RFP No. NIH-NIAID-DMID-98-19

Title:      MALARIA: CLINICAL RESEARCH AND TRIAL PREPARATION SITES
            IN ENDEMIC AREAS

Issued by:     Carl R. Henn
               Contracting Officer
               NIH/NIAID
               Contract Management Branch
               Solar Building, Room 3C07
               6003 Executive Boulevard (MSC 7610)
               Rockville, Maryland 20892-7610

DATE ISSUED:  OCTOBER 24, 1997

PROPOSAL DATE DUE:  JANUARY 23, 1998, 4:00 P.M. (EST)

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the
requirements of this RFP (NIH-NIAID-DMID-98-19) for "Malaria:
Clinical Research and Trial Preparation Sites in Endemic Areas".
The Government anticipates that three (3)to five (5) contracts will
be awarded for a period of five (5) years as a result of this RFP.

The documents included with this electronic RFP package are as
follows:

   Attachments:

   A.  Background and Work Statement, dated October 23, 1997

   B.  Deliverables and Reporting Requirements, dated October 23,
1997

   C.  Evaluation Factors for Award, dated October 23, 1997

   D.  Specific RFP Instructions and Provisions (includes page
limitations, the Technical Proposal Format, and the proposal intent
form)

   E.  Applicable RFP References

In addition to the directory in which you are currently located
(i.e., the streamlined RFP), there are five (5) other Subdirectories
in the Gopher System (under C, RFP References) which must be
retrieved, in  whole or in part, in order to submit a proposal (the
applicable portions are explained in Attachment E).  The
Subdirectories are:

   STANDARD RFP INSTRUCTIONS AND PROVISIONS
   OPTIONAL RFP INSTRUCTIONS AND PROVISIONS
   FORMS, FORMATS AND ATTACHMENTS
   REPRESENTATIONS AND CERTIFICATIONS
   SAMPLE CONTRACT FORMAT-GENERAL

If you are unable to download any of the applicable documents,
please contact Carl Henn, Contracting Officer, by phone/fax/Internet
(see contact numbers/addresses below).

The attachments/documents listed above represent all the necessary
information required for the submission of a proposal for this
acquisition.  Following proposal submission and review, additional
information will be requested by the Contracting Officer from all
offerors which comprise the Competitive Range.

The Business and Technical proposals must be separate portions in
the proposal package.  The Business Proposal must be signed by an
authorized official of your organization, and must contain a
detailed breakdown of costs by year for each cost category/element;
the basis for all costs must be explained, and the supporting
documentation must be submitted with the proposal.  See Standard RFP
Instructions and Provisions, in the subdirectory C, RFP References,
for more detail on the Business Proposal requirements.  Also, please
see Notes to Offeror in the Statement of Work (Attachment A)
information which offerors are required to submit in the proposals.

The Statement of Work is composed of two parts, the second of which,
Part B, would expand the contract to perform safety, immunogenicity
and efficacy testing of drugs or vaccines. The government will
decide whether and when to go forward with Part B.  All offerors
must address both parts A and B in their proposal.

It is recommended that any proposed annual increase in costs for
inflation be limited to no more than 3% of total costs per year,
which is also the maximum currently allowed by NIH for research
projects.

The format and content of your TECHNICAL PROPOSAL is detailed in the
"Technical Proposal Table of Contents", in Attachment D. SEE SECTION
D.5 FOR INFORMATION ON PAGE LIMITATIONS.

Your attention is further directed to the "Proposal Intent" form
contained in Attachment D, Item 6.  Please complete this form and
return it to this office on or before December 22, 1997.  This will
allow us to expedite preparations for the peer review of proposals.

The original and nineteen (19) copies of your technical proposal and
the original and five (5) copies of your business proposal must be
received by the Contracting Officer no later than January 23, 1998,
at 4:00 p.m. local time at the address listed in Attachment D, item
4.

If you have any additional questions regarding this RFP, please
contact Mr. Carl Henn at the Internet electronic mail address
ch24v@nih.gov, by phone at 301/496-0993, or by fax at 301/402-
5253.  Collect calls will NOT be accepted. Amendments fo the RFP
will be posted on the NIH homepage.  If you wish to be notified of
any amendments, please contact Mr. Henn.

Sincerely,

  /s/

Rosemary McCabe Hamill
Chief, Infectious and Allergic
     Diseases Contract Section
Contract Management Branch
National Institute of Allergy
      and Infectious Diseases

Attachments:  A - E

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RFP-NIH-NIAID-DMID-98-19

STREAMLINED RFP

ATTACHMENT A  (10/23/97)
----------------------------

INTRODUCTION
                                  

The objective of these contracts is to implement clinical and field-
based research on malaria at multidisciplinary field sites.  This
RFP details two different components, each with its own work
statement, evaluation criteria, and budget.  Part A solicits
proposals for work that includes: characterization of patient
populations in preparation for future clinical trials; provision of
baseline data with respect to epidemiology, parasite populations,
vector biology, immunity, and other factors influencing clinical
presentation; training of local scientists in research and clinical
trial methodology; development and validation of case-definitions
and field-appropriate diagnostics which will be valuable for
clinical trials; provision of research reagents to the NIAID Malaria
Reagent Repository; and, undertaking research on malaria
transmission and pathogenesis.  It is anticipated that three to five
completion type contracts will be awarded for Part A.  Part B
describes Optional Contract Activities (i.e. they are optional for
the Government to support), and solicits proposals describing
capacity for performance of safety, immunogenicity, and/or efficacy
trials of new prevention/intervention strategies when the need
arises.  When the Government exercises the Optional Contract
Activities in Part B, these will be accomplished under a completion
type contract.  Offerors submitting a proposal under this
solicitation must prepare a proposal which includes the required
work outlined above (Part A) AND the optional contract activities
identified in Part B.  Within the proposal, each part should be
distinct as each will be subject to its own review criteria.
PROPOSALS FOR PART A ALONE OR PART B ALONE SHALL NEITHER BE ACCEPTED
NOR CONSIDERED FOR AWARD UNDER THIS SOLICITATION.

