80 FR 33528 - Recommendations for Preparation and Submission of Animal Food Additive Petitions; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

Page Range		33528-33529
FR Document		2015-14364

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI) #221 entitled ``Recommendations for Preparation and Submission of Animal Food Additive Petitions.'' This guidance describes the types of information that FDA's Center for Veterinary Medicine recommends for inclusion in food additive petitions submitted for food additives intended for use in food for animals. It is intended to help the petitioner submit this information in a consistent and appropriate manner.

Federal Register, Volume 80 Issue 113 (Friday, June 12, 2015)

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33528-33529]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0928]


Recommendations for Preparation and Submission of Animal Food 
Additive Petitions; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry (GFI) #221 entitled 
``Recommendations for Preparation and Submission of Animal Food 
Additive Petitions.'' This guidance describes the types of information 
that FDA's Center for Veterinary Medicine recommends for inclusion in 
food additive petitions submitted for food additives intended for use 
in food for animals. It is intended to help the petitioner submit this 
information in a consistent and appropriate manner.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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, 7519 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Center for Veterinary Medicine, 
Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-7077; [email protected], in 
the subject line please include ATTN: Division of Animal Feeds.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 11, 2013 (78 FR 55727), FDA 
published the notice of availability for a draft guidance entitled 
``Recommendations for Preparation and Submission of Animal Food 
Additive Petitions'' giving interested persons until November 12, 2013, 
to comment on the draft guidance. In the Federal Register of December 
10, 2013 (78 FR 74154), FDA published a notice reopening the comment 
period for the draft guidance giving interested persons until January 
9, 2014, to comment on the draft guidance.
    FDA received four comments on the draft guidance and considered 
those comments as we finalized the guidance. The guidance announced in 
this notice finalizes the draft guidance dated September 2013.

II. Significance of Guidance

    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 recommendations for preparation and 
submission of animal food additive petitions. 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.

III. Paperwork Reduction Act of 1995

    This 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 21 CFR 571.1 and 571.6 have been approved 
under OMB control number 0910-0546.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.


[[Page 33529]]


    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14364 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P

