# 75 FR 79763: Regulatory Agenda > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_2010-30444 ## Section - **Citation:** 75 FR 79763 - **Heading:** Regulatory Agenda - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Federal Register / Vol. 75 / 75 FR 79763 ## Text Part VIII Department of Health and Human Services ----------------------------------------------------------------------- ###Semiannual Regulatory Agenda### DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) _______________________________________________________________________ DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 21 CFR Ch. I 42 CFR Chs. I-V 45 CFR Subtitle A; Subtitle B, Chs. II, III, and XIII Regulatory Agenda AGENCY: Office of the Secretary, HHS. ACTION: Semiannual Regulatory Agenda. _______________________________________________________________________ SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semi-annual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review. FOR FURTHER INFORMATION CONTACT: Dawn L. Smalls, Executive Secretary, Department of Health and Human Services, Washington, DC 20201. SUPPLEMENTARY INFORMATION: The information provided in the Agenda presents a forecast of the rulemaking activities that the Department of Health and Human Services (HHS) expects to undertake in the foreseeable future. Rulemakings are grouped according to pre-rulemaking actions, proposed rules, final rules, long-term actions, and rulemaking actions completed since the Spring 2009 Agenda was published. Please note that the rulemaking abstracts included in this paper issue of the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Department's submission to the Fiscal Year 2011 Regulatory Plan, as required under Executive Order 12866. paper issue of the Federal Register relate strictly to those prospective rulemakings that are likely to have a significant economic impact on a substantial number of small entities, as required by the Regulatory Flexibility Act of 1980. Also available in this issue of the Register is the Department's submission to the Fiscal Year 2011 Regulatory Plan, as required under Executive Order 12866. The purpose of the Agenda is to encourage more effective public participation in the regulatory process, and HHS invites all interested members of the public to comment on the rulemaking actions included in this issuance of the Agenda. The complete Regulatory Agenda of the Department is accessible online at www.reginfo.gov in an interactive format that offers users enhanced capabilities to obtain information from the Agenda's database. Dated: September 21, 2010. Dawn L. Smalls, Executive Secretary, Department of Health and Human Services. Office of the Secretary--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 302 Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money 0991-AB03 Penalties and Assessments (Section 610 Review)........................................ ---------------------------------------------------------------------------------------------------------------- ----------------------------------------------------------------------------------------------------------- 302 Revisions to Regulations Addressing the OIG's Authority To Impose Civil Money 0991-AB03 Penalties and Assessments (Section 610 Review)........................................ ---------------------------------------------------------------------------------------------------------------- Office of the Secretary--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 303 Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health 0991-AB57 Information Technology for Economic and Clinical Health Act (Reg Plan Seq No. 41)..... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Office of the Secretary--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 304 Health Information Technology: Initial Set of Standards, Implementation 0991-AB58 Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review)...................................... ---------------------------------------------------------------------------------------------------------------- ----------------------------- 304 Health Information Technology: Initial Set of Standards, Implementation 0991-AB58 Specifications, and Certification Criteria for Electronic Health Record Technology (Rulemaking Resulting From a Section 610 Review)...................................... ---------------------------------------------------------------------------------------------------------------- Substance Abuse and Mental Health Services Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 305 Requirements Governing the Use of Seclusion and Restraint in Certain Nonmedical 0930-AA10 Community-Based Facilities for Children and Youth..................................... 306 Opioid Drugs in Maintenance or Detoxification Treatment of Opiate Addiction (Section 0930-AA14 610 Review)........................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 307 Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman 0920-AA23 Primate............................................................................... ---------------------------------------------------------------------------------------------------------------- --------------------------------------------------------------------------------------------------------- 307 Control of Communicable Diseases: Foreign and Possessions Regulations; Nonhuman 0920-AA23 Primate............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 308 Control of Communicable Diseases: Foreign and Possessions............................. 0920-AA12 309 Possession, Use, and Transfer of Select Agents and Toxins: Chapare Virus (Section 610 0920-AA32 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Disease Control and Prevention--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 310 Quality Assurance Requirements for Respirators........................................ 0920-AA04 ---------------------------------------------------------------------------------------------------------------- ------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 310 Quality Assurance Requirements for Respirators........................................ 0920-AA04 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Prerule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 311 Food Labeling: Safe Handling Statements, Labeling of Shell Eggs; Refrigeration of 0910-AG06 Shell Eggs Held for Retail Distribution (Section 610 Review).......................... ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 312 Electronic Submission of Data From Studies Evaluating Human Drugs and Biologics (Reg 0910-AC52 Plan Seq No. 45)...................................................................... 313 Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products............... 0910-AF31 314 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 315 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 316 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 317 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products.............. 10-AF31 314 Over-the-Counter (OTC) Drug Review--Internal Analgesic Products....................... 0910-AF36 315 Over-the-Counter (OTC) Drug Review--Laxative Drug Products............................ 0910-AF38 316 Over-the-Counter (OTC) Drug Review--Sunscreen Products................................ 0910-AF43 317 Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products............... 0910-AF69 318 Import Tolerances for Residues of Unapproved New Animal Drugs in Food................. 0910-AF78 319 Laser Products; Amendment to Performance Standard..................................... 0910-AF87 320 Pet Food Labeling Requirements........................................................ 0910-AG09 321 Process Controls for Animal Feed Ingredients and Mixed Animal Feed.................... 0910-AG10 322 Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products.......... 0910-AG12 323 Electronic Distribution of Content of Labeling for Human Prescription Drug and 0910-AG18 Biological Products................................................................... 324 Unique Device Identification (Reg Plan Seq No. 46).................................... 0910-AG31 325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act............... 0910-AG38 326 Cigarette Warning Label Statements (Reg Plan Seq No. 47).............................. 0910-AG41 327 General Hospital and Personal Use Devices: Designation of Special Controls for 0910-AG54 Infusion Pumps........................................................................ 328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 0910-AG56 48)................................................................................... 329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg 0910-AG57 Plan Seq No. 49)..................................................................... ............................ 