[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70995-70996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22652]


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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.

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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, 
[email protected].

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

[[Page 70996]]

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 Sec.  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 Sec.  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/enforcement-report-information-and-definitions.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of
   Activity; 21 CFR section        Number of      responses per    Total annual   Average burden    Total hours
                                  respondents      respondent        responses     per response
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Firm initiated recall; Sec.              2,309                 1           2,309              25          57,725
 7.46.........................
Termination of recall; Sec.              2,128                 1           2,128              10          21,280
 7.55.........................
Recall status reports; Sec.              2,309                13          30,017              10         300,170
 7.53.........................
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    Total.....................  ..............  ................          34,454  ..............         379,175
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\1\ There 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\
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                                                                  Number of
          Activity; 21 CFR section               Number of     disclosures per   Total annual         Average burden per disclosure         Total hours
                                                respondents      respondent       disclosures
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Recall communications; Sec.   7.49..........           2,309             1,108       2,559,200  0.05 (3 minutes)........................         127,960
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\1\ There 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 Sec.  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 Sec.  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 FDA-
regulated 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