RFP No. NIH-NIAID-DMID-98-12
Title: "EVALUATION OF VACCINES AND THERAPEUTICS AGAINST
INFECTIOUS DISEASES OTHER THAN AIDS IN THE ELDERLY
AND ADULTS"
Issued by: Rosemary McCabe Hamill
Contracting Officer
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
DATE ISSUED: JUNE 2, 1997
PROPOSAL DATE DUE: AUGUST 8, 1997, 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-98-12) entitled "EVALUATION
OF VACCINES AND THERAPEUTICS AGAINST INFECTIOUS DISEASES OTHER THAN
AIDS IN THE ELDERLY AND ADULTS". The Government anticipates 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, Background and Work Statement, dated May 30,
1997 (Attachment 1)
b. Deliverables and Reporting Requirements, dated May 30,
1997 (Attachment 2)
c. Evaluation Factors for Award, dated May 30, 1997
(Attachment 3)
II. Specific RFP Instructions and Provisions, dated May 30, 1997
(Attachment 4)
III. Applicable RFP References, dated May 30, 1997 (Attachment 5)
In addition to this directory which provides access to this
streamlined RFP, there are five other subdirectories in the Gopher
System (under C. RFP References) which must be retrieved, in whole
or in part, in order to submit a proposal. The identity of these
additional documents are detailed in Attachment 5 (Applicable RFP
References) of this RFP. If you are unable to download any of these
documents, please contact Sara M. Southard, Contract Specialist, by
phone/fax/internet at the numbers/addresses 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 which
comprise the competitive range.
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 8, 1997, at
4:30 p.m. local time at the address listed in Attachment 4, Item 4.
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 3%
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 negotiation, taking into consideration the most current
consumer price index (CPI).
BE ADVISED THAT YOUR TECHNICAL PROPOSAL SUBMITTED IN RESPONSE TO
THIS RFP IS SUBJECT TO A 200 PAGE LIMIT (excluding required sample
protocols and consent forms). The format and content of your
TECHNICAL PROPOSAL along with page limitation information is detailed
in the "Technical Proposal Table of Contents/Format", Attachment 4,
Item 10.
In addition, 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 what 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
conflicts 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 30, 1997. 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. SARA SOUTHARD, CONTRACT
SPECIALIST, OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING
INTERNET ADDRESS:
ss63e@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU
WILL NOT RECEIVE NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP.
HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER AND/OR NIH
HOME PAGE.
If you have any additional questions regarding this RFP, please
contact Sara Southard at the internet electronic mail address
ss63e@nih.gov , by phone at 301/402-6289, or by fax at 301/480-5253. 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
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RFP-NIH-NIAID-DMID-98-12
I. STREAMLINED RFP
ATTACHMENT 1
5/30/97
INTRODUCTION
------------
The objectives of this contract are to evaluate control measures
(vaccines and therapeutic agents) for infectious diseases in the
elderly and in adults with compromised immune function from
underlying disorders and diseases other than AIDS and to enhance the
understanding of the immune response to infection and immunizations
in these at risk populations. In addition to the clinical
evaluation of candidate vaccines and therapeutic agents, there is a
special emphasis on defining the mechanisms that lead to the decline
in immune function with age and from underlying disorders and
diseases (other than AIDS).
This RFP solicits proposals for work that includes a) clinical
evaluations (including, but not limited to, Phase I and Phase II
trials) of candidate vaccines and therapeutic agents in the control
of infectious diseases in these populations, b) research on the
dynamics of the host response to infection and immunization in these
populations, and, c) infectious disease surveillance studies
relevant to vaccine preventable (and potentially vaccine
preventable) diseases in these populations. It is anticipated that
one level-of-effort contract will be awarded to an interested party
who has assembled the best team capable of performing these
functions.
BACKGROUND
----------
The capability and capacity to enhance the understanding of immune
protection from infectious diseases and to evaluate new and improved
vaccine and therapeutic candidates in an efficient and expeditious
manner is an essential element of the efforts of the Division of
Microbiology and Infectious Diseases (DMID)of the National Institute
of Allergy and Infectious Diseases (NIAID). These activities are
important for the continued success of the Program for the
Accelerated Development of Vaccines begun in the 1980s, to fulfill
the goals and objectives of the 1994 National Vaccine Plan, and is
in concert with the mission of the Department of Health and Human
Service's 1997 Adult Immunization Initiative to reduce the impact of
infectious diseases that can be prevented by immunization. The
Institute has supported efforts to evaluate control measures for
infectious diseases during past decades, and supports a Maternal
Immunization Group (MIG), two Mucosal Pathogens Units, a Cooperative
Antiviral Study Group (CASG), the Mycoses Study Group (MSG), the
Tuberculosis Research Unit (TBRU), a Data Coordinating Center, a
Clinical Regulatory Support contract, and several Vaccine and
Treatment Evaluation Units (VTEUs) to facilitate these efforts.
