Document ID: FDA-2017-N-6175-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Food and Drug
Administration Recall Regulations
Posted Date: 2018-02-26T05:00Z

[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8284-8286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03847]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6175]

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) 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: Fax written comments on the collection of information by March 
28, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0249. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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

    Section 701 of the Federal Food, Drug, and Cosmetic Act charges the 
Secretary of Health and Human Services, through FDA, with the 
responsibility of assuring recalls (21 U.S.C. 371, Regulations and 
Hearings, and 21 CFR part 7, Enforcement Policy, Subpart C, Recalls 
(Including Product Corrections)--Guidance on Policy, Procedures, and 
Industry Responsibilities which pertain to the recall regulations and 
provide guidance to manufacturers on recall responsibilities). The 
regulations and guidance apply to all FDA-regulated products (i.e., 
food, including animal feed; drugs, including animal drugs; medical 
devices, including in vitro diagnostic products; cosmetics; biological 
products intended for human use; and tobacco).
    These responsibilities of companies conducting recalls include 
providing FDA with complete details of the recall including: (1) 
Reason(s) for the removal or correction, risk evaluation, quantity 
produced, distribution information, firm's recall strategy, a copy of 
any recall communication(s), and a contact official (Sec.  7.46); (2) 
notifying direct accounts of the recall, providing guidance regarding 
further distribution, giving instructions as to what to do with

[[Page 8285]]

the product, providing recipients with a ready means of reporting to 
the recalling firm (Sec.  7.49); and (3) submitting periodic status 
reports so that FDA may assess the progress of the recall. Status 
report information may be determined by, among other things, evaluation 
return reply cards, effectiveness checks and product returns (Sec.  
7.53), and providing the opportunity for a firm to request in writing 
that FDA terminate the recall (Sec.  7.55(b)).
    A search of the FDA database was performed to determine the number 
of recalls that took place during fiscal years 2014 to 2016. The 
resulting number of total recalls and terminations (8,560) from this 
database search were then averaged over the 3 years, and the resulting 
per year average of recalls and terminations (2,853) are used in 
estimating the current annual reporting and third party disclosure 
burden in this notice.
    FDA estimates, in the following tables, the total annual reporting 
and third party burden to collect and provide the required information 
to be 584,477 hours.
    In the Federal Register of November 17, 2017 (82 FR 54359), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment that did not suggest 
any changes to the information collection or burden estimates.
    The following is a summary of the estimated annual burden hours for 
recalling firms (manufacturers, processors, and distributors) to comply 
with the reporting requirements of FDA's recall regulations. 
Recognizing that there may be a vast difference in the information 
collection and reporting time involved in different recalls of FDA's 
regulated products, this summary reflects numbers across FDA.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of
    Activity/21 CFR section         Number of     responses per    Total annual   Average burden    Total hours
                                   respondents      respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Firm initiated recall (Sec.               2,853                1           2,853              25          71,325
 7.46) and recall
 communications (Sec.   7.49)..
Recall status reports (Sec.               2,853               13          37,089              10         370,890
 7.53).........................
Termination of a recall (Sec.             2,853                1           2,853              10          28,530
 7.55(b))......................
General industry guidance (Sec.           2,853                1           2,853              15          42,795
   7.59).......................
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............         513,540
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

A. Firm Initiated Recall and Recall Communications
    We request firms that voluntarily remove or correct foods and drugs 
(human or animal), cosmetics, medical devices, biologics, and tobacco 
to immediately notify the appropriate FDA District Office of such 
actions. The firm is to provide complete details of the recall reason, 
risk evaluation, quantity produced, distribution information, firms' 
recall strategy, and a contact official as well as requires firms to 
notify their direct accounts of the recall and to provide recipients 
with a ready means of reporting to the recalling firm. The estimates in 
table 1 are multiplied across the FDA product centers to arrive at a 
reporting burden estimate of 71,325 for firm initiated recall and 
recall communications.
B. Recall Status Reports
    We request that recalling firms provide periodic status reports so 
FDA can ascertain the progress of the recall. This request only applies 
to firms with active recalls, and periodic status reports are estimated 
to be reported every 2 to 4 weeks. The estimates in table 1 are 
multiplied across the FDA product centers to arrive at a reporting 
burden estimate of 370,890 hours for recall status reports.
C. Termination of a Recall
    We provide the firms an opportunity to request in writing that FDA 
end the recall. The Agency estimates it will receive 2,853 responses 
annually based on the average number of terminations over the past 3 
fiscal years. The estimates in table 1 are multiplied across the FDA 
product centers to arrive at a reporting burden estimate of 28,530 for 
termination of a recall.
D. Enforcement Policy
    We request that firms prepare and maintain a current written 
contingency plan for use in initiating and effecting a recall in 
accordance with Sec. Sec.  7.40 through 7.49, 7.53, and 7.55; use 
sufficient coding of regulated products to make possible positive lot 
identification and to facilitate effective recall of all violative lots 
and maintain such product distribution records as are necessary to 
facilitate location of products that are being recalled. Such records 
should be maintained for a period of time that exceeds the shelf life 
and expected use of the product and is at least the length of time 
specified in other applicable regulations concerning records retention. 
The estimates in table 1 are multiplied across the FDA product centers 
to arrive at a reporting burden estimate of 42,795 for enforcement 
policy.
E. Recall Communications
    We request that firms notify their consignees of the recall and to 
provide recipients with a ready means of reporting to the recalling 
firm.

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
   Activity/21 CFR section        Number of    disclosures per   Total annual    Average burden     Total hours
                                 respondents      respondent      disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
Recall communications (Sec.             2,853              518       1,477,854  0.048 (2.88               70,937
 7.49).                                                                          minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collections.

[[Page 8286]]

    The estimates in table 2 are multiplied across the FDA product 
centers to arrive at a total third party disclosure burden estimate of 
70,937.
    FDA regulates many different types of products including, but not 
limited to, medical products, food and feed, cosmetics, and tobacco 
products. FDA notes that not all third-party disclosures provided by 
firms to their consignees are similar in nature and may entail 
different methods and mediums of communication. The total burden hours 
have decreased since the last information collection approval based on 
a reduction in the number of respondents.

    Dated: February 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03847 Filed 2-23-18; 8:45 am]
 BILLING CODE 4164-01-P