National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 29330 [05-10098]
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Federal Register / Vol. 70, No. 97 / Friday, May 20, 2005 / Notices
food effect. In its February 15, 1994,
letter accompanying NDA 50–711,
Pfizer explained that the tablets are
bioequivalent to the capsule formulation
and ‘‘* * * unlike the capsule, can be
taken without regard to meals.’’ After
NDA 50–711 was approved, Pfizer
decided not to market the capsule
formulation and ZITHROMAX
(azithromycin) 250-mg oral capsules
were moved from the prescription drug
product list to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
In a citizen petition submitted under
21 CFR 10.30 dated May 4, 2004 (Docket
No. 2004P–0220), as amended by a letter
dated May 17, 2004, Wapner, Newman,
Wigrizer & Brecher requested that FDA
determine whether ZITHROMAX
(azithromycin) 250-mg oral capsules
were withdrawn from sale for reasons of
safety or effectiveness. The agency has
determined that ZITHROMAX
(azithromycin) 250-mg oral capsules
were not withdrawn from sale for
reasons of safety or effectiveness. The
petitioners identified no data or other
information suggesting that
ZITHROMAX (azithromycin) 250-mg
oral capsules were withdrawn from sale
as a result of safety or effectiveness
concerns. FDA has independently
evaluated relevant literature and data
and has found no information that
would indicate this product was
withdrawn for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that, for the reasons outlined
in this document, ZITHROMAX
(azithromycin) 250-mg oral capsules,
approved under NDA 50–670, were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list
ZITHROMAX (azithromycin) 250-mg
oral capsules in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. As a result, ANDAs that refer to
ZITHROMAX (azithromycin) 250-mg
oral capsules may be approved by the
agency.
Dated: May 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–10032 Filed 5–19–05; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
that the following committee will
convene its fiftieth meeting:
Name: National Advisory Committee on
Rural Health and Human Services.
Dates and Times: June 12, 2005, 1:30 p.m.–
5:15 p.m., June 13, 2005, 8:45 a.m.–5 p.m.,
June 14, 2005, 9 a.m.–10:45 a.m.
Place: Carnegie Hotel, 1216 W State of
Franklin Road, Johnson City, TN 37604,
Phone: 423–979–6400, Fax: 423–979–6424.
Status: The meeting will be open to the
public.
Purpose: The National Advisory
Committee on Rural Health and Human
Services provides advice and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of health
and human services in rural areas.
Agenda: Sunday afternoon, June 12, at 1:30
p.m., the Chairperson, the Honorable David
Beasley, will open the meeting and welcome
the Committee. There will be a brief
discussion of Committee business and
updates by Federal staff. The first session
will open with an overview of East
Tennessee by Dr. Paul Stanton, President of
East Tennessee State University. The
remainder of the day’s meeting will be
devoted to panel discussions on the three
topics for the 2006 workplan: Pharmacy
Access, Health Information Technology
(HIT), and Elderly Caregiver Support. The
Sunday meeting will close at 5:15 p.m.
Monday morning, June 13, at 8:45 a.m., the
Committee will break into Subcommittees
and conduct site visits to local health and
human services facilities. Transportation to
these sites will not be provided to the general
public. The Pharmacy Access Subcommittee
will visit Wilson Pharmacy in Johnson City;
the HIT Subcommittee will visit Central
Appalachian Health Information Partnership
in Mountain City; and the Elderly Caregiver
Support Subcommittee will visit the
Mountain Empire Older Citizens Area
Agency on Aging in Big Stone Gap. The
Subcommittees will reconvene at 1:45 p.m. at
the Carnegie Hotel to continue discussions
on the workplan. The Committee of the
whole will reconvene at 4:30 p.m. for a brief
discussion of the workplan. The Monday
meeting will close at 5 p.m.
The final session will be convened
Tuesday morning, June 14, at 9 a.m. The
Committee will review the discussion of the
2006 Workplan and have updates on the
Subcommittees site visits. The meeting will
conclude with a discussion of the September
meeting. The meeting will be adjourned at
10:45 a.m.
