are required) is revised and Subsection 309.470-2 (Contents of reports) is deleted; the information deleted is considered internal procedures.
Part 310—Market Research
Part 310 is revised as follows:
Section 310.001 (Policy) is revised to instruct contracting offices to follow the FAR.
Part 311—Describing Agency Needs
Part 311 is revised as follows:
Section 311.7000 (Defining electronic information technology (EIT) requirements) is revised to clarify the contracting officer's role in identifying the agency needs for EIT supplies and services; information considered internal procedures is deleted
310.001 (Policy) is revised to instruct contracting offices to follow the FAR.
Part 311—Describing Agency Needs
Part 311 is revised as follows:
Section 311.7000 (Defining electronic information technology (EIT) requirements) is revised to clarify the contracting officer's role in identifying the agency needs for EIT supplies and services; information considered internal procedures is deleted.
Section 311.7001 (Section 508 accessibility standards for HHS Web site content and communications materials) is moved to Part 339 and updated.
Subpart 311.71 (Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities) is relocated from Part 370.
Subpart 311.72 (Conference Funding and Sponsorship) is relocated from Part 370.
Subpart 311.73 (Contractor Collection of Information) is relocated from Part 301.
Part 312—Acquisition of Commercial Items
Part 312 is revised as follows:
Section 312.101 (Policy) is revised to emphasize that the HHS Strategic Sourcing Program shall be utilized when possible.
Section 312.202(d) (Market research and description of agency need) is revised to identify that the requiring activity specifies electronic and information technology (EIT) supplies and services subject to Section 508 and to move Section 508 requirements to Part 339.
Part 313—Simplified Acquisition Procedures
Part 313 is revised as follows:
Section 313.003 (Policy) is revised by moving language related to Section 508 to Part 339.
Subpart 313.1 (Procedures) is deleted; this language is duplicative of the FAR.
Section 313.301 (Government-wide commercial purchase card), paragraph (b), is revised to reference the HHS Purchase Card Program; the remaining procedural language is removed.
Section 313.303 (Blanket purchase agreements) and Subsection 313.305-5 (Purchases under blanket purchase agreements) are deleted; this information is not current.
Subpart 313.5 (Test Program for Certain Commercial Items) is deleted; this is considered procedural information
ard), paragraph (b), is revised to reference the HHS Purchase Card Program; the remaining procedural language is removed.
Section 313.303 (Blanket purchase agreements) and Subsection 313.305-5 (Purchases under blanket purchase agreements) are deleted; this information is not current.
Subpart 313.5 (Test Program for Certain Commercial Items) is deleted; this is considered procedural information.
Part 314—Sealed Bidding
Part 314 is revised as follows:
Section 314.103 (Policy) is revised by moving language related to Section 508 to Part 339.
Subpart 314.2 (Solicitation of Bids) is deleted; the FAR language is sufficient.
Subsection 314.404-1 (Cancellation of invitations after opening) in Section 314.404 (Rejection of bids) is revised to retain and clarify the HCA authority for rejection of bids and cancellations of invitations after opening.
Section 314.407 (Mistakes in bids) is revised to retain and clarify the head of the contracting activity authority for mistakes in bid both before award and afterward and information considered internal procedures is removed.
Part 315—Contracting By Negotiation
Part 315 is revised as follows:
The term “Technical Evaluation Panel” is removed and replaced with “Source Selection Evaluation Team” throughout this part and material that is deemed redundant to the FAR has been deleted.
Section 315.201 (Exchanges with industry before receipt of proposals) is determined to be internal procedures and is removed.
Subsection 315.204-5 (Part IV—Representations and instructions), paragraph (c)(2), is deleted and the internal procedures are removed.
Section 315.208 (Submission, modification, revision, and withdrawal of proposals) is revised to update how the Government will handle proposals after the exact time specified for receipt.
Section 315.209 (Solicitation Provisions and Contract Clauses) is deleted
Subsection 315.204-5 (Part IV—Representations and instructions), paragraph (c)(2), is deleted and the internal procedures are removed.
Section 315.208 (Submission, modification, revision, and withdrawal of proposals) is revised to update how the Government will handle proposals after the exact time specified for receipt.
Section 315.209 (Solicitation Provisions and Contract Clauses) is deleted.
Section 315.304 (Evaluation factors and significant subfactors) is revised to move the text related to EIT acquisitions to Part 339, and the internal procedures are removed.
Section 315.305 (Proposal evaluation) is revised and the internal procedures are removed.
Sections 315.306 (Exchanges with offerors after receipt of proposals) and 315.307 (Proposal revisions) are removed.
Section 315.370 (Finalization of details with the selected source) is deleted as unnecessary; it is redundant to FAR 15.206.
Section 315.371 (Contract preparation and award) contains internal procedures which are removed.
Section 315.372 (Preparation of negotiation memorandum) contains internal procedures which are removed.
Subsection 315.404-2 (Information to support proposal analysis) is revised and internal procedures are removed.
Subsection 315.404-4 (Profit) is revised and the internal procedures related to developing weighted guidelines are removed.
Section 315.605 (Content of unsolicited proposals) is revised to clarify the requirements on the submitter of an unsolicited proposal. The requirement for a certification has been deleted and a warranty has been added to conform to current Federal law. This changes the government's remedy from a criminal sanction to a contract remedy.
Subsection 315.606-1 (Receipt and initial review) is revised for clarity.
Section 315.609 (Limited Use of Data) is deleted.
Subpart 315.70 (Acquisition of Electronic Information Technology) is moved to Part 339
r a certification has been deleted and a warranty has been added to conform to current Federal law. This changes the government's remedy from a criminal sanction to a contract remedy.
Subsection 315.606-1 (Receipt and initial review) is revised for clarity.
Section 315.609 (Limited Use of Data) is deleted.
Subpart 315.70 (Acquisition of Electronic Information Technology) is moved to Part 339.
Part 316—Types of Contracts
Part 316 is revised as follows:
Section 316.603 (Letter contracts) is revised to limit letter contract modifications as prescribed in the FAR.
Section 316.307 (Contract clauses) is revised to clarify the application of the cost principle in accordance with the governing statute.
Section 316.505 (Ordering) is revised to clarify the role of the Competition Advocate as the task order ombudsman.
Subsection 316.603-70 (Procedure for requesting authority to issue a letter contract) is deleted as unnecessary.
Subsection 316.603-71 (Approval for modifications to letter contracts) is moved to 316.603-3 in part and is otherwise deleted as unnecessary.
Subpart 316.7 (Agreements) is deleted as unnecessary.
Part 317—Special Contracting Methods
Part 317 is revised as follows:
Section 317.104 (General) is revised to identify the Senior Procurement Executive as the designated agency approving official.
Subsection 317.105-1 (Uses), paragraph (a), is revised to update current thresholds for cancellation ceilings.
Section 317.107 (Options) is revised to update guidance on the use of options for multi-year contracts.
Section 317.204 (Contracts), paragraph (e), is revised to provide guidance on contract periods exceeding the 5-year limitation provided in FAR 17.204(e).
Section 317.207 (Exercise of Options) is deleted; the information for current Section 508 policy is provided in Part 339.
Subpart 317.5 (Interagency Acquisitions Under the Economy Act) is deleted; this information is considered internal procedures
on 317.204 (Contracts), paragraph (e), is revised to provide guidance on contract periods exceeding the 5-year limitation provided in FAR 17.204(e).
Section 317.207 (Exercise of Options) is deleted; the information for current Section 508 policy is provided in Part 339.
Subpart 317.5 (Interagency Acquisitions Under the Economy Act) is deleted; this information is considered internal procedures.
Subpart 317.70 (Multi-agency and Intra-agency Contracts) is deleted; this information is considered internal procedures.
Part 319—Small Business Programs
Part 319 is revised as follows:
Section 319.201 (General policy) language is revised to align with the FAR.
Subsection 319.202-2 (Locating small business sources) is removed as unnecessary.
Subsection 319.270-1 (Mentor Protégé Program) is revised to change the section heading to “Mentor Protégé Program Solicitation provision and contract clause.”
Subpart 319.5 (Set-asides for Small Business) is deleted; the FAR coverage is sufficient.
Subpart 319.7 (Subcontracting with Small Business, Small Disadvantaged Business, and Women-Owned Small Business Concerns) is removed as unnecessary.
Part 322—Application of Labor Laws to Government Acquisitions
Part 322 is revised as follows:
Section 322.810 (Solicitation provisions and contract clauses) is revised to correct the clause prescriptions.
Part 323—Environment, Energy and Water Efficiency, Renewable Energy Technologies, Occupational Safety, and Drug-Free Workplace
Part 323 is revised as follows:
Section 323.7000 (Scope of subpart) is revised to clarify the applicable policy for safety and health situations.
Section 323.7001 (Policy) is revised to clarify guidance for safety and health situations.
Section 323.7002 (Actions required) is revised by removing information regarding roles other than the contracting officer.
Subpart 323.71 (Sustainable Acquisition Requirements) is revised by adding sustainable acquisition requirements
d to clarify the applicable policy for safety and health situations.
Section 323.7001 (Policy) is revised to clarify guidance for safety and health situations.
Section 323.7002 (Actions required) is revised by removing information regarding roles other than the contracting officer.
Subpart 323.71 (Sustainable Acquisition Requirements) is revised by adding sustainable acquisition requirements. This additional information provides policy and a new provision prescription for offerors to describe their approaches for meeting the requirements of FAR 23.1 (Sustainable Acquisition Policy).
Part 324—Protection of Privacy and Freedom of Information
Part 324 is revised as follows:
Sections 324.000 (Scope of subpart) and 324.102 (General) are removed; this information is considered internal procedures.
Section 324.103 (Procedures) is revised to change the section heading to “Procedures for the Privacy Act” and to ensure that the statement of work/performance work schedule specifies the system of record and the disposition of the system of record.
Section 324.104 (Restrictions on Contractor Access to Government or Third Party Information) is added to provide information on restrictions on contractor access to Government or third party information.
Section 324.105 (Contract clauses) is added to prescribe the clause at 352.224-70 (Privacy Act) and 352.224-71 (Confidential Information).
Subpart 324.2 (Freedom of Information Act) is deleted; the FAR is sufficient.
Subpart 324.70 (Health Insurance Portability and Accountability Act of 1996 (HIPAA)) is added to provide coverage for the Health Insurance Portability and Accountability Act of 1996 and subtitle D of title IV of the Health Information Technology for Economic and Clinical Health Act (HITECH Act)
idential Information).
Subpart 324.2 (Freedom of Information Act) is deleted; the FAR is sufficient.
Subpart 324.70 (Health Insurance Portability and Accountability Act of 1996 (HIPAA)) is added to provide coverage for the Health Insurance Portability and Accountability Act of 1996 and subtitle D of title IV of the Health Information Technology for Economic and Clinical Health Act (HITECH Act).
Pursuant to the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (August 21, 1996) and the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Investment Act, Public Law 111-5 (February 17, 2009), the Department issued regulations at 45 CFR parts 160 to 164 (HIPAA Rules).
The HIPAA Rules apply to “covered entities” and in part to “business associates,” as defined at 160.103. Covered entities are health plans, health care clearinghouses, and any health care provider who transmits health information in electronic form in connection with transactions for which the Secretary of HHS has adopted standards under the HIPAA statute. In general, business associates are persons or organizations that perform certain functions or activities on behalf of, or provides certain services to, covered entities that involve the use or disclosure of protected health information. When covered entities use contractors to perform services or activities that involve protected health information, the HIPAA Privacy and Security Rules require that covered entities enter into an agreement with business associates, commonly called business associate agreements, which must include specified terms set forth in these rules.
A covered entity that is a single legal entity and that conducts both covered and non-covered functions may elect to be a “hybrid entity,” as defined at 164.103. A covered function is an activity that makes a person or organization a covered entity
to an agreement with business associates, commonly called business associate agreements, which must include specified terms set forth in these rules.
A covered entity that is a single legal entity and that conducts both covered and non-covered functions may elect to be a “hybrid entity,” as defined at 164.103. A covered function is an activity that makes a person or organization a covered entity. To be a hybrid entity, a covered entity must designate in writing its operations that perform covered functions as one or more “health care components,” as defined at 164.103. After making this designation, most of the requirements of the HIPAA rules will apply only to the health care components. A covered entity that is a hybrid entity must include a component that performs business associate-like activities within its health care component(s) so that such component is directly subject to the HIPAA Rules.
The Department is a covered entity. However, because the Department has elected to be a hybrid entity, most Department activities are not subject to the HIPAA Rules. At this time, the designated HHS' HCCs fall into the following categories: the CMS Medicare fee-for-service program, the Indian Health Service, the Commissioned Corps and the CDC World Trade Center Health Program. Even when a covered entity is a hybrid entity, the duty to enter into agreements or contracts that include certain terms remains with the covered entity rather than the health care component. For operational purposes it may be the covered entity's HCC(s) that perform the contract function on behalf of the covered entity.
This proposed rule references the terms that the HHS HCCs on behalf of the Department must include in their contracts with their business associates. In complying with the HIPAA Rules, the HCCs and their business associates shall interpret the HIPAA Rules consistent with the Department's interpretations as found on the HHS Office for Civil Rights Web site at http://www.hhs.gov/ocr/privacy
ntity.
This proposed rule references the terms that the HHS HCCs on behalf of the Department must include in their contracts with their business associates. In complying with the HIPAA Rules, the HCCs and their business associates shall interpret the HIPAA Rules consistent with the Department's interpretations as found on the HHS Office for Civil Rights Web site at http://www.hhs.gov/ocr/privacy. In particular, HCCs should reference the Sample Business Associate Agreement (BAA) Provisions at http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/contractprov.html as they develop their business associate contracts.
The required business associate contract terms apply where the Department is required to enter into a business associate contract pursuant to the HIPAA Rules. We note that the definition of business associate includes “subcontractors.” However, under 45 CFR 164.502(e)(1)(i), a covered entity is not required to have a business associate contract with a subcontractor; this would be the responsibility of the business associate. Also, under 45 CFR 164.504(e)(3)(i)(A) and (B), the business associate contract terms are not required if the business associate is another government agency ( e.g., a state agency) and certain conditions are met. Also, under 164.504(e)(3)(ii), the business associate contract terms are not required where the business associate is required by law to perform business associate functions or activities on behalf of the HCC or to provide certain services to a HCC, and certain other conditions are met. For example the Department of Justice is required by law to provide legal services to HHS.
Part 326—Other Socioeconomic Programs
Part 326 is added as follows:
Subpart 326.5 (Indian Preference in Employment, Training, and Subcontracting Opportunities) is added to provide information on the Indian
