RFP No. NIH-NIAID-DMID-96-13

Title:  "VACCINE PRODUCTION FACILITY"

Issued by:    Cyndie Cotter  
              Contracting Officer
              NIH/NIAID
              Contract Management Branch
              Solar Building, Room 3C07
              6003 Executive Boulevard MSC 7610
              Bethesda, Maryland 20892-7610

DATE ISSUED:  NOVEMBER 29, 1995

PROPOSAL DATE DUE:   JANUARY 19, 1996,  4:30 P.M. (EST)

Ladies and Gentlemen:

You are invited to submit a proposal in accordance with the
requirements of this RFP (NIH-NIAID-DMID-96-13) for a "Vaccine
Production Facility."  The Government contemplates the award of one
(1), five (5) year, cost-reimbursement, completion-type contract as
a result of this RFP.

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

I.   Streamlined RFP

     a.  Introduction and Work Statement (Parts A and B), dated     
         November 29, 1995 (Attachment 1)    

     b.  Deliverables and Reporting Requirements, dated November    
         29, 1995 (Attachment 2)
  
     c.  Evaluation Factors for Award, dated November 29, 1995      
         (Attachment 3)

II.  Specific RFP Instructions and Provisions, dated November 29,   
     1995 (Attachment 4).

III. Applicable RFP References, dated November 29, 1995 (Attachment 
     5)
    
In addition to the information listed above, a listing of the
applicable Government clauses/provisions, sample contract format,
and terms and conditions which will be incorporated into the
eventual contract document may be obtained either through
accessing the NIH Gopher system or by sending a request to Cyndie
Cotter, Contracting Officer, using the internet electronic mail
listed below.

The attachments 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 intended to comprise the competitive range.  

NOTE:  The Representations and Certifications must be submitted
with the offeror's proposal (this form can be found in this RFP
Gopher under the REPRESENTATIONS AND CERTIFICATIONS subdirectory
found in C. RFP REFERENCES).

DUE TO THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES'
CURRENT BUDGET RESTRICTIONS, IT IS RECOMMENDED THAT ANY PROPOSED
ANNUAL INCREASE IN COSTS FOR INFLATION BE LIMITED TO NO MORE THAN
4% OF TOTAL COSTS PER YEAR WHICH IS ALSO THE MAXIMUM CURRENTLY
ALLOWED BY THE NIH FOR RESEARCH PROJECTS.

The original and twenty (20) 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 19, 1995,
at 4:30 p.m. local time at the address listed in Attachment 4, Item
5.  

You are reminded that the "Technical Proposal Cover Sheet" must
be completed in full detail and used as the cover sheet for each
copy of your technical proposal (a copy of this form is contained
in the NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS
subdirectory found in C. RFP REFERENCES).  New policies require
submission of more detailed information than has been previously
required.  It is important that you list all professional personnel
and organizations named in the proposal who have any role in the
proposed work, including: staff of the primary organization
(offeror), subcontractors, collaborating organizations, and
consultants.  Organizational affiliation(s) must be indicated for
every person named.  You may use additional sheets, as needed,
following the format shown in the Technical Proposal Cover Sheet.
This information will be used to ensure that there will be no
conflict of interest when selecting review committee members.

Your attention is further directed to the "Proposal Intent" form
contained in Attachment 4, item 11.  Please complete this form and
return it to this office on or before December 19, 1995.  This will
allow us to expedite preparations for the peer review of proposals.

PLEASE NOTE THAT ATTACHMENT 4, ITEM 10. PROVIDES GUIDELINES FOR
TECHNICAL PROPOSAL PAGE LIMITATIONS AND TABLE OF CONTENTS.

Funds are not presently available for this requirement.  The
Government's obligation under a resulting contract is contingent
upon availability of appropriated funds from which payment for
contract purposes can be made.

Please note that in addition to telephone and fax numbers, the
INTERNET addresses of both the Principal Investigator and the
responsible business representative are to be included on the Form
NIH-2043, "Proposal Summary and Data Record," contained in the NIH
Gopher under the FORMS, FORMATS, AND ATTACHMENTS subdirectory found
in C. RFP REFERENCES.

If you have any additional questions regarding this RFP, please
contact Cyndie Cotter at the internet electronic mail address
cc41w@nih.gov, by phone at 301/402-0641, or by fax at 301/402-0972.  Collect calls will NOT be accepted.

Sincerely,

\s\


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

Attachments:  1 - 5
              

*****************************************************************
*****************************************************************
RFP-NIH-NIAID-DMID-96-13

I.  STREAMLINED RFP
-------------------


ATTACHMENT  1
11/29/95

INTRODUCTION
------------
Building on its broad research base, the development and testing of
new vaccines and therapies has historically been a major focus of
the research supported by the National Institute of Allergy and
Infectious Diseases (NIAID) in the Division of Microbiology and
Infectious Diseases (DMID). Through its network of Vaccine and
Treatment Evaluation Units (VTEUs), the Division has supported the
development and clinical testing (Phase I and Phase II testing) of
a wide variety of vaccines including those designed to protect
against pertussis, influenza, hepatitis, meningitis, pneumonia
(e.g. Hib, pneumococcal, RSV), diarrhea (e.g. cholera and
rotavirus), typhoid fever, and malaria, among others.  Since many
of the candidate vaccines used in such trials have been developed
by vaccine companies, the capacity to develop a wide range of
candidate vaccines that are not currently under development will
enhance the ability of DMID to better fulfill its mission.  In its
initial effort to catalyze this process, in 1991, DMID awarded its
first vaccine production contract to DynCorp/Program Resources,
Inc. (N01-AI-15129) to develop and produce pilot lots of vaccines
appropriate for Phase I and Phase II testing in human volunteers. 
WITH THE COMPLETION OF THIS INITIAL FIVE YEAR CONTRACT IN 1996,
THIS REQUEST FOR PROPOSAL (RFP) REPRESENTS A RECOMPETITION OF THE
VACCINE PRODUCTION CONTRACT AND DMID'S RENEWED COMMITMENT TO THIS
ENDEAVOR.  

