Pediatric Advisory Committee; Notice of Meeting, 22941-22942 [E9-11317]
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Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices
Subcommittee topics. The first panel will
focus on Primary Care Workforce. The
confirmed speakers are Dr. Bruce Vogt, Chair
of Family Medicine, University of South
Dakota; Dr. Charles Hart, CEO of Regional
Health System; and Josie Peterson, South
Dakota PCO Director. The second panel is
Home-Based Care Options for Seniors. The
confirmed speakers are Deb Bowman,
Committee Member and Secretary of the
South Dakota Department of Social Services;
and Senator Jean Hunhoff, head of home care
services at Yankton, South Dakota, and
member of the task force on Meeting the
Continuum of Care Needs of the Elderly in
South Dakota. The final panel of the day is
Health Care Provider Integration. The
confirmed speakers are Tom Dean, MedPAC
Member; Scot Graff, Community Healthcare
Association of the Dakotas; and Matt
Michaels, Health Care Attorney. After the
panel discussions, the Committee Chair will
give an overview of the site visits. The
Tuesday meeting will close at 4:45 p.m.
Wednesday morning, at 8:45 a.m., the
Committee will break into Subcommittees
and depart to the site visits. The Primary
Care Workforce Subcommittee will visit
Phillip Health Services in Philip, South
Dakota. The Home-Based Care Options for
Seniors Subcommittee will visit Regional
Health Hospice Center in Rapid City, South
Dakota. The Health Care Provider Integration
Subcommittee will visit Custer Regional
Hospital in Custer, South Dakota.
Transportation to the site visits will not be
provided to the public. The Subcommittees
will return to Rapid City, South Dakota at 3
p.m. The Wednesday meeting will close at 3
p.m.
The final session will be convened on
Thursday morning at 8:45 a.m. The meeting
will open with a review of the Subcommittee
site visits. The staff of the Office of Rural
Health Policy will provide an update on the
Department of Health and Human Services.
The Committee will draft a letter to the
Secretary or Designee and discuss the
September meeting.
For Further Information Contact: Anyone
requiring information regarding the
Committee should contact Jennifer Chang,
MPH, Executive Secretary, National Advisory
Committee on Rural Health and Human
Services, Health Resources and Services
Administration, Parklawn Building, Room
9A–55, 5600 Fishers Lane, Rockville, MD
20857, Telephone (301) 443–0835, Fax (301)
443–2803.
Persons interested in attending any portion
of the meeting should contact Michele Pray
Gibson, Office of Rural Health Policy
(ORHP), Telephone (301) 443–0835. The
Committee meeting agenda will be posted on
ORHP’s Web site https://
www.ruralhealth.hrsa.gov.
Dated: April 11, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–11441 Filed 5–14–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pediatric 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: Pediatric
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 Tuesday, June 23, 2009, from
8:30 a.m. to 5 p.m.
Location: Hilton Washington DC/
Rockville Executive Meeting Center,
Plaza Ballroom, 1750 Rockville Pike,
Rockville, MD 20852.
˜
Contact Person: Carlos Pena, Office of
Science and Health Coordination, Office
of the Commissioner (HF–33), Food and
Drug Administration, 5600 Fishers Lane
(for express delivery, rm. 14B–08),
Rockville, MD 20857, 301–827–3340, or
˜
by e-mail: carlos.pena@fda.hhs.gov or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
8732310001. 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 June 23, 2009, the
Pediatric Advisory Committee will
review and discuss reports by the
agency, as mandated by the Best
Pharmaceuticals for Children Act and
the Pediatric Research Equity Act, for
ALVESCO (ciclesonide), ANDROGEL
(testosterone), ASMANEX (mometasone
furoate), COMBIGAN (brimonidine/
timolol), DEPAKOTE (divalproex
sodium), DERMA–SMOOTHE F/S
(fluocinolone acetate), DIOVAN
(valsartan), HEPSERA (adefovir
dipivoxil), INSPRA (eplerenone),
MOXATAG (amoxicillin), OMNARIS
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22941
(ciclesonide), and ZOMETA (zoledronic
acid).
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 committee. Written
submissions may be made to the contact
person on or before June 9, 2009. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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 June 1, 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 June 2, 2009.
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 Carlos Pena
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/oc/advisory/
default.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).
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22942
Federal Register / Vol. 74, No. 93 / Friday, May 15, 2009 / Notices
Dated: May 8, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–11317 Filed 5–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0191]
Request for Nominations for Voting
Consumer Representative Members on
Public Advisory Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting consumer
representatives to serve on the Food
Advisory Committee. This advisory
committee is under the purview of the
Center for Food Safety and Applied
Nutrition (CFSAN).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on its advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations will be accepted for
those voting consumer representative
vacancies that will occur on June 30,
2010. Nominations received before July
14, 2009, will be considered for June 30,
2010, vacancies. Nominations received
after July 14, 2009, will be accepted for
vacancies occurring after June 30, 2010.
