[Federal Register Volume 82, Number 221 (Friday, November 17, 2017)]
[Notices]
[Pages 54359-54361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24923]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 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 January 16, 2018.

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 January 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 16, 2018. 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 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.

[[Page 54360]]

     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-2017-N-6175 for ``Agency Information Collection Activities; 
Proposed Collection; Food and Drug Administration 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.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 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 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 (8,560) from this database search 
were then averaged over the 3 years, and the resulting per year average 
of recalls (2,853) are used in estimating the current annual reporting 
burden for this report. The resulting number of total terminations 
(8,560) from this database search were then averaged over the 3 years, 
and the resulting per year average of terminations (2,853) are used in 
estimating the current annual reporting burden for this report.
    FDA estimates the total annual industry burden to collect and 
provide the required information to be 470,745 burden hours.

[[Page 54361]]

    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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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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)).......................
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    Total.......................  ..............  ..............  ..............  ..............         470,745
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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

    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. Under these 
portions of the collection of information, the Agency estimates it will 
receive 2,853 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 equals 2,853. The average burden hours, 25, 
multiplied by total number of annual responses equal 71,325.

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. This collection of information will 
generate approximately 2,853 responses annually, based on the average 
number of recalls over the last 3 fiscal years, 8,560. The number of 
respondents multiplied by the number of responses per respondents (13) 
equals a total number of annual responses of 37,089. The total number 
of responses, 37,089, multiplied by an average burden hours of 10 per 
response equals a total of 370,890 total hours.

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 total annual responses of 2,853 multiplied by the 
average burden hours of 10 per response equals a total number of hours 
of 28,530.

II. Total Annual Third-Party Disclosure Burden

    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. Under this portion of the 
collection of information, the Agency estimates firms will provide 
4,433,562 notifications annually based on the number of respondents/
consignees (2,853) multiplied by the number of disclosures per 
respondent (1,554). The total number of hours is 248,279 (based on 
4,433,562 multiplied by 0.056 hours).

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
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Recall communications (Sec.                2,853           1,554       4,433,562           0.056         248,279
 7.49)..........................
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\1\ There are no capital costs or operating and maintenance costs associated with this information collections.

    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 (1,554) results in a burden per disclosure 
estimate of approximate hours (25 hours per recall/1,554 disclosures/
recall = 0.056 hours).

    Dated: November 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24923 Filed 11-16-17; 8:45 am]
 BILLING CODE 4164-01-P


