RFP No. NIH-NIAID-DAIDS-97-01
Title: PRECLINICAL EVALUATION OF THERAPIES FOR MYCOBACTERIUM
AVIUM INFECTION
Issued by: Joyce Sagami
Contract Specialist
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
DATE ISSUED: APRIL 15, 1996
PROPOSAL DATE DUE: AUGUST 15, 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-DAIDS-97-01) for a PRECLINICAL
EVALUATION OF THERAPIES FOR MYCOBACTERIUM AVIUM INFECTION. The
Government contemplates the award of one (1), five (5) year,
cost-reimbursement, level-of-effort 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, dated April 15, 1996
(Attachment 1)
b. Deliverables and Reporting Requirements, dated April 15,
1996 (Attachment 2)
c. Evaluation Factors for Award, dated April 15, 1996
(Attachment 3)
II. Specific RFP Instructions and Provisions, dated April 15, 1996
(Attachment 4)
III. Applicable RFP References, dated April 15, 1996 (Attachment 5)
IV. Agreement for Submitting Products to the Division of AIDS
(Attachment 6)
In addition to this directory which provides access to this
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. (These are
detailed in Attachment 5.) If you are unable to download any of
these documents, please contact Joyce Sagami, Contract Specialist,
by phone/fax/internet. (See contact numbers/addresses 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 which comprise the competitive range.
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, but supporting documentation need not be
submitted with the proposal. (COST AND PRICING DOCUMENTATION WILL
BE REQUESTED AFTER THE COMPETITIVE RANGE IS ESTABLISHED.) See
Standard RFP Instructions and Provisions, in the subdirectory C.
RFP References, for more detail on the BUSINESS PROPOSAL
requirements.
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. FINAL INFLATION
INCREASES WILL BE SUBJECT TO THE NEGOTIATION PROCESS TAKING INTO
CONSIDERATION THE MOST CURRENT CONSUMER PRICE INDEX (CPI).
With the Business Proposal, please submit 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. 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.
The format and content of your TECHNICAL PROPOSAL is detailed in
the technical proposal Table of Contents, Attachment 4. BE
ADVISED THAT THE NARRATIVE OF THE WORK STATEMENT, RESOURCES AND
DIRECT COSTS, PERSONNEL, AND OTHER CONSIDERATIONS ARE NOT TO EXCEED
50 PAGES. 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 July 15, 1996. This will
allow us to expedite preparations for the peer review of proposals.
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.
If you intend to submit a proposal in response to this RFP, IT IS
ESSENTIAL THAT YOU IMMEDIATELY NOTIFY MS. JOYCE SAGAMI, CONTRACT
SPECIALIST, OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING
INTERNET ADDRESS:
js73b@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU
WILL NOT RECEIVE ANY NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP.
HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER AND/OR NIH
HOME PAGE.
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 Contract Specialist no later than August 15, 1996,
at 4:30 p.m. local time at the address listed in Attachment 4, item
5.
Questions concerning any areas of uncertainty which in your opinion
require clarification or correction, must be furnished in writing
to Joyce Sagami. Your questions should be received no later than
May 15, 1996, at the address indicated in Attachment 4, item 5 (Fax
or E-mail is also acceptable.) and marked "Offeror's Questions,
RFP-NIH-NIAID-DAIDS-97-01."
If you have any additional questions regarding this RFP, please
contact Joyce Sagami at the internet electronic mail address
js73b@nih.gov, by phone at 301/496-7118, or by fax at 301/402-0972. Collect calls will NOT be accepted.
Sincerely,
/s/
Brenda J. Velez
Chief, AIDS Clinical Research Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases
Attachments: 1 - 6
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RFP-NIH-NIAID-DAIDS-97-01
I. STREAMLINED RFP
-------------------
ATTACHMENT 1
4/15/96
INTRODUCTION
------------
The opportunistic infections (OIs) associated with AIDS account for
the vast majority of all AIDS-related deaths and significantly
influence the quality of life of HIV-infected patients. The
management of OIs in AIDS patients is often difficult and
complicated due to simultaneous infections with other OIs, toxicity
and adverse side effects of therapeutic agents, long-term drug use
leading to patient intolerance or pathogen drug resistance,
occurrence of relapses after discontinuation of therapy, and lack
of effective therapies.
The NIAID has taken the lead in supporting OI drug development
efforts by providing contract resources for efficacy evaluations in
animals, a critical component in new drug approval. The
complexities of the animal models for certain OIs have limited the
access of the scientific community to evaluation systems capable of
identifying new classes of drugs with anti-OI activity. Through
the Opportunistic Infections Research Branchūs OI drug development
contract program, efficacy evaluations will continue to be
available to individual scientific investigators, to participants
in the National Cooperative Drug Discovery Group Program for the
Treatment of Opportunistic Infections associated with AIDS (NCDDG-
OI), and to private companies who have limited evaluation
capabilities. The availability of these test systems will allow
the Division of AIDS (DAIDS) to provide critical support for
investigator-initiated drug discovery, to stimulate private sector
sponsorship of new drugs, to perform comparison (or confirmatory)
studies from different sponsors, and to provide information for
selection of anti-OI drug candidates for design of clinical
studies.
MYCOBACTERIUM AVIUM complex (MAC) is the most common systemic
opportunistic bacterial infection in patients with AIDS. The
infection contributes significantly to morbidity and shortens
survival. Clinically, MAC is a late-stage HIV-related disease.
Disseminated MAC infection is generally characterized by extremely
high tissue burden of the organism coupled with nonspecific
symptoms including fever, night sweats, weight loss, weakness, and
anorexia. Diarrhea, malabsorption, and abdominal pain are
symptomatic of gastrointestinal involvement; enlargement of the
liver and spleen is common. As with other mycobacterial diseases,
treatment requires a multiple-drug therapeutic regimen; however,
present treatment regimens have limited effectiveness and rarely
result in a clearing of the organism. Treatment is usually
continued for life. The discovery and development of effective
agents that could be used to cure and prevent this disease is
needed, especially in AIDS patients.
The animal model most widely used to evaluate therapeutic agents
against MAC is the beige mouse, a strain lacking both T cells and
natural killer cells. The model is used extensively for the
assessment of therapeutic potency of promising drugs,
immunomodulators, and their combinations.
