Office of Biotechnology Activities; Recombinant DNA Research: Amended Notice of Meeting, 31795-31796 [2010-13484]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
new Information Sheet Guidances as
needed.
In the Federal Register of July 29,
2008 (73 FR 43940), FDA announced the
availability of a draft version of the
guidance entitled, ‘‘Draft Information
Sheet Guidance for Sponsors, Clinical
Investigators, and IRBs; Frequently
Asked Questions—Statement of
Investigator (Form FDA 1572).’’ The July
2008 guidance gave interested persons
an opportunity to submit comments
through September 29, 2008. All
comments received during the comment
period have been carefully reviewed
and, where appropriate, incorporated in
the guidance. As a result of the public
comments and editorial changes, the
guidance is clearer than the draft
version.
This information sheet guidance is
being issued consistent with FDA’s
GGPs regulation (21 CFR 10.115). The
information sheet guidance represents
the agency’s current thinking on
completing the Form FDA 1572. 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. The Paperwork Reduction Act of
1995
This 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 (44 U.S.C. 3501–
3520). The collections of information for
Form FDA 1572 have been approved
under OMB Control No. 0910–0014.
III. Comments
srobinson on DSKHWCL6B1PROD with NOTICES
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance7
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13420 Filed 6–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review, 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: Center for Scientific
Review Special Emphasis Panel; Cell Death
in Neurodegeneration.
Date: June 11, 2010.
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites, 1250 22nd Street,
NW., Washington, DC 20037.
Contact Person: Seetha Bhagavan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 27, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13412 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
31795
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; 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 of
Child Health and Human Development
Special Emphasis Panel, Pediatric Trials
Network.
Date: June 23, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304. (301)
435–6680. skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: May 26, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13482 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities;
Recombinant DNA Research:
Amended Notice of Meeting
ACTION: Notice of cancellation of
consideration of a proposed action
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
E:\FR\FM\04JNN1.SGM
04JNN1
31796
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
under Section III–A–1 of the NIH
Guidelines for Research Involving
Recombinant DNA Molecules (NIH
Guidelines).
SUMMARY: Notice of a discussion of a
proposed action under Section III–A–1
published on May 24, 2010 (75 FR
28811) is withdrawn. The discussion
that was to be held at the June 16–17,
2010 meeting of the NIH Recombinant
DNA Advisory Committee has been
deferred at the request of the principal
investigator.
FOR FURTHER INFORMATION CONTACT:
OBA by e-mail at oba@od.nih.gov, or
telephone at 301–496–9838, if you have
questions, or require additional
information.
Dated: May 26, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology
Activities, National Institutes of Health.
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Tooth
Development, Mobility and Mineralization.
Date: June 23, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Priscilla B. Chen, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4104,
MSC 7814, Bethesda, MD 20892, (301) 435–
1787, chenp@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 2, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13484 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
[FR Doc. 2010–13453 Filed 6–3–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
srobinson on DSKHWCL6B1PROD with NOTICES
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 meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; ARRA:
AIDS and Related Research Competitive
Revisions.
Date: June 17, 2010.
Time: 4 p.m. to 7 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Mark P. Rubert, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Advisory Board, June 21, 2010, 6:30
p.m. to June 23, 2010, 12 p.m., National
Institutes of Health, Building 31, 31
Center Drive, Bethesda, MD 20892
which was published in the Federal
Register on May 11, 2010, FR 26267–
26268.
This Federal Register Notice is being
amended to change the date, times, and
location of the meeting of the Ad Hoc
Subcommittee on Experimental
Therapeutics to June 22, 2010 from 12
p.m. to 1 p.m. at the National Institutes
of Health, Building 31, 31 Center Drive,
Conference Room 7, Bethesda, MD
20892 and to add the meeting of the
Subcommittee on Clinical Investigations
to June 21, 2010 from 6 p.m. to 7:30
p.m. at Embassy Suites, Chevy Chase
Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Dated: May 28, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–13451 Filed 6–3–10; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
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 meetings.
The meetings 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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Coordination Core for Programs to Increase
Diversity Among Individuals Engaged in
Health-Related Research (PRIDE).
Date: June 16, 2010.
Time: 2 p.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.
Contact Person: Stephanie J Webb, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7196,
Bethesda, MD 20892, 301–435–0291,
stephanie.webb@nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Atherosclerosis Risk in Communities (ARIC)
Study—Field Centers.
Date: June 24, 2010.
Time: 1:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Tony L Creazzo, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7180,
Bethesda, MD 20892–7924, 301–435–0725,
creazzot@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Atherosclerosis Risk in Communities (ARIC)
Study—Central Laboratory Center.
Date: June 24, 2010.
Time: 3:30 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Tony L Creazzo, PhD,
Scientific Review Officer, Review Branch/
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31795-31796]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13484]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of Biotechnology Activities; Recombinant DNA Research:
Amended Notice of Meeting
ACTION: Notice of cancellation of consideration of a proposed action
[[Page 31796]]
under Section III-A-1 of the NIH Guidelines for Research Involving
Recombinant DNA Molecules (NIH Guidelines).
-----------------------------------------------------------------------
SUMMARY: Notice of a discussion of a proposed action under Section III-
A-1 published on May 24, 2010 (75 FR 28811) is withdrawn. The
discussion that was to be held at the June 16-17, 2010 meeting of the
NIH Recombinant DNA Advisory Committee has been deferred at the request
of the principal investigator.
FOR FURTHER INFORMATION CONTACT: OBA by e-mail at oba@od.nih.gov, or
telephone at 301-496-9838, if you have questions, or require additional
information.
Dated: May 26, 2010.
Jacqueline Corrigan-Curay,
Acting Director, Office of Biotechnology Activities, National
Institutes of Health.
[FR Doc. 2010-13484 Filed 6-3-10; 8:45 am]
BILLING CODE 4140-01-P