The principle objective of this contract is to accelerate the
development of new and improved vaccines of public health
importance by providing appropriate expertise and equipment at a
facility capable of process development and pilot lot production of
candidate vaccines.  Where appropriate, this contract will also
include safety testing, characterization, purity and potency
testing, filling, labeling, storing and shipping of a broad range
of vaccine candidates and vaccine-related products.  It is
anticipated that these products may include bacterial, viral,
fungal, and parasitic preparations (or subfractions thereof) and
may consist of, but will not be limited to: polysaccharides,
nucleic acids, lipoproteins, purified proteins and/or synthetic
peptides (either linear or variations of branched multiple antigen
preparations) intended for evaluation in humans as experimental
vaccines in Phase I, II and/or Phase III clinical trials.  The
preparation of challenge lots of bacteria and viruses for
preclinical and clinical testing of candidate vaccines may also be
supported under this contract.

This contract consists of two work statements, described in detail
below.  The principle thrust of this contract (work statement Part
A) is to produce pilot lots of promising vaccine candidates and/or
vaccine-related materials, such as challenge lots of virus or
bacteria for Phase I and Phase II vaccine trials, and to support a
repository for serum specimens generated during DMID-supported
clinical trials.  

A secondary goal of this contract (work statement Part B), will
provide for the process development and pilot lot production of
vaccines or vaccine-related products for use in large Phase II
and/or Phase III clinical vaccine trials (i.e. produced under
current Good Manufacturing Practices (cGMP) standards).  This
OPTION will require additional funding support and will be invoked
by the Government if an appropriate candidate vaccine of high
public health priority, but not under commercial development, is
identified.

All proposals will be evaluated on Part A and Part B separately. 
Award and exercise of the Optional Contract Activities (Part B) is
solely at the discretion of the Government and will be based on
need and the availability of funds during the five year period of
performance.

Offerors submitting a proposal under this solicitation must prepare
a proposal which includes both the required work outlined in Part A
and the Optional Contract Activities identified in Part B. 
PROPOSALS FOR PART A ALONE OR FOR PART B ALONE SHALL NOT BE
ACCEPTED FOR REVIEW OR CONSIDERED FOR AWARD UNDER THIS
SOLICITATION.

It is anticipated that one contract will be awarded.  Given the
breadth and specialization required in the Work Statements, and in
order to assemble the strongest proposal possible, the Contractor
is encouraged to establish subcontracts (when appropriate) with
other facilities and/or institutions as necessary, in order to
produce and deliver required materials in an expeditious and cost-
effective manner.

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

PART A - PILOT LOT PRODUCTION
-----------------------------

BACKGROUND - PART A
-------------------
While advances in immunology and molecular biology continue to
offer an ever-expanding array of approaches towards the development
of new candidate vaccines, the limited national capacity to move
promising concepts through the development process--from the
research bench to pilot lot production to scale-up--presents a
substantial barrier to the full achievement of this potential.  

Toward this end, this contract provides the capability for pilot
lot production of promising vaccine candidates and vaccine-related
materials, such as challenge lots of bacteria and viruses,
appropriate for Phase I and Phase II testing in human volunteers. 
In addition, this contract will also fulfill DMID's need for a
central facility to systematically receive, label, store, track and
transport clinical specimens, such as serum, generated in DMID-
supported clinical trials.


WORK STATEMENT - PART A 
------------------------------------------------------------
Independently, and not as an agent of the Government, the
Contractor shall furnish all the necessary services, qualified
personnel, materials, equipment, facilities and methods, not
otherwise provided by the Government under the terms of this
contract as needed to perform the work set forth below.  

      [NOTE TO OFFEROR:  
       A.  While it is the intent of this "Request for Proposal"    
           (RFP) to award a single contract, because the tasks      
           outlined in the Work Statement may require capabilities, 
           expertise, and/or facilities that are beyond the scope   
           of a single Contractor, it is anticipated that           
           subcontracts may be proposed.  Letters of agreement and  
           pertinent information regarding the subcontractor's      
           experience, expertise, personnel, and facilities should  
           be included in the Offeror's proposal.]

Specifically, the Contractor shall:

1.  Develop, produce, characterize, test (safety, sterility,
purity, potency, immunogenicity and other appropriate tests),
formulate (including adjuvanting), vial, label, store and ship
pilot lots of vaccines and vaccine-related products.  These
products shall be prepared in facilities and by methods that meet
FDA standards for vaccines appropriate for Phase I and Phase II
human clinical trials as described in the Code of Federal
Regulations, Title 21, Chapter I, Parts 58, 210 & 211, and 600-640
[April 1994] and the Guidelines on Sterile Drug Products Produced
by Aseptic Processing [June 1987]. 

At the direction of the Project Officer, prepare or acquire
approximately 10 pilot lots of vaccine and/or vaccine-related
products per year.  These products shall be provided to the Project
Officer, or to recipients specified by the Project Officer, for use
in Phase I or Phase II human clinical trials.  The types of
vaccines and related products will be specified by the Project
Officer and may include, but are not restricted to, vaccines
against influenza viruses, parainfluenza viruses, rotaviruses,
respiratory syncytial viruses, rhinoviruses, Group B Streptococcus,
cholera, gonococcus, pneumococcus, Salmonella, meningococcus,
Cryptococcus, and malaria.  Seed strains will be provided by the
Project Officer, as appropriate.

      [NOTES TO OFFEROR:
       B.  The vaccine approaches and vaccine-related materials     
           that may be requested to be produced during the course   
           of this contract may include:
           i)   Conjugated polysaccharide vaccines.  Example: Group 
                B Streptococcus (type II) polysaccharide-protein    
                conjugate vaccine.
           ii)  Subunit vaccines. Example: Purified rotavirus       
                vaccine expressed in a baculovirus system. 
           iii) Inactivated viral vaccine.  Example: Formalin-      
                inactivated Rhesus rotavirus vaccine.  
           iv)  Live attenuated viral vaccines produced in tissue   
                culture.  Example: Cold-adapted type A (H3N2)       
                influenza virus vaccine.   
           v)   Challenge lots: live virus and/or live bacteria.    
                Example: challenge lots of Vibrio cholerae,         
                influenza, RSV, parainfluenza, or rotavirus.

       C.  For evaluation and costing purposes, the offeror should  
           provide sample production protocols, time lines and cost 
           estimates, including proposed procedures for safety,     
           sterility, purity and immunogenicity testing,            
           purification, characterization, formulation, filling,    
           labeling, storing; final container testing; other        
           appropriate tests; and shipping for each of the          
           following vaccine candidates.  Each of the sample        
           protocols should include thorough discussions of the     
           potential problems that might arise at each stage of the 
           project, and how these problems will be overcome.

