[Federal Register Volume 64, Number 224 (Monday, November 22, 1999)]
[Rules and Regulations]
[Pages 63721-63727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30068]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 52b
RIN 0925-AA04
National Institutes of Health Construction Grants
AGENCY: National Institutes of Health, Department of Health and Human
Services (HHS).
ACTION: Final rule.
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SUMMARY: The National Institutes of Health (NIH) is revising
regulations governing National Cancer Institute 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 programs
authorized by the National Institutes of Health Revitalization Act of
1993. The regulations are also being revised to update statutory
references in the regulations, add new administrative and technical
requirements for the awarding of these grants, and add procedures for
the recovery of grant funds for facilities no longer used for
biomedical research purposes.
DATES: This final rule is effective on December 22, 1999. The
incorporation by reference of certain publications listed in the rule
was approved by the Director of the Federal Register, effective
December 22, 1999.
FOR FURTHER INFORMATION CONTACT: Mr. Jerry Moore, NIH Regulations
Officer, National Institutes of Health, 6011 Executive Boulevard, Room
601, MSC 7669, Rockville, MD 20852, or telephone 301-496-4607 (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 is revising 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, except for certain alterations and
improvements under research project grants and center grants, and to
make other changes. NIH announced proposed revisions to the existing
regulations at 42 CFR part 52b (National Cancer Institute Construction
Grants) in a notice of proposed rulemaking (NPRM) published in the
Federal Register on July 6, 1995 (60 FR 35266). One comment was
received and it supported the proposed changes. With the exception of
minor editorial and the following changes, the regulations are the same
as those proposed in the NPRM.
In lieu of specifically listing in Sec. 52b.1, the applicability
section, each NIH construction grant program to which the regulations
apply, as proposed in the NPRM, the section has been revised and
simplified to apply across-the-board to all NIH construction grant
programs, except for those few programs specifically excluded by the
section. This will have the advantage of assuring that any new NIH
construction grant programs enacted by Congress will have implementing
regulations without the necessity of having to amend the regulations.
The final rule authorizes the Director of NIH to publish a list from
time to time of the construction grant programs covered by the
regulations. This list would be for informational purposes only and
would not restrict the applicability of the regulations.
Part 52b is retitled and the authority citation is amended to add
the construction and modernization grant authorities. Sections 52b.2
through 52b.5 are revised in their entirety. Although the current
National Cancer Institute (NCI) construction grants regulations do not
specify a specific length of time the grantee must use a facility for
the purpose for which constructed, Sec. 52b.10(a) of the current
regulations requires the applicant to have sufficient title to assure
``for the estimated useful life of the facility,'' as determined by the
Director, NCI, undisturbed use and possession for the purpose of the
construction and operation of the facility. The regulations governing
the administration of grants, 45 CFR part 74, which are incorporated in
the current part 52b, provide that the recipient shall use the real
property ``for the authorized purpose of the project as long as it is
needed'' (Sec. 74.32(a)). The revised regulations continue to specify
continued use of the facility for its originally authorized purpose so
long as needed, unless another period is prescribed by statute (e.g.,
20 years after completion of construction prescribed by section
481A(c)(1)(B) of the PHS Act for biomedical and behavioral research
facilities).
The NPRM continued without change the provisions relating to title
(sufficient for the estimated useful life as determined by the awarding
component director) and incorporation of 45 CFR part 74 (use for the
originally authorized purpose so long as needed), but added express
provisions authorizing alternate use in appropriate circumstances and
the right of the Federal Government to recover in the event a facility
is sold or transferred to an ineligible third party or diverted to an
unauthorized purpose, prior to the expiration of its useful life. Those
provisions remain in this final rule with minor modifications to
conform more closely to the pertinent provisions of 45 CFR part 74.
