Subcommittee on Procedures Reviews (SPR), Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH), 10807-10808 [2010-4890]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Selection
will also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
regions. Firms interested in offering a
site tour or learning more about this
training opportunity should respond by
(see DATES) by submitting a proposed
agenda to Beth Duvall-Miller (see FOR
FURTHER INFORMATION CONTACT).
Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on DSKD5P82C1PROD with NOTICES
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
Jkt 220001
Dated: February 26, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4586 Filed 3–8–10; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting for the
aforementioned subcommittee:
National Institutes of Health
19:04 Mar 08, 2010
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism, Special
Emphasis Panel, Member Conflicts SEP.
Date: April 22, 2010.
Time: 12 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: NIAAA, 5635 Fishers, Rockville, MD
20852.
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, lgunzera@mail.nih.gov.
(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)
Subcommittee on Procedures Reviews
(SPR), Advisory Board on Radiation
and Worker Health (ABRWH), National
Institute for Occupational Safety and
Health (NIOSH)
[FR Doc. 2010–4924 Filed 3–8–10; 8:45 am]
VerDate Nov<24>2008
would constitute a clearly unwarranted
invasion of personal privacy.
Time and Date: 9:30 a.m.–5 p.m., March
23, 2010.
Place: Cincinnati Airport Marriott, 2395
Progress Drive, Hebron, Kentucky 41018,
Telephone: (859) 334–4611, Fax: (859) 334–
4619.
Status: Open to the public, but without a
public comment period. To access by
conference call dial the following
information 1(866) 659–0537, Participant
Pass Code 9933701.
Background: The Advisory Board was
established under the Energy Employees
Occupational Illness Compensation Program
Act of 2000 to advise the President on a
variety of policy and technical functions
required to implement and effectively
manage the compensation program. Key
functions of the Advisory Board include
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
10807
providing advice on the development of
probability of causation guidelines that have
been promulgated by the Department of
Health and Human Services (HHS) as a final
rule; advice on methods of dose
reconstruction which have also been
promulgated by HHS as a final rule; advice
on the scientific validity and quality of dose
estimation and reconstruction efforts being
performed for purposes of the compensation
program; and advice on petitions to add
classes of workers to the Special Exposure
Cohort (SEC).
In December 2000, the President delegated
responsibility for funding, staffing, and
operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC.
NIOSH implements this responsibility for
CDC. The charter was issued on August 3,
2001, renewed at appropriate intervals, and
will expire on August 3, 2011.
Purpose: The Advisory Board is charged
with (a) Providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class. The Subcommittee on Procedures
Reviews was established to aid the Advisory
Board in carrying out its duty to advise the
Secretary, HHS, on dose reconstruction. It is
responsible for overseeing, tracking, and
participating in the reviews of all procedures
used in the dose reconstruction process by
the NIOSH Office of Compensation Analysis
and Support (OCAS) and its dose
reconstruction contractor.
Matters To Be Discussed: The agenda for
the Subcommittee meeting includes: the
development of recommendations for an
Advisory Board procedure for reviewing
OCAS Program Evaluation Reports; and
discussion of the following Oak Ridge
Associated Universities & OCAS procedures:
OTIB–013 (‘‘Special External Dose
Reconstruction Considerations for
Mallinckrodt Workers’’), OTIB–014 (‘‘Rocky
Flats Internal Dosimetry Co-Worker
Extension’’), OTIB–0029 (‘‘Internal Dosimetry
Coworker Data for Y–12’’), OTIB–0049
(‘‘Estimating Doses for Plutonium Strongly
Retained in the Lung’’), OTIB–0047 (External
Radiation Monitoring at the Y–12 Facility
During the 1948–1949 Period’’), OTIB–0051
(‘‘Effect of Threshold Energy and Angular
Response of NTA Film on Missed Neutron
Dose at the Oak Ridge Y–12 Facility’’), OTIB–
0054 (‘‘Fission and Activation Product
Assignment for Internal Dose-Related Gross
Beta and Gross Gamma Analyses’’), and
OTIB–0070 (‘‘Dose Reconstruction During
Residual Radioactivity Periods at Atomic
Weapons Employer Facilities’’); and a
continuation of the comment-resolution
process for other dose reconstruction
procedures under review by the
Subcommittee.
