[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54568-54569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22772]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-3056]
Distributor Labeling for New Animal Drugs; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry (GIF) #231 entitled
``Distributor Labeling for New Animal Drugs.'' This draft guidance
discusses FDA's current thinking with respect to the factors it
considers in determining whether to take regulatory action against
distributor labeling for a new animal drug that differs from the
labeling approved as part of a New Animal Drug Application or
Abbreviated New Animal Drug Application (NADA/ANADA) in ways other than
those permitted by regulation.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 9, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Policy and Regulations Staff (HFV-6), Center for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, 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INFORMATION section for electronic access to the draft guidance
document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Dorothy McAdams, Center for Veterinary
Medicine, Division of Surveillance (HFV-210), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5763,
email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft GFI #231 entitled
``Distributor Labeling for New Animal Drugs.'' ``Distributor labeling''
refers to the labeling of an approved new animal drug marketed by a
distributor who distributes the product under its own label or
proprietary name. Unlike the approved labeling, which the Center for
Veterinary Medicine reviews as part of a NADA/ANADA approval process to
ensure the safe and effective use of the drug and compliance with the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) and its
implementing regulations, distributor labeling does not ordinarily go
through a premarket approval process.
FDA regulations (21 CFR 514.80) require that distributor labeling
be identical to the labeling approved in the NADA/ANADA, except for a
different and suitable proprietary name and the name and address of the
distributor preceded by an appropriate qualifying phrase. These
requirements are meant to ensure that distributor labeling complies
with the requirements of the FD&C Act and its implementing regulations
and to prevent distributor label products from reaching the market with
labeling that compromises the safe and effective use of the new animal
drug.
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
distributor labeling for new animal drugs. 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 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 Sec. 514.80 have been approved under OMB
control number 0910-0284.
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
[[Page 54569]]
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 draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.
Dated: September 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22772 Filed 9-9-15; 8:45 am]
BILLING CODE 4164-01-P