Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine; Availability, 41406-41407 [05-14137]

Download as PDF 41406 Federal Register / Vol. 70, No. 137 / Tuesday, July 19, 2005 / Notices d. Budget. e. Measures of Effectiveness. f. Additional Requested Information. 2. Financial status report, no more than 90 days after the end of the budget period. 3. Final financial and performance reports, no more than 90 days after the end of the project period. These reports must be mailed to the Grants Management or Contract Specialist listed in the ‘‘Agency Contacts’’ section of this announcement. VII. Agency Contacts We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341; Telephone: 770–488–2700. For program technical assistance, contact: Michael Brown, Project Officer, Centers for Disease Control and Prevention (CDC), National Center on Birth Defects and Developmental Disabilities, Division of Human Development and Disability, 1600 Clifton Road NE., Mailstop E–88, Atlanta, GA 30333; Telephone: 404– 498–3006; E-mail: MABrown@cdc.gov. For financial, grants management, or budget assistance, contact: Mildred Garner, Grants Management Officer, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341; Telephone: (770) 488–2745; Email: mqg4@cdc.gov. VIII. Other Information This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: https://www.cdc.gov. Click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements.’’ Dated: July 13, 2005. Alan A. Kotch, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–14166 Filed 7–18–05; 8:45 am] Control and Prevention (CDC) announces the following meeting: Name: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Intervention for Individuals with Fetal Alcohol Syndrome: Transitioning Science to Community Project, Request for Application (RFA) #DD 05–079 and Implementing Community-Level Strategies for Fetal Alcohol Syndrome Prevention and Surveillance in South Africa, RFA #DD 05– 118. Times and Dates: 1 p.m.–5 p.m., August 3, 2005 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of applications received in response to: Intervention for Individuals with Fetal Alcohol Syndrome: Transitioning Science to Community Project, Request for Application (RFA) #DD 05–079 and Implementing Community-Level Strategies for Fetal Alcohol Syndrome Prevention and Surveillance in South Africa, RFA #DD 05– 118. For Further Information Contact: Pamela J. Wilkerson, MPA, Scientific Review Administrator, 24 Executive Park Drive, NE., Mailstop E74, Atlanta, GA 30333, Telephone (404) 498–2556. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: July 12, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–14162 Filed 7–18–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration BILLING CODE 4163–18–P [Docket No. 2003D–0167] (formerly Docket No. 03D–0167) DEPARTMENT OF HEALTH AND HUMAN SERVICES Guidance for Industry on Dispute Resolution Procedures for ScienceBased Decisions on Products Regulated by the Center for Veterinary Medicine; Availability Centers for Disease Control and Prevention Food and Drug Administration, Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel AGENCY: In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry VerDate jul<14>2003 17:15 Jul 18, 2005 Jkt 205001 HHS. ACTION: Notice. SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 (#79) entitled ‘‘Guidance for Industry: Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine (CVM).’’ This guidance document describes dispute resolution procedures by which sponsors, applicants, or manufacturers of FDAregulated products for animals may request review of science-based decisions. This guidance does not address procedures for handling issues associated with FDA’s new initiative to enhance pharmaceutical good manufacturing practices (GMPs). 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 selfaddressed 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 https:/// www.fda.gov/dockets/ecomments. Comments should be identified with the full title of the guidance and the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Marcia Larkins, Center for Veterinary Medicine (HFV–7), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301–827–4535, email: mlarkins@cvm.fda.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of May 19, 2003 (68 FR 27094), FDA published a notice of availability for a draft guidance for industry entitled ‘‘Dispute Resolution Procedures for ScienceBased Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)’’ giving interested persons until August 4, 2003, to submit comments on the draft guidance and until July 18, 2003, to comment on the information collection. FDA considered all comments received and, where appropriate, made changes in the guidance. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance E:\FR\FM\19JYN1.SGM 19JYN1 Federal Register / Vol. 70, No. 137 / Tuesday, July 19, 2005 / Notices practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on dispute resolution and the procedures regarding requests for review of scientific controversies relating to decisions affecting animal drugs or other products regulated by CVM. The document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations. If an applicant wants to discuss an alternative approach, the applicant should contact FDA staff responsible for implementing the guidance. If the applicant cannot identify appropriate FDA staff, the applicant should call the CVM Ombudsman at 301–827–4535. III. Paperwork Reduction Act of 1995 FDA is announcing that a collection of information entitled ‘‘Final Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. In the Federal Register of May 19, 2003 (68 FR 27094), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0566. The approval expires on June 30, 2008. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. VerDate jul<14>2003 17:15 Jul 18, 2005 Jkt 205001 IV. Comments As with all FDA’s guidances, the public is encouraged to submit written or electronic comments with new data or other new information pertinent to this guidance. FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance. The agency will notify the public of any such amendments through a document in the Federal Register. 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 individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the documents and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Copies of the guidance document entitled ‘‘Guidance for Industry: Dispute Resolution Procedures for ScienceBased Decisions on Products Regulated by the Center for Veterinary Medicine (CVM)’’ may be obtained on the Internet from the CVM home page at https:// www.fda.gov/cvm. Dated: July 12, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14137 Filed 7–18–05; 8:45 am] BILLING CODE 4160–01–S PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Notice of SAMHSA’s Anticipated FY 2006 Grant Funding Opportunities SUMMARY: This notice is to inform the public of SAMHSA’s anticipated grant funding opportunities for FY 2006, based on the President’s FY 2006 budget request. All information provided is tentative and preliminary. These plans may change and final figures will not be available until after SAMHSA receives its 2006 appropriation. In January 2005, SAMHSA ceased publishing notices of grant funding opportunities in the Federal Register, consistent with the Department of Health and Human Services management objectives. Announcements are instead posted on https://www.Grants.gov and on SAMHSA’s Web site at https:// www.samhsa.gov. Interested applicants should visit these Web sites for specific information about these programs as it becomes available. Applicants should also be aware that all the necessary information to apply for grant funds will continue to be available at SAMHSA’s two national clearinghouses: the National Clearinghouse for Alcohol and Drug Information (NCADI)–1–800–729– 6686—for substance abuse prevention or treatment grants; and the National Mental Health Information Center–1– 800–789–CMHS (2647)—for mental health grants. F0R FURTHER INFORMATION CONTACT: Cathy J. Friedman, M.A., SAMHSA, 1 Choke Cherry Road, Room 8–1097, Rockville, MD 20857; phone (240) 276– 2316; e-mail: cathy.friedman@samhsa.hhs.gov. BILLING CODE 4162–20–P Frm 00039 Fmt 4703 Sfmt 4703 41407 E:\FR\FM\19JYN1.SGM 19JYN1

