[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80120-80121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27256]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0064]


Pre-Submission Consultation Process for Animal Food Additive 
Petitions or Generally Recognized as Safe Notices; 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 final guidance for industry #262 
entitled ``Pre-Submission Consultation Process for Animal Food Additive 
Petitions or Generally Recognized as Safe (GRAS) Notices.'' The 
guidance provides uniform, consistent process information to industry 
to facilitate effective and efficient review of pre-consultation 
submissions for animal food additives or GRAS notices for intended use 
in animal food.

DATES: The announcement of the guidance is published in the Federal 
Register on December 11, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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 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-2020-D-0064 for ``Pre-Submission Consultation Process for Animal 
Food Additive Petitions or Generally Recognized as Safe (GRAS) 
Notices.'' 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, 240-402-7500.
     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.govinfo.gov/content/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

[[Page 80121]]

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, 
240-402-7500.
    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 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: William Burkholder, Center for 
Veterinary Medicine (HFV-229), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5900, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 13, 2020 (85 FR 8297), FDA 
published the notice of availability for a draft guidance entitled 
``Pre-Submission Consultation Process for Animal Food Additive 
Petitions or Generally Recognized as Safe (GRAS) Notices,'' giving 
interested persons until April 13, 2020, to comment on the draft 
guidance.
    FDA received two comments on the draft guidance and those comments 
were considered as the guidance was finalized. Editorial changes were 
made to improve clarity. The guidance announced in this notice 
finalizes the draft guidance dated February 2020.
    This guidance provides uniform, consistent process information to 
industry to facilitate effective and efficient review of pre-
consultation submissions for animal food additive petitions or GRAS 
substances and preparation of food use authorization requests.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on the pre-submission consultation process 
for animal food additive petitions or GRAS notices for intended use in 
animal food. 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance.
    The previously approved collections of information are subject to 
review by OMB under the PRA. The collections of information in 21 CFR 
570.17 and 571.1 have been approved under OMB control number 0910-0546; 
the collections of information under 21 CFR part 570, subpart E have 
been approved under OMB control number 0910-0342; and the collections 
of information under 21 CFR part 58 have been approved under OMB 
control number 0910-0119.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: December 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27256 Filed 12-10-20; 8:45 am]
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