The national response to the threat of childhood infectious diseases
has resulted in an effective expansion of our childhood immunization
efforts-from research and development to use in national
immunization programs. A parallel effort is needed to ensure a
similar success in the development of safe and effective vaccines
appropriate for adults and the elderly. In these populations, new
and improved vaccines are needed that will prevent both acute
infection and chronic sequelae of infection.
The major emphasis of this contract will be to conduct clinical
evaluations (including, but not limited to Phase I and Phase II
evaluations of candidate vaccines and therapeutic agents) to improve
the understanding of the impact of aging and underlying disorders
and diseases (other than AIDS) of adults on the immune response to
infection and immunization. Therefore, in addition to clinical
trials, this solicitation is also designed to encourage focused,
relevant, basic and preclinical research directly linked to
assessments of the immune response to infection and immunization in
these populations. The intent is to support research that will have
an impact on the design of preventive and therapeutic approaches of
interest to the Division of Microbiology and Infectious Diseases
(DMID), NIAID, in the control of infectious diseases. Ideally, the
assessment of the immune responses should be related to the clinical
investigations ongoing within this contract or in concert with
activities in other NIAID supported activities. Examples of
research that would be of interest include an examination of the
full spectrum of the immune response to natural infection and
immunization, studies of the pathogenesis of clinical infections,
and the identification and refinement of correlates of immunity and
protection in these populations. Animal models may be needed to aid
in these studies. Also of importance is the capacity to conduct
surveillance studies in these populations to better define the
burden of infections diseases and to facilitate the development and
evaluation of appropriate, sensitive and specific diagnostic tests
to facilitate both clinical management and disease surveillance
efforts.
Examples of infectious diseases for which vaccines and/or
therapeutic agents might be tested in the first eighteen months of
the contract and onward include, but are not restricted to: non-
typable Haemophilus influenzae, Neisseria meningitidis,
Streptococcus pneumoniae, Helicobacter pylori, Clostridium
difficile, respiratory syncytial virus, influenza, Bordetella
pertussis, varicella, hepatitis B, and parainfluenza virus. Vaccine
types available for testing may include, but are not restricted to:
inactivated, live attenuated, and subunit vaccines; polysaccharide
conjugate vaccines; recombinant peptides; DNA vaccines; as well as
promising new adjuvants and new delivery systems such as
microencapsulation and live recombinant vectors such as Salmonella.
If sufficient progress is made in the development of other vaccines,
such as fungal vaccines, these candidates may also be available for
clinical testing during the period of this contract. Evaluation of
vaccines or biologicals such as monoclonal antibodies as
immunotherapeutics for chronic infections or to prevent development
of chronic sequelae; e.g. therapeutic hepatitis vaccines given to
chronic carriers, may also be considered.
The Offeror should demonstrate access to appropriate populations as
well as appropriate staff, expertise, and facilities to test the
full range and number of candidate vaccines and therapies developed
by industry and government/academic scientists, and to conduct
research of the immune responses in these populations. As it is
anticipated that the full complement of expertise and access to
appropriate patient populations needed to fulfill the requirements
of this contract may extend beyond the range of geographically fixed
medical centers, collaboration with other individuals and
institutions is encouraged to provide the best expertise available
and to assure access to appropriate populations.
WORK STATEMENT
--------------
Independently and not as an agent of the Government, the Contractor
shall exert its best efforts to furnish all necessary services,
qualified professional and technical personnel, volunteer
populations, materials, equipment, and facilities, 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) Provide and retain patients from appropriate populations as
required to conduct all clinical studies identified under Work
Statement Item (2), below.
[NOTE TO OFFEROR:
A. The target populations for most vaccines and other
preventive/therapeutic regimens are the elderly and adults with
underlying disorders and diseases that affect their immune response
to infection and immunization other than AIDS. Specific high risk
groups may include nursing home residents, organ transplant
recipients, and patients with chronic diseases or specific co-morbid
conditions such as cancer. To fully appreciate the impact of aging
and/or underlying disorders and diseases on immune function, some
clinical studies may also require testing in healthy adult
volunteers of different ages before progressing into target
populations.