Sections 52b.6, 52b.7, 52b.8, 52b.9, 52b.10, and 52b.11 are revised
and redesignated as indicated on the following chart, which shows the
new section designations of all the sections of former part 52b:
------------------------------------------------------------------------
Former section New section
------------------------------------------------------------------------
52b.1..................................... 52b.1
52b.2..................................... 52b.2
52b.3..................................... 52b.3
52b.4..................................... 52b.4
52b.5..................................... 52b.5
52b.6..................................... 52b.14
52b.7..................................... 52b.6
52b.8..................................... 52b.10
52b.9..................................... 52b.11
52b.10.................................... 52b.13
52b.11.................................... 52b.12
None...................................... 52b.7
None...................................... 52b.8
None...................................... 52b.9
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Three new sections are added to part 52b. A new Sec. 52b.7 is added
specifying facility usage requirements; a new Sec. 52b.8 is added
concerning NIH monitoring of the usage of biomedical research
facilities constructed with federal funds; and a new Sec. 52b.9 is
added concerning procedures to recover federal funds for facilities
that cease to be used for biomedical research purposes. Section 52b.10
adds new
[[Page 63722]]
requirements relating to the recording of the Notice of Federal
Interest and the purchasing of insurance.
The introductory paragraph of Sec. 52b.11, as proposed in the NPRM,
is revised for editorial purposes. Sections 52b.12 and 52b.14, as
proposed in the NPRM, are revised to (1) include additional information
concerning where copies of the standards that are incorporated by
reference may be inspected and obtained, (2) comply with Federal
Register format requirements for the references, and (3) consolidate
the published standards that are incorporated by reference in
Sec. 52b.12 and the other laws, regulations, executive orders, and
policies referenced in Sec. 52b.14. Additionally, the heading of
Sec. 52b.14 is revised to include public laws and executive orders.
These construction grant regulations do not apply to minor
alterations and renovations under research project grants. Minor
alterations and renovations are covered under the regulations at 42 CFR
part 52 governing the award of research project grants. These
regulations also do not cover alterations and renovations under NIH
center grants. Those alterations and renovations are covered under the
regulations for that program at 42 CFR part 52a.
HHS strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
title X, part C of 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.
Executive Order 12866
Executive Order 12866 of September 30, 1993, Regulatory Planning
and Review, requires that all regulatory actions reflect consideration
of the costs and benefits they generate, and that they meet certain
standards, such as avoiding the imposition of unnecessary burdens on
the affected public. If a regulatory action is deemed to fall within
the scope of the definition of the term ``significant regulatory
action'' contained in section 3(f) of the Order, prepublication review
by the Office of Information and Regulatory Affairs (OIRA), Office of
Management and Budget (OMB), is necessary. This rule was reviewed under
Executive Order 12866 and was deemed not significant.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that
regulatory actions be analyzed to determine whether they will have a
significant impact on a substantial number of small entities. The
Secretary of Health and Human Services certifies that this final rule
will not have a significant economic impact on a substantial number of
small entities and, therefore, a regulatory flexibility analysis, as
defined under the Regulatory Flexibility Act, is not required. The rule
codifies in the CFR policies and procedures of the Federal Government
which are used by the NIH to administer construction grants awarded
under the authority set forth in sections 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 and updates the current
regulations. These grants do not have significant economic or policy
impact on a broad cross-section of the public. Furthermore, the revised
regulations only affect the limited number of public or private
nonprofit agencies or institutions which are interested in
participating in the construction grant programs. No agency or
institution is required to participate in these programs. Apart from
the requirements for applicants and award recipients necessary to
operate these programs, the revised regulations include no standards or
requirements which burden small entities.
Paperwork Reduction Act
Sections 52b.9(b), 52b.10(f), 52b.10(g), and 52b.11(b) of this rule
contain information collection requirements which are subject to OMB
approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter
35). Section 52b.10(g) also contains recordkeeping requirements which
are subject to OMB approval under the Paperwork Reduction Act. The
information collection language in Secs. 52b.9(b), 52b.10(f),
52b.10(g), and 52b.11(b), and the recordkeeping language in
Sec. 52b.10(g) is approved under OMB Control Number 0925-0424 (expires
November 30, 2001).