Subpart 326.6 (Acquisitions Under the Buy Indian Act) is added to provide information on acquisitions under the Buy Indian Act. This information is moved from part 370
l services to HHS.
Part 326—Other Socioeconomic Programs
Part 326 is added as follows:
Subpart 326.5 (Indian Preference in Employment, Training, and Subcontracting Opportunities) is added to provide information on the Indian
Subpart 326.6 (Acquisitions Under the Buy Indian Act) is added to provide information on acquisitions under the Buy Indian Act. This information is moved from part 370.
Subpart 326.7 (Acquisitions Requiring the Native American Graves Protection and Repatriation Act) is added to provide information on acquisitions requiring the Native American Graves Protection and Repatriation Act. This information is moved from part 342.
Part 327—Rights, Data, and Copyrights
Part 327 is revised as follows:
Subsection 327.404-70 (Solicitation provision and contract clause), is revised to clarify that the contractor may publish results of its work.
Part 328—Bonds and Insurance
Part 328 is deleted; the FAR is deemed sufficient.
Part 330—Cost Accounting Standards
Part 330 is revised as follows:
Subsection 330.201-5 (Waiver) is revised and internal procedures are removed.
Part 331—Contract Cost Principles and Procedures
Part 331 is revised as follows:
Section 331.101-70 (Salary Rate Limitation) is revised to update how HHS appropriated funds are to be used, and direct users to Office of Personnel Management for the rate tables.
Section 331.102-70 (Pricing of adjustments) contains internal procedures and is removed.
Part 332—Contract Financing
Part 332 is revised as follows:
Section 332.402 (General) is revised to clarify the HCA responsibility for advance payments.
Section 332.403 (Applicability) is deleted as unnecessary.
Section 332.407 (Interest) is revised and internal procedures are removed.
Section 332.409 (Contracting Officer action) and Subsection 332.409-1 (Recommendation for approval) are deleted as unnecessary
cing
Part 332 is revised as follows:
Section 332.402 (General) is revised to clarify the HCA responsibility for advance payments.
Section 332.403 (Applicability) is deleted as unnecessary.
Section 332.407 (Interest) is revised and internal procedures are removed.
Section 332.409 (Contracting Officer action) and Subsection 332.409-1 (Recommendation for approval) are deleted as unnecessary.
Section 332.702 (Policy), Section 332.703 (Contract funding requirements), and Subsection 332.703-71 (Incrementally funded cost-reimbursement contracts) are added to address contract funding issues.
Subsection 332.703-70 (Funding contracts during a continuing resolution) is removed since continuing resolution and their associated requirements change with each resolution.
Subsection 332.703-71 (Incrementally funded cost-reimbursement contracts) is added.
Subsection 332.703-72 (Incremental Funding Table) is added to provide a contract mechanism to track funding on an incrementally funded contract.
Section 332.704 (Limitation of cost or funds) is deleted as unnecessary.
Section 332.706 (Solicitation provision and contract clauses) is added to prescribe the clause at 352.232-70 (Incremental Funding).
Subsection 332.706-2 (Provision and clauses for limitation of cost or funds) is added to prescribe additional requirements for cost-reimbursement contract for severable services using incremental funding.
Part 333—Protests, Disputes, and Appeals
Part 333 is revised as follows:
Sections 333.102 (General) and 333.103 (Protests to the agency) are revised to remove internal procedures.
Sections 333.104 (Protests to GAO), 333.211 (Contracting Officer's decision), 333.212 (Contracting Officer's duties upon appeal), 333.212-70 (Formats), and 333.213 (Obligation to continue performance) are internal procedures and are deleted.
Subsection 333.215-70 (Contract clauses) is revised to reference the clause at 352.233-72 in all solicitations and contracts and to correct the clause prescriptions
333.104 (Protests to GAO), 333.211 (Contracting Officer's decision), 333.212 (Contracting Officer's duties upon appeal), 333.212-70 (Formats), and 333.213 (Obligation to continue performance) are internal procedures and are deleted.
Subsection 333.215-70 (Contract clauses) is revised to reference the clause at 352.233-72 in all solicitations and contracts and to correct the clause prescriptions.
Part 334—Major System Acquisition
Part 334 is revised as follows:
Section 334.200 (Definitions) is deleted.
Section 334.201 (Policy) is revised to provide the HHS contract value thresholds for the requirement of EVMS.
Section 334.203 (Solicitation provisions and contract clauses) and Subsection 334.203-70 (HHS solicitation provisions and contract clauses) are deleted.
Part 335—Research and Development Contracting
Part 335 is revised as follows:
Subsection 335.070-1 (Policy) is revised to relax the prior mandates in order to provide the contracting officer more flexibility regarding cost-sharing contracts.
Subsection 335.070-2 (Amount of cost-sharing) is revised to provide the contracting officer more flexibility regarding fees or profits in cost-sharing contracts.
Subsection 335.070-4 (Contract award) is deleted as unnecessary.
Section 335.071 (Special determinations and findings affecting research and development contracting) is deleted as an unnecessary determinations and findings.
Section 335.072 (Key Personnel) is added to emphasize the importance of Key Personnel in research and development contracting.
Part 336—Construction and Architect-Engineer Contracts
Part 336 is added.
Part 337—Service Contracting—General
Part 337 is revised as follows:
Section 337.103 (Contracting Officer Responsibility) is revised as follows:
• Paragraphs (d)(1), (2), and (3), are revised to prescribe clauses to comply with Federal law
e the importance of Key Personnel in research and development contracting.
Part 336—Construction and Architect-Engineer Contracts
Part 336 is added.
Part 337—Service Contracting—General
Part 337 is revised as follows:
Section 337.103 (Contracting Officer Responsibility) is revised as follows:
• Paragraphs (d)(1), (2), and (3), are revised to prescribe clauses to comply with Federal law.
• Paragraph (d)(4) is added to provide direction to the Indian Health Service contracting officers in complying with the Indian Child Protection And Family Violence Act (25 U.S.C. 3201 et seq. ).
• Paragraph (e) is added to prescribe a clause that requires contractors who deliver services to beneficiaries of HHS programs to do so in a non-discriminatory fashion.
• Paragraph (f) is added to prescribe the use of the new key personnel clause at 352.237-75.
Section 337.103-70 (Solicitation provision and contract clause) is moved to Section 337.103 (Contracting Officer Responsibility) to align with FAR numbering.
Part 339—Acquisition of Information Technology
Revised Part 339 as follows:
Section 339.101 (Policy) is revised to clarify that contracting officers shall collaborate with the requiring activity for the acquisition of information technology supplies, services, and systems.
Section 339.201 (Clarification) and Subsection 339.201-70 (Required provision and contract clause) are deleted; the information is obsolete.
Section 339.203 (Approval of exceptions) is revised and the title is changed to (Applicability) to align with the FAR.
Sections 339.203-70 (Contract clauses), 339.204 (Exceptions), 339.204-1 (Approval of exceptions), and 339.205 (Section 508 accessibility standards for contracts) are added to provide updated information for electronic and information technology supplies and services and the requirements for compliance with Section 508 of the Rehabilitation Act
is changed to (Applicability) to align with the FAR.
Sections 339.203-70 (Contract clauses), 339.204 (Exceptions), 339.204-1 (Approval of exceptions), and 339.205 (Section 508 accessibility standards for contracts) are added to provide updated information for electronic and information technology supplies and services and the requirements for compliance with Section 508 of the Rehabilitation Act.
Subparts 339.70 (Use of General Services Administration Blanket Purchase Agreements for Independent Risk Analysis Services) and 339.71
Part 342—Contract Administration
Part 342 is revised as follows:
Section 342.302 (Contract administration functions) is revised as follows:
• Paragraph (c)(1) is deleted;
• Paragraph (c)(2) is deleted and the clause prescription is moved to Part 337 and renumbered;
• Paragraph (c)(3) is deleted because it prescribes the use of clause 352.242-71 (Tobacco-Free Facilities) which is also deleted; and
• Paragraph (c)(4) is deleted and the clause prescription is moved to Part 326 and renumbered.
Section 342.705 (Final indirect cost rates) is revised to clarify the HHS component named as the cognizant Federal agency within HHS.
Subpart 342.70 (Contract Monitoring) is revised by removing information from Sections 342.7000 (Purpose), 342.7001 (Contract monitoring responsibilities), and 342.7002 (Procedures to be followed when a contractor fails to perform); this information is considered internal procedures.
Section 342.7003 (Withholding of contract payments) is deleted; the FAR is sufficient.
Subpart 342.71 (Administrative Actions for Cost Overruns) is removed.
Part 352—Solicitation Provisions and Contract Clauses
Part 352 is revised as follows:
Clause 352.201-70 (Paperwork Reduction Act) is re-numbered 352.211-3 and relocated to Part 311.
Clause 352.202-1 (Definitions) is deleted.
Clause 352.203-70 (Anti-Lobbying) related to Subpart 303.8 (Limitation on the Payment of Funds to Influence Federal Transactions) is updated
st Overruns) is removed.
Part 352—Solicitation Provisions and Contract Clauses
Part 352 is revised as follows:
Clause 352.201-70 (Paperwork Reduction Act) is re-numbered 352.211-3 and relocated to Part 311.
Clause 352.202-1 (Definitions) is deleted.
Clause 352.203-70 (Anti-Lobbying) related to Subpart 303.8 (Limitation on the Payment of Funds to Influence Federal Transactions) is updated.
Clause 352.204-70 (Prevention and Public Health Fund—Reporting Requirements) is added.
Clause 352.208-70 (Printing and Duplication) is added.
Clause 352.211-1 (Accessibility of meetings, conferences, and seminars to persons with disabilities) formerly 352.270-7 is relocated from part 370.
Clause 352.211-2 (Conference sponsorship request and conference materials disclaimer) formerly 352.270-1 is relocated from Part 370.
Clause 352.211-3 (Paperwork Reduction Act) formerly 352.201-70 is relocated from part 301.
Clause 352.215-1 (Instructions to offerors—competitive acquisition) is deleted.
Clause 352.215-70 (Late Proposals and Revisions) is revised.
Clause 352.216-70 (Additional Cost Principles) is revised to correct the prescription citation.
Clause 352.219-70 (Mentor-protégé program) is revised.
Clause 352.222-70 (Contractor cooperation in equal employment opportunity investigations) is corrected.
Clause 352.223-70 (Safety and health) is updated.
Provision 352.223-71 (Instructions to Offerors—Sustainable Acquisition) is added.
Clause 352.224-70 (Privacy Act) is updated.
Clause 352.224-71 (Confidential Information) is added.
Clauses 352.226-1 (Indian Preference), 352.226-2 (Indian Preference Program), and 352.226-3 (Native American Graves Protection and Repatriation Act) are added. These clauses are moved from Parts 370 and 342 and renumbered.
Clause 352.227-70 (Publications and Publicity) is revised to clarify that the contractor may publish results of its work. In addition, paragraph (b) of the clause is revised
Clauses 352.226-1 (Indian Preference), 352.226-2 (Indian Preference Program), and 352.226-3 (Native American Graves Protection and Repatriation Act) are added. These clauses are moved from Parts 370 and 342 and renumbered.
Clause 352.227-70 (Publications and Publicity) is revised to clarify that the contractor may publish results of its work. In addition, paragraph (b) of the clause is revised. Paragraph “c” is added to clarify the advertising of products or services provided under the contract.
Clause at 352.231-70 (Salary Rate Limitation) is revised.
Clause 352.231-71 (Pricing of adjustments) is deleted as unnecessary.
Clause 352.232-70 (Incremental funding) is revised.
Clauses 352.233-70 (Choice of Law (overseas)) and 352.233-71 (Litigation and claims) are revised.
Provisions 352.234-1 (Notice of Earned Value Management System—Pre-Award Integrated Baseline Review) and 352.234-2 (Notice of Earned Value Management System—Post-Award Integrated Baseline Review) are deleted; the FAR provisions are sufficient.
Clauses 352.234-3 (Full Earned Value Management System) and 352.234-4 (Partial Earned Value Management System) are deleted; the FAR clauses are sufficient.
Clause 352.236-70 (Design-Build Contracts) is added with an Alternate I to be used for Fast Track procedures.
Clauses 352.237-70 (Pro-Children Act), 352.237-71 (Crime Control Act—reporting of child abuse), and 352.237-72 (Crime Control Act—requirement for background checks) are updated. Clauses 352.237-73 (Indian Child Protection and Family Violence Act), 352.237-74 (Non-discrimination in Service Delivery), and 352.237-75 (Key Personnel) are added.
Clause 352.239-70 (Standard for Security Configurations) is deleted; the clause is obsolete.
Clause 352.239-71 (Standard for Encryption Language) is deleted; the clause is obsolete.
Clause 352.239-72 (Security Requirements for Federal Information Technology Resources) is deleted; the clause is obsolete
237-74 (Non-discrimination in Service Delivery), and 352.237-75 (Key Personnel) are added.
Clause 352.239-70 (Standard for Security Configurations) is deleted; the clause is obsolete.
Clause 352.239-71 (Standard for Encryption Language) is deleted; the clause is obsolete.
Clause 352.239-72 (Security Requirements for Federal Information Technology Resources) is deleted; the clause is obsolete.
Provision 352.239-73 (Electronic and Information Technology and Accessibility Notice) is revised to provide updated information for electronic and information technology supplies and services and the requirements for compliance with Section 508 of the Rehabilitation Act.
Clause 352.239-74 (Electronic and Information Technology Accessibility) is added.
Clause 352.242-70 (Key Personnel) is renumbered as 352.237-75.
Clause 352.242-71 (Tobacco Free Facilities) is deleted. The clause is no longer necessary.
Clause at 352.242-72 (Native American Graves Protection and Repatriation Act) is renumbered as 352.236-3.
Clause 352.242-73 (Withholding of Contract Payments) is deleted; the FAR is sufficient.
Clause 352.242-74 (Final decisions on audit findings) is deleted; the FAR is sufficient.
Clause 352.270-1 (Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities) is moved to 352.211-1;
Clause 352.270-2 (Indian preference) is moved to 352.226-1.
Clause 352.270-3 (Indian preference program) is moved to 352.226-2.
Provision 352.270-4a (Notice to Offerors, Protection of Human Subjects) is revised to update the Federal-wide assurance requirement and provide for the inclusion of an Alternate to this provision.
Clause at 352.270-4b (Protection of Human Subjects) is revised to update the Federal-wide assurance requirement.
Provision 352.270-5a (Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals) is updated.
Clause 352.270-5b (Care of Live Vertebrate Animals) is updated
or the inclusion of an Alternate to this provision.
Clause at 352.270-4b (Protection of Human Subjects) is revised to update the Federal-wide assurance requirement.
Provision 352.270-5a (Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals) is updated.
Clause 352.270-5b (Care of Live Vertebrate Animals) is updated.
Clause 352.270-6 (Restrictions on Use of Human Subjects) is revised to update the reference to the Institutional Review Board.
Clause 352.270-7 (Conference Sponsorship Request and Conference Materials Disclaimer) is moved to 352.211-2.
Clause 352.270-8 (Prostitution and related activities) is deleted.
Clause 352.270-9 (Non-discrimination for conscience) is updated.
Provision 352.270-10 (Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required) is added.
Clause 352.270-11 (Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required) is added.
Clause 352.270-12 (Needle Exchange) is added.
Clause 352.270-13 (Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research) is added.
Part 353—Forms
Form HHS 674, Structured Approach Profit/Fee Objective is deleted. There are no forms; therefore, the part is reserved.
Part 370—Special Programs Affecting Acquisition
Part 370 is revised as follows:
Subpart 370.1 (Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities) is moved to part 311.
Subpart 370.2 (Indian Preference in Employment, Training, and Subcontracting Opportunities) is moved to part 326.
Subpart 370.3 (Acquisitions Involving Human Subjects) is revised to update the policy in section 370.301 and the Federal-wide assurance in 370.302
d as follows:
Subpart 370.1 (Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities) is moved to part 311.
Subpart 370.2 (Indian Preference in Employment, Training, and Subcontracting Opportunities) is moved to part 326.
Subpart 370.3 (Acquisitions Involving Human Subjects) is revised to update the policy in section 370.301 and the Federal-wide assurance in 370.302.
Section 370.303 (Notice to offerors) is revised as follows:
• Paragraph (a) is revised to provide for the inclusion of an Alternate to the provision at 352.270-4a (Notice to Offerors, Protection of Human Subjects).
