[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Rules and Regulations]
[Pages 2885-2894]
[FR Doc No: 2018-00997]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules
and Regulations

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DEPARTMENT OF HOMELAND SECURITY

6 CFR Part 46

DEPARTMENT OF AGRICULTURE

7 CFR Part 1c

DEPARTMENT OF ENERGY

10 CFR Part 745

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

14 CFR Part 1230

DEPARTMENT OF COMMERCE

15 CFR Part 27

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1028

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 431

AGENCY FOR INTERNATIONAL DEVELOPMENT

22 CFR Part 225

DEPARTMENT OF LABOR

29 CFR Part 21

DEPARTMENT OF DEFENSE

32 CFR Part 219

DEPARTMENT OF EDUCATION

34 CFR Part 97

DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 16

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN 0937-AA06

NATIONAL SCIENCE FOUNDATION

45 CFR Part 690

DEPARTMENT OF TRANSPORTATION

49 CFR Part 11

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

AGENCY: Department of Homeland Security; Department of Agriculture;
Department of Energy; National Aeronautics and Space Administration;
Department of Commerce; Consumer Product Safety Commission; Social
Security Administration; Agency for International Development;
Department of Labor; Department of Defense; Department of Education;
Department of Veterans Affairs; Environmental Protection Agency;
Department of Health and Human Services; National Science Foundation;
and Department of Transportation.

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

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SUMMARY: In a final rule published on January 19, 2017, federal
departments and agencies listed in this document made revisions to the
Federal Policy for the Protection of Human Subjects. The Consumer
Product Safety Commission (CPSC) adopted the same regulatory changes in
a separate final rule published on September 18, 2017. The revised
policy, reflected in both final rules, is described here as the ``2018
Requirements.'' The 2018 Requirements are 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).
    This interim final rule delays the effective date and general
compliance date of the 2018 Requirements to July 19, 2018. The federal
departments and agencies listed in this document are in the process of
developing a proposed rule to further delay implementation of the 2018
Requirements. The limited implementation delay accomplished by this
interim final rule both provides additional time to regulated entities
for the preparations necessary to implement the 2018 Requirements, and
additional time for the departments and agencies listed in this
document to seek input from interested stakeholders through a notice
and comment rulemaking process that allows for public engagement on the
proposal for a further implementation delay.

DATES: This interim final rule is effective on July 19, 2018. This
interim final rule delays until July 19, 2018, the effective date and
general compliance date of the final rule published in the Federal
Register (82 FR 7149, Jan. 19 2017) and of the final rule published by
the Consumer Product Safety Commission in the Federal Register (82 FR
43459, Sept. 18, 2017). To be assured consideration, comments must be
received at one of the addresses provided below, no later than 11:59
p.m. Eastern Standard Time on March 19, 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] 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: Jerry Menikoff, M.D., J.D., Office for
Human Research Protections (OHRP), Department of Health and Human
Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852;
telephone:<PHONE_NUMBER> or 1-866-447-4777; facsimile:<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On September 8, 2015, HHS and 15 other federal departments and
agencies published a Notice of Proposed Rulemaking (NPRM) proposing
revisions to each agency's codification of the Federal Policy for the
Protection of Human Subjects, originally promulgated as a Common Rule
in 1991. 80 FR 53931. On January 19, 2017, HHS and other federal
departments and agencies published a final rule revising the Federal
Policy for the Protection of Human Subjects. 82 FR 7149. The revised
policy is hereafter referred to as the ``2018 Requirements.'' The 2018
Requirements are 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 Sec.
_.114(b), for which the compliance date is January 20, 2020).
    After publication of the 2018 Requirements, representatives of the
regulated community, including organizations representing recipients of
federal human subjects research awards, expressed concern regarding the
regulated community's ability to implement all of the 2018 Requirements
by the scheduled general compliance date.\1\ Some of these stakeholders
asked for a delay in the general compliance date of the 2018
Requirements with the exception of certain burden-reducing provisions
of the 2018 Requirements, including certain carve-outs from the
definition of ``research,'' exemptions, elimination of the continuing
review requirement for certain categories of research, and the
elimination of the requirement that institutional review boards (IRBs)
review grant applications. The HHS Secretary's Advisory Committee on
Human Research Protections (SACHRP) also recommended in August 2017
that implementation of the 2018 Requirements should be delayed.\2\
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    \1\ See the June 21, 2017 letter to Jerry Menikoff from the
Association of American Medical Colleges, Association of American
Universities, Association of Public & Land-grant Universities, and
Council on Governmental Relations, available at http://www.cogr.edu/sites/default/files/AAMC_AAU_APLU_COGR%20Common%20Rule%20Delay%20Letter%206-21-2017.pdf.
See the June 9, 2017 letter to Secretary Thomas Price from the
American Medical Informatics Association at https://www.amia.org/sites/default/files/AMIA%20Letter%20Regarding%20the%20Common%20Rule.pdf.
    \2\ SACHRP Recommendations of August 2, 2017, Attachment A:
https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-a-august-2-2017/index.html.
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II. Delay of the Effective Date and General Compliance Date

    Through this interim final rule, we are delaying the effective date
and the general compliance date of the 2018 Requirements for six
months, until July 19, 2018. As described below, we revise Sec.
_.101(l)(3)-(4) to specify that the general compliance date for the
2018 Requirements is July 19, 2018.
    Prior to July 19, 2018, regulated entities will continue to comply
with the pre-2018 Requirements and those requirements will be enforced
by the Common Rule departments and agencies. To clarify, regulated
entities are not allowed, prior to July 19, 2018, to comply with the
2018 Requirements in lieu of the pre-2018 Requirements. Unless further
regulatory action is taken, studies initiated on or after July 19,
2018, will be required to comply with the 2018 Requirements. Studies
initiated prior to July 19, 2018 (i.e., studies initially approved by
an IRB, studies for which IRB review was waived pursuant to Sec.
_.101(i), or studies determined to be exempt, before July 19, 2018)
would, as a default, continue to be subject to the pre-2018
Requirements for their duration. This will maintain the ability of
institutions to hold such studies to the same set of standards
throughout the studies' duration, and will avoid a requirement that
such research be subject to two sets of rules. However, on or after
July 19, 2018, institutions may elect instead to conduct such studies
in compliance with the 2018 Requirements, as set forth in Sec.
_.101(l)(3).
    This interim final rule does not delay the compliance date for the
cooperative research provision of the 2018 Requirements (Sec.
_.114(b)), which remains January 20, 2020.