33528 Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices

2. The date the application was DEPARTMENT OF HEALTH AND interested persons until November 12,
initially submitted with respect to the HUMAN SERVICES 2013, to comment on the draft guidance.
human drug product under section In the Federal Register of December 10,
505(b) of the FD&C Act: October 21, Food and Drug Administration 2013 (78 FR 74154), FDA published a
2011. FDA has verified the applicant’s [Docket No. FDA–2013–D–0928] notice reopening the comment period
claim that the new drug application for the draft guidance giving interested
(NDA) for XELJANZ (NDA 203214) was Recommendations for Preparation and persons until January 9, 2014, to
submitted on October 21, 2011. Submission of Animal Food Additive comment on the draft guidance.
Petitions; Guidance for Industry;
3. The date the application was FDA received four comments on the
Availability
approved: November 6, 2012. FDA has draft guidance and considered those
verified the applicant’s claim that NDA AGENCY: Food and Drug Administration, comments as we finalized the guidance.
203214 was approved on November 6, HHS. The guidance announced in this notice
2012. ACTION: Notice. finalizes the draft guidance dated
This determination of the regulatory September 2013.
SUMMARY: The Food and Drug
review period establishes the maximum II. Significance of Guidance
Administration (FDA) is announcing the
potential length of a patent extension. availability of a guidance for industry
However, the USPTO applies several This level 1 guidance is being issued
(GFI) #221 entitled ‘‘Recommendations
statutory limitations in its calculations consistent with FDA’s good guidance
for Preparation and Submission of
of the actual period for patent extension. Animal Food Additive Petitions.’’ This practices regulation (21 CFR 10.115).
In its application for patent extension, guidance describes the types of The guidance represents the current
this applicant seeks 5 years of patent information that FDA’s Center for thinking of FDA on recommendations
term extension. Veterinary Medicine recommends for for preparation and submission of
Anyone with knowledge that any of inclusion in food additive petitions animal food additive petitions. It does
the dates as published are incorrect may submitted for food additives intended not establish any rights for any person
submit to the Division of Dockets for use in food for animals. It is and is not binding on FDA or the public.
intended to help the petitioner submit You can use an alternative approach if
Management (see ADDRESSES) either
this information in a consistent and it satisfies the requirements of the
electronic or written comments and ask
appropriate manner. applicable statutes and regulations.
for a redetermination by August 11,
2015. Furthermore, any interested DATES: Submit either electronic or III. Paperwork Reduction Act of 1995
person may petition FDA for a written comments on Agency guidances
determination regarding whether the at any time. This guidance refers to previously
applicant for extension acted with due ADDRESSES: Submit written requests for approved collections of information
diligence during the regulatory review single copies of the guidance to the found in FDA regulations. These
period by December 9, 2015. To meet its Policy and Regulations Staff (HFV–6), collections of information are subject to
burden, the petition must contain Center for Veterinary Medicine, Food review by the Office of Management and
sufficient facts to merit an FDA and Drug Administration, 7519 Standish Budget (OMB) under the Paperwork
investigation. (See H. Rept. 857, part 1, Pl., Rockville, MD 20855. Send one self- Reduction Act of 1995 (44 U.S.C. 3501–
98th Cong., 2d sess., pp. 41–42, 1984.) addressed adhesive label to assist that 3520). The collections of information in
Petitions should be in the format office in processing your requests. See 21 CFR 571.1 and 571.6 have been
specified in 21 CFR 10.30. the SUPPLEMENTARY INFORMATION section approved under OMB control number
for electronic access to the guidance 0910–0546.
Interested persons may submit to the document.
Division of Dockets Management (see Submit electronic comments on the IV. Comments
ADDRESSES) electronic or written guidance to http://www.regulations.gov.
comments and written or electronic Interested persons may submit either
Submit written comments to the electronic comments regarding this
petitions. It is only necessary to send Division of Dockets Management (HFA–
one set of comments. Identify comments document to http://www.regulations.gov
305), Food and Drug Administration,
with the docket number found in or written comments to the Division of
5630 Fishers Lane, Rm. 1061, Rockville,
brackets in the heading of this Dockets Management (see ADDRESSES). It
MD 20852.
document. If you submit a written is only necessary to send one set of
FOR FURTHER INFORMATION CONTACT:
petition, two copies are required. A comments. Identify comments with the
Center for Veterinary Medicine, docket number found in brackets in the
petition submitted electronically must Division of Animal Feeds (HFV–220),
be submitted to http:// heading of this document. Received
Food and Drug Administration, 7519
www.regulations.gov, Docket No. FDA– comments may be seen in the Division
Standish Pl., Rockville, MD 20855, 240–
2013–S–0610. Comments and petitions of Dockets Management between 9 a.m.
402–7077; AskCVM@fda.hhs.gov, in the
that have not been made publicly subject line please include ATTN: and 4 p.m., Monday through Friday, and
available on http://www.regulations.gov Division of Animal Feeds. will be posted to the docket at http://
may be viewed in the Division of www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Dockets Management between 9 a.m.
mstockstill on DSK4VPTVN1PROD with NOTICES

V. Electronic Access
and 4 p.m., Monday through Friday. I. Background
In the Federal Register of September Persons with access to the Internet
Dated: June 9, 2015.
11, 2013 (78 FR 55727), FDA published may obtain the guidance at either http://
Leslie Kux, www.fda.gov/AnimalVeterinary/
the notice of availability for a draft
Associate Commissioner for Policy. guidance entitled ‘‘Recommendations GuidanceComplianceEnforcement/
[FR Doc. 2015–14433 Filed 6–11–15; 8:45 am] for Preparation and Submission of GuidanceforIndustry/default.htm or
BILLING CODE 4164–01–P Animal Food Additive Petitions’’ giving http://www.regulations.gov.

