Document ID: FDA-2008-D-0165-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
Posted Date: 2008-04-10T04:00Z

[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]               
[Page 19513-19514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap08-60]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0165] (formerly Docket No. 2006D-0413)

 
Guidance for Industry on Blue Bird Medicated Feed Labels; 
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 guidance for industry (181) entitled ``Blue 
Bird Medicated Feed Labels.'' This guidance provides new animal drug 
application (NADA) sponsors with the Center for Veterinary Medicine's 
current thinking on what constitutes recommended content and format of 
representative labels for new animal drugs intended for use in the 
manufacture of medicated feeds.

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

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), 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.
    Submit written comments on this guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for 
Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6856, e-mail: 
dragan.momcilovic@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 30, 2006 (71 FR 63328), FDA 
published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving 
interested persons until January 16, 2007, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 
comments were considered as the guidance was finalized. The guidance 
announced in this notice finalizes the draft guidance dated October 30, 
2006.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). This guidance represents 
the agency's current thinking on the topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. 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 514.1(b)(3) have been approved 
under OMB control number 0910-0032.

III. Comments

    Submit written requests for single copies of the guidance to the 
Communications Staff (HFV-12), 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments should be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cvm or http://www.regulations.gov.

[[Page 19514]]

    Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7500 Filed 4-9-08; 8:45 am]

BILLING CODE 4160-01-S