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41406 Federal Register / Vol. 70, No.

137 / Tuesday, July 19, 2005 / Notices

d. Budget. Control and Prevention (CDC) (#79) entitled ‘‘Guidance for Industry:
e. Measures of Effectiveness. announces the following meeting: Dispute Resolution Procedures for
f. Additional Requested Information. Name: Disease, Disability, and Injury Science-Based Decisions on Products
2. Financial status report, no more Prevention and Control Special Emphasis Regulated by the Center for Veterinary
than 90 days after the end of the budget Panel (SEP): Intervention for Individuals Medicine (CVM).’’ This guidance
period. with Fetal Alcohol Syndrome: Transitioning document describes dispute resolution
3. Final financial and performance Science to Community Project, Request for procedures by which sponsors,
reports, no more than 90 days after the Application (RFA) #DD 05–079 and applicants, or manufacturers of FDA-
end of the project period. Implementing Community-Level Strategies regulated products for animals may
for Fetal Alcohol Syndrome Prevention and
These reports must be mailed to the request review of science-based
Surveillance in South Africa, RFA #DD 05–
Grants Management or Contract 118. decisions. This guidance does not
Specialist listed in the ‘‘Agency Times and Dates: 1 p.m.–5 p.m., August 3, address procedures for handling issues
Contacts’’ section of this announcement. 2005 (Closed). associated with FDA’s new initiative to
Place: Teleconference. enhance pharmaceutical good
VII. Agency Contacts Status: The meeting will be closed to the manufacturing practices (GMPs).
We encourage inquiries concerning public in accordance with provisions set DATES: Submit written or electronic
this announcement. forth in Section 552b(c)(4) and (6), Title 5 comments on agency guidances at any
For general questions, contact: U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
time.
Technical Information Management
CDC, pursuant to Public Law 92–463. ADDRESSES: Submit written requests for
Section, CDC Procurement and Grants Matters To Be Discussed: The meeting will single copies of the guidance to the
Office, 2920 Brandywine Road, Atlanta, include the review, discussion, and Communications Staff (HFV–12), Center
GA 30341; Telephone: 770–488–2700. evaluation of applications received in for Veterinary Medicine, Food and Drug
For program technical assistance, response to: Intervention for Individuals with
Administration, 7519 Standish Pl.,
contact: Michael Brown, Project Officer, Fetal Alcohol Syndrome: Transitioning
Science to Community Project, Request for Rockville, MD 20855. Send one self-
Centers for Disease Control and addressed adhesive label to assist that
Prevention (CDC), National Center on Application (RFA) #DD 05–079 and
Implementing Community-Level Strategies office in processing your requests.
Birth Defects and Developmental Submit written comments on this
for Fetal Alcohol Syndrome Prevention and
Disabilities, Division of Human Surveillance in South Africa, RFA #DD 05– guidance to the Division of Dockets
Development and Disability, 1600 118. Management (HFA–305), Food and Drug
Clifton Road NE., Mailstop E–88, For Further Information Contact: Pamela J. Administration, 5630 Fishers Lane, rm.
Atlanta, GA 30333; Telephone: 404– Wilkerson, MPA, Scientific Review 1061, Rockville, MD 20852. Submit
498–3006; E-mail: MABrown@cdc.gov. Administrator, 24 Executive Park Drive, NE.,
electronic comments to http:///
For financial, grants management, or Mailstop E74, Atlanta, GA 30333, Telephone
(404) 498–2556. www.fda.gov/dockets/ecomments.
budget assistance, contact: Mildred Comments should be identified with the
Garner, Grants Management Officer, The Director, Management Analysis and
Services Office, has been delegated the full title of the guidance and the docket
CDC Procurement and Grants Office, authority to sign Federal Register notices number found in brackets in the
2920 Brandywine Road, Atlanta, GA pertaining to announcements of meetings and heading of this document. See the
30341; Telephone: (770) 488–2745; E- other committee management activities, for SUPPLEMENTARY INFORMATION section for
mail: mqg4@cdc.gov. both CDC and the Agency for Toxic electronic access to the guidance
Substances and Disease Registry.
VIII. Other Information document.
Dated: July 12, 2005.
This and other CDC funding FOR FURTHER INFORMATION CONTACT:
Alvin Hall, Marcia Larkins, Center for Veterinary
opportunity announcements can be
Director, Management Analysis and Services Medicine (HFV–7), Food and Drug
found on the CDC Web site, Internet Office, Centers for Disease Control and
address: http://www.cdc.gov. Click on Administration, 7519 Standish Pl.,
Prevention.
‘‘Funding’’ then ‘‘Grants and Rockville, MD 20855, 301–827–4535, e-
[FR Doc. 05–14162 Filed 7–18–05; 8:45 am] mail: mlarkins@cvm.fda.gov.
Cooperative Agreements.’’
BILLING CODE 4163–18–P
SUPPLEMENTARY INFORMATION:
Dated: July 13, 2005.
Alan A. Kotch, I. Background
Acting Director, Procurement and Grants DEPARTMENT OF HEALTH AND In the Federal Register of May 19,
Office, Centers for Disease Control and HUMAN SERVICES 2003 (68 FR 27094), FDA published a
Prevention.
Food and Drug Administration notice of availability for a draft guidance
[FR Doc. 05–14166 Filed 7–18–05; 8:45 am] for industry entitled ‘‘Dispute
BILLING CODE 4163–18–P [Docket No. 2003D–0167] (formerly Docket Resolution Procedures for Science-
No. 03D–0167) Based Decisions on Products Regulated
by the Center for Veterinary Medicine
DEPARTMENT OF HEALTH AND Guidance for Industry on Dispute
(CVM)’’ giving interested persons until
HUMAN SERVICES Resolution Procedures for Science-
August 4, 2003, to submit comments on
Based Decisions on Products
Centers for Disease Control and the draft guidance and until July 18,
Regulated by the Center for Veterinary
Prevention 2003, to comment on the information
Medicine; Availability
collection. FDA considered all
Meetings: Disease, Disability, and AGENCY: Food and Drug Administration, comments received and, where
Injury Prevention and Control Special HHS. appropriate, made changes in the
Emphasis Panel ACTION: Notice. guidance.