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Federal Register / Vol. 80, No. 113 / Friday, June 12, 2015 / Notices 33529

Dated: June 8, 2015. DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of
Leslie Kux, HUMAN SERVICES Health, 6701 Rockledge Drive, Room 4196,
MSC 7812, Bethesda, MD 20892, 301–435–
Associate Commissioner for Policy. 2902, gubina@csr.nih.gov.
[FR Doc. 2015–14364 Filed 6–11–15; 8:45 am]
National Institutes of Health
Name of Committee: Center for Scientific
BILLING CODE 4164–01–P
Center for Scientific Review; Notice of Review Special Emphasis Panel, Oral, Dental,
Closed Meetings and Craniofacial Sciences SBIR/STTR.
Date: July 14–15, 2015.
DEPARTMENT OF HEALTH AND Pursuant to section 10(d) of the Time: 8:00 a.m. to 6:00 p.m.
HUMAN SERVICES Federal Advisory Committee Act, as Agenda: To review and evaluate grant
amended (5 U.S.C. App.), notice is applications.
National Institutes of Health Place: National Institutes of Health, 6701
hereby given of the following meetings.
Rockledge Drive, Bethesda, MD 20892,
The meetings will be closed to the (Virtual Meeting).
National Institute of Neurological public in accordance with the
Disorders and Stroke; Amended Notice Contact Person: Yi-Hsin Liu, Ph.D.,
provisions set forth in sections Scientific Review Officer, Center for
of Meeting 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Scientific Review, National Institutes of
as amended. The grant applications and Health, 6701 Rockledge Drive, Room 4214,
Notice is hereby given of a change in the discussions could disclose MSC 7814, Bethesda, MD 20892, 301–435–
the meeting of the National Institute of confidential trade secrets or commercial 1781, liuyh@csr.nih.gov.
Neurological Disorders and Stroke property such as patentable material, Name of Committee:Center for Scientific
Special Emphasis Panel, July 09, 2015, and personal information concerning Review Special Emphasis Panel, Lung
09:00 a.m. to July 10, 2015, 01:00 p.m., individuals associated with the grant Diseases Member Conflicts.
The Fairmont Washington, DC, 2401 M Date: July 14–15, 2015.
applications, the disclosure of which Time: 9:00 a.m. to 6:00 p.m.
Street NW., Washington, DC 20037 would constitute a clearly unwarranted
which was published in the Federal Agenda: To review and evaluate grant
invasion of personal privacy. applications.
Register on May 13, 2015, 80
Name of Committee: Center for Scientific Place: National Institutes of Health, 6701
FRN27332. Rockledge Drive, Bethesda, MD 20892,
Review Special Emphasis Panel, PAR Panel:
The meeting notice is amended to Development of Appropriate Pediatric (Virtual Meeting).
change the location of the meeting from Formulations and Pediatric Drug Delivery Contact Person: George M Barnas, Ph.D.,
The Fairmont Washington DC to the System. Scientific Review Officer, Center for
Hyatt Regency Bethesda. The date and Date: July 8, 2015. Scientific Review, National Institutes of
Time: 2:00 p.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 4220,
time remain the same. The meeting is MSC 7818, Bethesda, MD 20892, 301–435–
closed to the public. Agenda: To review and evaluate grant
applications. 0696, barnasg@csr.nih.gov.
Dated: June 9, 2015. Place: National Institutes of Health, 6701 Name of Committee: Center for Scientific
Carolyn Baum, Rockledge Drive, Bethesda, MD 20892, Review Special Emphasis Panel, Small
(Telephone Conference Call). Business: Nephrology.
Program Analyst, Office of Federal Advisory
Contact Person: Robert C Elliott, Ph.D., Date: July 14–15, 2015.
Committee Policy.
Scientific Review Officer, Center for Time: 9:00 a.m. to 6:00 p.m.
[FR Doc. 2015–14427 Filed 6–11–15; 8:45 am] Agenda: To review and evaluate grant
