[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19516-19517]
From the Federal Register Online via the Government Printing 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:
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published a notice of availability for a draft guidance entitled
``Draft Guidance for Industry: Blue Bird Medicated Feed Labels'' giving
interested persons until January 16, 2007, to comment on the draft
guidance. FDA received several comments on the draft guidance and those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announced in this notice finalizes the draft guidance dated October 30,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 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