Center for Scientific Review; Notice of Closed Meetings, 55242-55243 [E9-25726]
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Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
enter into only those voluntary research
projects that lead to high-quality, peerreviewed scientific work. Additional
details regarding the process for
voluntary research are in the Federal
Register Notices cited in this section.
A. TSCA/FIFRA
In developing and implementing
SSARP, ATSDR and EPA established
procedures to identify priority data
needs of common interest to multiple
federal programs. Where practicable,
these data needs will be addressed
through a program of toxicologic testing
under TSCA or FIFRA. This part of the
research will be conducted according to
established TSCA/FIFRA procedures
and guidelines.
pwalker on DSK8KYBLC1PROD with NOTICES
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act. If the proposed project is
research involving human subjects, the
applicants must comply with
Department of Health and Human
Services regulations (45 CFR part 46)
and, if applicable, Food and Drug
Administration regulations (21 CFR
parts 50 and 56), regarding the
protection of human subjects. The
applicants must ensure that the project
will be subject to initial and continuing
review by the appropriate institutional
review boards. Overall, by providing
additional scientific information for the
risk assessment process, data generated
from this research will support other
researchers conducting human health
assessments involving these substances.
Below are the mechanisms for
implementing SSARP. The status of
SSARP in addressing priority data needs
of the first 60 priority hazardous
substances through these mechanisms
was described in a Federal Register
Notice on December 13, 2005 (70 FR
73749).
Dated: October 21, 2009.
Ken Rose,
Director, Office of Policy, Planning, and
Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. E9–25776 Filed 10–26–09; 8:45 am]
B. Private-Sector Voluntarism
As part of SSARP, on February 7,
1992, ATSDR announced a set of
proposed procedures for conducting
voluntary research (57 FR 4758).
Revisions based on public comments
were published on November 16, 1992
(57 FR 54160). ATSDR strongly
encourages private-sector organizations
to propose research to address priority
data needs at any time until ATSDR
announces that research has already
been initiated for a specific priority data
need. Private-sector organizations may
volunteer to conduct research to address
specific priority data needs identified in
this notice by submitting a letter of
intent.
The letter of intent should be a brief
statement (1–2 pages) that identifies the
priority data need(s) to be filled and the
methods to be used. TASARC will
review these proposals and recommend
to ATSDR the voluntary research
projects that should be pursued—and
how they should be conducted—with
the volunteer organizations. ATSDR will
National Institutes of Health
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C. CERCLA
Those priority data needs not
addressed by TSCA/FIFRA or initial
voluntarism will be considered for
funding by ATSDR through its CERCLA
budget. Much of this research program
is envisioned to be unique to CERCLA—
for example, research on substances not
regulated by other programs, or research
needs specific to public health
assessments.
Mechanisms to address these priority
data needs may include a second call for
voluntarism. Again, scientific peer
review of study protocols and results is
a requirement for all research conducted
under this auspice.
ATSDR encourages private-sector
organizations and other governmental
programs to use ATSDR’s priority data
needs to plan their research activities.
BILLING CODE 4163–70–P
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 Special
Emphasis Panel; AA–1 and AA–4 Study
Sections Members Conflict.
Date: November 10, 2009.
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Dated: October 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25623 Filed 10–26–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892.
(Telephone Conference Call.)
Contact Person: Lorraine Gunzerath, PhD,
MBA, Scientific Review Officer, National
Institute on Alcohol Abuse and Alcoholism,
Office of Extramural Activities, Extramural
Project Review Branch, 5635 Fishers Lane,
Room 2121, Bethesda, MD 20892–9304, 301–
443–2369, Igunzera@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the securing of
meeting attendees.
(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)
Sfmt 4703
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts in Language and Cognition.
Date: November 12, 2009.
Time: 3:30 p.m. to 5:30 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: Dana Jeffrey Plude, PhD,
Scientific Review Officer, Center for
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Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group; HIV/
AIDS Vaccines Study Section.
Date: November 20, 2009.
Time: 8 a.m. to 6 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: Mary Clare Walker, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5208,
MSC 7852, Bethesda, MD 20892, (301) 435–
1165, walkermc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AMCB, AIP
and NAED Member Conflicts.
