[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34256-34258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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 https://www.fda.gov/safety/enforcement-reports/enforcement-report-information-and-definitions.
    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.........................
                               ---------------------------------------------------------------------------------
    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