BACKGROUND - PART A

Malaria is an infectious disease caused by protozoan parasites of
Plasmodium spp. (primarily P. falciparum and P. vivax), which claims
an estimated 2 to 3 million lives annually and accounts for untold
morbidity in the approximately 300 to 500 million people who develop
clinical disease annually.  There are no licensed vaccines for
malaria.  Currently available drugs are losing their utility as a
result of the development of drug-resistant parasites.  Malaria is
considered a re-emerging disease, due largely to the spread of drug-
resistant parasite strains, decay of the health-care infrastructure,
and difficulties in implementing and maintaining vector control
programs in many developing countries.  Basic and applied research
is needed to develop and implement new tools to control this deadly
disease.  Enhanced capacity to conduct collaborative/multicenter
research was recognized as a critical need in  the report from the
International Conference on Malaria in Africa, held in Dakar,
Senegal, in January, 1997.  Consequently, one goal of
this solicitation is to increase the number of sites within endemic
regions that are capable of performing these types of studies.

One important area for increased collaboration is that of
pathogenesis research.  As noted in the 1991 IOM report on "Malaria:
Obstacles and Opportunities", even with current state-of-the-art
care, some 25% of people presenting with the most severe form of
malaria die.  The IOM committee ranked improved understanding of the
disease process as one of its highest priority recommendations.
The pathogenesis of malaria is complex; current evidence, albeit
limited,  indicates that host genetic factors and host immunity
(e.g. TNF-alpha polymorphisms, nitric oxide levels) are important,
but the role of other influences having to do with exposure to the
parasite (entomologic inoculation rate, seasonality of transmission,
etc.) as well as parasite strain have not yet been systematically
analyzed.  Improved understanding of the pathogenesis of severe
malaria can best be achieved by a multidisciplinary approach,
combining clinical, immunologic, genetic, entomologic, and other
related studies in endemic areas.  This information will  be
important for improved case management of severe malaria, and for
the development of potential  immuno- or chemotherapies and/or anti-
pathology vaccines, and will be central to overall vaccine
development efforts in order to avoid induction of potentially
immunopathologic responses.

Evaluation of new prophylactic, therapeutic and diagnostic
approaches to malaria requires an understanding of the epidemiology
and transmission dynamics in locations in which statistical
discriminatory power can be achieved and where the approach is
likely to be implemented.  While some such sites are currently
supported by various agencies/institutions, the development of
additional sites with appropriate baseline information, expertise,
and infrastructure will broaden our understanding and ultimately
allow for more efficient conduct of clinical trials.  Studies
carried out in these sites will contribute necessary field
information that can assist investigators to develop factually based
strategies for intervention and evaluation.  Linking of these sites
into a network will allow for greater comparability of malaria
studies and trials in both similar and different epidemiologic
settings.

     
WORK STATEMENT - PART A

Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities not otherwise provided by the
Government as needed to perform the work described below.

Specifically, the Contractor shall:

1.   Establish a field-based  research  program on P. falciparum
  malaria, including access to appropriate academic, laboratory and
  clinical facilities, and necessary collaborative arrangements.

(NOTE 1 TO OFFEROR:  Offerors should submit a plan which includes
documentation of access to patient populations and facilities which
will be adequate and appropriate for the work to be performed under
this contract.  Offerors proposing to work in sites where both
infections occur  may include studies on P. vivax, as well as P.
falciparum, in their plan. It is anticipated that at least 90% of
the work performed under these contracts will be conducted at the
overseas field site and that local scientists and physicians will be
involved in all facets of this work.  The plan should describe the
anticipated involvement of local scientists in the project.)

2.   Develop and implement a systematic longitudinal approach
towards understanding malaria epidemiology in populations with
substantial malaria morbidity and in a region with predictable
parasite transmission. Under the terms of this task, the contractor
shall:

     a.   Collect data on the incidence, prevalence, and clinical
       presentation of malaria in areas where malaria is endemic, including
       but not limited to the relationship among groups with different
       clinical presentations (e.g. asymptomatic parasitemic, symptomatic
       parasitemic, severe and complicated malaria);
     b.   Collect data with respect to entomologic parameters, including
       but not limited to identification of the species and population
       structure of vector mosquitoes, and the number of infective
       bites/person/year;
     c.   Collect data on parasite population dynamics and heterogeneity,
       including but not limited to information on the expression of
       alleles of major antigens that may be used in subsequent vaccine
       trials; final determination of antigens to be characterized for
       allelic variation will be subject to the approval of the Project
       Officer.
     
(NOTE 2 TO OFFEROR: For planning purposes, the offeror should
describe screening for expression of allelic variants of MSP-1, CSP,
and LSA-1 antigens.)
     
     d.   Document and monitor the prevalence and use of available
       interventions (e.g. drugs, bednets, spraying of insecticides);
     e.   Document and monitor the level of drug resistance in the local
       parasite population, and the clinical responsiveness of patients to
       antimalarials used in the community.

3.   Develop and validate case-definitions and diagnostics which
will be useful for subsequent clinical trials.  Under this task the
Contractor shall:

     a.   Develop and/or validate rapid, specific, sensitive and field-
       appropriate diagnostics for subclinical infection and specific
       clinical manifestations;
     b.   Develop and/or validate sensitive and specific case definitions
       of protection (e.g. reduction of parasitemia, reduction of
       pathologic complications, reduction of transmission)  appropriate
       for the conduct of field trials in endemic areas, and identify
       relevant confounders.

4.   Conduct a coordinated, multi-disciplinary, investigation of
malaria pathogenesis and immunity within the context of the local
epidemiologic conditions.  Under this task, the Contractor shall
address one or more of the following topics:

     a.   Characterize host, parasite and vector factors, including
       genetic factors, associated with  adverse clinical outcomes;
     b.   Characterize the role of infection intensity and parasite
       transmission patterns (e.g. seasonality, inoculation rate, etc.) in
       development of severe disease as well as protective immunity;
     c.   Characterize the relevance of the type and magnitude of human
       immune response in pathogenesis and resistance;

Selection of projects to perform under this task will be subject to the
approval of the Project Officer.

d.   Identify and/or validate surrogate markers for protection and
pathology;
e.   Characterize the role of other host-related factors (e.g.
behavioral, nutritional) in transmission and pathogenesis.

(NOTE 3 TO OFFEROR: The offeror must submit a complete description
of the specific aims to be addressed, experimental approach, and the
methods to be utilized for analyzing the resulting data.  It is
anticipated that this research component shall comprise
approximately 40% of the effort under the contract.)

