[Federal Register Volume 63, Number 212 (Tuesday, November 3, 1998)]
[Notices]
[Pages 59313-59315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29335]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Health Care Policy and Research
Nominations of Topics for Research on Therapeutics
AGENCY: Agency for Health Care Policy and Research, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Agency for Health Care Policy and Research (AHCPR) invites
nominations of topics of study and ideas for implementation of a new
program, Centers for Education and Research on Therapeutics, which will
be established by AHCPR in conjunction with the Food and Drug
Administration (FDA). The program is described in Section 409 of the
Food and Drug Modernization Act, quoted below. AHCPR plans to publish
during Fiscal Year 1999 a Request for Applications (RFA) for
cooperative agreements to establish and operate one or more Centers.
Nominated topics selected by AHCPR will be considered in developing the
RFA.
Sec. 409. Centers for Education and Research on Therapeutics
Title IX of the Public Health Service Act (42 U.S.C. 299 et
seq.) is amended by adding at the end of part A the following new
section:
Sec. 905. Demonstration Program Regarding Centers for Education and
Research on Therapeutics
(a) In General.--The Secretary, acting through the Administrator
and in consultation with the Commissioner of Food and Drugs, shall
establish a demonstration program for the purpose of making one or
more grants for the establishment and operation of one or more
centers to carry out the activities specified in subsection (b).
(b) Required Activities.--The activities referred to in
subsection (a) are the following:
(1) The conduct of state-of-the-art clinical and laboratory
research for the following purposes:
(A) To increase awareness of--
(i) New uses of drugs, biological products, and devices;
(ii) Ways to improve the effective use of drugs, biological
products, and devices; and
(iii) Risks of new uses and risks of combinations of drugs and
biological products.
(B) To provide objective clinical information to the following
individuals and entities:
(i) Health care practitioners or other providers of health care
goods or services;
(ii) Pharmacy benefit managers;
(iii) Health maintenance organizations or other managed health
care organizations;
(iv) Health care insurers or governmental agencies; and
(v) Consumers.
(C) To improve the quality of health care while reducing the
cost of health care through--
(i) The appropriate use of drugs, biological products, or
devices; and
(ii) The prevention of adverse effects of drugs, biological
products, and devices and the consequences of such effects, such as
unnecessary hospitalizations.
(2) The conduct of research on the comparative effectiveness and
safety of drugs, biological products, and devices.
(3) Such other activities as the Secretary determines to be
appropriate, except that the grant may not be expended to assist the
Secretary in the review of new drugs.
DATES: To be considered for Fiscal Year 1999, nominations of topics and
ideas for implementation for CERTS, in accordance with the criteria set
out below, should be submitted by December 18, 1998. Nominations after
that date will be accepted on an ongoing basis for consideration in
future studies.
ADDRESSES: Nominations of topics and ideas for implementation should be
sent to: Center for Outcomes and Effectiveness Research, AHCPR;
ATTENTION: Joanne Book; 6010 Executive Boulevard; Suite 300; Rockville,
Maryland 20852 or e-mail at jbook@ahcpr.gov. All responses will be
available for public inspection at AHCPR's Information Resource Center
(IRC) public reading room between the hours of 8:30 a.m. and 5 p.m. on
regular business days at 2101 East Jefferson Street, Suite 500,
Rockville, MD 20852.
[[Page 59314]]
Arrangements for reviewing the submissions may be made by calling 301
594-1360. Responses may also be accessed after December 1, 1998,
through AHCPR's Electronic FOIA Reading Room on AHCPR's Website
(www.ahcpr.gov).
FOR FURTHER INFORMATION CONTACT: Lynn Bosco, M.D., M.P.H., Medical
Officer, COER, AHCPR, at the above address. (Phone 301 594-1485; e-mail
lbosco@ahcpr.gov)
SUPPLEMENTARY INFORMATION: The Food and Drug Administration
Modernization Act of 1997 (Pub.L. 105-115) added a new section 905 to
Title IX of the PHS Act (codified at 42 U.S.C. 299a-3). Section 905
requires AHCPR, in consultation with FDA, to set up a demonstration
program for grants to establish Centers for Education and Research on
Therapeutics to conduct research for the purposes set out above. AHCPR
plans to publish, during Fiscal Year 1999, an RFA for cooperative
agreements to establish and operate one or more Centers.
In FY 1999 there will be up to $2 million available to fund one or
more centers. Recognizing the broad mission outlined in the
legislation, AHCPR is requesting comments on:
How the centers should be organized;
The appropriateness of AHCPR or these centers seeking
additional funding partners to increase the resources available for
research;
Initial area(s) of emphasis, drawing from the list
outlined in the statute (reprinted above);
High-priority research topics within the suggested initial
area(s) of emphasis;
Whether the Agency should include a list of specific
research topics in the RFA to which applicants would respond or whether
the RFA should focus primarily on the infrastructure and capacity of
applicants and identify specific research issues to be addressed
following selection of the centers; as well as
Other issues that respondents believe need to be taken
into account by the Agency in the implementation of this legislation.
