39534 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Use of a Single Institutional Review 

Board for Cooperative Research Draft 

Guidance 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health, is 

announcing the availability of a draft 

guidance document entitled, ‘‘Use of a 

Single Institutional Review Board for 

Cooperative Research Draft.’’ 

DATES: Submit written comments by 

August 30, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the draft guidance 

document entitled ‘‘Use of a Single 

Institutional Review Board for 

Cooperative Research Draft Guidance,’’ 

to the Division of Policy and 

Assurances, Office for Human Research 

Protections, 1101 Wootton Parkway, 

Suite 200, Rockville, MD 20852. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 240–453– 

8420. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the draft guidance 

documents. 

You may submit comments identified 

by docket ID number HHS–OASH– 

2022–0011 (Use of a Single Institutional 

Review Board for Cooperative Research 

Draft Guidance), by one of the following 

methods: 

D Federal eRulemaking Portal: http:// 

www.regulations.gov. Enter the docket 

ID number and click on ‘‘Search.’’ On 

the next page, click the ‘‘Comment 

Now’’ action and follow the 

instructions. 

D Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Natalie Klein, Ph.D., Office for Human 

Research Protections, 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: 

Natalie Klein, Ph.D., Office for Human 

Research Protections, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

Natalie.klein@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

OHRP is announcing the availability 

of a draft guidance document for public 

comment titled ‘‘Use of a Single 

Institutional Review Board for 

Cooperative Research.’’ The document 

is intended primarily for institutions, 

institutional review boards (IRBs), 

investigators, institutional officials, and 

other human research protection staff. 

The draft guidance document applies 

to activities that are conducted or 

supported by HHS. It is intended 

primarily to help entities implement the 

requirement for use of a single IRB for 

cooperative research (subpart A of 45 

CFR part 46.114). In particular, the draft 

guidance addresses the following topics: 

(1) What is cooperative research? 

(2) When must an institution rely on 

a single IRB for approval of cooperative 

research? 

(3) Who decides which IRB will be 

the IRB of record for the purposes of 

regulatory compliance? 

(4) Can an institution that is not 

required to comply with 45 CFR 

46.114(b)(1) for a particular study still 

choose to rely on a single IRB for review 

of cooperative research? 

(5) Can an institution involved in 

cooperative research choose to conduct 

its own IRB review of the research even 

though review is required by a single 

IRB that is located elsewhere? 

(6) Are there documentation 

requirements for use of a single IRB in 

cooperative research? 

(7) What are some of the operational 

capacities an IRB should have in order 

to serve as a single IRB? 

(8) What are the responsibilities of the 

reviewing IRB with respect to 

information pertaining to sensitivity to 

community attitudes and the local 

context for proposed research? 

(9) What are the responsibilities of the 

reviewing IRB pertaining to applicable 

State and local laws? 

II. Electronic Access 

Persons with access may obtain the 

draft guidance documents on OHRP’s 

website at https://www.hhs.gov/ohrp/ 

regulations-and-policy/requests-forcomments/index.html. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2022–14123 Filed 6–30–22; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0001] 

Agency Information Collection 

Request. 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before August 30, 2022. 

ADDRESSES: Submit your comments to 

sagal.musa@hhs.gov or by calling (202) 

205–2634. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 4040–0001–60D 

and project title for reference, to Sagal 

Musa, email: sagal.musa@hhs.gov, or 

call (202) 205–2634 the Reports 

Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: Application for 

Federal Assistance SF 424 R&R forms. 

Type of Collection: Renewal. 

OMB No. 4040–0001. 

Abstract: The SF–424 R&R family of 

forms provides the Federal grant-making 

agencies an alternative to the Standard 

Form 424 data set and form. Agencies 

may use the SF–424 R&R forms for grant 

programs not required to collect all the 

data that is required on the SF–424 core 

data set and form. This 4040–0001 

collection encompasses 18 forms. 

Type of respondent: The SF–424 R&R 

family of forms are used by 

organizations to apply for Federal 

financial assistance in the form of 

grants. These forms are submitted to the 

Federal grant-making agencies for 

evaluation and review. 


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