III. Good Cause for Interim Final Rule

    Under Section 553(b) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.), a notice of proposed rulemaking is not required
when an agency, for good cause, finds that notice and public comment
thereon are impracticable, unnecessary, or contrary to the public
interest. Pursuant to 5 U.S.C. 553(b)(3)(B), we find that good cause
exists to waive normal rulemaking requirements for the delay of the
effective date and general compliance date to July 19, 2018. We believe
that a notice-and-comment procedure, in this limited instance, is
impracticable, unnecessary, or contrary to the public interest.
    Representatives of the regulated community, and HHS's own advisory
committee, have requested a delay in implementation of the 2018
Requirements, citing the final rule's complexity, the absence of needed
guidance, and the need to revamp institutional procedures and
electronic systems in order to come into compliance with the
requirements of the rule. We agree that regulated entities need
additional time for implementation and compliance, which would be
furthered by the issuance of guidance by the Common Rule agencies.
Without a delay, and without guidance, institutions that have expected
a delay who hastily attempt to implement the revised rule without
adequate preparation are bound to make mistakes, the consequences of
which may jeopardize the proper conduct of research and the safety and
wellbeing of human subjects. At this point, it is impracticable to
gather comments on an implementation delay prior to January 19, 2018,
the scheduled effective date of the 2018 Requirements.
    In addition, the benefits underlying this interim final rule, i.e.,
providing certainty to entities in the regulated community that they
will be afforded additional time before being subject to compliance
with the 2018 Requirements prior to the date such requirements are
scheduled to go into effect, would be substantially undermined if a
notice and comment process were to occur before the delay set forth in
this interim final rule was finalized. For example, we understand that
regulated entities may need to devise new policies and procedures and
new information technology systems to accommodate the 2018 Requirements
in advance of the applicable effective and compliance date. In
addition, the effect of this interim final rule is simply to maintain
the status quo by continuing to require compliance with the pre-2018
Requirements for several months.
    Further, the federal departments and agencies named in this interim
final rule are developing a notice of proposed rulemaking in order to
fully engage regulated entities and the public regarding further delay
of the 2018 Requirements until January 21, 2019.

The additional time provided by the six month delay in this interim
final rule will allow sufficient time for the notice and comment
rulemaking process to be completed. Issuance of this interim final rule
avoids the possible result of having the federal departments and
agencies propose an implementation delay but be unable to complete the
rulemaking process and publish a final rule that would be effective by
January 19, 2018. This could have resulted in the absurd circumstance
in which regulated entities would be technically required to come into
compliance with the 2018 Requirements on January 19, 2018, only until
the date a final rule implementing the delay became effective. In this
unique circumstance, allowing the regulation to become effective while
further rulemaking for delay is ongoing would create confusion for, and
impose unnecessary burdens on, the regulated community.
    We also find that good cause exists for immediate implementation of
this interim final rule and waiver of the 30-day delay in the effective
date generally required by the APA. The APA provides that an agency is
not required to delay the effective date when the agency, for good
cause, finds that the requirement is impracticable, unnecessary, or
contrary to the public interest (5 U.S.C. 553(d)(3)). Given the reasons
identified above for the good cause to dispense with notice and
comment, we believe that this requirement is also met here. Further,
the 30-day delay in the effective date is normally intended to give
affected parties time to adjust their business practices and make
preparations before a final rule takes effect. Because the action being
taken delays the effective date to July 19, 2018 and thus maintains the
status quo, an additional 30-day delay of this action is unnecessary.

Department of Homeland Security

    The rule issued by the Department of Homeland Security (DHS) is
consistent with section 8306 of Public Law 108-458, the Intelligence
Reform and Terrorism Prevention Act of 2004, under which DHS shall
comply with 45 CFR part 46 or equivalent regulations issued by DHS;
continued adherence to the HHS standard best ensures that DHS does not
lose critical research opportunities as a result of inconsistent
federal standards. The DHS rule is also consistent with DHS's waiver
authority under forthcoming 6 CFR 46.101(i), as well as the exemption
at 5 U.S.C. 553(a)(2) for rules related to ``loans, grants, benefits,
or contracts.''

Department of Education

    Continued adherence to the HHS standard protects the Department of
Education (ED) from the potential loss of critical research
opportunities as a result of inconsistent federal standards. The ED
rule is also consistent with ED's waiver authority under 34 CFR
97.101(i).

IV. Legal Authorities

    The legal authorities for the departments and agencies that are
signatories to this action are as follows:
    Department of Homeland Security, 5 U.S.C. 301; Public Law 107-296,
sec. 102, 306(c); Public Law 108-458, sec. 8306. Department of
Agriculture, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of Energy, 5
U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b). National Aeronautics
and Space Administration, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department
of Commerce, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Consumer Product Safety
Commission, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Social Security
Administration, 5 U.S.C. 301; 42 U.S.C. 289(a). Agency for
International Development, 5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless
otherwise noted. Department of Labor, 5 U.S.C. 301; 29 U.S.C. 551.
Department of Defense, 5 U.S.C. 301. Department of Education, 5 U.S.C.
301; 20 U.S.C. 1221e-3, 3474. Department of Veterans Affairs, 5 U.S.C.
301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C. 300v-1(b). Environmental
Protection Agency, 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Public Law 109-54, 119 Stat. 531; and
42 U.S.C. 300v-1(b). Department of Health and Human Services, 5 U.S.C.
301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b). National Science
Foundation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b). Department of
Transportation, 5 U.S.C. 301; 42 U.S.C. 300v-1(b).

