RFP No.NIH-NIAID-DAIDS-98-18
Title: GENETIC VARIATION OF HIV AND RELATED LENTIVIRUSES
Issued by: Kristiane E. Cooper
Contract Specialist
NIH/NIAID/Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, Maryland 20892-7610
DATE ISSUED: OCTOBER 1, 1997
PROPOSAL DATE DUE: DECEMBER 19, 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-DAIDS-98-18) for GENETIC
VARIATION OF HIV AND RELATED LENTIVIRUSES. The Government
anticipates the award of one (1), six (6) year, cost-reimbursement,
completion type contract as a result of this RFP.
This RFP is a trial of NIAID's Electronic Proposal and Review
System (EPRS). Offerors must submit their proposals
ELECTRONICALLY, in addition to one (1) original signed HARDCOPY
(note: six paper copies of SOPs, other pertinent manuals,
nonscannable figures or data, and letters of collaboration/intent
are required - see Attachment G for details).
NIAID's EPRS system will save offerors the paper and postage costs
which the mailing of multiple copies of a standard RFP proposal
imposes on the offeror. This approach will also allow us to conduct
the peer review based on the electronic availability of proposals.
This will save the money that would otherwise be spent shipping
proposals out to reviewers and for travel and per diem to bring in
reviewers for the Peer Review meeting. We hope this will prove to
be convenient to offerors, peer reviewers and the Government. This
is a pilot project, so your comments and suggestions are welcome.
Adequate security will be provided by using a dedicated server with
access restricted through passwords.
You must submit your electronic proposal (via the Internet) and the
signed hardcopy (to the address listed in Attachment E), for
receipt no later than DECEMBER 19, 1997, at 4:30 p.m.(EST).
Please note that the electronic copy of your proposal will need to
be submitted in Adobe Acrobat portable document format (PDF). The
hardcopy of your proposal must be signed by an official authorized
to bind your organization.
PLEASE BE ADVISED THAT THIS RFP HAS PAGE LIMITATIONS ON THE
NARRATIVE PORTION OF THE TECHNICAL PROPOSAL. PAGES IN EXCESS OF THE
MAXIMUM WILL BE DELETED AND WILL NOT BE READ OR EVALUATED. SEE
ATTACHMENT G FOR COMPLETE DETAIL ON PAGE LIMITATIONS AND
INSTRUCTIONS ON HOW TO PREPARE AND SUBMIT A PROPOSAL.
The documents included with this streamlined electronic RFP package
are as follows:
STREAMLINED RFP
Attachments:
A. Introduction and Statement of Work, dated October 1, 1997
B. Deliverables and Reporting Requirements, dated October 1,
1997
C. Evaluation Factors for Award, dated October 1, 1997
D. Proposal Intent Form
E. Specific RFP Instructions and Provisions
F. Applicable RFP References
G. How To Prepare and Submit a Proposal
In addition to the directory which you are currently in (i.e., the
streamlined RFP), there are five (5) other subdirectories in the
Gopher System (under C. RFP References) which must be retrieved, in
whole or in part, in order to submit a proposal; the applicable
portions are explained in Attachment F. The subdirectories are:
Standard RFP Instructions and Provisions
Optional RFP Instructions and Provisions
Forms, Formats and Attachments
Representations and Certifications
Sample Contract Format-General
If you are unable to download any of the applicable documents,
please contact Kristiane E. Cooper, Contract Specialist, or
Lawrence M. Butler, Contracting Officer, by phone/fax/Internet (see
contact numbers/addresses below).
Your attention is further directed to the "Proposal Intent" form
which is Attachment D. Please complete this form and return it to
this office via fax or E-mail on or before NOVEMBER 11, 1997. This
will allow us to expedite preparations for the electronic
submission and peer review of proposals.
IF YOU INTEND TO SUBMIT A PROPOSAL, IT IS ESSENTIAL THAT YOU SUBMIT
THE PROPOSAL INTENT FORM, OR IMMEDIATELY NOTIFY MS. KRISTIANE
COOPER, CONTRACT SPECIALIST, OR MR. LAWRENCE BUTLER, CONTRACTING
OFFICER, OF THE NIAID CONTRACTING OFFICE OF YOUR INTENT, AT THE
FOLLOWING INTERNET ADDRESSES:
kc116y@nih.gov
lb13t@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST OR
INTENT, YOU WILL NOT RECEIVE ANY NOTIFICATION OF AMENDMENTS ISSUED
TO THE RFP (HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH
GOPHER AND/OR NIAID CONTRACTS MANAGEMENT HOME PAGE) AND YOU WILL
NOT RECEIVE ADDITIONAL INSTRUCTIONS NECESSARY TO SUBMIT THE
ELECTRONIC COPY OF YOUR PROPOSAL.
Questions concerning any areas of uncertainty which in your opinion
require clarification or correction, must be furnished in writing
(at the above E-mail address) to Ms. Kristiane Cooper or Mr.
Lawrence Butler. Your questions should be received no later than
DECEMBER 3, 1997, and marked "Offeror's Questions, RFP-NIH-NIAID-
DAIDS-98-18."
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 have any additional questions or concerns regarding this
RFP, or the electronic transmission of proposals, please contact
either: Ms. Cooper at the Internet electronic mail address:
kc116y@nih.gov, by phone at 301/496-7288, or by fax at 301/402-0972; or Mr. Butler at the Internet electronic mail address:
lb13t@nih.gov, by phone at 301/496-0192 or by fax at 301/402-
0972. Collect calls will NOT be accepted.
Sincerely,
/s/
Toni Kuhn
Chief, AIDS Preclinical Research Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases
Attachments: A - G
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RFP-NIH-NIAID-DAIDS-98-18
STREAMLINED RFP
---------------
ATTACHMENT A - INTRODUCTION AND STATEMENT OF WORK
10/01/97
INTRODUCTION
HIV genetic heterogeneity may provide a major obstacle in the
development of an efficacious AIDS vaccine. It is possible that
the rapidly changing structure of HIV-1 proteins will necessitate
not one, but a series of AIDS vaccines tailored for the virus
strain(s) that is prominent in a geographic area, and changing as
the virus evolves with time. Studies show that HIV isolates from
different locales vary significantly in terms of their genomic
sequence. This genetic heterogeneity is reflected in changes in
serologic determinants and/or susceptibility to neutralization by
given antisera or monoclonal antibodies, and may also affect
cellular immune recognition of the virus by the host. However,
studies have also shown that there are conserved neutralization and
cytotoxic T-lymphocyte epitopes shared by diverse isolates,
suggesting the possibility that broadly cross-reactive vaccines
could be developed.