• Paragraph (d) is added to provide a prescription for the provision added at 352.270-10 (Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required) in FDA solicitations that involve human subjects research such that the research will be reviewed and approved by the Research Involving Human Subjects Committee (RIHSC).
Section 370.304 (Contract clauses) is revised as follows:
• Paragraph (c) is added to provide a prescription for the clause added at 352.270-11 (Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required) in FDA solicitations that involve human subjects research such that the research will be reviewed and approved by the Research Involving Human Subjects Committee (RIHSC).
• Paragraph (d) is added to provide a prescription for the clause added at 352.270-12 (Needle Exchange).
• Paragraph (e) is added to provide a prescription for the clause added at 352.270-13 (Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research).
Subpart 370.4 (Acquisitions Involving the Use of Laboratory Animals) is revised to update the policy in Section 370.401 (Policy) and the assurances in Section 370.402 (Assurances)
added at 352.270-12 (Needle Exchange).
• Paragraph (e) is added to provide a prescription for the clause added at 352.270-13 (Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research).
Subpart 370.4 (Acquisitions Involving the Use of Laboratory Animals) is revised to update the policy in Section 370.401 (Policy) and the assurances in Section 370.402 (Assurances).
Sections 370.403 (Notice to offerors) and 370.404 (Contract clause) are revised to correct the provision and clause prescriptions.
Subpart 370.5 (Acquisitions Under the Buy Indian Act) is moved to part 326.
Subpart 370.6 (Conference Funding and Sponsorship) is moved to part 311.
Subpart 370.7 (Acquisitions under the Leadership Act) is revised for editorial corrections.
III. Executive Order 12866 and 13563
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
This is not a significant regulatory action and, therefore, is not subject to review under section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
IV. Regulatory Flexibility Act
These changes to the HHSAR will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601, et seq. The proposed rule improves HHS acquisition by removing duplicative regulatory language, provisions and clauses, and procedural information, and provides departmental level regulation and provisions and clauses
These changes to the HHSAR will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601, et seq. The proposed rule improves HHS acquisition by removing duplicative regulatory language, provisions and clauses, and procedural information, and provides departmental level regulation and provisions and clauses. Businesses, both small and large, can respond to uniform acquisition regulation, reducing their costs. As a result of these changes, the proposed rule should have a positive effect on small businesses allowing them to more readily compete for HHS contracts.
The Initial Regulatory Flexibility Analysis (IRFA) is summarized as follows:
INITIAL REGULATORY FLEXIBILITY ANALYSIS
This initial regulatory flexibility analysis has been prepared consistent with 5 U.S.C. 603.
1. Description of the reasons why action is being taken.
The Department of Health and Human Services (HHS) is proposing to amend its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation (HHSAR), to update its regulation to current FAR requirements; to move internal guidance which is procedural in nature to Procedures, Guidance and Instructions (PGI), to add or revise definitions; to correct certain terminology and to delete outdated material or material duplicative of the FAR.
2. Statement of the objectives of, and the legal basis for, the rule.
HHS made substantive changes in its Federal Acquisition Regulation (FAR) Supplement, the HHS Acquisition Regulation or HHSAR, in November, 2009, (74 FR 62396 on November 27, 2009). On April 26, 2010, HHS published in the Federal Register correcting amendments at 75 FR 2150. Since then numerous changes have been made to both statutory and regulatory (FAR) framework and requirements. Some of these new requirements were included in specific appropriations acts
ation (FAR) Supplement, the HHS Acquisition Regulation or HHSAR, in November, 2009, (74 FR 62396 on November 27, 2009). On April 26, 2010, HHS published in the Federal Register correcting amendments at 75 FR 2150. Since then numerous changes have been made to both statutory and regulatory (FAR) framework and requirements. Some of these new requirements were included in specific appropriations acts. This publication of the proposed rule changes the HHSAR to conform to these new requirements and to align the requirements with the current FAR. In addition, the procedural materials that were deemed internal or non-regulatory in nature are moved to procedures, guidance, and instructions documents. Further changes are proposed to permit the various HHS operational divisions (OPDIVS) or staff divisions (STAFFDIVS) the necessary flexibility in meeting their respective missions. OPDIV provisions and clauses were collected and are tailored for department-wide application.
3. Description of and, where feasible, an estimate of the number of small entities to which the rule will apply.
HHS awarded approximately 95 thousand contract actions in FY2014; over 44 percent (42,232) of those actions were for small businesses acting as prime contractors; therefore, it is estimated that the rule will apply to over 42,000 small entities. The primary industry sectors affected are as represented in the chart below:
HHS FY2014 3-Digit NAICS Total Small Business Dollars 221 (UTILITIES) $485,385.87 236 (CONSTRUCTION OF BUILDINGS) 164,277,302.92 325 (CHEMICAL MANUFACTURING) Total 262,207,229.87 334 (COMPUTER AND ELECTRONIC PRODUCT MANUFACTURING) 313,625,169.91 336 (TRANSPORTATION EQUIPMENT MANUFACTURING) 66,756,387.08 339 (MISCELLANEOUS MANUFACTURING) 29,127,192.37 423 (MERCHANT WHOLESALERS, DURABLE GOODS) 33,254,853.30 424 (MERCHANT WHOLESALERS, NONDURABLE GOODS) 21,355,796.73 443 (ELECTRONICS AND APPLIANCE STORES) 69,190,516.74 493 (WAREHOUSING AND STORAGE) 16,489,155.73 511 (PUBLISHING INDUSTRIES (EXCEPT INTERNET)) 49,671,265.41 517
) 313,625,169.91 336 (TRANSPORTATION EQUIPMENT MANUFACTURING) 66,756,387.08 339 (MISCELLANEOUS MANUFACTURING) 29,127,192.37 423 (MERCHANT WHOLESALERS, DURABLE GOODS) 33,254,853.30 424 (MERCHANT WHOLESALERS, NONDURABLE GOODS) 21,355,796.73 443 (ELECTRONICS AND APPLIANCE STORES) 69,190,516.74 493 (WAREHOUSING AND STORAGE) 16,489,155.73 511 (PUBLISHING INDUSTRIES (EXCEPT INTERNET)) 49,671,265.41 517 (TELECOMMUNICATIONS) 9,648,511.61 518 (DATA PROCESSING, HOSTING AND RELATED SERVICES) 104,142,979.21 519 (OTHER INFORMATION SERVICES) 36,729,861.34 524 (INSURANCE CARRIERS AND RELATED ACTIVITIES) 7,734,506.42 531 (REAL ESTATE) 2,107,755.53 541 (PROFESSIONAL, SCIENTIFIC, AND TECHNICAL SERVICES) 2,812,475,258.21 561 (ADMINISTRATIVE AND SUPPORT SERVICES) 221,619,313.74 611 (EDUCATIONAL SERVICES) 19,831,346.95 621 (AMBULATORY HEALTH CARE SERVICES) 86,140,044.62 Total 4,326,869,833.56 4. Description and estimate of compliance requirements including differences in cost, if any, for different groups of small entities.
The proposed rule will improve HHS acquisition by removing duplicative regulatory language, provisions and clauses, and procedures, guidance, and information (PGI) from HHS OPDIVS, and provides departmental level regulation, provisions and clauses, and PGI. This will enable businesses, both small and large, to respond to a uniform acquisition regulation and PGI, reducing their costs and decreasing their burden for compliance. After removing outdated reporting requirements, HHS found there were fewer data collections with less burden than the current HHSAR contains. The remaining compliance requirements do not require an update to computer software, nor does it impose additional recordkeeping or reporting responsibilities. As a result of these changes, the proposed rule should have a positive effect on small businesses allowing them to more readily compete for HHS contracts. There are no differences anticipated for the costs for compliance requirements for small businesses.
5
iance requirements do not require an update to computer software, nor does it impose additional recordkeeping or reporting responsibilities. As a result of these changes, the proposed rule should have a positive effect on small businesses allowing them to more readily compete for HHS contracts. There are no differences anticipated for the costs for compliance requirements for small businesses.
5. Identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the rule.
The proposed rule does not duplicate, overlap, or conflict with any other Federal rules. As detailed in #2 above, language has been updated to comply with current FAR requirements, added where appropriate and necessary to supplement FAR, and removed where duplicative of FAR.
6. Description of any significant alternatives to the rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the rule on small entities.
There are no viable alternatives. The rule is being amended to update the regulation to current FAR requirements and to delete outdated material so that the rule as a whole will be statutorily correct. As cited in paragraph 4 above, the economic burden on both large and small businesses will be decreased. Consideration was given to amending the HHSAR by prioritizing parts. It was determined that this would leave regulations in place that were outdated and inconsistent with FAR requirements governing one aspect of an acquisition, while another aspect would be done in accordance with updated regulation consistent with the FAR. The outdated and the updated regulation could be contradictory and certainly could result in acquisitions open to legal controversy leading not only to delays in acquisitions, but also improper acquisitions. This would be beneficial to neither the Government nor industry, including small businesses
n, while another aspect would be done in accordance with updated regulation consistent with the FAR. The outdated and the updated regulation could be contradictory and certainly could result in acquisitions open to legal controversy leading not only to delays in acquisitions, but also improper acquisitions. This would be beneficial to neither the Government nor industry, including small businesses. Therefore, it is believed that the approach taken of amending of the HHSAR in whole is the most practical and benefits both Government and industry.
The Department of HHS, Division of Acquisition (DA), will submit a copy of the Initial Regulatory Flexibility Analysis (IRFA) to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the IRFA may be obtained from the DA. HHS invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
HHS will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 in correspondence.
V. Paperwork Reduction Act
A. The Paperwork Reduction Act (44 U.S.C. chapter 35) applies. The proposed rule contains 6 information collection requirements. Accordingly, HHS has submitted requests for approval of the new information collection requirements concerning this rule to the Office of Management and Budget. The information collection requirements are discussed as follows:
1. HHSAR 311.7101(a) (Responsibilities) and the clause at 352.211-1 (Accessibility of meetings, conferences and seminars to persons with disabilities) require contractors to provide a plan describing the contractor's ability to meet the accessibility standards in 28 CFR part 36
ing this rule to the Office of Management and Budget. The information collection requirements are discussed as follows:
1. HHSAR 311.7101(a) (Responsibilities) and the clause at 352.211-1 (Accessibility of meetings, conferences and seminars to persons with disabilities) require contractors to provide a plan describing the contractor's ability to meet the accessibility standards in 28 CFR part 36.
HHSAR 311.7202(b) (Responsibilities) and the clause at 352.211-2 (Conference sponsorship request and conference materials disclaimer) require contractors to provide funding disclosure and a content disclaimer statement on conference materials. As a result of these clauses, HHS contractors providing conference, meeting, or seminars services are required to provide specific information to HHS.
Public reporting burden for this collection of information is estimated to average 1 hour per response, including
The annual reporting burden is estimated as follows:
Respondents: 1,157.
Responses per respondent: 1.
Total annual responses: 1,157.
Preparation hours per response: 1 hour.
Total response burden hours: 1,157 hours.
Total annual cost of compliance: $47,668.
2. HHSAR 311.7300 (Policy) and the clause at 352.211-3 (Paperwork Reduction Act) require contractors to not proceed with the collection of information on surveys, questionnaires, and other information requests until the contractor is provided an Office of Management and Budget (OMB) clearance from the contracting officer.
Public reporting burden for this collection of information is estimated to average 2.2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 20,088,262.
Responses per respondent: 1.
Total annual responses: 20,088,262.
Preparation hours per response: 2.2.
Total response burden hours: 9,021,953
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 20,088,262.
Responses per respondent: 1.
Total annual responses: 20,088,262.
Preparation hours per response: 2.2.
Total response burden hours: 9,021,953.
Total annual cost of compliance: $371,704,464.
3. HHSAR 337.103(d)(3) (Contracting Officer Responsibility) and the clause at 352.237-72 (Crime Control Act-Requirement for Background Checks) require persons engaged in a covered profession or activity under an HHS contract or subcontract to report any suspected child abuse incident. The report requirement is provided by the Childhelp USA, National Child Abuse Hotline.
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 40.
Responses per respondent: 4.
Total annual responses: 160.
Preparation hours per response: 1.
Total response burden hours: 160.
Total annual cost of compliance: $6,592.
4. HHSAR 337.103(d)(4) (Contracting Officer Responsibility) and the clause at 352.237-73 (Indian Child Protection and Family Violence Act) require contractors to provide information for a background check.
Public reporting burden for this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 40.
Responses per respondent: 4.
Total annual responses: 160.
Preparation hours per response: 1
is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 40.
Responses per respondent: 4.
Total annual responses: 160.
Preparation hours per response: 1.
Total response burden hours: 160.
Total annual cost of compliance: $6,592.
5 HHSAR 370.301 (Policy), the provision at 352.270-4a (Protection of Human Subjects), the clause at 352.270-4b (Protection of Human Subjects), the provision at 352.270-10 (Notice to Offerors—Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required), and the clause at 352.270-11 (Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required), require contractors to provide an acceptable federal-wide assurance to HHS when engaging in human subject research in performance of a contract.
Public reporting burden for this collection of information is estimated to average .50 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 4,644.
Responses per respondent: 1.
Total annual responses: 4,644.
Preparation hours per response: .50.
Total response burden hours: 2,322.
Total annual cost of compliance: $95,666.
6. HHSAR 370.401 (Policy), the provision at 352.270-5a (Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals), and the clause at 352.270-5b (Care of Live Vertebrate Animals) require contractors to provide an acceptable animal welfare assurance
l response burden hours: 2,322.
Total annual cost of compliance: $95,666.
6. HHSAR 370.401 (Policy), the provision at 352.270-5a (Notice to Offerors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals), and the clause at 352.270-5b (Care of Live Vertebrate Animals) require contractors to provide an acceptable animal welfare assurance.
Public reporting burden for this collection of information is estimated to average 2.7 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The annual reporting burden is estimated as follows:
Respondents: 36.
Responses per respondent: 4.
Total annual responses: 41.
Preparation hours per response: 2.7.
Total response burden hours: 111.
Total annual cost of compliance: $4,573.
B. Public comment is sought regarding: Whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, email your request, including your address, phone number, and document identifier, to Information.collectionclearance@hhs.gov. Written comments and recommendations for the proposed information collections must be directed to the Office of the Secretary, Paperwork Clearance Officer at the above email address within 60-days of this notice
orms for the proposed paperwork collections referenced above, email your request, including your address, phone number, and document identifier, to Information.collectionclearance@hhs.gov. Written comments and recommendations for the proposed information collections must be directed to the Office of the Secretary, Paperwork Clearance Officer at the above email address within 60-days of this notice.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.
List of Subjects in 48 CFR Parts 301 Through 370
Government procurement.