V. Regulatory Impact Analyses

    We have examined the effects of this interim final rule under
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), Executive Order 13771 on Reducing Regulation
and Controlling Regulatory Costs (January 30, 2017), the Paperwork
Reduction Act of 1995 (Pub. L. 104-13), the Regulatory Flexibility Act,
(Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism
(August 4, 1999).

A. Executive Orders 12866, 13563, and 13771

    Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 is supplemental to and reaffirms the principles,
structures, and definitions governing regulatory review as established
in Executive Order 12866, emphasizing the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. In accordance with the provisions of
Executive Order 12866, this interim final rule has been determined to
be a ``significant'' regulatory action and was submitted to the Office
of Management and Budget (OMB) for review.
    Executive Order 13771 directs Agencies to identify at least two
existing regulations to be repealed for every new regulation unless
prohibited by law. The total incremental cost of all regulations issued
in a given fiscal year must have costs within the amount of incremental
costs allowed by the Director of the Office of Management and Budget,
unless otherwise required by law or approved in writing by the Director
of the Office of Management and Budget. This action's designation as
regulatory or deregulatory will be informed by comments received in
response to this interim final rule. Details on the interim estimates
of costs and cost savings of this rule can be found in the economic
analysis below.
1. Need for Final Rule and Summary
    This interim final rule is intended to provide additional time to
regulated entities for the preparations necessary to implement the 2018
Requirements. This interim final rule further allows time for the
federal departments and agencies named in this interim final rule to
conduct a notice and comment rulemaking process that will allow for
public engagement as to whether a further delay in the implementation
of the 2018 Requirements would be desirable.
2. Analysis of Benefits (Cost-Savings) and Costs (Foregone Benefits)
\3\
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    \3\ Note, that the terms ``benefits'' and ``cost-savings'' are
used interchangeably in this RIA. Similarly, the terms ``costs'' and
``foregone benefits'' are also used interchangeably.
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    The RIA for the 2018 Requirements described the benefits and costs
of 16

broad categories of changes finalized. The RIA for this interim final
rule uses the information and calculations described in the preamble to
the 2018 Requirements as a base for estimating benefits and costs of
delaying implementation of the 2018 Requirements by six months. The
time period for the analysis in this RIA is January 2018 to July 2018.
    Table 1 summarizes the quantified costs and cost savings of
delaying implementation of 2018 Requirements. Over the period of
January 2018 to July 2018, annualized cost savings of $7.4 million are
estimated using a 3 percent discount rate; and $6.9 million using a 7
percent discount rate. Annualized costs of $49.5 million are estimated
using a 3 percent discount rate; and $45.9 million using a 7 percent
discount rate. Note that all values are represented in millions of 2016
dollars, and 2016 is used as the frame of reference for discounting.

Table 1--All Benefits and Costs of Delaying the 2018 Requirements by Six
                                 Months
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                                     Annualized value by discount rate
                                        (millions of 2016 dollars)
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BENEFITS (COST-SAVINGS).........  3 Percent.........  7 Percent.
Quantified Benefits.............  7.4...............  6.9.
COSTS (FOREGONE BENEFITS).......  3 Percent.........  7 Percent.
Quantified Costs................  49.5..............  45.9.
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    The estimated benefits and costs of delaying the 2018 Requirements
by six months are shown in Table 2 below. Note that the categorization
shown below includes the same 16 categories used in the RIA of 2018
Requirements.

  Table 2--Accounting Table of Quantified Benefits (Cost-Savings) and Costs (Foregone Benefits) of Delaying the
                                       2018 Requirements by Six Months \4\
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                                                    Annualized value over 1 year by discount rate (millions of
                                                                           2016 dollars)
                                                 ---------------------------------------------------------------
          2018 Requirement RIA category               Benefits (cost-savings)        Costs (foregone benefits)
                                                 ---------------------------------------------------------------
                                                        3%              7%              3%              7%
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Regulated Community Learning New Requirements                  -               -               -               -
 and Developing Training Materials; OHRP
 Developing Training and Guidance Materials, and
 Implementing the 2018 Requirements.............
Extending Oversight to IRBs Unaffiliated with an            4.47            4.14               -               -
 Institution Holding an FWA (impact to IRBs not
 operated by an FWA-holding institution)........
Excluding Activities from the Requirements of                  -               -            0.94            0.88
 the Common Rule because They are not Research..
Clarifying and Harmonizing Regulatory                          -               -               -               -
 Requirements and Agency Guidance...............
Modifying the Assurance Requirements............               -               -            0.31            0.29
Requirement for Written Procedures and                         -               -               -               -
 Agreements for Reliance on IRBs Not Operated by
 the Engaged Institution (impact to FWA-holding
 institutions)..................................
Eliminating the Requirement that the Grant                     -               -            17.0            15.7
 Application Undergo IRB Review and Approval....
Expansion of Research Activities Exempt from                0.01            0.01            20.8            19.3
 Full IRB Review................................
Elimination of Continuing Review of Research                2.07            1.92            7.73            7.17
 Under Specific Conditions......................
Amending the Expedited Review Procedures........               -               -            2.66            2.47
Cooperative Research (single IRB mandate in                    -               -               -               -
 multi-institutional research) \5\..............
Changes in the Basic Elements of Consent,                      -               -               -               -
 Including Documentation........................
Obtaining Consent to Secondary Use of                          -               -               -               -
 Identifiable biospecimens and Identifiable
 private information............................
Elimination of Pre-2018 Rule Requirement to                    -               -            0.07            0.06
 Waive Consent in Certain Subject Recruitment
 Activities.....................................
Requirement for Posting of Consent Forms for                0.85            0.79               -               -
 Clinical Trials Conducted or supported by
 Common Rule Department or Agencies.............
Alteration in Waiver for Documentation of                      -               -               -              -
 Informed Consent in Certain Circumstances......
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\4\ Zeroes in Table 2 (represented by ``-'') signify that the category has been unaffected by the six month
  delay of the 2018 Requirements, The category could be unaffected for one of two reasons: (1) No costs or
  benefits were associated with the category in the RIA for the 2018 Requirements; or (2) the costs and benefits
  of the provision during the six month delay are the same as those estimated in the RIA for the 2018
  Requirements.
\5\ Because compliance with this provision is not required until 2020, benefits and costs here are not included.