5.   Develop and implement mechanisms to facilitate linkage and
coordination with other contract field sites, such as electronic
computer-based networks, organization of joint workshops, and travel
of scientists between sites, for purposes of developing
collaborative protocols and compatible data management systems,
providing peer review of proposed protocols, facilitating
information exchange and transferring technology. The Contractor
shall attend an initial planning meeting to ensure compatibility of
clinical trial design and data management systems, as well as to
develop an ongoing system for internal review of research ideas,
concepts and proposals.  In addition, the Contractor shall attend
annual meetings with NIAID Program Staff in Bethesda, MD.

(NOTE 4 TO OFFEROR: The offeror should anticipate participating in
the annual meeting of the NIAID International Centers for Tropical
Disease Research meeting.  For purposes of developing a cost
proposal, the offeror should include travel for the P.I. and other
appropriate personnel to attend one four-day meeting per year, and
an additional three-day planning meeting in the first year, to be
held in the Bethesda, MD, area.)

6.   Provide relevant research experience and training  for local
and U.S. scientists and physicians in order to will strengthen the
capacity of the site to perform clinical trials.  Specifically, the
contractor shall:

     a.   Within the scope of activities described in (1) - (4) above,
       provide training in malaria surveillance and research, including but
       not limited to entomological and parasitological surveillance,
       diagnosis, laboratory technical training, and graduate or post-
       graduate research training, to local scientists;
     b.   Provide training in clinical trial methodology, management and
       support, including but not limited to trial design and methodology,
       data management, good laboratory practice, and good clinical
       practice, to local physicians and scientists;

 (NOTE 5 TO OFFEROR: Although it is likely that some of the
specified training activities will ultimately be developed jointly
among the several field sites to be established under these
contracts, for purposes of developing a cost proposal the offeror
should detail how training opportunities will be provided within
his/her own program, and how these are reflected in the cost
proposal.)

     c.  Within the scope of activities described in (1) - (4)
      above, provide opportunities for U.S. graduate and medical
      students to obtain short-term (< 3 months) training
      experiences in tropical disease research.
     
7.   Provide research reagents to the NIAID Malaria Research and
Reference Reagent Repository (Malaria Reagent Repository) and to
other researchers collaborating in comparative studies.  Under this
task the Contractor shall:

     a.   Collect clinical materials from patients with different
       manifestations of P. falciparum infection (e.g. asymptomatic
       parasitemic, symptomatic parasitemic, severe and complicated
       malaria), as well as uninfected individuals residing in the same
       locations, including but not limited to leukocytes, sera/plasma, and
       parasite samples;  the number of samples to be collected will be
       determined on an annual basis by the Project Officer, but will be no
       less than 200 serum and leukocyte samples;
     b.   Collect specimens of local vector mosquitoes;
     c.   Following approval of the Project Officer, arrange for these
       samples to be shipped under conditions appropriate to maintenance of
       viability/stability to the U.S.-based NIAID Malaria Reagent
       Repository and to collaborators within the network;
     d.   Provide any information that has been obtained regarding the
       characterization of these reagents (e.g. clinical status of donor,
       genetic characteristics of cells, antibody content of sera/plasma,
       drug resistance or genetic characteristics of parasites) to the
       NIAID Malaria Reagent Repository or collaborators within the
       network.

(NOTE 6 TO OFFEROR:  The offeror should submit a plan for collection, on
an annual basis, of 200 serum and leukocyte samples from malaria patients,
comprised of those exhibiting a range of clinical syndromes including
severe malaria. In addition, finger-prick filter paper blood samples from
approximately 1000 individuals should be collected on an annual
basis from malaria patients for submission to the repository.
Minimum characterization required for these samples would include
clinical history, physical findings, and appropriate laboratory
results (both positive and negative).  It is anticipated that these
patients will be followed longitudinally over the period of this
award, where possible.)

8.   Coordinate the preparation of all manuscripts and presentations
involving data from the project, for publication in a timely manner.
All publications shall acknowledge NIAID support and be submitted to
the Project Officer for review, prior to publication.  The Project
Officer shall have access to all data generated with the support of
this contract.

(GENERAL NOTES TO OFFEROR:  Some activities carried out under this
award may be governed by HHS Regulations for the Protection of Human
Subjects in Research, Title 45 Code of Federal Regulations Part 46
(45 CFR 46).  These regulations require awardees to establish
procedures for the protection of subjects involved in any research
activities.  Prior to funding and upon request of the Office for
Protection from Research Risks (OPRR), prospective awardees must
file an Assurance of Compliance with OPRR and establish or identify
an Institutional Review Board (IRB) to review and approve the
procedures for carrying out any research activities occurring in
conjunction with this award.  A formal request for the required
Assurance will be issued by OPRR at an appropriate point in the
review process, and examples of required materials will be supplied
at that time.  However, applicants may wish to contact OPRR (301-496-
7041) to obtain preliminary guidance on human subjects issues.

For contracts dealing with clinical research, it is the policy of
the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a
clear and compelling rationale and justification is provided that
inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-
43)

All investigators proposing research involving human subjects should
read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research", which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH
Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994.
This note applies to Part B as well as to Part A.)

BACKGROUND - PART B

The capacity to evaluate new and improved vaccine candidates or
other interventions in an efficient and expeditious manner is an
essential element of the NIAID Research Plan for Malaria Vaccine
Development.   As recommended at the International Conference on
Malaria in Africa  (Dakar, Senegal, 1997), "efficacy trials of
malaria vaccines will require the identification and
characterization of a number of field sites suitable for evaluating
the expected number of vaccine candidates".

The actual number of vaccines or other prevention/intervention
methods developed during the period of this award that will require
further evaluation under field conditions is difficult to
anticipate.  It is likely that these will include methods to prevent
infection, decrease disease and/or reduce transmission of parasites.
Under Part A of these contracts, patient contacts will be made and
laboratory/clinical infrastructure will be developed that will be
useful for clinical trials.   When the need arises,  these sites
will be utilized to conduct safety, immunogenicity and/or efficacy
trials in populations where malaria is endemic.  The mechanism to be
used is a priced Option to this contract.  The tasks to be performed
within the Optional Contract Activities will be consistent with the
Work Statement below.

 The offeror must provide appropriate clinical populations, staff,
expertise, and facilities to test the full range and number of
candidate vaccines developed by industry and government/academic
scientists.   It is anticipated that the offeror may need to
coordinate his/her response with other clinical sites and
laboratories in which access to populations or demonstrated
technical ability would complement the abilities and populations
available to the primary contractor.

WORK STATEMENT - PART B

Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
material, equipment, and facilities not otherwise provided by the
Government as needed to perform the work described below.