So that our program might be better prepared to address this
problem, the Division of AIDS has supported an HIV Variation
Program, consisting of two laboratories, a genetic cloning and
sequencing laboratory (University of Alabama at Birmingham; NO1-AI-
35170) and a virology/immunology laboratory (The Aaron Diamond AIDS
Research Center; NO1-AI-35168), in addition to a database and
analysis unit (Department of Energy, Los Alamos National
Laboratory; Y1-AI-7043), to study the potential impact of HIV
variation on vaccine efficacy. There is a continuing need to
develop well-characterized reagents that can be used in studies
designed to decipher the impact of genetic variation on
immunological recognition, such as: 1) functional envelope clones
for neutralization studies, protein production and SHIV constructs,
2) recombinant vaccinia viruses expressing HIV genes for use in CTL
studies, and 3) full-length proviruses for use in basic research
and vaccine design. Since the database is generally lacking in
full-length proviral sequences for all but the B-subtype viruses, a
sufficient number of representatives of all other subtypes need to
be characterized to determine the variable or conserved nature of
various, especially non-envelope, antigenic epitopes within and
between subtypes. Studies to investigate CTL recognition of
diverse HIV-1 subtypes are currently in progress at a number of
laboratories, and generation of recombinant vaccinia viruses
expressing HIV genes for all of the known genetic subtypes will be
valuable reagents for these studies.
The work described in the Statement of Work below for the study of
"Genetic Variation of HIV and Related Lentiviruses" is currently
being performed under contract NO1-AI-35170 with the University of
Alabama at Birmingham. This RFP is a recompetition of the contract
which is scheduled to end in July, 1998.
In general, the Contractor will receive samples derived from HIV-
infected individuals from laboratories or clinics identified by the
Project Officer. Using the polymerase chain reaction (PCR)
procedure or other state-of-the-art gene amplification procedure,
the Contractor will amplify and clone virus-specific genome
fragments or full-length proviruses into appropriate vectors for
genetic sequencing and expression. The Contractor will be required
to develop primer pairs for gene amplification that are both
appropriate for specified regions of the viral genome and for a
broad array of viral variants. Using state-of-the-art computer
technology the Contractor will compile and analyze the genetic
sequence data, including nucleotide and amino acid alignments, and
will transfer all data to the HIV Genetic Sequence Database and
Analysis Unit. Finally, the Contractor will be required to ship
specific clones to laboratories identified by the Project Officer.
STATEMENT OF WORK
Independently, and not as an agent of the Government, the
Contractor shall furnish all the necessary services, qualified
personnel, 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.
[NOTE 1 TO OFFEROR: IN RESPONDING TO THIS RFP, THE OFFEROR SHOULD
DESCRIBE IN DETAIL THE RESPONSIBILITIES AND LEVEL OF EFFORT OF ALL
PROPOSED PERSONNEL WHO WILL BE ASSIGNED TO THE CONTRACT. IN
ADDITION, THE OFFEROR SHOULD DESCRIBE AN ADMINISTRATIVE FRAMEWORK
SHOWING CLEAR LINES OF AUTHORITY AND A DETAILED WORK PLAN SHOWING
PROPOSED TIME SCHEDULES SATISFACTORY FOR ACHIEVING CONTRACT
OBJECTIVES AND MAINTAINING QUALITY CONTROL OVER THE IMPLEMENTATION
AND OPERATION OF THE CONTRACT.
DOCUMENTATION SHOULD ALSO BE PROVIDED ON THE QUALIFICATIONS,
EXPERIENCE, EDUCATION, COMPETENCE, AVAILABILITY, AND DECISION-
MAKING AUTHORITY OF THE PRINCIPAL INVESTIGATOR, TECHNICAL AND
ADMINISTRATIVE SUPPORT STAFFS; THE EXTENT TO WHICH OUTSIDE
CONSULTANTS SHALL BE USED AS WELL AS ASSURANCE OF THEIR
AVAILABILITY, AND THE PERCENTAGE OF TIME EACH STAFF MEMBER
(INCLUDING PROPOSED SUBCONTRACTORS AND CONSULTANTS) WHO WILL
CONTRIBUTE TO THE PROJECT. RESUMES, ENDORSEMENTS, AND EXPLANATIONS
OF PREVIOUS EFFORTS PROVIDED FOR THE PRINCIPAL INVESTIGATOR AND CO-
INVESTIGATOR(S) SHOULD CLEARLY DEMONSTRATE RELEVANT TRAINING,
EXPERIENCE, AND SPECIFIC ACCOMPLISHMENTS. NOTE: RFP INSTRUCTIONS
CAN BE ACCESSED BY USING /CONTRACT AND
SELECT THE "RFP" LINK AND THEN THE "NIH GOPHER RFP REFERENCE" LINK.
DOCUMENTATION SHOULD INCLUDE ALL PREVIOUS AND CURRENT PROJECTS OF A
SIMILAR NATURE, INCLUDING THE CONTRACT NUMBER OR GRANT NUMBER, THE
SPONSORING AGENCY, THE PROJECT OFFICER, AND DESCRIPTION OF THE
PROJECT.]
Specifically, the Contractor shall:
1. Amplify, clone and sequence HIV-1 and related lentivirus-
specific genes and full-length provirus genomes from samples
derived from HIV-infected individuals provided by the Project
Officer.
A. Design and generate nucleotide primer pairs for
amplification of specific regions of the viral genome, to
include but not be limited to the complete gp160 envelope
gene. Primers shall be designed in such a way as to
permit insertion of amplified sequences into various
vectors and subsequent removal of cloned fragments for
the purpose of transferring to other vectors of interest.
Also, design and generate primer pairs for amplification
of full-length proviruses.
[NOTE 2 TO OFFEROR: THE ORIGINAL SAMPLES WILL BE DERIVED FROM
SITES THROUGHOUT THE WORLD, INCLUDING BUT NOT LIMITED TO THE U.S.,
ASIA, AFRICA, EUROPE, CENTRAL AMERICA AND SOUTH AMERICA. THE
OFFEROR SHOULD PROVIDE DOCUMENTATION OF THEIR EXPERIENCE IN DESIGN
AND GENERATION OF PCR PRIMER SETS FOR AMPLIFICATION OF DIVERSE
SEQUENCES. THE OFFEROR SHOULD ALSO INDICATE, AND DOCUMENT IF
POSSIBLE, THEIR EXPERIENCE AT AMPLIFICATION AND CLONING OF FULL-
LENGTH GP160 GENES AND FULL-LENGTH PROVIRUSES OF HIV-1 AND/OR HIV-
2.]
