National Institutes of Health Construction Grants

SUMMARY: The National Institutes of Health (NIH) proposes to revise its

regulations governing construction grants for the purpose of making

them applicable to all NIH financial assistance programs with

construction grant authority, including programs transferred to NIH by

the ADAMHA Reorganization Act and two new programs authorized by the

National Institutes of Health Revitalization Act of 1993. The

regulations are also being revised for the purpose of correcting Public

Health Service (PHS) Act section numbers referenced in the regulations

and adding new administrative and technical requirements for the

awarding of these grants and cost recovery procedures for the recovery

of grant funds for facilities no longer used for biomedical research

purposes.

DATES: Comments on these proposed regulations must be received on or

before September 5, 1995 in order to ensure that NIH will be able to

consider the comments in preparing the final rule.

ADDRESSES: Comments should be sent to: Mr. Jerry E. Moore, NIH

Regulatory Affairs Officer, National Institutes of Health, Building 31,

Room 1B25, 31 Center DR MSC 2075, 9000 Rockville Pike, Bethesda,

Maryland 20892-2340.

FOR FURTHER INFORMATION CONTACT: Mr. Jerry E. Moore, NIH Regulatory

Affairs Officer, at the address above, or telephone (301) 496-4606

(this is not a toll-free number).

SUPPLEMENTARY INFORMATION: Under the Public Health Service (PHS) Act,

as amended (42 U.S.C. 201 et seq.), construction or modernization grant

authority exists in sections 413(b)(6)(B) and 414(b) for the National

Cancer Institute (construction grants); sections 421(b)(2)(B) and

422(c)(3) for the National Heart, Lung, and Blood Institute

(construction grants); section 441(a) for the National Institute of

Arthritis and Musculoskeletal and Skin Diseases (modernization grants);

section 455 for the National Eye Institute (construction grants);

section 464C(a) for the National Institute on Deafness and Other

Communication Disorders (modernization grants); section 464P(b)(3) for

the National Institute on Drug Abuse (construction grants); section

481A(a) for the Director of NIH, acting through the Director of the

National Center for Research Resources (construction and modernization

grants); section 481B(a) for the Director of NIH (construction grants);

and section 2354(a)(5)(B) for NIH AIDS research programs (construction

grants).

NIH proposes to revise the existing regulations at 42 CFR part 52b

(National Cancer Institute Construction Grants) to make them applicable

to all NIH financial assistance programs with construction or

modernization grant authority. Part 52b would be retitled and the

authority citation would be amended to add the additional construction

and modernization grant authorities. Sections 52b.2 and 52.3 would be

revised in their entirety. Section 52b.4 would be amended by revising

paragraph (d) to reference Executive Order 12372 and adding a new

paragraph (e) regarding the protection of Historical Properties listed

on National and State Historical Registers. Section 52b.5 would be

revised in its entirety. Sections 52b.6, 52b.7, 52b.8, 52b.9, 52b.10,

and 52b.11 would be revised and moved to Secs. 52b.14, 52b.6, 52b.10,

52b.11, 52b.13 and 52b.12, respectively. The PHS Act sections

referenced in the regulations would be corrected. Three new sections

would be added to part 52b. A new Sec. 52b.7 would be added specifying

facility usage requirements; a new Sec. 52b.8 would be added concerning

NIH monitoring of the usage of biomedical research facilities

constructed with Federal funds; and a new Sec. 52b.9 would be added

concerning procedures to recover Federal funds for facilities that

cease to be used for biomedical research purposes. Section 52b.10 would

add new requirements relating to the recording of notice of Federal

interest and the purchasing of insurance. Section 52b.12 concerning

minimal requirements of construction and equipment would be revised to

incorporate by reference additional published standards relating to

facility design, construction, and operation standards. In accordance

with section 552(a) of the Freedom of Information Act (5 U.S.C. 552)

and implementing regulations, 1 CFR part 51, NIH will request the

approval of the Director of the Federal Register prior to incorporating

by reference any new published material in the final rule.

Section 52b.14 would be revised to cite additional HHS regulations

and policies that apply to part 52b. These regulations do not apply to

minor alterations and renovations that are included in applications for

research project grants. Minor alterations and renovations are covered

under the regulations at 42 CFR part 52. These regulations also do not

cover alterations and renovations under NIH center grants. These

alterations and renovations are covered under the regulations at 42 CFR

part 52a. The purpose of this notice is to invite public comment on

these proposed changes.

PHS strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the nonuse of all tobacco products, and

Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in

certain facilities that receive Federal funds in which education,

library, day care, health care, and early childhood development

services are provided to children.

The following statements are provided for the information of the

public.