           1)  VIRAL CHALLENGE LOT.  Provide detailed description   
               of production of 1000 doses of 10 to the 4.7th power 
               pfu/ml titer Respiratory Syncytial Virus (RSV) for   
               challenge testing in the ferret model of RSV         
               infection.   Assume production requirements of 2     
               lots per year.

               Assume that the Project Officer will provide a seed  
               strain (isolated and passaged in AGMK cells, a       
               single clone selected and purified after             
               amplification in MRC5 cells and 3 serial passages in 
               Vero cells).  

               In addition to descriptions of safety testing, virus 
               characterization, purity and potency testing,        
               filling, labeling, storing and shipping, the         
               description should include the production of the     
               live virus pool, animal safety tests for             
               adventitious agents and Mycobacterium tuberculosis.

           2)  BACTERIAL VACCINE PRODUCTION

               a.  VIBRIO CHOLERAE: Provide a detailed description  
                   of production of a 10 liter batch for testing in 
                   humans as a frozen preparation containing 10 to  
                 the 9th power/ml viable V. cholerae.  Assume       
                 production requirement of two (2) lots per year.

                   Assume that the Project officer will provide a   
                   frozen master seed culture.  Describe how you    
                   would prepare, by fermentation, a 10 liter batch 
                   of Vibrio cholerae by fermentation to be used in 
                   Phase I/II clinical studies.  Optimize           
                   fermentation parameters in order to obtain       
                   maximum yield of viable organisms, to be         
                   harvested in the late logarithmic phase of the   
                   growth curve. Describe how you would produce,    
                   harvest, wash, quantify, and characterize the    
                   final product.  Describe stabilization, filling, 
                   labeling, and storage operations you would       
                   employ to produce the product as frozen cells in 
                   cryovials each vial to contain 2 ml of 10 to the 
                   9th power/ml viable V. cholerae.

               b.  Purification of cholera toxin to produce one     
                   thousand (1,000) 50 ug doses.  Assume production 
                   requirement of two (2) lots per year.

                   Using the same strain of V. cholerae and         
                   fermentation conditions described above          
                   (C.2)a.), provide description for processing the 
                   cell paste obtained from a 10 liter fermentation 
                   to purify the toxin as a subunit vaccine         
                   candidate suitable for Phase I/II clinical       
                   trials.  Describe methods for purification and   
                   detoxification of the protein, characterization  
                   and quantification of the product, and fill and  
                   label the vials to provide one thousand (1,000)  
                   50 ug doses.

               c.  Purification of lipopolysaccharide antigen.      
                   Assume production needs of one (1) lot per year.

                   Using the same strain of V. cholerae and         
                   fermentation conditions described above          
                   (C.(2)a), provide a detailed description of how  
                   you would process the cell paste obtained from a 
                   10 liter fermentation to purify the O-antigen    
                   lipopolysaccharide so that it could be           
                   detoxified and conjugated for use as a cholera   
                   vaccine in Phase I/II clinical trials.  Describe 
                   how you would purify, characterize and quantify  
                   the product, and fill and label the vials to     
                   provide one thousand (1,000) 50 ug doses of a    
                   lyophilate product.  

           3)  SYNTHETIC PEPTIDE VACCINE.  Assume production needs  
               of one (1) lot per year.

               Produce 100 mg of a well-characterized, alum-        
               adsorbed, thirty amino acid peptide appropriate for  
               a vaccine to be used in Phase I and Phase II human   
               clinical trials filled in 50 ug/dose vials.

               Describe how you would characterize the peptide,     
               adsorb to alum, fill and label 50 ug per dose vials. 
               For purposes of this example, assume no sequence-    
               specific problems or unusual amino acids.  

       D.  Award of a contract does not commit the Government       
           to approve the protocols outlined in the proposal.       
           The Project Officer will determine which studies are     
           actually undertaken.]

2.  Provide appropriate and qualified staff with documented
expertise and experience to accomplish the tasks outlined in item
1. above, as well as access to required equipment and facilities.

      [NOTES TO OFFEROR:
       E.  To fulfill the requirements of this contract, a well-    
           trained team consisting of a Principal Investigator,     
           research scientists, and technicians is required.  In    
           aggregate, the team should be experienced in vaccine     
           development and pilot lot production, including          
           filling, labeling, storing and shipping of vaccines      
           suitable for testing in human clinical trials.  The      
           team should have composite expertise in, but not         
           limited to, the following vaccine-related technologies:  
           fermentation (including 500 liter fermenters),           
           lyophilization, tissue culture systems, purification     
           (protein and carbohydrate), bacterial or viral           
           expression systems, and synthetic peptides as potential  
           vaccine candidates.  A two-page biosketch of each        
           proposed professional and technical personnel,           
           including those of proposed subcontractors, should be    
           included in the proposal, as well as an organizational   
           plan for coordinating the work of the contract. 

       F.  Documentation of available equipment and appropriate     
           certification of the facilities, including those of      
           proposed subcontractors, should be included in the       
           proposal to fulfill the requirements of this work        
           statement.  This should include documentation of         
           access to an AALAC, or equivalent facility and the       
           capacity for testing the safety and immunogenicity       
           of manufactured products.]  

3.  Provide final vaccine protocols appropriate for submission to
the CBER, FDA for Investigational New Drug Application.

      [NOTE TO OFFEROR:  
       G.  Provide one sample vaccine protocol, either for a        
           vaccine in Work Statement 1.C, or for another, in a      
           format appropriate for submission to the FDA for IND.]

4.  Receive, store, ship and track clinical specimens (primarily
serum) generated from clinical trials of vaccines and vaccine-
related products supported by DMID, including preparation of
appropriate certification.    

      [NOTE TO OFFEROR:
       H.  For purposes of evaluation, describe plans, facilities,  
           equipment, procedures, and budget for:

           a) receiving and storage, at -70 C, serum specimens. (It 
              is estimated that approximately 2,000 serum           
              specimens, 2 ml each, will be received per year.) 

           b) shipping serum specimens. (During the course of this  
              contract, it is estimated that approximately ten (10) 
              shipments of serum specimens (200 specimens/shipment, 
              2 ml each) will be performed.  Eight (8) shipments    
              within the United States and two (2) shipments to     
              Europe.)]

5.  Prepare a transition plan for transfer of all products,
documentation and samples to a new contractor or storage site at
the end of the contract period.

