[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1508-1510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1031]


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 or Agency) 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 information collection provisions 
associated with FDA recalls for products regulated by the Agency.

DATES: Submit either electronic or written comments on the collection 
of information by March 9, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 9, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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

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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-2014-N-1031 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 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 part 7 (21 CFR part 
7), subpart C promulgated to clarify and explain associated practices 
and procedures. Regulations in part 7, subpart C Sec. Sec.  7.49, 7.50, 
and 7.59 (21 CFR 7.49, 7.50, and 7.59) 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 requirements that 
enable us to monitor and assess the adequacy 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. 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

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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.com.
    We estimate the burden of the collection of information 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.                2,779               1           2,779              25          69,475
 7.46...........................
Termination of recall; Sec.                2,095               1           2,095              10          20,950
 7.55...........................
Recall status reports; Sec.                2,779              13          36,127              10         361,270
 7.53...........................
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    Total.......................  ..............  ..............          41,001  ..............         451,695
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    A review of Agency data shows that 8,337 recalls were conducted 
during fiscal years 2017 through 2019, for an average of 2,779 recalls 
annually. We assume an average of 25 hours is needed to submit the 
requisite notification to FDA, for a total annual burden of 69,475 
hours. Similarly, during the same period, 6,287 recalls were 
terminated, for an average of 2,095 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 divided the average number of annual 
submissions (36,127) by the average number of annual respondents 
(2,779) and assume 10 hours is necessary for the corresponding 
information collection, resulting in 361,270 hours annually.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                  Number of
    Activity; 21 CFR part        Number of       disclosures     Total annual    Average burden    Total hours
                                respondents    per respondent    disclosures     per disclosure
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Recall communications; Sec.   2,779..........             445  1,236,655......  0.05 (3          61,832.75
  7.49.                                                                          minutes).
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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 445 
disclosures per recall and attribute 3 minutes for each disclosure, 
resulting in 61,832.75 burden hours annually.
    These estimates reflect an overall decrease in the average number 
of annual responses by 245,846 and a decrease in the average number of 
annual burden hours by 70,949.25 since our last submission for OMB 
review and approval of the information collection.

    Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00125 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P