B. Availability of elderly populations and adults with co-morbid
conditions that elevate their risk of morbidity and/or mortality
from infections diseases should be described. Depending upon the
vaccine or the study, there may be a need for seropositive or
seronegative volunteers. Therefore, it is anticipated that access
to large numbers of volunteers will be needed to ensure adequate
enrollment in the studies.]
(2) Conduct clinical evaluations of candidate vaccines and/or
therapeutic agents. Depending on the protocol and the
intervention being tested, these evaluations may determine any
of the following: vaccine safety, immunogenicity, efficacy,
reactogenicity, optimal dose and schedule, degree of virulence
or attenuation, infectivity, transmissibility, and genetic
stability. ALL STUDIES AND CLINICAL PROTOCOLS ARE SUBJECT TO
PROJECT OFFICER APPROVAL.
[NOTES TO OFFEROR:
C. The range and number of studies anticipated requires enrollment
of a minimum of 150 subjects per year.
D. It is anticipated that the Government will provide all
candidate vaccines and/or therapeutics for testing.
E. For technical evaluation purposes, offerors should provide the
following sample protocols and consent forms for each of the vaccine
clinical trials outlined below:
i) Phase I clinical trial of a novel adjuvant to enhance
immunogenicity of a conjugate pneumococcal vaccine (Note:
see also 4.F below).
ii) Phase II clinical trial of a novel adjuvant to enhance
immunogenicity of a conjugate pneumococcal vaccine (Note:
see also 4.F below).
iii) Human challenge study to test the safety (infectivity,
transmissibility, genetic stability and reactogenicity),
immunogenicity and protective efficacy of a multicomponent
live attenuated influenza virus vaccine.
iv) Immunogenicity study of a Hepatitis B vaccine to better
understand the factors that contribute to the blunted
immune response in the elderly.
Sample protocols and consent forms submitted with the proposal
should demonstrate that the Offeror thoroughly understands testing
different types of vaccines. This includes testing up to and
including the target populations of elderly and appropriate
comparison groups such as healthy adults and those with defined at-
risk conditions such as cancer. Offerors should be poised to take
full advantage of vaccine evaluations by integrating assessments of
immune function and immune response to both infection and
immunization in these populations. In addition, integration of the
surveillance component (see Work Statement Item #8, below) is
encouraged.]
(3) Collect and appropriately store sera, other body fluids and
cells from study participants. Methods of collection, amounts,
types and storing specifications of samples shall depend upon
individual protocols.
(4) Conduct appropriate immunologic assays on sera and other
clinical specimens collected from study participants to
characterize the nature of the immune response to wild type
infections and/or candidate vaccines and/or therapeutic agents,
as required in the protocol. Assays may include but are not
limited to: humoral assays, cellular assays (such as,
measurement of cytokines and proliferative assays) and
appropriate mucosal assays. Assays for antigens/antibodies
shall be conducted by the Contractor unless otherwise directed
by the Project Officer.
[NOTE TO OFFEROR:
F. For evaluation purposes and as related to the protocols
described above (2.E.i/2.E.ii-Phase I and Phase II clinical trials
of a novel adjuvant to enhance immunogenicity of a conjugate
pneumococcal vaccine) describe the handling, storage and immune
assessments of:
i) pre- and post-vaccination blood draws to assess serum
antibody assays for relevant vaccine serotypes. These
serum assays should include type-specific IgM, IgA, and
IgG subclasses (IgG1, IgG2, IgG3, and IgG4) and
opsonophagocytic activity; and,
ii) nasal wash or nasopharyngeal aspirate samples for
detection of mucosal immune response (type-specific
mucosal IgA).]
(5) Establish and/or maintain a focused, coordinated, immunity
research component investigating elderly host immune response
and/or pathogenic mechanisms in infections that are relevant to
vaccine development for the target populations and are of
demonstrated importance to the Division of Microbiology and
Infectious Diseases, NIAID. This research effort shall be
integrated with the clinical evaluation of vaccines and/or
therapeutic agents in this contract.
Prior to initiating any studies within this research component,
detailed research plans including rationale and methodology
shall be submitted for review and written approval by the
Project Officer.
[NOTES TO OFFEROR:
G. The investigations into the details of the immune response
component may include, but are not limited to, the pathogenesis of
the infection and disease, and especially, the immune response to
infection and candidate vaccines in the elderly and special at-risk
adult populations. This may also include identification and
refinement of correlates of immunity and protection.