For the disease caused by Mycobacterium Avium complex, new
therapies are urgently required but few candidate drugs are under
development by the private sector. At the present time, NIAID has
an animal model contract which is scheduled to end on July 22,
1997, to evaluate agents for Mycobacterium Avium complex. The
current animal model contractor is:
California Pacific Medical Center Research Institute (formerly
Medical Research Institute of San Francisco): Evaluation of
Therapies for Treatment of MYCOBACTERIUM AVIUM,
N01-AI-25140.
IT IS ANTICIPATED THAT ONE CONTRACT WILL BE AWARDED, DEPENDENT UPON
AVAILABILITY OF FUNDS. THE GOVERNMENT RESERVES THE RIGHT TO MAKE
OR NOT MAKE AWARDS BASED UPON PROGRAMMATIC PRIORITIES AND
AVAILABILITY OF FUNDS.
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[GENERAL NOTE TO OFFEROR: IN RESPONDING TO THIS RFP, OFFERORS
SHOULD DESCRIBE IN DETAIL THE TECHNICAL APPROACH AND METHODS
PROPOSED, AND THE RESPONSIBILITIES AND LEVEL OF EFFORT OF ALL
PROPOSED PERSONNEL WHO WILL BE ASSIGNED TO THE CONTRACT.
DOCUMENTATION SHOULD ALSO BE PROVIDED ON THE QUALIFICATIONS,
EXPERIENCE, EDUCATION, COMPETENCE, AVAILABILITY (IN RELATION TO
OTHER COMMITMENTS), AND DECISION-MAKING AUTHORITY OF THE PRINCIPAL
INVESTIGATOR, KEY PERSONNEL, AND TECHNICAL AND SUPPORT STAFF.
OFFERORS MUST PROVIDE NECESSARY FACILITIES, INCLUDING ALL MAJOR
EQUIPMENT, ANIMALS (WELFARE ASSURANCES), AND CAPABILITIES TO
PERFORM ALL THE FUNCTIONS OF THE WORK STATEMENT.
OFFERORS SHOULD ADDRESS PLANS TO INSURE THAT NO IDENTIFIABLE DATA
ON THE COMPOUNDS OR PRODUCTS AND THE RESULTS OF TESTING WILL BE
KEPT IN FILES OPEN TO THE PUBLIC, AND THAT FACILITIES FOR COMPUTER
OPERATION, DATA ENTRY, AND FILE STORAGE ARE SECURE FROM
UNAUTHORIZED ACCESS. ONLY THOSE CONTRACT EMPLOYEES OR GOVERNMENT
EMPLOYEES DIRECTLY ENGAGED IN THIS PROJECT WILL HAVE ACCESS TO THE
FILES OF INFORMATION REGARDING SOURCE AND NATURE OF CONFIDENTIAL OR
PROPRIETARY MATERIALS AND RESULTS OF TESTING.
THE HANDLING AND TRANSPORTATION OF ALL REAGENTS AND GOVERNMENT-
OWNED PROPERTY UNDER THIS CONTRACT SHOULD BE IN ACCORDANCE WITH ALL
APPLICABLE LOCAL, STATE AND FEDERAL REGULATIONS INCLUDING HEALTH
AND SAFETY STANDARDS. (SEE ATTACHMENT 4 FOR THE SAFETY AND HEALTH
CLAUSE AND ITEM #8 OF THE WORK STATEMENT.)
IF A SUBCONTRACTOR IS PROPOSED, SIMILAR TECHNICAL INFORMATION SHALL
BE PROVIDED AS PART OF THE PROPOSAL AS THAT REQUIRED OF THE PRIME
CONTRACTOR, I.E., TECHNICAL APPROACH, METHODS, EXPERIENCE,
PERSONNEL QUALIFICATIONS, FACILITIES, RESOURCES, ETC., AND COST
DETAILS SHOULD ALSO BE PROVIDED BY THE SUBCONTRACTOR. THE PRIME
CONTRACTOR SHALL BE RESPONSIBLE FOR ALL WORK PERFORMED UNDER THIS
CONTRACT.]
WORK STATEMENT
--------------
Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel,
material, equipment, strains of microorganisms, and facilities, not
otherwise provided by the Government as needed to perform the Work
Statement below.
Specifically, the Contractor shall:
1. Evaluate therapeutic agents to be supplied and/or approved by
the Project Officer for efficacy against MYCOBACTERIUM AVIUM
in a standardized, validated mouse model test system. During
the term of the contract, the Contractor shall use his/her
best efforts to identify and propose agents to the Project
Officer for evaluation.
The primary evaluation system shall include the following:
a. Quantitative assessments which detect statistically valid
differences between treatment groups of animals,
specifically as indicators of the numbers of
MYCOBACTERIUM AVIUM present in blood and tissues
(including liver and spleen) of infected animals;
b. Microbiological analyses, including but not limited to,
special stains and cultures to document the purity,
severity, and location of the animal infection;
c. Appropriate observations and measures of general
toxicity, to include body weight and daily assessment of
appearance and general health, obtained during efficacy
studies;
d. Relevant strains of MYCOBACTERIUM AVIUM;
e. A standardized, validated protocol for testing new
therapies against an established infection of M. AVIUM
with a proven agent identified as a positive control
drug.
[NOTE 1 TO OFFEROR: THE OFFEROR SHOULD AT THE TIME OF THE
PROPOSAL, HAVE AVAILABLE A MOUSE TESTING SYSTEM, INCLUDING RELEVANT
MYCOBACTERIAL STRAINS, SUITABLE FOR EVALUATION OF THERAPIES WITH
POTENTIAL FOR TREATMENT OF MYCOBACTERIUM AVIUM INFECTIONS IN
HUMANS. THE OFFEROR SHOULD PROVIDE DOCUMENTATION OF THE TEST
SYSTEMS WHICH WILL BE EMPLOYED TO CONFIRM THE MICROBIOLOGICAL
PURITY OF THE EXPERIMENTAL INFECTION AND THE ABSENCE OF OTHER
PATHOGENIC MICROORGANISMS. THE PROPOSED TEST SYSTEM SHOULD
APPROXIMATE THE CLINICAL MANIFESTATIONS OF THE INFECTION AS IT
OCCURS IN AIDS, OR SHOULD HAVE DOCUMENTED UTILITY AS A MODEL OF
DRUG EFFICACY IN HUMAN DISEASE. THE OFFEROR SHOULD DISCUSS IN THE
PROPOSAL ANY LIMITATIONS AND POTENTIAL PROBLEMS OF THE PROPOSED
PRIMARY MODEL AND ANY SUGGESTED SOLUTIONS TO BE PERFORMED UNDER
ITEM #5 OF THE WORK STATEMENT.