6.  Attend and participate in two 2-day meetings per year in
Rockville, Maryland to discuss results and future plans, and/or
review regulatory issues related to vaccine production.

      [NOTE TO OFFEROR: 
       I.  Travel, lodging and meal costs for the Principal         
           Investigator and one other staff member should be        
           included in the business proposal.  The Project Officer  
           will determine the schedule and need for attending       
           meetings related to contract activities.] 

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

PART B:  OPTIONAL CONTRACT ACTIVITIES - cGMP PRODUCTION OF PILOT
LOTS OF VACCINES FOR LARGE PHASE II AND/OR PHASE III TESTING AND
CHALLENGE LOTS OF VIRUS AND/OR BACTERIA APPROPRIATE FOR TESTING IN
HUMANS.

BACKGROUND - PART B, OPTIONAL CONTRACT ACTIVITIES
-------------------------------------------------
During the course of the contract the Contractor may be required to
procure or provide a) scale-up and pilot lot production of vaccines
or vaccine-related products in current Good Manufacturing Practices
(cGMP) facilities for large phase II and/or Phase III clinical
vaccine trials and/or b) challenge lots of virus and/or bacteria
appropriate for testing in humans.  This option will be invoked by
the Government if an appropriate candidate vaccine, which is of
high public health priority but does not meet industrial
priorities, is identified, and assumes that additional funding
support and lead time will be available.  While the award and
exercise of this Optional Contract Activities (Part B) is solely at
the discretion of the Government and will be based on need and the
availability of funds during the five year period of performance,
Offerors submitting a proposal under this solicitation must prepare
a proposal which includes both the required work outlined in Part A
AND the Optional Contract Activities outlined in Part B.  Proposals
for Part A alone or for Part B alone shall not be accepted for
review or considered for award under this solicitation.  All
proposals will be evaluated on Part A and Part B separately.  


WORK STATEMENT - PART B, OPTIONAL CONTRACT ACTIVITIES
-----------------------------------------------------
Independently, and not as an agent of the Government, the
Contractor shall furnish all the necessary services, qualified
personnel, materials, equipment, facilities and methods, not
otherwise provided by the Government under the terms of this
contract as needed to perform the work set forth below.  

Specifically, the Contractor shall:

1.  Produce and/or procure up to 50,000 doses of candidate vaccines
(include characterization, testing [safety, sterility, purity,
potency, immunogenicity and other appropriate tests], formulation
[including adjuvanting], vialing, labeling, storing and shipping)
for viral, bacterial, parasitic or fungal diseases for clinical
evaluation in Phase II or Phase III trials. These products shall be
prepared in cGMP facilities and by methods that meet FDA standards
for vaccines appropriate for human clinical trials as described in
the Code of Federal Regulations, Title 21, Chapter I, Parts 58, 210
& 211, and 600-640 [April 1994] and the Guidelines on Sterile Drug
Products Produced by Aseptic Processing [June 1987]. 

     [NOTE TO OFFEROR:
      A.  For the purposes of evaluation, the offeror should        
          demonstrate understanding of the approach and document    
          capacity for production and scale-up under cGMP.          
          Therefore, a detailed description of the differences in   
          approach, preparation, production, and quality control    
          and costs of the manufacture under cGMP (including        
          safety, sterility, purity and potency, and immunogenicity 
          testing), time lines and potential pitfalls (and their    
          resolution) should be submitted for the following         
          vaccine:  

             A cholera toxin subunit vaccine, as described in Part  
             A.[C(2)b] above, in a cGMP facility appropriate for    
             clinical trials in humans.  Produce 50,000 doses each  
             containing 50 ug of lyophilized product appropriate    
             for phase III trials.]  

2.  Produce and/or procure (including characterization, testing
[safety, sterility, purity, potency, immunogenicity and other
appropriate tests], formulation [including adjuvanting], vialing,
labeling, storing and shipping) 1,000 doses of a viral or bacterial
challenge lot appropriate for use in clinical trials in humans. 
These products shall be prepared in cGMP facilities and by methods
that meet FDA standards appropriate for human clinical trials as
described in the Code of Federal Regulations, Title 21, Chapter I,
Parts 58, 210 & 211, and 600-640 [April 1994] and the Guidelines on
Sterile Drug Products Produced by Aseptic Processing [June 1987]. 

     [NOTES TO OFFEROR:
      B.  For the purposes of evaluation, the offeror should        
          demonstrate understanding of the approach for production  
          of live organisms under cGMP for human challenge studies. 
          Therefore, a detailed description of the differences in   
          approach, preparation, production, and quality control    
          and costs of the manufacture under cGMP (including        
          safety, sterility, purity and potency, and immunogenicity 
          testing), time lines and potential pitfalls (and their    
          resolution) should be submitted for the following         
          vaccines:  

          An RSV challenge lot in cGMP facility appropriate for     
          clinical trials in humans.  Produce one thousand          
          (1,000) doses of 10 to the 4.7th power pfu/ml titer RSV   
          for challenge testing in human clinical trials.  

          In contrast to RSV challenge lots prepared in Work        
          Statement - Part A of this contract (above) intended for  
          use in animal models, a viral challenge that may be used  
          in human clinical trials will require preparation and     
          production under cGMP conditions.  Therefore, describe    
          the differences in approach required for cGMP             
          preparation, production, immunogenicity and safety        
          testing and cost of producing one thousand (1000) doses   
          (10 to the 4.7th power pfu/dose) of an RSV challenge      
          appropriate for experiments in human subjects. 

      C.  Award of a contract does not commit the Government to     
          approve the protocols outlined in the proposal.  The      
          Project Officer will determine which pilot lot production 
          projects are actually undertaken.]

3.  Provide appropriate and qualified staff with documented
expertise and experience to accomplish the tasks outlined above,
specifically under cGMP, as well as access to required equipment
and facilities.

     [NOTES TO OFFEROR:
      D.  To fulfill the requirements of this contract, a well      
          trained team consisting of a Principal Investigator,      
          research scientists, technicians, and appropriate         
          Quality Assurance/Control personnel is required.  Any     
          differences in staffing from Work Statement - Part A      
          should be described and justified.  A two-page biosketch  
          of each additional proposed professional and technical    
          personnel, including those of proposed subcontractors,    
          should be included in the proposal. 

