Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and Submission,” Availability, 6143 [2011-2315]

Download as PDF Federal Register / Vol. 76, No. 23 / Thursday, February 3, 2011 / Notices The estimate of the time required for record preparation and maintenance is based on Agency communications with industry. Other information needed to calculate the total burden hours (i.e., manufacturing sites, number of type A medicated articles being manufactured, etc.) are derived from Agency records and experience. Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary Medicine (HFV–110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8318; e-mail: angela.clarke@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Dated: January 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. I. Background FDA is announcing the availability of a draft guidance for industry (#215) entitled ‘‘Target Animal Safety and Effectiveness Protocol Development and Submission.’’ The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the CVM, ONADE, to reduce the time to protocol concurrence. This guidance makes recommendations to aid in the preparation of protocols used to generate data to support new animal drug applications, specifically target animal safety and substantial evidence of effectiveness. [FR Doc. 2011–2355 Filed 2–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0023] Draft Guidance for Industry on ‘‘Target Animal Safety and Effectiveness Protocol Development and Submission,’’ Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#215) entitled ‘‘Target Animal Safety and Effectiveness Protocol Development and Submission.’’ The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to protocol concurrence. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2011. 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug jdjones on DSK8KYBLC1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:31 Feb 02, 2011 Jkt 223001 II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency’s current thinking on this 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. III. 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 this guidance have been approved under OMB Control No. 0910–0032 (expiration date 04/30/2011). IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 6143 V. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: January 28, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–2315 Filed 2–2–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2000–D–1542; formerly Docket No. 00D–0892] Draft Guidance on Positron Emission Tomography Drug Applications— Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ‘‘PET Drug Applications—Content and Format for NDAs and ANDAs.’’ The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in accordance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and FDA regulations. This draft guidance revises the draft guidance entitled ‘‘Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products; Availability,’’ issued on March 10, 2000. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to assist applicants in preparing NDAs or ANDAs for fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection used in PET imaging. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 4, 2011. SUMMARY: E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Page 6143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2315]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0023]


Draft Guidance for Industry on ``Target Animal Safety and 
Effectiveness Protocol Development and Submission,'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (215) entitled 
``Target Animal Safety and Effectiveness Protocol Development and 
Submission.''
    The purpose of this document is to provide sponsors guidance in 
preparation of study protocols for review by the Center for Veterinary 
Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce 
the time to protocol concurrence.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 19, 2011.

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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Angela Clarke, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8318; e-mail: angela.clarke@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
(215) entitled ``Target Animal Safety and Effectiveness 
Protocol Development and Submission.'' The purpose of this document is 
to provide sponsors guidance in preparation of study protocols for 
review by the CVM, ONADE, to reduce the time to protocol concurrence. 
This guidance makes recommendations to aid in the preparation of 
protocols used to generate data to support new animal drug 
applications, specifically target animal safety and substantial 
evidence of effectiveness.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the Agency's current thinking on this 
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.

III. 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 this guidance have been approved under 
OMB Control No. 0910-0032 (expiration date 04/30/2011).

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. 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

    Persons with access to the Internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov.

    Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2315 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P
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