PROTOCOLS SHOULD BE DESIGNED TO TEST THE EFFICACY OF AN AGENT
AGAINST AN ESTABLISHED INFECTION. TECHNICAL PROPOSALS SHOULD
PROVIDE DOCUMENTATION OF AND DATA SUPPORTING THE REPRODUCIBILITY,
STANDARDIZATION, AND VALIDATION OF THE PROPOSED PRIMARY MODEL, A
SAMPLE OF A DRUG EVALUATION PROTOCOL, AND THE POSITIVE CONTROL
DRUG. EVALUATION CRITERIA WILL CONSIDER THE INVESTIGATORūS
EXPERIENCE WITH THIS AND SIMILAR SYSTEMS, FACILITIES, AVAILABILITY
OF ORGANISMS, ANIMALS, AND REAGENTS, AND PUBLICATION RECORD IN THIS
FIELD.
AT THE PRESENT TIME, THE GOVERNMENT DOES NOT KNOW HOW MANY
THERAPIES (E.G., COMPOUNDS) WILL BE EVALUATED. ASSUME THAT MOST
THERAPIES WILL BE OBTAINED BY THE GOVERNMENT THROUGH
CONFIDENTIALITY AGREEMENTS WITH SUPPLIERS AND EVALUATED BY THE
CONTRACTOR UNDER THE TERMS OF SAID AGREEMENTS. FOR PURPOSES OF
PREPARING A COST PROPOSAL, THE OFFEROR SHOULD NOT INCLUDE COSTS OF
COMPOUND ACQUISITION EFFORTS, BUT SHOULD ASSUME THAT A TOTAL OF 30
INDIVIDUAL COMPOUNDS AT 4 DOSAGES PER COMPOUND WILL BE EVALUATED
PER YEAR, AND THAT EACH EVALUATION WILL CONSIST OF 15 GROUPS OF
ANIMALS TREATED AS FOLLOWS:
o 3 TEST COMPOUNDS AT 4 DOSAGES EACH ADMINISTERED TWICE A
DAY;
o A POSITIVE CONTROL, I.E., A THERAPY WITH DEMONSTRATED
EFFICACY FOR ANIMAL MYCOBACTERIUM AVIUM INFECTION,
o A NEGATIVE CONTROL, I.E., INFECTED ANIMALS RECEIVING NO
THERAPY, AND
o 1 TOXICITY CONTROL GROUP, I.E., UNINFECTED ANIMALS THAT
RECEIVE THE HIGHEST DOSAGE OF DRUG FOR THE DURATION OF
THE PROTOCOL.]
2. Perform additional studies as specified by the Project Officer
for evaluation of promising therapies in the primary mouse
model test system and in alternative model systems.
These studies shall include, but not limited to:
a. Evaluation of therapies in combination;
b. Determination of optimal dosages, routes and schedules of
administration;
c. Drug efficacy evaluations in prophylaxis protocols.
[NOTE 2 TO OFFEROR: THE OFFEROR SHOULD, AT THE TIME OF PROPOSAL,
HAVE AVAILABLE LABORATORY AND MOUSE SYSTEMS, INCLUDING RELEVANT
MYCOBACTERIAL STRAINS, SUITABLE FOR THESE ADDITIONAL STUDIES. THE
OFFEROR SHOULD DESCRIBE IN DETAIL THE TECHNICAL APPROACH, MODELS,
PROTOCOLS, AND DATA ANALYSIS PROPOSED FOR THESE STUDIES, AND
PROVIDE DOCUMENTATION OF THE STANDARDIZATION AND REPRODUCIBILITY OF
ANY ALTERNATIVE MODEL SYSTEMS PROPOSED.
AT THE PRESENT TIME, THE GOVERNMENT DOES NOT KNOW HOW MANY
ADDITIONAL STUDIES WILL BE NEEDED. FOR PURPOSES OF PREPARING A
COST PROPOSAL, THE OFFEROR SHOULD ASSUME THAT 2 THERAPIES PER YEAR
WILL REQUIRE STUDIES 2.A., 2.B., AND 2.C. AS DESCRIBED BELOW:
A. EVALUATION OF 2 INDIVIDUAL DRUGS IN COMBINATION AT 3
DOSAGES FOR TREATMENT EFFICACY;
B. COMPARISON EFFICACY OF 3 DOSAGE LEVELS ADMINISTERED TWICE
PER DAY BY GAVAGE AND BY INTRAVENOUS OR INTRAPERITONEAL
INJECTION;
C. EVALUATION OF THE PROPHYLACTIC EFFICACY OF INDIVIDUAL
DRUGS AT 3 DOSAGE LEVELS COMPARED TO A POSITIVE CONTROL
THERAPY AND A NEGATIVE CONTROL.]
3. Evaluate therapeutic agents as specified by the Project
Officer for efficacy against MYCOBACTERIUM AVIUM in
standardized, reproducible, and validated IN VITRO culture and
intracellular test systems, and provide a quantitative
assessment of cytotoxicity of the test therapies.
[NOTE 3 TO OFFEROR: THE OFFEROR SHOULD, AT THE TIME OF PROPOSAL,
HAVE AVAILABLE IN VITRO SYSTEMS SUITABLE FOR EVALUATION OF
THERAPIES WITH POTENTIAL FOR TREATMENT OF MYCOBACTERIUM AVIUM
INFECTIONS IN HUMANS. THE IN VITRO PROTOCOL DESIGN AND
QUANTITATIVE METHODS SHOULD INCLUDE APPROPRIATE STATISTICAL
ANALYSES TO DETECT DIFFERENCES BETWEEN GROUPS. AT THE PRESENT
TIME, THE GOVERNMENT DOES NOT KNOW HOW MANY THERAPIES WILL BE
EVALUATED. FOR PURPOSES OF PREPARING A COST PROPOSAL, THE OFFEROR
MAY ASSUME A TOTAL OF 25 COMPOUNDS AT 5 CONCENTRATIONS EACH WILL BE
EVALUATED PER YEAR AGAINST 5 M. AVIUM STRAINS ORIGINALLY ISOLATED
FROM AIDS PATIENTS BOTH IN IN VITRO CULTURE AND IN AN INTRACELLULAR
TEST SYSTEM. IF TISSUE CULTURE SYSTEMS ARE PROPOSED, QUANTIFIABLE
MEASURES OF CYTOTOXICITY CAUSED BY TEST COMPOUNDS SHOULD BE
INCLUDED.]