General Considerations in Responding to these Questions.
Organization of the Centers. Are there existing frameworks, such as
the NIH project or center grants (e.g. the Cancer Centers or
Multipurpose Arthritis Centers), that could serve as a model project
for the organization of these Centers?
Topic Selection. In developing topics and suggestions for how
Centers might be organized, the roles of AHCPR and FDA, as defined
below, should be considered. The FDA regulations most currently
marketed drugs, biologics and medical devices. In order for marketing
to occur, pre-marketing studies must be completed, with final approval
for marketing contingent on manufacturers providing FDA evidence of
safety and efficacy for a single indication through adequate and well-
controlled studies. (The majority of devices receive clearance rather
than approval after the manufacturer provides evidence that the product
is substantially equivalent to a device that is already on the market).
Current regulations do not require information on how these
products compare with the array of other existing therapies available,
or use in the every day clinical settings. FDA regulation continues
during the post-approval phase, through post marketing safety
monitoring and through regulation of advertising.
The AHCPR activities related to therapeutics begin after product
approval. The AHCPR supports research on the relative effectiveness,
appropriateness, and cost effectiveness of various strategies for the
prevention, diagnosis, treatment, and management of clinical
conditions. Activities have included development and administration of
a program to study patient outcomes, development of clinical guidelines
and evidence based practice centers, and support of the development of
quality measures.
The appropriate use of medical therapies, such as drugs, biologics
and devices is critical to effective, high quality, affordable health
care. Understanding which agents work; for which patients; and at what
cost and risk; can inform programs in managing the selection,
utilization, and cost of therapies and services within a changing
health care environment. The Centers for Education and Research on
Therapeutics will seek to make more information available after
marketing to fill the gap between the research required for approval
and the need for information to assist clinicians in the everyday use
of products.
Selection Criteria
FDA's needs related to the necessity for going beyond the current
voluntary reporting system to obtain needed safety and effectiveness
information for providing guidance to practitioners on appropriate
product use. The current post-marketing surveillance system provides
only a fraction of the actual number of problems associated with
product use, with only limited information available on the numbers of
patients exposed to products. Little information is available on the
interaction between the provider, product and patient. This is
particularly important when a high degree of skill is required of
either the provider or patient to use a product, thus making it
difficult to determine whether problems relate to provider or patient
error, product defect or an adverse event.
Selection criteria for AHCPR sponsored research have been the
following: (1) High incidence or prevalence in the general population
or in subpopulations, including racial and ethnic minorities, women and
children; (2) significance to the Medicare, Medicaid and other Federal
health programs; (3) high costs associated with a condition, procedure,
treatment, or technology, whether due to the number of people needing
care, high unit cost of care, or high indirect costs; (4) controversy
or uncertainty about the effectiveness or relative effectiveness of
available clinical strategies or technologies; (5) potential to inform
and improve patient or provider decision making; (6) potential to
reduce clinically significant variations in the prevention, diagnosis,
treatment, or clinical management of a disease or condition, or in the
use of a procedure or technology, or in the health outcomes achieved;
(7) availability of scientific data to support the study or analysis of
the topic; and (8) potential opportunities for rapid implementation.
Submission Process
Nominations of topics and suggestions for organization of the
Centers should focus on broad aspects of the legislative program as set
out above. For each topic nominated, nominators should provide a
rationale and any available supporting evidence reflecting the
importance and clinical relevance of the topic and should indicate the
potential usefulness of the research in improving the quality of health
care while reducing the cost of health care through--the appropriate
use of drugs, biological products, or devices; and the prevention of
adverse effects of drugs, biological products, and devices; and the
consequences of such effects.
Submissions should be brief (1-2 pages) and may be in the form of a
letter or e-mail, preferable along with an electronic file in a
standard work processing format on a 3\1/2\ floppy disk. Submissions
should provide:
A broadly defined topic or idea for organization and
implementation of the CERTS, with specific questions to be answered
that will establish the focus and boundaries of the research.
[[Page 59315]]
The availability of data and/or, any information on
product utilization, cost, the incidence, prevalence, and/or severity
of the particular disease, health condition, adverse event or medical
error relevant to the topic being nominated.
Include, if relevant, the significance to Federal Health
Programs or underserved populations; or an indication of how the
research results or Center activities might be used within the
professional or organizational setting.
AHCPR will not reply to individual responses, but will consider all
responses in developing the CERTS program and selecting topics for
study. AHCPR will review the submissions and supporting information
before making final determinations, seeking additional information as
appropriate.
Dated: October 26, 1998.
John M. Eisenberg,
Administrator.
[FR Doc. 98-29335 Filed 11-2-98; 8:45 am]
BILLING CODE 4160-90-M