H. It is anticipated that these studies may need to employ either
animal models or cultured cells as appropriate. However, it is not
the intent of this solicitation to support a basic research program
that is unrelated to the vaccine development and evaluation efforts
of DMID/NIAID. Continued support for activities in this research
component are subject to acceptable productivity and ongoing
relevance to the vaccine development and evaluation activities of
DMID/NIAID.
I. For technical evaluation purposes, one sample research plan
that demonstrates the Offeror's approach to an integrated immune
response component should be submitted with the technical proposal.
The plan should include details of rationale, significance,
approaches and methodology.]
(6) Follow vaccinees to document duration of antibody and/or immune
response, resistance to infection in the event of natural
exposure within the community, and potential hazards of
immunization as requested by the Project Officer.
(7) Develop and prepare protocols, consent forms, and other IND
information for submission to the Project Officer and local
Institutional Review Board (IRB) for approval and for NIAID to
submit to the FDA as part of an Investigational New Drug (IND)
package. Amend as necessary after comments by the Project
Officer, the DMID Clinical and Regulatory Affairs Branch, local
IRB, and regulatory authorities are provided.
(8) Initiate and maintain epidemiologic and laboratory surveillance
for infection in the populations proposed for study to provide
the necessary background information for vaccine and
therapeutic agent studies, and as directed by the Project
Officer. In addition to epidemiologic surveillance of the
proposed population, monitor appropriate personnel and project
staff for these same agents as directed by the Project Officer.
[NOTE TO OFFEROR:
J. The purpose of this surveillance activity is to aid in the
following:
a. Interpretation of the volunteers' response to
vaccination vs. natural infection.
b. Initiation of clinical trials with vaccine at a time
when the wild-type pathogen is not at its peak
circulation in the population chosen for the study.
c. Determination of the impact of a particular pathogen
in a selected high risk population.
K. A sample surveillance plan to determine the incidence of
infections with RSV, influenza, B. pertussis and pneumococcal
disease in these populations should be submitted with the proposal.
A description of other on-going infectious disease surveillance in
these populations should also be included.]
(9) Organize and administer the clinical and associated research
activities of the contract.
a. Plan, conduct, and report on the proposed clinical studies
and associated research studies. This shall include
developing the specifics of experimental design, receiving
and shipping of reagents and samples, coding of patients,
reagents, and samples, and coordinating all of the
subcontractors' activities (if applicable). This shall
also include conducting all clinical studies in compliance
with DMID/NIAID policy and in coordination with the
Clinical and Regulatory Affairs Branch, DMID/NIAID.
b. Manage the information generated, including transmission,
storage, confidentiality, retrieval, validation, analysis,
and publication.
c. Coordinate the preparation of all manuscripts and
presentations involving data from the studies. Establish a
publication policy for results of multi-center studies, if
applicable. All publications shall acknowledge NIAID
support and be submitted to the Project Officer for
review, prior to publication. The Project Officer shall
have access to all data generated with the support of this
contract.
d. Establish and manage laboratory facility(ies) to support
the various studies.
e. Perform, supervise, coordinate, and monitor the
project(s).
f. Report to the DMID Clinical and Regulatory Affairs Branch
and to the Project Officer all adverse reactions to comply
with FDA regulations.
[NOTES TO OFFEROR:
L. A detailed organizational plan/chart should be provided that
shows the administrative structure, reporting and publication
policy/structure, supervisory roles and, if applicable, the
interactions with potential collaborators.
M. Biostatistical and data management capabilities for analysis of
clinical data should be documented.]
(10) The Principal Investigator and one designated co-investigator
shall organize, attend and participate in one 2-day meeting per
year in Bethesda, Maryland, for protocol and study development
and/or to discuss results and future plans.
(11) The individual serving as the research nurse coordinator or
clinical trial coordinator and one other designated staff member
shall attend and participate in one 2-day meeting per year in
Bethesda, Maryland, to discuss clinical trial coordination, and
regulatory issues related to clinical trials.
[GENERAL NOTES TO OFFEROR:
AA. The technical proposals submitted in response to the RFP are
subject to a 200 page limitation, excluding sample protocols and
consent forms. Please see the RFP Attachment 4., entitled
"Technical Proposal - Table of Contents" for additional details.
BB. A two page biosketch for all proposed professional personnel
should be included in the proposal.