    We assume that, in almost all categories described in the RIA for
the 2018 Requirements, the foregone benefits (costs) of delaying the
2018 Requirements by six months are what would have been the benefits
of implementing the 2018 Requirements during the period of January
through July of 2018. Similarly, we assume that, in almost all
categories described in the RIA for the 2018 Requirements, the benefits
(cost-savings) associated with delaying the 2018 Requirements by six
months are what would have been the costs of implementing the 2018
Requirements during the period of January through July of 2018. We
assume this because these categories generally would not have required
significant guidance from Common Rule departments or agencies in order
to implement the provisions, and thus could have been implemented as
assumed in the economic analysis contained in the RIA for the 2018
Requirements.
    The exceptions to the above assumption relate to two RIA
categories: (1) Excluding activities from the Common Rule because they
are not research; and (2) the expansion of research activities exempt
from full IRB review. The 2018 Requirements include four explicit
categories of activities that have been deemed not research for the
purposes of the Common Rule. In the absence of guidance, it would be
difficult for institutions to fully take advantage of the exclusion of
activities from the definition of research; therefore we now assume
that many institutions would not have used these categories without
guidance.
    The 2018 Requirements also include five new exemption categories,
and modify all but one exemption that exists in the pre-2018
Requirements. We have received feedback from SACHRP that many of the
exemption categories will require significant guidance in order to be
implemented.\6\ Areas where significant guidance is needed include:
Applying the categories of the new exemptions themselves, conducting
limited IRB review (as required in four exemptions), developing and
using broad consent (as required in two exemptions), utilizing the
exemption for certain HIPAA covered activities, and understanding which
federally supported or conducted nonresearch information collections
qualify for exemption.
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    \6\ SACHRP Recommendations of August 2, 2017: https://www.hhs.gov/ohrp/sachrp-committee/recommendations/sachrp-recommendations/index.html.
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    Because the guidance necessary to implement these provisions has
not yet been developed, we now assume that 50 percent of the regulated
entities would not have taken advantage of the expansion in exemptions
or the revised definition of research during the six-month delay. For
these entities, we assume that there are no benefits and costs of the
proposed delay, because they would not have changed their operations.
We assume that 50 percent of the regulated entities would have gone
forward with using the new or expanded exemption categories under the
2018 Requirements; for these entities, there are costs of delaying the
implementation of this provision during the six-month delay of this
interim final rule. We are seeking comment on these assumptions.

B. Paperwork Reduction Act (PRA)

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

C. Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the
Small Business Regulatory Enforcement Fairness Act of 1996, which
amended the RFA, require agencies that issue a regulation to analyze
options for regulatory relief for small businesses. If a rule has a
significant impact on a substantial number of small entities, agencies
must specifically consider the economic effect of the rule on small
entities and analyze regulatory options that could lessen the impact of
the rule. The RFA generally defines a ``small entity'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA); (2) a nonprofit organization that is not dominant
in its field; or (3) a small government jurisdiction with a population
of less than 50,000 (states and individuals are not included in the
definition of ``small entity''). HHS considers a rule to have a
significant economic impact on a substantial number of small entities
if at least 5 percent of small entities experience an impact of more
than 3 percent of revenue.
    This action does not have a significant economic impact on a
substantial number of small entities under the RFA. In making this
determination, the impact of concern is any significant adverse
economic impact on small entities. An agency may certify that a rule
will not have a significant economic impact on a substantial number of
small entities if the rule relieves regulatory burden, has no net
burden or otherwise has a positive economic effect on the small
entities subject to the rule. This interim final rule does not impose a
regulatory burden for regulated small entities because it delays the
effective date and general compliance date of the 2018 Requirements,
allowing the status quo to be retained for the period of delay. We
have, therefore, concluded that this action will have no net regulatory
burden for all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $148 million, using the most current (2016) implicit
price deflator for the gross domestic product. We do not expect this
interim final rule to result in expenditures that will exceed this
amount. This action does not contain any unfunded mandate as described
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments.

E. Executive Order 13132: Federalism

    Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirement costs on state and local governments or has
federalism implications. We have determined that the interim final rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the Federal Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. The changes to the 2018 Requirements
contained in this interim final rule represent the Federal Government
regulating its own program. Accordingly, we conclude that the interim
final rule does not contain policies that have federalism implications
as defined in Executive Order 13132 and, consequently, a federalism
summary impact statement is not required.