B. Using the polymerase chain reaction, or other
state-of-the-art gene amplification system approved by
the Project Officer, amplify lentivirus genes and
proviruses using the primers generated under paragraph A.
above.
[NOTE 3 TO OFFEROR: AT THE PRESENT TIME, THE GOVERNMENT DOES NOT
KNOW THE NUMBER OF PCR AMPLIFICATIONS THAT WILL BE REQUIRED. FOR
THE PURPOSES OF BUDGET PREPARATION, THE OFFEROR SHOULD ASSUME THAT
A SUFFICIENT NUMBER OF AMPLIFICATIONS TO YIELD 25 GP160 GENES AND
15 FULL-LENGTH PROVIRUSES/YEAR WILL REQUIRED. ALTERNATIVE METHODS
(OTHER THAN LONG-RANGE PCR) FOR DERIVING PROVIRUSES FOR CLONING MAY
BE PROPOSED (SEE NOTE 5 BELOW).]
C. Provide stringent quality control to prevent PCR
contamination, and insure against cross-contamination of
samples before, during and after gene amplifications.
[NOTE 4 TO OFFEROR: THE OFFEROR SHOULD PROVIDE EXAMPLES OF THE
PROTOCOLS AND QUALITY CONTROL PROCEDURES CURRENTLY USED IN THEIR
LABORATORY THAT INSURE AGAINST PCR CONTAMINATION AND CROSS-
CONTAMINATION OF SAMPLES BEFORE, DURING, AND AFTER THE GENE
AMPLIFICATION REACTIONS IN THEIR TECHNICAL PROPOSAL.]
D. Clone viral genes and provirus genomes (derived by
long range PCR, lambda phage cloning or other method
approved by the Project Officer) into appropriate vectors
for functionality testing and sequencing.
[NOTE 5 TO OFFEROR: THE OFFEROR SHOULD PROPOSE THEIR METHOD OF
CHOICE FOR OBTAINING PROVIRAL CLONES, PROVIDING A JUSTIFICATION FOR
CHOOSING THIS PARTICULAR METHODOLOGY AND DESCRIBING THEIR
EXPERIENCE IN USING IT.]
E. Assess the functionality of all cloned genes and
provirus genomes. For envelope genes, devise and utilize
a strategy to test the ability of the cloned envelope
genes to function in cell binding and entry. For provirus
clones, test for infectivity and replication and repair
non-infectious clones utilizing genetic mutagenesis
procedures for clones identified by the Project Officer.
[NOTE 6 TO OFFEROR: FOR THE PURPOSE OF PREPARING A BUDGET, THE
OFFEROR SHOULD ASSUME THAT OF THE 25 GP160 CLONES ASSIGNED
ANNUALLY, 15 WILL BE REQUIRED TO BE FUNCTIONAL, AND OF THE 15 FULL-
LENGTH PROVIRUS GENOMIC CLONES ASSIGNED ANNUALLY, 5 WILL BE
REQUIRED TO BE FUNCTIONAL.]
F. Using automated sequencing techniques, derive the
nucleotide sequence of cloned genes and proviruses.
Sequencing shall be carried out in both the 3'to 5' and
5'to 3' directions to insure accuracy.
[NOTE 7 TO OFFEROR: AT THE PRESENT TIME, THE GOVERNMENT DOES NOT
KNOW THE VOLUME OF SEQUENCE DATA THAT WILL BE REQUIRED. FOR THE
PURPOSE OF PREPARING A BUDGET, THE OFFEROR SHOULD ASSUME THAT 25
GP160 CLONES AND 15 FULL-LENGTH PROVIRUSES WILL BE CLONED AND
SEQUENCED ANNUALLY.]
G. Subclone genes derived from provirus clones
identified by the Project Officer into shuttle vectors
(identified and/or provided by the Project Officer).
Mutagenize clones to optimize for their ultimate
function, as directed by the Project Officer. Ship these
constructs to laboratories identified by the Project
Officer.
[NOTE 8 TO OFFEROR: FOR THE PURPOSE OF PREPARING A BUDGET, ASSUME
A MINIMUM OF 20 SUBCLONES FOR THE ULTIMATE PURPOSE OF MAKING
RECOMBINANT VACCINIA VIRUSES (5 GAG GENES, 5 POL GENES, 5 NEF
GENES, AND 5 ENV GENES) WILL BE GENERATED ANNUALLY AND SHIPPED TO
THE PROJECT OFFICER. THE OFFEROR SHOULD PROVIDE IN THE TECHNICAL
PROPOSAL DETAILED INFORMATION ON THEIR EXPERIENCE WITH THE PCR,
GENETIC SEQUENCING, CLONING, AND QUALITY ASSURANCE REQUIRED TO
COMPLETE THIS TASK.]
2. Compile and analyze genetic sequence data, and transfer data
to Genbank and the HIV Genetic Sequence Database and Analysis
Unit at the Los Alamos National Laboratory.
A. Utilizing commercially available computer software,
examine sequence data generated to identify the reading
frames, frame-shifts and internal stop codons. Verify
the integrity of generated sequences by comparing them
with known HIV sequences to insure that the sequences
generated are HIV-specific and represent the proper gene
fragment.
B. Utilizing the services of the HIV Genetic Sequence
Database and Analysis Unit, electronically compile and
align all nucleotide sequence data, translate nucleotide
sequence data into amino acid sequence and align.
[NOTE 9 TO OFFEROR: THE CONTRACTOR WILL BE RESPONSIBLE FOR
VERIFYING THAT GENETIC SEQUENCES GENERATED ARE HIV-SPECIFIC BEFORE
ENLISTING THE SERVICES OF THE HIV GENETIC SEQUENCE DATABASE AND
ANALYSIS UNIT. THE HIV GENETIC SEQUENCE DATABASE AND ANALYSIS UNIT
WILL CARRY OUT ANALYSIS ON DATA GENERATED AND SUBMITTED BY THE
CONTRACTOR, INCLUDING NUCLEOTIDE AND AMINO ACID SEQUENCE
ALIGNMENTS, AT NO EXPENSE TO THE CONTRACTOR.]
C. Transfer all genetic data to Genbank and the
Sequence Database and Analysis Unit as specified in the
Deliverables and Reporting Requirements (Attachment B of
the RFP).
