[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Notices]
[Pages 45197-45198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18322]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 FDA recalls for human drugs, 
biological products, devices, animal drugs, food, cosmetics, and 
tobacco.

DATES: Submit either electronic or written comments on the collection 
of information by October 3, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 
Regulation--21 CFR Part 7 (OMB Control Number 0910-0249)--Extension
    Section 701 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) charges the Secretary of Health and Human Services (HHS), through 
the 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); 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.
    FDA estimates the total annual industry burden to collect and 
provide the previous information to be 627,165 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 45198]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
             Recall                  Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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)).......................
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    Total.......................  ..............  ..............  ..............  ..............         627,165
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\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. Hours per Response Estimates

    FDA has no information which would allow it to make a calculated 
estimate on the hours per response burden to FDA regulated firms to 
conduct recalls. Variables in the type of products, the quantity and 
level of distribution and the various circumstances of recall 
notifications could cause the hours per response to vary significantly. 
The best guesstimate of average burden hours per response from previous 
information collection request reports are utilized again for the 
current estimates on burden hours per response.

    Dated: July 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18322 Filed 8-1-14; 8:45 am]
BILLING CODE 4164-01-P