CC. Award of the contract does not commit the Government to approve
any of the studies outlined and/or protocols presented in the
proposal. The purpose of these proposed studies and protocols is to
demonstrate the Offeror's technical ability and approach. The
proposed studies will not necessarily be implemented during contract
performance. During contract performance, as scientific or public
health opportunities arise, the contractor will be requested to
submit protocols addressing these opportunities. Only studies
approved by the Project Officer will implemented under this
contract.
DD. For contracts dealing with clinical research, it is the policy
of the NIH to include women and minorities in study populations so
that research findings can be of benefit to all persons at risk of
the disease, disorder or condition under study. Special emphasis
should be placed on the inclusion of minorities and women in studies
of diseases, disorders and conditions that disproportionately affect
them. This policy applies to males and females of all ages.
Racial/ethnic minorities include Native American, Asian or Pacific
Islander, Black and Hispanic groups. Clinical research includes
human biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis and treatment of
diseases, disorders and conditions, including but not limited to
clinical trials. The composition of the proposed study population
must be described in terms of gender and racial/ethnic group,
together with the rationale for its choice. In addition, gender and
racial/ethnic issues should be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study. Offerors are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
EE. For additional information on the Government's level of effort
estimates for this project, please see the "Level of Effort
Estimate" provision outlined in RFP Attachment 4. In addition, to
assist with the cost proposal preparation and to further describe
the Government's requirements, an approximate breakout of each of
the three major components of this contract are provided:
- Conduct clinical trials/evaluations of candidate vaccines and
therapeutic agents: 70% of the overall yearly effort;
- Conduct immunologic studies to evaluate the senescent and/or
compromised immune system and its response to infectious
diseases and immunizations: 20% of the overall yearly effort;
- Conduct surveillance of vaccine-related infectious diseases
in these populations and of interest to the Institute and/or
relevant to on-going and/or proposed clinical trials: 10% of
the overall yearly effort.
The Project Officer will ultimately determine the actual level of
effort to be expended on any protocol or approach.]
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RFP-NIH-NIAID-DMID-98-12
ATTACHMENT 2
5/30/97
REPORTING REQUIREMENTS
______________________
The Contractor shall submit to the Contracting Officer and to the
Project Officer technical progress reports covering the work
accomplished during each reporting period. These reports are subject
to technical inspection and requests for clarification by the
Project Officer. These shall be brief and factual and prepared in
accordance with the following format:
A. TECHNICAL REPORTS
In addition to those reports required by SECTION I and other
terms of this contract, the Contractor shall prepare and submit
the following reports in the manner stated below:
(1) SEMI-ANNUAL TECHNICAL PROGRESS REPORTS - by the fifteenth
working day of the month following the end of each six month
period, the Contractor shall submit five (5) copies of the Semi-
Annual Technical Progress Report, comprising four (4) 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 name and address, the author(s), and the
date of submission;
b. SECTION I - An introduction covering the purpose and
scope of the contract effort;
c. SECTION II - A description of overall progress plus a
separate description for each task or other logical
segment of work on which effort was expended during the
report period. The description shall include pertinent
data and/or graphs in sufficient detail to explain any
significant results achieved and preliminary conclusions
resulting from analysis and scientific evaluation of data
accumulated to date under the project;
d. SECTION III - Substantive performance; a description of
current technical or substantive performance and any
problems encountered and/or which may exist along with
proposed corrective action. Each clinical study should be
reported separately according to the number assigned by
the Project Officer. An explanation of any difference
between planned progress and actual progress, why the
differences have occurred and if behind planned progress
what corrective steps are planned;
e. An anticipated work plan for the next six months; and
f. Pre-prints, reprints of papers and abstracts shall be
submitted along with the report.
Semi-Annual Technical Progress Reports are not due for periods
in which an annual or final report is due.
(2) ANNUAL REPORTS - On the anniversary date of the contract,
the Contractor shall submit 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 and shall include information regarding numbers
of women and minority subjects enrolled in trials. 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, in any, are set forth in Article
C.1, Work Statement. A one page summary of each ongoing and
completed protocol shall also be submitted at this time. Pre-
prints, reprints of papers and abstracts not submitted in the
semi-annual technical progress report shall be submitted.
An annual report will not be required for the period when the
final report is due.
(3) 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.
These final reports shall detail, document and summarize the
results of the entire contract period of performance. These
reports shall be in sufficient detail to explain
comprehensively the results achieved. Pre-prints, reprints of
papers and abstracts not included previously shall be
submitted.
(4) SUMMARY OF SALIENT RESULTS - With the annual and final
reports the Contractor shall submit a summary (not to exceed
200 words) of salient results achieved during performance of
the contract.