    For the reasons set forth in the preamble, the Federal Policy for
the Protection of Human Subjects, as published in the Federal Register
on January 19, 2017 (82 FR 7149) and as adopted in a final rule
published by the CPSC on September 18, 2017 (82 FR 43459), this common
rule is further amended as follows:

Text of the Amended Common Rule

PART _--PROTECTION OF HUMAN SUBJECTS

0
1. Amend Sec.  _.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  _.101   To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  _.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.  _.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.
* * * * *

DEPARTMENT OF HOMELAND SECURITY

List of Subjects in 6 CFR Part 46

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Homeland
Security further amends 6 CFR part 46 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:

PART 46--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 46 continues to read as follows:

    Authority: 5 U.S.C. 301; P.L. 107-296, sec. 102, 306(c); P.L.
108-458, sec. 8306.

0
2. Amend Sec.  46.101 by revising paragraphs (l)(1), (2), (3), and (4)
to read as follows:

Sec.  46.101  To what does this policy apply?

* * * * *
    (l) * * *
    (1) For purposes of this section, the pre-2018 Requirements means
Subpart A to 45 CFR part 46, as published in the 2016 edition of the
Code of Federal Regulations, which is the rule that DHS applied before
it first promulgated this subpart.
    (2) For purposes of this section, the 2018 Requirements means the
Federal Policy for the Protection of Human Subjects requirements
contained in this part. The general compliance date for the 2018
Requirements is July 19, 2019. The compliance date for Sec.  46.114(b)
(cooperative research) of the 2018 Requirements is January 20, 2020.
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  46.101(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.  46.101(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.
* * * * *

William Bryan,

Deputy Under Secretary for Science & Technology.

DEPARTMENT OF AGRICULTURE

List of Subjects in 7 CFR Part 1c

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of
Agriculture further amends 7 CFR part 1c as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:

PART 1c--PROTECTION OF HUMAN SUBJECTS

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

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

0
2. Amend Sec.  1c.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  1c.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  1c.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.  1c.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.
* * * * *

Chavonda Jacobs-Young,

Acting Deputy Under Secretary for Research, Education, and
Economics, USDA.

DEPARTMENT OF ENERGY

List of Subjects in 10 CFR Part 745

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Energy
further amends 10 CFR part 745 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:

PART 745--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 745 continues to read as follows:

    Authority:  5 U.S.C. 301; 42 U.S.C. 7254; 42 U.S.C. 300v-1(b).

0
2. Amend Sec.  745.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  745.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  745.101(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.  745.101(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.
* * * * *

Dan Brouillette,

Deputy Secretary of Energy.

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION

List of Subjects in 14 CFR Part 1230

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the National Aeronautics
and Space Administration further amends 14 CFR part 1230 as published
in the Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 1230--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 1230 continues to read as follows:

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

0
2. Amend Sec.  1230.101 by revising paragraphs (l)(3) and (4) to read
as follows:

Sec.  1230.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  1230.101(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.  1230.101(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.
* * * * *

James D. Polk,

Chief Health & Medical Officer, National Aeronautics and Space
Administration.

DEPARTMENT OF COMMERCE

List of Subjects in 15 CFR Part 27

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Commerce
further amends 15 CFR part 27 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:

PART 27--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 27 continues to read as follows:

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

0
2. Amend Sec.  27.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  27.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  27.101(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.  27.101(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.
* * * * *

Wilbur L. Ross,
The Secretary of Commerce.

CONSUMER PRODUCT SAFETY COMMISSION

List of Subjects in 16 CFR Part 1028

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Consumer Product Safety
Commission further amends 16 CFR part 1028 as published in the Federal
Register on January 19, 2017 (82 FR 7149) and as adopted in a final
rule published by the CPSC on September 18, 2017 (82 FR 43459) as
follows:

PART 1028--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 1028 continues to read as follows:

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

0
2. Amend Sec.  1028.101 by revising paragraphs (l)(3) and (4) to read
as follows:

Sec.  1028.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  1028.101(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.  1028.101(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.
* * * * *
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.

SOCIAL SECURITY ADMINISTRATION

List of Subjects in 20 CFR Part 431

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Social Security
Administration further amends 20 CFR part 431 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 431--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 431 continues to read as follows:

    Authority:  5 U.S.C. 301; 42 U.S.C. 289(a).

0
2. Amend Sec.  431.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  431.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  431.101(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.  431.101(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.
* * * * *

Nancy Berryhill,

Acting Commissioner, Social Security Administration.

AGENCY FOR INTERNATIONAL DEVELOPMENT

List of Subjects in 22 CFR Part 225

    Human research subjects, Reporting and record-keeping requirements,
Research.
    For the reasons stated in the preamble, the Agency for
International Development further amends 22 CFR part 225 as published
in the Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 225--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 225 continues to read as follows:

    Authority:  5 U.S.C. 301; 42 U.S.C. 300v-1(b), unless otherwise
noted.

0
2. Amend Sec.  225.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  225.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  225.101(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.  225.101(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.
* * * * *

Irene Koek,

Senior Deputy Assistant Administrator for Global Health, U.S. Agency
for International Development.

DEPARTMENT OF LABOR

List of Subjects in 29 CFR Part 21

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Labor
further amends 29 CFR part 21 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:

PART 21--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 21 continues to read as follows:

    Authority:  5 U.S.C. 301; 29 U.S.C. 551.

0
2. Amend Sec.  21.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  21.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  21.101(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.  21.101(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.
* * * * *

R. Alexander Acosta,

Secretary of Labor.

DEPARTMENT OF DEFENSE

List of Subjects in 32 CFR Part 219

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Defense
further amends 32 CFR part 219 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:

PART 219--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 219 continues to read as follows:

    Authority:  5 U.S.C. 301.

0
2. Amend Sec.  219.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  219.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  219.101(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.  219.101(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.
* * * * *

Mary J. Miller,

Principal Deputy, Assistant Secretary of Defense for Research and
Engineering.

DEPARTMENT OF EDUCATION

List of Subjects in 34 CFR Part 97

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Education
further amends 34 CFR part 97 as published in the Federal Register on
January 19, 2017 (82 FR 7149) as follows:

PART 97--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 97 continues to read as follows:

    Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474.

