[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]


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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.

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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 [email protected]. 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 
[email protected])

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