Notice2024-09177
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
April 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 84 (Tuesday, April 30, 2024)</title>
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[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34256-34258]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4066]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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: Submit written comments (including recommendations) on the
collection of information by May 30, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0249. 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-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#f4a4a6b5a780959292b4929095da9c9c87da939b82"><span class="__cf_email__" data-cfemail="bfefedfeeccbded9d9ffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 34257]]
collection of information to OMB for review and clearance.
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>.
In the Federal Register of October 13, 2023, (88 FR 70995), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received offering general
support for the information collection. The comment also suggested that
reporting might be enhanced through the use of automated technology and
that FDA monitor and utilize such technology to track improvement.
Finally, the comment questioned the rationale for our estimate of the
time necessary for preparing and submitting recall reports. Based on
experience with compiling and submitting a report along with its
attachments, the commenter communicated that less time was likely
needed.
We appreciate this feedback and will continue to monitor burden
associated with product recall activity. We also continue to look for
ways to enhance our IT systems as our limited resources allow and
public health priorities require. With regard to our current estimates,
we note that our figures reflect what we believe to be the average
burden incurred among more than 2,000 respondents, and in conjunction
with more than 30,000 reports, annually, and therefore we have made no
adjustment in our assumptions at this time.
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.
[[Page 34258]]
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: April 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09177 Filed 4-29-24; 8:45 am]
BILLING CODE 4164-01-P
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