0
2. Amend Sec.  97.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  97.101  To what does this policy apply?

* * * * *
    (l) * * *

    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  97.101(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.  97.101(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.
* * * * *

Betsy DeVos,

Secretary of Education.

DEPARTMENT OF VETERANS AFFAIRS

List of Subjects in 38 CFR Part 16

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Veterans
Affairs further amends 38 CFR part 16 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:

PART 16--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 16 continues to read as follows:

    Authority: 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334; 42 U.S.C.
300v-1(b).

0
2. Amend Sec.  16.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  16.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  16.101(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.  16.101(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.
* * * * *

Gina S. Farrisee,

Deputy Chief of Staff, Department of Veterans Affairs.

ENVIRONMENTAL PROTECTION AGENCY

List of Subjects in 40 CFR Part 26

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Environmental
Protection Agency further amends 40 CFR part 26 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 26--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 26 continues to read as follows:

    Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21
U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and
42 U.S.C. 300v-1(b).

0
2. Amend Sec.  26.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  26.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  26.101(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.  26.101(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.
* * * * *

E. Scott Pruitt,

Administrator, Environmental Protection Agency.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

List of Subjects in 45 CFR Part 46

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of Health
and Human Services further amends 45 CFR part 46 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 46--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 46 continues to read as follows:

    Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).

0
2. Amend Sec.  46.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  46.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  46.101(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.  46.101(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.
* * * * *

Eric D. Hargan,

Acting Secretary, Department of Health and Human Services.

NATIONAL SCIENCE FOUNDATION

List of Subjects in 45 CFR Part 690

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the National Science
Foundation further amends 45 CFR part 690 as published in the Federal
Register on January 19, 2017 (82 FR 7149) as follows:

PART 690--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 690 continues to read as follows:

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

0
2. Amend Sec.  690.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  690.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  690.101(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.  690.101(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.
* * * * *

Lawrence Rudolph,

General Counsel.

DEPARTMENT OF TRANSPORTATION

49 CFR Part 11

List of Subjects in 49 CFR Part 11

    Human research subjects, Reporting and record-keeping requirements,
Research.

    For the reasons stated in the preamble, the Department of
Transportation further amends 49 CFR part 11 as published in the
Federal Register on January 19, 2017 (82 FR 7149) as follows:

PART 11--PROTECTION OF HUMAN SUBJECTS

0
1. The authority citation for 11 continues to read as follows:

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

0
2. Amend Sec.  11.101 by revising paragraphs (l)(3) and (4) to read as
follows:

Sec.  11.101  To what does this policy apply?

* * * * *
    (l) * * *
    (3) Research initially approved by an IRB, for which such review
was waived pursuant to Sec.  11.101(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.  11.101(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.
* * * * *
Elaine L. Chao,
Secretary of Transportation.

[FR Doc. 2018-00997 Filed 1-17-18; 4:15 pm]
 BILLING CODE 4150-36-P


[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Pages 41618-41619]
[FR Doc No: 2017-18538]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC17-14-000]

Commission Information Collection Activities (FERC-725U); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC-725U, Mandatory Reliability Standards:
Mandatory Reliability Standard CIP-014.

DATES: Comments on the collection of information are due October 31,
2017.

ADDRESSES: You may submit comments (identified by Docket No. IC17-14-
000) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: Mandatory Reliability Standards: Reliability Standard CIP-
014.
    OMB Control No.: 1902-0274.
    Type of Request: Three-year extension of the FERC-725U information
collection requirements with no changes to the current reporting
requirements.
    Abstract: Reliability Standard CIP-014-2 \1\ requires applicable
transmission owners and transmission operators to identify and protect
transmission stations and transmission substations, and their
associated primary control centers that if rendered inoperable or
damaged as a result of a physical attack could result in instability,
uncontrolled separation, or cascading within an Interconnection.
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    \1\ Reliability Standard CIP-014-2 was implemented by the letter
Order in Docket RD15-4-000 issued on 7/14/2015. RD15-4-000 was not
submitted to OMB because it did not implicate the Paperwork
Reduction Act. The revised standard became effective on 10/2/2015
and is now included in the FERC-725U information collection.
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    Transmission owners and transmission operators must keep data or
evidence to show compliance with the standard for three years unless
directed by its Compliance Enforcement Authority. If a responsible
entity is found non-compliant, it must keep information related to the
non-compliance until mitigation is complete and approved, or for the
three years, whichever is longer.
    Type of Respondents: Transmission owners (TO) and transmission
operators (TOP).
    Estimate of Annual Burden: \2\ The Commission estimates the annual
public reporting burden for the information collection as:
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    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, reference 5 CFR 1320.3.