In accordance with Section 10(a)(2) of SUMMARY: The Food and Drug II. Significance of Guidance
the Federal Advisory Committee Act Administration (FDA) is announcing the This level 1 guidance is being issued
(Pub. L. 92–463), the Centers for Disease availability of a guidance for industry consistent with FDA’s good guidance

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Federal Register / Vol. 70, No. 137 / Tuesday, July 19, 2005 / Notices 41407

practices regulation (21 CFR 10.115). IV. Comments DEPARTMENT OF HEALTH AND
The guidance represents the agency’s HUMAN SERVICES
current thinking on dispute resolution As with all FDA’s guidances, the
and the procedures regarding requests public is encouraged to submit written Substance Abuse and Mental Health
for review of scientific controversies or electronic comments with new data Services Administration
relating to decisions affecting animal or other new information pertinent to
drugs or other products regulated by this guidance. FDA periodically will Notice of SAMHSA’s Anticipated FY
CVM. The document does not create or review the comments in the docket, and 2006 Grant Funding Opportunities
confer any rights for or on any person where appropriate, will amend the SUMMARY: This notice is to inform the
and will not operate to bind FDA or the guidance. The agency will notify the public of SAMHSA’s anticipated grant
public. Alternative methods may be public of any such amendments through funding opportunities for FY 2006,
used as long as they satisfy the a document in the Federal Register. based on the President’s FY 2006 budget
requirements of the applicable statutes request. All information provided is
Interested persons may submit to the
and regulations. If an applicant wants to tentative and preliminary. These plans
discuss an alternative approach, the Division of Dockets Management (see
ADDRESSES) written or electronic may change and final figures will not be
applicant should contact FDA staff
comments regarding this document. available until after SAMHSA receives
responsible for implementing the
Submit a single copy of electronic its 2006 appropriation.
guidance. If the applicant cannot
comments or two paper copies of any In January 2005, SAMHSA ceased
identify appropriate FDA staff, the
mailed comments, except that publishing notices of grant funding
applicant should call the CVM
individuals may submit one paper copy. opportunities in the Federal Register,
Ombudsman at 301–827–4535.
Comments are to be identified with the consistent with the Department of
III. Paperwork Reduction Act of 1995 Health and Human Services
docket number found in the brackets in
FDA is announcing that a collection management objectives.
the heading of this document. A copy of
of information entitled ‘‘Final Guidance Announcements are instead posted on
the documents and received comments
for Industry on Dispute Resolution http://www.Grants.gov and on
may be seen in the Division of Dockets SAMHSA’s Web site at http://
Procedures for Science-Based Decisions Management between 9 a.m. and 4 p.m.,
on Products Regulated by the Center for www.samhsa.gov. Interested applicants
Monday through Friday. should visit these Web sites for specific
Veterinary Medicine’’ has been
approved by the Office of Management V. Electronic Access information about these programs as it
and Budget (OMB) under the Paperwork becomes available. Applicants should
Reduction Act of 1995. In the Federal Copies of the guidance document also be aware that all the necessary
Register of May 19, 2003 (68 FR 27094), entitled ‘‘Guidance for Industry: Dispute information to apply for grant funds will
the agency announced that the proposed Resolution Procedures for Science- continue to be available at SAMHSA’s
information collection had been Based Decisions on Products Regulated two national clearinghouses: the
submitted to OMB for review and by the Center for Veterinary Medicine National Clearinghouse for Alcohol and
clearance under 44 U.S.C. 3507. An (CVM)’’ may be obtained on the Internet Drug Information (NCADI)–1–800–729–
agency may not conduct or sponsor, and from the CVM home page at http:// 6686—for substance abuse prevention or
a person is not required to respond to, www.fda.gov/cvm. treatment grants; and the National
a collection of information unless it Mental Health Information Center–1–
Dated: July 12, 2005. 800–789–CMHS (2647)—for mental
displays a currently valid OMB control
Jeffrey Shuren, health grants.
number. OMB has now approved the
information collection and has assigned Assistant Commissioner for Policy. F0R FURTHER INFORMATION CONTACT:
OMB control number 0910–0566. The [FR Doc. 05–14137 Filed 7–18–05; 8:45 am] Cathy J. Friedman, M.A., SAMHSA, 1
approval expires on June 30, 2008. A BILLING CODE 4160–01–S Choke Cherry Road, Room 8–1097,
copy of the supporting statement for this Rockville, MD 20857; phone (240) 276–
information collection is available on 2316; e-mail:
the Internet at http://www.fda.gov/ cathy.friedman@samhsa.hhs.gov.
ohrms/dockets. BILLING CODE 4162–20–P

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