4. At the specific request of the Project Officer, provision
shall be made to obtain and preserve samples of purified
organisms or animal tissues and fluids. Samples shall be
sent, at the direction of the Project Officer, to another
contractor or grantee who may perform additional experiments
with the samples or may analyze samples for drug or metabolite
concentrations. The Contractor shall cooperate or collaborate
with other investigators as requested.
[NOTE 4 TO OFFEROR: FOR PURPOSES OF PREPARING A COST PROPOSAL, THE
OFFEROR SHOULD ASSUME THAT THE FOLLOWING SAMPLES WILL BE SHIPPED
PER YEAR TO BETHESDA, MARYLAND: 25 ANIMAL BLOOD SAMPLES, AND 25
PURE CULTURES OF VIABLE M. AVIUM. THE OFFEROR SHOULD INCLUDE THE
COST OF ALL SHIPMENTS IN THE COST PROPOSAL.]
5. As designated by the Project Officer, further characterize
and/or modify the IN VITRO models and/or animal model, or
develop other models to improve model utility in the
evaluation of therapies.
[NOTE 5 TO OFFEROR: THE MAIN PURPOSE OF THIS PROJECT IS EVALUATION
OF PROMISING THERAPIES FOR MYCOBACTERIUM AVIUM INFECTION. IF, AND
WHEN, APPROVED BY THE PROJECT OFFICER, CHARACTERIZATION AND/OR
MODIFICATION OF PROPOSED MODELS WILL BE DONE IN PLACE OF DRUG
TESTING. BECAUSE THE GOVERNMENT DOES NOT KNOW IF OR WHAT
MODIFICATIONS ARE LIKELY TO BE NEEDED, THIS SECTION SHOULD NOT BE
CONSIDERED AS PART OF THE BUSINESS PROPOSAL. IT IS EXPECTED THAT
ANY NECESSARY MODIFICATIONS OF THE MODEL SYSTEM WILL NOT INCREASE
THE NEGOTIATED CONTRACT COST, BUT THAT EXISTING RESOURCES WILL BE
REDIRECTED TO ACCOMPLISH THIS TASK. THE OFFEROR SHOULD INCLUDE IN
THE PROPOSAL DOCUMENTATION OF QUALIFICATIONS, EXPERTISE, AND
ABILITY TO MODIFY MODELS OR DEVELOP NEW MODELS FOR THERAPY
COMPARISONS.]
6. The Contractor shall report data generated under this contract
to the Project Officer in the form of interim and semiannual
reports (written reports and computer files) as described in
the contract Reporting Requirements. In order to facilitate
timely transmission of data and information, the Contractor
shall establish and maintain an efficient electronic
communication system with the Project Officerūs office. The
Contractor shall insure that no identifiable data on the
compounds or products and the results of testing will be kept
in files open to the public, and that facilities for computer
operation, data entry, and file storage are secure from
unauthorized access. Only those contract employees directly
engaged in this project shall have access to the files of
information regarding source and nature of confidential or
proprietary materials and results of testing.
[NOTE 6 TO OFFEROR: THE OFFEROR SHOULD PROPOSE A PLAN FOR DATA
MANAGEMENT, ANALYSIS, AND ELECTRONIC DIGITAL COMMUNICATION WITH THE
PROJECT OFFICER. COMMUNICATIONS SHOULD INCLUDE THE ABILITY TO
TRANSMIT AND RECEIVE ELECTRONIC MAIL WITH THE DIVISION OF AIDS
COMPUTER NETWORK SYSTEM. THE GOVERNMENT WILL NOT AUTHORIZE
PURCHASE OF STAND-ALONE COMPUTERS UNDER THIS CONTRACT FOR THIS
PURPOSE. THE NIAID IS CONNECTED TO THE INTERNET AND USES IBM-
COMPATIBLE COMPUTER HARDWARE FOR DATA MANAGEMENT AND
COMMUNICATIONS. THE OFFEROR SHOULD SUPPLY AN IBM-COMPATIBLE
COMPUTER AND SHOULD SUBMIT ELECTRONIC DOCUMENTS IN EITHER MICROSOFT
WORD (TM) VERSION 6.0 FOR WINDOWS AND MICROSOFT EXCEL (TM) VERSION
5.0 FOR WINDOWS OR WORD PERFECT 6.1 FOR WINDOWS (TO BE DETERMINED
BY THE PROJECT OFFICER). THE OFFEROR MUST ASSURE CONFIDENTIALITY
OF DATA.]
7. The Contractor shall provide advance copies of draft
manuscripts for publication (including abstracts and public
presentations) based on data generated under this contract to
the Project Officer, and obtain clearance before submitting
for publication or presentation. Support from the Government
contract must be acknowledged in all abstracts, presentations,
and publications. The Contractor shall be bound by the same
terms as the Government under the AGREEMENT FOR SUBMITTING
PRODUCTS TO THE DIVISION OF AIDS, NIAID. (See Attachment 6.)
[NOTE 7 TO OFFEROR: AN ADVANCE UNDERSTANDING WILL BE INSERTED IN
ANY RESULTANT CONTRACT, STATING THAT THE CONTRACTOR AGREES THAT
MANUSCRIPTS BASED ON DATA GENERATED UNDER THIS CONTRACT WILL NOT BE
SUBMITTED FOR PUBLICATION UNTIL WRITTEN CLEARANCE HAS BEEN RECEIVED
FROM THE PROJECT OFFICER.]
8. The Contractor shall conduct work under this contract in
accordance with the following basic references and all related
modifications and updates by the Centers for Disease Control
and Prevention/NIH and state, Federal, and local regulations.
a. Biosafety in Microbiological and Biomedical Laboratory,
published by CDC, third edition, May 1993.
b. Guide for the Care and Use of Laboratory Animals, NIH
Publication No. 86-23, Revised 1985.
c. All etiologic agents, blood, and tissue samples shipped
under this contract shall be packaged, marked and shipped
in accordance with the "Interstate Shipment of Etiologic
Agents (42 CFR, Part 72)" revised July 21, 1980 which
provides for packaging and labelling requirements for
etiologic agents and certain other materials shipped in
interstate traffic. The Contractor shall guarantee that
all required materials shall be delivered in immediate
usable and acceptable condition.
