RFP No.NIH-NIAID-DAIDS-98-03
Title: NIH-AIDS RESEARCH AND REFERENCE REAGENT
PROGRAM
Issued by: Bruce E. Anderson
Contracting Officer
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, Maryland 20892-7610
DATE ISSUED: JANUARY 28, 1997
PROPOSAL DATE DUE: APRIL 28, 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-98-03) for the
NIH-AIDS RESEARCH AND REFERENCE REAGENT PROGRAM. The
Government anticipates the award of ONE (1), SEVEN (7) 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:
STREAMLINED RFP
Attachments:
A. Background and Work Statement, dated January 28,
1997 including Appendices A-1 and A-2
B. Deliverables and Reporting Requirements, dated
January 28, 1997
C. Evaluation Factors for Award, dated January 28,
1997
D. Specific RFP Instructions and Provisions (INCLUDES
THE TECHNICAL PROPOSAL FORMAT, and the proposal
intent form)
E. Applicable RFP References
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 E). The SUBDIRECTORIES are:
STANDARD RFP INSTRUCTIONS AND PROVISIONS
OPTIONAL RFP INSTRUCTIONS AND PROVISIONS
FORMS, FORMATS AND ATTACHMENTS
REPRESENTATIONS AND CERTIFICATIONS
SAMPLE CONTRACT FORMAT-GENERAL
If you are unable to download any of the applicable
documents, please contact Bruce Anderson, Contracting
Officer, by phone/fax/Internet (see contact
numbers/addresses below).
Offerors interested in responding to this RFP are encouraged
to request a hard copy of the 1996 þNIH AIDS Research and
Reference Reagent Program Catalogþ and a copy of a recent
newsletter ("Courier"). The catalog includes a current
listing of reagents in the AIDS Reagent Program, and
includes forms for: 1) registration for receiving reagents
in 1996; 2) indemnification agreements; 3) acknowledgment of
commercial rights; and 4) request for ordering reagents.
Requests for Catalog and newsletter should be addressed to:
Bruce E. Anderson, Contracting Officer, CMB, NIAID, Solar
Building, Room 3C07, 6003 Executive Boulevard (MSC 7610),
Rockville, Maryland 20892-7610.)
The attachments/documents listed above represent all the
necessary information required for the submission of a
proposal for this acquisition. Following proposal
submission and review, additional information will be
requested by the Contracting Officer from all offerors which
comprise the COMPETITIVE RANGE.
The BUSINESS and TECHNICAL proposals must be separate
portions in the proposal package. The BUSINESS PROPOSAL
must be signed by an authorized official of your
organization, and must contain a detailed breakdown of costs
by year, for each cost category/element; the BASIS for all
costs must be explained, but supporting documentation need
NOT be submitted with the proposal (COST AND PRICING
DOCUMENTATION WILL BE REQUESTED AFTER THE COMPETITIVE RANGE
IS ESTABLISHED). REFERENCES FOR EVALUATION OF PAST
PERFORMANCE SHOULD BE SUBMITTED IN THE BUSINESS PROPOSAL
(SEE ATTACHMENT C, EVALUATION CRITERIA, FOR MORE
INFORMATION). See Standard RFP Instructions and Provisions,
in the subdirectory C. RFP References, for more detail on
the BUSINESS PROPOSAL requirements.
DUE TO THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS
DISEASES' CURRENT BUDGET RESTRICTIONS, IT IS RECOMMENDED
THAT ANY PROPOSED ANNUAL INCREASE IN COSTS FOR INFLATION BE
LIMITED TO NO MORE THAN 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 THE
NEGOTIATION PROCESS TAKING INTO CONSIDERATION THE MOST
CURRENT CONSUMER PRICE INDEX (CPI).
With the Business Proposal, please submit Form NIH-2043,
"Proposal Summary and Data Record," contained in the NIH
Gopher under the FORMS, FORMATS, AND ATTACHMENTS
subdirectory found in C. RFP REFERENCES. Note that in
addition to telephone and fax numbers, the INTERNET
addresses of both the Principal Investigator and the
responsible business representative are to be included on
the form.
The format and content of your TECHNICAL PROPOSAL is
detailed in the þTechnical Proposal Table of Contentsþ, in
Attachment D. BE ADVISED THAT THE NARRATIVE FOR THE WORK
STATEMENT, RESOURCES/OTHER CONSIDERATIONS, AND PERSONNEL,
ARE NOT TO EXCEED 75 PAGES. You are reminded that the
"Technical Proposal Cover Sheet" must be completed in full
detail and used as the cover sheet for each copy of your
technical proposal (a copy of this form is contained in the
NIH Gopher under the FORMS, FORMATS, AND ATTACHMENTS
subdirectory found in C. RFP REFERENCES). New policies
require submission of more detailed information than has
been previously required. It is important that you list all
professional personnel and organizations named in the
proposal who have any role in the proposed work, including:
staff of the primary organization (offeror), subcontractors,
collaborating organizations, and consultants. Organizational
affiliation(s) must be indicated for every person named.
You may use additional sheets, as needed, following the
format shown in the Technical Proposal Cover Sheet. This
information will be used to ensure that there will be no
conflict of interest when selecting review committee
members.
