Comparisons of Community with Facility Management of Malaria and Pneumonia in Rural Tanzania; Notice of Intent To Fund Single Eligibility Award, 11677-11678 [05-4552]
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Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
of, or restrict, physicians in contracting
with payors outside of the arrangement.
As defined in the proposed order, a
‘‘qualified risk-sharing joint
arrangement’’ possesses two key
characteristics. First, all physician
participants must share substantial
financial risk through the arrangement,
such that the arrangement creates
incentives for the physician participants
jointly to control costs and improve
quality by managing the provision of
services. Second, any agreement
concerning reimbursement or other
terms or conditions of dealing must be
reasonably necessary to obtain
significant efficiencies through the joint
arrangement.
A ‘‘qualified clinically-integrated joint
arrangement,’’ on the other hand, need
not involve any sharing of financial risk.
Instead, as defined in the proposed
order, physician participants must
participate in active and ongoing
programs to evaluate and modify their
clinical practice patterns in order to
control costs and ensure the quality of
services provided, and the arrangement
must create a high degree of
interdependence and cooperation
among physicians. As with qualified
risk-sharing arrangements, any
agreement concerning price or other
terms of dealing must be reasonably
necessary to achieve the efficiency goals
of the joint arrangement.
Paragraph III, for three years, requires
Preferred Health to notify the
Commission before participating in
contracting with health plans on behalf
of a qualified risk-sharing joint
arrangement or qualified clinicallyintegrated joint arrangement. Paragraph
III sets out the information necessary to
make the notification complete.
Paragraph IV, for three years after the
bar on messengering ends, requires
Preferred Health to notify the
Commission before entering into any
arrangement to act as a messenger, or as
an agent on behalf of any physicians,
with payors regarding contracts.
Paragraph IV also sets out the
information necessary to make the
notification complete.
Paragraph V requires Preferred Health
to distribute the complaint and order to
all physicians who have participated in
Preferred Health, and to payors that
negotiated contracts with Preferred
Health or indicated an interest in
contracting with Preferred Health.
Paragraph V.C requires Preferred Health,
at any payor’s request and without
penalty, or within one year after the
Order is made final, to terminate its
current contracts with respect to
providing physician services. Paragraph
V.D requires Preferred Health to
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distribute payor requests for contract
termination to all physicians who
participate in Preferred Health.
Paragraph V.E.1.b requires Preferred
Health to distribute the complaint and
order to any payors that negotiate
contracts with Preferred Health in the
next three years.
Paragraphs VI and VII of the proposed
order impose various obligations on
Respondent to report or provide access
to information to the Commission to
facilitate monitoring Respondent’s
compliance with the order.
The proposed order will expire in 20
years.
By direction of the Commission, Chairman
Majoras not participating.
Donald S. Clark,
Secretary.
[FR Doc. 05–4594 Filed 3–8–05; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Comparisons of Community with
Facility Management of Malaria and
Pneumonia in Rural Tanzania; Notice
of Intent To Fund Single Eligibility
Award
A. Purpose
The Centers for Disease Control and
Prevention (CDC) announces the intent
to fund fiscal year (FY) 2005 funds for
a cooperative agreement program to
establish the effectiveness of
combination antimalarial therapy
policies within the context of intense
malaria transmission and to develop an
evidence-based comparison between
two approaches to managing febrile
illness in rural sub-Sahara Africa.
Specifically, the two approaches of
interest are an enhanced facility-based
management approach and a
community- or household-based
approach. The aim is to generate
detailed data enabling international
public health organizations to make
recommendations to national
governments based on quality scientific
evidence. The Catalog of Federal
Domestic Assistance number for this
program is 93.283.
11677
institution located in Tanzania that
possesses the requisite scientific and
technical expertise, the infrastructure
capacity and experience in conducting
the described research topics and which
has collaborative relationships with the
Ministry of Health to ensure that all
aspects of this agreement can be
fulfilled. Because of its work in malaria
for more than 15 years, the IHDRC is an
internationally respected research
institution.
Investigators at IHDRC have a detailed
understanding of the epidemiologic
patterns and geographic distribution of
malaria infection and transmission in
their area, are actively engaged in using
state-of-the-art techniques for evaluating
antimicrobial drug resistance, and have
needed and proven expertise in sociobehavioral and economic research
related to febrile illness. In addition, the
IHDRC has the following required
experience and capabilities:
• Maintains a DSS covering over
100,000 individuals, allowing for
measurement of public health impact of
malaria treatment policies.
