Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability, 26307-26308 [2011-11102]

Download as PDF 26307 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents (investigational applications) FDA Center Activity Number of respondents (marketing applications) Number of responses per respondent Average burden per response (in hours) 2 Total annual responses Total hours CDER New Applications (IND) ............................ Clinical Protocol Amendments (IND) ....... New Marketing Applications/Resubmissions (NDA/BLA) .................................. Clinical Amendments to Marketing Applications .................................................. Efficacy Supplements/Resubmissions ..... 1,752 11,769 ........................ ........................ 1 1 1,752 11,769 15/60 15/60 438 2,943 ........................ 157 1 157 45/60 118 ........................ ........................ 1,466 166 1 1 1,466 166 45/60 45/60 1,100 125 CBER New Applications (IND) ............................ Clinical Protocol Amendments (IND) ....... New Marketing Applications/Resubmissions ..................................................... Clinical Amendments to Marketing Applications .................................................. Efficacy Supplements/Resubmissions (BLA only) ............................................. 281 1,471 ........................ ........................ 1 1 281 1,471 15/60 15/60 70 368 ........................ 8 1 8 45/60 6 ........................ 17 1 17 45/60 13 ........................ 25 1 25 45/60 19 1 892 45/60 669 CDRH New Marketing Applications (includes PMAs, HDEs, Supplements and 510(k)s expected to contain clinical data) ..................................................... ........................ 892 OGD Original Applications ................................ BE Supplements/Amendments ................ ........................ ........................ 854 495 1 ........................ 854 ........................ 45/60 45/60 641 372 Total .................................................. ........................ ........................ ........................ ........................ ........................ 6,882 1 There are no capitol costs or operating and maintenance costs associated with this collection of information. estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. 2 Burden Dated: May 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–11073 Filed 5–5–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration emcdonald on DSK2BSOYB1PROD with NOTICES [Docket No. FDA–2009–D–0126] Guidance for Industry on the Submission of Summary Bioequivalence Data for 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 guidance for industry SUMMARY: VerDate Mar<15>2010 18:58 May 05, 2011 Jkt 223001 entitled ‘‘Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.’’ The guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods. PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this 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 that office in processing your requests. See the SUPPLEMENTARY 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: Aida L. Sanchez, Center for Drug Evaluation and Research (HFD–650), DATES: E:\FR\FM\06MYN1.SGM 06MYN1 26308 Federal Register / Vol. 76, No. 88 / Friday, May 6, 2011 / Notices Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240– 276–8782. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Submission of Summary Bioequivalence Data for ANDAs.’’ The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs. The guidance provides information on the following subjects: • Types of ANDA submissions covered by the regulations on BE studies; • Recommended format for summary reports of BE studies; and • Types of formulations the Agency considers to be the same drug product formulation for different dosage forms based on differences in composition. The guidance is applicable to BE studies conducted for ANDAs during both preapproval and postapproval periods. On April 17, 2009, FDA announced the availability of the draft version of this guidance (74 FR 17872). The public comment period closed on July 16, 2009. A few comments were received from the public, all of which the Agency considered carefully as it finalized the guidance and made appropriate changes. Changes to the guidance were minor and made to clarify statements in the draft guidance. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on submission of summary bioequivalence data for ANDAs. 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. emcdonald on DSK2BSOYB1PROD with NOTICES 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. 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. VerDate Mar<15>2010 17:26 May 05, 2011 Jkt 223001 BILLING CODE 4160–01–P Open: June 9, 2011, 9 a.m. to 3 p.m. Agenda: Presentation and other business of the council. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. Contact Person: Abraham P. Bautista, PhD, Executive Secretary, National Institute on Alcohol Abuse & Alcoholism National Institutes of Health, 5635 Fishers Lane, Rm 2085, Rockville, Md 20852, 301–443–9737, bautistaa@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: silk.nih.gov/ silk/niaaa1/about/roster.htm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: May 2, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. III. Paperwork Reduction Act of 1995 This guidance refers to information collection provisions that 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 314.94(a)(7), 314.96(a)(1), and 314.97 have been approved under OMB control number 0910–0630. IV. 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: May 2, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–11102 Filed 5–5–11; 8:45 am] [FR Doc. 2011–11170 Filed 5–5–11; 8:45 am] National Institutes of Health BILLING CODE 4140–01–P National Institute on Alcohol Abuse And Alcoholism; Notice of Meeting. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Alcohol Abuse and Alcoholism. Date: June 8–9, 2011. Closed: June 8, 2011, 5:30 p.m. to 7:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Alcohol Abuse and Alcoholism Initial Review Group, Epidemiology, Prevention and Behavior Research Review Subcommittee. Date: July 19, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Notices]
[Pages 26307-26308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11102]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0126]


Guidance for Industry on the Submission of Summary Bioequivalence 
Data for Abbreviated New Drug Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Submission of 
Summary Bioequivalence Data for Abbreviated New Drug Applications.'' 
The guidance is intended to assist abbreviated new drug application 
(ANDA) applicants in complying with the requirements in the final rule 
on the submission of bioequivalence data that published in the Federal 
Register in January 2009 (74 FR 2849, January 16, 2009). The final rule 
requires ANDA applicants to submit data from all bioequivalence studies 
(BE studies) the applicant conducts on a drug product formulation 
submitted for approval, including both studies that demonstrate and 
studies that fail to demonstrate that a generic product meets the 
current bioequivalence criteria. The guidance provides recommendations 
to applicants planning to include BE studies for submission in ANDAs 
and is applicable to BE studies conducted during both preapproval and 
postapproval periods.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 that office in processing your requests. See 
the SUPPLEMENTARY 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:  Aida L. Sanchez, Center for Drug 
Evaluation and Research (HFD-650),

[[Page 26308]]

Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 
240-276-8782.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The 
guidance provides recommendations to applicants planning to include BE 
studies for submission in ANDAs. The guidance provides information on 
the following subjects:
     Types of ANDA submissions covered by the regulations on BE 
studies;
     Recommended format for summary reports of BE studies; and
     Types of formulations the Agency considers to be the same 
drug product formulation for different dosage forms based on 
differences in composition.

The guidance is applicable to BE studies conducted for ANDAs during 
both preapproval and postapproval periods.
    On April 17, 2009, FDA announced the availability of the draft 
version of this guidance (74 FR 17872). The public comment period 
closed on July 16, 2009. A few comments were received from the public, 
all of which the Agency considered carefully as it finalized the 
guidance and made appropriate changes. Changes to the guidance were 
minor and made to clarify statements in the draft guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on submission of summary bioequivalence data 
for ANDAs. 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. 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions that 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 314.94(a)(7), 314.96(a)(1), and 
314.97 have been approved under OMB control number 0910-0630.

IV. 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: May 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-11102 Filed 5-5-11; 8:45 am]
BILLING CODE 4160-01-P
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