[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Rules and Regulations]
[Pages 36462-36463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17557]



[[Page 36461]]


_______________________________________________________________________

Part V





Department of Housing and Urban Development





_______________________________________________________________________



24 CFR Part 60



Office of the Secretary: Streamlining of HUD Regulations Governing the 
Protection of Human Subjects; Final Rule

  Federal Register / Vol. 61, No. 133 / Wednesday, July 10, 1996 / 
Rules and Regulations  

[[Page 36462]]



DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

24 CFR Part 60

[Docket No. FR-4069-F-01]
RIN 2501-AC26


Office of the Secretary; Streamlining of HUD Regulations 
Governing the Protection of Human Subjects

AGENCY: Office of the Secretary, HUD.

ACTION: Final rule.

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

SUMMARY: HUD's regulations at 24 CFR part 60 govern the protection of 
human subjects involved in research conducted or sponsored by HUD. 
These regulations are identical to those set forth by the Department of 
Health and Human Services (HHS). This final rule, which is part of 
HUD's continuing efforts to implement the President's regulatory reform 
initiative, amends part 60 to simply cross-reference to the HHS 
regulations, rather than repeating these identical provisions.

EFFECTIVE DATE: August 9, 1996.

FOR FURTHER INFORMATION CONTACT: Camille E. Acevedo, Assistant General 
Counsel for Regulations, Office of General Counsel, Room 10276, 
Department of Housing and Urban Development, 451 Seventh Street, SW., 
Washington, DC 20410, telephone (202) 708-3055. (This is not a toll-
free number.) Hearing- or speech-impaired individuals may access this 
number via TTY by calling the toll-free Federal Information Relay 
Service at 1-800-877-8339.

SUPPLEMENTARY INFORMATION:

I. Background

    On June 18, 1991 (56 FR 28003), HUD and fifteen other Federal 
Departments and Agencies published a common rule establishing 
guidelines for the protection of human subjects involved in research 
conducted or funded by these Departments and Agencies. Adoption of 
these common requirements implemented a recommendation made by the 
President's Commission for the Study of Ethical Problems in Medicine 
and Biomedical and Behavioral Research (the President's Commission), 
which was established by 42 U.S.C. 300v. HUD has codified these 
requirements at 24 CFR part 60.
    The President's Commission is directed by 42 U.S.C. 300v-1(c) to 
report biennially to the President, the Congress, and appropriate 
Federal Departments and Agencies on the protection of human research 
subjects involved in biomedical or behavioral research. In carrying out 
that charge, the President's Commission must conduct a review of ``the 
rules, policies, guidelines, and regulations of all Federal agencies 
regarding the protection of human subjects of biomedical or behavioral 
research which such agencies conduct or sponsor.'' Further, the review 
``may include such recommendations for legislation and administrative 
action as the [President's] Commission deems appropriate.'' (See 42 
U.S.C. 300v-1(c).)
    In December 1981, the President's Commission issued its first 
biennial report. Each Department or Agency receiving recommendations 
from the President's Commission with respect to its rules, policies, 
guidelines or regulations, is required by 42 U.S.C. 300v-1(b)(1) to 
publish the recommendations for public comment. On March 29, 1982 (47 
FR 13272), the Department of Health and Human Services (HHS) published 
the recommendations on behalf of all affected Departments and Agencies. 
Among other suggestions, the President's Commission recommended that:

    The President should, through appropriate action, require that 
all federal departments and agencies adopt as a common core the 
regulations governing research with human subjects issued by the 
Department of Health and Human Services (codified at 45 CFR part 
46), as periodically amended or revised, while permitting additions 
needed by any department or agency that are not inconsistent with 
these core provisions. (47 FR 13272, 13294)

    In May 1982, the affected Federal Departments and Agencies formed a 
committee, chaired by an HHS representative, to consider the 
recommendations made by the President's Commission and the public 
comments submitted on these recommendations. On June 3, 1986 (51 FR 
20204), the committee published for public comment a proposed model 
policy for the protection of human subjects. In accordance with the 
recommendation made by the President's Commission, the proposed model 
policy was based on subpart A of the HHS regulations at 45 CFR part 46. 
The June 18, 1991 rule finalized the requirements set forth in the June 
3, 1986 proposed model policy and considered the public comments 
submitted on the proposed policy.
    HUD's regulations at 24 CFR part 60, which implement the model 
policy, are identical to the HHS regulations at 45 CFR part 46, subpart 
A. One of the goals of President's Clinton's regulatory reform 
initiative is the elimination of repetitious regulatory provisions. 
Accordingly, this final rule amends 24 CFR part 60 to simply cross-
reference to the HHS requirements, rather than repeating these 
identical provisions. Elimination of these redundant provisions will 
assist in HUD's goal of streamlining the content of title 24.