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 42 CFR Part 52b
Grant programs--health, Health facilities, Incorporation by
reference, Medical research, Reporting and recordkeeping requirements.
Dated: August 29, 1999.
Harold Varmus,
Director, National Institutes of Health.
For the reasons set out in the preamble, part 52b of title 42 of
the Code of Federal Regulations is revised to read as follows:
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 of construction and
equipment?
52b.13 Additional conditions.
52b.14 Other federal laws, regulations, executive orders, and
policies that apply.
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?
(a) General. Except as provided in paragraph (c) of this section,
this part applies to all grants awarded by NIH and its components for
construction of new buildings and the alteration, renovation,
remodeling, improvement, expansion, and repair of existing buildings,
including the provision of equipment necessary to make the building (or
applicable part of the building) suitable for the purpose for which it
was constructed.
(b) Specific programs covered. From time to time the Director may
publish a list of the construction grant programs covered by this part.
The list is for informational purposes only and is not intended to
restrict the statement of applicability in paragraph (a) of this
section. In addition, information on particular construction grant
programs,
[[Page 63723]]
including applications and instructions, may be obtained from the
component of NIH that administers the program.
(c) Specific programs excluded. The regulations of this part do not
apply to minor alterations, renovations, or repairs funded under a
research project grant (see part 52 of this chapter) or alterations or
renovations funded under an NIH center grant (see part 52a of this
chapter).
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 this part.
Director means the Director of NIH or 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 a 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.
Modernization means the alteration, renovation, remodeling,
improvement, expansion, and/or 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 construction 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 is 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
at the times and in the form and manner as the Secretary may prescribe.
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 assigned to the application by an NIH peer
review group as described in paragraph (b) of this section;
(2) The relevance of the project for which construction is proposed
to the objectives and priorities of the particular program authorized
by the Act;
(3) The scientific merit of the research activities that 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 for 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;
(3) The organization of the applicant's research program and its
relationship with the applicant's overall research programs;
(4) The anticipated effect of the project on other relevant
research programs and facilities in the geographic area, and
nationwide;
(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 by statute, the rate of federal
financial 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, or other period
prescribed by statute, unless the grantee obtains advance approval from
the Director, in the form and manner as the Director may prescribe, to
use the facility for another purpose. Use for other purposes shall be
limited as prescribed in Sec. 52b.9(c)(2).
(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 used by the grantee or other owner for a
purpose described in Sec. 52b.9(c)(2); or
(2) There are reasonable assurances that alternative facilities not
previously used for NIH supported research will be utilized to carry
out the original purpose as prescribed in Sec. 52b.9(c)(1).
(c) Sale or transfer. In the form and manner as the Director may
prescribe,
[[Page 63724]]
the grantee may request the Director's approval to sell the facility or
transfer title to a third party eligible under Sec. 52b.3 for continued
use of the facility for an authorized purpose 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, the
regulations of this part, and the other terms and conditions 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 originally
authorized research purpose, by means of reviewing 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 the grantee plans to cease using the facility for the
particular biomedical research or training purposes for which it was
constructed as required by Sec. 52b.7 (or alternate use authorized
under Sec. 52b.7(a) or paragraph (c) of this section), or the grantee
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 in the form and manner as the Director may prescribe. Those
instructions shall 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). The sales procedures must provide for competition to
the extent practicable, and be designed to provide the highest possible
return;
(2) The grantee may retain title and shall pay to the United States
an amount computed by multiplying the current fair market value of the
facility by the federal share of the facility; or
(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 current fair market value of the facility by the
nonfederal share of the facility.
(b) The grantee or 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 report that action
in writing to the Director not later than 10 days from the date on
which the sale, transfer, or change occurs, in the form and manner as
the Director may prescribe.