328 Food Labeling: Nutrition Labeling for Food Sold in Vending Machines (Reg Plan Seq No. 0910-AG56 48)................................................................................... 329 Food Labeling: Nutrition Labeling of Standard Menu Items in Chain Restaurants (Reg 0910-AG57 Plan Seq No. 49)...................................................................... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 330 Postmarketing Safety Reporting Requirements for Human Drug and Biological Products.... 0910-AA97 331 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. 0910-AC53 332 Content and Format of Labeling for Human Prescription Drugs and Biologics; 0910-AF11 Requirements for Pregnancy and Lactation Labeling..................................... 333 Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; 0910-AF27 Notification Requirements; Records and Reports; and Quality Factors (Reg Plan Seq No. 50)................................................................................... 334 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 335 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 336 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 337 Over-the-Counter (OTC) Drug Review--Skin Protectant Products......................... ....... 334 Over-the-Counter (OTC) Drug Review--Cough/Cold (Bronchodilator) Products.............. 0910-AF32 335 Over-the-Counter (OTC) Drug Review--Cough/Cold (Combination) Products................. 0910-AF33 336 Over-the-Counter (OTC) Drug Review--External Analgesic Products....................... 0910-AF35 337 Over-the-Counter (OTC) Drug Review--Skin Protectant Products.......................... 0910-AF42 338 Use of Materials Derived From Cattle in Human Food and Cosmetics...................... 0910-AF47 339 Label Requirement for Food That Has Been Refused Admission Into the United States..... 0910-AF61 ---------------------------------------------------------------------------------------------------------------- References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Food and Drug Administration--Long-Term Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 340 Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding 0910-AB88 Operations for Dietary Supplements.................................................... 341 Over-the-Counter (OTC) Drug Review--Cough/Cold (Nasal Decongestant) Products.......... 0910-AF34 342 Over-the-Counter (OTC) Drug Review--Labeling of Drug Products for OTC Human Use....... 0910-AF37 343 Over-the-Counter (OTC) Drug Review--Ophthalmic Products............................... 0910-AF39 344 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 345 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 346 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 347 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products........ 10-AF39 344 Over-the-Counter (OTC) Drug Review--Oral Health Care Products......................... 0910-AF40 345 Over-the-Counter (OTC) Drug Review--Vaginal Contraceptive Products.................... 0910-AF44 346 Over-the-Counter (OTC) Drug Review--Weight Control Products........................... 0910-AF45 347 Over-the-Counter (OTC) Drug Review--Overindulgence in Food and Drink Products......... 0910-AF51 348 Over-the-Counter (OTC) Drug Review--Antacid Products.................................. 0910-AF52 349 Over-the-Counter (OTC) Drug Review--Skin Bleaching Products........................... 0910-AF53 350 Over-the-Counter (OTC) Drug Review--Stimulant Drug Products........................... 0910-AF56 351 Over-the-Counter (OTC) Drug Review--Antidiarrheal Drug Products....................... 0910-AF63 352 Over-the-Counter (OTC) Drug Review--Urinary Analgesic Drug Products................... 0910-AF70 353 Over-the-Counter (OTC) Drug Review--Certain Category II Active Ingredients............ 0910-AF95 354 Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; 0910-AG14 Policies, Requirements, and Administrative Procedures (Section 610 Review)............ 355 Produce Safety Regulation............................................................. 0910-AG35 356 Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36 ---------------------------------------------------------------------------------------------------------------- olicies, Requirements, and Administrative Procedures (Section 610 Review)............ 355 Produce Safety Regulation............................................................. 0910-AG35 356 Modernization of the Current Food Good Manufacturing Practices Regulation............. 0910-AG36 ---------------------------------------------------------------------------------------------------------------- Food and Drug Administration--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 357 Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation (Completion 0910-AG25 of a Section 610 Review).............................................................. 358 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco 0910-AG33 To Protect Children and Adolescents................................................... 359 Over-the-Counter Human Drugs; Labeling Requirements (Completion of a Section 610 0910-AG34 Review)............................................................................... ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Proposed Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 360 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... --------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 360 Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-P) (Section 610 0938-AG81 Review)............................................................................... 361 Requirements for Long-Term Care Facilities: Hospice Services (CMS-3140-F) (Section 610 0938-AP32 Review)............................................................................... 362 Influenza Vaccination Standard for Certain Medicare Participating Providers and 0938-AP92 Suppliers(CMS-3213-P)................................................................. 363 Hospital Conditions of Participation: Requirements for Hospital Inpatient Psychiatric 0938-AP97 and Rehabilitation Units Excluded From the Prospective Payment System and LTCH Requirements (CMS-3177-P)............................................................. 364 Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care 0938-AQ24 Hospitals and FY 2012 Rates and to the Long-Term Care Hospital PPS and RY 2012 Rates (CMS-1518-P) (Reg Plan Seq No. 55).................................................... 365 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AQ26 Center Payment System for CY 2012 (CMS-1525-P) (Reg Plan Seq No. 57).................. 366 Changes to the ESRD Prospective Payment System for CY 2012 (CMS-1577-P)............... 0938-AQ27 367 Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS- 0938-AQ53 2346-P)............................................................................... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Federal Funding for Medicaid Eligibility Determination and Enrollment Activities (CMS- 0938-AQ53 2346-P)............................................................................... ---------------------------------------------------------------------------------------------------------------- References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. Centers for Medicare & Medicaid Services--Final Rule Stage ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 368 Revisions to Payment Policies Under the Physician Fee Schedule and Part B for CY 2011 0938-AP79 (CMS-1503-C).......................................................................... 369 Changes to the Hospital Outpatient Prospective Payment System and Ambulatory Surgical 0938-AP82 Center Payment System for CY 2011 (CMS-1504-C)........................................ ---------------------------------------------------------------------------------------------------------------- Centers for Medicare & Medicaid Services--Completed Actions ---------------------------------------------------------------------------------------------------------------- Regulation Sequence Title Identifier Number Number ---------------------------------------------------------------------------------------------------------------- 370 Revisions to the Medicare Advantage and Medicare Prescription Drug Benefit Programs 0938-AP77 for Contract Year 2011 (CMS-4085-F)................................................... 371 Electronic Health Record (EHR) Incentive Program (CMS-0033-F)......................... 0938-AP78 372 Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital 0938-AP80 Prospective Payment System........................................................... enefit Programs 0938-AP77 for Contract Year 2011 (CMS-4085-F)................................................... 371 Electronic Health Record (EHR) Incentive Program (CMS-0033-F)......................... 0938-AP78 372 Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital 0938-AP80 Prospective Payment System............................................................ 