(5) OTHER REPORTS - The Contractor shall submit to the Project
Officer seven (7) copies of: a) a one page summary of each
ongoing and completed protocol one year and thirty days after
an individual IND goes into effect; and b) yearly IRB approvals
and supporting documentation.
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 any anticipated delays with reasons.
C. Technical Report Distribution
Copies of the technical reports shall be submitted as follows:
Type of No. of
Report Copies Addressee Due Dates
-------------------------------------------------------------
Semi-Annual 4 Project Officer Semi-Annually
Progress DMID, NIAID, NIH (Specific dates
Solar Building, Room will be listed
6003 Executive Blvd. in the contract
Bethesda, MD 20892 document.)
Semi-Annual 1 Contracting Officer Same as above
Progress CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Blvd.
Bethesda, MD 20892
Annual 7 Same as P.O. above Annually
(Specific dates
will be listed
in the contract
document.)
Annual 1 Same as C.O. above Same as above
Final 7 Same as P.O. above Expiration date
Final 1 Same as C.O. above Same as above
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RFP-NIH-NIAID-DMID-98-12
ATTACHMENT 3
5/30/97
EVALUATION FACTORS FOR AWARD
____________________________
1. GENERAL
Proposals submitted in response to this solicitation will be subject
to review by an ad hoc technical review committee. The evaluation
will be based on the demonstrated capabilities of the prospective
contractor 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 THE PROPOSALS
The technical proposal will receive paramount consideration in the
selection of the Contractor for this acquisition, but not to the
exclusion of cost or price. All evaluation factors other than cost
or price, when combined, are significantly more important than cost
or price. During the source selection process, the closer that
offerors are determined to be in technical ability, the greater the
importance of cost or price. When offerors are considered to be
essentially equal in technical ability, a greatest value analysis
will be conducted to determine the award.
The Government reserves the right to make an award based on the
greatest value to the Government in terms of cost or price, and
other factors.
3. MANDATORY QUALIFICATION FOR FACILITIES
Prior to award the offeror must document the adequacy and
suitability of the facilities for performing all of the requirements
of the Work Statement.
4. TECHNICAL EVALUATION CRITERIA
Proposals submitted in response to this RFP will be evaluated based
on the following factors which are listed and weighted in order of
their relative importance. Proposals will be judged solely on the
written material provided by the Offeror.
CRITERION ELEMENT WEIGHT
_________________ ______
1. TECHNICAL APPROACH 80
Scientific merit of proposed approach to:
a) Perform clinical evaluations of vaccines and therapeutic
agents (30)
This includes the methods and approaches for evaluating
primarily bacterial and viral vaccines, but may also
include capability and capacity to evaluate antiviral
compounds or other agents. Suitability and originality of
the sample clinical protocols, appropriateness of consent
forms, handling of data, plans for handling, storing and
performing assays on sera and other body fluids, and for
other relevant laboratory procedures as required in the
protocols and as requested in the Work Statement.
b) Perform evaluation of the senescent and/or compromised
immune system (20)
Methods and approaches for developing and/or maintaining
an integrated research component to assess the impact of
aging and/or underlying disorders or diseases other than
AIDS on the immune system's response to infection and/or
immunization that is relevant to the NIAID's vaccine
development and evaluation efforts and integrated with the
clinical evaluation and the infectious disease
surveillance components.
c) Access appropriate populations (10)
Offeror should demonstrate an ability to recruit, retain,
and follow appropriate populations. Strategies for follow-
up of volunteers should be presented. The recruitment
plan should describe specific plans to include minorities
and women.
d) Perform Infectious Disease Surveillance (10)
This includes the proposed methods and approaches for
collecting surveillance data to support trials of vaccines
and/or therapeutic agents, evaluating risk factors for
infection, evaluating screening protocols, suitability of
the sample protocols, appropriateness of the consent forms
(if necessary), strategies for follow-up of patients,
handling of data, and plans for integrating these findings
with the clinical evaluations and the and immune response
component.
e) Administration (10)
Proposed plans for managing the clinical and basic
research activities to ensure a cooperative, integrated
scientific effort.
2. PERSONNEL 20
Documented adequacy and relevance of expertise, experience,
education, and availability of personnel for performing all the
requirements of the Work Statement.
