[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25466-25468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0920]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food

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 the information collection requirements 
associated with current good manufacturing practice, hazard analysis, 
and risk-based preventive controls for human food.

DATES: Submit either electronic or written comments on the collection 
of information by July 31, 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 July 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 31, 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.
     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.

[[Page 25467]]

     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-2011-N-0920 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food 
for Animals.'' 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: 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, 
[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.

Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based 
Preventive Controls for Human Food--21 CFR Part 117

OMB Control Number 0910-0751--Extension

    This information collection supports FDA regulations. As amended by 
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to 
better protect the public health by helping to ensure the safety and 
security of the food supply. It enables FDA to focus more on preventing 
food safety problems rather than relying primarily on reacting to 
problems after they occur. FSMA recognizes the important role industry 
plays in ensuring the safety of the food supply, including the adoption 
of modern systems of preventive controls in food production. 
Specifically, section 418 of the FD&C Act (21 U.S.C. 350g) sets forth 
requirements for hazard analysis and risk-based preventive controls for 
facilities that produce food for human consumption. To implement these 
provisions, regulations were codified under 21 CFR part 117--Current 
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food. The regulations establish requirements for a 
written food safety plan; hazard analysis preventive controls; 
monitoring; corrective actions and corrections; verification; supply-
chain program; recall plan; and associated records, and became 
effective November 16, 2015. Currently, we continue to evaluate burden 
associated with the information collection requirements; however, for 
purposes of extending the information collection we retain the 
currently approved figures as shown below.
    Our estimate of the burden for the information collection is as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                                  Number of
                21 CFR section                    Number of     responses per    Total annual          Average burden per response          Total hours
                                                 respondents      respondent       responses
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117.201(e); qualified facility...............          37,134              0.5          18,567  0.5 (30 minutes)........................           9,284
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 25468]]


                                                    Table 2--Estimated Annual Recordkeeping Burden 1
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                                                                  Number of
                21 CFR section                    Number of      records per     Total annual       Average burden per recordkeeping        Total hours
                                                recordkeepers    recordkeeper       records
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117.126(c) and 117.170(d); food safety plan            46,685                1          46,685  110.....................................       5,135,350
 and reanalysis.
117.136; assurance records...................          16,285                1          16,285  0.25 (15 minutes).......................           4,071
117.145(c); monitoring records...............           8,143              730       5,944,390  0.05 (3 minutes)........................         297,220
117.150(d); corrective actions and                     16,285                2          32,570  1.......................................          32,570
 corrections records.
117.155(b); verification records.............           8,143              244       1,986,892  0.05 (3 minutes)........................          99,345
117.160; validation records..................           3,677                6          22,062  0.25 (15 minutes).......................           5,515
117.475(c)(7)-(9); supplier records..........          16,285               10         162,850  4.......................................         651,400
117.180(d); training records for preventive            46,685                1          46,685  0.25 (15 minutes).......................          11,671
 controls qualified individual.
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    Total....................................  ..............  ...............  ..............  ........................................       6,237,142
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                Table 3--Estimated Annual Third-Party Disclosure Burden 1
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                                                                  Number of
                21 CFR section                    Number of    disclosures per   Total annual         Average burden per disclosure         Total hours
                                                 respondents      respondent      disclosures
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117.201(e); disclosure of food manufacturing           37,134                1          37,134  0.25 (15 minutes).......................           9,284
 facility address.
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    These figures are based on our regulatory impact analysis in 
support of the final rule on preventive controls for human food, which 
published in the Federal Register of September 17, 2015 (80 FR 55908). 
Using Agency data, we estimated the number of food facilities that we 
believe are subject to the regulations. We base our estimate of the 
time necessary for the individual reporting, recordkeeping, and third-
party disclosure activities on our experience with similar information 
collections.

    Dated: May 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11801 Filed 5-31-18; 8:45 am]
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