Regulatory Impact Statement

Executive Order 12866 of September 30, 1993, Regulatory Planning

and Review, requires us to prepare an analysis for any rule that meets

one of the E. O. 12866 criteria for a significant regulatory action;

that is, that may--

Have an annual effect on the economy of $100 million or more or

adversely affect in a material way the economy, a sector of the

economy, productivity, competition, jobs, the environment, public

health or safety, or State, local, or tribal governments or

communities;

Create a serious inconsistency or otherwise interfere with an

action taken or planned by another agency;

Materially alter the budgetary impact of grants, user fees, or loan

programs or the rights and obligations of recipients thereof; or

Raise novel legal or policy issues arising out of legal mandates,

the President's priorities, or the principles set forth in E.O. 12866.

In addition, the Department prepares a regulatory flexibility

analysis, in accordance with the Regulatory Flexibility Act of 1980 (5

U.S.C. chapter 6), if the rule is expected to have a significant impact

on a substantial number of small entities.

For the reasons outlined below, we do not believe this NPRM is

economically significant nor do we believe that it will have a

significant impact on a substantial number of small entities. In

addition, this NPRM is not inconsistent with the actions of any other

agency.

[[Page 35267]]

This NPRM would merely update internal policies and procedures of

the Federal government which are used by the NIH to administer

construction grants awarded under the authority set forth in section

413(b)(6)(B), 414(b), 421(b)(2)(B), 422(c)(3), 441(a), 455, 464C(a),

464P(b)(3), 481A(a), 481B(a) and 2354(a)(5)(B) of the PHS Act. These

grants do not have significant economic or policy impact on a broad

cross-section of the public. Furthermore, the revised regulations would

only affect the limited number of public or private nonprofit agencies

of institutions which are interested in participating in the

construction grant program. No agency or institution is required to

participate in the program. The revised regulations include no

standards or requirements which would burden small entities.

For these same reasons, the Secretary certifies this NPRM will not

have a significant economic impact on a substantial number of small

entities, and that a Regulatory Flexibility Analysis, as defined under

the Regulatory Flexibility Act of 1980, is not required.

Paperwork Reduction Act

This proposed rule contains information collection requirements

which are subject to Office of Management and Budget (OMB) approval

under the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 35). The

title, description, and respondent description of the information

collection requirements in this proposed rule are presented below with

an estimated annual burden. The information collection requirements

contained in these regulations have been submitted to OMB for review.

Other organizations and individuals desiring to submit comments on the

information collection requirements should send their comments to (1)

Dr. Charles MacKay, Project Clearance Officer, National Institutes of

Health, Building 31, Room 5B33, 9000 Rockville Pike, Bethesda, Maryland

20892-2174, and (2) the Office of Information and Regulatory Affairs,

OMB, New Executive Office Building, Room 10235, 725 17th St., N.W.,

Washington, D.C. 20503. Attention: Desk Officer for the National

Institutes of Health, Department of Health and Human Services. After

OMB approval is obtained, the OMB control number will be published in

the Federal Register.

Title: NIH Construction Grants.

Description: The information collections will be used by NIH to

evaluate grant applications, oversee the transfer of the title of a

constructed facility, and monitor the use being made of a constructed

facility.

Respondent Description: Public or private nonprofit agencies or

institutions.

Estimated Annual Reporting and Recordkeeping Burden

----------------------------------------------------------------------------------------------------------------

Annual number Annual Average burden

of respondents frequency per response Annual burden hours

----------------------------------------------------------------------------------------------------------------

Reporting:

Sec. 52b.9(b).................. 1 1 .50 .50

Sec. 52b.10(f)................. 15 1 1 15

Sec. 52b.10(g)................. 30 12 1 360

Sec. 52b.11(b)................. 100 1 1 * (100)

---------------------------

Subtotal.................... 375.5

---------------------------

Recordkeeping:

Sec. 52b.10(g)................. 30 260 1 7800

---------------------------

Total....................... 8175.5

----------------------------------------------------------------------------------------------------------------

* This burden is approved under OMB Approval Number 0937-0189

Based on an average of 30 active grants in the construction phase.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance numbered programs

affected by these proposed regulations are:

93.392--Cancer Construction

93.131--Shared Research Facilities for Heart, Lung, and Blood

Diseases

93.846--Arthritis, Musculoskeletal and Skin Diseases Research

List of Subjects in Part 52b

AIDS research facilities construction; Basic biomedical research

laboratory facilities construction; Cancer research facilities

construction; Clinical biomedical and behavioral research facilities

construction; Grants--construction; Incorporation by reference; Primate

research facilities construction; Research facilities construction for

AIDS; Research facilities construction for arthritis, musculoskeletal

and skin diseases; Research facilities construction for heart, lung,

and blood diseases; Vision research facilities construction.