[NOTE 10 TO OFFEROR: ALL GENETIC SEQUENCE DATA WILL BE MADE
AVAILABLE BY THE SEQUENCE DATABASE AND ANALYSIS UNIT THROUGH THE
INTERNET AND VIA PUBLICATION IN THEIR ANNUAL COMPENDIUM. ALL
PROVIDERS OF SAMPLES AND INVESTIGATORS WHO HAVE CONTRIBUTED
DIRECTLY TO THE DATA GENERATION WILL BE CITED FOR THEIR
CONTRIBUTIONS. IN ADDITION, SEQUENCE DATA AND GENETIC CLONES MAY
BE MADE AVAILABLE BY THE PROJECT OFFICER TO VACCINE MANUFACTURERS
AS NEEDED.]
3. Receive, catalog, process and store samples, and distribute
samples to other investigators.
A. Receive samples from laboratories or clinics identified
by the Project Officer, including but not limited to HIV
culture fluids, frozen peripheral blood mononuclear cells
(PBMC) derived from either HIV-infected individuals or
from virus cultures, frozen blood plasma, and whole blood
collected in the presence of anticoagulants and shipped
either at ambient temperature or on ice.
[NOTE 11 TO OFFEROR: SAMPLE SUPPLIERS WILL INCLUDE, BUT ARE NOT
LIMITED TO THE UNAIDS NETWORK FOR HIV ISOLATION AND
CHARACTERIZATION, THE NIAID-SPONSORED AIDS VACCINE EVALUATION GROUP
CENTRAL IMMUNOLOGY LABORATORY, CURRENTLY LOCATED AT DUKE
UNIVERSITY, AND THE NIAID-SPONSORED HIVNET CENTRAL SUPPORT
LABORATORY, CURRENTLY LOCATED AT THE CALIFORNIA DEPARTMENT OF
HEALTH SERVICES. PAYMENT FOR SHIPMENT OF SAMPLES TO THE CONTRACTOR
WILL BE THE RESPONSIBILITY OF THE SUPPLIER.]
B. Advise investigators, identified by the Project
Officer, of the most suitable manner for preparing and
shipping samples.
C. Catalog and store all incoming samples in
preparation of genetic analysis.
D. Catalog and store aliquots of all amplification
reactions and all virus-specific clones derived.
E. Ship contract-derived samples, to include but not be
limited to cloned viral genes and proviruses, to
investigators identified by the Project Officer,
including the AIDS Reagent Program.
[NOTE 12 TO OFFEROR: AT THE CURRENT TIME, THE GOVERNMENT DOES NOT
KNOW WHAT NUMBER OF SAMPLES WILL NEED TO BE SHIPPED. FOR THE
PURPOSES OF BUDGET PREPARATION, THE OFFEROR SHOULD ASSUME THAT 5
SAMPLES/MONTH WILL BE SHIPPED TO THE AIDS REAGENT PROGRAM IN
ROCKVILLE, MD]
F. Handle and transport of all samples under this
contract in accordance with all applicable local, state,
Federal and international regulations including health
and safety standards. Obtain appropriate licenses and
permits required by local, state, and Federal authorities
for the safe import and distribution of biohazardous
samples.
G. Obtain evidence from direct suppliers of human blood
or tissue samples documenting that the specimens provided
were obtained in accordance with the Code of Federal
Regulations 45 CFR 46.
4. Provide Inventory and Database Management System. Provide and
maintain a computerized inventory and distribution database to
track samples and activities under this contract.
A. Maintain documentation on file for all incoming and
outgoing samples including method of processing, storage
conditions and specific storage location.
B. Maintain a tracking system such that samples can be
traced from receipt through processing, storage, genetic
analysis, and distribution.
C. Ensure protection against the loss of data by the
duplication of data base files on at least a monthly
basis. The system in its entirety shall be capable of
being transferred to the Government without interruption.
D. Provide for the security and safety of data on the
samples and information related to the use of the
isolates.
5. Provide facilities and resources
A. Provide facilities and equipment to receive, store
and manipulate biohazardous materials in an appropriate
manner, including Biosafety Level 2 containment. The
facilities shall provide aseptic and/or sterile
conditions as appropriate.
B. Provide, maintain and operate facilities for
controlled storage of samples and reagents at -10 to -20
degrees C, at -70 to -90 degrees C, and all other items
necessary for appropriate storage of biological reagents
with requisite monitoring of storage conditions to
guarantee continuous proper storage. The reliability of
supply systems, electrical power and backup support
systems shall be confirmed by the Contractor on a monthly
basis.
C. Provide protective garments, equipment and
sufficient monitoring to assure safe handling of
potentially hazardous materials, including biohazardous
and radioactive materials. Specifically, the Contractor
shall comply with all applicable health and safety
regulations while conducting the work set forth herein.
D. The Contractor shall conduct work under this
contract in accordance with all applicable Federal,
state, and local laws, codes, ordinances and regulations.
[NOTE 13 TO OFFEROR: THE OFFEROR SHOULD PROVIDE IN THE TECHNICAL
PROPOSAL THE FLOOR PLAN OF THE PROPOSED FACILITY AND LIST THE
EQUIPMENT AND RESOURCES TO BE DEDICATED TO THE PROJECT. THE
OFFEROR SHOULD INCLUDE A SAFETY, HEALTH, AND ACCIDENT PLAN IN THE
TECHNICAL PROPOSAL AND INCLUDE A SUMMARY OF THE OFFEROR'S SAFETY
AND HEALTH OPERATING PROCEDURES MANUAL. THE OFFEROR SHOULD INCLUDE
IN THE TECHNICAL PROPOSAL DOCUMENTATION OF ONGOING PROGRAMS AND
PLANS FOR PROGRAMS FOR: ADEQUATE TRAINING OF PERSONNEL HANDLING
INFECTIOUS AGENTS INCLUDING OPPORTUNISTIC PATHOGENS ASSOCIATED WITH
HIV INFECTION, DECONTAMINATION PROCEDURES, ACCIDENT PROCEDURES, AND
MONITORING FOR INFECTION, AS WELL AS THE ABILITY TO IDENTIFY SAFETY
STANDARDS APPLICABLE TO PARTICULAR REAGENTS LIKELY TO BE ACQUIRED
FOR THE PROJECT, IN CONFORMITY WITH THE HEALTH AND SAFETY CLAUSE,
PHS 352.223-70, ATTACHED TO THE RFP. DOCUMENTATION OF THE
CERTIFICATION OF THE BIOSAFETY LEVEL 2 CONTAINMENT FACILITY SHOULD
BE PROVIDED IN THE TECHNICAL PROPOSAL.]
[NOTE 14 TO OFFEROR: THE GOVERNMENT HAS PURCHASED EQUIPMENT FOR
THE CURRENT CONTRACTOR, INCLUDING AN AUTOMATED DNA SEQUENCER AND
BAR CODE TRACKING EQUIPMENT, THAT WILL BE TRANSFERRED TO THE
SUCCESSFUL OFFEROR IF NEEDED.]
