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56078 Federal Register / Vol. 72, No.

190 / Tuesday, October 2, 2007 / Notices


No. of Annual Frequency per Total Annual Hours per
FDA Form 3602A Total Hours
Respondents Response Responses Response

Sections I and II (completed by the busi-

ness seeking ‘‘small business’’ status) 229 1 229 1 229

Section III (completed by the foreign na-

tional taxing authority) 33 7 229 1 229

Total Burden 458

1There are no capital costs or operating and maintenance costs associated with this collection of information.

This burden estimate is based on an (FDA). The meeting will be open to the National Antimicrobial Resistance
examination of 510(k) premarket public. Monitoring System (NARMS) Program
notifications received during FY 2006 Name of Committee: Science Board to and activities related to melamine from
and FDA’s estimation of the time the Food and Drug Administration the March 31, 2006, and June 14, 2007,
required to collect the required (Science Board). Science Board meetings. The Science
information to complete the form. The General Function of the Committee: Board will then hear about and discuss
evidence supporting each 3602A must The Board shall provide advice the subcommittee review of the agency’s
be reviewed by a foreign national taxing primarily to the Commissioner and science programs. The Science Board
authority to complete Section III, the other appropriate officials on specific will also hear about and discuss the
National Taxing Authority Certification, complex and technical issues as well as agency’s updates on drug safety.FDA
of each 3602A. Because this is a new emerging issues within the scientific intends to make background material
activity, and neither FDA nor any community in industry and academia.
available to the public no later than 2
foreign national taxing authority has any Additionally, the Board will provide
business days before the meeting. If
data that would provide an objective advice to the agency on keeping pace
FDA is unable to post the background
measure of the effort required to with technical and scientific evolutions
in the fields of regulatory science, on material on its Web site prior to the
complete Section III, FDA is estimating meeting, the background material will
that the burden will be the same as FDA formulating an appropriate research
agenda, and on upgrading it’s scientific be made publicly available at the
experiences in reviewing the Form FDA location of the advisory committee
3602, approved under OMB control and research facilities to keep pace with
these changes. It will also provide the meeting, and the background material
number 0910–0508. will be posted on FDA’s Web site after
means for critical review of agency-
FDA believes most entities that the meeting. Background material is
sponsored intramural and extramural
submit a Form FDA 3602A will not have available at
scientific research programs.
any affiliates, and very few will have Date and Time: The meeting will be dockets/ac/acmenu.htm, click on the
more than three or four affiliates. Based held on October 30, 2007, from 8 a.m. year 2007 and scroll down to the
on our experience with Form FDA 3602, to 5:30 p.m. appropriate advisory committee link.
FDA believes each business will require Location: Washington DC North/
1 hour to complete Sections I and II. Procedure: Interested persons may
Gaithersburg Hilton, 620 Perry Pkwy., present data, information, or views,
Because this is a new requirement, FDA Gaithersburg, MD 20877, Salons A, B,
does not have any data on the time that orally or in writing, on issues pending
and C. before the committee. Written
will be required to complete Section III, Contact Person: Carlos Peña, Office of
the National Taxing Authority submissions may be made to the contact
the Commissioner, Food and Drug
Certification. Administration (HF–33), 5600 Fishers person on or before October 15, 2007.
Lane, Rockville, MD 20857, 301–827– Oral presentations from the public will
Dated: September 26, 2007.
6687, carlos.Peñ, or FDA be scheduled between approximately 4
Jeffrey Shuren,
Advisory Committee Information Line, p.m. and 5 p.m. Those desiring to make
Assistant Commissioner for Policy. formal oral presentations should notify
[FR Doc. E7–19411 Filed 10–1–07; 8:45 am]
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code the contact person and submit a brief
3014512603. Please call the Information statement of the general nature of the
Line for up-to-date information on this evidence or arguments they wish to
meeting. A notice in the Federal present, the names and addresses of
DEPARTMENT OF HEALTH AND proposed participants, and an
HUMAN SERVICES Register about last minute modifications
that impact a previously announced indication of the approximate time
Food and Drug Administration advisory committee meeting cannot requested to make their presentation on
always be published quickly enough to or before October 5, 2007. Time allotted
Science Board to the Food and Drug provide timely notice. Therefore, you for each presentation may be limited. If
Administration; Notice of Meeting should always check the agency’s Web the number of registrants requesting to
site and call the appropriate advisory speak is greater than can be reasonably
AGENCY: Food and Drug Administration, committee hot line/phone line to learn accommodated during the scheduled
HHS. about possible modifications before open public hearing session, FDA may
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ACTION: Notice. coming to the meeting. conduct a lottery to determine the

Agenda: The Science Board will hear speakers for the scheduled open public
This notice announces a forthcoming about and discuss the agency’s critical hearing session. The contact person will
meeting of a public advisory committee path program. The Science Board will notify interested persons regarding their
of the Food and Drug Administration hear about and discuss updates on the request to speak by October 8, 2007.

