Draft Guidance for Industry; Blue Bird Medicated Feed Labels; Availability, 63328 [E6-18148]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 209 (Monday, October 30, 2006)]
[Notices]
[Page 63328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0413]


Draft Guidance for Industry; Blue Bird Medicated Feed Labels; 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availability of a draft guidance for industry (181) entitled 
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels.'' This 
draft guidance is intended to provide new animal drug application 
(NADA) sponsors with the Center for Veterinary Medicine's (CVM'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DATES: Submit written or electronic comments on the draft guidance by 
January 16, 2007, to ensure their adequate consideration in preparation 
of the final document. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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 the 
draft guidance document to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to https:///www.fda.gov/
dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.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: 
DMomcilo@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Draft Guidance for Industry: Blue Bird Medicated Feed 
Labels.'' This draft guidance is intended to provide NADA sponsors with 
CVM'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. An NADA for a Type A medicated 
article is required to include, among other things, representative 
labeling proposed to be used for Type B and Type C medicated feeds 
containing the new animal drug (21 CFR 514.1(b)(3)(v)(b)). A Type A 
medicated article is defined in Sec.  558.3(b)(2) (21 CFR 558.3(b)(2)) 
as ``intended solely for use in the manufacture of another Type A 
medicated article or a Type B or Type C medicated feed.'' Type B 
medicated feed is defined in Sec.  558.3(b)(3) as ``intended solely for 
the manufacture of other medicated feeds (Type B or Type C).'' Type C 
medicated feed is defined in Sec.  558.3(b)(4) as ``intended as the 
complete feed for the animal or may be fed ``top dressed'' (added on 
top of usual ration) on or offered ``free-choice'' (e.g., supplement) 
in conjunction with other animal feed.''
    This draft guidance provides recommendations on the content and 
format of the representative labeling for Type B and Type C medicated 
feeds only. This representative labeling is also known as ``Blue Bird'' 
labeling. This draft guidance does not address the labeling of Type A 
medicated articles.

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 FDA's current thinking on this topic. It 
does not create or confer any rights for or on any person and will 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.

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

IV. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
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 are to be identified with the docket number found in brackets 
in the heading of this document. A copy of the draft guidance and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Electronic comments may be submitted on the Internet at https://
www.fda.gov/dockets/ecomments. Once on the Internet site, select Docket 
No. 2006D-0413, ``Draft Guidance for Industry: Blue Bird Medicated Feed 
Labels'' and follow the directions. Copies of this draft guidance may 
be obtained on the Internet from the CVM home page at https://
www.fda.gov/cvm.

    Dated: October 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18148 Filed 10-27-06; 8:45 am]
BILLING CODE 4160-01-S