6. Report progress according to Reporting Requirements (refer to
the "Deliverables and Reporting Requirements" in this contract
(Attachment B of this RFP).
7. Meet with Project Officer.
A. The Contractor's Principal Investigator and 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 continuing work to be performed. A portion
of these meetings will also include investigators
involved in other segments of the NIAID-supported HIV
Variation Initiative, in addition to advisors identified
by the Project Officer.
B. At least one of the Contractor's key personnel must
attend and present information on the results obtained
under this contract at one scientific meeting per year
identified by the Project Officer.
[NOTE 15 TO OFFEROR: FOR THE PURPOSE OF PREPARING A BUDGET, ASSUME
A MINIMUM OF 2 VISITS PER YEAR TO BETHESDA, MARYLAND TO MEET WITH
THE PROJECT OFFICER, AND ATTENDANCE FOR FOUR DAYS AT THE ANNUAL
MEETING OF THE NATIONAL COOPERATIVE VACCINE DEVELOPMENT GROUPS TO
BE HELD IN THE GREATER WASHINGTON, D.C. AREA FOR TWO CONTRACT
PERSONNEL.]
8. Obtain clearance for publication.
Provide advance copies of draft manuscripts (including
abstracts and public presentations) resulting from this
contact to the Project Officer, and obtain clearance in
writing before submitting for publication or presentation.
The Contractor shall be bound by the same terms as the
Government with respect to the confidential nature of
information provided by contributing investigators (as
specified by the Project Officer). Government support for
this contract must be acknowledged in all abstracts,
presentations, and publications.
[NOTE 16 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 OR PRESENTATION UNTIL WRITTEN CLEARANCE
HAS BEEN RECEIVED FROM THE PROJECT OFFICER. THIS IS NECESSARY TO
ENSURE PROTECTION OF THE RIGHTS OF THIRD PARTIES. APPROXIMATELY
ONE MONTH SHOULD BE ALLOWED FOR CLEARANCE BY NIAID AFTER RECEIPT.]
9. Implement an orderly transition to a successor Contractor.
Provide for an orderly transition of data and samples to a
subsequent Contractor or to the Government, subject to Project
Officer approval. The Contractor shall deliver, if requested
by the Project Officer and by the completion date of the
Contract, the following items: original data, preserved
reagents, samples, and any necessary information related
thereto, and Government-owned equipment and property.
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ATTACHMENT B - REPORTING REQUIREMENTS
10/01/97
RFP-NIH-NIAID-DAIDS-98-18
I. Monthly sample reports:
Within five working days of the start of each month, the Contractor
shall submit a monthly report on samples received the previous
month. Two (2) copies shall be submitted to the Project Officer
and one (1) copy to the Contracting Officer. Each monthly report
shall consist of:
1. A cover page containing:
a) Contract number and title;
b) Period of performance being reported;
c) Contractor's name and address;
d) Author(s); and
e) Date of submission.
2. Summary of all sample acquisition and status
information from the previous month. This document
should list for each sample, but not be limited to, the
following data:
a) Numerical identifier of sample received;
b) Laboratory or geographical site from which sample
was received;
c) Verification that samples were obtained in
accordance with 45 CFR 46;
d) Date of collection;
e) Type of sample received;
f) Number and types of aliquots stored;
g) Whether gene amplification has been attempted, and
if so, whether in progress, successful or unsuccessful.
II. Quarterly Technical Reports:
By the fifteenth working day of the month following the end of each
quarter, the Contractor shall submit three (3) copies of a
quarterly progress report as described below. Two (2) copies
should be submitted to the Project Officer and one (1) copy to the
Contracting Officer. The quarterly report should be factual and
concise and consist of the following:
1. A cover page containing:
a) Contract number and title;
b) Period of performance being reported;
c) Contractor's name and address;
d) Author(s); and
e) Date of submission.
2. Reports shall include but not be limited to the
following:
a) Section A - An introduction covering the purpose and scope of
the contract effort.
b) Section B - 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. Description
shall include pertinent data and/or figures 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.
Specifically, this section shall include, but not be limited
to the following:
1) An inventory of samples received, type of sample, source of
sample, geographic locale from which sample was derived;
2) An inventory of all reagents derived from each sample,
including amplified DNA and clones derived;
3) A report of all genetic analyses carried out on each
sample;
4) Nucleotide and amino acid alignments, highlighting
similarities, differences or unique observations
between samples originating from the same and different
geographical locations;
5) An inventory on all samples sent out to collaborating
laboratories;
6) Need for replacement or repair of Government furnished
equipment;
7) Description of current technical or administrative
problems encountered, their resolution or the proposed
corrective action;
8) Selected other additional information as may be required by
the Project Officer.
III. Sequence data and alignments transfer via electronic mail or
computer diskette:
At the time of submission of each quarterly report, the Contractor
shall submit via electronic mail or computer diskette all sequence
data and all nucleotide and amino acid alignments generated during
that reporting period. Choice of transfer will be determined by
the Project Officer. Diskettes shall be formatted and data
recorded in a format specified by the Project Officer.
IV. Final Report:
The Contractor shall submit three (3) copies of the final report
documents, two (2) copies to the Project Officer and one (1) copy
to the Contracting Officer, which shall summarize the results of
the entire contract work for the complete performance period. This
report shall be in sufficient detail to explain comprehensively the
results achieved and shall be submitted no later than the
completion date of the Contract.
The final report shall contain:
1. Title Page as described above in paragraph I.
2. Introduction covering the purpose and scope of the contract
effort.
3. Description of the overall progress, including a list and
description of all clones and sequences derived as well as
GenBank accession numbers for all sequences, conclusions
resulting from analysis of genetic sequences, and a
scientific evaluation of the data accrued under the contract.
V. Distribution of reports and diskettes:
Copies of the reports shall be submitted as follows:
Type of No. of
Report Copies Addresses:
______ ______ __________
Monthly sample report 2 Project Officer
Quarterly report 2 Preclinical Research Branch
Quarterly data diskette 1 VPRP/DAIDS/NIAID
Final report 2 Solar Building, Rm 2A32
6003 Executive Blvd.
Bethesda, MD 20892-7620
Monthly sample report 1 Contracting Officer
Quarterly report 1 CMB, DEA, NIAID
Final report 1 Solar Building, Room 3C07
6003 Executive Blvd.
Bethesda, MD 20892-7620
If the Contractor is unable to deliver the reports specified above
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 for the delays.
