E8-7634. 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: [e-mail].

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In the Federal Register of October 30, 2006 (71 FR 63328), FDA published a notice of availability for a draft guidance entitled “Draft Guidance for Industry: Blue Bird Medicated Feed Labels” giving interested persons until January 16, 2007, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance dated October 30, 2006.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 individualproposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on [phone].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.

Proposed Project: Health Education Assistance Loan (HEAL) Program: Lender's Application for Insurance Claim Form and Request for Collection Assistance Form (OMB No. 0915-0036)—Extension

The HEAL program provided federally insured loans to students in certain health professions to pay for their educational costs. HEAL Lenders use the Lender's Application for Insurance Claim to request payment from the Federal Government for federally insured loans lost due to borrower's death, disability, bankruptcy, or default. The Request for Collection Assistance form is used by HEAL lenders to request Federal assistance with the collection of delinquent payments from HEAL borrowers.

The burden estimates are as follows:

Form	Number of respondents	Responses per respondent	Total responses	Hours per response	Total burden hours
Lender's Application for Insurance Claim Form 510	17	25	425	.5	213
Request for Collection Assistance Form 513	17	550	9,350	.167	1,561
Total	17		9,775		1,774

Send comments to Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.

Dated: April 7, 2008.

Alexandra Huttinger,

Director, Division of Policy Review and Coodination.