E:\FR\FM\09MRN1.SGM
09MRN1
10808
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices
The agenda is subject to change as
priorities dictate.
This meeting is open to the public, but
without a public comment period. In the
event an individual wishes to provide
comments, written comments may be
submitted. Any written comments received
will be provided at the meeting and should
be submitted to the contact person below in
advance of the meeting.
Contact Person for More Information:
Theodore Katz, Executive Secretary, NIOSH,
CDC, 1600 Clifton Road, Mailstop E–20,
Atlanta, Georgia 30333, Telephone: (513)
533–6800, Toll Free: 1(800) CDC–INFO, Email ocas@cdc.gov.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2010–4890 Filed 3–8–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice of Closed Meeting
sroberts on DSKD5P82C1PROD 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 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
Nursing Research, Special Emphasis Panel,
NINR Loan Repayment Program Review
(L30/L40).
Date: March 29, 2010.
Time: 9 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Ste. 710, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Mario Rinaudo, MD,
Scientific Review Administrator, Office of
Review, National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Blvd (DEM 1), Suite 710,
VerDate Nov<24>2008
19:04 Mar 08, 2010
Jkt 220001
Bethesda, MD 20892, 301–594–5973,
mrinaudo@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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: March 1, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4753 Filed 3–8–10; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
and Research Support Awards, National
Institutes of Health, HHS)
Dated: March 1, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–4750 Filed 3–8–10; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2005–C–0245, FDA–
2005–C–0416, and FDA–2005–C–0504]
(formerly Docket Nos. 2005C–0302, 2005C–
0303, and 2005C–0304)
CIBA Vision Corp.; Withdrawal of Color
Additive Petitions
AGENCY:
Food and Drug Administration,
National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meeting
HHS.
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.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
withdrawal, without prejudice to a
future filing, of three color additive
petitions (CAP 5C0278, CAP 5C0279,
and CAP 5C0280) proposing that the
color additive regulations be amended
to provide for the safe use of Color
Index (C.I.) Pigment Violet 19, C.I.
Pigment Yellow 154, and C.I. Pigment
Red 122 as color additives in contact
lenses.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; Review of Alcohol Resource
Grant Applications.
Date: April 6, 2010.
Time: 2 p.m. to 6 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: Richard A Rippe, Ph.D.,
Scientific Review Officer, National Institute
on Alcohol Abuse & Alcoholism, National
Institutes of Health, 5635 Fishers Lane, Rm.
2109, Rockville, MD 20852, 301–443–8599,
rippera@mail.nih.gov.
(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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
ACTION:
Notice.
FOR FURTHER INFORMATION CONTACT:
Celeste Johnston, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1282.
In a notice
published in the Federal Register of
August 17, 2005 (70 FR 48426), FDA
announced that three color additive
petitions had been filed by CIBA Vision
Corp., 11460 Johns Creek Pkwy.,
Duluth, GA 30097–1556. The petitions
proposed to amend the color additive
regulations in Part 73 Listing of Color
Additives Exempt from Certification (21
CFR part 73) to provide for the safe use
of C.I. Pigment Violet 19 (CAP 5C0278,
Docket No. FDA–2005–C–0245), C.I.
Pigment Yellow 154 (CAP 5C0279,
Docket No. FDA–2005–C–0416), and C.I.
Pigment Red 122 (CAP 5C0280, Docket
No. FDA–2005–C–0504) as color
additives in contact lenses. CIBA Vision
Corp. has now withdrawn the petitions
without prejudice to a future filing (21
CFR 71.6(c)(2)).
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10807-10808]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4890]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Subcommittee on Procedures Reviews (SPR), Advisory Board on
Radiation and Worker Health (ABRWH), National Institute for
Occupational Safety and Health (NIOSH)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC), announces the following meeting for the
aforementioned subcommittee:
Time and Date: 9:30 a.m.-5 p.m., March 23, 2010.
Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron,
Kentucky 41018, Telephone: (859) 334-4611, Fax: (859) 334-4619.
Status: Open to the public, but without a public comment period.
To access by conference call dial the following information 1(866)
659-0537, Participant Pass Code 9933701.
Background: The Advisory Board was established under the Energy
Employees Occupational Illness Compensation Program Act of 2000 to
advise the President on a variety of policy and technical functions
required to implement and effectively manage the compensation
program. Key functions of the Advisory Board include providing
advice on the development of probability of causation guidelines
that have been promulgated by the Department of Health and Human
Services (HHS) as a final rule; advice on methods of dose
reconstruction which have also been promulgated by HHS as a final
rule; advice on the scientific validity and quality of dose
estimation and reconstruction efforts being performed for purposes
of the compensation program; and advice on petitions to add classes
of workers to the Special Exposure Cohort (SEC).
In December 2000, the President delegated responsibility for
funding, staffing, and operating the Advisory Board to HHS, which
subsequently delegated this authority to CDC. NIOSH implements this
responsibility for CDC. The charter was issued on August 3, 2001,
renewed at appropriate intervals, and will expire on August 3, 2011.
Purpose: The Advisory Board is charged with (a) Providing advice
to the Secretary, HHS, on the development of guidelines under
Executive Order 13179; (b) providing advice to the Secretary, HHS,
on the scientific validity and quality of dose reconstruction
efforts performed for this program; and (c) upon request by the
Secretary, HHS, advise the Secretary on whether there is a class of
employees at any Department of Energy facility who were exposed to
radiation but for whom it is not feasible to estimate their
radiation dose, and on whether there is reasonable likelihood that
such radiation doses may have endangered the health of members of
this class. The Subcommittee on Procedures Reviews was established
to aid the Advisory Board in carrying out its duty to advise the
Secretary, HHS, on dose reconstruction. It is responsible for
overseeing, tracking, and participating in the reviews of all
procedures used in the dose reconstruction process by the NIOSH
Office of Compensation Analysis and Support (OCAS) and its dose
reconstruction contractor.
Matters To Be Discussed: The agenda for the Subcommittee meeting
includes: the development of recommendations for an Advisory Board
procedure for reviewing OCAS Program Evaluation Reports; and
discussion of the following Oak Ridge Associated Universities & OCAS
procedures: OTIB-013 (``Special External Dose Reconstruction
Considerations for Mallinckrodt Workers''), OTIB-014 (``Rocky Flats
Internal Dosimetry Co-Worker Extension''), OTIB-0029 (``Internal
Dosimetry Coworker Data for Y-12''), OTIB-0049 (``Estimating Doses
for Plutonium Strongly Retained in the Lung''), OTIB-0047 (External
Radiation Monitoring at the Y-12 Facility During the 1948-1949
Period''), OTIB-0051 (``Effect of Threshold Energy and Angular
Response of NTA Film on Missed Neutron Dose at the Oak Ridge Y-12
Facility''), OTIB-0054 (``Fission and Activation Product Assignment
for Internal Dose-Related Gross Beta and Gross Gamma Analyses''),
and OTIB-0070 (``Dose Reconstruction During Residual Radioactivity
Periods at Atomic Weapons Employer Facilities''); and a continuation
of the comment-resolution process for other dose reconstruction
procedures under review by the Subcommittee.
[[Page 10808]]
The agenda is subject to change as priorities dictate.
This meeting is open to the public, but without a public comment
period. In the event an individual wishes to provide comments,
written comments may be submitted. Any written comments received
will be provided at the meeting and should be submitted to the
contact person below in advance of the meeting.
Contact Person for More Information: Theodore Katz, Executive
Secretary, NIOSH, CDC, 1600 Clifton Road, Mailstop E-20, Atlanta,
Georgia 30333, Telephone: (513) 533-6800, Toll Free: 1(800) CDC-
INFO, E-mail ocas@cdc.gov.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both CDC and the Agency for Toxic Substances and
Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2010-4890 Filed 3-8-10; 8:45 am]
BILLING CODE 4163-18-P