[NOTE 8 TO OFFEROR: SEE ATTACHMENT 4 FOR THE PHS SAFETY AND HEALTH
CLAUSE WHICH WILL BECOME PART OF ANY RESULTANT CONTRACT. A COPY OF
THE GUIDE FOR B. ABOVE MAY BE OBTAINED FROM THE INSTITUTE OF
LABORATORY ANIMAL RESOURCES, NATIONAL RESEARCH COUNCIL, 2101
CONSTITUTION AVENUE, N.W., WASHINGTON, D.C. 20418, TELEPHONE (202)
334-2000. INFORMATION ON THE REGULATION FOR C. ABOVE MAY BE
OBTAINED FROM THE CDC BIOHAZARD CONTROL OFFICER, 1600 CLIFTON ROAD,
ATLANTA, GA, 30333, TELEPHONE (404) 639-3883.]
9. By the end of the fourth year of this contract, the Contractor
shall have developed and submitted procedures for an orderly
transition of data and samples to a subsequent contractor or
to the Government, subject to Project Officer approval, and
shall deliver, if requested by the Project Officer and by the
completion date of the contract, the following items:
accurate and updated protocols and databases, original data,
preserved strains, samples, and any necessary information
related thereto.
10. The contract's Principal Investigator/key personnel shall meet
with the Project Officer at periodic intervals, to be
scheduled after contract award, to review progress,
anticipated or existing problems, and discuss the work to be
performed. At least one of the Contractor's key personnel
must attend and present information, at the direction of the
Project Officer, on therapies evaluated under the contract at
one NIAID-sponsored meeting per year.
[NOTE 9 TO OFFEROR: FOR THE PURPOSE OF PREPARING A COST PROPOSAL,
ASSUME 3 VISITS OF ONE KEY PERSONNEL PER YEAR TO 6003 EXECUTIVE
BOULEVARD, ROCKVILLE, MD 20852 TO MEET WITH THE PROJECT OFFICER FOR
ONE DAY, AND ATTENDANCE OF ONE KEY PERSONNEL FOR FOUR DAYS AT THE
ANNUAL MEETING OF THE NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS
FOR THE TREATMENT OF OPPORTUNISTIC INFECTIONS TO BE HELD IN THE
GREATER WASHINGTON, D.C. AREA.]
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RFP-NIH-NIAID-DAIDS-97-01
ATTACHMENT 2
4/15/96
DELIVERABLES AND REPORTING REQUIREMENTS
---------------------------------------
The Contractor shall submit technical progress reports covering the
work accomplished during each reporting period. Distribution of
written reports is listed below in D.
A. Interim Progress Reports
The Contractor shall submit two paper copies of Interim
Progress Reports AND one copy on magnetic media (3.5 inch
diskettes) as computer files in either Microsoft Word (TM)
version 6.0 for Windows and Microsoft Excel (TM) version 5.0
for Windows or Word Perfect 6.1 for Windows (to be determined
by the Project Officer), formats readable using an IBM-type
personal computer, within 21 calendar days of the completion
of each protocol or evaluation conducted under Work Statements
1 to 4 to the Project Officer. The Project Officer may
approve alternate forms of transmittal of Interim Reports
(such as via modem). It remains the responsibility of the
Contractor to assure receipt by the Project Officer of all
reports by the established due dates. For purposes of
preparing a budget, offerors may assume six such reports will
be submitted per year and will contain approximately three
pages of narrative text. The Project Officer may require
responses to electronic mail described in Item #6 of the Work
Statement. Interim Progress reports shall include the
following:
1. Cover page containing:
a. Contract number and title;
b. Period of performance being reported;
c. Contractor's name and address;
d. Author (s);
e. Date of submission; and
f. Interim Progress Report number.
2. Background: summary of available information on each
therapy which was considered in designing the protocol,
chemical structures of compounds tested (if known), and
brief description of known biological activity.
3. Study protocol design.
4. Report of results and data from study including tables,
graphs, and statistical analyses.
5. Interpretation and brief discussion of data, based on
literature and other studies done under contract, and
recommendations for further development or testing of the
therapy.
The Contractor shall retain the original data obtained under
the contract. The Contractor shall furnish these original
data or copies or photographs thereof if requested by the
Project Officer.
B. Semi-Annual Progress Reports
The Contractor shall submit three paper copies of a progress
report 15 days after the end of the sixth month of the project
and at the end of each six month period thereafter both as
written reports AND one copy on magnetic media (3.5 inch, high
density diskettes) as computer files in either Microsoft Word
(TM), version 6.0, or in Microsoft Excel (TM) version 5.0 or
Word Perfect 6.1 for Windows (to be determined by the Project
Officer) formats readable using an IBM-compatible personal
computer. It remains the responsibility of the Contractor to
assure receipt by the indicated government official listed
below of all reports by the established due dates. Reports
shall include the following specific information:
a. A cover page containing:
1. Contract number and title;
2. Period of performance being reported;
3. Contractor's name and address;
4. Author(s);
5. Date of submission; and
6. Semi-Annual Progress Report number.
b. A Table of Contents with page numbers for each section.
c. SECTION A: A CONCISE, narrative description of the work
performed during the reporting period and the anticipated
work plan for the following six months.
d. SECTION B: A chronological listing of evaluations
performed during the reporting period (supported by
reference to the data contained within the Interim
Progress Reports described in A), in sufficient detail to
identify the protocol employed, significant results, and
conclusions. Conclusions from statistical analyses and
scientific comparisons of data to previous studies
conducted under the contract and to studies in the
published literature shall be included in a concise
format.
e. SECTION C: Tables of therapies studied during the
reporting period IN VITRO and IN VIVO, and tables
containing cumulative listings of drugs or therapies
studied IN VITRO and IN VIVO during the entire contract.
These should be presented in separate tables and include
the name of the therapy (in alphabetical order),
concentrations or doses tested, the test system, a
concise indication of the relative activity, and the date
and number of the Interim Progress Report containing the
complete data.
f. SECTION D: A brief discussion of problems encountered,
their resolution or proposed corrective action, and an
explanation of any differences between planned progress
and actual progress.
g. SECTION E: Copies of manuscripts, abstracts, or
presentations (published or unpublished) derived from
research under the contract during the reporting period,
and a cumulative list of publications derived from
research under the contract.