Dated: December 28, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Approved: June 19, 1995.

Donna E. Shalala,

Secretary.

For reasons set out in the preamble, it is proposed to revise part

52b of title 42 of the Code of Federal Regulations to read as set forth

below.

PART 52b--NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Sec.

52b.1 To what programs do these regulations apply?

52b.2 Definitions.

52b.3 Who is eligible to apply?

52b.4 How to apply.

52b.5 How will NIH evaluate applications?

52b.6. What is the rate of Federal financial participation?

52b.7 How is the grantee obligated to use the facility?

52b.8 How will NIH monitor the use of facilities constructed with

Federal funds?

52b.9 What is the right of the United States to recover Federal

funds when facilities are not used for research or are transferred?

52b.10 What are the terms and conditions of awards?

52b.11 What are the requirements for acquisition and modernization

of existing facilities?

52b.12 What are the minimum requirements for construction and

equipment?

52b.13 Additional conditions.

52b.14 Other HHS regulations and policies that apply.

[[Page 35268]]

Authority: 42 U.S.C. 216, 285a-2, 285a-3, 285b-3, 285b-4, 285d-

6, 285i, 285m-3, 285o-4, 287a-2, 287a-3, 300cc-41.

Sec. 52b.1 To what programs do these regulations apply?

The provisions of this part apply to grants authorized by: section

413(b)(6)(B) of the Act for construction or renovation of basic cancer

research laboratory facilities, including clinical facilities; section

414(b) of the Act for the construction of centers for basic and

clinical research into, training in, and demonstration of advanced

diagnostic, prevention, control, and treatment methods for cancer;

section 421(b)(2)(B) of the Act for the construction or renovation of

heart, blood vessel, lung, and blood disease and blood resource

laboratories, research, training, and other facilities as the Director

determines necessary; section 422(c)(3) of the Act for the construction

of centers for basic and clinical research into, training in, and

demonstration of, the management of blood resources and advanced

diagnostic, prevention, and treatment methods for heart, blood vessel,

lung, or blood diseases; section 441(a) of the Act for the

modernization of existing buildings to serve as centers for basic and

clinical research into the cause, diagnosis, early detection,

prevention, control, and treatment of and rehabilitation from arthritis

and musculoskeletal diseases, including research into implantable

biomaterials and biomechanical and other orthopedic procedures; section

455 of the Act for the construction of vision research facilities;

section 464C(a) for the modernization of existing buildings to serve as

multipurpose centers for basic and clinical research into the cause,

diagnosis, early detection, prevention, control and treatment of

disorders of hearing and other communication processes including

research into rehabilitative aids, implantable biomaterials, auditory

speech processors, speech production devices, and other otolaryngologic

procedures; section 464P(b)(3) of the Act for the construction of

pharmacotherapeutic research centers, laboratories, and other necessary

facilities and equipment to conduct research on the development and use

of medications to treat drug addiction; section 481A(a) of the Act for

the expansion, remodeling or alteration of existing research

facilities, or the construction of new research facilities; section

481B(a) of the Act for the construction or renovation of regional

centers for research on primates; and section 2354(a)(5)(B) of the Act

for the construction of facilities for acquired immunodeficiency

syndrome (AIDS) research. The provisions of this part do not apply to

minor alteration and renovation that is included in the application for

a research project grant. This type of alteration and renovation is

covered under the regulations at 42 CFR part 52.

Sec. 52b.2 Definitions.

As used in this part:

Act means the Public Health Service Act, as amended (42 U.S.C. 201

et seq.).

Construction means the construction of new buildings or the

modernization of, or the completion of shell space in, existing

buildings (including the installation of fixed equipment), but

excluding the cost of land acquisition and off-site improvements.

Construction grant means funds awarded for construction in

accordance with the applicable provisions of the Act and with this

part.

Director means the director of an NIH national research institute,

center, or other component of NIH, authorized to award grants for

construction under the applicable provisions of the Act, and any

official to whom the authority involved is delegated.

Federal share with respect to any construction project means the

proportion, expressed as a percentage, of the cost of the project to be

paid by a grant award under the Act.

HHS, DHHS, and Department mean the Department of Health and Human

Services.

Institute means any national research institute, center, or other

agency of the National Institutes of Health as set forth in or

established by the Secretary under section 401 of the Act.

Modernization means the alteration, renovation, remodeling,

improvement, expansion, and repair of existing buildings and the

provision of equipment necessary to make the building suitable for use

for the purposes of the particular program.

NIH means the National Institutes of Health and its organizational

components that award grants.

Nonprofit as applied to any agency or institution means an agency

or institution which is a corporation or an association, no part of the

net earnings of which inures or may lawfully inure to the benefit of

any private shareholder or individual.

