Pediatric Advisory Committee; Notice of Meeting, 1721 [05-382]
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Federal Register / Vol. 70, No. 6 / Monday, January 10, 2005 / Notices
Section 1116 of the Social Security Act (42
U.S.C. 1316); 42 CFR 430.18.
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program)
Dated: January 5, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 05–445 Filed 1–7–05; 8:45 am]
BILLING CODE 4120–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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. The committee
also advises and makes
recommendations to the Secretary of
Health and Human Services under 45
CFR 46.407 on research involving
children as subjects that is conducted or
supported by the Department of Health
and Human Services, when that
research is also regulated by FDA.
Date and Time: The meeting will be
held on February 14, 2005, from 2 p.m.
to 6 p.m. and on February 15, 2005,
from 8 a.m. to 4:30 p.m.
Location: Center for Drug Evaluation
and Research Advisory Committee
Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Jan N. Johannessen,
Office of Science and Health
Coordination of the Office of the
Commissioner (HF–33), Food and Drug
Administration, 5600 Fishers Lane, (for
express delivery, rm. 14C–06) Rockville,
MD 20857, 301–827–6687, e-mail:
jjohannessen@fda.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.
Agenda: On Monday, February 14,
2005, the committee will discuss an
agency report on Adverse Event
VerDate jul<14>2003
18:09 Jan 07, 2005
Jkt 205001
Reporting, as mandated in Section 17 of
the Best Pharmaceuticals for Children
Act (BPCA), for LOTENSIN (benazepril),
BREVIBLOC (esmolol), MALARONE
(atovaquone/proguanil), VIRACEPT
(nelfinavir), XENICAL (orlistat), and
GLUCOVANCE (glyburide/metformin).
The committee will also be asked to
advise the agency on how to improve
the process and content of the adverse
event reviews and reporting as
mandated by BPCA.
On Tuesday, February 15, 2005, the
committee will discuss risk evaluation,
labeling, risk communication, and
dissemination of information on
potential cancer risk among pediatric
patients treated for atopic dermatitis
with topical dermatological
immunosuppressants.
The background material will become
available no later than the day before
the meeting and will be posted under
the Pediatric Advisory Committee (PAC)
docket Web site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm (click on
the year 2005 and scroll down to PAC
meetings).
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 by February 7, 2005. Oral
presentations from the public will be
scheduled on Monday, February 14,
2005, between approximately 4 p.m.
and 4:30 p.m. and on Tuesday, February
15, 2005, between approximately 12
noon and 12:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person by February 7, 2005, 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.
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 notify Jan
Johannessen at least 7 days in advance
of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
1721
Dated: December 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and
Planning.
[FR Doc. 05–382 Filed 1–7–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000P–1378]
Guidance for Industry: Labeling for
Topically Applied Cosmetic Products
Containing Alpha Hydroxy Acids as
Ingredients; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Guidance for Industry:
Labeling for Topically Applied
Cosmetic Products Containing Alpha
Hydroxy Acids as Ingredients.’’ The
guidance recommends content for a
labeling statement for cosmetic products
containing alpha hydroxy acids (AHAs)
as ingredients. This action was
prompted by a citizen petition filed by
the Cosmetic, Toiletry, and Fragrance
Association, which requested that FDA
issue a regulation establishing labeling
requirements relating to sun protection
with use of cosmetic products
containing AHAs.
DATES: You may submit written or
electronic comments on the guidance
document at any time.
ADDRESSES: Submit written requests for
single copies of the guidance document
to the Office of Cosmetics and Colors,
Center for Food Safety and Applied
Nutrition (HFS–100), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835.
Include a self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the guidance document may be
sent.
Submit written comments on the
guidance document to the Division of
Dockets Management (HFA–305), 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to
https://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Julie
N. Barrows, Center for Food Safety and
Applied Nutrition (HFS–125), Food and
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 70, Number 6 (Monday, January 10, 2005)]
[Notices]
[Page 1721]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-382]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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. The committee
also advises and makes recommendations to the Secretary of Health and
Human Services under 45 CFR 46.407 on research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services, when that research is also regulated by FDA.
Date and Time: The meeting will be held on February 14, 2005, from
2 p.m. to 6 p.m. and on February 15, 2005, from 8 a.m. to 4:30 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination of the Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane, (for express delivery, rm. 14C-06)
Rockville, MD 20857, 301-827-6687, e-mail: jjohannessen@fda.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.
Agenda: On Monday, February 14, 2005, the committee will discuss an
agency report on Adverse Event Reporting, as mandated in Section 17 of
the Best Pharmaceuticals for Children Act (BPCA), for LOTENSIN
(benazepril), BREVIBLOC (esmolol), MALARONE (atovaquone/proguanil),
VIRACEPT (nelfinavir), XENICAL (orlistat), and GLUCOVANCE (glyburide/
metformin). The committee will also be asked to advise the agency on
how to improve the process and content of the adverse event reviews and
reporting as mandated by BPCA.
On Tuesday, February 15, 2005, the committee will discuss risk
evaluation, labeling, risk communication, and dissemination of
information on potential cancer risk among pediatric patients treated
for atopic dermatitis with topical dermatological immunosuppressants.
The background material will become available no later than the day
before the meeting and will be posted under the Pediatric Advisory
Committee (PAC) docket Web site at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm (click on the year 2005 and scroll down to PAC meetings).
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 by February 7,
2005. Oral presentations from the public will be scheduled on Monday,
February 14, 2005, between approximately 4 p.m. and 4:30 p.m. and on
Tuesday, February 15, 2005, between approximately 12 noon and 12:30
p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person by
February 7, 2005, 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.
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 notify Jan Johannessen at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-382 Filed 1-7-05; 8:45 am]
BILLING CODE 4160-01-S