Dated: February 10, 2015. Angela Billups, Associate Deputy Assistant Secretary for Acquisition.
For the reasons stated in the preamble, HHS proposes revising 48 CFR chapter 3, parts 301 through 370, as set forth below.
Title 48—Federal Acquisition Regulations System
CHAPTER 3—HEALTH AND HUMAN SERVICES
SUBCHAPTER A—GENERAL
PART 301—HHS ACQUISITION REGULATION SYSTEM PART 302—DEFINITIONS OF WORDS AND TERMS PART 303—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST PART 304—ADMINISTRATIVE MATTERS SUBCHAPTER B—COMPETITION AND ACQUISITION PLANNING
PART 305—PUBLICIZING CONTRACT ACTIONS PART 306—COMPETITION REQUIREMENTS PART 307—ACQUISITION PLANNING PART 308—REQUIRED SOURCES OF SUPPLIES AND SERVICES PART 309—CONTRACTOR QUALIFICATIONS PART 310—MARKET RESEARCH PART 311—DESCRIBING AGENCY NEEDS PART 312—ACQUISITION OF COMMERCIAL ITEMS SUBCHAPTER C—CONTRACTING METHODS AND CONTRACT TYPES
PART 313—SIMPLIFIED ACQUISITION PROCEDURES PART 314—SEALED BIDDING PART 315—CONTRACTING BY NEGOTIATION PART 316—TYPES OF CONTRACTS PART 317—SPECIAL CONTRACTING METHODS SUBCHAPTER D—SOCIOECONOMIC PROGRAMS
PART 319—SMALL BUSINESS PROGRAMS PART 322—APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS PART 323—ENVIRONM
ISITION OF COMMERCIAL ITEMS SUBCHAPTER C—CONTRACTING METHODS AND CONTRACT TYPES
PART 313—SIMPLIFIED ACQUISITION PROCEDURES PART 314—SEALED BIDDING PART 315—CONTRACTING BY NEGOTIATION PART 316—TYPES OF CONTRACTS PART 317—SPECIAL CONTRACTING METHODS SUBCHAPTER D—SOCIOECONOMIC PROGRAMS
PART 319—SMALL BUSINESS PROGRAMS PART 322—APPLICATION OF LABOR LAWS TO GOVERNMENT ACQUISITIONS PART 323—ENVIRONMENT, ENERGY AND WATER EFFICIENCY, RENEWABLE ENERGY TECHNOLOGIES, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE PART 324—PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION PART 326—OTHER SOCIOECONOMIC PROGRAMS SUBCHAPTER E—GENERAL CONTRACTING REQUIREMENTS
PART 327—PATENTS, DATA, AND COPYRIGHTS PART 328—BONDS AND INSURANCE PART 330—COST ACCOUNTING STANDARDS PART 331—CONTRACT COST PRINCIPLES AND PROCEDURES PART 332—CONTRACT FINANCING PART 333—PROTESTS, DISPUTES, AND APPEALS SUBCHAPTER F—SPECIAL CATEGORIES OF CONTRACTING
PART 334—MAJOR SYSTEM ACQUISITION PART 335—RESEARCH AND DEVELOPMENT CONTRACTING PART 336—CONSTRUCTION AND ARCHITECT-ENGINEER CONTRACTS PART 337—SERVICE CONTRACTING—GENERAL PART 339—ACQUISITION OF INFORMATION TECHNOLOGY SUBCHAPTER G—CONTRACT MANAGEMENT
PART 342—CONTRACT ADMINISTRATION SUBCHAPTER H—CLAUSES AND FORMS
PART 352—SOLICITATION PROVISIONS AND CONTRACT CLAUSES PART 353—FORMS SUBCHAPTERS I, J, K AND L [RESERVED]
SUBCHAPTER M—HHS SUPPLEMENTATIONS
PART 370—SPECIAL PROGRAMS AFFECTING ACQUISITION SUBCHAPTER A—GENERAL
PART 301—HHS ACQUISITION REGULATION SYSTEM
Subpart 301.1 Purpose, Authority, and Issuance
Sec. 301.101 Purpose. 301.103 Authority. 301.106 Office of Management and Budget approval under the Paperwork Reduction Act. Subpart 301.2—[Reserved]
Subpart 301.4—Deviations From the FAR
301.401 Deviations. Subpart 301.6—Career Development, Contracting Authority, and Responsibilities
301.602 Contracting Officers.
301.602-3 Ratification of unauthorized commitments.
301.603 Selection, appointment, and termination of appointment of contracting officers.
301.603-1 General
oval under the Paperwork Reduction Act. Subpart 301.2—[Reserved]
Subpart 301.4—Deviations From the FAR
301.401 Deviations. Subpart 301.6—Career Development, Contracting Authority, and Responsibilities
301.602 Contracting Officers.
301.602-3 Ratification of unauthorized commitments.
301.603 Selection, appointment, and termination of appointment of contracting officers.
301.603-1 General. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 301.1—Purpose, Authority, and Issuance
301.101 Purpose. (a) The Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) establishes uniform HHS acquisition policies and procedures that implement and supplement the Federal Acquisition Regulation (FAR).
(b)(1) The HHSAR contains HHS policies that govern the acquisition process or otherwise control acquisition relationships between HHS' contracting activities and contractors. The HHSAR contains—
(i) Requirements of law;
(ii) HHS-wide policies;
(iii) Deviations from FAR requirements; and
(iv) Policies that have a significant effect beyond the internal procedures of HHS or a significant cost or administrative impact on contractors or offerors.
(2) Relevant internal procedures, guidance, and information not meeting the criteria in paragraph (b)(1) of this section are issued by HHS in other announcements, internal procedures, guidance, or information.

