Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee, 63989-63990 [2013-25188]
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Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
of clinical trials. The course will cover
a wide variety of key topics, including
material on novel safety concerns,
adverse event monitoring, compliance
with the legal and ethical obligations of
clinical research, and acceptable
scientific and analytic standards in the
design and conduct of clinical studies.
The faculty will include a diverse
representation of senior FDA staff,
enabling FDA to communicate directly
with clinical investigators on issues of
greatest importance for successful
clinical research.
II. Description of the Training Course
A. Purpose
The training course is designed to
provide clinical investigators with an
overview of the following information:
• The essential toxicological,
pharmacological, and manufacturing
data to support investigational use in
humans;
• Fundamental issues in the design
and conduct of clinical trials;
• Statistical and analytic
considerations in the interpretation of
trial data;
• Appropriate safety evaluation
during studies; and
• The ethical considerations and
regulatory requirements for clinical
trials.
In addition, the course should
accomplish the following:
• Foster a cadre of clinical
investigators with knowledge,
experience, and commitment to
investigational medicine;
• Promote communication between
clinical investigators and FDA;
• Enhance investigators’
understanding of FDA’s role in
experimental medicine; and
• Improve the quality of data while
enhancing subject protection in the
performance of clinical trials.
emcdonald on DSK67QTVN1PROD with NOTICES
B. Proposed Agenda
The course will be conducted over 3
days and comprised of approximately
26 lectures, each lasting between 30 and
45 minutes. The course will be
presented mainly by senior FDA staff,
with guest lecturers presenting selected
topics.
The course will address FDA’s role in
clinical studies, regulatory
considerations for clinical trials, and
review of the material generally
appearing in an ‘‘investigator’s
brochure,’’ i.e., the preclinical
information (toxicology, animal studies,
and chemistry/manufacturing
information) that supports initial
clinical trials in humans. Presenters will
discuss the role of clinical
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17:55 Oct 24, 2013
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pharmacology in early clinical studies
and how this information is used in the
design of subsequent studies. The
course will also include discussions of
scientific, statistical, ethical, and
regulatory aspects of clinical studies. On
November 14, 2013, participants will
choose among three breakout sessions
that will explain how to put together an
application to FDA for drugs, biologics,
or devices.
C. Target Audience
The course is targeted toward health
care professionals responsible for, or
involved in, the conduct and/or design
of clinical trials.
Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25127 Filed 10–24–13; 8:45 am]
BILLING CODE 4160–01–P
63989
member to represent the interests of the
tobacco manufacturing industry must
send a letter stating the interest to FDA
by November 25, 2013, for the vacancy
listed in this notice. Concurrently,
nomination materials for prospective
candidates should be sent to FDA by
November 25, 2013.
All letters of interest and
nominations should be submitted in
writing to TPSAC@fda.hhs.gov, or by
mail to Caryn Cohen, Office of Science,
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,1–877–287–1373
(choose Option 5), FAX: 240–276–3655,
email: TPSAC@fda.hhs.gov.
The
Agency requests nominations for a
nonvoting industry representative on
the Tobacco Products Scientific
Advisory Committee to represent the
interests of the tobacco manufacturing
industry.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Tobacco
Products Scientific Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
industry organizations interested in
participating in the selection of a
nonvoting industry representative to
represent the interests of the tobacco
manufacturing industry on the Tobacco
Products Scientific Advisory Committee
for the Center for Tobacco Products,
notify FDA in writing. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
upcoming vacancy effective with this
notice. Elsewhere in this issue of the
Federal Register, FDA is publishing a
separate document announcing the
Request for Notification for Voting
Members on the Tobacco Products
Scientific Advisory Committee.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
SUMMARY:
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Fmt 4703
Sfmt 4703
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner or designee
in discharging responsibilities as they
relate to the regulation of tobacco
products. The Committee reviews and
evaluates safety, dependence, and
health issues relating to tobacco
products and provides appropriate
advice, information and
recommendations to the Commissioner
of Food and Drugs.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative of the
tobacco manufacturing industry, one
representative of the interests of tobacco
growers, and one representative of the
interests of the small business tobacco
manufacturing industry. The
representative of the interests of the
small business tobacco manufacturing
industry may be filled on a rotating
basis by representatives of different
small business tobacco manufacturers
based on areas of expertise relevant to
the topics being considered by the
Committee.
With this notice, nominations are
sought for one representative of the
interests of the tobacco manufacturing
industry, and an alternate to this
representative.
E:\FR\FM\25OCN1.SGM
25OCN1
63990
Federal Register / Vol. 78, No. 207 / Friday, October 25, 2013 / Notices
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days of the receipt
of the FDA letter, to serve as the
nonvoting member to represent the
tobacco manufacturing industry for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner of Food and Drugs
will select the nonvoting member to
represent industry interests.
emcdonald on DSK67QTVN1PROD with NOTICES
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the tobacco
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
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Jkt 232001
Dated: October 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–25188 Filed 10–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
HIV/AIDS Bureau; Ryan White HIV/
AIDS Program Core Medical Services
Waiver; Application Requirements
Health Resources and Services
Administration, HHS.
ACTION: Final notice.
AGENCY:
Title XXVI of the Public
Health Service Act, as amended by the
Ryan White HIV/AIDS Treatment
Extension Act of 2009 (Ryan White
Program or RWHAP), requires that
grantees expend 75 percent of Parts A,
B, and C funds on core medical services,
including antiretroviral drugs, for
individuals with HIV/AIDS identified
and eligible under the statute. The
statute also grants the Secretary
authority to waive this requirement if
there are no waiting lists for the AIDS
Drug Assistance Program (ADAP) and
core medical services are available to all
individuals identified and eligible
under Title XXVI in an applicant’s state,
jurisdiction, or service area, as
applicable.