1.   Provide facilities and staff necessary to conduct safety,
immunogenicity and efficacy trials of prophylactic and therapeutic
vaccines or drugs in human volunteers living in regions where
malaria is endemic.

2.   Provide patients from appropriate populations as required to
conduct Phase I, II and/or III clinical evaluation of prophylactic
or therapeutic methodologies.   The target population for many of
these studies will be children 1 to 6 years of age, although all
vaccines/drugs will be tested at a minimum for safety in adults
prior to extending evaluation to include children.

(NOTE 1 TO OFFEROR:  Any prophylactic or therapeutic method to be
tested at the NIAID field sites will first have undergone safety
testing on human volunteers within the U.S.  It is anticipated that
such initial testing will be conducted at the Vaccine and Treatment
Evaluation Units supported by NIAID or at similar sites provided by
other collaborators. )

3.   Determine safety,  reactogenicity, immunogenicity, optimal dose
and schedule, as specified by the Project Officer depending on the
prophylactic or therapeutic method being assessed. Conduct
appropriate assays to determine volunteer eligibility, baseline
parameters upon entry into the study, and response to treatment.
Collect sera, and other body fluids or blood cells, from study
participants, and arrange for appropriate storage or shipment as
directed by the Project Officer.  Amounts and types of samples to be
collected will depend on the study protocol. For prophylactic
agents, the follow-up period required for assessment of efficacy
under conditions of natural re-exposure  to parasites is expected to
vary according to the epidemiologic characteristics of the region,
but should be no less than 6 months.

(NOTE 2 TO OFFEROR:  It is anticipated that most trials to be
conducted under this option will involve assessment of candidate
vaccines for safety and immunogenicity.  Small scale efficacy trials
may also be required at individual field sites.  In the case that
more extensive efficacy trials are called for, it is likely that
multiple NIAID field sites will be required to carry out the trial
under a common protocol, as directed by the Project Officer.
Vaccine types will include, but are not limited to,  those based on
single or multiple epitopes from pre-erythrocytic, erythrocytic or
sexual stages of the parasite, or combinations thereof.   In
addition, it is possible that the safety and efficacy of  immuno- or
chemotherapies may be evaluated.   For immunologic assays to be
performed by the contractor, antigen or antibody reagents will be
made available by the Government.  Wherever relevant or appropriate,
assays shall be conducted in a standardized manner, and in
cooperation and collaboration with other Government-supported
laboratories as directed by the Project Officer.)

(NOTE 3 TO THE OFFEROR:   In order to demonstrate that the Offeror
understands the approach to, and has the capacity to undertake
clinical evaluation of a malaria vaccine, the Offeror must submit a
sample protocol for safety and immunogenicity testing of a vaccine
based on the MSP-1 antigen from blood-stage P. falciparum parasites
in an alum formulation, involving a minimum of  50 subjects,
followed by efficacy evaluation in a minimum of 500 subjects.   This
shall include a "Vaccine Evaluation Plan" describing detailed
strategies, with appropriate justification, for:

1)   Development of the clinical trial design, including but not
  limited to, determination of the required sample size for efficacy
  testing based on current knowledge of re-infection rates in the
  population, choice of clinical endpoints, and compliance with
  regulations for protection of human subjects;
2)   Recruitment, enrollment and randomization of subjects,
  including exclusion criteria;
3)   Drug treatment prior to immunization;
4)   Assessment of safety and immunogenicity, assuming an
  immunization protocol involving three intramuscular injections given
  at times 0, 1 and 4 months, including plans for data management and
  reporting of any adverse reactions to NIAID, as well as protocols
  for immunologic assays to be performed;
5)   Follow-up for assessment of safety and efficacy upon natural re-
  exposure to the parasite;
6)   Analysis of the resulting efficacy data (i.e. an analytic
  plan).

This "Vaccine Evaluation Plan" is required for evaluation of the
offeror's technical approach, and a budget for this Plan should be
included in the cost proposal.  Any clinical trials ultimately
carried out under Part B will be planned and executed as directed by
the Project Officer.)

4.   Prepare detailed protocols, consent forms, etc. for submission
to the Project Officer and  Institutional Review Boards at relevant
U.S. and foreign institutions for approval and for NIAID to submit
to the FDA as part of an Investigational New Drug (IND) package.
Amend as necessary after comments by the Project Officer, local IRB,
and regulatory authorities. Final protocols shall, at a minimum,
include the following sections: an introduction, including
background and rationale; a statement of the study objectives;
criteria for selection of subjects, and enrollment procedures;
clinical and laboratory evaluations to be performed; plans for data
management, collection, and monitoring, and for reporting of adverse
events;  a complete description of the study treatment;  and
statistical considerations, including general design issues,
endpoints, sample size, accrual and power, monitoring and analysis,
stopping rules.

5.   Manage the information generated, including transmission,
storage, maintenance of confidentiality, retrieval, validation, and
analysis.  Report all adverse reactions to the DMID Clinical and
Regulatory Affairs Branch, the NIAID Medical Officer, and the
Project Officer.

6.   Attend and support regularly scheduled meetings of a Data and
Safety Monitoring Board (DSMB), as well as investigator meetings to
be held for purposes of  protocol and study development and/or
evaluation.

(NOTE 4 TO OFFEROR:  For planning purposes, assume semi-annual
meetings of the DSMB, which will involve 10 persons and will take
place in the Bethesda, MD, area.   In addition, assume an average of
two investigator meetings/year to rotate between the field site and
the Bethesda, MD area.  Travel costs for the Principal Investigator,
essential co-investigators and appropriate external advisors should
be included in the business proposal.)

7.   Coordinate the preparation of all manuscripts and presentations
involving data from the project, for publication in a timely manner.
All publications shall acknowledge NIAID support and be submitted to
the Project Officer for review and clearance, prior to publication.
The Project Officer shall have access to all data generated with the
support of this contract.

(GENERAL NOTES TO OFFEROR: Only when the need arises will the
Government invoke the Optional Activities in Part B.  Because the
actual protocol design or number of subjects to be enrolled in the
Optional contract Activities of Part B is not known at this time,
the "Vaccine Evaluation Plan" is presented for evaluation of the
offeror's technical approach.  The business proposal for Part B
should comprise costs for the administration, conduct and reporting
of the "Vaccine Evaluation Plan", including meetings described in
(6).  As negotiations progress for Part B, alternative and
additional Options may be presented to the offeror for response,
e.g. the costs required to enroll a different number of subjects or
to test a different type of prophylactic or therapeutic method.

