Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 37230-37231 [2013-14675]

Download as PDF 37230 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices II. Award Information/Funds Available A. Award Amount Food and Drug Administration The Center for Food Safety and Applied Nutrition at FDA intends to fund one award up to $2 million for FY13, with the possibility of four additional years of support, subject to the availability of funds. Future year amounts will depend on annual appropriations and successful performance. [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: ACTION: The award will provide 1 year of support, with the possibility of four additional years of support, contingent upon satisfactory performance in the achievement of project and program reporting objectives during the preceding year and the availability of Federal fiscal year appropriations. III. Paper Application, Registration, and Submission Information To submit a paper application in response to this FOA, applicants should first review the full announcement located at www.fda.gov/food/ newsevents/default.htm. (FDA has verified the Web site addresses throughout this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Persons interested in applying for a grant may obtain an application at https://grants.nih.gov/grants/forms.htm. For all paper application submissions, the following steps are required: TKELLEY on DSK3SPTVN1PROD with NOTICES • Step 1: Obtain a Dun and Bradstreet (DUNS) Number • Step 2: Register With System for Award Management (SAM) • Step 3: Register With Electronic Research Administration (eRA) Commons Steps 1 and 2, in detail, can be found at https://www07.grants.gov/applicants/ organization_registration.jsp. Step 3, in detail, can be found at https:// commons.era.nih.gov/commons/ registration/registrationInstructions.jsp. After you have followed these steps, submit paper applications to the Grants Management Officer/Specialist listed above. Dated: June 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14673 Filed 6–19–13; 8:45 am] BILLING CODE 4160–01–P 17:01 Jun 19, 2013 Jkt 229001 Food and Drug Administration, HHS. B. Length of Support VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 August 19, 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 00032 Fmt 4703 Sfmt 4703 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/Guidance ComplianceRegulatoryInformation/ 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 December 17, 2012 (77 FR 74669). 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 Apixaban Artemether; Lumefantrine Asenapine maleate B Balsalazide disodium C Cycloserine Cyclosporine E Eltrombopag olamine F Fluoxetine H Hydrochlorothiazide; Triamterene M Medroxyprogesterone (multiple reference listed drugs) Methyltestosterone E:\FR\FM\20JNN1.SGM 20JNN1 Federal Register / Vol. 78, No. 119 / Thursday, June 20, 2013 / Notices Mirabegron S Sodium ferric gluconate T Timolol maleate Trientine 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: A Albuterol sulfate (multiple reference listed drugs) Ambrisentan C Carbidopa; Entacapone; Levodopa Colesevelam 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https://www. regulations.gov. Dated: June 14, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–14675 Filed 6–19–13; 8:45 am] D Dexamethasone; Tobramycin (multiple reference listed drugs and dosage forms) Didanosine Drospirenone; Estradiol E BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Entacapone F Food and Drug Administration Fentanyl citrate I Isotretinoin [Docket No. FDA–2012–D–0938] Minocycline hydrochloride Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability M P Phentermine hydrochloride; Topiramate T Tenofovir disoproxil fumarate Topiramate (multiple reference listed drugs and dosage forms) TKELLEY on DSK3SPTVN1PROD with NOTICES 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 either electronic comments on any of the specific BE recommendations posted on FDA’s Web site to https:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket VerDate Mar<15>2010 17:01 Jun 19, 2013 Jkt 229001 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ‘‘ANDAs: Stability Testing of Drug Substances and Products.’’ FDA is recommending generic drug manufacturers follow the stability testing recommendations in the International Conference on Harmonisation (ICH) guidances Q1A (R2) through Q1E. The use of these ICH recommendations will standardize FDA’s stability testing policies, which will help make the abbreviated new drug application (ANDA) review process more efficient. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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. Send one self-addressed adhesive label to assist the office in processing your requests. See the SUPPLEMENTARY SUMMARY: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 37231 INFORMATION section for electronic access to the guidance document. Submit electronic comments on the 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: Radhika Rajagopalan, Center for Drug Evaluation and Research, Food and Drug Administration, 7500 Standish Pl., MPN2, rm. 243, HFD–640, Rockville, MD 20855, 240–276–8546. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘ANDAs: Stability Testing of Drug Substances and Products.’’ Because of increases in the number and complexity of ANDAs and FDA’s desire to standardize generic drug review, FDA is recommending that the generic drug industry follow the approach in the following stability related ICH guidances: (1) ‘‘Q1A (R2) Stability Testing of New Drug Substances and Products,’’ November 2003; (2) ‘‘Q1B Photostability Testing of New Drug Substances and Products,’’ November 1996; (3) ‘‘Q1C Stability Testing for New Dosage Forms,’’ November 1996; (4) ‘‘Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products,’’ January 2003; and (5) ‘‘Q1E Evaluation of Stability Data,’’ June 2004. These guidances can be found on the FDA Guidances (Drugs) Web site under International Conference on Harmonisation—Quality at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/ucm065005.htm. FDA also recommends that industry follow the ICH outlined definitions, glossaries, references, and attachments. Although the ICH stability guidances were developed for new drug applications to ensure the stability of new drug substances and products, FDA believes the recommendations provided in the ICH guidances on stability testing also are appropriate for ANDAs. FDA is recommending that applicants follow the ICH stability guidances for all ANDA submissions under section 505(j) of the Federal Food Drug, and Cosmetic Act (21 U.S.C. 355(j)) and relying on drug master files. This guidance also replaces stability study storage condition recommendations made by the Office of Generic Drugs (OGD) in an August 18, 1995, letter to all ANDA applicants. E:\FR\FM\20JNN1.SGM 20JNN1

Agencies

[Federal Register Volume 78, Number 119 (Thursday, June 20, 2013)]
[Notices]
[Pages 37230-37231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14675]


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

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 August 19, 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 December 17, 2012 (77 FR 74669). 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
    Apixaban
    Artemether; Lumefantrine
    Asenapine maleate
B
    Balsalazide disodium
C
    Cycloserine
    Cyclosporine
E
    Eltrombopag olamine
F
    Fluoxetine
H
    Hydrochlorothiazide; Triamterene
M
    Medroxyprogesterone (multiple reference listed drugs)
    Methyltestosterone

[[Page 37231]]

    Mirabegron
S
    Sodium ferric gluconate
T
    Timolol maleate
    Trientine

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:

A
    Albuterol sulfate (multiple reference listed drugs)
    Ambrisentan
C
    Carbidopa; Entacapone; Levodopa
    Colesevelam
D
    Dexamethasone; Tobramycin (multiple reference listed drugs and 
dosage forms)
    Didanosine
    Drospirenone; Estradiol
E
    Entacapone
F
    Fentanyl citrate
I
    Isotretinoin
M
    Minocycline hydrochloride
P
    Phentermine hydrochloride; Topiramate
T
    Tenofovir disoproxil fumarate
    Topiramate (multiple reference listed drugs and dosage forms)

    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 either electronic comments on any of 
the specific BE recommendations posted on FDA's Web site to https://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). 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: June 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14675 Filed 6-19-13; 8:45 am]
BILLING CODE 4160-01-P
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