301.103 Authority. (b) The Assistant Secretary for Financial Resources (ASFR) prescribes the HHSAR under the authority of 5 U.S.C. 301 and section 205(c) of the Federal Property and Administrative Services Act of 1949, as amended (40 U.S.C. 121(c)(2)), as delegated by the Secretary).
b)(1) of this section are issued by HHS in other announcements, internal procedures, guidance, or information.

301.103 Authority. (b) The Assistant Secretary for Financial Resources (ASFR) prescribes the HHSAR under the authority of 5 U.S.C. 301 and section 205(c) of the Federal Property and Administrative Services Act of 1949, as amended (40 U.S.C. 121(c)(2)), as delegated by the Secretary).
(c) The HHSAR is issued in the Code of Federal Regulations (CFR) as chapter 3 of title 48, Department of Health and Human Services Acquisition Regulation. It may be referenced as “48 CFR chapter 3.”

301.106 Office of Management and Budget approval under the Paperwork Reduction Act. (a) The Paperwork Reduction Act of 1980 (44 U.S.C 3501 et seq. ) imposes a requirement on Federal agencies to obtain approval from the Office of Management and Budget (OMB) before collecting the same information from 10 or more members of the public.
(b) The following OMB control numbers apply to the information collection and recordkeeping requirements contained in this chapter:
HHSAR Segment OMB Control No. 311.7101(a) TBD 311.7300 TBD 327.404-70(c) TBD 337.103(d)(3) TBD 337.103(d)(4) TBD 370.301 TBD 370.401 TBD 352.211-1 TBD 352.211-3 TBD 352.227-71 TBD 352.237-72 TBD 352.237-73 TBD 352.270-4a TBD 352.270-4b TBD 352.270-10 TBD 352.270-11 TBD 352.270-5a TBD 352.270-5b TBD
Subpart 301.2—[Reserved]
Subpart 301.4—Deviations from the FAR
301.401 Deviations. Contracting officers are not permitted to deviate from the FAR or HHSAR without seeking proper approval. With full acknowledgement of FAR 1.102(d) regarding innovative approaches, any deviation to FAR or the HHSAR requires approval by the Senior Procurement Executive (SPE).

Subpart 301.6—Career Development, Contracting Authority, and Responsibilities
301.602 Contracting Officers.
301.602-3 Ratification of unauthorized commitments. (b) Policy
m the FAR or HHSAR without seeking proper approval. With full acknowledgement of FAR 1.102(d) regarding innovative approaches, any deviation to FAR or the HHSAR requires approval by the Senior Procurement Executive (SPE).

Subpart 301.6—Career Development, Contracting Authority, and Responsibilities
301.602 Contracting Officers.
301.602-3 Ratification of unauthorized commitments. (b) Policy. (1) The Government is not bound by agreements with, or contractual commitments made to, prospective contractors by individuals who do not have delegated contracting authority. Unauthorized commitments do not follow the appropriate process for the expenditure of Government funds. Consequently, the Government may not be able to ratify certain actions, putting a contractor at risk for taking direction from a Federal official other than the contracting officer. See FAR 1.602-1. Government employees responsible for unauthorized commitments are subject to disciplinary action. Contractors perform at their own risk when accepting direction from unauthorized officials. Failure to follow statutory and regulatory processes for the expenditure of Government funds is a very serious matter.
(2) The head of the contracting activity (HCA) is the official authorized to ratify an unauthorized commitment. No other re-delegations are authorized.
(c) Limitations. (5) The HCA shall coordinate the request for ratification with the Office of General Counsel, General Law Division and submit a copy to the Department SPE.