The business proposal should present TOTAL COSTS including: 1) FIXED
COSTS to include effort in trial design, meeting costs, data
analysis costs, technical and financial reporting costs; 2) VARIABLE
COSTS to include costs related to the actual conduct of the clinical
trial.  These costs should include related effort, patient treatment
costs, materials and supplies, and assays.)

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ATTACHMENT A.2

SAFETY CONTROLS AND STANDARDS

A.   In order to provide safety controls for protection to the life
and health of employees and other persons; for prevention of damage
to all property; and for avoidance of work interruptions in the
performance of the contract; the Contractor and any subcontractors
shall comply with the following standards or subsequent issues, and
any supplements.  In addition, the Contractor shall comply with all
applicable Federal, state and local laws, codes, ordinances and
regulations, including obtaining of all required licenses and
permits in connection with biological and hazardous materials.

         (1)   Biosafety in Microbiological and Biomedical
Laboratories, U.S. Department of Health and Human Services, Centers
for Disease Control (CDC) and the NIH, HHS Pub. No. (CDC) 93-8395.

         (2)   NIH Guidelines for the Laboratory Use of Chemical
Carcinogens, NIH Publication No. 81-2385.

         (3)   Occupational Safety and Health Administration (OSHA)
Publications: (I) 29 CFR Part 1910.1030, Occupational Exposure to
Blood Borne Pathogens; Final Rule; and (ii) 29 CFR Part 1910,
Occupational Exposure in Laboratories; Final Rule.

     The above, 1 and 2, may be obtained from:

          Division of Safety
          Office of Research Services
          National Institutes of Health
          Building 31 - Room 1C02
          Bethesda, Maryland  20892

OSHA Publications listed above (item 3) may be obtained by
contacting US Government Publication Office at (202) 783-3238.

B.   The contractor, or subcontractor, shall identify any particular
safety standards that are not referenced above as applicable to a
particular reagent, and after approval by the Project Officer,
communicate that information to the recipient of the reagent.

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RFP-NIH-NIAID-DMID-98-19

ATTACHMENT B   (10/23/97)

DELIVERABLES AND REPORTING REQUIREMENTS
-----------------------------------------

The Contractor shall submit to the Contracting Officer and to the
Project Officer technical progress reports covering the work
accomplished during each reporting period.  These reports are
subject to the technical inspection and requests for clarification
by the Project Officer.  These shall be brief and factual and
prepared in accordance with the following format:

A.   Technical Reports - Part A

     In addition to those reports required by SECTION I and other
     terms of this contract, the Contractor shall prepare and submit
     the following reports in the manner stated below:

          (1)  Semi-Annual Technical Progress Reports - by the
          fifteenth working day of the month following the end
          of each six month period, the Contractor shall submit
          (3) copies of a semi-annual Technical Progress
          Report, comprising two (2) copies to the Project
          Officer and one (1) copy to the Contracting Officer.
          Such reports shall include the following specific
          information:

                    a.   A cover page that lists the contract number
               and title, the period of performance being reported,
               the contractor's names and address, the author(s),
               and the date of submission;

                    b.   SECTION I - An introduction covering the
               purpose and scope of the contract effort;

                    c.   SECTION II - A description of overall
               progress plus a separate description for each task or
               other logical segment of work on which effort was
               expended during the report period.  The description
               shall include pertinent data and/or graphs in
               sufficient detail to explain any significant results
               achieved and preliminary conclusions resulting from
               analysis and scientific evaluation of data
               accumulated to date under the project;

                    d.   SECTION III - Substantive performance; a
               description of current technical or substantive
               performance and any problems encountered and/or which
               may exist along with proposed corrective action.
               Each clinical study should be reported separately
               according to the number assigned by the Project
               Officer.  An explanation of any difference between
               planned progress and actual progress, why the
               differences have occurred, and if behind planned
               progress what corrective steps are planned.

                    e.   An anticipated work plan for the
               following six months.

                    f.   A table reporting the numbers of women and
               minority subjects enrolled in each clinical trial.

        American   Asian or   Black,   Hispanic  White,    Other    Total
        Indian     Pacific    not of             not of      or
        or         Islander   Hispanic           Hispanic  Unknown
        Alaskan               origin             origin
        Native                                  
        
Female

Male

TOTAL                                                     

                    g.   Preprints, reprints, and abstracts shall be
               submitted along with the report.

     Semi-annual Technical Progress Reports are not due for
     periods in which an annual or final report is due.

          (2)  Annual Reports - On the anniversary date of the
          contract, the Contractor shall submit four (4) copies of
          an Annual Technical Progress Report, as above, comprising
          three (3) copies to the Project Officer and one (1) copy
          to the Contracting Officer.  Such reports shall detail,
          document, and summarize the results of the entire contract
          work for the period covered.  These reports shall be in
          sufficient detail to explain comprehensively the results
          achieved.  Also to be included in the report is a summary
          of work proposed for the next reporting period.  Specific
          requirements are set forth in the Work Statement.  A one
          page summary of each ongoing and completed protocol shall
          be submitted at this time.  An annual report will not be
          required for the period when the final report is due.
          Preprints and reprints of papers and abstracts not
          submitted in the semi-annual report shall be submitted.

          (3)  Final Report - By the expiration date of the
          contract, the Contractor shall submit four (4) copies of a
          comprehensive Final Report, as above, comprising three (3)
          copies to the Project Officer and one (1) copy to the
          Contracting Officer.  This final report shall detail,
          document and summarize the results of the entire contract
          work for the period covered.  This report shall be in
          sufficient detail to explain comprehensively the results
          achieved.  Specific requirements are set forth in the Work
          Statement.  Preprints and reprints not included previously
          submitted shall be submitted.

          (4)  Summary of Salient Results - With the annual/final
          reports the Contractor shall submit a summary (not to
          exceed 200 words) of salient results achieved during the
          performance of the contract.

          (5)  Other Reports - The Contractor shall submit seven (7)
          copies of: a) a one page summary of each ongoing and
          completed protocol one year and thirty days after an
          individual IND goes into effect and b) yearly IRB
          approvals and supporting documents.

B.   Technical Reports - Part B

     When the Government exercises the Optional Contract Activities
     in Part B, Technical Progress reports shall be due on a
     quarterly basis.  In addition to the schedule described above,
     the Contractor shall submit two (2) copies of the quarterly
     progress report to the Project Officer and one (1) copy to the
     Contracting Officer.

