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

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]

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