80 FR 54568 - Distributor Labeling for New Animal Drugs; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 175 (September 10, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GIF) #231 entitled ``Distributor Labeling for New Animal Drugs.'' This draft guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a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.

[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54568-54569]
From the Federal Register Online  [www.thefederalregister.org]
[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Distributor Labeling for New Animal Drugs; Draft Guidance for 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availability of a draft guidance for industry (GIF) #231 entitled 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 9, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Policy and Regulations Staff (HFV-6), Center for 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