Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices 70995 

Dated: October 10, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22653 Filed 10–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4066] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food and Drug 

Administration Recall Regulations 

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 FDA Recall 

Regulations. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

December 12, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

December 12, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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– 

2023–N–4066 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; FDA 

Recall Regulations.’’ 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. 

‘‘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 


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70996 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices 

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. 

FDA Recall Regulations—21 CFR Part 7 

OMB Control Number 0910–0249— 

Extension 

This information collection helps 

support implementation of section 701 

of the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 371) pertaining to 

product recalls, and regulations in 21 

CFR part 7, subpart C (21 CFR 7.40 

through 7.59) promulgated to clarify and 

explain associated practices and 

procedures by FDA. Sections 7.49, 7.50, 

and 7.59 (21 CFR 7.49, 7.50, and 7.59) 

of the regulations apply specifically to 

product recalls, which may be 

undertaken voluntarily and at any time 

by manufacturers and distributors, or at 

the request of the Agency. 

Recalls are terminated when all 

reasonable efforts have been made to 

remove or correct the product in 

accordance with the recall strategy. The 

regulations also provide for corrective 

actions to be taken regarding violative 

products and establish specific 

guidelines that enable us to monitor and 

assess the effectiveness of a firm’s 

efforts in this regard. The provisions 

include reporting to FDA on the 

initiation and termination of a recall, as 

well as submitting recall status reports 

and making required communication 

disclosures. The regulations also permit 

FDA to evaluate whether a recall has 

been completed in a manner which 

assures that unreasonable risk of 

substantial harm to the public health 

has been eliminated and that violative 

products have been corrected or 

removed from the market. Specific 

guidance regarding recalls is set forth in 

§ 7.59, although product-specific 

guidance documents may also be 

developed to assist respondents to the 

information collection. Agency 

guidance documents are issued in 

accordance with our good guidance 

regulations in 21 CFR 10.115, which 

provide for public comment at any time. 

Consistent with § 7.50, all recalls 

monitored by FDA are included in an 

‘‘Enforcement Report’’ once they are 

classified and may be listed prior to 

classification when FDA determines the 

firm’s removal or correction of a 

marketed product(s) meets the 

definition of a recall. Recall data in the 

Enforcement Report can be accessed 

through the weekly report publication, 

the quick and advanced search 

functionalities, and an Application 

Programming Interface (API). 

Instructions for navigating the report, 

accessing and using the API, and 

definitions of the report contents are 

found at https://www.fda.gov/safety/ 

enforcement-reports/enforcementreport-information-and-definitions. 

We estimate the burden of the 

information collection 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 

Firm initiated recall; § 7.46 ............................................... 2,309 1 2,309 25 57,725 

Termination of recall; § 7.55 ............................................ 2,128 1 2,128 10 21,280 

Recall status reports; § 7.53 ............................................ 2,309 13 30,017 10 300,170 

Total .......................................................................... ........................ ............................ 34,454 ........................ 379,175 

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

A review of Agency data shows that 

6,928 recall events were conducted 

during fiscal years 2020 through 2022, 

for an average of 2,309 recalls annually. 

We assume an average of 25 hours is 

needed to submit the requisite 

notification to FDA, for a total annual 

burden of 57,725 hours. Similarly, 

during the same period, 6,385 recalls 

were terminated, for an average of 2,128 

recall terminations annually, and we 

assume an average of 10 hours is needed 

for the corresponding information 

collection activity. To determine burden 

associated with recall status reports, we 

multiplied the average number of 

annual respondents (2,309) by the 

average number of status reports per 

recall (13), producing the number 

annual submissions (30,017), which, 

assuming 10 hours per response, results 

in a burden of 300,170 hours annually. 

TABLE 2—ESTIMATED THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure Total hours 

Recall communications; § 7.49 ................................ 2,309 1,108 2,559,200 0.05 (3 minutes) ..... 127,960 

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

To determine burden associated with 

recall communication disclosures 

described in § 7.49, we calculated an 

average of 1,108 disclosures per recall 

and attribute 3 minutes for each 

disclosure, resulting in 127,960 burden 

hours annually. We provide no estimate 

for recordkeeping in § 7.59 as these 

activities are provided as guidance only, 

and we regard them to be usual and 

customary to these respondents. 

Cumulatively, these adjustments 

reflect an overall decrease in our 

estimate, which we attribute to a 

corresponding decrease in FDAregulated product recalls since our last 

evaluation of the information collection. 

Dated: October 10, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22652 Filed 10–12–23; 8:45 am] 

BILLING CODE 4164–01–P 


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