• Proven experience in carrying out
large-scale community-based public
health interventions, to conduct malaria
research, and to correctly diagnose drug
resistant malaria infections in its
laboratories and field activities.
• Located in an area of very intense
malaria transmission in a country that is
has adopted a national malaria
treatment policy of ACT while
remaining actively engaged in
investigating future treatment options.
• Maintains a close relationship with
the National Malaria Control Program of
the Ministry of Health and as well as
close relationship with other relevant
research and public health entities in
the country and region.
• Actively engaged in research
activities that are directly related to the
objectives of this RFA with proven
experience and capacity.
C. Funding
Approximately $1,000,000 is available
in FY 2004 to fund this award. It is
expected that the award will begin on or
before September 1, 2005, and will be
made for a 12-month budget period
within a project period of up to three
years. Funding estimates may change.
B. Eligible Applicant
D. Where to Obtain Additional
Information
Assistance will be provided only to
the Ifakara Health Research and
Development Centre, Ifakara, Tanzania.
No other applications are solicited.
The Ifakara Health Research and
Development Centre (IHRDC) is the only
For general comments or questions
about this announcement, contact:
Technical Information Management,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341–4146, Telephone: 770–488–2700.
PO 00000
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11678
Federal Register / Vol. 70, No. 45 / Wednesday, March 9, 2005 / Notices
For technical questions about this
program, contact: Dr. Trudy Messmer,
Scientific Review Administrator, 1600
Clifton Rd, MS C–19, Atlanta, GA
30333, Telephone: 404–639–3770, email: TMessmer@cdc.gov.
Dated: March 3, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–4552 Filed 3–8–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0075]
Notice to Industry on the Development
of a Web-Based System for Obtaining
a User Fee Payment Identification
Number and Prescription Drug User
Fee Cover Sheet (FDA Form 3397);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a new Web-based system
to electronically obtain a user fee
payment identification number and to
submit your Prescription Drug User Fee
(PDUFA) cover sheet (FDA Form 3397)
to the Office of Financial Management.
The system will enable FDA to
electronically track your company’s
application payments and will allow
your organization to obtain the user fee
payment identification number over the
Web. By making the user fee payment
identification number and the PDUFA
cover sheet available on-line, we will be
able to improve service, one of PDUFA’s
performance goals.
DATES: Submit written or electronic
comments by April 8, 2005.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20857. Submit
electronic comments to https://
www.fda.gov/dockets.ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the new system.
FOR FURTHER INFORMATION CONTACT:
Martha Louviere, Office of Financial
Management (HFA–100), Food and Drug
Administration, 5600 Fishers Lane, rm.
11–83, Rockville, MD 20857, 301–827–
3912, e-mail: userfees@fda.gov.
SUPPLEMENTARY INFORMATION: Under
sections 735 and 736 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C.
379g and 379h), FDA has the authority
to assess and collect user fees for certain
drug and biologics license applications
and supplements. Under this authority,
pharmaceutical companies pay fees for
certain new human drug applications,
biologics applications, and supplements
submitted to the agency for review.
Because the submission of user fees
concurrently with applications and
supplements is required, review of an
application by FDA cannot begin until
the fee has been submitted. Form FDA
3397, the user fee cover sheet, is
designed to provide the minimum
necessary information to determine
whether a fee is required for review of
an application, to determine the amount
of the fee required, and to help FDA
track payments.
The form provides a cross-reference of
the fee submitted for an application
with the actual application by using a
unique number tracking system to
assign the user fee payment
identification number. The information
collected is used by FDA’s Center for
Drug Evaluation and Research (CDER)
and Center for Biologics Evaluation and
Research (CBER) to initiate the
administrative screening of new drug
applications, biologics license
applications, and supplemental
applications.
FDA has created an on-line user fee
cover sheet which will assist FDA and
pharmaceutical companies by
improving service and reducing the time
for applicants and their affiliates to file
and comply with PDUFA through more
automated channels. The new system
will allow customers to obtain a user fee
payment identification number, create
and complete a user fee cover sheet online, and submit it electronically to
FDA’s Office of Financial Management.
