83 FR 3589 - Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects

DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

Federal Register Volume 83, Issue 18 (January 26, 2018)

On January 19, 2017, HUD and other federal departments and agencies published a final rule which revised the Federal Policy for the Protection of Human Subjects (2018 Requirements). Most of the 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018. On January 22, 2018, the Federal departments and agencies that adopted the 2018 Requirements published an interim final rule (``the interagency interim final rule'') that delays the effective date and general compliance date of the 2018 Requirements for six months, to July 19, 2018. The purpose of the delay is to provide additional time to regulated entities for the preparations necessary to implement the 2018 requirements. Due to statutory prepublication requirements applicable to HUD rules, HUD was unable to be a signatory to the interagency interim final rule. Through this interim final rule, HUD adopts the interagency interim final rule.

[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3589-3591]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-01497]


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DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT

24 CFR Part 60

[Docket No. FR-6077-I-01]


Federal Policy for the Protection of Human Subjects: Delay of the 
Revisions to the Federal Policy for the Protection of Human Subjects

AGENCY: Office of the Assistant Secretary for Policy, Development and 
Research, HUD.

ACTION: Interim final rule; delay of effective and compliance dates; 
request for comments.

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SUMMARY: On January 19, 2017, HUD and other federal departments and 
agencies published a final rule which revised the Federal Policy for 
the Protection of Human Subjects (2018 Requirements). Most of the 2018 
Requirements were scheduled to become effective on January 19, 2018, 
with a general compliance date of January 19, 2018. On January 22, 
2018, the Federal departments and agencies that adopted the 2018 
Requirements published an interim final rule (``the interagency interim 
final rule'') that delays the effective date and general compliance 
date of the 2018 Requirements for six months, to July 19, 2018. The 
purpose of the delay is to provide additional time to regulated 
entities for the preparations necessary to implement the 2018 
requirements. Due to statutory prepublication requirements applicable 
to HUD rules, HUD was unable to be a signatory to the interagency 
interim final rule. Through this interim final rule, HUD adopts the 
interagency interim final rule.

DATES: Effective date: February 26, 2018.
    Comment due date: March 27, 2018.

ADDRESSES: You may submit comments, identified by docket ID number HHS-
OPHS-2017-0001 by one of the following methods:
     Federal eRulemaking Portal (http://www.regulations.gov):
    [cir] Enter the following link into your web browser's address bar: 
https://www.regulations.gov/document?D=HHS-OPHS-2017-0001.
    [cir] Click the blue ``Comment Now!'' button in the upper right-
hand corner and follow the instructions on how to submit a comment.
    [cir] Alternatively, you can enter the docket ID number into the 
``search'' box on the main page of the Federal eRulemaking Portal 
(http://www.regulations.gov) to find the electronic docket.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]

[[Page 3590]]

to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, 
Rockville, MD 20852.
     Comments received, including any personal information, 
will be posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Barry L. Steffen, Policy Development 
Division, Office of Policy Development and Research, Department of 
Housing and Urban Development, 451 7th Street SW, Room 8114, 
Washington, DC 20410-8000, telephone 202-402-5926. (This is not a toll-
free number.) Persons with hearing- or speech-impairments may access 
this number through TTY number by calling the Federal Relay Service 
number at 800-877-8339 (this is a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    On January 19, 2017, HUD and other Federal departments and agencies 
that are subject to the Federal Policy for the Protection of Human 
Subjects published a final rule amending that policy (82 FR 7149) (2018 
Requirements). The Department of Health and Human Services (HHS) is the 
lead agency on this rulemaking. The 2018 Requirements were scheduled to 
become effective on January 19, 2018, with a general compliance date of 
January 19, 2018 (with the exception of the revisions to the 
cooperative research provision at 24 CFR 60.114(b), for which the 
compliance date is January 20, 2020). After publication of the 2018 
Requirements, representatives of the regulated community expressed 
concern regarding their ability to implement all of the 2018 
Requirements by the scheduled general compliance date and some asked 
for a delay. The HHS Secretary's Advisory Committee on Human Research 
Protections recommended in August 2017 that the required implementation 
of the 2018 Requirements be delayed.
    On January 22, 2018, at 83 FR 2885, the Federal departments and 
agencies published an interagency interim final rule, which delays the 
effective date and general compliance date of the 2018 Requirements for 
six months, to July 19, 2018. The interagency interim final rule also 
solicits public comment on whether changes to the rule are justified. 
Due to statutory prepublication requirements applicable to HUD rules, 
HUD was unable to be a signatory to the interagency interim final rule. 
Specifically, section 7(o) the Department of Housing and Urban 
Development Act (42 U.S.C. 3535(o)) provides for 15-day Congressional 
prepublication review of certain HUD rules. Rather than potentially 
delay publication of the interagency rule to comply with this HUD-
specific requirement, HUD has opted to issue this interim final rule. 
HUD's rule adopts the interagency interim final rule and also solicits 
public comment on whether changes to the effective and compliance dates 
are justified. Please see the interagency interim final rule for 
further background and explanation.