Project means the particular construction activity which is

supported by a grant under this part.

Secretary means the Secretary of Health and Human Services and any

official to whom the authority involved may be delegated.

Sec. 52b.3 Who is eligible to apply?

In order to be eligible for a construction grant under this part,

the applicant must:

(a) Be a public or private nonprofit agency or institution;

(b) Be located in a State, the District of Columbia, Puerto Rico,

the Virgin Islands, the Canal Zone, Guam, American Samoa, or the

successor States of the Trust Territory of the Pacific Islands (the

Federated States of Micronesia, the Republic of the Marshall Islands,

and the Republic of Palau); and

(c) Meet any additional eligibility criteria specified in the

applicable provisions of the Act.

Sec. 52b.4 How to apply.

Applications for construction grants under this part shall be made

in such form and at such times as the Secretary may specify.

Sec. 52b.5 How will NIH evaluate applications?

(a) In evaluating and approving applications for construction

grants under this part, the Director shall take into account, among

other pertinent factors, the following:

(1) The priority score,

(2) The relevance of the project for which construction is proposed

to the objectives and priorities of the particular statutory program

under the Act,

(3) The scientific merit of the research program activities which

will be carried out in the proposed facility,

(4) The scientific or professional standing or reputation of the

applicant and of its existing or proposed officers and research staff,

(5) The availability, by affiliation, or other association, of

other scientific or health personnel and facilities to the extent

necessary to carry out effectively the program proposed for the

facility, including the adequacy of an acceptable biohazard control and

containment program when warranted,

(6) The need for the facility and its total effects on similar or

related facilities in the locale, and the need to accomplish

appropriate geographic distribution of similar facilities, and

(7) The financial need of the applicant.

(b) The priority score of the application shall be based, among

other pertinent factors, on the following criteria:

(1) The scientific merit of the total program and its component

parts to be carried out in the facility,

(2) The administrative and leadership capabilities of the

applicant's officers and staff,

[[Page 35269]]

(3) The organization of the applicant's research program and its

relationship with the overall institutional settings,

(4) The anticipated effect of the project on other relevant

research programs and facilities in the geographic area, and nation-

wide,

(5) The need for the project or additional space, and

(6) The project cost and design.

Sec. 52b.6 What is the rate of Federal financial participation?

(a) Unless otherwise specified in statute, the rate of Federal

participation in a construction project supported by a grant under this

part shall not be more than 50 percent of the necessary allowable costs

of construction as determined by the Director, except that when the

Director finds good cause for waiving this limitation, the amount of

the construction grant may be more than 50 percent of the necessary

allowable costs of construction.

(b) Subject to paragraph (a) of this section, the Director shall

set the actual rate of Federal financial participation in the necessary

allowable costs of construction taking into consideration the most

effective use of available Federal funds to further the purposes of the

applicable provisions of the Act.

Sec. 52b.7 How is the grantee obligated to use the facility?

(a) The grantee shall use the facility (or that portion of the

facility supported by a grant under this part) for its originally

authorized purpose so long as needed for that purpose, unless that

grantee obtains advance written approval from the Director to use the

facility for another purpose. Use for other purposes shall be limited

to, in order of priority:

(1) Projects or programs supported by other Federal grants or

assistance agreements,

(2) Activities not supported by other Federal grants or assistance

agreements, but whose purposes are consistent with those of the

legislation under which the original grant was made.

(b) The Director, in determining whether to approve an alternative

use of the facility, shall take into consideration the extent to which:

(1) the facility will be devoted by the grantee or other owner to a

use described in paragraph (a)(1) or (2) of this section; or

(2) there are reasonable assurances that for the remainder of the

useful life of the facility, alternative facilities not previously used

for NIH supported research will be utilized for this purpose and are

substantially equivalent in nature and extent for these purposes.

(c) Sale, transfer, or change in use; general. Approval may be

requested from the Director to transfer title to a third party eligible

under Sec. 52b.3 for continued use for authorized purposes in

accordance with paragraphs (a) and (b) of this section. If approval is

permissible under the Act or other Federal statute and is granted, the

terms of the transfer shall provide that the transferee shall assume

all the rights and obligations of the transferor set forth in 45 CFR

part 74, subpart O, or other terms of the grant.

Sec. 52b.8 How will NIH monitor the use of facilities constructed with

Federal funds?

NIH may monitor the use of each facility constructed with funds

awarded under this part to ensure its continued use for the original

authorized research purpose, by means of requesting periodic facility

use certifications or reports, site visits, and other appropriate

means.

Sec. 52b.9 What is the right of the United States to recover Federal

funds when facilities are not used for research or are transferred?