(c) In lieu of disposition of a facility pursuant to the provisions
of paragraph (a) of this section, the Director may, for good cause,
supported by assurances provided by the grantee or transferee, approve
one of the following alternatives:
(1) Transfer of the remaining usage obligation to facilities of
substantially comparable or greater value or utility, to carry out the
biomedical research or training purpose for which the grant was
awarded. In this event, the remaining usage obligation shall be
released from the original facility constructed with grant funds and
transferred to the new facility, and the grantee shall remain subject
to all other requirements imposed under this part with respect to the
new facility; or
(2) Use the facility for as long as needed, in order of priority,
for one of the following purposes:
(i) For other health related activities consistent with the
purposes of one or more of the activities of the awarding institute as
authorized under title IV or other provisions of the Act;
(ii) To provide training and 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 of
the purposes authorized under the Act.
(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 supported in whole or in part by a federal
grant, including a construction grant under this part.
(e) Any amount required to be paid to the United States under this
section will be paid to the awarding institute for disposition as
required by law.
(Approved by the Office of Management and Budget under Control
Number 0925-0424; expires November 30, 2001)
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 to fulfill the purposes of
the grant, each construction grant shall be subject to the terms and
conditions and the grantee assurances required by this section,
supported by such documentation as the Director may 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 provisions of the Act and the purposes of the
particular program:
(a) Title. The applicant must have a fee simple or 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. Approval by the Director of the final
working drawings, specifications, and cost estimates must be obtained
before the project is advertised or placed on the market for bidding.
The approval must 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.
(c) Relocation assistance. An applicant with an approved project
which involves the displacement of persons or businesses shall comply
with the provisions of the Uniform Relocation Assistance and Real
Property Acquisition Policies Act of 1970, as amended (42 U.S.C. 4601
et seq.) and the applicable regulations issued under that Act (45 CFR
part 15; 49 CFR part 24).
(d) Approval of changes in estimated cost. Unless approved by the
Director, the applicant shall not enter into any construction contracts
for the project or a part of the project, the cost of which exceeds the
estimated cost approved in the terms of an award for that portion of
the work covered by the plans and specifications. Exceptions shall be
requested in the form and manner as the Director may prescribe.
(e) Completion responsibility. The applicant must construct the
project, or cause it to be constructed, to final completion in
accordance with the grant application, the terms and conditions of the
award, and the approved plans and specifications.
(f) Construction schedule inspection. Prior to the start of
construction, the grantee shall submit an approved copy of the
construction schedule (critical path method) to the Director in the
form and manner as the Director may prescribe.
(g) Construction management. The applicant must provide and
maintain competent and adequate construction
[[Page 63725]]
management services for inspection at the construction site to ensure
that the completed work conforms with the approved plans and
specifications. Construction management services shall include daily
construction logs and monthly status reports which shall be maintained
at the job site and shall be submitted to the Director at the times and
in the form and manner as the Director may prescribe.
(h) Nonfederal share. Sufficient funds must be available to meet
the nonfederal share of the costs of constructing the facility.
(i) Funds for operation. Sufficient funds must be available when
construction is completed for effective use of the facility for the
purposes for which it is being constructed.
(j) Inspection. The Director and the Director's representatives
shall have access at all reasonable times to all work areas and
documents during any stage of construction and the contractor shall
provide proper facilities for this access and inspection.
(k) Accessibility to handicapped persons. The facility must be
designed to comply with the Uniform Federal Accessibility Standards (41
CFR part 101-19, subpart 101-19.6, Appendix A), as modified by other
standards prescribed by the Director or the Administrator of General
Services. The applicant shall conduct inspections to ensure 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 land 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. The Director may waive this
requirement upon a request from the grantee adequately documenting
self-insurance against the risks involved and containing such other
information as the Director may prescribe.
(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 for the full appraised value of the property using state
certified appraisers. The insurance policy must protect the property
from total and partial physical destruction. The insurance policy must
be maintained throughout the period of federal interest. The Director
may waive this requirement upon a written request from the grantee
adequately documenting self-insurance against the risks involved and
containing such other information as the Director may prescribe.