      E.  Documentation of available equipment and appropriate      
          certification as a GMP facility, including those of       
          proposed subcontractors should be included in the         
          proposal to fulfill the requirements of this work         
          statement (see Attachment 3, item 3. MANDATORY            
          QUALIFICATIONS FOR FACILITIES).  This should also         
          include documentation of access to an AALAC, or           
          equivalent animal facility and the capacity for testing   
          the safety and immunogenicity of manufactured products.] 

4.  Provide final vaccine protocol appropriate for submission to
the CBER, FDA for Investigational New Drug Application.  

5.  Attend and participate in two 2 day meetings per year in
Rockville, Maryland to discuss results and future plans, and/or
review regulatory issues related to vaccine production.

     [NOTE TO OFFEROR:
      F.  Travel, lodging and meal costs for the Principal          
          Investigator and one other staff member should be         
          included in the business proposal.  The Project Officer   
          will determine the schedule and need for attending        
          meetings related to contract activities.] 
            

*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DMID-96-13

ATTACHMENT  2
11/29/95

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

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

A.    TECHNICAL REPORTS

      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)   Monthly Reports - by the first day of every month,
            the Contractor shall submit to the Project Officer
            seven (7) copies of a monthly report detailing
            project activities and inventory and shipping
            records.  

      (2)   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 eight (8) copies of a semi-annual Technical
            Progress Report, comprising seven (7) 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 project
                  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 subsequent six
                  months.
            
            f.    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.

      (3)   Annual Reports - On the anniversary date of the contract,
            the Contractor shall submit eight (8) copies of an Annual
            Technical Progress Report, as above, comprising seven (7)
            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, if any, are set forth in
            ARTICLE C.1., 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.  

      (4)   Final Report - By the expiration date of the contract,
            the Contractor shall submit eight (8) copies of a
            comprehensive Final Report, as above, comprising seven
            (7) 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.  Additional specific requirements are set forth
            in ARTICLE C.1.  Preprints and reprints not included
            previously shall be submitted.  

      (5)   Summary of Salient Results - With the Final Report the
            Contractor shall submit a summary (not to exceed 200
            words) of salient results achieved during the performance
            of the contract.

      (6)   Final Manufacturing and Safety Tests Protocols - The
            Contractor shall submit seven (7) copies of completed
            protocols to the Project Officer appropriate for
            submission to CBER, FDA in support of Investigational New
            Drug applications, at the end of each project, regardless
            of the calendar date of completion.  

B.    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.

C.    Technical Report Distribution 
 
      Copies of the technical reports shall be submitted as follows:
      
      Type of    No. of 
      Report     Copies   Addresses                Due Dates        
                              
     Monthly        7     Project Officer          *Monthly 
     Semi-Annual    7     DMID, NIAID, NIH         *Semi-Annually
     Annual         7     Solar Bldg.              *Annually
     Final          7     6003 Exec. Blvd, MSC 7630 Completion date
                          Bethesda, MD 20892-7630 

     Semi-Annual    1     Contracting Officer      *Semi-Annually
     Annual         1     CMB, DEA, NIAID, NIH     *Annually
     Final          1     Solar Bldg., Rm. 3C07     Completion date
                          6003 Exec. Blvd, MSC 7610
                          Bethesda, MD 20892-7610

     Final Manuf.   7     Chief, Clinical and         At end of 
     & Safety Test        Regulatory Affairs Branch   each project
     Protocols            DMID/NIAID
                          Solar Building, Rm. 3A01
                          6003 Executive Blvd, MSC 7610
                          Bethesda, MD  20892-7610


         * specific dates will be listed in the contract document


******************************************************************
*******************************************************************
RFP-NIH-NIAID-DMID-96-13

ATTACHMENT  3
11/29/95

EVALUATION FACTORS FOR AWARD
----------------------------              

1.    GENERAL

      The technical proposal will receive paramount consideration   
      in the selection of the contractor for this acquisition. 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 proposals 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 requested.

2.    COMPARATIVE IMPORTANCE OF PROPOSALS

      You are advised that paramount consideration shall be given   
      to the evaluation of the technical proposals, but not to the  
      exclusion of cost considerations.  In the event that the      
      technical evaluation reveals that two or more offerors are    
      approximately equal in technical ability, then the estimated  
      cost of performance will become paramount.  In any event, the 
      Government reserves the right to make an award to the best    
      advantage of the Government, cost and other factors           
      considered.

3.    MANDATORY QUALIFICATIONS FOR FACILITIES

      Listed below are mandatory qualification criteria.  The       
      mandatory qualification criteria establish conditions that    
      MUST be met at the time of receipt of Best and Final Offers   
      (BAFO) by the Contracting Officer in order for your proposal  
      to be considered any further for award.

      o  The offeror must provide documentation that they meet the  
         requirements listed in the Code of Federal Regulations     
         (Number 21, April 1, 1994) for an establishment engaged in 
         the preparation of vaccines licensed for human use by the  
         Center for Biologics Evaluation and Research (CBER). 

      Please note that while it is expected that facilities used    
      and procedures followed in Part A (Phase I and II trials)     
      will approach, if not achieve cGMP standards, this will be    
      REQUIRED for products produced under Part B of this contract  
      (vaccines for large Phase II and Phase III clinical trials    
      and bacterial and/or viral challenge lots appropriate for     
      human clinical trials).  Therefore, the Offeror may be        
      subject to inspections under the "Good Laboratory Practices   
      Act" and "Good Manufacturing Practices Act".
      
4.    TECHNICAL EVALUATION CRITERIA (for Part A and Part B)

      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 technically acceptable.  FOLLOWING        
      EVALUATION OF BOTH PART A AND PART B, A FINAL SCORE FOR EACH  
      TECHNICAL PROPOSAL WILL BE CALCULATED BY WEIGHTING AS         
      FOLLOWS:  80% PART A AND 20% PART B.

      PART A
      ------

      CRITERION ELEMENT                                      WEIGHT
      -----------------                                      ------

      1.  TECHNICAL APPROACH                                   60

          Documented adequacy of the technical approach for         
          preparing experimental vaccines and vaccine-related       
          products, as  requested in the Work Statement.  
          Soundness of the sample protocols, including the 
          adequacy of discussion of problems likely to occur 
          and plans for addressing them.   