C.   If the Contractor becomes unable to deliver the reports
     specified hereunder within the period of performance because of
     unforeseen difficulties, notwithstanding the exercise of good
     faith and diligent efforts in performance of the work, the
     Contractor shall give the Contracting Officer immediate written
     notice of anticipated delays with reasons, therefore.

D.   Technical Report Distribution

     Copies of the technical reports shall be submitted as follows:
     
     Type of        No.    Addressee                      Due Dates
     report        Copies
     Semi-Annual     3     Project Officer                Semi-
     Progress                                             Annually
                                                          (Specific
                                                          dates will
                                                          be listed
                                                          in the
                                                          contract
                                                          document)

     Semi-Annual     1     Contracting Officer            Same as
     Progress              CMB/NIAID/NIH                  above
                           Solar Building, Room 3C07
                           6003 Executive Blvd. MSC 7610
                           Bethesda, MD 20892-7610

     Annual          3     Same as P.O. above             Annually
                                                          (Specific
                                                          dates will
                                                          be listed
                                                          in the
                                                          contract
                                                          document)

     Annual          1     Same as C.O. above             Same as
                                                          above
     Final           3     Same as P.O. above             Expiration
                                                          date
     Final           1     Same as C.O. above             Same as
                                                          above
     
E.   Other Deliverables.  The Contractor, subject to approval of the
     Contracting Officer, shall deliver to the Government, or its designee,
     research reagents as specified under Article 7 of the Work Statement.

********************************************************************

RFP-NIH-NIAID-DMID-98-19

ATTACHMENT C  (10/23/97)

PROPOSAL EVALUATION CRITERIA
----------------------------

                                  
1.   GENERAL

     Proposals submitted in response to this solicitation will be
     subjected to review by an ad hoc technical review committee.
     The evaluation will be based on the demonstrated capabilities
     of the prospective contractors in relation to the needs of the
     project as set forth in the RFP.  The merit of each proposal
     will be evaluated carefully, based on responsiveness to the RFP
     and thoroughness and feasibility of the technical approach
     taken.  Offerors must submit information sufficient to evaluate
     their proposal based on the detailed criteria listed below.
     Failure to provide the information required to evaluate the
     proposal may result in rejection of that proposal without
     further consideration.  While high competency is sought,
     capabilities that exceed those needed for successful
     performance of the contract work statement are not required.
     
2.   COMPARATIVE IMPORTANCE OF PROPOSALS
     
     Selection of an offeror for contract award will be based on an
     evaluation of proposals against two factors.  The factors in
     order of importance are technical merit and cost.  Although
     technical factors are of paramount consideration in the award
     of the contract, cost is also important to the overall contract
     award decision.  Technical merit is significantly more
     important than cost.  Costs for Part A will be more important
     than Part B costs to the selection decision.

     Offerors are advised that award will be made to that offeror
     whose proposal provides the best overall value to the
     Government.

     Site diversity is also a factor in the decision.
     Program staff intends to establish a geographically balanced
     program using this RFP. This is a multiple award RFP, and the
     government will consider possible overlap and under-
     representation in making the award decision.

3.   PROPOSAL EVALUATION CRITERIA

     Proposals submitted in response to this RFP will be evaluated
     based on the following factors which are listed and weighted in
     order of their relative importance.  Proposals will be judged
     solely on the written material provided by the offeror.  Part A
     and Part B will be evaluated separately.  In order to be
     eligible for a contract award, both Part A and Part B must be
     determined to be acceptable.  Following evaluation of both Part
     A and Part B, a final score for each proposal will be
     calculated by weighting as follows:  75% Part A and 25% Part B.
     

TECHNICAL EVALUATION CRITERIA - PART A

1.   Technical Approach   (80 Points)

The technical adequacy and feasibility of the proposed plans for
establishment of  multidisciplinary field sites for clinical and
field-based research on malaria, including:

     a)   Documented adequacy and feasibility of the proposed methods and
       approaches  for epidemiologic studies, development and validation of
       case definitions and diagnostics, training, and collection of
       reagents for the NIAID repository.  (40 Points)
     b)   Documented adequacy and suitability of  the field sites with
       regard to establishment of appropriate collaborative arrangements
       with local government and scientists, access to appropriate human
       populations in areas of substantial malaria morbidity and
       predictable  parasite transmission, access to requisite academic,
       laboratory and clinical facilities; plans for communications linkage
       between collaborators and other network members.   (20 points)
     c)   Documented adequacy and suitability of the methods and
       approaches proposed for the integrated research component on malaria
       pathogenesis and immunity.  (20 Points)

2.   Personnel and Experience

Documented adequacy and relevance of the expertise, experience,
education, and availability of the Principal Investigator, co-
investigators and staff for conducting all aspects of the Work
Statement, including expertise in conducting clinical research on
malaria.  (20 Points)

TOTAL     100 Points

TECHNICAL EVALUATION CRITERIA - PART B

1.   Technical Approach   (80 Points)

The technical adequacy and feasibility of the proposed plans for
conducting safety, immunogenicity and efficacy trials of vaccines or
drugs against malaria, including:

     a)   Documented technical adequacy and feasibility of the methods
       and approaches proposed in the "Vaccine Evaluation Plan",
       appropriateness of the consent forms and plans for fulfilling
       regulatory requirements, appropriateness and feasibility of proposed
       methods and approaches for  determining vaccine immunogenicity,
       adequacy and feasibility of plans for handling and interpreting data,
       and appropriateness of the overall plan for managment of this
       clinical research effort. (50 Points)
     b)   Adequacy, suitability and availability of the necessary
       populations, including demonstrated ability to recruit, retain and
       follow-up patients. (30 Points)

2.   Personnel and Experience

Documented adequacy and relevance of the expertise, experience,
education, and availability of the Principal Investigator, co-
investigators and staff for conducting all aspects of the Work
Statement, including expertise in infectious diseases, pediatrics, and
clinical trials.  (20 Points)

TOTAL     100 Points

********************************************************************

RFP-NIH-NIAID-DMID-98-19

ATTACHMENT D  (10/23/97)

SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
----------------------------------------

NOTICE TO OFFERORS:  This attachment contains proposal instructions
and information which are specifically related to this acquisition.
The information provided below is only a portion of the instructions
and notices required for the submission of a proposal.  References
to additional, more general information, and forms regarding
proposal preparation are contained in Attachment E, "Applicable RFP
References."

-------------------------------------------------------

1.   NUMBER AND TYPE OF AWARD(S)  (NIH 2980) (APR 1984)

It is anticipated that three (3)to five (5) awards will be made from
this solicitation and that the awards will be made on/about
September 25, 1998.

It is anticipated that the award from this solicitation will be a
cost reimbursement completion type contract with a 5 year
performance period, and that incremental funding will be used [see
paragraph (6) of Business Proposal Instructions, in the "Standard
RFP Instructions and Provisions" of the Gopher RFP]

2.   ESTIMATE OF EFFORT

It is expected that a completion type contract will be awarded as
a result of this RFP.  To assist you in the preparation of your
proposal, the Government considers the effort to be approximately
11,750%.  This estimate is furnished for the offeror's information
only and is not to be considered restrictive for proposal purposes.
As further assistance, it is estimated that the above total labor
effort is constituted as follows:

                           Labor Percentages
Labor
Category                 Annual Effort      Total

Principal Investigator        50%            250%
Research Associates         1000%           5000%
Field Workers & Nurses      1300%           6500%
   Total                    2350%          11750%

These percentages are based on a 12 month calendar year.

3.   SERVICE OF PROTEST (AUG 1996) - FAR 52.233-2

(1)  Protests, as defined in section 33.101 of the Federal
Acquisition Regulation, that are filed directly with an agency, and
copies of any protests that are filed with the General Accounting
Office (GAO), shall be served on the Contracting Officer (addressed
as follows) by obtaining written and dated acknowledgment of receipt
from:

Hand-Carried Address:

Carl R. Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

Mailing address (U.S.) Postal Service

Carl R. Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE:  All material sent to this office by Federal Express should be
sent to the Hand Carried Address.

(2)  The copy of any protest shall be received in the office
designated above within one day of filing a protest with the GAO.

4.  PACKAGING AND DELIVERY OF THE PROPOSAL  (NIH 2995) (JUL 1994)

Your proposal shall be organized as specified in Section C.1.,
"Standard RFP Instructions and Provisions".  Shipment and marking
shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as
follows:

          "RFP NO. NIH-NIAID-DMID-98-19
           TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"
--------------------------------------------------------------------

NUMBER OF COPIES

The number of copies required of each part of your proposal are as
specified below.

TECHNICAL PROPOSAL:  ORIGINAL AND 19 COPIES

BUSINESS PROPOSAL:   ORIGINAL AND 5 COPIES

NOTE:  THE ORIGINAL PROPOSAL MUST BE READILY ACCESSIBLE FOR DATE
STAMPING.
--------------------------------------------------------------------
--------------------------------------------------------------------

COPIES TO:

If hand-delivered or delivery service

Carl R. Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, MD 20852

If using U.S. Postal Service

Carl R. Henn
Contract Management Branch
DEA, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610

NOTE:  All material sent to this office by Federal Express should be
sent to the Hand Carried Address.

NOTE:     The U.S. Postal Service's "Express Mail" does not deliver
to the Rockville, Maryland address.  Any package sent to the
Rockville address via this service will be held at a local post
office for pick-up.  THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING
UP ANY MAIL AT A LOCAL POST OFFICE.  If a proposal is not received
at the place, date, and time specified herein, it will be considered
a "late proposal," in accordance with PHSAR 352.215-10,  Late
Proposals, Modifications of Proposals and Withdrawals of Proposals
(NOV 1986).

5.   TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT-ORGANIZATION OF THE
TECHNICAL PROPOSAL

PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR
TECHNICAL PROPOSAL.  THIS WILL AID IN THE REVIEW OF THE PROPOSALS
RECEIVED.

TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT

       (NOTE: INSTRUCTIONS TO OFFERORS ARE INDICATED IN PARENTHESES
        OR AS FOOTNOTES.)
                                                             PAGE
                                                            NUMBERS

1.  TECHNICAL PROPOSAL COVER SHEET (Format in Section C
     of Gopher RFP: FORMS, FORMAT & ATTACHMENTS)...............1

2.  TECHNICAL PROPOSAL TABLE OF CONTENTS ..................... 2

3.  SUMMARY OF OBJECTIVES AND METHODS (Abstract)* ............ 3

4.  TECHNICAL PLAN** (Refer to Technical Proposal Instructions,
    located in the Gopher RFP, STANDARD RFP INSTRUCTIONS AND
    PROVISIONS, for more details)

     a.  STATEMENT OF WORK
         1. Objectives ........................................ 4-
         2. Approach .......................................... ___
         3. Methods ........................................... ___
         4. Schedule .......................................... ___

     b.  PERSONNEL (List by name, title, department and
         organization, and detail each person's qualifications
         and role in the Project; provide narrative for:
         1. Principal Investigator/Project Director ........... ___
         2. Other Investigators ............................... ___
         3. Additional Personnel e.g. technical support/
            subcontractors/consultants) ....................... ___
          [Note: For personnel, include 2 page biosketch/resume
          and the form entitled "Summary of Current and Proposed
          Activities" under Items 5. and 6. below.]

     c.  FACILITIES/RESOURCES AND DIRECT COSTS (list/describe all
         equipment, facilities and other resources available for
         this project; attach "Technical Proposal Cost Information"
         form, and marked laboratory/clinical space floor plan in
         Item 6. below)........................................ ___

     d.  OTHER CONSIDERATIONS (provide brief narrative of any
         unique arrangements, safety procedures in place, animal
         welfare issues, human subject and minority and gender
         issues, etc.) ........................................ ___

5.  APPENDICES (protocols, literature citations,
    resumes/biosketches, policy manuals, etc. for above Technical
    Plan); list each Appendix; Appendices must be clear and
    legible, and easily located ............................... ___

6.  OTHER ATTACHMENTS:

    a. "Summary of Current and Proposed Activities" (All Key
       Personnel must be listed on this form; it is located in
       the FORMS, FORMATS, ATTACHMENTS subdirectory found in
       the Gopher RFP)......................................... ___

    b. "Technical Proposal Cost Information" form (located in
       the Gopher RFP, FORMS, FORMATS, & ATTACHMENTS).......... ___

    c. Laboratory and Clinical Facility Design and Floor Plan
      (clearly indicate the space available for this Project).. ___

7.
*  State the proposal's broad, long-term objectives and specific
aims.  Describe concisely the research design and methods for
achieving these goals.

** Section 4 should be presented once for Part A and a second time
for Part B.  This will provide a clear distinction between the two
parts and will facilitate the review process.