The PI should have an M.D. and/or Ph.D. degree and should
provide documented evidence of experience in clinical trials
involving appropriate populations. The team of professional
personnel (including the nursing personnel) should have
composite expertise in internal medicine, geriatrics,
infectious diseases, immunology, clinical trials,
immunodiagnostics, host response to pathogens and vaccines,
epidemiologic studies, data management and biostatistics. The
technical personnel should have documented training and
experience to perform the assay and laboratory procedures. The
support staff should possess the requisite experience to
perform their clerical and administrative duties.
TOTAL POSSIBLE POINTS ....................................... 100
5. EVALUATION OF MINORITY GROUP AND GENDER REPRESENTATION
(NIH 3185) (JUL 1994)
This research project involves human subjects. NIH Policy requires
that woman and members of minority groups and their sub-populations
must be included in the study population of all NIH supported
biomedical and behavioral research projects involving human
subjects, unless a clear and compelling rationale and justification
are provided that inclusion is inappropriate with respect to the
health of the subjects or the purpose of the research.
Where inclusion of women and minority populations is not feasible, a
detailed rationale and justification for exclusion of one or both
groups from the study population must be submitted with the
technical proposal. The NIH will review the exclusion rationale to
determine if it is appropriate with respect to the health of the
subjects and/or the purpose of the research. If the rationale is
not considered acceptable by the Government and you are included in
the competitive range, you will be afforded the opportunity to
further discuss and/or clarify your position during discussions or
include women and minorities in your best and final (BAFO). If your
exclusion position is still considered unacceptable by the Government
after discussions, your proposal may not be considered further for
award.
This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing research
involving human subjects should read the "NIH Guidelines for
Inclusion of Women and Minorities as Subjects in Clinical Research",
which have been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol.
23, No.11, March 18, 1994.
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RFP-NIH-NIAID-DMID-98-12
ATTACHMENT 4
5/30/97
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 $5,000,000.
(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 $5,000,000.
(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 April 1, 1998.
It is anticipated that the award from this solicitation will be
multiple-year cost reimbursement, level of effort type 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
It is expected that a level of effort 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 direct labor effort to
be approximately 3,875% (775%/year). This estimate 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:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
-------- ---- ---- ---- ---- ---- -----
P.I. 25% 25% 25% 25% 25% 125%
Investigators 200% 200% 200% 200% 200% 1,000%
RNs 250% 250% 250% 250% 250% 1,250%
Tech. Support 250% 250% 250% 250% 250% 1,250%
Admin. Support 50% 50% 50% 50% 50% 250%
==== ==== ==== ==== ==== ======
TOTAL 775% 775% 775% 775% 775% 3,875%
* 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. 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-98-12"
"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).
5. GOVERNMENT NOTICE FOR HANDLING PROPOSALS
An Offeror shall place this notice on top of each copy of its
technical proposal.
"This proposal shall be used and disclosed for evaluation purposes
only, and a copy of this Government notice shall be applied to
any reproduction or abstract thereof. Any authorized restrictive
notices which the submitter places on this proposal shall also be
strictly complied with. Disclosure of this proposal outside the
Government for evaluation purposes shall be made only to the
extent authorized by, and in accordance with, the procedures in
HHSAR paragraph 315.608-72."
(For information regarding authorized restrictive notices, offerors
should refer to the "Confidentiality of Proposals" section of the
STANDARD RFP INSTRUCTIONS AND PROVISIONS subdirectory of the RFP
REFERENCES directory of the Gopher RFP).
6. 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 S. 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.
7. PRIVACY ACT SYSTEM OF RECORDS
The Privacy Act System of Records Notice that applies to this RFP
was published in the Federal Register dated January 13, 1993, Vol.
58, No. 8, Pages 4226-4228. This notice will be incorporated into
any contract resulting from this RFP. If you would like a copy,
please contact the Contracting Officer identified in the cover
letter to this RFP.
8. PHS 352.223-70 SAFETY AND HEALTH
(a) In order to help ensure the protection of the life and health
of all persons, as well as to help prevent damage to property,
the Contractor shall comply with all Federal, State, and local
laws and regulations applicable to the work being performed
under the contract. These laws are implemented and/or enforced
by the Environmental Protection Agency, Occupational Safety and
Health Administration, and other agencies at the Federal,
State, and local levels (Federal, State, and local
regulatory/enforcement agencies).