A semi-annual progress report is not due when the final report
falls due.
C. Final Report
The Contractor shall submit three copies of the final report
AND one copy on magnetic media that provides a summary of the
work accomplished since the last semi-annual report and the
work accomplished during the entire contract period. The
final report shall be submitted by the expiration date of the
contract. A separate semi-annual progress report will not be
required for the period when the final report is due. Final
reports shall follow the format described above.
D. Technical Reports Distribution
Copies of the written technical reports shall be submitted as
follows:
Type of No. of
Report Copies Addressee Due Dates*
------- ------ --------- ---------
Progress 2 Project Officer
semi-annual OIRB, TRP, Div. AIDS
Solar Bldg, Rm. 2C40
6003 Executive Blvd. (MSC 7620)
Bethesda, MD 20892-7620
Progress 1 Contracting Officer, ACRCS
semi-annual CMB, DEA, NIAID
Solar Bldg., Rm. 3C07
6003 Executive Blvd. (MSC 7610)
Bethesda, MD 20892-7610
Interim 1 Same as P.O. above within 21
calendar days of
the completion of
each protocol or
evaluation
conducted under
Work Statement
items 1 - 4
Interim 1 Same as C.O. above same as above
Final 2 Same as P.O. above expiration
date
Final 1 Same as C.O. above same as above
* specific dates will be listed in the contract document
(Note: The Project Officer also receives a copy of each of the
reports above on a 3.5 inch diskette.)
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 therefor.
E. Other Deliverables. The Contractor, subject to Project
Officer approval shall deliver to the Government or its
designee by the expiration date of the contract, the following
items (with the exception of item (4) which shall be delivered
by the end of the fourth year):
(1) A computer-generated listing of accurate and updated
information on compound inventory, including activities
of the Contractor, data files, original data and any
necessary information related thereto;
(2) Labeled and inventoried paper files;
(3) Any other government-owned property; and
(4) The transition plan required in Item #9 of the Work
Statement.
F. Level of Effort
The Government's requirement for the work set forth in the
Work Statement of this solicitation is 1,450% direct labor
effort. It is estimated that the labor effort is constituted
as specified below and will be expended approximately as
follows:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
---------------------------------------------------
P. I. 20% 20% 20% 20% 20% 100%
Professional 60% 60% 60% 60% 60% 300%
Support 210% 210% 210% 210% 210% 1,050%
---- ---- ---- ---- ---- ------
TOTAL 290% 290% 290% 290% 290% 1,450%
*EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT = 2,080
HOURS PER YEAR, WHICH INCLUDES HOLIDAYS AND OTHER PAID
ABSENCES. IF YOU ARE USING A DIFFERENT BASE, PLEASE STATE THE
WORK YEAR USED IN YOUR PROPOSAL. THE ABOVE LEVEL OF EFFORT IS
THE GOVERNMENT'S ESTIMATE OF THE EFFORT THAT WILL BE NECESSARY
TO SATISFACTORILY ACCOMPLISH THE OBJECTIVE OF THESE STUDIES,
AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. HOWEVER, YOU
CAN PROPOSE DEVIATIONS FROM THIS ESTIMATED LEVEL OF EFFORT,
WITH JUSTIFICATION.
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-01
ATTACHMENT 3
4/15/96
EVALUATION FACTORS FOR AWARD
----------------------------
PROPOSAL EVALUATION CRITERIA
The technical proposal will receive paramount consideration in the
selection of the Contractor(s) for this acquisition. In the event
that the technical evaluation reveals that two or more offerors are
approximately equal in technical ability, then cost may become a
significant factor in determining award(s). In any event, the
Government reserves the right to make an award to the best
advantage of the Government, cost and other factors considered.
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 merits of each proposal will be
evaluated carefully. Each proposal must document the feasibility
of successful implementation of the requirement of the RFP.
Offerors must submit information sufficient to evaluate their
proposals based on the detailed criteria listed below. While high
performance is sought, capabilities that exceed those needed for
successful performance of the Work Statement are not requested.
Listed below are the technical evaluation criteria. The evaluation
criteria are used by the technical evaluation committee when
reviewing the technical proposals. The criteria are listed in the
order of relative importance with weights assigned for evaluation
purposes. PROPOSALS WILL BE EVALUATED SOLELY ON THE WRITTEN
MATERIAL PROVIDED BY THE OFFERORS.
TECHNICAL EVALUATION CRITERIA
POINTS
------
1. TECHNICAL APPROACH TO ANIMAL MODELS AND PROTOCOLS 50 PTS
The technical adequacy and feasibility of the approach
presented in the technical proposal, as reflected in the
documentation provided including the alternative
strategies and relevant experience, for:
(a) AVAILABILITY AND ADEQUACY OF THE PROPOSED PRIMARY
MODEL FOR THERAPY EVALUATIONS (25 POINTS)
The availability of an appropriate mouse model at the time of
proposal, including relevant strains and defined clinically/
biologically relevant indicators of efficacy, suitable for
evaluation of potential therapies; availability is defined as
the ability to begin therapy testing immediately after
contract award.
Points to consider include:
o current ability to perform preclinical drug evaluations
as indicated in the Work Statement;
o suitability of proposed IN VIVO model and proposed
protocol for drug testing (suitability includes
feasibility, reproducibility, identification of positive
controls, testing capacity, and practicality};
o appropriateness of the model for predicting therapeutic
efficacy of response in humans;
o appropriate and quantitative, statistically valid
assessments of infection, morbidity and therapeutic
efficacy;
o understanding of limitations and potential problems of
the proposed primary model and adequacy of suggested
solutions.
(b) QUALITY OF APPROACH TO DESIGNING STUDIES WITH
ALTERNATIVE PROTOCOLS AND MODELS (15 POINTS)
Points to consider include:
o technical approach to design of combination studies;
o documented experience in developing and using additional
animal models and protocols for therapy evaluations;
o technical approach to determination of optimal dosages,
routes and schedules of administration;
o quality of proposed plan for use and availability of
alternative animal models to evaluate drug efficacy.
(c) QUALITY OF PLAN FOR DATA MANAGEMENT, STATISTICAL
ANALYSIS, AND SECURITY (10 POINTS)
Points to consider include:
o adequacy of plans for data management and statistical
analyses;
o adequacy of plans for electronic communication with the
Project Officer;
o adequacy of data security measures.