(a) If, during its useful life, a facility supported by a

construction grant under this part ceases to be used for the particular

biomedical research or training purposes for which it was constructed

(or alternate use authorized under Sec. 52b.7(a)), or the grantee sells

or decides to sell or transfer title to an entity ineligible for a

grant under Sec. 52b.3, the grantee shall request disposition

instructions from NIH. Those instructions will provide for one of the

following alternatives:

(1) The facility may be sold and the grantee or transferee shall

pay to the United States an amount computed by multiplying the Federal

share of the facility times the proceeds from the sale (after deducting

the actual and reasonable selling and fix-up expenses, if any, from the

sales proceeds), plus interest, if any, as may be allowed by law.

Proper sales procedures shall be used that provide for competition to

the extent practicable and result in the highest possible return.

(2) The grantee may retain title and shall pay to the United States

an amount computed by multiplying the market value of the facility by

the Federal share of the facility.

(3) The grantee shall transfer the title to either the United

States or to an eligible non-Federal party approved by the Director.

The grantee shall be entitled to be paid an amount computed by

multiplying the market value of the facility by the non-Federal share

of the facility.

(b) The transferor of a facility which is sold or transferred, or

the owner of a facility the use of which has changed, as described in

paragraph (a) of this section, shall provide the Director written

notice of the sale, transfer, or change not later than 30 days from the

date on which the sale, transfer, or change occurs.

(c) The Secretary may waive the recovery rights of the United

States set forth in paragraph (a) of this section with respect to a

facility if the Secretary determines that there is good cause for

waiving the rights with respect to the particular facility. In

determining whether there is good cause, the Secretary shall take into

consideration the extent to which (and the grantee or transferee

provides reasonable assurances that):

(1) the facility will be utilized for the remainder of its useful

life, in order of priority:

(i) For other health related activities consistent with the

purposes of one or more of the activities of the awarding Institute

authorized under title IV of the Act,

(ii) To provide training or instruction in the health fields for

health professionals or health related information programs for the

public, or

(iii) Other health related purposes consistent with one or more

purposes authorized under the Act; or,

(2) facilities of substantially comparable value or utility will be

utilized for the remainder of the facility's useful life to carry out

the biomedical research or training purpose for which the grant was

awarded. Alternative facilities (and the grantee) shall be subject to

the same use obligation and the other requirements imposed on the

grantee by this part.

(d) The right of recovery of the United States set forth in

paragraph (a) of this section shall not, prior to judgment, constitute

a lien on any facility with respect to which funds have been paid under

this part.

(e) Any amount recovered under this section will be paid to the

awarding institute for disposition as required by law.

Sec. 52b.10 What are the terms and conditions of awards?

In addition to any other requirement imposed by law or determined

by the Director to be reasonably necessary with respect to any

particular grant to fulfill the purposes of the grant, each

construction grant shall be subject to the terms and conditions, and

the grantee shall provide the assurances, required by this section,

supported by such documentation as the Director may

[[Page 35270]]

reasonably require. The Director may, by general policy or for good

cause shown by an applicant, approve exceptions to these terms and

conditions or assurances where the Director finds that the exceptions

are consistent with the applicable provision of the Act and the

purposes of the particular program:

(a) Title. That the applicant has a fee simple or such other estate

or interest in the site, including necessary easements and rights-of-

way sufficient to assure for the estimated useful life of the facility,

as determined by the Director, undisturbed use and possession for the

purpose of the construction and operation of the facility.

(b) Plans and specifications. That approval by the Director of the

final working drawings, specifications, and cost estimate shall be

obtained before the project is advertised or placed on the market for

bidding. The approval shall include a determination by the Director

that the final plans and specifications conform to the minimum

standards of construction and equipment as set forth in Sec. 52b.12 of

this part.

(c) Relocation assistance. That in the case of a public applicant

with an approved project which involves the displacement of persons or

businesses on or after January 4, 1971, the applicant will comply with

the provisions of the Uniform Relocation Assistance and Real Property

Acquisition Policies Act of 1970 (42 U.S.C. 4601 et seq.) and the

applicable regulations issued under that Act (45 CFR part 15).

(d) Approval of changes in estimated cost. That the applicant will

not enter into any construction contract or contracts for the project

or a part thereof, the cost of which is in excess of the estimated cost

approved in the terms of an award for that portion of the work covered

by the plans and specifications, without the prior approval of the

Director.

(e) Completion responsibility. That the applicant will construct

the project, or cause it to be constructed, to final completion in

accordance with the grant application, the terms of award, and the

approved plans and specifications.

(f) Construction inspection. Prior to the start of construction,

the grantee shall submit an approved copy of the construction schedule

(critical path method) to the Director.

