[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accordance with FDA's draft guidance for industry (GIF) #230,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, [email protected].
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