2. TECHNICAL APPROACH TO EVALUATION OF THERAPIES IN IN
VITRO TEST SYSTEMS 20 PTS
Points to consider include:
o appropriateness, documented reproducibility of
quantitative screening assay;
o appropriateness, reproducibility of minimum inhibitory
concentration assays;
o suitability of procedures for interpretation and
reporting of results;
o appropriateness of indicators and methods to assess
cytotoxicity of candidate therapies.
3. PERSONNEL QUALIFICATIONS 20 PTS
(a) PRINCIPAL INVESTIGATOR (10 POINTS)
Points to consider include:
o Relevance and quality of recent work including
publications;
o Documented experience with technical approaches proposed;
o Documented availability for the proposed project in
relation to other commitments;
o Documented experience with managing projects of similar
complexity.
(b) OTHER PERSONNEL/STAFFING PLAN (10 POINTS)
Points to consider include:
o Relevant experience of other professional and technical
staff and their documented capability to conduct proposed
activities utilizing appropriate skills;
o Documented experience of staff with models of infectious
diseases;
o Adequacy of the staffing plan, including clear lines of
authority, for the conduct of the project.
o Adequacy of plans for compliance with all safety
guidelines and regulations, including training and
monitoring of personnel for exposure to infectious or
hazardous reagents and safe disposal of such agents.
4. FACILITIES AND RESOURCES 10 PTS
(a) Documented availability of adequate facilities (office,
computer, and laboratory space), equipment, and resources
necessary to meet the requirements of the RFP.
NOTE: a detailed floor plan of the proposed facility which
shows location of the equipment and resources to be DEDICATED
to this project MUST be provided.
(b) Documentation of facilities to receive and store
compounds, and maintain their stability.
TOTAL: 100 PTS
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-01
ATTACHMENT 4
4/15/96
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 8733.
(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 July 23,
1997.
It is anticipated that the award from this solicitation will
be multiple-year cost reimbursement type level-of-effort
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. LEVEL OF EFFORT
The Government's requirement for the work set forth in the
Work Statement of this solicitation is 1,450% direct labor
effort. It is estimated that the labor effort is constituted
as specified below and will be expended approximately as
follows:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
---------------------------------------------------
P. I. 20% 20% 20% 20% 20% 100%
Professional 60% 60% 60% 60% 60% 300%
Support 210% 210% 210% 210% 210% 1,050%
---- ---- ---- ---- ---- ------
TOTAL 290% 290% 290% 290% 290% 1,450%
*EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT = 2,080
HOURS PER YEAR, WHICH INCLUDES HOLIDAYS AND OTHER PAID
ABSENCES. IF YOU ARE USING A DIFFERENT BASE, PLEASE STATE THE
WORK YEAR USED IN YOUR PROPOSAL. THE ABOVE LEVEL OF EFFORT IS
THE GOVERNMENT'S ESTIMATE OF THE EFFORT THAT WILL BE NECESSARY
TO SATISFACTORILY ACCOMPLISH THE OBJECTIVE OF THESE STUDIES,
AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. HOWEVER, YOU
CAN PROPOSE DEVIATIONS FROM THIS ESTIMATED LEVEL OF EFFORT,
WITH JUSTIFICATION.
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. Bruce Anderson
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-DAIDS-97-01
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) 93-8395.
(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
31 CENTER DR MSC 2260
BETHESDA, MARYLAND 20892-2260
(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
31 CENTER DR MSC 2250
BETHESDA, MARYLAND 20892-2250
(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. 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.
8. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT
(NOTE: INSTRUCTIONS TO OFFERORS ARE INDICATED IN PARENTHESES
OR AS FOOTNOTES.)
SECTION # PAGE #
--------- ------
1. TECHNICAL PROPOSAL COVER SHEET (Format in Section C
of Gopher RFP: FORMS, FORMATS, ATTACHMENTS) .............. 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS ..................... 2
3. SUMMARY OF OBJECTIVES AND METHODS* ....................... 3
4. TECHNICAL PLAN** (Refer to Technical Proposal Instructions,
Section C.1., Standard RFP Instructions and Provisions,
Gopher RFP for more detail)
a. WORK STATEMENT
1. Objectives ...................................... 4
2. Approach .......................................____
3. Methods ........................................____
4. Schedule .......................................____
b. RESOURCES AND DIRECT COSTS (list/describe all equip-
ment, facilities and other resources available for
this project; attach "Technical Proposal Cost
Information" form, and marked laboratory floor plan
in Section 6, below)...............................____
c. 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 (technical support/
subcontractors/consultants) .......................____
Note: For personnel, include resumes and the form
entitled "Summary of Current and Proposed Activities"
under Sections 5 and 6 below.
d. OTHER CONSIDERATIONS (provide brief narrative
of any unique arrangements, safety procedures
in place, animal welfare issues etc.)..............____
5. APPENDICES (Literature citations, Protocols, Resumes
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
Directory found in Section C, Gopher RFP)..........____
b. "Technical Proposal Cost Information" form (located
in Section C, Gopher RFP, FORMS, FORMATS, &
ATTACHMENTS).......................................____
c. Laboratory Design and Floor Plan (clearly indicate
the space available for this Project)............ .____
*State the proposal's broad, long-term objectives and specific
aims. Briefly and concisely describe the research design and
methods for achieving these goals (limit to one page).
** Sections 4.a. through 4.d. above MUST NOT EXCEED 50 PAGES (this
does not include copies of resumes and any required forms, but only
the NARRATIVE description of the Technical Plan). 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.
**********************************************************
9. PROPOSAL INTENT RESPONSE SHEET
PROPOSAL INTENT
---------------
RFP No.:NIH-NIAID-DAIDS-97-01
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: Joyce Sagami
RFP NIH-NIAID-DAIDS-97-01
Fax # 301/402-0972
PLEASE RETURN BY JULY 15, 1996
***********************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-01
ATTACHMENT 5
4/15/96
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 Cover Sheet
(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, (Rev. 10/95)
(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) Instructions for Completing Form NIH 2706 (Financial
Report
(10) Procurement of Certain Equipment, NIH(RC)-7
Other - to be submitted as directed by Contracting Officer
----------------------------------------------------------
(11) Certificate of Current Cost or Pricing Data, NIH-1397
(12) Subcontracting Plan Format
4. The Representations and Certifications are applicable.
5. The "Sample Contract Format-General" is applicable.
*******************************************************************
*******************************************************************
RFP-NIH-NIAID-DAIDS-97-01
ATTACHMENT 6
4/15/96
IV. AGREEMENT FOR SUBMITTING PRODUCTS TO THE DIVISION OF AIDS
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SCREENING AGREEMENT FOR SUBMITTING PRODUCTS TO THE DIVISION OF
ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, HEREAFTER REFERRED TO AS
THE DIVISION,
BY
______________________________________________________,
HEREAFTER REFERRED TO AS THE SUPPLIER.