Sections 4.a. through 4.d. above MUST NOT EXCEED 100 PAGES (This
does not include copies of resumes and any required forms, but only
the NARRATIVE description of the Technical Plan). This limit applies
to the combined page count for Section 4 narrative for both Part A
and Part B.  The front side of a page equals one page (front and
back of a page equals two pages). Type density and size must be 10
to 12 points.  If constant spacing is used, there should be no more
than 15 cpi, whereas proportional spacing should provide an average
of no more than 15 cpi.  There must be no more than six lines of
text within a vertical inch.

-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-

6.  PROPOSAL INTENT RESPONSE SHEET

RFP No.  NIH-NIAID-DMID-98-19

MALARIA: Clinical Research and Trial Preparation Sites in Endemic
Areas

Please review the attached Request for Proposals.  Furnish the
information requested below and return this page by December 22,
1997.  Your expression of intent is not binding but will greatly
assist us in planning for proposal evaluation.

===============================================

[  ]  DO INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING:

RFP No.  NIH-NIAID-DMID-98-19
MALARIA: Clinical Research and Trial Preparation Sites in Endemic Areas

[  ]  DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:

____________________________________________________________________

COMPANY/INSTITUTION NAME:  _________________________________________
ADDRESS:
_________________________________________
_________________________________________
_________________________________________
_________________________________________

PROJECT DIRECTOR'S NAME:
_________________________________________
TITLE:
_________________________________________
SIGNATURE:
_________________________________________
(Date)
TELEPHONE NUMBER AND E-MAIL ADDRESS:
_________________________________________

NAMES OF COLLABORATING INSTITUTIONS AND INVESTIGATORS (include
Subcontractors and Consultants):
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________

(Continue list on reverse if necessary)

===============================================
RETURN TO:

CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, MD 20892-7610
Attn: Carl Henn
      RFP-NIH-NIAID-DMID-98-19

<End form (Proposal Intent)>
_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-_-

7.   SIC CODE AND SIZE STANDARD

Note: The following information is to be used by the offeror in
preparing its Representations and Certifications (see Section C.4 of
the Gopher RFP), specifically in completing the provision entitled,
SMALL BUSINESS PROGRAM REPRESENTATIONS (JAN 1997), FAR 52.219-1:

     The standard industrial classification (SIC) code for this
acquisition is 8733.  The small business size standard is $5.0
million.

     THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS.  However,
the Federal Acquisition Regulation (FAR) requires in every
solicitation, (except for foreign acquisitions) the inclusion of the
Standard Industrial Classification (SIC) Code and corresponding size
standard which best describes the nature of the requirement in the
solicitation.

8.   GOVERNMENT NOTICE FOR HANDLING PROPOSALS

AN OFFEROR SHALL PLACE THIS NOTICE ON TOP OF EACH COPY OF ITS
TECHNICAL PROPOSAL.

This proposal shall be used and disclosed for evaluation purposes
only, and a copy of this Government notice shall be applied to any
reproduction or abstract thereof.  Any authorized restrictive
notices which the submitter places on this proposal shall also be
strictly complied with.  Disclosure of this proposal outside the
Government for evaluation purposes shall be made only to the extent
authorized by, and in accordance with, the procedures in HHSAR
paragraph 315.608-72.

(For information regarding authorized restrictive notices, offerors
should refer to the "Confidentiality of Proposals" section of the
STANDARD RFP INSTRUCTIONS AND PROVISIONS subdirectory of the RFP
REFERENCES directory of the Gopher RFP.).

RFP-NIH-NIAID-DMID-98-19

ATTACHMENT E

APPLICABLE RFP REFERENCES
-------------------------

This section identifies the items found in the Gopher directory
entitled RFP REFERENCES that are applicable to this RFP.

1.  The entire file entitled "STANDARD RFP INSTRUCTIONS AND
PROVISIONS" is applicable to this RFP, except as otherwise may be
modified by the inclusion of an item from the "OPTIONAL RFP
INSTRUCTIONS AND PROVISIONS".

2.  The following items are applicable from the file entitled
"OPTIONAL RFP INSTRUCTIONS AND PROVISIONS":

    a.   LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS
OF PROPOSALS, PHS 352.215-10

    b.   HUMAN SUBJECTS NOTICE TO OFFERORS OF REQUIREMENTS OF 45 CFR
PART 46, Protection of Human Subjects (SEPTEMBER 1985)

    c .  CARE OF LIVE VERTEBRATE ANIMALS

    d.  SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS
SUBCONTRACTING PLAN (does not apply to small business or to work
performed in foreign countries)

    Note: A Subcontracting Plan is not due with the initial
proposal.  The Contracting Officer will notify offerors if a plan
becomes due.

    e.  PAST PERFORMANCE INFORMATION

    f.  FACILITIES CAPITAL COST OF MONEY (for commercial
organizations)

               
3.   The following items/files are applicable from the subdirectory
entitled "FORMS, FORMATS, AND ATTACHMENTS":

     Applicable to Technical Proposal

     a.  Technical Proposal Cover Sheet

     b.  Technical Proposal Cost Information, Dec. 1988

     c.  Summary of Current and Proposed Activities, July 1995

     d.  Technical Proposal Table of Contents, July 1995

     Applicable to Business Proposal

     e.  Contract Pricing Proposal, SF 1411, (Rev. 10/95)

     f.  Proposal Summary and Data Record, NIH-2043 (Rev. 9/96)

     g.  Business Proposal Cost Information

     h.  Disclosure of Lobbying Activities, OMB Form SF-LLL, Dec.
1989

     To Become Contract Attachments

     i.  Invoice/Financing Requests Instructions for NIH
Cost-Reimbursement Type Contracts, NIH(RC)-1, May1997.

     j.  Procurement of Certain Equipment, NIH(RC)-7 (OMB Bulletin
81-16), Apr. 1984.

     k.  Form NIH 2706 (Financial Report) and Instructions for
Completing Form NIH 2706

     Note:  Financial reports are not always required.  This will be
discussed during negotiations.

     l.  Protection of Human Subjects Assurance
Identification/Certification/Declaration, Optional Form 310,
(Rev. 1/95).

     Other-to be submitted as directed by Contracting Officer

     m.  Certificate of Current Cost or Pricing Data, NIH-1397.

     n.  Subcontracting Plan Format

4.   The Representations And Certifications are applicable.

5.   The "Sample Contract Format-General" is applicable.

<End of List of Applicable RFP References>