[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19513-19514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7500]
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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:
[email protected].
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published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving
interested persons until January 16, 2007, to comment on the draft
guidance. FDA received several comments on the draft guidance and those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announced in this notice finalizes the draft guidance dated October 30,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