Document ID: FDA-2015-N-1196-0003
Agency: fda
Document Type: Notice
Title: List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period
Posted Date: 2015-07-20T04:00Z

[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42827-42828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17729]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1196]

List of Bulk Drug Substances That May Be Used by an Outsourcing 
Facility To Compound Drugs for Use in Animals; Extension of Nomination 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of nomination period.

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SUMMARY: The Food and Drug Administration (FDA) is extending the 
nomination period for the notice that appeared in the Federal Register 
of May 19, 2015. In the notice, FDA requested nominations for a list of 
bulk drug substances that may be used by facilities registered as 
outsourcing facilities under the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) to compound animal drugs from bulk substances, in 
accordance with FDA's draft guidance for industry (GIF) #230, 
``Compounding Animal Drugs from Bulk Drug Substances.'' The FDA is 
taking this action in response to a request for an extension to allow 
interested persons additional time to submit nominations.

DATES: Submit either electronic or written nominations for the bulk 
drug substances list by November 16, 2015.

ADDRESSES: You may submit nominations by any of the following methods:

Electronic Submissions

    Submit electronic nominations in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written nominations in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1196. All nominations received may be posted without change 
to http://www.regulations.gov, including any personal information 
provided. For additional information on submitting nominations, see the 
``Request for Nominations'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
nominations received, go to http://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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Neal Bataller, Center for Veterinary 
Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5745, neal.bataller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of May 19, 2015 (80 FR 28622), FDA 
published a notice with a 90-day nomination period for the list of bulk 
drug substances that may be used by a facility registered as an 
outsourcing facility under section 503B of the FD&C Act (21 U.S.C. 
353B) to compound drugs for use in animals in accordance with FDA's 
draft GFI #230, ``Compounding Animal Drugs from Bulk Drug Substances.'' 
That notice describes the information that should be provided to the 
FDA in support of each nomination.
    FDA has received a request for a 90-day extension of the nomination 
period as the requestor wanted more time to nominate drugs to the list 
and to provide supporting data. FDA has considered the request and is 
extending the nomination period for 90 days, until November 16, 2015. 
The FDA believes that a 90-day extension allows adequate time for 
interested persons to submit nominations without significantly delaying 
consideration of these nominations.

II. Nomination Process

    The process for nominations for bulk drug substances that may be 
used by facilities registered as outsourcing facilities under section 
503B of the FD&C Act to compound animal drugs from bulk drug substances 
is described in the previous notice published May 19, 2015. FDA cannot 
guarantee that all drugs nominated during the nomination period will be 
considered for initial inclusion in Appendix A at the time of its 
initial publication. Nominations submitted during the nomination period 
(ending on November 16, 2015) that are not evaluated and included in 
Appendix A at the time of its initial publication will receive 
consideration for later addition to Appendix A. In addition, 
individuals and organizations may petition FDA, in accordance with 21 
CFR 10.30, to make additional amendments to Appendix A after the 
nomination period.

III. Request for Nominations

    Interested persons may submit either electronic nominations to 
http://www.regulations.gov or written nominations to the Division of 
Dockets Management (see ADDRESSES). It is only necessary to send one 
set of nominations. Identify nominations with the docket number found 
in brackets in the heading of this document. Received nominations 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.

[[Page 42828]]

    Dated: July 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17729 Filed 7-17-15; 8:45 am]
 BILLING CODE 4164-01-P