      2.  PERSONNEL                                            30

          Documented expertise and proficiency of the Principal     
          Investigator, professional and technical staff in         
          development and pilot lot production, including           
          appropriate testing, according to standards set forth 
          in the Code of Federal Regulations, of vaccines for 
          use in human clinical trials, and in preparing final      
          protocols to be submitted to the CBER, FDA for            
          Investigational New Drug review.   (20 points)

          Demonstration of coordination of the various 
          components of the contract and distribution of senior     
          investigators and technicians time for the performance 
          of various phases of work described in the Work           
          Statement.  (10 points)

      3.  FACILITIES AND RESOURCES                             10

          Adequacy and availability of the facilities and 
          resources to accomplish the work described in 
          the Work Statement.
                                                             -----  
                                     TOTAL                    100

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

      PART B
      ------

      CRITERION ELEMENT                                      WEIGHT
      -----------------                                      ------ 
 
      1.   TECHNICAL APPROACH                                  60

           Documented adequacy of the technical approach for        
           preparing experimental vaccines and vaccine-related      
           products under cGMP as requested in the Work 
           Statement.  Soundness of the sample protocols, 
           including the adequacy of discussion of problems 
           likely to occur and plans for addressing them.   

      2.  PERSONNEL                                            30   
                                             
          Documented expertise and proficiency of the 
          Principal Investigator, professional and technical 
          staff in development and production, including            
          appropriate testing, according to standards set 
          forth in the Code of Federal Regulations, of 
          vaccines for use in human clinical trials, and in         
          preparing final protocols to be submitted to the CBER,    
          FDA for Investigational New Drug review.  (20 points)
      
          Demonstration of coordination of the various 
          components of the contract and distribution of senior     
          investigators and technicians time for the 
          performance of various phases of work described in 
          the Work Statement.  (10 points)

      3.  FACILITIES AND RESOURCES                             10

          Adequacy and availability of the facilities and 
          resources to accomplish the work described in 
          the Work Statement.
                                                            ------
                                 TOTAL                        100
 
5.    EVALUATION OF OPTIONS

      It is anticipated that any contract(s) awarded from this      
      solicitation will contain option provision(s) and period(s).

      In accordance with FAR Clause 52.217-5, Evaluation of Options 
      (July 1990), the Government will evaluate offers for award    
      purposes by adding the total price for all options to the     
      total price for the basic requirement, except when it is      
      determined in accordance with FAR 17.206(b) not to be in the  
      Government's best interests.  Evaluation of options will not  
      obligate the Government to exercise the option(s).

*******************************************************************
*******************************************************************
  RFP-NIH-NIAID-DMID-96-13

  ATTACHMENT 4
  11/29/95

II.  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 5,
"Applicable RFP References."

  1.  SIC CODE AND SMALL BUSINESS SIZE STANDARD
      (NIH 3150) (JUN 1988)
    
      Note:  The following information is to be used by the offeror 
      in preparing its Representations and Certifications (see      
      Attachment 5, item 4. of this RFP), specifically in           
      completing the provision entitled, SMALL BUSINESS PROGRAM     
      REPRESENTATIONS (OCT 1995), FAR 52.219-1:

      (a)  The standard industrial classification (SIC) code for    
           this acquisition is 8731.

      (b) (1)  The small business size standard is 500 employees.

          (2)  The small business size standard for a concern which
               submits an offer in its own name, other than on a
               construction or service contract, but which proposes
               to furnish a product which it did not itself
               manufacture, is 500 employees.

      (c)  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.

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

      It is anticipated that one (1) award will be made from this
      solicitation and that award will be made on or about 
      September 30, 1996.

      It is anticipated that the award from this solicitation will
      be multiple-year cost reimbursement type completion contract  
      with a period of performance of 5 years, 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].

  3.  ESTIMATE OF EFFORT  (NIH 2985) (APR 1984)

      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    
      total effort to perform this contract to be approximately     
      2,000% for Part A and 600% for Part B (Option).  This number  
      is furnished for your 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:

                              PART A
                        Percentages of Effort
 Labor                                                        5 YR
 Category                   Yr1    Yr2    Yr3    Yr4    Yr5  :TOTAL
 --------                  -----  -----  -----  -----  ----- :-----
Prin. Investigator           25%    25%    25%    25%    25% : 125%
Other Prof. (Inv. + QA/QC)   75%    75%    75%    75%    75% : 375%
Technicians (Lab + Animal)  275%   275%   275%   275%   275% :1375%
Administrative               25%    25%    25%    25%    25% : 125%
                           -----  -----  -----  -----  ----- :-----
     TOTAL                  400%   400%   400%   400%   400% :2000%


                              PART B
                        Percentages of Effort
 Labor                                                        5 YR
 Category                    Yr1   Yr2    Yr3    Yr4    Yr5  :TOTAL
 --------                   ----- -----  -----  -----  ----- :-----
Prin. Investigator            10%   10%    10%    10%    10% :  50%
Other Prof. (Inv. + QA/QC)    10%   10%    10%    10%    10% :  50%
Other Support (Tech + Admin) 100%  100%   100%   100%   100% : 500%
                            -----  ----  -----  -----  ----- :-----
     TOTAL                   120%  120%   120%   120%   120% : 600%

     The above percentages are based on a twelve (12) month effort.

  4.  52.233-2   SERVICE OF PROTEST  (NOV 1988)

      (a)  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) or the General       
           Services Administration Board of Contract Appeals        
           (GSBCA), shall be served on the Contracting Officer      
           (addressed as follows) by obtaining written and dated    
           acknowledgement of receipt from:

           Mr. Lewis Pollack

           Hand-Carried Address:

           NIH/NIAID
           Contract Management Branch
           Solar Building, Room 3C07
           6003 Executive Boulevard
           Rockville, Maryland  20852


           Mailing Address:

           NIH/NIAID
           Contract Management Branch
           Solar Building, Room 3C07
           6003 Executive Boulevard MSC 7610
           Bethesda, Maryland  20892-7610

     (b)  The copy of any protest shall be received in the office
          designated above on the same day a protest is filed with
          the GSBCA or within one day of filing a protest with the
          GAO.