301.603 Selection, appointment, and termination of appointment of contracting officers.
301.603-1 General. (a) The Agency head has delegated broad authority to the Chief Acquisition Officer, who in turn has further delegated this authority to the SPE. The SPE has further delegated specific acquisition authority to the Operating and Staff Division heads and the HCAs. The HCA (non-delegable) shall select, appoint, and terminate the appointment of contracting officers.
ting officers.
301.603-1 General. (a) The Agency head has delegated broad authority to the Chief Acquisition Officer, who in turn has further delegated this authority to the SPE. The SPE has further delegated specific acquisition authority to the Operating and Staff Division heads and the HCAs. The HCA (non-delegable) shall select, appoint, and terminate the appointment of contracting officers.
(b) To ensure proper control of redelegated acquisition authorities, HCAs shall maintain a file containing successive delegations of HCA authority through the contracting officer level.

PART 302—DEFINITIONS OF WORDS AND TERMS
Subpart 302.1—Definitions
Sec. 302.101 Definitions. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 302.1—Definitions
302.101 Definitions. (a) Agency head or head of the agency, unless otherwise stated, means the head of the Staff Division (STAFFDIV) or Operating Division (OPDIV).
(b) Contracting Officer's Representative (COR) is a Federal employee designated in writing by a contracting officer to act as the contracting officer's representative in monitoring and administering specified aspects of contractor performance after award of a contract or order. In accordance with local procedures, STAFFDIV or OPDIVs may designate CORs for firm fixed-price contracts or orders. COR's responsibilities may include verifying that:
(1) The contractor's performance meets the standards set forth in the contract or order;
(2) The contractor meets the contract or order's technical requirements by the specified delivery date(s) or within the period of performance; and
(3) The contractor performs within cost ceiling stated in the contract or order. CORs must meet the training and certification requirements specified in 301.604.
) The contractor's performance meets the standards set forth in the contract or order;
(2) The contractor meets the contract or order's technical requirements by the specified delivery date(s) or within the period of performance; and
(3) The contractor performs within cost ceiling stated in the contract or order. CORs must meet the training and certification requirements specified in 301.604.
(c) Head of the Contracting Activity (HCA) is an official having overall responsibility for managing a contracting activity— i.e., the organization within a STAFFDIV or OPDIV or other HHS organization which has been delegated broad authority regarding the conduct of acquisition functions.

PART 303—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST
Subpart 303.1—Safeguards
Sec. 303.101 Standards of conduct. 303.101-3 Agency regulations. 303.104-7 Violations or possible violations of the Procurement Integrity Act. Subpart 303.2—Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause. Subpart 303.6—Contracts With Government Employees or Organizations Owned or Controlled by Them
303.602 Exceptions. Subpart 303.7—Voiding and Rescinding Contracts
303.704 Policy. Subpart 303.8—Limitation on the Payment of Funds to Influence Federal Transactions
303.808-70 Solicitation provision and contract clause. Subpart 303.10—Contractor Code of Business Ethics and Conduct
303.1003 Requirements. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 303.1—Safeguards
303.101 Standards of conduct.
303.101-3 Agency regulations. (a)(3) The HHS Standards of Conduct are prescribed in 45 CFR part 73.

303.104-7 Violations or possible violations of the Procurement Integrity Act
on and contract clause. Subpart 303.10—Contractor Code of Business Ethics and Conduct
303.1003 Requirements. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 303.1—Safeguards
303.101 Standards of conduct.
303.101-3 Agency regulations. (a)(3) The HHS Standards of Conduct are prescribed in 45 CFR part 73.

303.104-7 Violations or possible violations of the Procurement Integrity Act. (a)(1) The contracting officer shall submit to the head of the contracting activity (HCA) for review and concurrence the determination (along with supporting documentation) that a reported violation or possible violation of the statutory prohibitions has no impact on the pending award or selection of a contractor for award.
(2) The contracting officer shall refer the determination that a reported violation or possible violation of the statutory prohibitions has an impact on the pending award or selection of a contractor, along with all related information available, to the HCA. The HCA shall—
(i) Refer the matter immediately to the Associate Deputy Assistant Secretary (DAS) for Acquisition for review, who may consult with the appropriate legal office representative and the Office of Inspector General as appropriate; and
(ii) Determine the necessary action in accordance with FAR 3.104-7(c) and (d). The HCA shall obtain the approval or concurrence of the Associate DAS for Acquisition before proceeding with an action.
to the Associate Deputy Assistant Secretary (DAS) for Acquisition for review, who may consult with the appropriate legal office representative and the Office of Inspector General as appropriate; and
(ii) Determine the necessary action in accordance with FAR 3.104-7(c) and (d). The HCA shall obtain the approval or concurrence of the Associate DAS for Acquisition before proceeding with an action.
(b) The HCA (non-delegable) shall act with respect to actions taken under the Federal Acquisition Regulation (FAR) clause at 52.203-10, Price or Fee Adjustment for Illegal or Improper Authority.

Subpart 303.2—Contractor Gratuities to Government Personnel
303.203 Reporting suspected violations of the Gratuities clause. HHS personnel shall report suspected violations of the clause at FAR 52.203-3, Gratuities, to the Contracting Officer, who will in turn report the matter to the OGC Ethics Division for disposition.

Subpart 303.6—Contracts With Government Employees or Organizations Owned or Controlled by Them
303.602 Exceptions. The HCA (non-delegable) is the official authorized to approve an exception to the policy stated in FAR 3.601.

Subpart 303.7—Voiding and Rescinding Contracts
303.704 Policy. (a) For purposes of implementing FAR subpart 3.7, the HCA (non-delegable) shall exercise the authorities granted to the “agency head or designee.”

Subpart 303.8—Limitation on the Payment of Funds to Influence Federal Transactions
303.808-70 Solicitation provision and contract clause. The contracting officer shall insert the clause at 352.203-70, Anti-lobbying, in solicitations and contracts that exceed the simplified acquisition threshold.

Subpart 303.10—Contractor Code of Business Ethics and Conduct
303.1003 Requirements. (b) The contracting officer, when notified of a possible contractor violation, in accordance with FAR 3.1003(b), shall notify the Office of Inspector General and the HCA.
er shall insert the clause at 352.203-70, Anti-lobbying, in solicitations and contracts that exceed the simplified acquisition threshold.

Subpart 303.10—Contractor Code of Business Ethics and Conduct
303.1003 Requirements. (b) The contracting officer, when notified of a possible contractor violation, in accordance with FAR 3.1003(b), shall notify the Office of Inspector General and the HCA.
(c)(2) The contracting officer shall specify the title of HHS' OIG hotline poster and the Web site where the poster can be obtained in paragraph (b)(3) of the clause at FAR 52.203-14.

PART 304—ADMINISTRATIVE MATTERS
Subpart 304.6—Contract Reporting
Sec. 304.602 General. 304.604 Responsibilities. Subpart 304.13—Personal Identity Verification
304.1300 Policy. Subpart 304.16 Unique Procurement Instrument Identifiers
304.1600 Scope of subpart. Subpart 304.70—[Reserved]
Subpart 304.71—Review and Approval of Proposed Contract Actions
304.7100 Policy. Subpart 304.72 Affordable Care Act Prevention and Public Health Fund—Reporting Requirements
Sec. 304.7200 Scope of subpart. 304.7201 Procedures. 304.7202 Contract clause. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 304.6—Contract Reporting
304.602 General. Follow internal department procedures for reporting information to the Federal Procurement Data System (FPDS) and for resolving technical or policy issues relating to FPDS contract reporting.

304.604 Responsibilities. The Department of Health and Human Services (HHS) acquisition officials and staff shall report their contract information in FPDS accurately and timely.

Subpart 304.13—Personal Identity Verification
304.1300 Policy. To ensure compliance with Homeland Security Presidential Directive-12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD-12) and the Presidential Cross Agency Priority for strong authentication, contracting officers shall provide in each acquisition those HSPD-12 requirements necessary for contract performance
—Personal Identity Verification
304.1300 Policy. To ensure compliance with Homeland Security Presidential Directive-12: Policy for a Common Identification Standard for Federal Employees and Contractors (HSPD-12) and the Presidential Cross Agency Priority for strong authentication, contracting officers shall provide in each acquisition those HSPD-12 requirements necessary for contract performance.

Subpart 304.16—Unique Procurement Instrument Identifiers
304.1600 Scope of subpart. This subpart provides guidance for assigning identification numbers to solicitation or contract actions. The Senior Procurement Executive shall be responsible for establishing a numbering system within the department that conforms to Federal Acquisition Regulation subpart 4.16.

Subpart 304.70—[Reserved]
Subpart 304.71—Review and Approval of Proposed Contract Actions
304.7100 Policy. In accordance with internal Operating Division or Staff Division policy the head of the contracting activity (non-delegable) shall establish review and approval procedures for proposed contract actions to ensure that—
(a) Contractual documents are in conformance with law, established policies and procedures, and sound business practices;
(b) Contract actions properly reflect the mutual understanding of the parties; and
(c) The contracting officer is informed of deficiencies and items of questionable acceptability, and takes corrective action.

Subpart 304.72—Affordable Care Act Prevention and Public Health Fund—Reporting Requirements
304.7200 Scope of subpart. This subpart implements Section 220 of Pub. L. 112-74, FY 2012 Labor, HHS and Education Appropriations Act, which requires, semi-annual reporting on the use of funds from the Prevention and Public Health Fund (PPHF), Pub. L. 111-148, sec. 4002
y, and takes corrective action.

Subpart 304.72—Affordable Care Act Prevention and Public Health Fund—Reporting Requirements
304.7200 Scope of subpart. This subpart implements Section 220 of Pub. L. 112-74, FY 2012 Labor, HHS and Education Appropriations Act, which requires, semi-annual reporting on the use of funds from the Prevention and Public Health Fund (PPHF), Pub. L. 111-148, sec. 4002. Contractors that receive awards (or modifications to existing awards) with a value of $25,000 or more funded, in whole or in part, from the Prevention and Public Health Fund, shall report information specified in the clause at 352.204-70, including, but not limited to—
(a) The dollar amount of contractor invoices;
(b) The supplies delivered and services performed; and
(c) Specific information on subcontracts with a value of $25,000 or more.

304.7201 Procedures. (a) In any contract action funded in whole or in part by the PPHF, the contracting officer shall indicate that the contract action is being made under the PPHF, and indicate which products or services are funded under the PPHF. This requirement applies whenever PPHF funds are used, regardless of the contract instrument.
(b) To maximize transparency of PPHF funds that shall be reported by the contractor, the contracting officer shall structure contract awards to allow for separately tracking PPHF funds. For example, the contracting officer may consider awarding dedicated separate contracts when using PPHF funds or establishing contract line item number structures to prevent commingling of PPHF funds with other funds.
To maximize transparency of PPHF funds that shall be reported by the contractor, the contracting officer shall structure contract awards to allow for separately tracking PPHF funds. For example, the contracting officer may consider awarding dedicated separate contracts when using PPHF funds or establishing contract line item number structures to prevent commingling of PPHF funds with other funds.
(c) Contracting officers shall ensure that the contractor complies with the reporting requirements of 352.204-70, Prevention and Public Health Fund—Reporting Requirements. Upon receipt of each report, the contracting officer shall review it for completeness, address http://www.hhs.gov/open/recordsandreports/prevention/index.html no later than 30 days after the end of the reporting period. If the contractor fails to comply with the reporting requirements, the contracting officer shall exercise appropriate contractual remedies.
(d) The contracting officer shall make the contractor's failure to comply with the reporting requirements a part of the contractor's performance information under FAR subpart 42.15.