ADDRESSES: All nominations for
membership should be sent
electronically to CV@OC.FDA.GOV, or
by mail to Advisory Committee
Oversight and Management Staff (HF–
4), 5600 Fishers Lane, rm. 15A–12,
Rockville, MD 20857. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/oc/advisory/default.htm.
FOR FURTHER INFORMATION CONTACT:
Carolyn Jeletic, Center for Food Safety
and Applied Nutrition (HFS–024), 5100
Paint Branch Pkwy., College Park, MD
20740, 301–436–1913, FAX: 301–436–
2637, e-mail:
Carolyn.Jeletic@fda.hhs.gov.
FDA is
requesting nominations for voting
consumer members on the following
CFSAN committee:
SUPPLEMENTARY INFORMATION:
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I. Function
Food Advisory Committee
The Committee provides advice
primarily to Commissioner of Food and
Drugs and other appropriate officials, on
emerging food safety, food science,
nutrition, and other food-related health
issues that FDA considers of primary
importance for its food and cosmetics
programs. The Committee may be
charged with reviewing and evaluating
available data and making
recommendations on matters such as
those relating to the following topics: (1)
Broad scientific and technical food or
cosmetic related issues, (2) the safety of
new foods and food ingredients, (3)
labeling of foods and cosmetics, (4)
nutrient needs and nutritional
adequacy, and (5) safe exposure limits
for food contaminants. The Committee
may also be asked to provide advice and
make recommendations on ways of
communicating to the public the
potential risks associated with these
issues and on approaches that might be
considered for addressing the issues.
II. Criteria for Members
Persons who are nominated for
membership on the committees as
consumer representatives must meet the
following criteria: (1) Demonstrate ties
to consumer and community-based
organizations, (2) be able to analyze
scientific and technical data, (3)
understand research design, and (4)
discuss benefits and risks. The
consumer representative must be able to
represent the consumer perspective on
issues and actions before the advisory
committee; serve as a liaison between
the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
III. Selection Procedures
The selection of members
representing consumer interests is
conducted through procedures that
include the use of organizations
representing the public interest and
consumer advocacy groups. The
organizations have the responsibility of
recommending candidates of the
agency’s selection.
IV. Nomination Procedures
All nominations must include a cover
letter, a curriculum vitae or resume (that
includes the nominee’s office address,
telephone number, and e-mail address),
and a list of consumer or communitybased organizations for which the
candidate can demonstrate active
participation. Nominations will specify
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the advisory committee for which the
nominee is recommended. Nominations
will include confirmation that the
nominee is aware of the nomination.
Any interested person or organization
may nominate one or more qualified
persons for membership on one or more
of the advisory committees to represent
consumer interests. Self-nominations
are also accepted. FDA will ask the
potential candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
a conflict of interest. The nomination
should specify the committee of
interest. The term of office is up to 4
years, depending on the appointment
date. 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: May 7, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–11319 Filed 5–14–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0209]
Small Entity Compliance Guide: Health
Claims; Calcium and Osteoporosis,
and Calcium, Vitamin D, and
Osteoporosis; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Food Labeling: Health Claims;
Calcium and Osteoporosis, and
Calcium, Vitamin D, and Osteoporosis—
Small Entity Compliance Guide.’’ The
small entity compliance guide (SECG) is
being issued for a final rule published
in the Federal Register of September 29,
2008, as corrected on November 12,
2008, and it is intended to set forth in
plain language the legal requirements of
the regulation and to help small
businesses understand the regulation.
DATES: Submit written or electronic
comments on the SECG at any time.
ADDRESSES: Submit written comments
on the SECG to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments on the SECG to
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]]>Agencies
[Federal Register Volume 74, Number 93 (Friday, May 15, 2009)]
[Notices]
[Pages 22941-22942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-11317]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Pediatric 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: Pediatric 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 Tuesday, June 23, 2009,
from 8:30 a.m. to 5 p.m.
Location: Hilton Washington DC/Rockville Executive Meeting Center,
Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: Carlos Pe[ntilde]a, Office of Science and Health
Coordination, Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08),
Rockville, MD 20857, 301-827-3340, or by e-mail:
carlos.pe[ntilde]a@fda.hhs.gov or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
8732310001. 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 June 23, 2009, the Pediatric Advisory Committee will
review and discuss reports by the agency, as mandated by the Best
Pharmaceuticals for Children Act and the Pediatric Research Equity Act,
for ALVESCO (ciclesonide), ANDROGEL (testosterone), ASMANEX (mometasone
furoate), COMBIGAN (brimonidine/timolol), DEPAKOTE (divalproex sodium),
DERMA-SMOOTHE F/S (fluocinolone acetate), DIOVAN (valsartan), HEPSERA
(adefovir dipivoxil), INSPRA (eplerenone), MOXATAG (amoxicillin),
OMNARIS (ciclesonide), and ZOMETA (zoledronic acid).
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and 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 committee.
Written submissions may be made to the contact person on or before June
9, 2009. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 June 1, 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 June 2,
2009.
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 Carlos Pe[ntilde]a
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/oc/advisory/default.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).
[[Page 22942]]
Dated: May 8, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-11317 Filed 5-14-09; 8:45 am]
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