21126 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 

21 CFR part; guidance Topic OMB control No. 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions; pre-submissions ............................................. 0910–0756 

Dated: April 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07684 Filed 4–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5225] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Foreign Supplier 

Verification Programs for Food 

Importers 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 11, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0752. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–45, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Foreign Supplier Verification Programs 

(FSVP) for Food Importers—21 CFR 

Part 1, Subpart L 

OMB Control Number 0910–0752— 

Extension 

This information collection supports 

FDA regulations in 21 CFR part 1, 

subpart L (21 CFR 1.500 through 1.514 

(§§ 1.500 through (§§ 1.514)), which 

help to implement section 805 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 384a). Section 

805 authorizes the Agency’s FSVP and 

establishes requirements applicable to 

imported food. Respondents to the 

information collection are importers, as 

defined in section 805(a)(1) of the FD&C 

Act. The regulations are intended to 

provide verification that imported food 

is produced in compliance with 

statutory requirements that include the 

implementation of appropriate riskbased preventive controls. The 

regulations also establish that importers 

of foods must develop, maintain, and 

follow an FSVP that provides adequate 

assurances a foreign supplier is 

producing the food in compliance with 

processes and procedures that provide 

at least the same level of public health 

protection as those required under 

section 418 of the FD&C Act (21 U.S.C. 

350g) (regarding hazard analysis and 

risk-based preventive controls for 

certain foods) or 419 (21 U.S.C. 350h) 

(regarding standards for produce safety), 

if either is applicable, and the 

implementing regulations, and is 

producing the food in compliance with 

sections 402 (21 U.S.C. 342) (regarding 

adulteration) and 403(w) (21 U.S.C. 

343(w)) (if applicable) (regarding 

misbranding with respect to labeling for 

the presence of major food allergens) of 

the FD&C Act. The regulations also 

provide for certain exemptions. To 

assist respondents with understanding 

the requirements we have developed 

Agency guidance, available at: https://

www.fda.gov/food/food-safetymodernization-act-fsma/fsma-final-ruleforeign-supplier-verification-programsfsvp-importers-food-humans-andanimals. 

Specifically, regulations in § 1.501 set 

forth the applicability of requirements 

for FSVP, while regulations in §§ 1.502 

through 1.508, prescribe specific 

activities for developing, maintaining, 

and following an FSVP; as well as for 

evaluating compliance and for 

identifying and correcting hazards. 

Finally, regulations in § 1.509 identify 

required data elements applicable to 

food products offered for importation 

into the United States, while regulations 

in § 1.510 govern required records, 

providing that records be made 

available to FDA upon request and that 

records be maintained electronically. 

On May 10, 2021, FDA launched the 

FSVP Importer Portal for FSVP Records 

Submission as a means for importers to 

upload FSVP records electronically and 

submit them to the Agency, after 

receiving a request for records from 

FDA. The portal may be found at 

https://www.access.fda.gov/, and a user 

guide is available at https://

www.fda.gov/media/148312/download. 

In the Federal Register of January 28, 

2022 (87 FR 4607), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Exemption for food for research; 1.501(c) ............... 36,360 40 1,454,400 0.083 (5 minutes) ..... 120,715 

Identifier for filing with U.S. Customs and Border 

Protection; 1.509.

56,800 157 8,917,600 0.02 (1.2 minutes) .... 178,352 

Total ................................................................... ........................ ........................ 10,372,000 ................................... 299,067 

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


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Notices 21127 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

Controls for low-acid canned foods; 1.502(b) .......... 2,443 4 9,772 1 ................................ 9,772 

Hazard determinations, controls, and audits; 1.504, 

1.506, 1.511.

56,800 87.74 4,984,036 0.38 (23 minutes) ..... 1,917,174 

Written assurances for food produced under dietary 

supplement current good manufacturing practices; 1.511.

11,701 2.88 33,664 2.25 ........................... 75,744 

Document very small importer/certain small foreign 

supplier status; 1.512(b)(1).

50,450 1 50,450 1 ................................ 50,450 

Written assurances associated with very small importer/certain small foreign supplier; 1.512(b)(3).50,450 2.79 141,084 2.25 ........................... 317,439 

Total ................................................................... ........................ ........................ 5,219,006 ................................... 2,370,579 

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

2Figures have been rounded to the nearest one hundredth. 

Upon evaluation of the information 

collection, we are retaining the 

currently approved burden estimates. 

Dated: April 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07617 Filed 4–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3049] 

E8(R1) General Considerations for 

Clinical Studies; International Council 

for Harmonisation; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance for industry entitled ‘‘E8(R1) 

General Considerations for Clinical 

Studies.’’ The guidance was prepared 

under the auspices of the International 

Council for Harmonisation (ICH), 

formerly the International Conference 

on Harmonisation. The guidance 

describes internationally accepted 

principles and practices for the design 

and conduct of clinical studies of drug 

and biological products. In addition, the 

guidance provides an overview of the 

types of clinical studies that may be 

performed and data sources used during 

the product’s life cycle. The guidance is 

intended to promote the quality of the 

studies submitted to regulatory 

authorities, while allowing for 

flexibility. This guidance revises the 

guidance for industry ‘‘E8 General 

Considerations for Clinical Trials’’ 

issued in December 1997. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 11, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2019–D–3049 for ‘‘E8(R1) General 

Considerations for Clinical Studies.’’ 

Received comments 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 


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