                                        FERC-725U--Mandatory Reliability Standards: Reliability Standard CIP-014
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                                                                                Number of     Total number   hours and cost   Total burden
                                                    Number and type of respondents         responses per   of responses    per response      hours and
                                                                                respondent                          \3\         total cost
                                              (1).......................................             (2)     (1) * (2) =             (4)       (3) * (4)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Year 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
R1..........................................  334 TO....................................               1             334              20           6,680
                                                                                $1,280        $427,520
R2..........................................  334 TO....................................               1             334              34          11,356
                                                                                $2,448        $817,632
R3..........................................  2 TOP.....................................               1               2               1               2
                                                                                $129            $258
R4..........................................  30 TO and 2 TOP...........................               1              32              80           2,560
                                                                                $5,120        $163,840
R5..........................................  30 TO and 2 TOP...........................               1              32             320          10,240
                                                                                $20,480        $655,360
R6..........................................  30 TO and 2 TOP...........................               1              32             304           9,728
                                                                                $19,456        $622,592
Record Retention............................  334 TO and 2 TOP..........................               1             336               2             672
                                                                                $76         $25,536
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Year 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Record Retention............................  334 TO and 2 TOP..........................               1             336               2             672
                                                                                $76         $25,536
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                         Year 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
R1..........................................  30 TO.....................................               1              30              20             600
                                                                                $1,280         $38,400
R2..........................................  30 TO.....................................               1              30              34           1,020
                                                                                $2,436         $73,080
R3..........................................  2 TOP.....................................               1               2               1               2
                                                                                $129            $258
R4..........................................  30 TO and 2 TOP...........................               1              32              80           2,560
                                                                                $5,120        $163,840
R5..........................................  30 TO and 2 TOP...........................               1              32              80           2,560
                                                                                $5,120        $163,840
R6..........................................  30 TO and 2 TOP...........................               1              32             134           4,288
                                                                                $8,576        $274,432
Record Retention............................  334 TO and 2 TOP..........................               1             336               2             672
                                                                                $76         $25,536
                                                                                ---------------------------------------------------------------
    Year 1 Total............................  ..........................................  ..............  ..............  ..............          41,238
                                                                                $2,712,738
                                                                                ---------------------------------------------------------------
    Year 2 Total............................  ..........................................  ..............  ..............  ..............             672
                                                                                $25,536
                                                                                ---------------------------------------------------------------
    Year 3 Total............................  ..........................................  ..............  ..............  ..............          11,702
                                                                                $739,386
                                                                                ---------------------------------------------------------------
        TOTAL (for Years 1-3)...............  ..........................................  ..............  ..............  ..............          53,612
                                                                                $3,477,660
                                                                                ---------------------------------------------------------------
            Average Annual Burden and Cost..  ..........................................  ..............  ..............  ..............          17,871
            (for Years 1-3).................                                                                                $1,159,220
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \3\ The estimates for cost per response are derived using the
following formula: Average Burden Hours per Response times XX per
Hour = Average Cost per Response.
    The hourly cost figures are based on data for wages plus
benefits from the Bureau of Labor Statistics (as of 11/9/2016) at
https://www.bls.gov/oes/current/naics2_22.htm and http://www.bls.gov/news.release/ecec.nr0.htm. The figures are rounded for
the purposes of calculations in this table and are:
    1. For electrical engineers, $64.29/hr., rounded to $64/hr.
    2. for attorneys, $129.12/hr., rounded to $129/hr.
    3. for administrative staff, $37.75/hr., rounded to $38/hr.
    The record retention cost is based on the administrative staff
category; R3 is based on the attorney category; Requirements R1, R4,
R5 and R6 are based on the electrical engineer category; and R2 is a
mix of the electrical engineer and related engineering review
process (30 hrs. at $64/hr.) and attorney (4 hrs. at $129/hr.)
categories. The resulting average hourly figure is $71.65, rounded
to $72/hr.

    Dated: August 25, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-18538 Filed 8-31-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: April 21, 2006 (Volume 71, Number 77)]
[Notices]
[Page 20661]
[DOCID:fr21ap06-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2006-0310; FRL-8160-9]

Human Studies Review Board; Notice of Public Meeting; Correction
of Docket Number

AGENCY: Environmental Protection Agency.

ACTION: Notice; correction.

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SUMMARY: On April 17, 2006, the U.S. Environmental Protection Agency's
(EPA or Agency) Office of the Science Advisor (OSA) announced a public
meeting of the Human Studies Review Board (HSRB) to be held May 2-4,
2006 from 8:30 a.m. to approximately 5 p.m., eastern time. However, the
third day may not be needed. Please be advised the docket number for
that notice was incorrect.

DATES: Effective on April 21, 2006.

FOR FURTHER INFORMATION CONTACT: Paul I. Lewis, Designated Federal
Officer (DFO), EPA, Office of the Science Advisor, (8105),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax: (202) 564
2070; e-mail address<EMAIL_ADDRESS>
Correction

    In the Federal Register of April 17, 2006, in FR Doc.06-3635, on
page 19725 (3rd column) and page 19726 (2nd column), correct the
entries for docket ID number to read docket ID number EPA-HQ-ORD-2006-
0310.

    Dated: April 18, 2006.
William H. Farland,
Acting Deputy Assistant Administrator for Science, EPA Office of
Research & Development, EPA Science Advisor.
 [FR Doc. E6-6005 Filed 4-20-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 80 (Tuesday, April 26, 2016)]
[Notices]
[Pages 24688-24689]
[FR Doc No: 2016-09648]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2016-0050]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below is being forwarded to the
Office of Management and Budget (OMB) for review and comments. A
Federal Register Notice with a 60-day comment period soliciting
comments on the following information collection was published on
December 4, 2015 (80 FR 75894). No comments were received.

DATES: Comments must be submitted on or before May 26, 2016.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Management and
Budget, Attention: Desk Officer for the Office of the Secretary of
Transportation, 725 17th Street NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:
    Walter Culbreath, NIO-300, National Highway Traffic Safety
Administration, Room W51-316, Department of Transportation, 1200 New
Jersey Avenue SE., Washington, DC 20590.
    Mr. Culbreath's telephone number is<PHONE_NUMBER>. Please identify
the relevant collection of information by referring to its OMB Control
Number.