373 Hospital IPPS for Acute Care Hospitals and Fiscal Year 2010 Rates and to the Long-Term 0938-AQ03 Care Hospital PPS and Rate Year 2010 Rates (CMS-1406-N)............................... ---------------------------------------------------------------------------------------------------------------- _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 302. REVISIONS TO REGULATIONS ADDRESSING THE OIG'S AUTHORITY TO IMPOSE CIVIL MONEY PENALTIES AND ASSESSMENTS (SECTION 610 REVIEW) Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 USC 1396b; PL 99-660; PL 107-188 Abstract: This proposed rule would revise part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; clarify the availability of exclusion for certain violations in addition to civil money penalties and assessments; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e mail communications. gories of violations; clarify the availability of exclusion for certain violations in addition to civil money penalties and assessments; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e mail communications. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: No Agency Contact: Patrice S. Drew, Department of Health and Human Services, Office of the Secretary, Office of the Inspector General, 330 Independence Avenue SW., Washington, DC 20201 Phone: 202 619-1368 Email: [email protected] RIN: 0991-AB03 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Office of the Secretary (OS) _______________________________________________________________________ 303. MODIFICATIONS TO THE HIPAA PRIVACY, SECURITY, AND ENFORCEMENT RULES UNDER THE HEALTH INFORMATION TECHNOLOGY FOR ECONOMIC AND CLINICAL HEALTH ACT Regulatory Plan: This entry is Seq. No. 41 in part II of this issue of the Federal Register. RIN: 0991-AB57 _______________________________________________________________________ Department of Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 304. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Legal Authority: 42 USC 300jj-14 Health and Human Services (HHS) Completed Actions Office of the Secretary (OS) _______________________________________________________________________ 304. HEALTH INFORMATION TECHNOLOGY: INITIAL SET OF STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA FOR ELECTRONIC HEALTH RECORD TECHNOLOGY (RULEMAKING RESULTING FROM A SECTION 610 REVIEW) Legal Authority: 42 USC 300jj-14 Abstract: The Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology, will issue an interim final rule with a request for comments to adopt an initial set of standards, implementation specifications, and certification criteria, as required by section 3004(b)(1) of the Public Health Service Act. The certification criteria adopted in this initial set establish the technical capabilities and related standards that certified electronic health record (EHR) technology will need to include in support of the Medicare and Medicaid EHR Incentive Programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Interim Final Rule 01/13/10 75 FR 2014 Interim Final Rule Comment Period End 03/15/10 Interim Final Rule Effective 02/12/10 Final Action 07/28/10 75 FR 44590 Regulatory Flexibility Analysis Required: No Agency Contact: Steven Posnack, Policy Analyst, Department of Health and Human Services, Office of the Secretary, Office of the National Coordinator for Health Information Technology, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 690-7151 RIN: 0991-AB58 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ for Health Information Technology, 200 Independence Avenue SW., Washington, DC 20201 Phone: 202 690-7151 RIN: 0991-AB58 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Substance Abuse and Mental Health Services Administration (SAMHSA) _______________________________________________________________________ 305. REQUIREMENTS GOVERNING THE USE OF SECLUSION AND RESTRAINT IN CERTAIN NONMEDICAL COMMUNITY-BASED FACILITIES FOR CHILDREN AND YOUTH Legal Authority: PL 106-310, 42 USC 290jj to 290jj-2 Abstract: The Secretary is required by statute to publish regulations governing States that license nonmedical, community-based residential facilities for children and youth. The regulation requires States to develop licensing rules and monitoring requirements concerning behavior management practice that will ensure compliance; requires States to develop and implement such licensing rules and implementation requirements within one year; and ensures that States require such facilities to have adequate staff, and that the States provide training for professional staff. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Paolo Del Vecchio, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Room 13-103, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 _______________________________________________________________________ 306. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDICTION (SECTION 610 REVIEW) Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11 arklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone: 301 443-2619 RIN: 0930-AA10 _______________________________________________________________________ 306. OPIOID DRUGS IN MAINTENANCE OR DETOXIFICATION TREATMENT OF OPIATE ADDICTION (SECTION 610 REVIEW) Legal Authority: 21 USC 823 (9); 42 USC 257a; 42 USC 290aa(d); 42 USC 290dd-2; 42 USC 300xx-23; 42 USC 300x-27(a); 42 USC 300y-11 Abstract: This rule will amend the Federal opioid treatment program regulations. It will modify the dispensing requirements for buprenorphine and buprenorphine combination products that are approved by the Food and Drug Administration (FDA) for opioid dependence and used in federally certified and registered opioid treatment programs. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/09 74 FR 29153 NPRM Comment Period End 08/18/09 Final Action To Be Determined Regulatory Flexibility Analysis Required: No Agency Contact: Nicholas Reuter, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Suite 2-1063, One Choke Cherry Road, Rockville, MD 20857 Phone: 240 276-2716 RIN: 0930-AA14 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 307. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS REGULATIONS; NONHUMAN PRIMATE Legal Authority: 42 USC 264 RIN: 0930-AA14 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 307. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS REGULATIONS; NONHUMAN PRIMATE Legal Authority: 42 USC 264 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. The Secretary has delegated the authority to prevent the introduction of diseases from foreign countries to the Director, CDC. CDC also enforces entry requirements for certain animals, etiologic agents, and vectors deemed to be of public health significance. CDC is proposing to amend its regulations related to the importation of live nonhuman primates (NHPs) by extending existing requirements for the importation of cynomolgus, African green, and rhesus monkeys to all NHPs. The agency also is proposing to reduce the frequency at which importers of the three species are required to renew their registrations, (from every 180 days to every two years). CDC proposes to incorporate existing guidelines into the regulations and add new provisions to address NHPs imported as part of a circus or trained animal act, NHPs imported by zoological societies, the transfer of NHPs from approved laboratories, and non- live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/11 Regulatory Flexibility Analysis Required: Yes and non- live imported NHP products. CDC is also proposing that all NHPs be imported only through ports of entry where a CDC quarantine station is located. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 01/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA23 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 308. CONTROL OF COMMUNICABLE DISEASES: FOREIGN AND POSSESSIONS Legal Authority: 42 USC 243; 42 USC 264 and 265; 42 USC 267 and 268; 42 USC 270 and 271 Abstract: By statute, the Secretary of Health and Human Services has broad authority to prevent introduction, transmission, and spread of communicable diseases from foreign countries into the United States and from one State or possession into another. Communicable disease regulations are divided into two parts: Part 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 71) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease 71 pertaining to foreign arrivals and part 70 pertaining to interstate matters. This rule (42 CFR Part 71) will update and improve CDC's response to both global and domestic disease threats by creating a multi-tiered illness detection and response process thus substantially enhancing the public health system's ability to slow the introduction, transmission, and spread of communicable disease. The final rule focuses primarily on requirements relating to the reporting of deaths and illnesses onboard aircrafts and ships, and the collection of specific traveler contact information for the purpose of CDC contacting travelers in the event of an exposure to a communicable disease. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 11/30/05 70 FR 71892 NPRM Comment Period End 01/20/06 Final Action 12/00/10 Regulatory Flexibility Analysis Required: Yes Agency Contact: Stacy Howard, Department of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA12 _______________________________________________________________________ 309. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE VIRUS (SECTION 610 REVIEW) Legal Authority: PL 107-188 rtment of Health and Human Services, Centers for Disease Control and Prevention, MS E03, CLFT Building 16, Room 4324, Atlanta, GA 30329 Phone: 404 498-1600 Email: [email protected] RIN: 0920-AA12 _______________________________________________________________________ 309. POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS: CHAPARE VIRUS (SECTION 610 REVIEW) Legal Authority: PL 107-188 Abstract: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 authorizes the HHS Secretary to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. These regulations are set forth at 42 CFR 73. Criteria used to determine whether a select agent or toxin should be included under the provisions of these regulations are based on: (1) The effect on human health as a result of exposure to the agent or toxin, (2) the degree of contagiousness of the agent or toxin, (3) the methods by which the agent or toxin is transferred to humans, (4) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent and illness resulting from infection by the agent or toxin, and (5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After s of pharmacotherapies and immunizations to treat and prevent and illness resulting from infection by the agent or toxin, and (5) any other criteria, including the needs of children and other vulnerable populations that the HHS Secretary considers appropriate. Based on these criteria, we are proposing to amend the list of HHS select agents and toxins by adding Chapare virus to the list. After consulting with subject matter experts from CDC, the National Institutes of Health (NIH), the Food Drug Administration (FDA), the United States Department of Agriculture (USDA) /Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/CVB (Center for Veterinary Biologics), and the Department of Defense (DOD)/United States Army Medical Research Institute for Infectious Diseases (USAMRIID) and review of relevant published studies, we believe the Chapare virus should be added to the list of HHS select agents and toxins based on our conclusion that the Chapare virus has been phylogenetically identified as a Clade B arenavirus and is closely related to other South American arenaviruses that cause haemorrhagic fever, particularly Sabia virus. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/19/09 74 FR 159 NPRM Comment Period End 10/19/09 Final Action 11/00/11 Regulatory Flexibility Analysis Required: No Agency Contact: Robbin Weyant, Department of Health and Human Services, Centers for Disease Control and Prevention, CLFT Building 20, Room 4202, 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 718-2000 RIN: 0920-AA32 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 310. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS oom 4202, 1600 Clifton Road NE., Atlanta, GA 30333 Phone: 404 718-2000 RIN: 0920-AA32 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Centers for Disease Control and Prevention (CDC) _______________________________________________________________________ 310. QUALITY ASSURANCE REQUIREMENTS FOR RESPIRATORS Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 USC 811; 30 USC 842(h); 30 USC 844 Abstract: NIOSH plans to modify the Administrative/Quality Assurance sections of 42 CFR part 84, Approval of Respiratory Protective Devices. Areas for potential modification in this module are: (1) Upgrade of quality assurance requirements; (2) ability to use private sector quality auditors and private sector testing laboratories in the approval program; and (3) revised approval label requirements. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 12/10/08 73 FR 75045 NPRM Comment Period End 02/09/09 NPRM Comment Period Reopened 03/04/09 74 FR 9381 NPRM Comment Period Reopened End04/10/09 NPRM Comment Period Reopening Extended 05/21/09 74 FR 23815 NPRM Comment Period End 10/09/09 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: William E. Newcomb, Physical Scientist, Department of Health and Human Services, Centers for Disease Control and Prevention, 626 Cochran Mill Road, PO Box 18070, Pittsburgh, PA 15236 Phone: 412 386-5200 RIN: 0920-AA04 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 311. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) 20-AA04 _______________________________________________________________________ Department of Health and Human Services (HHS) Prerule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 311. FOOD LABELING: SAFE HANDLING STATEMENTS, LABELING OF SHELL EGGS; REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION (SECTION 610 REVIEW) Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 331; 21 USC 342 and 343; 21 USC 348; 21 USC 371; 42 USC 243; 42 USC 264; 42 USC 271 Abstract: Section 101.17(h) (21 CFR 101.17(h)) describes requirements for the labeling of the cartons of shell eggs that have not been treated to destroy Salmonella microorganisms. Section 115. 50 (21 CFR 115.50) describes requirements for refrigeration of shell eggs held for retail distribution. Section 16.5(a)(4) (21 CFR 16.5(a)(4)) provides that part 16 does not apply to a hearing on an order for relabeling, diversion, or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264) and sections 101.17(h) and 115.50. FDA amended 21 CFR 101.17(h) on August 20, 2007 (72 FR 46375) to permit the safe handling statement to appear on the inside lid of egg cartons to provide the industry greater flexibility in the placement of the statement, provided the words ``keep refrigerated'' appear on the principal display panel or information panel. FDA is undertaking a review of 21 CFR sections 101.17(h), 115.50, and 16.5(a)(4) under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities der section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulations in sections 101.17(h), 115.50 and 16.5(a)(4) should be continued without change, or whether they should be amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize any significant economic impact on a substantial number of small entities. FDA will consider, and is soliciting comments on, the following: (1) The continued need for the rule; (2) the nature of complaints or comments received concerning the rule from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other Federal rules, and, to the extent feasible, with State and local governmental rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Begin Review 12/15/09 End Review 12/00/10 Regulatory Flexibility Analysis Required: Undetermined Agency Contact: Geraldine A. June, Supervisor, Product Evaluation and Labeling Team, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS- 820), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-1802 Fax: 301 436-2636 Email: [email protected] RIN: 0910-AG06 _______________________________________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 312. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. _________________________________________ Department of Health and Human Services (HHS) Proposed Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 312. ELECTRONIC SUBMISSION OF DATA FROM STUDIES EVALUATING HUMAN DRUGS AND BIOLOGICS Regulatory Plan: This entry is Seq. No. 45 in part II of this issue of the Federal Register. RIN: 0910-AC52 _______________________________________________________________________ 313. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (ANTIHISTAMINE) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses antihistamine labeling claims for the common cold. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Reopening of Administrative Record 08/25/00 65 FR 51780 NPRM (Amendment) (Common Cold) 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF31 _______________________________________________________________________ 314. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e O22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF31 _______________________________________________________________________ 314. OVER-THE-COUNTER (OTC) DRUG REVIEW--INTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Required Warnings and Other Labeling) 12/26/06 71 FR 77314 NPRM Comment Period End 05/25/07 Final Action (Required Warnings and Other Labeling) 04/29/09 74 FR 19385 Final Action (Correction) 06/30/09 74 FR 31177 Final Action (Technical Amendment) 11/25/09 74 FR 61512 NPRM (Acetaminophen) 03/00/11 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Sodium Bicarbonate) To Be Determined NPRM (Overindulgence/ Hangover) To Be Determined Final Action (Internal Analgesics) To Be Determined n (Required Warnings and Other Labeling) 04/29/09 74 FR 19385 Final Action (Correction) 06/30/09 74 FR 31177 Final Action (Technical Amendment) 11/25/09 74 FR 61512 NPRM (Acetaminophen) 03/00/11 NPRM (Amendment) (Pediatric) To Be Determined NPRM (Amendment) (Sodium Bicarbonate) To Be Determined NPRM (Overindulgence/ Hangover) To Be Determined Final Action (Internal Analgesics) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF36 _______________________________________________________________________ 315. OVER-THE-COUNTER (OTC) DRUG REVIEW--LAXATIVE DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first NPRM listed will address the professional labeling for sodium phosphate drug products. The second NPRM listed will address all other professional labeling requirements for laxative drug products. The final action will address laxative drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)03/29/07 72 FR 14669 NPRM (Professional Labeling-- Sodium Phosphate) 12/00/10 NPRM (Professional Labeling) To Be Determined Final Action (Laxative Drug Products) To Be Determined Regulatory Flexibility Analysis Required: Yes _____________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Granular Psyllium)03/29/07 72 FR 14669 NPRM (Professional Labeling-- Sodium Phosphate) 12/00/10 NPRM (Professional Labeling) To Be Determined Final Action (Laxative Drug Products) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF38 _______________________________________________________________________ 316. OVER-THE-COUNTER (OTC) DRUG REVIEW--SUNSCREEN PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses active ingredients reviewed under Time and Extent Applications. The second action addresses other safety and effectiveness issues for OTC sunscreen drug products. The third action finalizes sunscreen labeling and testing requirements for both ultraviolet B and ultraviolet A radiation protection. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ultraviolet B and ultraviolet A radiation protection. The fourth action addresses the safety of sunscreen products. The last action addresses combination products containing sunscreen and insect repellent ingredients. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Sunscreen and Insect Repellent) 02/22/07 72 FR 7941 ANPRM Comment Period End 05/23/07 NPRM (UVA/UVB) 08/27/07 72 FR 49070 NPRM Comment Period End 12/26/07 NPRM (Safety and Effectiveness) 12/00/10 Final Action (UVA/UVB) 12/00/10 NPRM (Time and Extent Applications) 04/00/11 ANPRM (Safety) 04/00/11 NPRM (Sunscreen and Insect Repellent) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF43 _______________________________________________________________________ 317. OVER-THE-COUNTER (OTC) DRUG REVIEW--TOPICAL ANTIMICROBIAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, food handlers, and first aid antiseptic drug products respectively. d new drug application, may be legally marketed. The first action addresses food handler products. The second action addresses testing requirements for healthcare professional products. The third action addresses the safety and effectiveness of consumer products. The final actions listed will address the healthcare, consumer, food handlers, and first aid antiseptic drug products respectively. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Healthcare) 06/17/94 59 FR 31402 NPRM (Consumer) 03/00/11 NPRM (Food Handlers) To Be Determined NPRM (Testing -- Healthcare Professional Products) To Be Determined Final Action (Healthcare) To Be Determined Final Action (Consumer) To Be Determined Final Action (Food Handlers) To Be Determined Final Action (First Aid Antiseptic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF69 _______________________________________________________________________ 318. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN FOOD Legal Authority: 21 USC 360b(a)(6); 21 USC 371 d Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF69 _______________________________________________________________________ 318. IMPORT TOLERANCES FOR RESIDUES OF UNAPPROVED NEW ANIMAL DRUGS IN FOOD Legal Authority: 21 USC 360b(a)(6); 21 USC 371 Abstract: The Food and Drug Administration (FDA) plans to publish a proposed rule related to the implementation of the import tolerances provision of the Animal Drug Availability Act of 1996 (ADAA). The ADAA authorizes FDA to establish tolerances for unapproved new animal drugs where edible portions of animals imported into the United States may contain residues of such drugs (import tolerances). It is unlawful to import animal-derived food that bears or contains residues of a new animal drug that is not approved in the United States, unless FDA has established an import tolerance for that new animal drug and the residue of the new animal drug in the animal-derived food does not exceed that tolerance. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Thomas Moskal, Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9242 Fax: 240 276-9241 Email: [email protected] RIN: 0910-AF78 _______________________________________________________________________ 319. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393 d and Drug Administration, Center for Veterinary Medicine, Room 101, (MPN-4, HFV-232), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9242 Fax: 240 276-9241 Email: [email protected] RIN: 0910-AF78 _______________________________________________________________________ 319. LASER PRODUCTS; AMENDMENT TO PERFORMANCE STANDARD Legal Authority: 21 USC 360hh to 360ss; 21 USC 371; 21 USC 393 Abstract: FDA is proposing to amend the performance standard for laser products to achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The proposed amendment is intended to update FDA's performance standard to reflect advancements in technology. The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science. In addition, the proposal would include an alternative mechanism for providing certification and identification, address novelty laser products, and clarify the military exemption for laser products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-6248 Fax: 301 847-8145 Email: [email protected] RIN: 0910-AF87 _______________________________________________________________________ 320. PET FOOD LABELING REQUIREMENTS Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3) Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-6248 Fax: 301 847-8145 Email: [email protected] RIN: 0910-AF87 _______________________________________________________________________ 320. PET FOOD LABELING REQUIREMENTS Legal Authority: 21 USC 343; 21 USC 371; PL 110-85, sec 1002(a)(3) Abstract: The President signed into law the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007 (Pub. L. 110-85). Title X of the FDAAA includes several provisions pertaining to food safety, including the safety of pet food. Section 1002(a) of the new law directs FDA to issue new regulations to establish updated standards for the labeling of pet food that include nutritional and ingredient information. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: William Burkholder, Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855 Phone: 240 453-6865 Email: [email protected] RIN: 0910-AG09 _______________________________________________________________________ 321. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110-85, sec 1002(a)(2) terinary Medicine, Room 2642 (MPN-4, HFV-228), 7519 Standish Place, Rockville, MD 20855 Phone: 240 453-6865 Email: [email protected] RIN: 0910-AG09 _______________________________________________________________________ 321. PROCESS CONTROLS FOR ANIMAL FEED INGREDIENTS AND MIXED ANIMAL FEED Legal Authority: 21 USC 342; 21 USC 350e; 21 USC 371; 21 USC 374; 42 USC 264; PL 110-85, sec 1002(a)(2) Abstract: The Food and Drug Administration (FDA) is proposing regulations for process controls for animal feed ingredients and mixed animal feed to provide greater assurance that marketed animal feed ingredients and mixed feeds intended for all animals, including pets, are safe. This action is being taken as part of the FDA's Animal Feed Safety System initiative. The proposed process controls will apply to animal feed ingredients and mixed animal feed, including pet food. This action is also being taken to carry out the requirements of the Food and Drug Administration Amendments Act of 2007. Section 1002(a) directs FDA to establish by regulation processing standards for pet food. This same provision of the law also directs that, in developing these new regulations, FDA obtain input from its stakeholders, including the Association of American Feed Control Officials, veterinary medical associations, animal health organizations, and pet food manufacturers. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/00/11 NPRM Comment Period End 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9207 Email: [email protected] RIN: 0910-AG10 _______________________________________________________________________ y Analysis Required: Yes Agency Contact: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855 Phone: 240 276-9207 Email: [email protected] RIN: 0910-AG10 _______________________________________________________________________ 322. OVER-THE-COUNTER (OTC) DRUG REVIEW--PEDIATRIC DOSING FOR COUGH/COLD PRODUCTS Legal Authority: 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a monograph is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AG12 _______________________________________________________________________ 323. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 _________________________________________________________ 323. ELECTRONIC DISTRIBUTION OF CONTENT OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: This rule would require electronic package inserts for human drug and biological prescription products, in lieu of paper, which is currently used. These inserts contain prescribing information intended for healthcare practitioners. This would ensure that the information accompanying the product is the most up-to-date information regarding important safety and efficacy issues about these products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Connie T. Jung, Senior Advisor for Pharmacy Affairs, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO32, Room 4254, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-4830 Email: [email protected] RIN: 0910-AG18 _______________________________________________________________________ 324. UNIQUE DEVICE IDENTIFICATION Regulatory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0910-AG31 _______________________________________________________________________ 325. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act tory Plan: This entry is Seq. No. 46 in part II of this issue of the Federal Register. RIN: 0910-AG31 _______________________________________________________________________ 325. CIGARS SUBJECT TO THE FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act; PL 111-31, The Family Smoking Prevention and Tobacco Control Act Abstract: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the Tobacco Control Act. This proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 9200 Corporate Boulevard, Rockville, MD 20850 Phone: 877 287-1373 Fax: 240 276-3904 Email: [email protected] RIN: 0910-AG38 _______________________________________________________________________ 326. CIGARETTE WARNING LABEL STATEMENTS Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910-AG41 _______________________________________________________________________ 327. GENERAL HOSPITAL AND PERSONAL USE DEVICES: DESIGNATION OF SPECIAL CONTROLS FOR INFUSION PUMPS Legal Authority: 21 USC 351 371; 21 USC 360 and 360c; 21 USC 360e and 360j; 21 USC 371 E WARNING LABEL STATEMENTS Regulatory Plan: This entry is Seq. No. 47 in part II of this issue of the Federal Register. RIN: 0910-AG41 _______________________________________________________________________ 327. GENERAL HOSPITAL AND PERSONAL USE DEVICES: DESIGNATION OF SPECIAL CONTROLS FOR INFUSION PUMPS Legal Authority: 21 USC 351 371; 21 USC 360 and 360c; 21 USC 360e and 360j; 21 USC 371 Abstract: Since 2003, FDA has seen a dramatic increase in the number of device recalls, as well as an increase in the number of death and serious injury reports submitted regarding infusion pumps. An analysis of the reports reveals that a majority of the recalls and failures were caused by user error and/or device design flaw. As a result of these incidents, FDA is proposing to designate a special controls guidance document as the special controls for infusion pumps. The agency believes that establishing these special controls for infusion pumps is necessary to provide reasonable assurance of the safety and effectiveness of these devices. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/00/11 NPRM Comment Period End 12/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Nancy Pirt, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-6248 Fax: 301 847-8145 Email: [email protected] RIN: 0910-AG54 _______________________________________________________________________ 328. FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD IN VENDING MACHINES Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910-AG56 _______________________________________________________________________ 1 796-6248 Fax: 301 847-8145 Email: [email protected] RIN: 0910-AG54 _______________________________________________________________________ 328. FOOD LABELING: NUTRITION LABELING FOR FOOD SOLD IN VENDING MACHINES Regulatory Plan: This entry is Seq. No. 48 in part II of this issue of the Federal Register. RIN: 0910-AG56 _______________________________________________________________________ 329. FOOD LABELING: NUTRITION LABELING OF STANDARD MENU ITEMS IN CHAIN RESTAURANTS Regulatory Plan: This entry is Seq. No. 49 in part II of this issue of the Federal Register. RIN: 0910-AG57 _______________________________________________________________________ Department of Health and Human Services (HHS) Final Rule Stage Food and Drug Administration (FDA) _______________________________________________________________________ 330. POSTMARKETING SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262 and 263; 42 USC 263a to 263n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b to 360j; 21 USC 361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381 Abstract: The final rule would amend the postmarketing expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonisation and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to propose other revisions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. isions to these regulations to enhance the quality of safety reports received by FDA. These revisions were proposed as part of a single rulemaking (68 FR 12406) to clarify and revise both premarketing and postmarketing safety reporting requirements for human drug and biological products. FDA plans to finalize the premarket and postmarket safety reporting requirements in separate final rules. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 03/14/03 68 FR 12406 NPRM Comment Period Extended 06/18/03 NPRM Comment Period End 07/14/03 NPRM Comment Period Extension End 10/14/03 Final Action 08/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Jane E. Baluss, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6362, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3469 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AA97 _______________________________________________________________________ 331. MEDICAL GAS CONTAINERS AND CLOSURES; CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS Legal Authority: 21 USC 321; 21 USC 351 to 21 USC 353 Abstract: The Food and Drug Administration is amending its current good manufacturing practice regulations and other regulations to clarify and strengthen requirements for the label, color, dedication, and design of medical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury dical gas containers and closures. Despite existing regulatory requirements and industry standards for medical gases, there have been repeated incidents in which cryogenic containers of harmful industrial gases have been connected to medical oxygen supply systems in hospitals and nursing homes and subsequently administered to patients. These incidents have resulted in death and serious injury. There have also been several incidents involving high-pressure medical gas cylinders that have resulted in death and injuries to patients. These amendments, together with existing regulations, are intended to ensure that the types of incidents that have occurred in the past, as well as other types of foreseeable and potentially deadly medical gas accidents, do not occur in the future. FDA has described a number of proposals in the proposed rule including requiring that gas use outlet connections on portable cryogenic medical gas containers be permanently attached to the valve body. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 04/10/06 71 FR 18039 NPRM Comment Period End 07/10/06 Final Action 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Patrick Raulerson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3522 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AC53 _______________________________________________________________________ 332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Center for Drug Evaluation and Research, WO 51, Room 6368, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-3522 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AC53 _______________________________________________________________________ 332. CONTENT AND FORMAT OF LABELING FOR HUMAN PRESCRIPTION DRUGS AND BIOLOGICS; REQUIREMENTS FOR PREGNANCY AND LACTATION LABELING Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 Abstract: To amend the regulations governing the format and content of labeling for human prescription drugs and biological products (21 CFR parts 201.56, 201.57, and 201.80). Under FDA's current regulations, labeling concerning the use of prescription drugs in pregnancy uses letter categories (A, B, C, D, X) to characterize the risk to the fetus of using the drug in pregnancy. One of the deficiencies of the category system is that drugs may be assigned to the same category when the severity, incidence, and types of risk are quite different. Dissatisfaction with the category system has been expressed by health care providers, medical organizations, experts in the study of birth defects, women's health researchers, and women of childbearing age. Stakeholders consulted through a public hearing, several focus groups, and several advisory committees have recommended that FDA replace the category system with a concise narrative summarizing a product's risks to pregnant women and to women of childbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ldbearing age. Therefore, the revised format and the information provided in the labeling would make it easier for health care providers to understand the risks and benefits of drug use during pregnancy and lactation. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 05/29/08 73 FR 30831 NPRM Comment Period End 08/27/08 Final Action 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Rachel S. Bressler, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation Research, WO 51, Room 6224, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone: 301 796-4288 Fax: 301 847-8440 Email: [email protected] RIN: 0910-AF11 _______________________________________________________________________ 333. INFANT FORMULA: CURRENT GOOD MANUFACTURING PRACTICES; QUALITY CONTROL PROCEDURES; NOTIFICATION REQUIREMENTS; RECORDS AND REPORTS; AND QUALITY FACTORS Regulatory Plan: This entry is Seq. No. 50 in part II of this issue of the Federal Register. RIN: 0910-AF27 _______________________________________________________________________ 334. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (BRONCHODILATOR) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ le) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for single ingredient bronchodilator products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment--Ephedrine Single Ingredient) 07/13/05 70 FR 40237 NPRM Comment Period End 11/10/05 Final Action (Technical Amendment) 11/30/07 72 FR 67639 Final Action (Amendment--Single Ingredient Labeling) 01/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF32 _______________________________________________________________________ 335. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (COMBINATION) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ drug application, may be legally marketed. This action addresses cough/cold drug products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant or any oral nasal decongestant. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 07/13/05 70 FR 40232 NPRM Comment Period End 11/10/05 Final Action (Technical Amendment) 03/19/07 72 FR 12730 Final Action 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF33 _______________________________________________________________________ 336. OVER-THE-COUNTER (OTC) DRUG REVIEW--EXTERNAL ANALGESIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final action addresses the 2003 proposed rule on patches, plasters, and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (GRASE dosage forms) 10/00/11 NPRM (Amendment) To Be Determined Regulatory Flexibility Analysis Required: Yes and poultices. The proposed rule will address issues not addressed in previous rulemakings. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (GRASE dosage forms) 10/00/11 NPRM (Amendment) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF35 _______________________________________________________________________ 337. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN PROTECTANT PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The first action identifies safe and effective skin protectant active ingredients to treat and prevent diaper rash. The second action addresses skin protectant products used to treat fever blisters and cold sores. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Aluminum Acetate) (Technical Amendment) 03/06/09 74 FR 9759 Final Action (Technical Amendments) 02/01/08 73 FR 6014 Final Action (Diaper Rash) 10/00/11 Final Action (Fever Blisters/ Cold Sores) 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug __________________________________ Final Action (Aluminum Acetate) (Technical Amendment) 03/06/09 74 FR 9759 Final Action (Technical Amendments) 02/01/08 73 FR 6014 Final Action (Diaper Rash) 10/00/11 Final Action (Fever Blisters/ Cold Sores) 10/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF42 _______________________________________________________________________ 338. USE OF MATERIALS DERIVED FROM CATTLE IN HUMAN FOOD AND COSMETICS Legal Authority: 21 USC 342; 21 USC 361; 21 USC 371 Abstract: On July 14, 2004, FDA issued an interim final rule (IFR), effective immediately, to prohibit the use of certain cattle material and to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. Prohibited cattle materials under the IFR include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS) beef. Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. This action minimizes human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease rkway, College Park, MD 20740 Phone: 301 436-2131 Fax: 301 436-2644 Email: [email protected] RIN: 0910-AF47 _______________________________________________________________________ 339. LABEL REQUIREMENT FOR FOOD THAT HAS BEEN REFUSED ADMISSION INTO THE UNITED STATES Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 342 and 343; 21 USC 371; 21 USC 374; 21 USC 381; 42 USC 216; 42 USC 264 Abstract: The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, ``UNITED STATES: REFUSED ENTRY.'' The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 09/18/08 73 FR 54106 NPRM Comment Period End 12/02/08 Final Action 03/00/11 Regulatory Flexibility Analysis Required: Yes Agency Contact: Daniel Sigelman, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, WO Building 1, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-4706 Email: [email protected] RIN: 0910-AF61 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 340. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS l protected] RIN: 0910-AF61 _______________________________________________________________________ Department of Health and Human Services (HHS) Long-Term Actions Food and Drug Administration (FDA) _______________________________________________________________________ 340. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264 Abstract: The Food and Drug Administration published a final rule in the Federal Register of June 25, 2007 (72 FR 34752), on current good manufacturing practice (CGMP) regulations for dietary supplements. FDA also published an Interim Final Rule in the same Federal Register (72 FR 34959) that provided a procedure for requesting an exemption from the final rule requirement that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met. This IFR also establishes a requirement for retention of records relating to the FDA's response to an exemption request. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM 02/06/97 62 FR 5700 ANPRM Comment Period End 06/06/97 NPRM 03/13/03 68 FR 12157 NPRM Comment Period End 08/11/03 Final Rule 06/25/07 72 FR 34752 Interim Final Rule 06/25/07 72 FR 34959 Interim Final Rule Comment Period End 10/24/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes e FR Cite ________________________________________________________________________ ANPRM 02/06/97 62 FR 5700 ANPRM Comment Period End 06/06/97 NPRM 03/13/03 68 FR 12157 NPRM Comment Period End 08/11/03 Final Rule 06/25/07 72 FR 34752 Interim Final Rule 06/25/07 72 FR 34959 Interim Final Rule Comment Period End 10/24/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Linda Kahl, Senior Policy Analyst, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-024), 5100 Paint Branch Parkway, College Park, MD 20740 Phone: 301 436-2784 Fax: 301 436-2657 Email: [email protected] RIN: 0910-AB88 _______________________________________________________________________ 341. OVER-THE-COUNTER (OTC) DRUG REVIEW--COUGH/COLD (NASAL DECONGESTANT) PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the ingredient phenylpropanolamine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Sinusitis Claim) 08/02/04 69 FR 46119 NPRM Comment Period End 11/01/04 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 NPRM Comment Period End 01/31/05 NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988 NPRM Comment Period End 03/22/06 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenyl- propanolamine) To Be Determined Regulatory Flexibility Analysis Required: Yes 04 NPRM (Phenylephrine Bitartrate) 11/02/04 69 FR 63482 NPRM Comment Period End 01/31/05 NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988 NPRM Comment Period End 03/22/06 Final Action (Amendment) (Sinusitis Claim) 10/31/05 70 FR 58974 Final Action (Phenylephrine Bitartrate) 08/01/06 71 FR 83358 Final Action (Phenyl- propanolamine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF34 _______________________________________________________________________ 342. OVER-THE-COUNTER (OTC) DRUG REVIEW--LABELING OF DRUG PRODUCTS FOR OTC HUMAN USE Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 UCS 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses labeling for convenience (small) size OTC drug packages. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Convenience Sizes) 12/12/06 71 FR 74474 NPRM Comment Period End 04/11/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] 12/12/06 71 FR 74474 NPRM Comment Period End 04/11/07 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF37 _______________________________________________________________________ 343. OVER-THE-COUNTER (OTC) DRUG REVIEW--OPHTHALMIC PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action finalizes the monograph for emergency first aid eyewash drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Emergency First Aid Eyewashes) 02/19/03 68 FR 7917 Final Action (Amendment) (Emergency First Aid Eyewashes) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF39 _______________________________________________________________________ 344. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF39 _______________________________________________________________________ 344. OVER-THE-COUNTER (OTC) DRUG REVIEW--ORAL HEALTH CARE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360 to 360a; 21 USC 371 to 371a Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM and final action will address oral health care products used to reduce or prevent dental plaque and gingivitis. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ ANPRM (Plaque Gingivitis) 05/29/03 68 FR 32232 ANPRM Comment Period End 08/27/03 NPRM (Plaque Gingivitis) To Be Determined Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF40 _______________________________________________________________________ 345. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e ampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF40 _______________________________________________________________________ 345. OVER-THE-COUNTER (OTC) DRUG REVIEW--VAGINAL CONTRACEPTIVE PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The proposed rule addresses vaginal contraceptive drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Warnings) 12/19/07 72 FR 71769 NPRM (Vaginal Contraceptive Drug Products) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF44 _______________________________________________________________________ 346. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 g Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF44 _______________________________________________________________________ 346. OVER-THE-COUNTER (OTC) DRUG REVIEW--WEIGHT CONTROL PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The NPRM addresses the use of benzocaine for weight control. The first final action finalizes the 2005 proposed rule for weight control products containing phenylpropanolamine. The second final action will finalize the proposed rule for weight control products containing benzocaine. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Phenyl- propanolamine) 12/22/05 70 FR 75988 NPRM Comment Period End 03/22/06 NPRM (Benzocaine) To Be Determined Final Action (Phenyl- propanolamine) To Be Determined Final Action (Benzocaine) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF45 _______________________________________________________________________ 347. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 esearch, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF45 _______________________________________________________________________ 347. OVER-THE-COUNTER (OTC) DRUG REVIEW--OVERINDULGENCE IN FOOD AND DRINK PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses products containing bismuth subsalicylate for relief of symptoms of upset stomach due to overindulgence resulting from food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) 01/05/05 70 FR 741 NPRM Comment Period End 04/05/05 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF51 _______________________________________________________________________ 348. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF51 _______________________________________________________________________ 348. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTACID PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses the labeling of products containing sodium bicarbonate as an active ingredient. The other action addresses the use of antacids to relieve upset stomach associated with overindulgence in food and drink. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ Final Action (Sodium Bicarbonate Labeling) To Be Determined Final Action (Overindulgence Labeling) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF52 _______________________________________________________________________ 349. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 g Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF52 _______________________________________________________________________ 349. OVER-THE-COUNTER (OTC) DRUG REVIEW--SKIN BLEACHING PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses skin bleaching drug products containing hydroquinone. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 08/29/06 71 FR 51146 NPRM Comment Period End 12/27/06 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF53 _______________________________________________________________________ 350. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF53 _______________________________________________________________________ 350. OVER-THE-COUNTER (OTC) DRUG REVIEW--STIMULANT DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the use of stimulant active ingredients to relieve symptoms associated with a hangover. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Amendment) (Hangover) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF56 _______________________________________________________________________ 351. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIDIARRHEAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 aluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF56 _______________________________________________________________________ 351. OVER-THE-COUNTER (OTC) DRUG REVIEW--ANTIDIARRHEAL DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. These actions address new labeling for antidiarrheal drug products. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (New Labeling) To Be Determined Final Action (New Labeling) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF63 _______________________________________________________________________ 352. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 tion and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF63 _______________________________________________________________________ 352. OVER-THE-COUNTER (OTC) DRUG REVIEW--URINARY ANALGESIC DRUG PRODUCTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action addresses the products used for urinary pain relief. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM (Urinary Analgesic) To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: M. Scott Furness, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF70 _______________________________________________________________________ 353. OVER-THE-COUNTER (OTC) DRUG REVIEW--CERTAIN CATEGORY II ACTIVE INGREDIENTS Legal Authority: 21 USC 321p; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 371 Abstract: The Food and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. ood and Drug Administration (FDA) is proposing that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA issued this proposed rule because we did not receive any data and information on these ingredients in response to our request on December 31, 2003 (68 FR 75585). This rule will finalize the 2008 proposed rule. Timetable: ________________________________________________________________________ Action Date FR Cite ________________________________________________________________________ NPRM 06/19/08 73 FR 34895 NPRM Comment Period End 09/17/08 Final Action To Be Determined Regulatory Flexibility Analysis Required: Yes Agency Contact: Matthew R. Holman, Ph.D., Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, WO 22, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone: 301 796-2090 Fax: 301 796-9899 Email: [email protected] RIN: 0910-AF95 _______________________________________________________________________ 354. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE PROCEDURES (SECTION 610 REVIEW) Legal Authority: 21 USC 331; 21 USC 333; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 381 Abstract: Pursuant to section 610 of the Regulatory Flexibility Act, FDA is currently undertaking a review of regulations promulgated under the Prescription Drug Marketi [Text truncated at 120,000 characters. 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Check the current official text before relying on it. Not legal advice.