II. Justification for Final Rulemaking

    HUD generally publishes a rule for public comment before issuing a 
rule for effect, in accordance with its own regulations on rulemaking 
in 24 CFR part 10. However, part 10 provides for exceptions to the 
general rule if the agency finds good cause to omit advance notice and 
public participation. The good cause requirement is satisfied when 
prior public procedure is ``impracticable, unnecessary, or contrary to 
the public interest'' (24 CFR 10.1). HUD finds that good cause exists 
to publish this rule for effect without first soliciting public 
comment. This rule merely eliminates unnecessary repetition by reducing 
HUD's regulations at 24 CFR part 60 to a single section which cross-
references the identical HHS requirements at 45 CFR part 46, subpart A. 
It does not establish or affect substantive policy. Therefore, prior 
public comment is unnecessary.

III. Other Matters

Environmental Impact

    A Finding of No Significant Impact with respect to the environment 
has been made in accordance with HUD regulations at 24 CFR part 50, 
which implements section 102(2)(C) of the National Environmental Policy 
Act of 1969. The Finding of No Significant Impact is available for 
public inspection between 7:30 a.m. and 5:30 p.m. weekdays in the 
Office of the Rules Docket Clerk. Office of General Counsel, Department 
of Housing and Urban Development, Room 10276, 451 Seventh Street, SW, 
Washington, DC 20410.

Executive Order 12612, Federalism

    The General Counsel has determined, as the Designated Official for 
HUD under section 6(a) of Executive Order 12612, Federalism, that the 
policies contained in this final rule will not have federalism 
implications and, thus, are not subject to review under that Order. 
This final rule eliminates unnecessary repetition by amending 24 CFR 
part 60 to merely cross-reference to the identical HHS regulatory 
provisions. The final rule will not impinge upon the relationship 
between the Federal Government and State and local governments.

[[Page 36463]]

Executive Order 12606, The Family

    The General Counsel, as the Designated Official under Executive 
Order 12606, The Family, has determined that this final rule does not 
have a potential for significant impact on family formation, 
maintenance, and general well-being. This rule, as part of HUD's 
continuing efforts to implement the President's regulatory reform 
initiative, eliminates redundant regulatory provisions from title 24 of 
the CFR. No substantial change in existing HUD policies or programs 
will result from promulgation of this rule.

Regulatory Flexibility Act.

    The Secretary, in accordance with the Regulatory Flexibility Act (5 
U.S.C. 605(b)) has reviewed and approved this final rule, and in so 
doing certifies that this final rule will not have a significant 
economic impact on a substantial number of small entities. This final 
rule eliminates unnecessary repetition from title 24 of the CFR. The 
rule reduces HUD's regulations at 24 CFR part 60 to a single section 
which simply cross-references to the identical HHS requirements at 45 
CFR part 46, subpart A. Elimination of these redundant provisions will 
assist in HUD's continuing efforts to implement the President's 
regulatory reform initiative. This rule does not establish or affect 
substantive policy, and will not have any meaningful economic impact on 
any entity.

List of Subjects in 24 CFR Part 60

    Human research subjects, Reporting and recordkeeping requirements.

    Accordingly, 24 CFR part 60 is amended as follows:

PART 60--PROTECTION OF HUMAN SUBJECTS

    1. The authority citation for 24 CFR part 60 is revised to read as 
follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 300v-1(b) and 3535(d).

    2. Section 60.101 is revised to read as follows:


Sec. 60.101  Cross-reference.

    The provisions set forth at 45 CFR part 46, subpart A, concerning 
the protection of human research subjects, apply to all research 
conducted, supported, or otherwise subject to regulation by HUD.


Secs. 60.102 through 60.124  [Removed]

    3. Sections 60.102 through 60.124 are removed.

    Dated: June 28, 1996.
Henry G. Cisneros,
Secretary.
[FR Doc. 96-17557 Filed 7-9-96; 8:45 am]
BILLING CODE 4210-32-P