[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46499-46500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 October 
15, 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 <a href="/cdn-cgi/l/email-protection#93fcfae1f2cce0e6f1fefae0e0fafcfdd3fcfef1bdf6fce3bdf4fce5"><span class="__cf_email__" data-cfemail="d1beb8a3b08ea2a4b3bcb8a2a2b8bebf91bebcb3ffb4bea1ffb6bea7">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-0751. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="76262437250217101036101217581e1e0558111900">[email protected]</span></a>.

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.

[[Page 46500]]

Current Good Manufacturing Practice, 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 in the tables below.
    In the Federal Register of June 1, 2018 (83 FR 25466), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received stating that our 
estimate of burden associated with creating a food safety plan was too 
low and suggested a much higher figure. We appreciate this comment. 
However, because the annual burden is based on an industry average and 
because we continue to evaluate this relatively new collection, we are 
not adjusting our current estimate. At the same time, we continue to 
invite comment so that we might better refine our estimates for all 
elements of the collection.
    Our estimate of the burden for the information collection is as 
follows:

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


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of       Total
                 21 CFR section                     Number of      records per      annual           Average burden per recordkeeping        Total hours
                                                  recordkeepers   recordkeeper     records
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan and          46,685               1       46,685  110..........................................    5,135,350
 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 corrections           16,285               2       32,570  1............................................       32,570
 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.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ...........  .............................................    6,237,142
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                               Number of
                                                  Number of   disclosures     Total       Average
                 21 CFR section                  respondents      per         annual     burden per  Total hours
                                                               respondent  disclosures   disclosure
----------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food manufacturing          37,134            1       37,134     0.25 (15        9,284
 facility address..............................                                            minutes)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    As stated previously, we retain the currently approved burden for 
the information collection. 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19911 Filed 9-12-18; 8:45 am]
 BILLING CODE 4164-01-P


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