[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27999-28001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12894]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1861]


Hazard Analysis and Risk-Based Preventive Controls for Food for 
Animals: Supply-Chain Program; Draft Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is 
announcing the availability of a draft guidance for industry #246 
entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food 
for Animals: Supply-Chain Program.'' This draft guidance document, when 
finalized, will help animal food facilities comply with the 
requirements for the supply-chain program under our regulation 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals.''

DATES: Submit either electronic or written comments on the draft 
guidance by December 12, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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

[[Page 28000]]

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.
     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-2018-D-1861 for ``Hazard Analysis and Risk-Based Preventive 
Controls for Food for Animals: Supply-Chain Program.'' Received 
comments 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Policy and Regulations Staff (HFV-6), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jenny Murphy, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6246, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
enables FDA to better protect public (human and animal) health by 
helping to ensure the safety and security of the food supply. FSMA 
enables FDA to focus more on preventing animal food safety problems 
rather than relying primarily on reacting to problems after they occur.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic 
Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with 
requirements for hazard analysis and risk-based preventive controls for 
establishments that are required to register as food facilities under 
our regulations in 21 CFR part 1, subpart H, in accordance with section 
415 of the FD&C Act (21 U.S.C. 350d). We have established regulations 
to implement the hazard analysis and risk-based preventive controls 
requirements within part 507 (21 CFR part 507).
    We are announcing the availability of a draft guidance for industry 
#246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for 
Food for Animals: Supply-Chain Program.'' This draft guidance for 
industry is intended to explain how to comply with the requirements for 
the supply-chain program of the hazard analysis and risk-based 
preventive controls for food for animals under part 507. In the Federal 
Register of January 23, 2018 (83 FR 3163), we announced the 
availability of a related multichapter draft guidance for industry, 
#245 entitled ``Hazard Analysis and Risk-Based Preventive Controls for 
Food for Animals.'' In the Federal Register of February 5, 2018 (83 FR 
5106), we announced a correction to the docket number for that draft 
guidance.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on how to 
comply with the supply-chain program requirements for the regulation 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 507 have been approved under OMB 
control number 0910-0789.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.


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    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12894 Filed 6-14-18; 8:45 am]
 BILLING CODE 4164-01-P