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.

Rules and Regulations Federal Register

2885 

Vol. 83, No. 14 

Monday, January 22, 2018 

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. 

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): 

Æ Enter the following link into your 

web browser’s address bar: https://www.

regulations.gov/document?D=HHSOPHS-2017-0001. 

Æ Click the blue ‘‘Comment Now!’’ 

button in the upper right hand corner 

and follow the instructions on how to 

submit a comment. 

Æ 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, 


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2886 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations 

1See 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%20

Regarding%20the%20Common%20Rule.pdf. 

2SACHRP Recommendations of August 2, 2017, 

Attachment A: https://www.hhs.gov/ohrp/sachrpcommittee/recommendations/attachment-a-august2-2017/index.html. 

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: 

240–453–6900 or 1–866–447–4777; 

facsimile: 301–402–2071; email 

Jerry.Menikoff@hhs.gov. 

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 § l.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

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 

§ l.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 §l.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 §l.101(l)(3). 

This interim final rule does not delay 

the compliance date for the cooperative 

research provision of the 2018 

Requirements (§l.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. 


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3Note, that the terms ‘‘benefits’’ and ‘‘costsavings’’ are used interchangeably in this RIA. 

Continued 

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

The RIA for the 2018 Requirements 

described the benefits and costs of 16 


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Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’ 

are also used interchangeably. 

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

Annualized value by discount rate 

(millions of 2016 dollars) 

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. 

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

2018 Requirement RIA category 

Annualized value over 1 year by discount rate 

(millions of 2016 dollars) 

Benefits 

(cost-savings) 

Costs 

(foregone benefits) 

3% 7% 3% 7% 

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 Institution Holding an FWA 

(impact to IRBs not operated by an FWA-holding institution) ..................... 4.47 4.14 – – 

Excluding Activities from the Requirements of the Common Rule because 

They are not Research ................................................................................ – – 0.94 0.88 

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 Application Undergo IRB Review and Approval ........................................................................................ – – 17.0 15.7 

Expansion of Research Activities Exempt from Full IRB Review ................... 0.01 0.01 20.8 19.3 

Elimination of Continuing Review of Research Under Specific Conditions .... 2.07 1.92 7.73 7.17 

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 Waive Consent in Certain 

Subject Recruitment Activities ..................................................................... – – 0.07 0.06 

Requirement for Posting of Consent Forms for Clinical Trials Conducted or 

supported by Common Rule Department or Agencies ................................ 0.85 0.79 – – 

Alteration in Waiver for Documentation of Informed Consent in Certain Circumstances .................................................................................................. – – – – 

4Zeroes 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. 5Because compliance with this provision is not required until 2020, benefits and costs here are not included. 


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6SACHRP Recommendations of August 2, 2017: 

https://www.hhs.gov/ohrp/sachrp-committee/ 

recommendations/sachrp-recommendations/ 

index.html. 

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. 

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 sixmonth 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. 


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2890 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations 

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 l—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. Amend § l.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§l.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § l.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 § l.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 

■ 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. 

■ 2. Amend § 46.101 by revising 

paragraphs (l)(1), (2), (3), and (4) to read 

as follows: 

§ 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 § 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 § 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 § 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 

■ 1. The authority citation for 1c 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1c.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

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

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 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). 

■ 2. Amend § 745.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 745.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 


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Requirements and an IRB documents 

such determination. 

(4) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 

■ 1. The authority citation for 1230 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1230.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 1230.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 27 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 27.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 27.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 1028 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 1028.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 1028.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 431 

continues to read as follows: 

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

■ 2. Amend § 431.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 431.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 431.101(i), or for which a 

determination was made that the 


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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 § 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 

■ 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. 

■ 2. Amend § 225.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 225.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 21 

continues to read as follows: 

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

■ 2. Amend § 21.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 21.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 219 

continues to read as follows: 

Authority: 5 U.S.C. 301. 

■ 2. Amend § 219.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 219.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 97 

continues to read as follows: 

Authority: 5 U.S.C. 301; 20 U.S.C. 1221e– 

3, 3474. 

■ 2. Amend § 97.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 97.101 To what does this policy apply? 

* * * * * 

(l) * * * 


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(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 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). 

■ 2. Amend § 16.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 16.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 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). 

■ 2. Amend § 26.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 26.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 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). 

■ 2. Amend § 46.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 46.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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: 


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2894 Federal Register / Vol. 83, No. 14 / Monday, January 22, 2018 / Rules and Regulations 

PART 690—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for 690 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 690.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 690.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

■ 1. The authority citation for 11 

continues to read as follows: 

Authority: 5 U.S.C. 301; 42 U.S.C. 300v– 

1(b). 

■ 2. Amend § 11.101 by revising 

paragraphs (l)(3) and (4) to read as 

follows: 

§ 11.101 To what does this policy apply? 

* * * * * 

(l) * * * 

(3) Research initially approved by an 

IRB, for which such review was waived 

pursuant to § 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 § 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 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2018–0023; Product 

Identifier 2017–NM–084–AD; Amendment 

39–19164; AD 2018–02–11] 

RIN 2120–AA64 

Airworthiness Directives; Airbus 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for certain 

Airbus Model A330–301, –321, –322 

and –342 airplanes. This AD requires 

contacting the FAA to obtain 

instructions for addressing the unsafe 

condition on these products, and doing 

the actions specified in those 

instructions. This AD was prompted by 

a report of cracking in the top skin of 

the horizontal stabilizer (HS) center box 

(CB) of an airplane in pre-modification 

41330 configuration. We are issuing this 

AD to address the unsafe condition on 

these products. 

DATES: This AD becomes effective 

February 6, 2018. 

We must receive comments on this 

AD by March 8, 2018. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue SE, Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, 

M–30, West Building Ground Floor, 

Room W12–140, 1200 New Jersey 

Avenue SE, Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

Examining the AD Docket 

You may examine the AD docket on 

the internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2018– 

0023; or in person at the Docket 

Operations office between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone: 

800–647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Vladimir Ulyanov, Aerospace Engineer, 

International Section, Transport 

Standards Branch, FAA, 1601 Lind 

Avenue SW, Renton, WA 98057–3356; 

telephone: 425–227–1138; fax: 425– 

227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Union, has issued EASA AD 2017–0078, 

dated May 3, 2017 (referred to after this 

as the Mandatory Continuing 

Airworthiness Information, or ‘‘the 

MCAI’’), to correct an unsafe condition 

for certain Airbus Model A330–301, 

–321, –322 and –342 airplanes. The 

MCAI states: 

Cracks were found in the horizontal 

stabilizer (HS) centre box (CB) top skin of an 

aeroplane in pre-modification 41330 

configuration. The cracks were initiated at 

the upper flange corner at Rib 3 rear spar area 

on left hand side of the CB. 

This condition, if not detected and 

corrected, could lead to reduced structural 

integrity of the HS CB of the aeroplane. 

To address this unsafe condition, Airbus 

published Service Bulletin (SB) A330–55– 

3046 to provide inspection instructions for 

the affected area. 

For the reason described above, this 

[EASA] AD requires a one-time special 

detailed inspection (SDI) of the HS CB top 


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