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

      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-96-13"

            "TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"


        Number of Copies:
        ________________

        TECHNICAL PROPOSAL:  ORIGINAL AND 20 COPIES
        BUSINESS PROPOSAL:  ORIGINAL AND 5 COPIES

        If hand delivered or delivery service
        -------------------------------------

              Contract Specialist
              Contract Management Branch
              DEA, NIAID, NIH
              Solar Building, Room 3C07
              6003 Executive Boulevard
              Rockville, Maryland 20852

        
            If using U.S. Postal Service
            ----------------------------

              Contract Specialist
              Contract Management Branch
              DEA, NIAID, NIH
              Solar Building, Room 3C07
              6003 Executive Boulevard MSC 7610
              Bethesda, Maryland 20892-7610


      * THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING
        PURPOSES

    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" and   
    handled in accordance with PHSAR 352.215-10 LATE PROPOSALS,     
    MODIFICATIONS OF PROPOSALS AND WITHDRAWALS OF PROPOSALS (NOV    
    1986).

 6.   PHS 352.223-70  SAFETY AND HEALTH (APRIL 1984)

      (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 will consult, comply with, and  
           include in all applicable subcontracts, the following    
           standards, as appropriate: 

           (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) 88-8395.

           (2)  Recommendations for Prevention of HIV Transmission  
                in Health-Care Settings, Morbidity and Mortality    
                Report, August 21, 1987, Vol. 35, No. 2S.

           (3)  Update:  Universal Precautions for Prevention of    
                Transmission of Human Immunodeficiency Virus,       
                Hepatitis B Virus, and Other Bloodborne Pathogens   
                in Health-Care Settings.  Morbidity and Mortality   
                Weekly Report, June 24, 1988, Vol. 37, No. 24.

           (4)  Agent Summary Statement for Human Immunodeficiency  
                Viruses (HIV); Included are GTLV-III, LAV, HIV-1,   
                and HIV-2.  Morbidity and Mortality Weekly Report,  
                April 1, 1988, Vol. 37, No. S4.

           (5)  Recommendations for the Safe Handling of Parenteral 
                Antineoplastic Drugs, NIH Publication No. 83-2621.

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

           The above, (1) - (6), may be obtained from:

                  Division of Safety
                  Office of Research Services
                  National Institutes of Health
                  Building 31, Room 1CO2
                  Bethesda, Maryland  20892

           (7)  Guidelines for Research Involving Recombinant DNA   
                Molecules (49 FR 46266 or latest revision) and      
                Administrative Practices Supplement.  These may be  
                obtained from:

                  Office of Recombinant DNA Activities
                  Office of Science Policy and Legislation
                  National Institutes of Health
                  Building 31, Room B1C34
                  Bethesda, Maryland  20892

           (8)  Procedures for the Domestic handling and Transport  
                of Diagnostic Specimens and Etiologic Agents,       
                National Committee for Clinical Laboratory          
                Standards, July 17, 1985, Vol. 5.  This may be      
                obtained from

                National Committee for Clinical 
                 Laboratory Standards
                771 East Lancaster Avenue
                Villanova, Pennsylvania  19085

           Further, the Contractor shall take or cause to be taken  
           such additional safety measures as the Contracting       
           Officer may determine to be reasonably necessary;        
           Provided, that if compliance with such additional safety 
           measures results in a material increase in the cost or   
           time of performance of the contract, an equitable        
           adjustment will be made in accordance with the clause of 
           this contract entitled "Changes."

      (b)  Prior to commencement of work, the Contractor will       
           submit in writing its plan for complying with the safety 
           and health provisions of this contract, and will meet    
           with the Contracting Officer or his/her designated       
           representative to discuss and develop a mutual           
           understanding relative to administration of the overall  
           safety program.

      (c)  During the performance of work under this contract, the  
           Contractor shall comply with all procedures prescribed   
           by the Contracting Officer for the control and safety of 
           persons visiting the job site and will comply with such  
           requirements to prevent accidents as may be prescribed   
           by the Contracting Officer.

      (d)  The Contractor will maintain an accurate record of, and  
           report to the Contracting Officer in such manner as the  
           Contracting Officer may prescribe, all accidents and     
           incidents resulting in death, traumatic injury,          
           occupational disease, and/or damage to all property      
           incident to work performed under the contract.

      (e)  The Contracting Officer shall notify (if otherwise,      
           confirm in writing) the Contractor of any noncompliance  
           with the provisions of this clause and corrective action 
           to be taken.  After receipt of such notice, the          
           Contractor shall immediately take such corrective        
           action.  (Such notice, when delivered to the Contractor  
           or its representative at the site of the work, shall be  
           deemed sufficient for the purpose.)  If the Contractor   
           fails or refuses to comply promptly, the Contracting     
           Officer may issue an order stopping all or part of the   
           work until satisfactory corrective action has been       
           taken.  No part of the time lost due to any such stop    
           order shall be the subject of claim for extension of     
           time or for costs or damages by the Contractor.

      (f)  The Contractor shall insert the substance of this clause 
           in each subcontract involving the use of hazardous       
           materials or operations.  Compliance with the provisions 
           of this clause by subcontractors will be the             
           responsibility of the Contractor.

 7.   OPTIONAL CONTRACT ACTIVITIES PROVISION

      (a)  Unless the Government exercises its option pursuant to   
           paragraph (b) of this article, the contract consists     
           only of Work Statement - Part A.  Pursuant to the clause 
           set forth in paragraph (b), below, the Government may,   
           by unilateral contract modification, require the         
           Contractor to perform the optional contract activities   
           described in Work Statement - Part B.  If the Government 
           exercises this option, notice must be given 60 days      
           prior to the effective date of the option period and     
           the estimated cost of the contract will be increased at  
           an amount consistent with the schedule stated in         
           paragraph (b), below.

      (b)  The Government may require the performance of the        
           additional work, identified in the Work Statement - Part 
           B as optional contract activities within the limits and  
           at the estimated costs to be determined during contract  
           negotiations.

 8.   52.227-6   ROYALTY INFORMATION  (APR 1984)

       (a) Cost or charges for royalties.  When the response to     
           this solicitation contains costs or charges for          
           royalties totaling more than $250, the following         
           information shall be included in the response relating   
           to each separate item of royalty or license fee:

           (1) Name and address of licensor.

           (2) Date of license agreement.

           (3) Patent numbers, patent application serial numbers,
               or other basis on which the royalty is payable.

           (4) Brief description, including any part or model
               numbers of each contract item or component on which
               the royalty is payable.

           (5) Percentage or dollar rate of royalty per unit.

           (6) Unit price of contract item.

           (7) Number of units.

           (8) Total dollar amount of royalties.