(Approved by the Office of Management and Budget under Control
Number 0925-0424; expires November 30, 2001)
Sec. 52b.11 What are the requirements for acquisition and
modernization of existing facilities?
Grant awards for the acquisition and modernization of existing
facilities are permitted if authorized by the statutes authorizing the
construction grant program and shall be subject to the requirements of
this section.
(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
shall be obtained before entering into a final or unconditional
contract for the acquisition and/or modernization of facilities. Where
the Director finds that exceptions to or modifications of these minimum
standards would be consistent with the purposes of the applicable
section of the Act under which the acquisition or modernization 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 the 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 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 previously funded by a federal grant. No grant for the
acquisition or modernization of a facility which has previously been
funded in whole or in part by 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.
(Approved by the Office of Management and Budget under Control
Number 0925-0424; expires November 30, 2001)
Sec. 52b.12 What are the minimum requirements of construction and
equipment?
(a) General. In addition to being subject to other laws,
regulations, executive orders, 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 of 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 this
part. The publications referenced in this section are hereby
incorporated by reference and made a part of the regulations in this
part.
(b) Incorporation by reference. The Director of the Federal
Register approves the incorporations by reference in paragraph (c) of
this section in accordance with 5 U.S.C. 552(a)(1) and 1 CFR part 51.
Copies may also be obtained from the organizations at the addresses
listed in paragraph (c) of this section. Copies may be inspected at the
National Cancer Institute, Executive Plaza North, Room 539, 6130
Executive Boulevard, Rockville, MD 20852 (telephone 301-496-8534; not a
toll-free number); the National Center for Research Services, Building
31, Room 3B11, 9000 Rockville Pike, Bethesda, MD 20892 (telephone 301-
496-5793); not a toll-free number); and at the Office of the Federal
Register, 800 North Capital Street, NW, Suite 700, Washington, DC. The
Director may for good cause shown, approve plans and specifications
which contain deviations from the requirements prescribed in paragraph
(c) of this section, 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 the
applicable state and local codes and ordinances relating to
construction.
(c) Design and construction standards. The facility shall comply
with the following mandatory design and construction standards:
[[Page 63726]]
(1) ``Guidelines for Design and Construction of Hospital and Health
Care Facilities'' (1996-97). American Institute of Architects Academy
of Architecture for Health (AIA); available from AIA Rizzoli Catalogue
Sales, 117 Post Street, San Francisco, CA 94108 (telephone 1-800-522-
6657, fax 415-984-0024).
(2) 1995 ASHRAE Handbook: Heating, Ventilating, and Air
Conditioning Applications (1995), Chapter 13, ``Laboratory Systems.''
American Society of Heating, Refrigerating and Air Conditioning
Engineers, Inc., 1791 Tullie Circle, NE, Atlanta, GA 30329 (telephone
404-636-8400).
(3) ICBO ``Uniform Building Code,'' Volumes 1-3 (1997).
International Conference of Building Officials (ICBO), 5360 South
Workman Mill Road, Whittier, CA 90601-2298 (telephone 562-699-0541 or
800-284-4406).
(4) BOCA National Building Code (1996) 1998 Supplement, Building
Officials and Code Administrators International, Inc. (BOCA), 4051 West
Fossmoor Road, Country Club Hills, IL 60478-5795 (telephone 708-799-
4981; fax 708-799-4981).
(5) ``Recommended Lateral Force Requirements and Commentary''
(1996). Structural Engineers Association of California; available from
International Conference of Building Officials, 5360 South Workman Mill
Road, Whittier, CA 90601-2298 (telephone 562-699-0541).
(6) ``Prudent Practices in the Laboratory: Handling and Disposal of
Chemicals'' (1995). National Research Council; available from National
Academy Press, 8700 Spectrum Drive, Landover, MD 20785 (telephone 1-
800-624-6242).
