Previous Article 73 FR 70 pgs. 19513-19514 - Guidance for Industry on Blue Bird Medicated Feed Labels; Availability
Type: NOTICEVolume: 73Number: 70Pages: 19513 - 19514
Docket number: [Docket No. FDA-2008-D-0165] (formerly Docket No. 2006D-0413)
FR document: [FR Doc. E8-7500 Filed 4-9-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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In the Federal Register of October 30, 2006 (71 FR 63328), FDA published a notice of availability for a draft guidance entitled "Draft Guidance for Industry: Blue Bird Medicated Feed Labels" giving interested persons until January 16, 2007, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized.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 .
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