(g) Construction management. That the applicant will provide and

maintain competent and adequate construction management services for

inspection at the construction site to ensure that the completed work

conforms with the approved plans and specifications. Construction

management services will also include daily construction logs and

monthly status reports which will be maintained at the job site and

shall be submitted to the Director at the time and in the form and

manner as the Director may prescribe.

(h) Non-Federal share. That sufficient funds are available to meet

the non-Federal share of the costs of constructing the facility.

(i) Funds for operation. That sufficient funds will be available

when construction is completed for effective use of the facility for

the purposes for which it is being constructed.

(j) Inspection. That the Director and the Director's

representatives shall have access at all reasonable times to all work

during any stage of construction and the contractor shall provide

proper facilities for this access and inspection.

(k) Accessibility to handicapped. That the facility shall be

designed to comply with the Federal Accessibility Standards (41 CFR

subpart 101-19.6), as modified by other standards prescribed by the

Director or the Administrator of General Services. The applicant will

be responsible for conducting inspections to insure compliance with

these specifications by the contractor.

(l) Notice of Federal interest. The grantee shall record a Notice

of Federal Interest in the appropriate official records of the

jurisdiction in which the property is located.

(m) Title insurance. The grantee shall purchase a title insurance

policy unless a legal opinion has been provided which certifies that

the grantee institution has fee simple title to the site free and clear

of all liens, easements, rights-of-way, and any other adverse interests

which would encumber the project. A waiver to this requirement may be

obtained if the grantee is adequately self-insured against the risks

involved.

(n) Physical destruction insurance. At the time construction is

completed or at the time of beneficial occupancy, whichever comes

first, the grantee shall purchase an insurance policy which insures the

facility at the full appraised value of the property using State

certified appraisers. The insurance policy must protect the property

from total or partial physical destruction and must be maintained

throughout the period of Federal interest. A waiver to this requirement

may be obtained if the grantee is adequately self-insured against the

risks involved.

Sec. 52b.11 What are the requirements for acquisition and

modernization of existing facilities?

In addition to the other requirements of this part, the following

requirements are applicable to the acquisition and modernization of

existing facilities.

(a) Minimum standards of construction and equipment. A

determination by the Director that the facility conforms (or upon

completion of any necessary construction will conform) to the minimum

standards of construction and equipment as set forth in Sec. 52b.12 of

this part, shall be obtained before entering into a final or

unconditional contract for the acquisition and/or remodeling of

facilities. Where the Director finds that exceptions to or

modifications of construction or equipment would be consistent with the

purposes of the applicable section of the Act under which the

acquisition is supported, the Director may authorize the exceptions or

modifications.

(b) Estimated cost of acquisition and remodeling: Suitability of

facility. Each application for a project involving the acquisition of

existing facilities shall include in the detailed estimates of the

costs of the project, the cost of acquiring these facilities, and any

cost of remodeling, renovating or altering the facilities to serve the

purposes for which they are acquired. The application shall demonstrate

to the satisfaction of the Director that the architectural, mechanical,

electrical, plumbing, structural, and other pertinent features of the

facility, as modified by any proposed expansion, remodeling,

renovation, or alteration, will be clearly suitable for the purposes of

the applicable sections of the Act.

(c) Bona fide sale. Grant awards for the acquisition of existing

facilities shall be subject to the condition that the acquisition

constitutes a bona fide sale involving an actual cost to the applicant

and will result in additional or improved facilities for purposes of

the applicable provisions of the Act.

(d) Facility which has previously received a Federal grant. No

grant for the acquisition or modernization of a facility which has

previously received a Federal grant for construction, acquisition, or

equipment shall serve either to reduce or restrict the liability of the

applicant or any other transferor or transferee from any obligation of

accountability imposed by the Federal Government by reason of the prior

grant.

[[Page 35271]]

Sec. 52b.12 What are the minimum requirements for construction and

equipment?

In addition to being subject to other regulations and policies

referred to in Sec. 52b.14, the standards set forth in this section

have been determined by the Director to constitute minimum requirements

for construction and equipment, including the expansion, remodeling,

renovation, or alteration of existing buildings, and these standards as

may be amended, or any revisions or successors of these standards,

shall apply to all projects for which Federal assistance is requested

under the applicable sections of the Act. In accordance with 5 U.S.C.

552(a)(1), the publications to which reference is made in this section,

unless otherwise indicated, are hereby incorporated by reference and

made a part of the regulations in this part. The Director may for good

cause shown approve plans and specifications which contain deviations

from the requirements prescribed, if the Director is satisfied that the

purposes of the requirements have been fulfilled. In addition to these

requirements, each project shall meet the requirements of State and/or

local codes and ordinances relating to construction.

