Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37867 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; and the collections 

of information in section 506 of the 

FD&C Act have been approved under 

OMB control number 0910–0765. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: June 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13528 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0403] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Protection of 

Human Subjects and Institutional 

Review Boards 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with statutory and 

regulatory provisions governing human 

subject protection and institutional 

review boards. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 23, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 23, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 23, 2022. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2013–N–0403 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Protection of Human Subjects and 

Institutional Review Boards.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 


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37868 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Protection of Human Subjects; Informed 

Consent; and Institutional Review 

Boards—21 CFR Parts 50 and 56 

OMB Control Number 0910–0130— 

Extension 

This information collection supports 

Agency regulations pertaining to the 

protection of human subjects, informed 

consent, and responsibilities of 

institutional review boards (IRBs) as set 

forth in parts 50 and 56 (21 CFR parts 

50 and 56). Parts 50 and 56 apply to all 

clinical investigations regulated by FDA 

under sections 505(i) and 520(g) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(i) and 360j(g), 

respectively), as well as clinical 

investigations that support applications 

for research or marketing permits for 

products regulated by FDA. The 

regulations in parts 50 and 56 are 

intended to protect the rights and safety 

of subjects involved in such 

investigations. The regulations also 

contain the standards for composition, 

operation, and responsibilities of IRBs 

that review clinical investigations 

regulated by FDA. 

21 CFR Part 50—Protection of Human 

Subjects 

Provisions in part 50 provide for the 

protection of human subjects involved 

in FDA-regulated clinical investigations. 

With few exceptions, no investigator 

may involve a human being as a subject 

in FDA-regulated research unless the 

investigator has obtained the legally 

effective informed consent of the subject 

or the subject’s legally authorized 

representative. Basic elements of 

informed consent are set forth in § 50.25 

(21 CFR 50.25) and include, among 

other things: (1) a statement of the 

purpose and duration of a subject’s 

participation in the research; (2) a 

description of the procedures to be 

followed; (3) identification of any 

experimental procedures; (4) a 

description of risks, benefits, and 

appropriate alternative procedures or 

treatments; (5) a description of extent to 

which confidentiality of records 

identifying the subject will be 

maintained; (6) certain contact 

information; and (7) a statement that 

participation is voluntary and may be 

discontinued at any time. Additional 

elements set forth in § 50.25 are 

required in the informed consent as 

appropriate. Exceptions to these 

requirements are governed by 21 CFR 

50.23, which requires both investigator 

and physician to certify in writing that 

necessary elements for exception from 

general requirements have been 

satisfied; and § 50.24 (21 CFR 50.24), 

which covers exception from informed 

consent requirements for emergency 

research. In accordance with § 50.27 (21 

CFR 50.27) informed consent must be 

documented, except as provided in 

§ 56.109(c) (21 CFR 56.109(c)), which 

provides for an IRB to waive 

documentation of informed consent in 

certain circumstances. 

Informed consent must be 

documented using a written consent 

form approved by the IRB and signed 

and dated by the subject or the subject’s 

legally authorized representative at the 

time of consent. For each clinical 

investigation reviewed by an IRB, we 

believe there will typically be one 

associated written consent form 

developed by an investigator. In some 

cases, investigators will seek IRB 

approval of changes in the research and/ 

or consent form after initial IRB 

approval. For some multi-institutional 

clinical investigations, the IRB of each 

institution involved may separately 

conduct initial and continuing review of 

the research, including review of the 

written consent form to determine 

whether it is in accordance with § 50.25. 

However, in cases where a multiinstitutional clinical investigation uses a 

single IRB review process, there may 

only be one IRB conducting such 

reviews. Additional safeguards are 

required for children, as prescribed in 

subpart D (21 CFR 50.50 through 50.56) 

of the regulations. 

21 CFR Part 56—Institutional Review 

Boards 

The general standards for the 

composition, operation, and 

responsibilities of an IRB are set forth in 

part 56. IRBs serve in an oversight 

capacity by reviewing, among other 

things, informed consent documents 

and protocols for FDA-regulated studies, 

to make findings required to approve 

research, and document IRB actions. 

Part 56 also regulates the administrative 

activities of IRBs reviewing FDAregulated research including, among 

other things, identification of types of 

IRB records that must be prepared and 

maintained. Required recordkeeping 

includes documentation pertaining to 

written procedures, proposals reviewed, 

committee membership, meeting 

minutes, actions taken by the IRB, 

correspondence, as well as other 

functional and operational aspects of 

the IRB. Finally, the regulations 

describe administrative actions for noncompliance, including both 

disqualification of IRBs or IRB parent 

institutions, as well as reinstatement 

and alternative and additional actions. 

Description of Respondents: 

Respondents to the information 

collection are IRBs that review and 

approve clinical investigations regulated 

by FDA and clinical investigators of 

such research who obtain informed 

consent of human subjects prior to 

research participation. 

We estimate the annual burden for the 

collection of information as follows: 


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Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37869 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

§ 56.113; suspension or termination of research ................ 2,520 1 2,520 * 0.5 1,260 

§ 56.120(a); IRB response to lesser administration actions 

for noncompliance ............................................................ 7 1 7 10 70 

§ 56.123; reinstatement of an IRB or an institution ............. 1 1 1 5 5 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,335 

* 30 minutes. 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on available data, there are 

approximately 2,520 IRBs overseeing 

FDA-regulated clinical research. We 

have organized the table summarizing 

estimated annual reporting burden to 

list only one requirement per row 

recognizing that some provisions may 

also include recordkeeping or thirdparty disclosure tasks. We believe we 

have accounted for all burden 

cumulatively across the information 

collection activity tables and invite 

comments on our estimates. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total 

hours 

§ 50.24; exceptions from informed consent for emergency 

research ............................................................................ 8 3 24 1 24 

§ 50.27; documentation of informed consent ....................... 2,520 40 100,800 * 0.5 50,400 

§ 56.115; IRB records (documentation of IRB activities) ..... 2,520 14.6 36,792 40 1,471,680 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,522,104 

* 30 minutes. 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

We characterize activities associated 

with §§ 50.24 and 50.27 as 

recordkeeping burden. We assume each 

of the 2,520 IRBs meets an average of 

14.6 times annually and assume 40 

hours of person-time per meeting are 

required to meet the IRB recordkeeping 

requirements of § 56.115. We also 

assume most recordkeeping is 

completed electronically. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

§ 50.25; elements of informed consent ................................ 2,520 40 100,800 * 0.5 50,400 

§ 56.109(d); written statement about minimal risk research 

when documentation of informed consent is waived ....... 2,520 2 5,040 * 0.5 2,520 

§ 56.109(e); written notification to approve or disapprove 

research ............................................................................ 2,520 40 100,800 * 0.5 50,400 

§ 56.109(g); IRB written statement about public disclosures to sponsor of emergency research under 50.24 .... 8 2 16 1 16 

Total .............................................................................. ........................ ........................ ........................ ........................ 103,336 

* 30 minutes 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

We characterize activities associated 

with §§ 50.25, 56.109(d) and 56.109(e) 

as disclosure burden. We estimate that 

eight IRBs per year will receive a 

request to review emergency research 

under § 50.24, thus requiring written 

notification under § 56.109(g) from the 

IRB to the sponsor. We estimate that it 

will take an IRB approximately 1 hour 

to prepare each written statement, for a 

total of 2 hours per study. The total 

annual third-party disclosure burden for 

IRBs to fulfill this requirement is 

estimated at 16 hours. 

Dated: June 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13517 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 


jspears on DSK121TN23PROD with NOTICES1