National Institute of Nursing Research; Notice of Meeting, 17873-17874 [E9-8899]
Download as PDF
<![CDATA[
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 The draft guidance is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 The draft
guidance provides recommendations to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considers your comments on this draft
guidance before it begins work on the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draft guidance by July 16, 2009.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single copies of this draft guidance to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the draft guidance to the Division of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electronic access to the draft guidance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
17874
Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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 for Nursing Research.
Date: May 19–20, 2009.
Open: May 19, 2009, 1 p.m. to
Adjournment.
Agenda: Discussion of Program Policies
and Issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6C, Room 6, Bethesda, MD 20892.
Closed: May 20, 2009, 9 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6C, Room 6, Bethesda, MD 20892.
Contact Person: Mary E. Kerr, FAAN, RN,
PhD, Deputy Director, National Institute of
Nursing, National Institutes of Health, 31
Center Drive, Room 5B–05, Bethesda, MD
20892–2178. 301/496–8230.
kerrme@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.nih.gov/ninr/a_advisory.html, where an
agenda and any additional information for
the meeting will be posted when available.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
NIMH/ARMY RFA Project.
Date: May 1, 2009.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852. (Telephone
Conference Call)
Contact Person: David I. Sommers, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
6001 Executive Blvd., Room 6154, MSC 9606,
Bethesda, MD 20892–9606, 301–443–7861,
dsommers@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: April 10, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–8899 Filed 4–16–09; 8:45 am]
National Institutes of Health
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
National Institutes of Health
National Institute of Mental Health;
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.
VerDate Nov<24>2008
16:13 Apr 16, 2009
Jkt 217001
Dated: April 10, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–8892 Filed 4–16–09; 8:45 am]
BILLING CODE 4140–01–P
National Institute of Mental Health;
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel.
Biobehavioral Research Awards for
Innovative New Sciences.
Date: May 14, 2009.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave., NW., Washington, DC 20037.
Contact Person: Megan Libbey, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6148, MSC 9609,
Rockville, MD 20852–9609. 301–402–6807.
libbeym@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: April 13, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–8891 Filed 4–16–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Disease Control and
Prevention (CDC)
Board of Scientific Counselors,
Coordinating Office for Terrorism
Preparedness and Emergency
Response (BSC, COTPER)
Correction: This notice was published
in the Federal Register on March 20,
2009, Volume 74, Number 53, Page
11958. The time and date, place, status,
and matters to be discussed for the
aforementioned meeting have been
changed to the following:
Time and Date: 2 p.m.–4:30 p.m.,
April 27, 2009.
Place: Web Conference. Please contact
the BSC Coordinator (see Contact Person
for More Information) to obtain further
instructions on how to participate by
phone and online. Members of the
public may also attend this meeting in
person at CDC, 1600 Clifton Road, NE.,
Global Communications Center,
Building 19, Room 245/246, Atlanta,
Georgia 30333.
Status: This Web conference will be
open to the public, limited only by the
public meeting space available for
individuals participating in person. The
public meeting room accommodates
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 74, Number 73 (Friday, April 17, 2009)]
[Notices]
[Pages 17873-17874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8899]
-----------------------------------------------------------------------
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,
[[Page 17874]]
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 for Nursing
Research.
Date: May 19-20, 2009.
Open: May 19, 2009, 1 p.m. to Adjournment.
Agenda: Discussion of Program Policies and Issues.
Place: National Institutes of Health, Building 31, 31 Center
Drive, Conference Room 6C, Room 6, Bethesda, MD 20892.
Closed: May 20, 2009, 9 a.m. to 1 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Building 31, 31 Center
Drive, Conference Room 6C, Room 6, Bethesda, MD 20892.
Contact Person: Mary E. Kerr, FAAN, RN, PhD, Deputy Director,
National Institute of Nursing, National Institutes of Health, 31
Center Drive, Room 5B-05, Bethesda, MD 20892-2178. 301/496-8230.
kerrme@mail.nih.gov.
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
Information is also available on the Institute's/Center's home
page: https://www.nih.gov/ninr/a_advisory.html, where an agenda and
any additional information for the meeting will be posted when
available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.361,
Nursing Research, National Institutes of Health, HHS)
Dated: April 10, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-8899 Filed 4-16-09; 8:45 am]
BILLING CODE 4140-01-P