The requirements for submitting an
application to waive the statutory
requirement that a grantee spend at least
75 percent of its funds on core medical
were previously outlined in HIV/AIDS
Bureau (HAB) Policy Notice 08–02. On
May 24, 2013, the Health Resources and
Services Administration (HRSA)
published a Final Notice with
Opportunity to Comment in the Federal
Register, revising HAB Policy Notice
08–02, and requesting public comment
on this revised policy. This Federal
Register notice seeks to address
comments made by the public and to
implement this policy as originally
written.
DATES: The policy will become effective
on September 23, 2013.
SUPPLEMENTARY INFORMATION: HRSA
received several comments on the
waiver application process published in
the Federal Register. Overall, the
comments were supportive of the
revised requirements. Commenters
indicated that the revised application
process will provide grantees with the
flexibility to adjust resource allocation
SUMMARY:
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Fmt 4703
Sfmt 4703
based on the current situation in their
local environment.
Several commenters suggested that
the application process and the
documentation required to apply for a
waiver was burdensome, especially for
grantees with limited administrative
staff to respond to the waiver
requirements. HRSA believes that the
application process and the
documentation required are necessary
for the agency to understand the
availability of core medical services in
the applicant’s state, jurisdiction, or
service area, as applicable. This
required documentation is intended to
provide HRSA with sufficient
information to make an informed
decision on each waiver request and to
understand the availability of core
medical services in a grantee’s state,
jurisdiction, or service area, as
applicable. Further, the requirements
are similar to those under the previous
policy. Waiver applicants under the
previous policy were expected to
provide adequate documentation, which
may have included additional data,
supporting letters, and other
information that justified the need for
the waiver. As such, HRSA is only
clarifying what documentation is
necessary to meet each requirement in
the application. This will ensure that
the applicant provides adequate
documentation to demonstrate the need
for a waiver of the core medical services
requirement
Under the previous policy, letters
from Medicaid directors and other State
and local HIV/AIDS entitlement and
benefits programs, which may include
private insurers, were optional. Under
this revision, item #2(c) of the policy
now requires the submission of
documentation regarding the
availability of relevant services, and
lists examples of the types of programs
that may provide documentation,
including private insurers. Specific to
this requirement, several commenters
suggested that letters from private
insurers would be burdensome to
provide. HRSA wishes to clarify that
letters from private insurers are not
required; these entities are only listed to
provide an example of a type of
entitlement and benefit provider. Other
types of entitlement and benefit
providers might include local
foundations that provide funding for
medical care to low-income HIV
patients or a county or state sponsored
drug-assistance program. As part of their
application, grantees must provide
letters from the state Medicaid Director
and relevant HIV/AIDS entitlement and
benefits programs available in their
state, jurisdiction, or service area, as
E:\FR\FM\25OCN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Notices]
[Pages 63989-63990]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25188]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Tobacco Products Scientific Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that
industry organizations interested in participating in the selection of
a nonvoting industry representative to represent the interests of the
tobacco manufacturing industry on the Tobacco Products Scientific
Advisory Committee for the Center for Tobacco Products, notify FDA in
writing. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for upcoming vacancy effective with this
notice. Elsewhere in this issue of the Federal Register, FDA is
publishing a separate document announcing the Request for Notification
for Voting Members on the Tobacco Products Scientific Advisory
Committee.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent the interests
of the tobacco manufacturing industry must send a letter stating the
interest to FDA by November 25, 2013, for the vacancy listed in this
notice. Concurrently, nomination materials for prospective candidates
should be sent to FDA by November 25, 2013.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to TPSAC@fda.hhs.gov, or by mail to Caryn Cohen, Office of
Science, Center for Tobacco Products, Food and Drug Administration,
9200 Corporate Blvd., Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850,1-877-287-1373 (choose Option 5), FAX: 240-
276-3655, email: TPSAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency requests nominations for a
nonvoting industry representative on the Tobacco Products Scientific
Advisory Committee to represent the interests of the tobacco
manufacturing industry.
I. Tobacco Products Scientific Advisory Committee
The Tobacco Products Scientific Advisory Committee (the Committee)
advises the Commissioner or designee in discharging responsibilities as
they relate to the regulation of tobacco products. The Committee
reviews and evaluates safety, dependence, and health issues relating to
tobacco products and provides appropriate advice, information and
recommendations to the Commissioner of Food and Drugs.
The Committee includes three nonvoting members who represent
industry interests. These members include one representative of the
tobacco manufacturing industry, one representative of the interests of
tobacco growers, and one representative of the interests of the small
business tobacco manufacturing industry. The representative of the
interests of the small business tobacco manufacturing industry may be
filled on a rotating basis by representatives of different small
business tobacco manufacturers based on areas of expertise relevant to
the topics being considered by the Committee.
With this notice, nominations are sought for one representative of
the interests of the tobacco manufacturing industry, and an alternate
to this representative.
[[Page 63990]]
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days of the receipt of the
FDA letter, to serve as the nonvoting member to represent the tobacco
manufacturing industry for the committee. The interested organizations
are not bound by the list of nominees in selecting a candidate.
However, if no individual is selected within 60 days, the Commissioner
of Food and Drugs will select the nonvoting member to represent
industry interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and therefore, encourages nominations of
appropriately qualified candidates from these groups. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from the tobacco manufacturing industry.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 21, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-25188 Filed 10-24-13; 8:45 am]
BILLING CODE 4160-01-P