(a) Mandatory design and construction standards. The facility

design and construction shall comply with the following standards:

(1) ``Guidelines for Construction and Equipment for Hospital and

Medical Facilities'' (current edition). American Institute of

Architects, 1735 New York Avenue, NW., Washington, DC 20006.

(2) ``Laboratories Chapter, American Society of Heating,

Refrigerating and Air Conditioning Engineers (ASHRAE) Handbook''

(current edition). ASHRAE, 1791 Tullie Circle, NE., Atlanta, Georgia

30329.

(3) ``Uniform Federal Accessibility Standards,'' Federal Standard

795 (current edition). General Services Administration.

(4) Seismic safety for federally assisted construction--Earthquake

Hazards Reduction Act of 1977, as amended (42 U.S.C. 7701 et seq.) and

Executive Order 12699, ``Seismic Safety of Federal and Federally

Assisted or Regulated New Building Construction,'' dated January 5,

1990. The Executive Order requires that, effective January 5, 1993, new

federally assisted or regulated buildings are to be designed and

constructed using appropriate seismic standards. The latest edition of

the model codes listed below provide a level of seismic safety that is

considered appropriate for implementing E.O. 12699 and are applicable

to all federally assisted construction, depending on geographical

location. State, county, or local jurisdictional building ordinances

adopting and enforcing these model codes in their entirety, without

significant revisions in the direction of less seismic safety, are also

acceptable.

(i) 1991 International Conference of Building Officials (ICBO)

Uniform Building Code;

(ii) 1992 Supplement to the Building Officials and Code

Administrators International (BOCA) National Building Code;

(iii) 1992 Amendments to the Southern Building Code Congress (SBCC)

Standard Building Code; and

(iv) ``Recommended Lateral Force Requirements and Commentary'' of

the Seismology Committee, Structural Engineers Association of

California.

(5) ``Life Safety Code'' (current edition). National Fire

Protection Association (NFPA) Publication 101. NFPA, 1 Batterymarch

Park, Quincy, Massachusetts 02269.

(6) ``Standards on Fire Protection for Laboratories Using

Chemicals'' (current edition). National Fire Protection Association

(NFPA) Publication No. 45. NFPA, 1 Batterymarch Park, Quincy,

Massachusetts 02269.

(7) ``Prudent Practices for Handling Hazardous Chemicals in

Laboratories.'' (National Academy Press (1981)) National Research

Council, 2001 Wisconsin Avenue, NW., Washington, DC 20007.

(8) ``National Sanitation Foundation Standard No. 49 for Class II

(Laminar Flow) Biohazard Cabinetry'' (current edition). National

Sanitation Foundation (NSF), 3475 Plymouth Road, P.O. Box 1468, Ann

Arbor, Michigan 48106.

(9) ``Industrial Ventilation'' (current edition). American

Conference of Governmental Industrial Hygienists, 6500 Glenwood Avenue,

Cincinnati, Ohio 45211.

(10) ``Health Care Facilities Handbook'' (current edition).

National Fire Protection Association, 1 Batterymarch Park, Quincy,

Massachusetts 02269.

(11) ``Standards for Nonflammable Medical Gas Systems'' (current

edition). National Fire Protection Association (NFPA) Publication No.

99. NFPA, 1 Batterymarch Park, Quincy, Massachusetts 02269.

(12) ``National Electric Code'' (current edition). National Fire

Protection Association (NFPA) Publication No. 70. NFPA, 1 Batterymarch

Park, Quincy, Massachusetts 02269.

(13) ``Guide for the Care and Use of Laboratory Animals'' (current

edition). DHHS Publication No. (NIH) 85-23.

(14) ``Laboratory Ventilation'' standards, ANSI/AIHA (current

edition).

(15) ``Design Policy and Guidelines'' (current edition). Division

of Engineering Services, National Institutes of Health.

(b) [Reserved]

Sec. 52b.13 Additional conditions.

The Director may with respect to any grant award impose additional

conditions consistent with the regulations of this part prior to or at

the time of any award when in the Director's judgment the conditions

are necessary to assure or protect advancement of the approved project,

the purposes of the applicable provisions of the Act, or the

conservation of grant funds.

Sec. 52b.14 Other Federal regulations and policies that apply.

Several other Federal regulations and policies apply to grants

under this part. These include, but are not necessarily limited to:

(a) Regulations.

9 CFR part 3--Animal welfare; standards.

29 CFR part 1910--Occupational safety and health standards;

Sec. 1910.1450--Occupational exposure to hazardous chemicals in

laboratories.

36 CFR part 1190--Minimum guidelines and requirements for accessible

design.

