[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Proposed Rules]
[Pages 35266-35272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15703]
[[Page 35265]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
_______________________________________________________________________
42 CFR Part 52b
National Institutes of Health Construction Grants; Proposed Rule
Federal Register / Vol. 60, No. 129 / Thursday, July 6, 1995 /
Proposed Rules
[[Page 35266]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 52b
RIN 0905-AD49
National Institutes of Health Construction Grants
AGENCY: Public Health Service, Department of Health and Human Services
(HHS).
ACTION: Notice of proposed rulemaking.
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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
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Annual number Annual Average burden
of respondents frequency per response Annual burden hours
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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)
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Subtotal.................... 375.5
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Recordkeeping:
Sec. 52b.10(g)................. 30 260 1 7800
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Total....................... 8175.5
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* 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