(7) The following material is available for purchase from the
National Fire Protection Association (NFPA), 11 Tracy Drive, Avon, MA
02322-9908 (telephone 617-770-3000 or 1-800-735-0100):
(i) NFPA 45, ``Standard on Protection for Laboratories Using
Chemicals'' (1996).
(ii) NFPA 70, ``National Electric Code'' (1996).
(iii) NFPA 99, Chapter 4, ``Gas and Vacuum Systems'' (1996).
(iv) NFPA 101, ``Life Safety Code'' (1997).
(v) NFPA ``Health Care Facilities Handbook'' (1996).
(8) NSF Standard No. 49 for Class II (Laminar Flow) Biohazard
Cabinetry (1992). National Sanitation Foundation (NSF), 3475 Plymouth
Road, Box 1468, Ann Arbor, MI 48106 (telephone 734-769-9010).
(9) ACGIH ``Industrial Ventilation: A Manual of Recommended
Practice'' (1998). American Conference of Governmental Industrial
Hygienists (ACGIH), 1330 Kemper Meadow Drive, Cincinnati, OH 45240-1634
(telephone 513-742-2020).
(10) AIHA ``Laboratory Ventilation Workbook'' (1994). American
Industrial Hygiene Association (AIHA), 2700 Prosperity Avenue, Suite
250, Fairfax, VA 22031 (telephone 703-849-8888).
(11) The following material is available for purchase from the
Southern Building Code Congress (SBCC), 900 Montclair Road, Birmingham,
AL 35213-1206 (telephone 205-591-1853; fax 202-591-0075:
(i) SBCC ``International Standard Plumbing Code'' (1997).
(ii) SBCC ``Standard Building Code'' (1997).
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 laws, regulations, executive orders, and
policies that apply.
Other federal laws, regulations, executive orders, and policies
apply to grants under this part. These include, but are not necessarily
limited to:
(a) Laws.
An Act to Provide for the Preservation of Historical and
Archeological Data (and other purposes), as amended (16 U.S.C. 469 et
seq.).
Architectural Barriers Act of 1968, as amended (42 U.S.C. 4151
et seq.).
Earthquake Hazards Reduction Act of 1977, as amended (42 U.S.C.
7701 et seq.).
Flood Disaster Protection Act of 1973, section 202, as amended
(42 U.S.C. 4106).
National Historic Preservation Act, section 106, as amended (16
U.S.C. 470f).
Safe Drinking Water Act, as amended (42 U.S.C. 300f et seq.).
(b) Regulations.
9 CFR part 3--Standards (Animal Welfare).
29 CFR 1910.1450--Occupational exposure to hazardous chemicals
in laboratories.
36 CFR part 1190--Minimum guidelines and requirements for
accessible design.
41 CFR part 101-19, subpart 101-19.6--Accommodations for the
physically handicapped.
41 CFR part 101-19, subpart 101-19.6, Appendix A--Uniform
Federal accessibility standards.
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 15--Uniform relocation assistance and real property
acquisition for Federal and federally assisted programs.
45 CFR part 16--Procedures of the Departmental Grant Appeals
Board.
45 CFR part 46--Protection of human subjects.
45 CFR part 74--Uniform administrative requirements for awards
and subawards to institutions of higher education, hospitals, other
nonprofit organizations, and commercial organizations; and certain
grants and agreements with states, local governments and Indian
tribal governments.
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 chapter.
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 benefitting 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 92--Uniform administrative requirements for grants
and cooperative agreements to State and local governments.
45 CFR part 93--New restrictions on lobbying.
49 CFR part 24--Uniform relocation assistance and real property
acquisition for Federal and federally assisted programs.
(c) Executive orders.
Executive Order 11988, Floodplain Management (May 24, 1977)(3
CFR, 1977 Comp., p. 117).
Executive Order 11990, Protection of Wetlands (May 24, 1977)(3
CFR, 1977 Comp., p. 121).
Executive Order 12699, Seismic Safety of Federal and Federally
Assisted or Regulated New Building Construction (January 5, 1990)(3
CFR, 1990 Comp., p. 269).