VI. Other deliverables
1. The Contractor, subject to Project Officer approval, shall
deliver to the Government or its designee at any time during
the course of this Contract any samples acquired as part of
this contract or any reagents or viral genetic clones generated
during the course of this Contract.
2. The Contractor, subject to Project Officer approval shall
deliver to the Government or a successor contractor by the
expiration date of the Contract, the following items:
a) All human subject-derived samples
accumulated during the contract period;
b) All reagents generated during the course of the
Contract;
c) A listing, on computer diskette, of
accurate and updated information pertaining to
samples received and stored, amplified and cloned
fragments, and other reagents acquired in the course
of this contract, copies of custom software programs
developed or acquired during the course of this
contract for the purpose of carrying out contract
tasks, and any necessary information related
thereto;
d) Labeled and inventoried paper files; and
e) Government-owned equipment and property.
*******************************************************************
*******************************************************************
ATTACHMENT C - EVALUATION FACTORS FOR AWARD
10/01/97
RFP-NIH-NIAID-DAIDS-98-18
Selection of an offeror for contract award will be based on an
evaluation of proposals against two factors. The factors in order
of importance are: technical and cost. Although technical factors
are of paramount consideration in the award of the contract,
cost/price is also important to the overall contract award
decision.
Offerors are advised that award will be made to that offeror whose
proposal provides the best overall value to the Government.
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 requirements of the RFP.
Offerors must submit information sufficient to evaluate their
proposals based on the detailed criteria listed below.
TECHNICAL EVALUATION CRITERIA POINTS
1. Technical Approach . . . . . . . . . . . . . . . . . . . . . 50
The technical adequacy, feasibility, and approaches of the
proposal, including alternative strategies and relevant experience,
for:
(a) Amplifying, cloning, functionality testing, and sequencing
HIV-1 genes and full-length proviruses (40 points).
1) Development and evaluation of nucleotide primers
sufficient to amplify specific viral genes,
including but not limited to HIV-1 gp120 and full
length gp160 genes, and full-length proviruses, for
all known genetic subtypes of HIV.
2) Amplification of viral genes and full-length proviruses,
including those specified in the paragraph above,
using the polymerase chain reaction (PCR), from
HIV-infected tissues and virus cultures.
3) Cloning of genes and full-length proviruses, derived
by PCR amplification or other state-of-the-art procedure
that has a high likelihood of preserving the functionality
of the genes, into various vectors, including prokaryotic
and eucaryotic expression vectors.
4) Testing functionality of cloned genes for ability to
encode protein of proper size and/or function, and testing
functionality proviral clones for infectiousness.
5) Genetic sequencing of amplified fragments using state-of
-the-art automated sequencing systems.
6) Quality control procedures to insure against sample cross-
contamination.
7) New assay development and adaptation for large scale use of
assays designed to increase the efficiency of genetic
sequencing, cloning, gene/provirus functionality testing,
and sequence analysis.
(b) Compiling and analyzing sequence data and management of
samples and data (10 points).
1) Nucleotide sequence analysis and alignment using
state-of-the-art computer software.
2) Specimen management and administrative/logistical
approach to address receiving, handling, storing
and tracking of samples.
2. Qualifications and availability of scientific staff . . . . 35
(a) Principal investigator:
Relevance and quality of recent work, experience with
technical approaches required, documented availability
for the proposed project, and experience with managing
projects of similar complexity.
(b) Other scientific and technical staff:
Relevance and extent of experience of other
professional and research technical and support staff and
their documented capability to perform their roles in
proposed studies, expertise in similar projects, the
logistical adequacy of the staffing plan for the conduct
of the project, including the time commitment of the
professional and technical staff.
3. Facilities and Resources . . . . . . . . . . . . . . . . . . 15
Availability and adequacy of facilities, equipment and
resources necessary to 1) receive and process and store
hazardous and infectious agents and, 2) to carry out
sophisticated gene amplification, cloning, sequencing and
analysis.
The offeror must provide:
(a) a detailed floor plan of the proposed facility which
shows the location and proximity of the equipment and
resources;
(b) information regarding ownership/lease of the facility
which demonstrates availability for the duration of the
proposed contract;
(c) plan for compliance with all safety guidelines and
regulations, including training and monitoring of
personnel for exposure to infectious and hazardous
reagents.
(d) Plan for orderly transition of data and samples to a
subsequent contractor or to the Government.
TOTAL 100 POINTS
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ATTACHMENT D - PROPOSAL INTENT RESPONSE SHEET
RFP-NIH-NIAID-DAIDS-98-18
FURNISH THE INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE
EARLIEST PRACTICABLE DATE (NO LATER THAN BY NOVEMBER 11, 1997).
IF YOU INTEND TO SUBMIT A PROPOSAL, IT IS ESSENTIAL THAT YOU SUBMIT
THE PROPOSAL INTENT FORM, OR IMMEDIATELY NOTIFY MS. KRISTIANE E.
COOPER, CONTRACT SPECIALIST, OR LAWRENCE BUTLER, CONTRACTING
OFFICER, OF THE NIAID CONTRACTING OFFICE OF YOUR INTENT, AT THE
FOLLOWING INTERNET ADDRESSES:
kc116y@nih.gov
lb13t@nih.gov
_____________________________________________________________
(ORGANIZATION)
[] DO INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING:
"GENETIC VARIATION OF HIV AND RELATED LENTIVIRUSES"
RFP-NIH-NIAID-DAIDS-98-18
______________________________)_____________________________
(ORGANIZATION)
[] 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: Fax # 301/402-0972
E-mail: kc116y@nih.gov or lb13t@nih.gov
Attn: Kristiane E. Cooper or Lawrence Butler
RETURN BY: NOVEMBER 11, 1997
***********************************************************
*******************************************************************
ATTACHMENT E - SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
RFP-NIH-NIAID-DAIDS-98-18
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 F,
"Applicable RFP References."
1. 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 14, 1998.
It is anticipated that the award from this solicitation will be
multiple-year, cost-reimbursement type level-of-completion contract
with a period of performance of 6 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].
2. LEVEL OF EFFORT
The Government's estimate for the work set forth in the Statement
of Work of this solicitation is 550% per year for each of the 6
years of the contract. It is estimated that the effort will be
constituted as specified below and will be expended approximately
as follows:
Percent Effort Per Year*
Position Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Total
-------- ------ ------ ------ ------ ------ ------ -----
P.I. 25% 25% 25% 25% 25% 25% 150%
Investigator 100% 100% 100% 100% 100% 100% 600%
Sr. Res. Assoc. 100% 100% 100% 100% 100% 100% 600%
Lab. Supv. 50% 50% 50% 50% 50% 50% 300%
Res. Asst. 200% 200% 200% 200% 200% 200% 1,200%
Admin. Asst. 25% 25% 25% 25% 25% 25% 150%
Data Manager 50% 50% 50% 50% 50% 50% 300%
Total 550% 550% 550% 550% 550% 550% 3,300%
* 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.
