Draft Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability, 17872-17873 [E9-8833]
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Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0010]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Investigational Device Exemption
Guidance for Retinal Prostheses;
Availability
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Investigational Device
Exemption (IDE) Guidance for Retinal
Prostheses.’’ This draft guidance
document provides recommendations to
industry about developing pre-clinical
and clinical tests of retinal prosthetic
devices for submission to FDA in an IDE
application. This draft guidance is not
final nor is it in effect at this time.
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considers your comment on this draft
guidance before it begins work on the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
written or electronic comments on the
draft guidance by July 16, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Investigational
Device Exemption (IDE) Guidance for
Retinal Prostheses’’ to the Division of
Small Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850.
Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 240–
276–3151. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Everette T. Beers, Center for Devices and
Radiological Health, HFZ–460, Food
and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–4200.
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16:13 Apr 16, 2009
Jkt 217001
I. Background
A retinal prosthesis is a visual
prosthetic device, implanted on or
beneath the retina or on the outer
surface of the globe, that uses electrical
stimulation to provide some level of
visual stimulation for persons suffering
from degenerative retinal conditions.
This draft guidance helps device
manufacturers submit an IDE to FDA so
that they may conduct feasibility and/or
pivotal human clinical trials of their
retinal prostheses in the United States
in order to support a premarket
approval application (PMA). The draft
guidance provides recommendations
about pre-clinical and clinical tests of
retinal prosthetic devices. The draft
guidance does not apply to prostheses
that stimulate the optic nerve or other
higher brain areas such as the visual
cortex or the lateral geniculate nucleus.
II. Significance of Guidance
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 investigational device exemption
(IDE) applications for retinal prostheses.
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 statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Investigational
Device Exemption (IDE) Guidance for
Retinal Prostheses,’’ you may either
send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number 1651 to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
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The CDRH Web site may be accessed at
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
at https://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078;
collections of information in 21 CFR
parts 50 and 56 have been approved
under OMB control number 0910–0130;
and collections of information in 21
CFR part 814, subpart E, have been
approved under OMB control number
0910–0231.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8774 Filed 4–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0126]
Draft 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 draft guidance for
E:\FR\FM\17APN1.SGM
17APN1
Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices
mstockstill on PROD1PC66 with NOTICES
industry entitled ‘‘Submission of
Summary Bioequivalence Data for
ANDAs.’’ The draft guidance is
intended to assist abbreviated new drug
application (ANDA) applicants in
complying with the new requirements
in the final rule on the submission of
bioequivalence data published in the
Federal Register in January 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 draft
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: 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 this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by July 16, 2009.
ADDRESSES: Submit written requests for
single copies of this 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. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Aida L. Sanchez, Center for Drug
Evaluation and Research (HFD–650),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–5847.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29,
2003 (68 FR 61640), FDA published a
proposed rule to require an ANDA
applicant to submit data from all BE
studies that the applicant conducts on a
drug product formulation submitted for
approval. The agency’s final rule
amending its bioequivalence regulations
VerDate Nov<24>2008
16:13 Apr 16, 2009
Jkt 217001
was published in the Federal Register
on January 16, 2009 (74 FR 2849). All
BE studies conducted on the same drug
product formulation, including studies
that demonstrate and studies that fail to
demonstrate that a generic product
meets the current bioequivalence
criteria, must be submitted to the
agency. Information from all BE studies
is important to the agency for the
following reasons:
• Data contained in any BE study
could be important to FDA’s assessment
of bioequivalence for a specific product;
and
• Even when additional BE studies
are not critical to the agency’s
bioequivalence determination for the
specific product being reviewed, the
data provide valuable scientific
information that increases the agency’s
knowledge and understanding of
bioequivalence and generic drug
development and promotes further
development of science-based
bioequivalence policies.
II. The Draft Guidance
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Submission of Summary
Bioequivalence Data for ANDAs.’’ The
draft guidance provides
recommendations to applicants
planning to include BE studies for
submission in ANDAs. The draft
guidance provides information on the
following subjects:
• The types of ANDA submissions
covered by the new regulations on BE
studies;
• A recommended format for
summary reports of BE studies; and
• What formulations FDA considers
the ‘‘same drug product formulation’’
for different dosage forms based on
differences in composition.
The draft guidance is applicable to BE
studies conducted for ANDAs during
both preapproval and postapproval
periods.
The 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 summary bioequivalence data reports
to be submitted in 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.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
17873
comments regarding the draft guidance.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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.
IV. Paperwork Reduction Act of 1995
The draft 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.
V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: April 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8833 Filed 4–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
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 for Nursing
Research.
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,
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Notices]
[Pages 17872-17873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0126]
Draft 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 draft guidance for
[[Page 17873]]
industry entitled ``Submission of Summary Bioequivalence Data for
ANDAs.'' The draft guidance is intended to assist abbreviated new drug
application (ANDA) applicants in complying with the new requirements in
the final rule on the submission of bioequivalence data published in
the Federal Register in January 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 draft 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: 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
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by July 16, 2009.
ADDRESSES: Submit written requests for single copies of this 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. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Aida L. Sanchez, Center for Drug
Evaluation and Research (HFD-650), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5847.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29, 2003 (68 FR 61640), FDA
published a proposed rule to require an ANDA applicant to submit data
from all BE studies that the applicant conducts on a drug product
formulation submitted for approval. The agency's final rule amending
its bioequivalence regulations was published in the Federal Register on
January 16, 2009 (74 FR 2849). All BE studies conducted on the same
drug product formulation, including studies that demonstrate and
studies that fail to demonstrate that a generic product meets the
current bioequivalence criteria, must be submitted to the agency.
Information from all BE studies is important to the agency for the
following reasons:
Data contained in any BE study could be important to FDA's
assessment of bioequivalence for a specific product; and
Even when additional BE studies are not critical to the
agency's bioequivalence determination for the specific product being
reviewed, the data provide valuable scientific information that
increases the agency's knowledge and understanding of bioequivalence
and generic drug development and promotes further development of
science-based bioequivalence policies.
II. The Draft Guidance
FDA is announcing the availability of a draft guidance for industry
entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The
draft guidance provides recommendations to applicants planning to
include BE studies for submission in ANDAs. The draft guidance provides
information on the following subjects:
The types of ANDA submissions covered by the new
regulations on BE studies;
A recommended format for summary reports of BE studies;
and
What formulations FDA considers the ``same drug product
formulation'' for different dosage forms based on differences in
composition.
The draft guidance is applicable to BE studies conducted for ANDAs
during both preapproval and postapproval periods.
The 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 summary
bioequivalence data reports to be submitted in 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.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
IV. Paperwork Reduction Act of 1995
The draft 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.
V. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/cder/guidance/index.htm or https://www.regulations.gov.
Dated: April 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8833 Filed 4-16-09; 8:45 am]
BILLING CODE 4160-01-S
