Document ID: FDA-2014-N-1031-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Food and Drug Administration Recall Regulations
Posted Date: 2021-04-09T04:00Z

[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18543-18544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07287]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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.

-----------------------------------------------------------------------

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 10, 2021.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed 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 part 7 (21 CFR part 
7), subpart C promulgated to clarify and explain associated practices 
and procedures. Sections 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 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 January 8, 2021 (86 FR 1508), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of the collection of information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
    Activity; 21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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...........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............          41,001  ..............         451,695
----------------------------------------------------------------------------------------------------------------
\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,

[[Page 18544]]

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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   Activity; 21 CFR section        Number of      disclosures    Total annual    Average burden     Total hours
                                  respondents   per respondent    disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
Recall communications; Sec.              2,779             445       1,236,655  0.05 (3 minutes)       61,832.75
 7.49.
----------------------------------------------------------------------------------------------------------------
\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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07287 Filed 4-8-21; 8:45 am]
BILLING CODE 4164-01-P