Antiviral Drugs Advisory Committee; Notice of Meeting, 4136 [05-1578]
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Federal Register / Vol. 70, No. 18 / Friday, January 28, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs 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: Antiviral Drugs
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 March 11, 2005, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Anuja Patel, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail: patela@cder.fda.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512531. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: The committee will discuss
new drug applications 21–797 and 21–
798, entecavir tablets and entecavir oral
solution, respectively, Bristol-Myers
Squibb Co., proposed for the treatment
of patients with chronic hepatitis B
infection (HBV).
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 25, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before February 25, 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 contact Angie
Whitacre at 301–827–7001, 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: January 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–1578 Filed 1–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Access to Recovery (ATR) Program—
New
In preparation for implementing
Performance Partnership Grants,
Number of
respondents
Data collection point
Client Interviews:
ATR Intake ....................................................................
Discharge/30 day interview** ........................................
3 months .......................................................................
5 months .......................................................................
7 months .......................................................................
9 months .......................................................................
VerDate jul<14>2003
15:43 Jan 27, 2005
Jkt 205001
PO 00000
Frm 00053
Responses
per
respondent
42,095
42,095
28,625
22,732
18,101
15,155
Fmt 4703
Sfmt 4703
SAMHSA has developed a set of
performance outcome measures for
substance abuse treatment that cover
seven domains. The domains are:
Abstinence from drug use and alcohol
abuse, or decreased mental illness
symptomatology; increased or retained
employment and school enrollment;
decreased involvement with the
criminal justice system; increased
stability in family and living conditions;
increased access to services; increased
retention in services for substance abuse
treatment or decreased utilization of
psychiatric inpatient beds for mental
health treatment; and increased social
connectedness to family, friends, coworkers and classmates.
SAMHSA’s Center for Substance
Abuse Treatment (CSAT), is responsible
for implementing the new Access to
Recovery (ATR) grant program. States
funded in the ATR program will use
these outcome measures to meet the
reporting requirements of the
Government Performance and Results
Act (GPRA) by quantifying the effects
and accomplishments of the funded
programs. The ATR Program is part of
a Presidential initiative to: (1) Provide
client choice among substance abuse
clinical treatment and recovery support
service providers, (2) expand access to
a comprehensive array of clinical
treatment and recovery support options
(including faith-based programmatic
options), and (3) increase substance
abuse treatment capacity. Monitoring
outcomes, tracking costs, and
preventing waste, fraud and abuse to
ensure accountability and effectiveness
in the use of Federal funds are also
important elements of the ATR program.
Grantees, as a contingency of their
award, are responsible for collecting
data from their clients at intake,
discharge, at 30 days after intake, and
every two months during an episode of
care. An episode of care is defined as a
client’s entry to and exit from the ATR.
The following tables summarize the
annual response burden for the ATR
activities using the performance
outcome measures.
Total
responses
1
1
1
1
1
1
42,095
42,095
28,625
22,732
18,101
15,155
E:\FR\FM\28JAN1.SGM
28JAN1
Hours per
response
0.33
0.33
0.33
0.33
0.33
0.33
Total hour burden (proportion of added
burden)*
7,640
13,891
9,446
7,502
5,973
5,001
]]>Agencies
[Federal Register Volume 70, Number 18 (Friday, January 28, 2005)]
[Notices]
[Page 4136]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1578]
[[Page 4136]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Antiviral Drugs 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: Antiviral Drugs 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 March 11, 2005, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Anuja Patel, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX: 301-827-6776, e-mail: patela@cder.fda.gov, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014512531. Please call the Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss new drug applications 21-797 and
21-798, entecavir tablets and entecavir oral solution, respectively,
Bristol-Myers Squibb Co., proposed for the treatment of patients with
chronic hepatitis B infection (HBV).
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 25,
2005. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before February 25, 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 contact Angie Whitacre at
301-827-7001, 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: January 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1578 Filed 1-27-05; 8:45 am]
BILLING CODE 4160-01-S