42 CFR part 50, subpart A--Responsibility of PHS awardee and

applicant institutions for dealing with and reporting possible

misconduct in science.

42 CFR part 50, subpart D--Public Health Service grant appeals

procedure.

45 CFR part 16--Procedures of the Departmental Grant Appeals Board.

45 CFR part 46--Protection of human subjects.

45 CFR part 74--Administration of grants.

45 CFR part 75--Informal grant appeals procedures.

45 CFR part 76--Governmentwide debarment and suspension

(nonprocurement) and governmentwide requirements for drug-free

workplace (grants).

45 CFR part 80--Nondiscrimination under programs receiving Federal

assistance through the Department of Health and Human Services--

effectuation of title VI of the Civil Rights Act of 1964.

45 CFR part 81--Practice and procedure for hearings under part 80 of

this title.

45 CFR part 84--Nondiscrimination on the basis of handicap in

programs and activities receiving Federal financial assistance.

45 CFR part 86--Nondiscrimination on the basis of sex in education

programs and activities receiving or benefiting from Federal

financial assistance.

45 CFR part 91--Nondiscrimination on the basis of age in HHS

programs or activities receiving Federal financial assistance.

45 CFR part 93--New restrictions on lobbying.

[[Page 35272]]

45 CFR part 92--Uniform administrative requirements for grants and

cooperative agreements to State and local governments.

(b) Policies.

(1) 51 FR 16958 (May 7, 1986)--NIH Guidelines for Research

Involving Recombinant DNA Molecules. [Note: this policy is subject to

changes, and interested persons should contact the Office of

Recombinant DNA Activities, NIH, Suite 323, 6006 Executive Blvd., MSC

7052, BETHESDA, MD 20892-7052 (301-496-9838; not a toll-free number) to

obtain the current version and any amendments. There may be a charge

for materials provided.]

(2) 59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion

of Women and Minorities as Subjects in Clinical Research. [Note: this

policy is subject to changes, and interested persons should contact the

Office of Research on Women's Health, NIH, Room 201, Building 1, MSC

0161, BETHESDA, MD 20892-0161 (301-402-1770; not a toll-free number) to

obtain the current version and any amendments. There may be a charge

for materials provided.]

(3) ``Public Health Service Policy on Humane Care and Use of

Laboratory Animals,'' Office for Protection from Research Risks, NIH

(Revised September 1986). [Note: this policy is subject to changes, and

interested persons should contact the Office for Protection from

Research Risks, NIH, Suite 3B01, 6100 Executive Blvd., MSC 7507,

ROCKVILLE, MD 20852-7507 (301-496-7005; not a toll-free number) to

obtain the current version and any amendments. There may be a charge

for materials provided.]

(4) ``PHS Grants Policy Statement,'' DHHS Publication No. (OASH)

94-50,000 (Rev.) April 1, 1994. [Note: this policy is subject to

changes, and interested persons should contact the Grants Policy

Branch, OASH, Room 17A45, Parklawn Building, 5600 Fishers Lane,

Rockville, MD 20857 (301-443-1874; not a toll-free number) to obtain

the current version and any amendments. There may be a charge for

materials provided.]

(5)``Biosafety in Microbiological and Biomedical Laboratories.''

Centers for Disease Control and Prevention (CDCP). DHHS Publication No.

(CDC) 88-8395. [Note: this policy is subject to changes, and interested

persons should contact the Division of Safety, Occupational Safety and

Health Branch, NIH, Room 3K04, 13 South Drive, MSC 5760, BETHESDA, MD

20892-5760 (301-496-2960; not a toll-free number) to obtain the current

version and any amendments. There may be a charge for materials

provided.]

(6) ``NIH Guidelines for the Laboratory Use of Chemical

Carcinogens.'' DHHS Publication No. (NIH) 81-2385. [Note: this policy

is subject to changes, and interested persons should contact the

Division of Safety, Occupational Safety and Health Branch, NIH, Room

3K04, 13 South Drive, MSC 5760, BETHESDA, MD 20892-5760 (301-496-2960;

not a toll-free number) to obtain the current version and any

amendments. There may be a charge for materials provided.]

(7) ``Guide for the Care and Use of Laboratory Animals.'' DHHS

Publication No. (NIH) 85-23. Office for Protection from Research Risks,

NIH (Revised September 1986). [Note: this policy is subject to changes,

and interested persons should contact the Office for Protection from

Research Risks, NIH, Suite 3B01, 6100 Executive Blvd., MSC 7507,

ROCKVILLE, MD 20852-7507 (301-496-7005; not a toll-free number) to

obtain the current version and any amendments. There may be a charge

for materials provided.]

[FR Doc. 95-15703 Filed 7-5-95; 8:45 am]

BILLING CODE 4140-01-P