[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19516-19517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7634]


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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published a notice of availability for a draft guidance entitled 
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving 
interested persons until January 16, 2007, to comment on the draft 
guidance. FDA received several comments on the draft guidance and those 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announced in this notice finalizes the draft guidance dated October 30, 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 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 (301) 443-1129.
    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

[[Page 19517]]

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:

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                                     Number of     Responses per       Total         Hours per     Total burden
              Form                  respondents     respondent       responses       response          hours
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Lender's Application for                      17              25             425            .5               213
 Insurance Claim Form 510.......
Request for Collection                        17             550           9,350            .167           1,561
 Assistance Form 513............
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    Total.......................              17  ..............           9,775  ..............           1,774
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    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.
 [FR Doc. E8-7634 Filed 4-9-08; 8:45 am]
BILLING CODE 4165-15-P