Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability, 74670-74671 [2012-30274]

Download as PDF 74670 Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices U V. Electronic Access Ulipristal acetate Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. W Warfarin sodium III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients: Dated: December 11, 2012. Leslie Kux, Assistant Commissioner for Policy. D BILLING CODE 4160–01–P Desmopressin acetate Diflunisal Dipyridamole H Hydrochlorothiazide; lisinopril Hydrochlorothiazide; losartan potassium L [FR Doc. 2012–30308 Filed 12–14–12; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Liothyronine sodium [Docket No. FDA–2012–D–1145] Phenoxybenzamine hydrochloride Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability P Q Quinine sulfate R Risedronate sodium T Tacrolimus Thalidomide Tinidazole AGENCY: HHS. ACTION: For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to https:// www.regulations.gov and enter docket number FDA–2007–D–0369. These draft and revised draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These guidances represent the Agency’s current thinking on product-specific design of BE studies to support ANDAs. They do not create or confer any rights for or on any person and do 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. srobinson on DSK4SPTVN1PROD with IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments on any of the specific BE recommendations posted on FDA’s Web site to https://www.regulations.gov. 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. The guidances, notices, and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. VerDate Mar<15>2010 16:21 Dec 14, 2012 Food and Drug Administration, Jkt 229001 Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.’’ The purpose of this document is to provide guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). This document defines several types of enrichment strategies, provides examples of various potential clinical trial designs, and discusses potential regulatory considerations when using enrichment strategies in clinical trials. 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 February 15, 2013. SUMMARY: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach and Development (HFM–40), Center for ADDRESSES: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448 (1–800–835–4709 or 301–827–1800), or the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002, or fax your request to 301–847–8149. 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: Robert Temple, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4212, Silver Spring, MD 20993–0003, 301– 796–2270; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210; or Robert L. Becker, Center for Device and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5674, Silver Spring, MD 20993–0003, 301–796–5450. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.’’ This document provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims in new drug applications (NDAs) and biologics license applications (BLAs). Similar approaches could be used in clinical trials in earlier phases of drug development. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA IV), FDA committed to certain performance goals (see letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the E:\FR\FM\17DEN1.SGM 17DEN1 Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices Congressional Record).1 This draft guidance addresses one of these goals with the creation of a guidance document that addresses enriched trial designs. The guidance defines and discusses three enrichment strategies: Decreasing heterogeneity, predictive enrichment, and prognostic enrichment. The guidance also discusses general clinical trial design considerations, provides examples of potential clinical trial designs, and discusses regulatory considerations when using enrichment strategies. This 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 clinical trial designs employing enrichment strategies to support approval of human drugs and biological products. 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. II. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https://www.fda. gov/BiologicsBloodVaccines/Guidance ComplianceRegulatoryInformation/ default.htm, https://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/GuidanceDocuments/ default.htm, or https:// www.regulations.gov. Dated: November 20, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30274 Filed 12–14–12; 8:45 am] srobinson on DSK4SPTVN1PROD with BILLING CODE 4160–01–P 1 See ‘‘Section A: PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2008 Through 2012’’ (https://www.fda.gov/For Industry/UserFees/PrescriptionDrugUserFee/ ucm119243.htm). VerDate Mar<15>2010 16:21 Dec 14, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1002] Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Fifth Edition).’’ The guidance provides updated information pertaining to registration of human and animal food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA) on January 4, 2011. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit electronic comments on the guidance to https:// www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition (HFS– 615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Amy Barringer, Center for Food Safety and Applied Nutrition (HFS–615), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–1988. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Questions and Answers Regarding Food Facility Registration (Fifth Edition),’’ which replaces the fourth edition of a guidance entitled ‘‘Questions and Answers Regarding Registration of Food Facilities (Edition PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 74671 4)’’ issued in August 2004. The guidance provides updated information pertaining to the registration of food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. On October 10, 2003, FDA issued an interim final rule (68 FR 58894) to implement amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107–188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415. Section 102 of FSMA (Pub. L. 111– 353), enacted on January 4, 2011, amended section 415 of the FD&C Act, in relevant part, to require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA. This revised edition of the guidance includes new information relating to the FSMA amendments to section 415. The first edition of this document was issued as level 2 guidance under § 10.115 (21 CFR 10.115) and was made available on FDA’s Web site on December 4, 2003. The second, third, and fourth editions of this document were issued as level 1 guidance documents under § 10.115 and were made available on FDA’s Web site on January 12, 2004, February 17, 2004, and August 2004, respectively. This revision (fifth edition) is being issued as a level 1 guidance and includes questions and answers relating to the FSMA amendments to section 415 of the FD&C Act. In addition, the guidance provides non-substantive revisions to clarify, delete, and renumber the questions and answers in edition 4. This guidance is being issued consistent with FDA’s good guidance practices regulation § 10.115 as a level 1 guidance. The Agency will accept comments at any time, but it is implementing this guidance immediately, in accordance with § 10.115(g)(2) because the Agency has determined that prior public participation is not feasible or appropriate. E:\FR\FM\17DEN1.SGM 17DEN1

Agencies

[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74670-74671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-1145]


Draft Guidance for Industry on Enrichment Strategies for Clinical 
Trials to Support Approval of Human Drugs and Biological Products; 
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 entitled ``Enrichment 
Strategies for Clinical Trials to Support Approval of Human Drugs and 
Biological Products.'' The purpose of this document is to provide 
guidance to industry on enrichment strategies that can be used in 
clinical trials intended to support effectiveness and safety claims in 
new drug applications (NDAs) and biologics license applications (BLAs). 
This document defines several types of enrichment strategies, provides 
examples of various potential clinical trial designs, and discusses 
potential regulatory considerations when using enrichment strategies in 
clinical trials.

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 February 15, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or 
the Office of Communication, Outreach and Development (HFM-40), Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448 (1-800-835-
4709 or 301-827-1800), or the Division of Small Manufacturers, 
International and Consumer Assistance, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002, or fax your 
request to 301-847-8149. 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: Robert Temple, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4212, Silver Spring, MD 20993-0003, 301-
796-2270; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210; or Robert L. Becker, 
Center for Device and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5674, Silver 
Spring, MD 20993-0003, 301-796-5450.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Enrichment Strategies for Clinical Trials to Support 
Approval of Human Drugs and Biological Products.'' This document 
provides guidance to industry on enrichment strategies that can be used 
in clinical trials intended to support effectiveness and safety claims 
in new drug applications (NDAs) and biologics license applications 
(BLAs). Similar approaches could be used in clinical trials in earlier 
phases of drug development. As part of the reauthorization of the 
Prescription Drug User Fee Act (PDUFA IV), FDA committed to certain 
performance goals (see letters from the Secretary of Health and Human 
Services to the Chairman of the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Chairman of the Committee on Energy 
and Commerce of the House of Representatives, as set forth in the

[[Page 74671]]

Congressional Record).\1\ This draft guidance addresses one of these 
goals with the creation of a guidance document that addresses enriched 
trial designs. The guidance defines and discusses three enrichment 
strategies: Decreasing heterogeneity, predictive enrichment, and 
prognostic enrichment. The guidance also discusses general clinical 
trial design considerations, provides examples of potential clinical 
trial designs, and discusses regulatory considerations when using 
enrichment strategies.
---------------------------------------------------------------------------

    \1\ See ``Section A: PDUFA Reauthorization Performance Goals and 
Procedures Fiscal Years 2008 Through 2012'' (https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
---------------------------------------------------------------------------

    This 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 clinical 
trial designs employing enrichment strategies to support approval of 
human drugs and biological products. 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.

II. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: November 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30274 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P
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