       (b) Copies of current licenses.  In addition, if             
           specifically requested by the Contracting Officer before 
           execution of the contract, the offeror shall furnish a   
           copy of the current license agreement and an             
           identification of applicable claims of specific patents.

 9.   FACILITIES CAPITAL COST OF MONEY

      (This is applicable if you are a commercial organization)

      Facilities capital cost of money (see FAR 15.904) will be an  
      allowable cost under the contemplated contract, but only if   
      the Contractor specifically identifies or proposes it in the  
      cost proposal for the contract and elects to claim this cost  
      by checking the appropriate box below.  If the contractor     
      does not specifically identify or propose facilities capital  
      cost of money and does not elect to claim this cost, the      
      contract will include the Waiver of Facilities Capital Cost   
      of Money clause.

      _____ The prospective Contractor has specifically identified  
            or proposed facilities capital cost of money in its     
            cost proposal and elects to claim this cost as an       
            allowable cost under the contract.  Submit form CASB-   
            CMF (see FAR 31.205-10).

      _____ The prospective Contractor has not specifically         
            identified or proposed facilities capital cost of money 
            in its proposal and elects not to claim it as an        
            allowable cost under the contract.



10.   TECHNICAL PROPOSAL TABLE OF CONTENTS 

(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,FORMATS,ATTACHMENTS) ................. 1 
2.  Technical Proposal Table of Contents ..................... 2
3.  Abstract *................................................ 3
4.  Technical Plan (Refer to Technical Proposal Instructions,       
     Section C.1., Standard RFP Instructions and Provisions, 
     Gopher RFP)
     a.  Statement of Work
         1. Objectives ...............(Items a.1............... 4-
         2. Approach ...........through a.4 are not............ ___
         3. Methods ...................to exceed............... ___ 
         4. Schedule .................. 100 pages**)........... ___
     b.  Personnel ***,****
         1. List of All Personnel on the Project, including
            Subcontractors, Consultants/Collaborators, by Name,
            Title, Department and Organization ................ ___
         2. Principal Investigator/Project Director ........... ___
         3. Other Investigators ............................... ___
         4. Additional Personnel .............................. ___
     c.  Resources and Environment ............................ ___
     d.  Other Considerations (use specifically titled 
          subparagraphs, as applicable) ....................... ___
5.  Other Support (Refer to "Summary of Current and Proposed        
    Activities in the FORMS, FORMATS, ATTACHMENTS Directory 
    found in Section C, Gopher RFP) ........................... ___
6.  Human Subjects and Minority and Gender Issues Not 
     Otherwise Addressed ..(if applicable)..................... ___
7.  Vertebrate Animals ..(if applicable)....................... ___
8.  Technical Proposal Cost Information (Format in Section C,       
     Gopher RFP, FORMS,FORMATS,& ATTACHMENTS).................. ___
9.  Literature Cited  ......................................... ___
10. Appendices (Appendices, Literature citations, Protocols and 
    4b. through 8. above; list each Appendix.  Appendices must be   
    clear and legible.)

*  State the proposal's broad, long-term objectives and specific
aims.  Describe concisely the research design and methods for
achieving these goals.  DO NOT EXCEED one page in providing the
abstract.  Identify the RFP Number, Institution and Principal
Investigator on the abstract.

** The front side of a page equals one page.  The 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 and average of no more than 15
cpi.  There must be no more than six lines of text within a
vertical inch.  

**** An individual biosketch should not exceed two pages.

<End form (Technical Proposal Table of Contents)>


11.   PROPOSAL INTENT RESPONSE SHEET

                         PROPOSAL INTENT  
                         ---------------
                    
RFP No.:  NIH-NIAID-DMID-96-13

PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL.  FURNISH THE
INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST
PRACTICABLE DATE.  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:
          
          ____________________________________________________
     
          ____________________________________________________     

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

TYPED NAME AND TITLE:   ________________________________________
                    
INSTITUTION:            ________________________________________

SIGNATURE:              ________________________________________   

                    
TELEPHONE NO.:          ________________________________________   

                                 
DATE:                   ________________________________________   

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

 COLLABORATORS/CONSULTANTS - Provide name(s) and institution(s):
          (Continue list on reverse if necessary)
________________________________________________________________

________________________________________________________________

RETURN TO:     CMB, NIAID, NIH
               Solar Building, Room 3C07
               6003 Executive Boulevard MSC 7610
               Bethesda, Maryland 20892-7610
                 Attn: Cyndie Cotter
               RFP NIH-NIAID-DMID-96-13
               Fax # 301/402-0972

PLEASE RETURN BY DECEMBER 19, 1995

<End form (Proposal Intent) / />***********************************************************
*******************************************************************
RFP-NIH-NIAID-DMID-96-13

ATTACHMENT 5
11/29/95


III.  APPLICABLE RFP REFERENCES
-------------------------------

This section identifies the items located in the Gopher directory
"C.  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":

   (1)   LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS 
         OF PROPOSALS, PHS 352.215-10

   (2)   NOTICE TO OFFERORS OF REQUIREMENT FOR ADEQUATE ASSURANCE   
         OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS (SEP 1985),    
         PHSAR 352.280-2(a)

   (3)   SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS            
         SUBCONTRACTING PLAN [NOTE: A Subcontracting Plan is not    
         due with the initial proposal.  The Contracting Officer    
         will notify offerors if a plan becomes due.]


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

    Applicable to Technical Proposal
    --------------------------------
    (1) Technical Proposal Coversheet
    (2) Technical Proposal Cost Information, Dec 1988
    (3) Summary of Current and Proposed Activities, July 1995
      
    Applicable to Business Proposal
    -------------------------------
    (4) Contract Pricing Proposal, SF-1411, July 1987
    (5) Proposal Summary and Data record, NIH-2043 (Rev. 6/82)
    (6) Business Proposal Cost Information
    (7) Disclosure of Lobbying Activities, OMB SF-LLL

    To Become Contract Attachments
    ------------------------------
    (8) Invoice/Financing Requests Instructions for NIH Cost-       
        Reimbursement Type Contracts, NIH(RC)-1, JUN 1992
    (9) Procurement of Certain Equipment, NIH(RC)-7

    Other - to be submitted as directed by Contracting Officer
    ----------------------------------------------------------
   (10) Certificate of Current Cost or Pricing Data, NIH-1397
   (11) Subcontracting Plan Format

4.  The Representations and Certifications are applicable.

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