NIH GUIDE, Volume 22, Number 21, June 11, 1993


P.T. 34



  Clinical Medicine, General 

National Institute of Allergy and Infectious Diseases

The Division of AIDS (DAIDS), National Institute of Allergy and

Infectious Diseases (NIAID), has a requirement for the continuation

of the Terry Beirn Community Programs for Clinical Research on AIDS

(TB CPCRA).  The purpose of these contracts is to expand and

strengthen the HIV clinical research effort, support community

participation in HIV research, enhance the participation of women,

minorities and injection drug users in HIV clinical research and to

ensure the prompt translation of research findings to primary care

providers.  This is a recompetition of an ongoing program.

Proposals must describe the offeror organization and document the

availability of patient population, recruitment and follow-up plans

appropriate for the conduct of community-based trials.  The offeror

must be able to initiate a minimum of three, but not to exceed a

maximum of ten community based research projects per year, depending

on size and complexity and designed in conjunction with NIAID staff.

Offerors are expected to enroll at least 30 to 50 patients into

studies.  These may be investigator-initiated or NIAID-initiated

multicenter collaborative trials.  All CPCRA research must be

approved by the DAIDS Clinical Trials Review Committee prior to being


The successful offerors to this Request for Proposal (RFP) must have

the demonstrated or potential ability to implement and manage a

clinical research program based in primary care settings.  Proposals

will be accepted from domestic organizations made up of licensed

physicians and nurses with access to a substantial patient population

infected with HIV.  Particular emphasis will be given to

organizations which serve minorities, women at risk for HIV infection

and persons who use IV drugs and/or organizations composed of women

and minorities.  Evidence of substantial experience by the members of

the organization in the care and treatment of persons with HIV

infection must be documented in the proposal.  Mandatory Criterion:

Offeror's must document, e.g., by including letters of commitment

from the organization, that, with respect to the CPCRA scientific and

clinical issues, the overall direction and decision processes rest

with the primary care clinicians.  Proposals must also demonstrate

support from the community served by the offering organization, such

as endorsement by relevant community organizations, and community

participation in the decision process of the provision of clinical

care, clinical management or research priorities and conduct of

research.  Offerors must demonstrate relationships with community

health care facilities such as hospitals, public health departments,

and regional tertiary care centers, to ensure integration of the

offeror clinicians within the local medical care structure.  This

must include affiliations with local hospitals so participating

patients can be followed by offeror physicians if hospitalization is

required.  Offerors must have access to a clinical laboratory

competent to perform the studies required for community-based

clinical trials.  Offerors in cities that include one or more AIDS

Clinical Trial Unit (ACTU), must describe a formalized communication

link with an NIAID supported ACTU(s).  This should include relevant

researchers, clinicians, and/or administrators of both the community

organization and the ACTU and should provide a forum for discussion

of goals, protocols, and entry criteria of clinical research at both

the ACTU and the Community Program for Clinical Research on AIDS.

This is an announcement for an anticipated RFP.  RFP NIH-NIAID-DAIDS-

94-11 will be available on or about June 30, 1993 and proposals will

be due by 4:30 p.m., local time, on  November 3, 1993.  It is

anticipated that fifteen to twenty contracts will be awarded as a

result of this solicitation.  It is expected that the contract will

have a five year period of performance, and a completion cost-

reimbursement type contract is anticipated.


To receive a copy of the RFP, provide this office with five self-

addressed mailing labels.  Telephone inquiries will not be honored

and all inquiries must be in writing.  A short-form version of the

RFP will be provided first, which includes only the Statement of

Work, Reporting Requirements and the Evaluation Criteria to be used

for selection of the awardees.  After examining this, a full-text

version of the RFP must be requested, in writing, for those offerors

interested in responding.  FAX requests are acceptable for the full

text versions of the RFP only.

Requests for the RFP may be directed in writing to:

Nancy Hershey

Contract Management Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3C07

6003 Executive Boulevard

Bethesda, MD  20892

FAX:  (301) 402-0972

All proposals from responsible sources will be considered by the

NIAID.  This advertisement does not commit the Government to award a



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