SUPPLEMENTARY INFORMATION:
    Title: 23 CFR Parts Uniform Safety Program Cost Summary Form for
Highway Safety Plan.
    OMB Control Number: 2127-0003.
    Type of Request: Extension of a previously approved information
collection.
    Abstract: Each State shall have a highway safety program approved
by the Secretary, designed to reduce traffic accidents and deaths,
injuries, and

property damage resulting there from. Such program shall be in
accordance with uniform guidelines promulgated by the Secretary to
improve driver performance, and to improve pedestrian performance,
motorcycle safety and bicycle safety. Under this program, States submit
the Highway Safety Program and other documentation explaining how they
intend to use the grant funds. In order to account for funds expended
under these priority areas and other program areas, States are required
to submit a Program Cost Summary. The Program Cost Summary is completed
to reflect the State's proposed Allocation of funds (including carry-
forward funds) by program area, based on the projects and activities
identified in the Highway Safety Plan
    Affected Public: State, Local, or Tribal Government.
    Estimated Number of Respondents: 57.
    Frequency: 20 per year.
    Number of Responses: 1,140.
    Estimated Total Annual Burden hours: 570 hours.
    Estimated Total Annual Cost Burden: 0.
    Public Comments Invited: You are asked to comment on any aspects of
this information collection, including (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the Department, including whether the information will
have practical utility; (b) the accuracy of the Department's estimate
of the burden of the proposed information collection; (c) ways to
enhance the quality, utility and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

Kevin Mahoney,
Director, Office of Corporate Customer Services.
[FR Doc. 2016-09648 Filed 4-25-16; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Notices]
[Page 48615-48616]
[DOCID:fr23se09-121]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 8b-1 to 8b-33, SEC File No. 270-135, OMB Control No. 3235-
0176.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995
    (44 U.S.C. 3501 et seq.), the Securities and Exchange Commission
(the ``Commission'') has submitted to the Office of Management and
Budget a request for extension of the previously approved collection of
information discussed below.
    Rules 8b-1 to 8b-33 (17 CFR 270.8b-1 to 8b-33) under the Investment
Company Act of 1940 (15 U.S.C. 80a-1 et seq.) (the ``Act'') are the
procedural rules an investment company must follow when preparing and
filing a registration statement. These rules were adopted to
standardize the mechanics of registration under the Act and to provide
more specific guidance for persons registering under the Act than the
information contained in the statute. For the most part, these
procedural rules do not require the disclosure of information. Two of
the rules, however, require limited disclosure of information.\1\ The
information required by the rules is necessary to ensure that investors
have clear and complete information upon which to base an investment
decision. The Commission uses the information that investment companies
provide on registration statements in its regulatory, disclosure
review, inspection and policy-making roles. The respondents to the
collection of information are investment companies filing registration
statements under the Act.
---------------------------------------------------------------------------

    \1\ Rule 8b-3 (17 CFR 270.8b-3) provides that whenever a
registration form requires the title of securities to be stated, the
registrant must indicate the type and general character of the
securities to be issued. Rule 8b-22 (17 CFR 270.8b-22) provides that
if the existence of control is open to reasonable doubt, the
registrant may disclaim the existence of control, but it must state
the material facts pertinent to the possible existence of control.
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    The Commission does not estimate separately the total annual
reporting and recordkeeping burden associated with rules 8b-1 to 8b-33
because the burden associated with these rules are included in the
burden estimates the Commission submits for the investment company
registration statement forms (e.g., Form N-1A (17 CFR 239.15A and
274.11A), Form N-2 (17 CFR 239.14 and 274.11a-1), Form N-3 (17 CFR
239.17a and 274.11b), Form N-4 (17 CFR 239.17b and 274.11c), and Form
N-6 (17 CFR 239.17c and 274.11d)). For example, a mutual fund that
prepares a registration statement on Form N-1A must comply with the
rules under section 8(b), including rules on riders, amendments, the
form of the registration statement, and the number of copies to be
submitted. Because the fund only incurs a burden from the section 8(b)
rules when preparing a registration statement, it would be impractical
to measure the compliance burden of these rules separately. The
Commission believes that including the burden of the section 8(b) rules
with the burden estimates for the investment company registration
statement forms provides a more accurate and complete estimate of the
total burdens associated with the registration process. For
administrative purposes, however, we are requesting approval for an
information collection burden of one hour per year. This estimate of
burden hours is not derived from a comprehensive or necessarily even
representative study of the cost of the Commission's rules and forms.
    Investment companies seeking to register under the Act are required
to provide the information specified in rules 8b-1 to 8b-33 if
applicable. Responses will not be kept confidential.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number.
    Please direct general comments regarding the above information to
the following persons: (i) Desk Officer for the Securities and Exchange
Commission, Office of Management and Budget, Room 10102, New Executive
Office Building, Washington, DC 20503 or send an e-mail to Shagufta
Ahmed at<EMAIL_ADDRESS>and (ii) Charles Boucher,
Director/CIO, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: September 16, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-22879 Filed 9-22-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 45 (Wednesday, March 10, 2021)]
[Rules and Regulations]
[Page 13645]
[FR Doc No: 2021-04960]

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SECURITIES AND EXCHANGE COMMISSION

17 CFR Part 201

[Release No. 34-90442; File No. S7-19-15]
RIN 3235-AL98

Amendments to the Commission's Rules of Practice; Correction

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; correction.

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SUMMARY: The Securities and Exchange Commission (``Commission'') is
correcting a final rule that appeared in the Federal Register on
December 30, 2020. The final rule adopted amendments to its Rules of
Practice to require persons involved in Commission administrative
proceedings to file and serve documents electronically.

DATES: The corrections are effective March 10, 2021.

FOR FURTHER INFORMATION CONTACT: Naomi P. Lewis, Office of the
Secretary<PHONE_NUMBER>, Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549.

SUPPLEMENTARY INFORMATION: In FR Doc. 2020-25747, starting on page
86464 in the Federal Register of December 30, 2020, the following
corrections are made:
    1. On page 86464, in column 3, the file number is corrected to read
``S7-19-15''.
    2. On page 86464, in column 3, the RIN number is corrected to read
``3235-AL98''.

    Dated: March 5, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.

[FR Doc. 2021-04960 Filed 3-9-21; 8:45 am]
BILLING CODE P