3. 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 acknowledgment of
receipt from:
Mr. Lawrence M. Butler
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.
*******************************************************************
*******************************************************************
ATTACHMENT F - APPLICABLE RFP REFERENCES
RFP-NIH-NIAID-DAIDS-98-18
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" (item 2.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) FACILITIES CAPITAL COST OF MONEY (FOR COMMERCIAL
ORGANIZATIONS)
(3) SMALL, SMALL DISADVANTAGED AND WOMEN OWNED SMALL
BUSINESS SUBCONTRACTING PLAN (DOES NOT APPLY TO
SMALL BUSINESS CONCERNS)
3. The following items are applicable from the subdirectory
entitled "FORMS, FORMATS, AND ATTACHMENTS":
Applicable to TECHNICAL PROPOSAL (SUBMIT WITH ORIGINAL
PROPOSAL)
------------------------------------------------------
(1) Technical Proposal Cover Sheet
(2) Technical Proposal Cost Information
(3) Summary of Current and Proposed Activities
Applicable to BUSINESS PROPOSAL (SUBMIT WITH ORIGINAL
PROPOSAL)
-----------------------------------------------------
(4) Contract Pricing Proposal, SF-1411
(5) Proposal Summary and Data record, NIH-2043
(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
(9) Form NIH 2706 (Financial Report) and Instructions for
Completing Form NIH 2706; note - financial reports are
not always required and this will be discussed during
negotiations
(10) Procurement of Certain Equipment, NIH(RC)-7
(11) Safety and Health, PHSAR Clauese 352.223-70
OTHER - TO BE SUBMITTED AFTER DETERMINATION OF THE
COMPETITIVE RANGE
--------------------------------------------------
(12) Certificate of Current Cost or Pricing Data, NIH-1397
(13) Small, Small Disadvantaged & Women-Owned Small
Business Subcontracting Plan
4. The Representations and Certifications are applicable and
should be submitted with the original proposal.
5. The "Sample Contract Format-General" is applicable.
*******************************************************************
*******************************************************************
ATTACHMENT G - HOW TO PREAPRE AND SUBMIT A PROPOSAL
RFP-NIH-NIAID-DAIDS-98-18
1. ABOUT NIAID'S ELECTRONIC PROPOSAL AND REVIEW SYSTEM (EPRS)
The National Institute of Allergy and Infectious Diseases is using
RFP NIH-NIAID-DAIDS-98-18 to test the Electronic Proposal and
Review System (EPRS) developed by the NIAID. Proposals in response
to this Request For Proposal (RFP) will be submitted electronically
over the Internet. Adequate security will be provided by using a
dedicated server with access restricted through passwords.
Following the initial phase of electronic submission by the
offerors, proposals will be forwarded to the selected peer
reviewers where they will be read and evaluated electronically. The
peer review is designed so that a face-to-face meeting is not
required. Instead the proposals will be accessed by peer reviewers
through the Internet. Best and Final Offers (BAFOs) will also be
submitted and reviewed electronically.
This electronic acquisition approach will save the government and,
hence, the taxpayer the costs of travel and per diem for the
reviewers, and of shipping proposals to the reviewers.
Offerors will be spared the cost of copying and shipping proposals,
which can be a significant expense. This approach should also
reduce the staff time needed to process an action through to award.
We anticipate that the savings in staff time will be much greater
than the savings in postage and paper costs.
2. ELECTRONIC SUBMISSION INSTRUCTIONS
a. GENERAL. To submit a proposal electronically under this RFP,
Offerors will need to prepare the proposal on a word processor or
spreadsheet program (for the cost portions) and convert them to
Adobe Acrobat Portable Document Format (PDF). The technical
proposal and business proposal must be contained on separate files.
Further, to expedite the file transferring process, the two files
must be named using the following DOS naming convention:
Technical Proposal c:\rfp9818\techprop.pdf
Business Proposal c:\rfp9818\busiprop.pdf
Approximately THREE weeks prior to the due date of proposals, all
offerors will be provided with specific electronic access
information and electronic proposal transmission instructions. For
this reason, it is imperative that all offerors who are intending
to submit a proposal in response to this RFP contact the Contract
Specialist identified in this RFP and complete and submit the
attached Proposal Intent Form by NOVEMBER 11, 1997.
Note: THERE IS NO LIMIT TO THE SIZE (MB) OF THE TWO ELECTRONIC PDF
FILES TO BE SUBMITTED; HOWEVER, THE SIZE OF THE TECHNICAL PROPOSAL
IS LIMITED TO THE PAGE LIMITATION LANGUAGE OUTLINED BELOW. FOR
PURPOSES OF ASSESSING COMPLIANCE WITH THE PAGE COUNT, TECHNICAL
PROPOSALS WILL BE VIEWED USING THE PRINT FUNCTION OF THE ADOBE
ACROBAT READER.
b. ADDITIONAL SUGGESTIONS. Do not embed sound or video (e.g.,
MPEG) files into the proposal documents. The evaluation system will
not incorporate a capability to read these files. Graphics which
are embedded into documents should be kept as simple as possible.
Complex graphics require longer periods for the computers used in
the evaluation system to draw, and redraw these figures and
scrolling through the document is slowed significantly. Suggestions
include:
- Limit colors to 256 colors at 1024x768 resolution; avoid color
gradients.
- Simplify the color palette used in creating figures.
- Be aware of how large these graphics files become. Large files
are discouraged.
c. PAGE LIMITS. THE NARRATIVE PORTION OF THE TECHNICAL PROPOSAL
IS LIMITED TO ONE HUNDRED (100) PAGES. Cover pages, tables of
contents, listing of figures, and indices may be used and will not
be included in the page count (See technical proposal table of
contents, below, for specific exceptions). PAGES IN EXCESS OF THE
MAXIMUM WILL BE DELETED AND WILL NOT BE READ OR EVALUATED. A
transmittal letter may be used to forward proposals to the Contract
Specialist and will not count against the page count. PLEASE NOTE
THAT NO PAGE LIMITATION HAS BEEN PLACED ON THE CONTENTS OF THE
BUSINESS PROPOSAL.
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."
Margins must be set to 1 inch around.
