Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability, 37059 [2012-14988]

Download as PDF Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Notices a hard copy. Please use the document number 1781 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to currently approved collections of information found in FDA regulations.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 part 807, subpart E are currently approved under OMB control number 0910–0120; the collections of information in 21 CFR 56.115 are currently approved under OMB control number 0910–0130; the collections of information in 21 CFR part 812 are currently approved under OMB control number 0910–0078; and the collections of information in 21 CFR part 801 are currently approved under OMB control number 0910–0485. V. 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. Dated: June 15, 2012. Nancy K. Stade, Deputy Director for Policy, Center for Devices and Radiological Health. [FR Doc. 2012–15025 Filed 6–19–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–0419] mstockstill on DSK4VPTVN1PROD with NOTICES Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability AGENCY: Food and Drug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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #204 entitled ‘‘Active Controls in Studies to Demonstrate Effectiveness SUMMARY: VerDate Mar<15>2010 16:14 Jun 19, 2012 Jkt 226001 of a New Animal Drug for Use in Companion Animals.’’ This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The intent of the guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles. 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 August 20, 2012. 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 Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for Veterinary Medicine (HFV–116), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8322, lisa.troutman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry #204 entitled ‘‘Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.’’ The purpose of this draft guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles. The draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The draft guidance compares studies that use active controls to studies that use either placebo concurrent controls or untreated concurrent controls, and it uses these comparisons to illustrate the PO 00000 Frm 00078 Fmt 4703 Sfmt 9990 37059 advantages and disadvantages of using a study with an active control. Examples are provided to illustrate some of the different outcomes that are possible when employing active controls in studies. 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 draft 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 part 514 have been approved under OMB control number 0910–0032. 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. 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: June 14, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–14988 Filed 6–19–12; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Page 37059]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14988]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0419]

Draft Guidance for Industry on Active Controls in Studies To
Demonstrate Effectiveness of a New Animal Drug for Use in Companion
Animals; 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 204 entitled
``Active Controls in Studies to Demonstrate Effectiveness of a New
Animal Drug for Use in Companion Animals.''
This draft guidance advises industry on the use of active controls
in studies intended to provide substantial evidence of effectiveness of
new animal drugs for use in companion animals. The intent of the
guidance is to provide information to clinical investigators who
conduct studies using active controls and have a basic understanding of
statistical principles.

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 August 20, 2012.

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: Lisa M. Troutman, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8322,
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry
204 entitled ``Active Controls in Studies to Demonstrate
Effectiveness of a New Animal Drug for Use in Companion Animals.'' The
purpose of this draft guidance is to provide information to clinical
investigators who conduct studies using active controls and have a
basic understanding of statistical principles. The draft guidance
advises industry on the use of active controls in studies intended to
provide substantial evidence of effectiveness of new animal drugs for
use in companion animals. The draft guidance compares studies that use
active controls to studies that use either placebo concurrent controls
or untreated concurrent controls, and it uses these comparisons to
illustrate the advantages and disadvantages of using a study with an
active control. Examples are provided to illustrate some of the
different outcomes that are possible when employing active controls in
studies.

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 draft 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 part 514 have been approved under
OMB control number 0910-0032.

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. 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: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14988 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P

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