Scientific Review, National Institutes of
BILLING CODE 4140–01–P Health, 6701 Rockledge Drive, Room 3130, applications.
MSC 7850, Bethesda, MD 20892, 301–435– Place: National Institutes of Health, 6701
3009, elliotro@csr.nih.gov. Rockledge Drive, Bethesda, MD 20892,
DEPARTMENT OF HEALTH AND (Virtual Meeting).
Name of Committee: Center for Scientific
HUMAN SERVICES Contact Person: Atul Sahai, Ph.D.,
Review Special Emphasis Panel, Glia
Scientific Review Officer, Center for
Development, Function and Disease.
National Institutes of Health Scientific Review, National Institutes of
Date: July 9, 2015.
Health, 6701 Rockledge Drive, Room 2188,
Time: 1:00 p.m. to 4:00 p.m.
Center for Scientific Review Amended; MSC 7818, Bethesda, MD 20892, 301–435–
Agenda: To review and evaluate grant
1198, sahaia@csr.nih.gov.
Notice of Meeting applications.
Name of Committee: Center for Scientific
Place: National Institutes of Health, 6701
Review Special Emphasis Panel,
Notice is hereby given of a change in Rockledge Drive, Bethesda, MD 20892, Neurogenesis and Neurodevelopment.
the meeting of the Center for Scientific (Telephone Conference Call). Date: July 14, 2015.
Review Special Emphasis Panel, June Contact Person: Time: 1:00 p.m. to 5:00 p.m.
25, 2015, 11:00 a.m. to June 25, 2015, Carol Hamelink, Ph.D., Scientific Review Agenda: To review and evaluate grant
Officer, Center for Scientific Review, applications.
12:00 p.m., National Institutes of Health, National Institutes of Health, 6701 Rockledge
6701 Rockledge Drive, Bethesda, MD, Place: National Institutes of Health, 6701
Drive, Room 4192, MSC 7850, Bethesda, MD Rockledge Drive, Bethesda, MD 20892,
20892 which was published in the 20892, (301) 213–9887, hamelinc@ (Virtual Meeting).
Federal Register on May 28, 2015, 80 csr.nih.gov. Contact Person: Laurent Taupenot, Ph.D.,
FR 30475. Name of Committee: Center for Scientific Scientific Review Officer, Center for
The meeting will be held on June 24, Review Special Emphasis Panel, Fellowship: Scientific Review, National Institutes of
2015. The meeting time and location Cell Biology, Developmental Biology and Health, 6701 Rockledge Drive, Room 4188,
Bioengineering. MSC 7850, Bethesda, MD 20892, 301–435–
remain the same. The meeting is closed
Date: July 14–15, 2015. 1203, laurent.taupenot@nih.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES

to the public. Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific
Dated: June 9, 2015. Agenda: To review and evaluate grant Review Special Emphasis Panel, Center on
Melanie J. Gray, applications. Membrane Protein Production and Analysis
Place: Doubletree Hotel Bethesda, (COMPPAA).
Program Analyst, Office of Federal Advisory
(Formerly Holiday Inn Select), 8120 Date: July 14–16, 2015.
Committee Policy.
Wisconsin Avenue, Bethesda, MD 20814. Time: 5:00 p.m. to 11:00 a.m.
[FR Doc. 2015–14428 Filed 6–11–15; 8:45 am] Contact Person: Alexander Gubin, Ph.D., Agenda: To review and evaluate grant
BILLING CODE 4140–01–P Scientific Review Officer, Center for applications.

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Document Created: 2018-02-22 10:16:31
Document Modified: 2018-02-22 10:16:31

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on Agency guidances at any time.
Contact		Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-7077; [email protected], in the subject line please include ATTN: Division of Animal Feeds.
FR Citation		80 FR 33528

80 FR 33528 - Recommendations for Preparation and Submission of Animal Food Additive Petitions; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 113 (June 12, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration