Statement of Organization, Functions, and Delegations of Authority, 54351-54352 [2010-21764]
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
will determine the amount of time
allotted to each presenter and the
approximate time that each oral
presentation is scheduled to begin. Prior
to the meeting, presenters will be
notified of their allotted time and the
approximate scheduled time of their
remarks. An agenda of the public
meeting, including the oral presentation
schedule, will be available
approximately 3 days before the public
meeting at the Division of Dockets
Management (Docket No. FDA–2009–D–
0007) and on the Internet at https://
www.regulations.gov.
Pre-registered participants will
receive additional information on
parking and public transportation with
their e-mail registration confirmation.
IV. Comments on the Draft Guidance
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments
regarding the Draft Guidance. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (see ADDRESSES). 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
FDA–2009–D–0007. 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this draft guidance before it begins work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 either electronic or written
comments on Draft Guidance by January
5, 2011. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
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V. Transcripts
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 45 days after the
meeting. A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Written requests
are to be sent to Division of Freedom of
Information (HFI–35), Office of
Management Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
Dated: September 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22198 Filed 9–3–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Cell and Gene Therapy Clinical Trials
in Pediatric Populations; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER) is announcing a
public workshop entitled ‘‘Cell and
Gene Therapy Clinical Trials in
Pediatric Populations.’’ The purpose of
the workshop is to gather information
from Institutional Review Boards (IRBs),
gene and cellular therapy clinical
researchers, and other stakeholders
regarding best practices related to cell
and gene therapy clinical trials in
pediatric populations, as well as
challenges and considerations in the
review of these clinical trials.
Date and Time: The public workshop
will be held on November 2, 2010, from
8 a.m. to 5:30 p.m.
Location: The public workshop will
be held at the Bethesda North Marriott
Hotel and Conference Center, 5701
Marinelli Rd., North Bethesda, MD
20852.
Contact Person: Bernadette Kawaley,
Center for Biologics Evaluation and
Research (HFM–43), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX 301–827–3079;
email: CBERTraining@fda.hhs.gov
(Subject line: Pediatrics Ethics
Workshop).
Registration: Email, mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by October 1, 2010.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Bernadette Kawaley (see Contact
Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The
workshop will include presentations on
cell and gene therapy clinical trials in
pediatric populations. The workshop
will include panel discussions regarding
best practices related to cell and gene
therapy clinical trials in pediatric
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54351
populations including those related to:
(1) Evaluating these novel therapeutic
products prior to initiating pediatric
clinical studies; (2) identifying and
minimizing risks associated with the
administration of cell and gene therapy
products in pediatric populations; (3)
obtaining informed consent and assent;
and (4) conducting continuing review of
cell and gene therapy products in
pediatric populations. The workshop
also will include panel discussions
addressing the challenges and
considerations in the review of cell and
gene therapy clinical trials in pediatric
populations and the role of IRBs.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857. A
transcript of the public workshop will
be available on the Internet at https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetings
Conferences/TranscriptsMinutes/
default.htm.
Dated: August 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22168 Filed 9–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 45134–45142,
dated August 2, 2010) is amended to
reflect the reorganization of the Office of
Health and Safety, Office of the Chief
Operating Officer, Office of the Director,
Centers for Disease Control and
Prevention.