Business Proposal and Technical Proposal preparation instructions
along with proposal table of contents are detailed below:
3. TECHNICAL PROPOSAL INSTRUCTIONS
a. GENERAL. THE ENTIRE TECHNICAL PROPOSAL, EXCEPT AS NOTED BELOW
IN THE TECHNICAL PROPOSAL TABLE OF CONTENTS, IS TO BE SUBMITTED
ELECTRONICALLY.
The Standard RFP Instructions and Provisions, in the subdirectory
C. RFP References, provide more detail on the TECHNICAL PROPOSAL
requirements.
The format of your TECHNICAL PROPOSAL is detailed in the "Technical
Proposal Table of Contents," below. 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.
b. TECHNICAL PROPOSAL TABLE OF CONTENTS
PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR
TECHNICAL PROPOSAL:
SECTIONS/FORMAT
1. TECHNICAL PROPOSAL COVER SHEET (Form in Section C of Gopher
RFP: FORMS, FORMATS, ATTACHMENTS)
2. TECHNICAL PROPOSAL TABLE OF CONTENTS
3. TECHNICAL/PROJECT PLAN (IN NARRATIVE)*
a. STATEMENT OF WORK - addresses objectives, approach, methods
and schedule; discusses the offeror's experience with
comparable work, and methods/approach to be used for
accomplishing each item in the Statement of Work, including
potential problems and solutions.
b. PERSONNEL (List individuals by name, title, department and
organization, and detail each person's qualifications, role,
and level of effort and availability for this project, in
NARRATIVE format (ATTACH RESUMES IN SECTION 4 BELOW AND A
FLOWCHART SHOWING ORGANIZATIONAL LINES OF AUTHORITY); identify
any subcontractor/consultant personnel and provide their
qualifications)
[NOTE: FOR KEY PERSONNEL, ALSO INCLUDE THE FORM
ENTITLED "SUMMARY OF CURRENT AND PROPOSED ACTIVITIES" UNDER
PARAGRAPH 4b. BELOW]
c. FACILITIES AND RESOURCES/OTHER CONSIDERATIONS
(list/describe all equipment, facilities and other resources
available for this project; discuss Contractor's location in
relation to the NIH/DAIDS and plans for ensuring close
communications during the contract);
4. APPENDICES: (list each appendix; appendices should be clear
and legible, and easily located)
ELECTRONIC SUBMISSION OF APPENDICES:
a. Individual biosketches; flowchart of organizational structure
for this project;
b. "Summary of Current and Proposed Activities" (ALL key
personnel should be listed on this form; it is located in the
FORMS, FORMATS, ATTACHMENTS Directory found in Section C,
Gopher RFP);
c. "Technical Proposal Cost Information" form (located in
Section C, Gopher RFP, FORMS, FORMATS, & ATTACHMENTS);
d. Table of Contents of SOP manual; any representative samples
of SOPs particularly pertinent to this effort which are
available electronically;
e. A list of collaborators for whom commitment letters have been
submitted in hardcopy (see below); and
HARDCOPY SUBMISSION OF APPENDICES:**
(Note: THESE ITEMS ARE EXCLUDED FROM OUR ELECTRONIC SUBMISSION
REQUIREMENT AND WILL NOT BE SUBJECT TO PAGE LIMITATIONS. INSTEAD
ALL OFFERORS MUST SUBMIT TEN (10) PAPER COPIES OF THIS INFORMATION)
f. Complete SOPs; any other pertinent policy manuals; any
letters of collaboration from other investigators;
nonscannable figures or data.
* Sections 3.a through 4.e. above MUST NOT EXCEED 100 PAGES
** The offeror may choose to use a scanner to scan letters or
relatively small documents to be submitted electronically rather
than in hardcopy; this is encouraged, but not mandatory.
***********************************************************
*******************************************************************
4. BUSINESS PROPOSAL INSTRUCTIONS
a. GENERAL. THE ENTIRE BUSINESS PROPOSAL IS TO BE SUBMITTED
ELECTRONICALLY. There are no page limits with the business
proposal. The Standard RFP Instructions and Provisions, in the
subdirectory C. RFP References, provide more detail on the BUSINESS
PROPOSAL requirements. Following proposal submission and review,
additional information will be requested by the Contracting Officer
from all offerors which comprise the competitive range. The format
of your BUSINESS PROPOSAL is detailed in the "Business Proposal
Table of Contents", below.
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.
b. ESCALATION. 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. Final inflation
increases will be subject to the negotiation process taking into
consideration the most current consumer price index (cpi).
c. BUSINESS PROPOSAL TABLE OF CONTENTS
PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR
BUSINESS PROPOSAL:
SECTIONS/FORMAT
1. Contract Pricing Proposal Cover Sheet - SF 1411 (located in
the NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS
subdirectory found in C. RFP REFERENCES)
2. Proposal Summary and Data Record, NIH 2043 (located in the NIH
Gopher under the FORMS, FORMATS, AND ATTACHMENTS subdirectory
found in C. RFP REFERENCES)
3. Business Proposal Cost Information and Cost Spreadsheets
(instructions located in the NIH Gopher under the FORMS,
FORMATS, AND ATTACHMENTS subdirectory found in C. RFP
REFERENCES) which include an itemized cost element breakdown,
for each year of the contract. Cost elements on these
spreadsheets include (as applicable): Direct Labor, Fringe
Benefits, Materials, Subcontracts, Travel, Equipment, ODC, Raw
Materials, Purchased Parts, Indirect Costs, Fee.
4. Business Plan - the business plan has the following
components:
A narrative of the BASIS of costs proposed; do not provide
documentation with initial proposal;
Qualification of the Offeror - This includes: General
Experience, Organizational Experience Related to the RFP,
Performance History, Pertinent Contracts and Grants;
Property, Equipment, Facilities to be dedicated to this
work;
Royalties, Financial Capacity, Subcontractors
5. Representations and Certifications (from the subdirectory
entitled "FORMS, FORMATS, AND ATTACHMENTS)
6. Other Forms/Information
Disclosure of Lobbying Activities, OMB LLL (from the
subdirectory entitled "FORMS, FORMATS, AND ATTACHMENTS)
***********************************************************
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-98-18
TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY
Number of Copies:
________________
TECHNICAL PROPOSAL: ONE (1) ORIGINAL WITH TEN (10) COPIES OF
SOPs, PERTINENT MANUALS, NONSCANNABLE
FIGURES OR DATA, AND LETTERS OF
COLLABORATION/INTENT)
BUSINESS PROPOSAL: ONE (1) ORIGINAL
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
NOTE: Please refrain from using the U.S. Postal Services
"Express Mail." 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).
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