(b) Further, the Contractor shall take or cause to be taken such
additional safety measures as the Contracting Officer, in
conjunction with the project or other appropriate officers,
determines to be reasonably necessary. If compliance with such
additional safety measures results in an increase or decrease
in the cost or time required of performance of any part of work
under this contract, an equitable adjustment will be made in
accordance with whichever applicable "Changes" Clause as set
forth in this contract (FAR 52.243-1, Changes-Fixed Price; FAR
52.243-2, Changes-Cost-Reimbursement; or FAR 52.243-3,
Changes-Time and Materials or Labor-Hours).
(c) The Contractor shall maintain an accurate record of, and
promptly report to the Contracting Officer, all accidents or
incidents resulting in the exposure of persons to toxic
substances, hazardous materials or hazardous operations; the
injury or death of any person; and/or damage to property
incidental to work performed under the contact and all
violations for which the Contractor has been cited by any
Federal, State, or local regulatory/enforcement agency. The
report shall include a copy of the notice of violation and the
findings of any inquiry or inspection, and an analysis
addressing the impact these violations may have on the work
remaining to be performed. The report shall also state the
required action(s), if any, to be taken to correct any
violation(s) noted by the Federal, State, or local
regulatory/enforcement agency and the time frame allowed by the
agency to accomplish the necessary corrective action.
(d) If the Contractor fails or refuses to comply promptly with the
Federal, State, or local regulatory/enforcement agency's
directive(s) regarding any violation(s) and prescribed
corrective action(s), the Contracting Officer may issue an
order stopping all or part of the work until satisfactory
corrective action (as approved by the Federal, State, or local
regulatory/enforcement agencies) has been taken and documented
to the Contracting Officer. No part of the time lost due to
any such stop work order shall be subject to a claim for
extension of time or costs or damages by the Contractor.
(e) The Contractor shall insert the substance of this clause in
each subcontract involving toxic substances, hazardous
materials, or hazardous operations. Compliance with the
provisions of this clause by subcontractors will be the
responsibility of the Contractor.
9. 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.
10. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT
IMPORTANT: Technical proposals submitted in response to this
RFP MUST NOT EXCEED 200 PAGES, however, this limitation does not
include copies of the requested sample protocols and consent forms.
PAGES SUBMITTED IN EXCESS OF THIS LIMIT WILL BE DELETED AND WILL
NOT BE REVIEWED. PLEASE NUMBER EACH PAGE. 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.
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
equipment, 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 2 page biosketch and the
form entitled "Summary of Current and Proposed Activities"
under Sections 6 and 7 below.]
d. OTHER CONSIDERATIONS (provide brief narrative
of any unique arrangements, safety procedures
in place, animal welfare issues, human subject
and minority and gender issues, etc.)............. ___
5. SAMPLE PROTOCOLS AND CONSENT FORMS (Note: These
documents are excluded from the page limitation
requirement.) ....................................... ___
6. APPENDICES (resumes/biosketches, literature
citations, policy manuals, etc. for above Technical
Plan); list each Appendix; Appendices must be clear
and legible, and easily located ...................... ___
7. 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 Space 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).
**********************************************************
11. PROPOSAL INTENT RESPONSE SHEET
PROPOSAL INTENT
---------------
RFP No.: NIH-NIAID-DMID-98-12
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: Sara M. Southard
RFP NIH-NIAID-DMID-98-12
Fax # 301/480-5253
PLEASE RETURN BY: JULY 30, 1997
************************************************************
********************************************************************
RFP-NIH-NIAID-DMID-98-12
ATTACHMENT 5
5/30/97
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" (below).
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) HUMAN SUBJECTS
(3) CARE OF LIVE VERTEBRATE ANIMALS - NOTICE TO OFFERORS OF
REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE
ANIMAL SUBJECTS (SEP 1985), PHSAR 352.280-2(a)
(4) SMALL, SMALL DISADVANTAGED AND WOMEN-OWNED SMALL BUSINESS
SUBCONTRACTING PLAN, FAR 52.219-9 [NOTE: A Subcontracting Plan
is not due with the initial proposal. The Contracting Officer
will notify offerors if a plan becomes due.]
(5) INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
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
(11) Research Patient Care Costs, NIH(RC)-11
(12) NIH Women and Minority Policy
(13) Protection of Human Subjects - Assurance Identification/
Certification/Declaration, OF 310
OTHER - TO BE SUBMITTED AS DIRECTED BY CONTRACTING OFFICER
----------------------------------------------------------
(11) Certificate of Current Cost or Pricing Data, NIH-1397
(12) Subcontracting Plan
4. The Representations and Certifications are applicable and a
completed copy must be submitted with offeror's business proposal.
5. The "Sample Contract Format-General" is applicable.
********************************************************************
End of document