(d) Policies.
(1) Design Policy and Guidelines (1996). Division of Engineering
Services, National Institutes of Health (Note: To obtain copies of
the policy, interested persons should contact the Division of
Engineering Services, 9000 Rockville Pike, Building 13, Room 2E43,
Bethesda, MD 20892 (telephone 301-496-6186; not a toll-free number)
or visit the following site on the World Wide Web
(http://des.od.nih/gov/nihpol.html).).
(2) NIH Guidelines on the Inclusion of Women and Minorities as
Subjects in Clinical Research (1994) (Note: To obtain copies of the
policy, interested persons should contact the Office of Research on
[[Page 63727]]
Women's Health, NIH, Room 201, Building 1, MSC 0161, Bethesda, MD
20892-0161 (telephone 301-402-1770; not a toll-free number).).
(3) NIH Guidelines for Research Involving Recombinant DNA
Molecules (1994) (Note: To obtain copies of the policy, interested
persons should contact the Office of Recombinant DNA Activities,
NIH, 6000 Executive Boulevard, Suite 323, MSC 7010, Bethesda, MD
20892-7010 (telephone 301-496-9838; not a toll-free number).).
(4) ``NIH Grants Policy Statement.'' NIH Pub. No. 99-80 (Oct.
1998) (Note: To obtain copies of the policy, interested persons
should contact the Extramural Outreach and Information Resources
Office (EOIRO), Office of Extramural Research, NIH, 6701 Rockledge
Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910 (telephone 301-
435-0714; not a toll-free number). Information may also be obtained
by contacting the EOIRO via its e-mail address
([email protected]) and by browsing the NIH Home Page site
on the World Wide Web (http://www.nih.gov).).
(5) ``Guide for the Care and Use of Laboratory Animals (1996).
Institute of Laboratory Animal Resources, Commission on Life
Sciences, National Research Council (Note: To obtain copies of the
policy, interested persons should contact the Office for Protection
from Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC
7507, Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-
free number).).
(6) ``Public Health Service Policy on Humane Care and Use of
Laboratory Animals.'' (Rev. Sept. 1986). Office for Protection from
Research Risks, NIH (Note: To obtain copies of the policy,
interested persons should contact the Office for Protection from
Research Risks, NIH, 6100 Executive Boulevard, Suite 3B01, MSC 7507,
Rockville, MD 20852-7507 (telephone 301-496-7005; not a toll-free
number).).
(7) ``Biosafety in Microbiological and Biomedical
Laboratories.'' DHHS Publication No. (CDC) 88-8395 (1993). Centers
for Disease Control and Prevention (CDC) (Note: To obtain copies of
the policy, interested persons should contact the Division of
Safety, Occupational Safety and Health Branch, NIH, 13 South Drive,
Room 3K04, MSC 5760, Bethesda, MD 20892-5760 (telephone 301-496-
2960; not a toll-free number).).
(8) ``NIH Guidelines for the Laboratory Use of Chemical
Carcinogens,'' DHHS Publication No. (NIH) 81-2385 (May 1981) (Note:
To obtain copies of the policy, interested persons should contact
the Division of Safety, Occupational Safety and Health Branch, NIH,
13 South Drive, Room 3K04, MSC 5760, Bethesda, MD 20892-5760
(telephone 301-496-2960; not a toll-free number).).
(9) ``NIH Policy and Guidelines on the Inclusion of Children as
Participants in Research Involving Human Subjects (March 6, 1998).''
NIH Guide for Grants and Contracts (Note: To obtain copies of the
policy, interested persons should contact the Office of Extramural
Research, NIH, 6701 Rockledge Drive, Room 6208, MSC 7910, Bethesda,
MD 20817-7910 (telephone 301-435-0714; not a toll-free number).
Information may also be obtained by browsing the NIH Home Page site
on the World Wide Web (http://www.nih.gov).).
[FR Doc. 99-30068 Filed 11-19-99; 8:45 am]
BILLING CODE 4140-01-P