Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 74669-74670 [2012-30308]

Download as PDF Federal Register / Vol. 77, No. 242 / Monday, December 17, 2012 / Notices availability of CPG Sec. 400.210 entitled ‘‘Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs.’’ Previous extensions of the expiration date of the CPG were published in 2007, 2008, and 2010 (72 FR 65750, November 23, 2007; 73 FR 78371, December 22, 2008; 75 FR 80827, December 23, 2010). FDA has identified RFID as a promising technology to be used in the various efforts to combat counterfeit drugs. The CPG describes how the Agency intends to exercise its enforcement discretion regarding certain regulatory requirements that might otherwise be applicable to studies involving RFID technology for drugs. The goal of the CPG is to facilitate performance of RFID studies and to allow industry to gain experience with the use of RFID technology and its effect on the long-term safety and integrity of the U.S. drug supply. On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110–85) (FDAAA) was signed into law. Section 913 of FDAAA addressed pharmaceutical safety and created section 505D of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355e). Section 505D(b) of the FD&C Act requires the development of standards for the identification, validation, authentication, and tracking and tracing of prescription drugs. Section 505D(b)(3) of the FD&C Act states that these new standards must address promising technologies, which may include RFID technology. In implementing section 505D of the FD&C Act, FDA is currently addressing issues, such as promising technologies, that also are relevant for the CPG. In addition, FDA is considering further the experience of stakeholders and the Agency under the CPG. As we consider all of these issues, the CPG will remain in effect until December 31, 2014. Dated: December 11, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–30297 Filed 12–14–12; 8:45 am] srobinson on DSK4SPTVN1PROD with BILLING CODE 4160–01–P VerDate Mar<15>2010 16:21 Dec 14, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. 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 comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by February 15, 2013. ADDRESSES: Submit written requests for single copies of the individual BE guidances 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. 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 recommendations. Submit electronic comments on the draft product-specific BE recommendations 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: Kris ´ Andre, Center for Drug Evaluation and SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 74669 Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9326. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register of September 14, 2012 (77 FR 56851). This notice announces draft product-specific recommendations, either new or revised, that are being posted on FDA’s Web site concurrently with publication of this notice. II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available FDA is announcing new draft product-specific BE recommendations for drug products containing the following active ingredients: A Abiraterone acetate Albendazole Amlodipine besylate, hydrochlorothiazide, and olmesartan medoxomil C Clindamycin phosphate; tretinoin Clorazepate dipotassium F Ferumoxytol G Gabapentin P Piroxicam S Sodium Phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate E:\FR\FM\17DEN1.SGM 17DEN1 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

Agencies

[Federal Register Volume 77, Number 242 (Monday, December 17, 2012)]
[Notices]
[Pages 74669-74670]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Draft and Revised Draft Guidances for Industry Describing 
Product-Specific Bioequivalence Recommendations; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. The recommendations provide 
product-specific guidance on the design of BE studies to support 
abbreviated new drug applications (ANDAs). In the Federal Register of 
June 11, 2010, FDA announced the availability of a guidance for 
industry entitled ``Bioequivalence Recommendations for Specific 
Products,'' which explained the process that would be used to make 
product-specific BE recommendations available to the public on FDA's 
Web site. The BE recommendations identified in this notice were 
developed using the process described in that guidance.

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 comments on 
these draft and revised draft guidances before it begins work on the 
final versions of the guidances, submit either electronic or written 
comments on the draft and revised draft product-specific BE 
recommendations listed in this notice by February 15, 2013.

ADDRESSES: Submit written requests for single copies of the individual 
BE guidances 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. 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 recommendations.
    Submit electronic comments on the draft product-specific BE 
recommendations 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: Kris Andr[eacute], Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as 
a means to develop and disseminate product-specific BE recommendations 
and provide a meaningful opportunity for the public to consider and 
comment on those recommendations. Under that process, draft 
recommendations are posted on FDA's Web site and announced periodically 
in the Federal Register. The public is encouraged to submit comments on 
those recommendations within 60 days of their announcement in the 
Federal Register. FDA considers any comments received and either 
publishes final recommendations or publishes revised draft 
recommendations for comment. Recommendations were last announced in the 
Federal Register of September 14, 2012 (77 FR 56851). This notice 
announces draft product-specific recommendations, either new or 
revised, that are being posted on FDA's Web site concurrently with 
publication of this notice.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing new draft product-specific BE recommendations for 
drug products containing the following active ingredients:

A
    Abiraterone acetate
    Albendazole
    Amlodipine besylate, hydrochlorothiazide, and olmesartan 
medoxomil
C
    Clindamycin phosphate; tretinoin
    Clorazepate dipotassium
F
    Ferumoxytol
G
    Gabapentin
P
    Piroxicam
S
    Sodium Phosphate, dibasic, anhydrous; sodium phosphate, 
monobasic, monohydrate

[[Page 74670]]

U
    Ulipristal acetate
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:

D
    Desmopressin acetate
    Diflunisal
    Dipyridamole
H
    Hydrochlorothiazide; lisinopril
    Hydrochlorothiazide; losartan potassium
L
    Liothyronine sodium
P
    Phenoxybenzamine hydrochloride
Q
    Quinine sulfate
R
    Risedronate sodium
T
    Tacrolimus
    Thalidomide
    Tinidazole

    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.

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.

V. Electronic Access

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

    Dated: December 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30308 Filed 12-14-12; 8:45 am]
BILLING CODE 4160-01-P
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