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