1. The SUPPLIER may supply products, patented or unpatented, to
the DIVISION which may proceed to screen and test for possible
treatment for AIDS and associated opportunistic infections
including tuberculosis. These products are to be used for
screening and testing as anti-viral, anti-bacterial, anti-
fungal, anti-parasitic, immunomodulating, and biological
modifying agents with potential for the treatment of AIDS and
associated infections, and for no other purpose.
Using protocols evaluated and approved mutually by the
DIVISION and the SUPPLIER, the products will be screened by
one or more of the DIVISION's contract testing laboratories,
or in any other testing laboratories which may from time to
time be added to the DIVISION's portfolio but in any event
will not be placed in the laboratories of any company in the
pharmaceutical or chemical industries without the SUPPLIER's
written permission.
2. In order to facilitate records keeping and handling of
confidential materials, the DIVISION utilizes the following
procedures:
a. The SUPPLIER shall forward to the [INSERT BRANCH NAME] of
the DIVISION the products to be tested together with data
sheets in duplicate for each product, giving pertinent
available data as to chemical constitution, solubility,
toxicity, previous biological efficacy and any
precautions which need to be followed in handling,
storing, and shipping.
b. It is clearly understood that no data about the products
and the results of the testing will be kept in files open
to the public either by the DIVISION, the testing
laboratories, or the data processing activities. Only
those employees directly engaged in the operation of the
DIVISION will have access to the files of information
regarding source and nature of confidential materials and
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results of testing, except as required pursuant to the
Freedom of Information Act, 5 U.S.C.552.
c. Whenever possible the SUPPLIER will be given the choice
of the DIVISION's contract testing laboratories, although
at present there is no preference; and it is understood
that the DIVISION reserves the right to send the
SUPPLIER's products to another screening contractor if
the need arises. It is furthermore understood that the
contracts between the DIVISION and the testing
laboratories will contain provisions to safe guard the
SUPPLIER's rights under this Agreement.
d. Because the DIVISION's screening effort will be
accomplished in collaboration with the DIVISION's
scientific staff and academic collaborators, as well as
the SUPPLIER's own staff, the DIVISION will work in
concert to assure rapid ongoing communications of
screening data to the SUPPLIER, and the SUPPLIER will in
turn use its best efforts to keep the DIVISION informed
on the SUPPLIER's own ongoing concomitant studies.
3. Although the SUPPLIER recognizes that the interchange of
information is generally desirable in the field of treatment
for AIDS, it is mutually understood that the SUPPLIER, in
voluntarily supplying appropriately marked information deemed
proprietary, including product and information regarding this
product hereunder, is entitled to protection for any such
technical information it may furnish.
a. It is understood and agreed to, subject to applicable
law, that the SUPPLIER shall retain all rights to those
compounds or products in which the SUPPLIER has a
proprietary interest. The SUPPLIER understands that
contractors have the right to elect to retain title to
inventions made under NIAID-supported contracts [37 CFR
401.14(b)]. The SUPPLIER deserves the right to reach an
agreement with these contractors concerning the
disposition of these intellectual property rights. The
DIVISION agrees to notify the SUPPLIER of the names of
the contractors prior to submitting compounds or products
to them.
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Subject notwithstanding, to the provision that, with
respect only to those drugs which have been
determined by means of the various screening and
testing processes to possess such significant
activity (strong potential to be scheduled for
clinical trial by the DIVISION, using mutually
approved protocols), the Government shall have a
royalty-free, irrevocable, nonexclusive license for
clinical trials under any patent which the SUPPLIER
may have or obtain on such compound or product or on
a process for use of such compound or product, to
manufacture and/or use by or for the Government the
invention(s) claimed by the patent(s) only for
medical research purposes related to or connected
with the treatment of AIDS and associated infections
including tuberculosis.
b. The DIVISION agrees that the publication of biological
data on products provided by the SUPPLIER is worthwhile
and shall be encouraged. Specifically:
(1) With regard to screening results on compounds in
which the SUPPLIER has a proprietary interest, and
that the DIVISION deems significant for the research
on therapies for AIDS and associated infections
including tuberculosis, the SUPPLIER agrees that the
DIVISION may publish or otherwise publicly disclose
such results after a period of 6 months from the
date of final reporting of screening and testing
results to the SUPPLIER in order for patent
applications to be filed. The DIVISION will consult
with the SUPPLIER prior to publication within this
period on screening and testing results.
(2) For all other compounds, the SUPPLIER will consult
with the DIVISION prior to publishing screening data
along with the available biological and physical
data; such consent shall not be unreasonably
withheld.
(3) In no case will the DIVISION publish information
identifying the SUPPLIER as the source of the
compound without written approval.
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c. As soon as tests are completed and reported to the
[INSERT BRANCH NAME] of the DIVISION, the SUPPLIER will
receive from the DIVISION a full report including all
screening data.
The products scheduled for clinical trial, referred
to herein, shall be designated by the DIVISION, and
the aforementioned report will specify the compounds
so selected. The [INSERT BRANCH NAME] of the
DIVISION shall be consulted whenever the SUPPLIER
desires to include screening data in a publication,
and appropriate credit shall be given to the U.S.
Public Health Service.
The DIVISION is confident that this agreement will lay the basis
for mutually satisfactory cooperation in the field and in the
treatment of AIDS and associated diseases.
In agreeing to the above, the SUPPLIER signs below, as well as the
attached duplicate of this agreement, and returns both to the
DIVISION for countersignature. One original will be returned for
the SUPPLIER's files.
_____________________________________ ________________________
Director, Division of AIDS Name (Signature)
NIAID, NIH
_____________________________________ ________________________
Date Title
________________________
Organization
________________________
________________________
Address
________________________
Date
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