304.7202 Contract clause. Insert the clause at 352.204-70, Prevention and Public Health Fund—Reporting Requirements, in all solicitations and contract actions funded in whole or in part with PPHF funds, except classified solicitations and contracts. This includes, but is not limited to, awarding or modifying orders against existing or new contracts issued under FAR subparts 8.4 and 16.5 that will be funded with PPHF funds. Contracting officers shall include this clause in any existing contract or order that will be funded with PPHF funds. This clause is not required for any contract or order which contains a prior version of the clause at 352.204-70.

SUBCHAPTER B—COMPETITION AND ACQUISITION PLANNING
PART 305—PUBLICIZING CONTRACT ACTIONS
Subpart 305.3—Synopses of Contract Awards
Sec. 305.303 Announcement of contract awards. Subpart 305.5—Paid Advertisements
305.502 Authority
r order that will be funded with PPHF funds. This clause is not required for any contract or order which contains a prior version of the clause at 352.204-70.

SUBCHAPTER B—COMPETITION AND ACQUISITION PLANNING
PART 305—PUBLICIZING CONTRACT ACTIONS
Subpart 305.3—Synopses of Contract Awards
Sec. 305.303 Announcement of contract awards. Subpart 305.5—Paid Advertisements
305.502 Authority. Subpart 305.70—Publicizing Requirements Funded From the Affordable Care Act Prevention and Public Health Fund
305.7001 Scope. 305.7002 Applicability. 305.7003 Publicizing preaward. 305.7004 Publicizing postaward. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 305.3—Synopses of Contract Awards
305.303 Announcement of contract awards. (a) Public announcement. The contracting officer shall report awards, not exempt under Federal Acquisition Regulation (FAR) 5.303, to the Office of the Assistant Secretary for Legislation (Congressional Liaison Office.)

Subpart 305.5—Paid Advertisements
305.502 Authority. Written approval at least one level above the contracting officer shall be obtained prior to placing advertisements or notices in newspapers.

Subpart 305.70—Publicizing Requirements Funded From the Affordable Care Act Prevention and Public Health Fund
305.7001 Scope. Pursuant to appropriations acts, this subpart prescribes requirements for posting presolicitation and award notices for actions funded in whole or in part from the Prevention and Public Health Fund (PPHF). The requirements of this subpart enhance transparency to the public.

305.7002 Applicability. This subpart applies to all actions funded in whole or in part by the PPHF.

305.7003 Publicizing preaward. Notices of all proposed contract actions, funded in whole or in part by the PPHF, shall be identified on HHS' Prevention and Public Health Fund Web site at http://www.hhs.gov/open/recordsandreports/prevention/index.html no later than 1 day after issuance of the solicitation or other request for proposal or quotation document
unded in whole or in part by the PPHF.

305.7003 Publicizing preaward. Notices of all proposed contract actions, funded in whole or in part by the PPHF, shall be identified on HHS' Prevention and Public Health Fund Web site at http://www.hhs.gov/open/recordsandreports/prevention/index.html no later than 1 day after issuance of the solicitation or other request for proposal or quotation document. When applicable, the notice shall provide a link to the full text; for example, a link to the FedBizOpps notice required by FAR 5.201.

305.7004 Publicizing postaward. Notices of contract actions exceeding $25,000, funded in whole or in part by the PPHF, shall be identified on HHS' PPHF Web site at http://www.hhs.gov/open/recordsandreports/prevention/index.html no later than 5 days after the contract action occurs.

PART 306—COMPETITION REQUIREMENTS
Subpart 306.2—Full and Open Competition After Exclusion of Sources
Sec. 306.202 Establishing or maintaining alternative sources. Subpart 306.3—Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open competition. 306.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. 306.302-7 Public interest. Subpart 306.5—Competition Advocates
306.501 Requirement. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 306.2—Full and Open Competition after Exclusion of Sources
306.202 Establishing or maintaining alternative sources. (a) The reference to the “agency head” in FAR 6.202(a) shall mean the Department Competition Advocate (CA).
satisfy agency requirements. 306.302-7 Public interest. Subpart 306.5—Competition Advocates
306.501 Requirement. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 306.2—Full and Open Competition after Exclusion of Sources
306.202 Establishing or maintaining alternative sources. (a) The reference to the “agency head” in FAR 6.202(a) shall mean the Department Competition Advocate (CA).
(b)(1) The contracting officer shall prepare the required determination and findings (D&F). See FAR 6.202(b)(1) based on the data provided by program personnel. The appropriate CA (non-delegable) shall sign the D&F.

Subpart 306.3—Other Than Full and Open Competition
306.302 Circumstances permitting other than full and open competition.
306.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. See FAR 6.302-1. For acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A), “available from only one responsible source” shall be deemed to mean “available from only one responsible source or only from a limited number of responsible sources”.

306.302-7 Public interest. (a) Authority. (2) Agency head, in this instance, means the Secretary.
(c) Limitations. The contracting officer shall prepare a written request for approval and provide it through appropriate acquisition channels, including the head of the contracting activity and Associate Deputy Assistant Secretary for Acquisition, to the Secretary. The request shall include a D&F for the Secretary's signature that contains all pertinent information to support the justification for using the authority in 41 U.S.C. 3304(a)(7), and a letter for the Secretary's signature notifying Congress of the determination to award a contract under that authority.

Subpart 306.5—Competition Advocates
306.501 Requirement. The Department Competition Advocate for Health and Human Services (HHS) is located in the Division of Acquisition.

PART 307—ACQUISITION PLANNING
Sec. 307.105 Contents of written acquisition plans
4(a)(7), and a letter for the Secretary's signature notifying Congress of the determination to award a contract under that authority.

Subpart 306.5—Competition Advocates
306.501 Requirement. The Department Competition Advocate for Health and Human Services (HHS) is located in the Division of Acquisition.

PART 307—ACQUISITION PLANNING
Sec. 307.105 Contents of written acquisition plans. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
307.105 Contents of written acquisition plans. Federal Acquisition Regulation 7.105 specifies the content requirements for a written Acquisition Plan (AP). The Department of Health and Human Services requires a written AP for all acquisitions above the simplified acquisition threshold.

PART 308—REQUIRED SOURCES OF SUPPLIES AND SERVICES
Subpart 308.4—Federal Supply Schedules
Sec. 308.405-6 Limited source justification and approval. Subpart 308.8—Acquisition of Printing and Related Supplies
308.800 Scope of subpart. 308.801 Definitions. 308.802 Policy. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 308.4—Federal Supply Schedules
308.405-6 Limited source justification and approval. (d)(1) As required by Federal Acquisition Regulation (FAR) 8.405-1 or 8.405-2, the responsible program office must provide a written justification whenever it requests an acquisition under the Federal Supply Service program that restricts consideration of the number of schedule contractors or to an item peculiar to one manufacturer.

Subpart 308.8—Acquisition of Printing and Related Supplies
308.800 Scope of subpart. This subpart provides the Department of Health and Human Services (HHS) policy for the acquisition of Government printing and related supplies. The HHS Office of the Assistant Secretary for Public Affairs is responsible for the review and clearance of print and electronic publications, printing and related supplies, audiovisual products, and communication service contracts. See FAR 8.802 for exceptions.

308.801 Definitions
rtment of Health and Human Services (HHS) policy for the acquisition of Government printing and related supplies. The HHS Office of the Assistant Secretary for Public Affairs is responsible for the review and clearance of print and electronic publications, printing and related supplies, audiovisual products, and communication service contracts. See FAR 8.802 for exceptions.

308.801 Definitions. The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing. The regulations are available at http://www.gpo.gov.

308.802 Policy. In accordance with FAR 8.802(b), the Central Printing and Publications Management Organization at Program Support Center is the HHS designated central printing authority.

308.803 Solicitation provision and contract clause. The contracting officer shall insert the clause at 352.208-70, Printing and Duplication, in all solicitations, contracts, and orders over the simplified acquisition threshold, unless printing or increased duplication is authorized by statute.

PART 309—CONTRACTOR QUALIFICATIONS
Subpart 309.4—Debarment, Suspension, and Ineligibility
Sec. 309.403 Definitions. 309.404 System for Award Management (SAM) exclusions. 309.405 Effect of listing (compelling reason determinations). 309.406 Debarment. 309.406-3 Procedures. 309.407 Suspension. 309.407-3 Procedures. 309.470 Reporting of suspected causes for debarment or suspension or the taking of evasive actions. 309.470-1 Situations where reports are required. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 309.4—Debarment, Suspension, and Ineligibility
309.403 Definitions. The following definitions apply to this subpart:
Acquiring agency's head or designee, as used in this subpart is the head of the contracting activity (HCA)
ses for debarment or suspension or the taking of evasive actions. 309.470-1 Situations where reports are required. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 309.4—Debarment, Suspension, and Ineligibility
309.403 Definitions. The following definitions apply to this subpart:
Acquiring agency's head or designee, as used in this subpart is the head of the contracting activity (HCA). The HCA may make the required justifications or determinations and take the necessary actions specified in FAR 9.405, 9.406, and 9.407, only after obtaining the written approval of the Suspension or Debarment Official, as appropriate.
Suspension and Debarment Official means the Deputy Assistant Secretary for Grants and Acquisition Policy and Accountability.

309.404 System for Award Management (SAM) exclusions. (c) For actions made by HHS pursuant to FAR 9.406 and 9.407, the Office of Recipient Integrity Coordination shall perform the actions required by FAR 9.404(c).

309.405 Effect of listing (compelling reason determinations). (a) The HCA (non-delegable) may, with the written concurrence of the Suspension and Debarment Official, make the determinations referenced in FAR 9.405(a) regarding contracts.
(1) If a contracting officer considers it necessary to award a contract, or consent to a subcontract with a debarred or suspended contractor, the contracting officer shall prepare a determination, including all pertinent documentation, and submit it through appropriate acquisition channels to the HCA. The documentation shall include the date by which approval is required and a compelling reason for the proposed action. Compelling reasons for award of a contract or consent to a subcontract with a debarred or suspended contractor include the following:
officer shall prepare a determination, including all pertinent documentation, and submit it through appropriate acquisition channels to the HCA. The documentation shall include the date by which approval is required and a compelling reason for the proposed action. Compelling reasons for award of a contract or consent to a subcontract with a debarred or suspended contractor include the following:
(i) Only the cited contractor can provide the property or services, and
(ii) The urgency of the requirement dictates that HHS conduct business with the cited contractor.
(2) If the HCA decides to approve the requested action, the HCA shall request the concurrence of the Suspension and Debarment Official and, if given, shall inform the contracting officer in writing of the determination within the required time period.