Date: November 23, 2009.
Time: 1 p.m. to 3 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: Eduardo A. Montalvo,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7852, Bethesda, MD 20892, (301) 435–
1168, montalve@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: October 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25726 Filed 10–26–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric Oncology
Subcommittee of the Oncologic Drugs
Advisory Committee.
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General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on December 15, 2009, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/
Gaithersburg, Montgomery Ballroom, 620
Perry Pkwy., Gaithersburg, MD. The hotel
phone number is 301–977–8900.
Contact Person: Diem-Kieu Ngo, Center for
Drug Evaluation and Research (HFD–21),
Food and Drug Administration, 5600 Fishers
Lane, (for express delivery, 5630 Fishers
Lane, rm. 1093) Rockville, MD 20857, 301–
827–7001, FAX: 301–827–6776, e-mail:
diem.ngo@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512542. Please call the
Information Line for up-to-date information
on this meeting. A notice in the Federal
Register about last minute modifications that
impact a previously announced advisory
committee meeting cannot always be
published quickly enough to provide timely
notice. Therefore, you should always check
the agency’s Web site and call the
appropriate advisory committee hot line/
phone line to learn about possible
modifications before coming to the meeting.
Agenda: On December 15, 2009, the
subcommittee will consider and discuss: (1)
FDA expectations regarding the development
of pediatric formulations for cancer drugs,
and (2) the development of dosing regimens
in infants and toddlers with cancer.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. If FDA is
unable to post the background material on its
Web site prior to the meeting, the background
material will be made publicly available at
the location of the advisory committee
meeting, and the background material will be
posted on FDA’s Web site after the meeting.
Background material is available at https://
www.fda.gov/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present
data, information, or views, orally or in
writing, on issues pending before the
subcommittee. Written submissions may be
made to the contact person on or before
December 1, 2009. Oral presentations from
the public will be scheduled between
approximately 10:45 a.m. to 11:15 a.m., and
3:15 p.m. to 3:45 p.m. Those desiring to make
formal oral presentations should notify the
contact person and submit a brief statement
of the general nature of the evidence or
arguments they wish to present, the names
and addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on or
before November 20, 2009. Time allotted for
each presentation may be limited. If the
number of registrants requesting to speak is
greater than can be reasonably
accommodated during the scheduled open
public hearing session, FDA may conduct a
lottery to determine the speakers for the
scheduled open public hearing session. The
contact person will notify interested persons
regarding their request to speak by November
23, 2009.
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Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Diem-Kieu
Ngo at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25806 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic and
Metabolic Drugs Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on December 15, 2009, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/
Gaithersburg, The Ballrooms, 620 Perry
Pkwy., Gaithersburg, MD. The hotel
telephone number is 301–977–8900.
Contact Person: Paul Tran, Center for Drug
Evaluation and Research (HFD–21), Food and
Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–7001,
FAX: 301–827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512536. Please call the
Information Line for up-to-date information
on this meeting. A notice in the Federal
Register about last minute modifications that
impact a previously announced advisory
committee meeting cannot always be
published quickly enough to provide timely
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Agencies
[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Pages 55242-55243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25726]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific Review Special Emphasis
Panel; Member Conflicts in Language and Cognition.
Date: November 12, 2009.
Time: 3:30 p.m. to 5:30 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: Dana Jeffrey Plude, PhD, Scientific Review
Officer, Center for
[[Page 55243]]
Scientific Review, National Institutes of Health, 6701 Rockledge
Drive, Room 3176, MSC 7848, Bethesda, MD 20892, 301-435-2309,
pluded@csr.nih.gov.
Name of Committee: AIDS and Related Research Integrated Review
Group; HIV/AIDS Vaccines Study Section.
Date: November 20, 2009.
Time: 8 a.m. to 6 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: Mary Clare Walker, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5208, MSC 7852, Bethesda, MD
20892, (301) 435-1165, walkermc@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AMCB, AIP and NAED Member Conflicts.
Date: November 23, 2009.
Time: 1 p.m. to 3 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: Eduardo A. Montalvo, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD
20892, (301) 435-1168, montalve@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: October 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-25726 Filed 10-26-09; 8:45 am]
BILLING CODE 4140-01-P