
[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7609-7610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02788]


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

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) 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 
13, 2015.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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 Regulation--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 
guidelines 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 include providing FDA with complete details 
of the recall including reason(s) for the removal or correction, risk 
evaluation, quantity produced, distribution information, the firm's 
recall strategy, a copy of any recall communication(s), and a contact 
official (Sec.  7.46 (21 CFR 7.46)); notifying direct accounts of the 
recall, providing guidance regarding further distribution, giving 
instructions as to what to do with the product, providing recipients 
with a ready means of reporting to the recalling firm (Sec.  7.49); and 
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 FDA's database was performed to determine the number of 
recalls that took place during fiscal years 2011 to 2013. The resulting 
number of total recalls (11,403) from this database search were then 
averaged over the 3 years, and the resulting per year average of 
recalls (3,801) are used in estimating the current annual reporting 
burden for this report. The resulting number of total terminations 
(11,403) from this database search were then averaged over the 3 years, 
and the resulting per year average of terminations (3,801) are used in 
estimating the current annual reporting burden for this report.
    In the Federal Register of August 4, 2014 (79 FR 45197), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the total annual industry burden to collect and 
provide the previous information to be 721,886 burden hours.
    The following is a summary of the estimated annual burden hours for 
recalling firms (manufacturers, processors, and distributors) to comply 
with the voluntary 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7610]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
             Recall                  Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Firm Initiated Recall (21 CFR              3,801               1           3,801              25          95,025
 7.46) and Recall Communications
 (21 CFR 7.49)..................
Recall Status Reports (21 CFR              3,801              13          49,413              10         494,130
 7.53)..........................
Termination of a Recall (21 CFR            3,801               1           3,801              10          38,010
 7.55(b)).......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         627,165
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

I. Total Annual Reporting

A. Firm Initiated Recall and Recall Communications

    Request firms 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. Under these portions of 
the collection of information, the Agency estimates it will receive 
3,801 responses annually based on the average number of recalls over 
the last 3 fiscal years. The number of responses multiplied by the 
number of respondents equal 3,801. The average burden hours of 25 
multiplied by the total number of annual responses equal 95,025. The 
average burden hour person response was 30 and has decreased by 5.

B. Recall Status Reports

    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 is estimated to be reported every 2 to 4 
weeks. This collection of information will generate approximately 3,801 
responses annually, based on the average number of recalls over the 
last 3 fiscal years (11,403). The number of respondents multiplied by 
the number of responses per respondents (13) equal a total number of 
annual responses of 49,413. The total number of responses 49,413 with 
an average burden hours of 10 per response equal a total of 494,130 
total hours.

C. Termination of a Recall

    Provide the firms an opportunity to request in writing that FDA end 
the recall. The Agency estimates it will receive 3,801 responses 
annually based on the average number of terminations over the past 3 
fiscal years. The total annual responses of 3,801 multiplied by the 
average burden hours of 10 per response equal a total number of hours 
of 38,010.

II. Total Annual Third-Party Disclosure Burden

    Recall Communications. Request firms to notify their consignees of 
the recall and to provide recipients with a ready means of reporting to 
the recalling firm. Under this portion of the collection of 
information, the Agency estimates firms will provide 1,691,445 
notifications annually based on the number of respondents/consignees 
(3,807) multiplied by the number of disclosures per respondent (445). 
The total number of hours is 94,721 (based on 1,691,445 multiplied by 
0.056 hours).

                                                 Table 2--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Number of
                          21 CFR Part                              Number of     disclosures per    Total annual    Average  burden per    Total hours
                                                                  respondents       respondent      disclosures         disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recall Communications (21 CFR 7.49)...........................           3,801              445        1,691,445     0.056 (3 minutes)           94,721
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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. FDA estimates the 
burden for third-party disclosure per recall event to be an average of 
25 hours. This burden estimate factored out to the average number of 
consignees per recall (445) results in a burden per disclosure estimate 
of approximate hours (25 hours per recall/445 disclosures/recall = 
0.056 hours).

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02788 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P