309.406 Debarment.
309.406-3 Procedures. Refer all matters appropriate for consideration by an agency Suspension and Debarment Official as soon as practicable to the appropriate Suspension and Debarment Official identified in 309.403. Any person may refer a matter to the Suspension and Debarment Official.

309.407 Suspension.
309.407-3 Procedures. Refer all matters appropriate for consideration by an agency Suspension and Debarment Official as soon as practicable to the appropriate Suspension and Debarment Official identified in 309.403. Any person may refer a matter to the Suspension and Debarment Official.

309.470 Reporting of suspected causes for debarment or suspension or the taking of evasive actions.
309.470-1 Situations where reports are required. The contracting officer shall report to the HCA and the Associate Deputy Assistant Secretary for Acquisition whenever the contracting officer—
(a) Knows or suspects that a contractor is committing or has committed any of the acts described in FAR 9.406-2 or 9.407-2; or
spected causes for debarment or suspension or the taking of evasive actions.
309.470-1 Situations where reports are required. The contracting officer shall report to the HCA and the Associate Deputy Assistant Secretary for Acquisition whenever the contracting officer—
(a) Knows or suspects that a contractor is committing or has committed any of the acts described in FAR 9.406-2 or 9.407-2; or
(b) Suspects a contractor is attempting to evade the prohibitions of debarment or suspension imposed under FAR 9.405, or any other comparable regulation, by changes of address,

PART 310—MARKET RESEARCH
Sec. 310.001 Policy. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
310.001 Policy. The HHS contracting offices shall conduct market research as prescribed in Federal Acquisition Regulation part 10.

PART 311—DESCRIBING AGENCY NEEDS
Subpart 311.70—Section 508 Accessibility Standards
Sec. 311.7000 Defining electronic information technology Requirements (see part 339). Subpart 311.71—Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities
311.7100 Policy. 311.7101 Responsibilities. 311.7102 Contract clause. Subpart 311.72—Conference Funding and Sponsorship
311.7200 Policy. 311.7201 Funding and sponsorship. 311.7202 Contract clause. Subpart 311.73—Contractor Collection of Information
311.7300 Policy. 311.7301 Contract clause. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
Subpart 311.70—Section 508 Accessibility Standards
311.7000 Defining electronic and information technology requirements (see part 339). The contracting officer shall ensure that requiring activities specify agency needs for electronic and information technology (EIT) supplies and services, and document market research document EIT requirements, and identify the applicable Section 508 accessibility standards. See FAR 11.002(f) and subpart 39.2.

Subpart 311.71—Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities
311.7100 Policy
ensure that requiring activities specify agency needs for electronic and information technology (EIT) supplies and services, and document market research document EIT requirements, and identify the applicable Section 508 accessibility standards. See FAR 11.002(f) and subpart 39.2.

Subpart 311.71—Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities
311.7100 Policy. (a) It is HHS policy that all meetings, conferences, and seminars be accessible to persons with disabilities. For the purpose of this policy, accessibility is defined as both physical access to meeting, conference, and seminar sites, and access to aids and services enabling individuals with sensory disabilities to fully participate in meetings, conferences, and seminars.
(b) This policy applies to all contracts requiring contractors to conduct meetings, conferences, or seminars open to the public or involving HHS personnel, but not ad hoc meetings necessary or incidental to contract performance.

311.7101 Responsibilities. (a) The contractor shall submit a plan assuring that any meeting, conference, or seminar held will meet or exceed the minimum accessibility standards set forth in 28 CFR part 36.
(b) The contracting officer representative (COR) shall obtain, review, and approve the contractor's plan submitted in response to paragraph (a) of the contract clause at 352.211-1, Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities; a consolidated or master plan for contracts requiring numerous meetings, conferences, or seminars is acceptable. Prior to approving the plan, the COR shall consult with the operating division (OPDIV) or other designated organization responsible for monitoring compliance with the Architectural Barriers Act of 1968 and the Americans with Disabilities Act of 1990, to ensure that the contractor's plan meets the accessibility requirements of the contract clause
us meetings, conferences, or seminars is acceptable. Prior to approving the plan, the COR shall consult with the operating division (OPDIV) or other designated organization responsible for monitoring compliance with the Architectural Barriers Act of 1968 and the Americans with Disabilities Act of 1990, to ensure that the contractor's plan meets the accessibility requirements of the contract clause. The COR shall request the responsible organization review and determine the adequacy of the contractor's plan, and respond to the COR, in writing, within 10 working days of receiving the request.

311.7102 Contract clause. The contracting officer shall insert the clause at 352.211-1, Accessibility of Meetings, Conferences, and Seminars to Persons with Disabilities, in solicitations, contracts, and orders requiring the contractor to conduct meetings, conferences, or seminars in accordance with 311.7100(b).

Subpart 311.72—Conference Funding and Sponsorship
311.7200 Policy. HHS policy requires that all conferences the agency funds or sponsors shall: be consistent with HHS missions, objectives, and policies; represent an efficient and effective use of taxpayer funds; and withstand public scrutiny.

311.7201 Funding and sponsorship. Funding a conference through a HHS contract does not automatically imply HHS sponsorship, unless the conference is funded entirely by the agency. Also, HHS staff attendance or participation at a conference does not imply HHS conference sponsorship. Accordingly, for non-conference contracts funded entirely by HHS prior to a contractor claiming HHS sponsorship, the contractor must provide the contracting officer a written request for permission to designate HHS the conference sponsor. The OPDIV or STAFFDIV (operating division or staff division) head, or designee, shall approve such requests. The determination on what constitutes a “conference contract” or a “non-conference contract” shall be made by the contracting officer.

311.7202 Contract clause
, the contractor must provide the contracting officer a written request for permission to designate HHS the conference sponsor. The OPDIV or STAFFDIV (operating division or staff division) head, or designee, shall approve such requests. The determination on what constitutes a “conference contract” or a “non-conference contract” shall be made by the contracting officer.

311.7202 Contract clause. To ensure that a contractor:
(a) Properly requests approval to designate HHS the conference sponsor, where HHS is not the sole provider of conference funding; and
(b) Includes an appropriate Federal funding disclosure and content disclaimer statement for conference materials, the contracting officer shall include the clause at 352.211-2, Conference Sponsorship Request and Conference Materials Disclaimer, in solicitations, contracts, and orders providing funding which partially or fully supports a conference.

Subpart 311.73—Contractor Collection of Information
311.7300 Policy. In accordance with the Paperwork Reduction Act (PRA), contractors shall not proceed with collecting information from surveys, questionnaires, or interviews until the COR obtains an Office of Management and Budget clearance and the contracting officer issues written approval to proceed. For any contract involving a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties, the contracting officer must comply with the PRA of 1995 (44 U.S.C. 3501 et seq. ).

311.7301 Contract clause. The contracting officer shall insert the clause at 352.211-3, Paperwork Reduction Act, in solicitations, contracts, and orders that require a contractor to collect the same information from 10 or more persons.

PART 312—ACQUISITION OF COMMERCIAL ITEMS
Subpart 312.1—Acquisition of Commercial Items—General
Sec
ply with the PRA of 1995 (44 U.S.C. 3501 et seq. ).

311.7301 Contract clause. The contracting officer shall insert the clause at 352.211-3, Paperwork Reduction Act, in solicitations, contracts, and orders that require a contractor to collect the same information from 10 or more persons.

PART 312—ACQUISITION OF COMMERCIAL ITEMS
Subpart 312.1—Acquisition of Commercial Items—General
Sec. 312.101 Policy. Subpart 312.2—Special Requirements for the Acquisition of Commercial Items
312.202(d) Market research and description of agency need. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 312.1—Acquisition of Commercial Items—General
312.101 Policy. Contracting offices shall use the HHS Strategic Sourcing Program to the maximum extent possible. See HHSAR part 307 (Acquisition Planning).

Subpart 312.2—Special Requirements for the Acquisition of Commercial Items
312.202(d) Market research and description of agency need. Whenever a requiring activity specifies electronic and information technology (EIT) supplies and services subject to Section 508 of the Rehabilitation Act of 1973, as amended, the requiring activity shall acquire commercially available supplies and services to the maximum extent possible while ensuring Section 508 compliance. See part 339.

SUBCHAPTER C—CONTRACTING METHODS AND CONTRACT TYPES
PART 313—SIMPLIFIED ACQUISITION PROCEDURES
Sec. 313.003 Policy. Subpart 313.3—Simplified Acquisition Methods
313.301 Government-wide commercial purchase card. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).
313.003 Policy. Electronic and information technology (EIT) supplies and services acquired pursuant to Federal Acquisition Regulation part 13 shall comply with Section 508 of the Rehabilitation Act of 1973, as amended. See part 339.

Subpart 313.3—Simplified Acquisition Methods
313.301 Government-wide commercial purchase card. (b) Make all HHS transactions utilizing the Government-wide commercial purchase card in accordance with the HHS Purchase Card Program
s and services acquired pursuant to Federal Acquisition Regulation part 13 shall comply with Section 508 of the Rehabilitation Act of 1973, as amended. See part 339.

Subpart 313.3—Simplified Acquisition Methods
313.301 Government-wide commercial purchase card. (b) Make all HHS transactions utilizing the Government-wide commercial purchase card in accordance with the HHS Purchase Card Program.
PART 314—SEALED BIDDING Subpart 314.1—Use of Sealed Bidding
Sec. 314.103 Policy. Subpart 314.4—Opening of Bids and Award of Contract
314.404 Rejection of bids. 314.404-1 Cancellation of invitations after opening. 314.407 Mistakes in bids. 314.407-3 Other mistakes disclosed before award. 314.407-4 Mistakes after award. Authority:
5 U.S.C. 301; 40 U.S.C. 121(c)(2).

Subpart 314.1—Use of Sealed Bidding
314.103 Policy. Electronic and information technology (EIT) supplies and services acquired using sealed-bid procedures shall comply with Section 508 of the Rehabilitation Act of 1973, as amended. See part 339.

Subpart 314.4—Opening of Bids and Award of Contract
314.404 Rejection of bids.
314.404-1 Cancellation of invitations after opening. (c) The head of the contracting activity (HCA) shall make the agency head determinations specified in FAR 14.404-1.

314.407 Mistakes in bids.
314.407-3 Other mistakes disclosed before award. (e) The HCA has the authority to make determinations under paragraphs (a), (b), (c), and (d) of FAR 14.407-3.

314.407-4 Mistakes after award. (c) The HCA has the authority to make administrative determinations in connection with alleged post-award mistakes.

PART 315—CONTRACTING BY NEGOTIATION
Subpart 315.2—Solicitation and Receipt of Proposals and Information
Sec. 315.204-5 Part IV—Representations and instructions. 315.208 Submission, modification, revision, and with

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2015-03391. Check the current official text before relying on it. Not legal advice.