Notice2023-22652
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 197 (Friday, October 13, 2023)</title>
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[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70995-70996]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#ca9a988b99beabacac8aacaeabe4a2a2b9e4ada5bc"><span class="__cf_email__" data-cfemail="732321322007121515331517125d1b1b005d141c05">[email protected]</span></a>.
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 <a href="https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions">https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions</a>.
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
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