E:\FR\FM\07SEN1.SGM
07SEN1
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54352
Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
Section C–B, Organization and
Functions, is hereby amended as
follows:
Delete in its entirety the title and
functional statements for the Office of
Health and Safety (CAJP), and insert the
following:
Office of Safety, Health, and
Environment (CAJP). The mission of the
Office of Safety, Health, and
Environment (OSHE) of the Centers for
Disease Control and Prevention (CDC) is
to help workers protect themselves as
they carry out their public health
mission. By helping staff create a safe,
healthful workplace environment, by
assisting in the prevention of workrelated injury and illness, and by
promoting safe work practices, the
Office improves worker morale,
increases efficiency and contributes to
the creation of sound public health
science. In carrying out its mission,
OSHE: (1) Provides leadership and
service for the CDC Health and Safety
Program to proactively ensure safe and
healthy workplaces at CDC worksites for
CDC employees, contractors, and
visitors (including deployed personnel),
and to protect the environment and
communities adjacent to CDC-owned
and leased facilities; (2) promotes
healthy and safe work practices to
prevent injury and illness, and provides
occupational medical, employee
assistance, and worksite health
promotion/lifestyle services; (3)
provides advice and counsel to the CDC
Director and other senior OD and
Centers/Institute/Offices (ClO) staff on
health, safety, and environment-related
matters, and to individuals and
organizations nationally and
internationally, as requested; (4)
provides advice, counsel, and direct
support services to supervisors and
employees on health, safety, and
environment-related matters; (5) assures
compliance with applicable federal,
state, and local health, safety, and
environmental (HSE) laws and
regulations; (6) provides liaison with
both CDC safety officers and staff, and
other partners such as Health and
Human Services (HHS) health and
safety officials, Occupational Safety and
Health Administration (OSHA),
Environmental Protection Agency
(EPA), Nuclear Regulatory Commission
(NRC), and other governmental and nongovernmental organizations on HSE
issues; (7) coproduces the CDC/NIH
Biosafety in Microbiological and
Biomedical Laboratories; (8) serves as a
World Health Organization
Collaborating Center for Applied
Biosafety Programs and Training; (9)
serves as a significant resource of
subject matter expertise for the national
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15:24 Sep 03, 2010
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and international community in the
field of biosafety; and, (10) works with
key partners, such as the World Health
Organization, on critical health and
safety issues around the globe.
Office of the Director (CAJP1). (1)
Serves as the principal advisor to the
Director, CDC, with responsibility for
the CDC Health and Safety Program; (2)
plans, identifies, and requests required
resources; directs, manages, and
evaluates the operations and programs
of OSHE; (3) assures coordination and
cooperation among OSHE staff; (4)
provides advice and counsel to the CDC
Director, the Chief Operating Officer,
and other senior OD and CIO officials
on workplace HSE matters; (5) assures
compliance with applicable federal,
state, and local HSE laws, regulations,
and policies; (6) develops and
implements new HSE injury/illness
prevention programs indicated by
surveys, incident investigations, reports
of unsafe/unhealthful working
conditions and other means; (7) assures
cross-cutting, collaborative team
functionality in building and
maintaining a successful safety program;
(8) assures OSHE coordination with the
Office of Security and Emergency
Preparedness, the Building and
Facilities Office, and other staff and staff
service offices on HSE matters; (9)
provides liaison with both CDC safety
officers and staff, and other partners
such as HHS, OSHA, EPA, NRC, and
other governmental and nongovernmental organizations on HSE
issues; (10) when asked, consults with
individuals and organizations nationally
and internationally on issues such as
laboratory safety, biosafety,
occupational health issues in the
biomedical laboratory and animal care
setting, and deployment health and
safety; (11) maintains oversight and
support for the CDC safety committees
in operational components with
representation, attendance, interaction
and collaboration, and collaboration
with non-Atlanta health and safety
officers and staff and (12) provides an
annual report on the CDC HSE and other
4 reports required or requested by CDC
management officials, HHS, and
regulatory agencies.
Dated: August 22, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–21764 Filed 9–3–10; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Free Trade Agreements
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0117.
AGENCY:
As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning: Free Trade
Agreements. This request for comment
is being made pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13; 44 U.S.C. 3505(c)(2)).
DATES: Written comments should be
received on or before November 8, 2010,
to be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
799 9th Street, NW., 7th Floor,
Washington, DC 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 799 9th Street,
NW., 7th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3505(c)(2)). The comments
should address: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual costs burden to respondents or
record keepers from the collection of
information (a total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
SUMMARY:
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54351-54352]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21764]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Statement of Organization, Functions, and Delegations of
Authority
Part C (Centers for Disease Control and Prevention) of the
Statement of Organization, Functions, and Delegations of Authority of
the Department of Health and Human Services (45 FR 67772-76, dated
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as
amended most recently at 75 FR 45134-45142, dated August 2, 2010) is
amended to reflect the reorganization of the Office of Health and
Safety, Office of the Chief Operating Officer, Office of the Director,
Centers for Disease Control and Prevention.
[[Page 54352]]
Section C-B, Organization and Functions, is hereby amended as
follows:
Delete in its entirety the title and functional statements for the
Office of Health and Safety (CAJP), and insert the following:
Office of Safety, Health, and Environment (CAJP). The mission of
the Office of Safety, Health, and Environment (OSHE) of the Centers for
Disease Control and Prevention (CDC) is to help workers protect
themselves as they carry out their public health mission. By helping
staff create a safe, healthful workplace environment, by assisting in
the prevention of work-related injury and illness, and by promoting
safe work practices, the Office improves worker morale, increases
efficiency and contributes to the creation of sound public health
science. In carrying out its mission, OSHE: (1) Provides leadership and
service for the CDC Health and Safety Program to proactively ensure
safe and healthy workplaces at CDC worksites for CDC employees,
contractors, and visitors (including deployed personnel), and to
protect the environment and communities adjacent to CDC-owned and
leased facilities; (2) promotes healthy and safe work practices to
prevent injury and illness, and provides occupational medical, employee
assistance, and worksite health promotion/lifestyle services; (3)
provides advice and counsel to the CDC Director and other senior OD and
Centers/Institute/Offices (ClO) staff on health, safety, and
environment-related matters, and to individuals and organizations
nationally and internationally, as requested; (4) provides advice,
counsel, and direct support services to supervisors and employees on
health, safety, and environment-related matters; (5) assures compliance
with applicable federal, state, and local health, safety, and
environmental (HSE) laws and regulations; (6) provides liaison with
both CDC safety officers and staff, and other partners such as Health
and Human Services (HHS) health and safety officials, Occupational
Safety and Health Administration (OSHA), Environmental Protection
Agency (EPA), Nuclear Regulatory Commission (NRC), and other
governmental and non-governmental organizations on HSE issues; (7)
coproduces the CDC/NIH Biosafety in Microbiological and Biomedical
Laboratories; (8) serves as a World Health Organization Collaborating
Center for Applied Biosafety Programs and Training; (9) serves as a
significant resource of subject matter expertise for the national and
international community in the field of biosafety; and, (10) works with
key partners, such as the World Health Organization, on critical health
and safety issues around the globe.
Office of the Director (CAJP1). (1) Serves as the principal advisor
to the Director, CDC, with responsibility for the CDC Health and Safety
Program; (2) plans, identifies, and requests required resources;
directs, manages, and evaluates the operations and programs of OSHE;
(3) assures coordination and cooperation among OSHE staff; (4) provides
advice and counsel to the CDC Director, the Chief Operating Officer,
and other senior OD and CIO officials on workplace HSE matters; (5)
assures compliance with applicable federal, state, and local HSE laws,
regulations, and policies; (6) develops and implements new HSE injury/
illness prevention programs indicated by surveys, incident
investigations, reports of unsafe/unhealthful working conditions and
other means; (7) assures cross-cutting, collaborative team
functionality in building and maintaining a successful safety program;
(8) assures OSHE coordination with the Office of Security and Emergency
Preparedness, the Building and Facilities Office, and other staff and
staff service offices on HSE matters; (9) provides liaison with both
CDC safety officers and staff, and other partners such as HHS, OSHA,
EPA, NRC, and other governmental and non-governmental organizations on
HSE issues; (10) when asked, consults with individuals and
organizations nationally and internationally on issues such as
laboratory safety, biosafety, occupational health issues in the
biomedical laboratory and animal care setting, and deployment health
and safety; (11) maintains oversight and support for the CDC safety
committees in operational components with representation, attendance,
interaction and collaboration, and collaboration with non-Atlanta
health and safety officers and staff and (12) provides an annual report
on the CDC HSE and other 4 reports required or requested by CDC
management officials, HHS, and regulatory agencies.
Dated: August 22, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-21764 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-18-M