II. Justification for Interim-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 advanced notice and 
public participation. The good cause requirement is satisfied when 
prior public procedure is ``impractical, unnecessary, or contrary to 
the public interest'' (see 24 CFR 10.1). For the following reasons, HUD 
has determined that it would be contrary to the public interest to 
delay the effectiveness of this rule in order to solicit prior public 
comments.
    The rule does not substantively alter the requirements of the 2018 
Requirements, which were issued following advance notice and an 
opportunity for comment. Rather, the sole purpose of this rulemaking is 
to delay the effective date and general compliance date of those 
requirements. As noted, the delay is being issued in response to 
concerns from the public. HUD is issuing this rule separately from the 
other agencies due to statutory prepublication review requirements. A 
delay for prior public procedure would result in HUD program 
participants being subject to a unique set of regulatory requirements 
different than those applicable for other, substantially identical, 
Federal activities. Participants in programs administered by HUD as 
well as those of other agencies would be required with two different 
set of regulations for undertaking similar activities.
    Given the burdensome outcomes resulting from a delay, the non-
substantive nature of the rule, and the fact that the rule responds to 
concerns raised by the public, HUD believes that good cause exists to 
publish this rule for effect without prior public comment. HUD, 
however, recognizes the value of public comment in the development of 
its regulations. HUD has, therefore, issued these regulations on an 
interim basis and has provided the public with a 60-day comment period. 
HUD welcomes comments on the regulatory amendments made by this interim 
rule. The public comments will be addressed in the final rule.

III. Findings and Certifications

Regulatory Review--Executive Orders 12866 and 13563

    Under Executive Order 12866 (Regulatory Planning and Review), a 
determination must be made whether a regulatory action is significant 
and therefore, subject to review by the Office of Management and Budget 
(OMB) in accordance with the requirements of the order. Executive Order 
13563 (Improving Regulations and Regulatory Review) directs executive 
agencies to analyze regulations that are ``outmoded, ineffective, 
insufficient, or excessively burdensome, and to modify, streamline, 
expand, or repeal them in accordance with what has been learned.'' For 
further discussion of the significance of this interim final rule and 
its anticipated benefits and costs, see the interagency interim final 
rule.

Paperwork Reduction Act (PRA)

    This interim final rule does not impose any additional information 
collection burden under the PRA. If finalized, this interim final rule 
will not contain any information collection activities beyond the 
information collection already approved by OMB under control number 
0990-0260.

Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), 
generally requires an agency to conduct a regulatory flexibility 
analysis of any rule subject to notice and comment rulemaking 
requirements unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
This interim final rule does not impose a regulatory burden for 
regulated small entities because it delays the effective date and the 
general compliance date of the 2018 Requirements, allowing the status 
quo to be retained for the period of delay. Therefore, the undersigned 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities.

Environmental Impact

    This interim final rule does not direct, provide for assistance or 
loan and mortgage insurance for, or otherwise govern or regulate, real 
property acquisition, disposition, leasing, rehabilitation, alteration, 
demolition, or new construction, or establish, revise, or provide for 
standards for construction or

[[Page 3591]]

construction materials, manufactured housing, or occupancy. 
Accordingly, under 24 CFR 50.19(c)(1), this rule is categorically 
excluded from environmental review under the National Environmental 
Policy Act (42 U.S.C. 4321).

Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1531-1538) (UMRA) establishes requirements for federal agencies to 
assess the effects of their regulatory actions on state, local, and 
tribal governments and the private sector. This interim final rule does 
not impose any federal mandates on any state, local, or tribal 
governments or the private sector within the meaning of UMRA.

Executive Order 13132: Federalism

    Executive Order 13132 (entitled ``Federalism'') prohibits an agency 
from publishing any rule that has federalism implications if the rule 
either (1) imposes substantial, direct compliance costs on state and 
local governments, and is not required by statute, or (2) preempts 
state law, unless the agency meets the consultation and funding 
requirements of section 6 of the Executive Order. This interim final 
rule does not have federalism implications and does not impose 
substantial direct compliance costs on state and local governments or 
preempt state law within the meaning of the Executive Order.

Executive Order 13771: Reducing Regulation and Controlling Regulatory 
Costs

    Executive Order 13771, Reducing Regulation and Controlling 
Regulatory Costs was issued on January 30, 2017. For further discussion 
of E.O. 13771, please see the interagency interim final rule.

List of Subjects for 24 CFR Part 60

    Human research subjects, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, HUD amends part 60 of title 
24 of the Code of Federal Regulations as follows:

PART 60--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for part 60 continues to read as follows:

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


0
2. Amend Sec.  60.101 by revising paragraphs (l)(3) and (4) to read as 
follows:


Sec.  60.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review 
was waived pursuant to Sec.  60.101(i), or for which a determination 
was made that the research was exempt before July 19, 2018, shall 
comply with the pre-2018 Requirements, except that an institution 
engaged in such research on or after July 19, 2018 may instead comply 
with the 2018 Requirements if the institution determines that such 
ongoing research will comply with the 2018 Requirements and an IRB 
documents such determination.
    (4) Research initially approved by an IRB, for which such review 
was waived pursuant to Sec.  60.101(i), or for which a determination 
was made that the research was exempt on or after July 19, 2018, shall 
comply with the 2018 Requirements.
* * * * *

    Dated: January 11, 2018.
Todd M. Richardson,
Acting General Deputy Assistant Secretary for Policy Development and 
Research.
[FR Doc. 2018-01497 Filed 1-25-18; 8:45 am]
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