It will decrease the administrative
burden on FDA, improve service by
automating the cover sheet application
process, and allow applicants to
securely view their payments received
by FDA on-line. This new system,
which replaces the previous process,
will be available on February 15, 2005.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
Frm 00074
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You can access this new system from
the https://www.fda.gov/oc/pdufa/
coversheet.html Web site. You may then
select ‘‘PDUFA User Fee Cover Sheet’’
from Web site. Detailed instructions on
how to use the user fee system are
included at the Web site.
Dated: March 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4635 Filed 3–8–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal 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: Cardiovascular
and Renal 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 April 5, 2005, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Cathy Groupe, 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, e-mail:
groupec@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
line for up-to-date information on this
meeting.
Agenda: The committee will discuss
supplemental new drug application
(sNDA) S–036 to approved new drug
application (NDA) 19–787, NORVASC
(amlodipine besylate) Tablets (2.5
milligrams (mg), 5 mg, and 10 mg),
Pfizer Inc., proposing a change in
labeling for the following two additional
indications of: (1) Reducing the risk of
fatal coronary heart disease and nonfatal
myocardial infarction and (2) reducing
the risk of stroke, based on the
effectiveness demonstrated in the
E:\FR\FM\09MRN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Pages 11677-11678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4552]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Comparisons of Community with Facility Management of Malaria and
Pneumonia in Rural Tanzania; Notice of Intent To Fund Single
Eligibility Award
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
intent to fund fiscal year (FY) 2005 funds for a cooperative agreement
program to establish the effectiveness of combination antimalarial
therapy policies within the context of intense malaria transmission and
to develop an evidence-based comparison between two approaches to
managing febrile illness in rural sub-Sahara Africa. Specifically, the
two approaches of interest are an enhanced facility-based management
approach and a community- or household-based approach. The aim is to
generate detailed data enabling international public health
organizations to make recommendations to national governments based on
quality scientific evidence. The Catalog of Federal Domestic Assistance
number for this program is 93.283.
B. Eligible Applicant
Assistance will be provided only to the Ifakara Health Research and
Development Centre, Ifakara, Tanzania. No other applications are
solicited.
The Ifakara Health Research and Development Centre (IHRDC) is the
only institution located in Tanzania that possesses the requisite
scientific and technical expertise, the infrastructure capacity and
experience in conducting the described research topics and which has
collaborative relationships with the Ministry of Health to ensure that
all aspects of this agreement can be fulfilled. Because of its work in
malaria for more than 15 years, the IHDRC is an internationally
respected research institution.
Investigators at IHDRC have a detailed understanding of the
epidemiologic patterns and geographic distribution of malaria infection
and transmission in their area, are actively engaged in using state-of-
the-art techniques for evaluating antimicrobial drug resistance, and
have needed and proven expertise in socio-behavioral and economic
research related to febrile illness. In addition, the IHDRC has the
following required experience and capabilities:
Maintains a DSS covering over 100,000 individuals,
allowing for measurement of public health impact of malaria treatment
policies.
Proven experience in carrying out large-scale community-
based public health interventions, to conduct malaria research, and to
correctly diagnose drug resistant malaria infections in its
laboratories and field activities.
Located in an area of very intense malaria transmission in
a country that is has adopted a national malaria treatment policy of
ACT while remaining actively engaged in investigating future treatment
options.
Maintains a close relationship with the National Malaria
Control Program of the Ministry of Health and as well as close
relationship with other relevant research and public health entities in
the country and region.
Actively engaged in research activities that are directly
related to the objectives of this RFA with proven experience and
capacity.
C. Funding
Approximately $1,000,000 is available in FY 2004 to fund this
award. It is expected that the award will begin on or before September
1, 2005, and will be made for a 12-month budget period within a project
period of up to three years. Funding estimates may change.
D. Where to Obtain Additional Information
For general comments or questions about this announcement, contact:
Technical Information Management, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
[[Page 11678]]
For technical questions about this program, contact: Dr. Trudy
Messmer, Scientific Review Administrator, 1600 Clifton Rd, MS C-19,
Atlanta, GA 30333, Telephone: 404-639-3770, e-mail: TMessmer@cdc.gov.
Dated: March 3, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-4552 Filed 3-8-05; 8:45 am]
BILLING CODE 4163-18-P