Agencies

[Federal Register Volume 70, Number 137 (Tuesday, July 19, 2005)]
[Notices]
[Pages 41406-41407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14137]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0167] (formerly Docket No. 03D-0167)


Guidance for Industry on Dispute Resolution Procedures for 
Science-Based Decisions on Products Regulated by the Center for 
Veterinary Medicine; 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 (79) entitled 
``Guidance for Industry: Dispute Resolution Procedures for Science-
Based Decisions on Products Regulated by the Center for Veterinary 
Medicine (CVM).'' This guidance document describes dispute resolution 
procedures by which sponsors, applicants, or manufacturers of FDA-
regulated products for animals may request review of science-based 
decisions. This guidance does not address procedures for handling 
issues associated with FDA's new initiative to enhance pharmaceutical 
good manufacturing practices (GMPs).

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 https:///
www.fda.gov/dockets/ecomments. Comments should be identified with the 
full title of the guidance and the docket number found in brackets in 
the heading of this document. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Marcia Larkins, Center for Veterinary 
Medicine (HFV-7), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 301-827-4535, e-mail: mlarkins@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 19, 2003 (68 FR 27094), FDA 
published a notice of availability for a draft guidance for industry 
entitled ``Dispute Resolution Procedures for Science-Based Decisions on 
Products Regulated by the Center for Veterinary Medicine (CVM)'' giving 
interested persons until August 4, 2003, to submit comments on the 
draft guidance and until July 18, 2003, to comment on the information 
collection. FDA considered all comments received and, where 
appropriate, made changes in the guidance.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance

[[Page 41407]]

practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on dispute resolution and the procedures 
regarding requests for review of scientific controversies relating to 
decisions affecting animal drugs or other products regulated by CVM. 
The document does not create or confer any rights for or on any person 
and will not operate to bind FDA or the public. Alternative methods may 
be used as long as they satisfy the requirements of the applicable 
statutes and regulations. If an applicant wants to discuss an 
alternative approach, the applicant should contact FDA staff 
responsible for implementing the guidance. If the applicant cannot 
identify appropriate FDA staff, the applicant should call the CVM 
Ombudsman at 301-827-4535.

III. Paperwork Reduction Act of 1995

    FDA is announcing that a collection of information entitled ``Final 
Guidance for Industry on Dispute Resolution Procedures for Science-
Based Decisions on Products Regulated by the Center for Veterinary 
Medicine'' has been approved by the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. In the Federal 
Register of May 19, 2003 (68 FR 27094), the agency announced that the 
proposed information collection had been submitted to OMB for review 
and clearance under 44 U.S.C. 3507. An agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number. 
OMB has now approved the information collection and has assigned OMB 
control number 0910-0566. The approval expires on June 30, 2008. A copy 
of the supporting statement for this information collection is 
available on the Internet at https://www.fda.gov/ohrms/dockets.

IV. Comments

    As with all FDA's guidances, the public is encouraged to submit 
written or electronic comments with new data or other new information 
pertinent to this guidance. FDA periodically will review the comments 
in the docket, and where appropriate, will amend the guidance. The 
agency will notify the public of any such amendments through a document 
in the Federal Register.
    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 individuals may submit one paper copy. 
Comments are to be identified with the docket number found in the 
brackets in the heading of this document. A copy of the documents and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Copies of the guidance document entitled ``Guidance for Industry: 
Dispute Resolution Procedures for Science-Based Decisions on Products 
Regulated by the Center for Veterinary Medicine (CVM)'' may be obtained 
on the Internet from the CVM home page at https://www.fda.gov/cvm.

    Dated: July 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14137 Filed 7-18-05; 8:45 am]
BILLING CODE 4160-01-S

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