For Further Information Contact: Anyone
requiring information regarding the
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
Committee should contact Tom Morris,
M.P.A., 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 PrayGibson, 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: May 13, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and
Coordination.
[FR Doc. 05–10098 Filed 5–19–05; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Opportunity for a Cooperative
Research and Development Agreement
(CRADA) for Research and
Development of Vigabatrin as a
Potential Pharmacotherapy for the
Treatment of Cocaine and
Methamphetamine Dependence
National Institutes of Health,
PHS, DHHS.
AGENCY:
ACTION:
Notice.
SUMMARY: The National Institute on
Drug Abuse, a component of the
National Institutes of Health,
Department of Health and Human
Services (DHHS) seeks an agreement
with a pharmaceutical or biotechnology
company to test the hypotheses that
vigabatrin may be a safe and effective
medication for the treatment of cocaine
and methamphetamine dependence.
A body of literature relevant to
preclinical studies of vigabatrin as a
potential treatment agent for various
types of substance dependence
(including cocaine and
methamphetamine) and a more limited
body of literature concerning clinical
results exists. As there are currently no
medications approved by the U. S. Food
and Drug Administration (FDA) for the
treatment of cocaine and/or
methamphetamine dependence, and
cocaine and methamphetamine
dependence have substantial negative
public health impacts, the National
Institute on Drug Abuse is interested in
evaluating the safety and efficacy of
vigabatrin for the treatment of cocaine
and methamphetamine dependence.
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Notices]
[Page 29330]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10098]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services;
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given that the
following committee will convene its fiftieth meeting:
Name: National Advisory Committee on Rural Health and Human
Services.
Dates and Times: June 12, 2005, 1:30 p.m.-5:15 p.m., June 13,
2005, 8:45 a.m.-5 p.m., June 14, 2005, 9 a.m.-10:45 a.m.
Place: Carnegie Hotel, 1216 W State of Franklin Road, Johnson
City, TN 37604, Phone: 423-979-6400, Fax: 423-979-6424.
Status: The meeting will be open to the public.
Purpose: The National Advisory Committee on Rural Health and
Human Services provides advice and recommendations to the Secretary
with respect to the delivery, research, development, and
administration of health and human services in rural areas.
Agenda: Sunday afternoon, June 12, at 1:30 p.m., the
Chairperson, the Honorable David Beasley, will open the meeting and
welcome the Committee. There will be a brief discussion of Committee
business and updates by Federal staff. The first session will open
with an overview of East Tennessee by Dr. Paul Stanton, President of
East Tennessee State University. The remainder of the day's meeting
will be devoted to panel discussions on the three topics for the
2006 workplan: Pharmacy Access, Health Information Technology (HIT),
and Elderly Caregiver Support. The Sunday meeting will close at 5:15
p.m.
Monday morning, June 13, at 8:45 a.m., the Committee will break
into Subcommittees and conduct site visits to local health and human
services facilities. Transportation to these sites will not be
provided to the general public. The Pharmacy Access Subcommittee
will visit Wilson Pharmacy in Johnson City; the HIT Subcommittee
will visit Central Appalachian Health Information Partnership in
Mountain City; and the Elderly Caregiver Support Subcommittee will
visit the Mountain Empire Older Citizens Area Agency on Aging in Big
Stone Gap. The Subcommittees will reconvene at 1:45 p.m. at the
Carnegie Hotel to continue discussions on the workplan. The
Committee of the whole will reconvene at 4:30 p.m. for a brief
discussion of the workplan. The Monday meeting will close at 5 p.m.
The final session will be convened Tuesday morning, June 14, at
9 a.m. The Committee will review the discussion of the 2006 Workplan
and have updates on the Subcommittees site visits. The meeting will
conclude with a discussion of the September meeting. The meeting
will be adjourned at 10:45 a.m.
For Further Information Contact: Anyone requiring information
regarding the Committee should contact Tom Morris, M.P.A., 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: May 13, 2005.
Tina M. Cheatham,
Director, Division of Policy Review and Coordination.
[FR Doc. 05-10098 Filed 5-19-05; 8:45 am]
BILLING CODE 4165-15-P