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Federal Register / Vol. 72, No. 190 / Tuesday, October 2, 2007 / Notices 56079

Persons attending FDA’s advisory addressed adhesive label to assist that person and does not operate to bind
committee meetings are advised that the office in processing your requests. See FDA or the public. An alternative
agency is not responsible for providing the SUPPLEMENTARY INFORMATION section approach may be used if such approach
access to electrical outlets. for electronic access to the guidance satisfies the requirements of the
FDA welcomes the attendance of the document. applicable statutes and regulations.
public at its advisory committee Submit written comments to the
meetings and will make every effort to IV. Comments
Division of Dockets Management (HFA–
accommodate persons with physical 305), Food and Drug Administration, Interested persons may, at any time,
disabilities or special needs. If you 5630 Fishers Lane, rm. 1061, Rockville, submit to the Division of Dockets
require special accommodations due to MD 20852. Submit electronic comments Management (see ADDRESSES) written or
a disability, please contact Dr. Carlos to either electronic comments regarding the
Peña at least 7 days in advance of the ecomments or http:// guidance. Submit a single copy of
meeting. electronic comments or two paper
FDA is committed to the orderly copies of any mailed comments, except
conduct of its advisory committee that individuals may submit one paper
Michelle L. Stull, Center for Veterinary
meetings. Please visit our Web site at copy. Comments are to be identified
Medicine (HFV–133), Food and Drug with the full title of the guidance and
Administration, 7500 Standish Pl.,
default.htm for procedures on public the docket number found in brackets in
Rockville, MD 20855, 301–827–5058, e-
conduct during advisory committee the heading of this document. A copy of
meetings. the guidance and received comments
Notice of this meeting is given under SUPPLEMENTARY INFORMATION: are available for public examination in
the Federal Advisory Committee Act (5 I. Background the Division of Dockets Management
U.S.C. app. 2). between 9 a.m. and 4 p.m., Monday
In the Federal Register of April 14,
Dated: September 23, 2007. through Friday.
2006 (71 FR 19526), FDA published a
Randall W. Lutter, notice of availability of a draft guidance V. Electronic Access
Deputy Commissioner for Policy. entitled ‘‘Recommended Study Design Persons with access to the Internet
[FR Doc. E7–19349 Filed 10–1–07; 8:45 am] and Evaluation of Effectiveness Studies may obtain the guidance from either the
BILLING CODE 4160–01–S for Swine Respiratory Disease Claims.’’ CVM home page (
The notice gave interested persons until cvm) or the Division of Dockets
June 28, 2006, to comment on the draft Management Web site (http://
DEPARTMENT OF HEALTH AND guidance. FDA received a few
HUMAN SERVICES comments on the draft guidance. We default.htm).
considered those comments as we
Food and Drug Administration finalized the guidance. The guidance, Dated: September 24, 2007.
[Docket No. 2006D–0138] announced in this document, finalizes Jeffrey Shuren,
the draft guidance that we announced Assistant Commissioner for Policy.
Guidance for Industry: Recommended on April 14, 2006. [FR Doc. E7–19412 Filed 10–1 –07; 8:45 am]
Study Design and Evaluation of The purpose of the guidance is to BILLING CODE 4160–01–S
Effectiveness Studies for Swine provide the Center for Veterinary
Respiratory Disease Claims; Medicine’s (CVM’s) current thinking
Availability regarding the recommended design and DEPARTMENT OF THE INTERIOR
evaluation of effectiveness studies for
AGENCY: Food and Drug Administration,
swine respiratory disease (SRD) claims. Fish and Wildlife Service
This guidance identifies specific,
ACTION: Notice. detailed recommendations for sponsors Endangered Species Recovery Permit
SUMMARY: The Food and Drug of new animal drug applications to Applications
Administration (FDA) is announcing the consider when they design and write
AGENCY: Fish and Wildlife Service,
availability of a guidance for industry protocols for SRD effectiveness studies.
(#178) entitled ‘‘Recommended Study II. Paperwork Reduction Act of 1995 ACTION: Notice of receipt of permit
Design and Evaluation of Effectiveness applications; request for comment.
Studies for Swine Respiratory Disease This guidance refers to previously
Claims.’’ This guidance provides approved collections of information
SUMMARY: We invite the public to
recommendations to industry relating to found in FDA regulations. These
comment on the following applications
study design and describes the criteria collections of information are subject to
to conduct certain activities with
that the Center for Veterinary Medicine review by the Office of Management and
endangered species.
(CVM) intends to use to evaluate Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501– DATES: Comments on these permit
effectiveness studies for swine applications must be received on or
respiratory disease (SRD) claims. 3520). The collections of information in
21 CFR 514.1 have been approved under before November 1, 2007.
DATES: Submit written or electronic ADDRESSES: Written data or comments
OMB Control Number 0910–0032.
comments on agency guidances at any should be submitted to the U.S. Fish
time. III. Significance of Guidance and Wildlife Service, Endangered
ADDRESSES: Submit written requests for This level 1 guidance is being issued Species Program Manager, California/
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single copies of the guidance to the consistent with FDA’s good guidance Nevada Operations Office (CNO), 2800
Communications Staff (HFV–12), Center practices regulation (21 CFR 10.115). Cottage Way, Room W–2606,
for Veterinary Medicine, Food and Drug The guidance represents the agency’s Sacramento, California, 95825
Administration, 7519 Standish Pl., current thinking on the topic. It does not (telephone: (916) 414–6464; fax: (916)
Rockville, MD 20855. Send one self- create or confer any rights for or on any 414–6486). Please refer to the respective

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