Your attention is further directed to the "Proposal Intent"
form contained in Attachment D, item 11. Please complete
this form and return it to this office on or before MARCH
28, 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 MR. BRUCE
ANDERSON, CONTRACTING OFFICER, OF THE NIAID CONTRACTING
OFFICE AT THE FOLLOWING INTERNET ADDRESS:
ba9i@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR
INTEREST, YOU WILL NOT RECEIVE ANY NOTIFICATION OF
AMENDMENTS ISSUED TO THE RFP. HOWEVER, ALL AMENDMENTS WILL
BE POSTED ON THE NIH GOPHER AND/OR NIH HOME PAGE.
The original and fifteen (15) copies of your technical
proposal and the original and five (5) copies of your
business proposal must be received by the Contracting
Officer no later than APRIL 28, 1997, at 4:30 p.m. local
time at the address listed in Attachment D,
item 7.
Questions concerning any areas of uncertainty which in your
opinion require clarification or correction, must be
furnished in writing to Mr. Bruce Anderson. Your questions
should be received no later than FEBRUARY 28, 1997, at the
address indicated in Attachment D, item 5 (Fax or E-mail
communication is preferred) and marked "Offeror's Questions,
RFP-NIH-NIAID-DAIDS-98-03."
If you have any additional questions regarding this RFP,
please contact Mr. Anderson at the Internet electronic mail
address: ba9i@nih.gov, by phone at 301/496-8371, or by fax
at 301/402-0972. Collect calls will NOT be accepted.
Sincerely,
/s/
Brenda J. Velez
Chief, AIDS Clinical Research Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases
Attachments: A - E
*********************************************************
RFP-NIH-NIAID-DAIDS-98-03
STREAMLINED RFP
-------------------
ATTACHMENT A - INTRODUCTION AND STATEMENT OF WORK
(January 28, 1997)
INTRODUCTION
---------------------
The purpose of this contract is to support the National
Institutes of Health (NIH) AIDS Research and Reference
Reagent Program (AIDS Reagent Program), in achieving its
goal of providing novel AIDS-related reagents and resources
to the scientific community.
An important rate-limiting step in basic research is the
identification and distribution of state-of-the-art reagents
and technology. To address this need, the National
Institute of Allergy and Infectious Diseases (NIAID)
supports the AIDS Reagent Program. Since its establishment
in 1988, the AIDS Reagent Program has evolved from a small
bank of research materials to a large unique resource of
many reagents for research on HIV/AIDS and related
opportunistic infectious agents. It acquires state-of-the-
art HIV/AIDS-related research and reference reagents;
produces these reagents, standardized panels, and protocols;
and then provides these reagents at minimal cost to
qualified investigators throughout the world. Additionally,
the reagent program collects information about AIDS-related
reagents and standards and disseminates this information
through print, electronic media, and workshops; enhances
technology transfer through development and publication of
methods; facilitates commercial development of reagents
through proactive communication with biotechnology and
pharmaceutical companies; and participates as an AIDS
Collaborating Center of the World Health Organization.
Contributors and users include scientists from the NIH,
academic and non-profit institutions, and from industry. The
success of the Program is evident in the expanding network
of users. Over 900 scientists from 33 countries in North
and South America, Europe, Asia, Africa, and Australia have
registered and obtained reagents from the Program. During
the past four years, over 30,000 reagents have been
distributed. More than 1,200 scientific publications have
referenced the use of reagents obtained from the Program.
Approximately 25% of activities of the Reagent Program
involve other government-sponsored activities (e.g.,
participants may be collaborators in NIAID cooperative
agreements, ACTG investigators, and NIAID contractors). The
Reagent Program is a major provider of reagents to AIDS
investigators worldwide. The Reagent Program also provides
technical assistance in handling and shipping of infectious
materials .
The current five year contract with McKesson Bioservices
Corporation (formerly Ogden Bioservices Corporation),
Rockville, MD, expires in January 1998. The purpose of this
solicitation is to re-compete this effort.
WORK STATEMENT
_________________________
Independently and not as an agent of the Government, the
Contractor shall exert its best efforts to furnish all the
necessary services, qualified personnel, material, equipment,
and facilities not otherwise provided by the Government as needed
to perform the work described below.
(NOTE 1 TO THE OFFEROR: THE GOVERNMENT MUST HAVE DIRECT
OVERSIGHT OF THIS CONTRACT IN ORDER TO ENSURE QUALITY
CONTROL AND SAFE HANDLING AND DISTRIBUTION OF THE REAGENTS,
MANY OF WHICH ARE BIOHAZARDOUS AND INFECTIOUS (INCLUDING
HIV). THE PRIME CONTRACTOR IS RESPONSIBLE FOR ALL WORK
PERFORMED UNDER THIS CONTRACT. WHILE SUBCONTRACTING IS
PERMITTED, THE REAGENT ACQUISITION EFFORTS, STORAGE AND
DISTRIBUTION OF REAGENTS, AND THE MANAGEMENT OF THE AIDS
REAGENT PROGRAM DESCRIBED UNDER THE WORK STATEMENT MUST BE
PERFORMED BY THE PRIME CONTRACTOR; REAGENT PRODUCTION, AND
QUALITY CONTROL OF REAGENTS MAY BE SUBCONTRACTED OUT, AS
WELL AS OTHER ACTIVITIES.
(NOTE 2 TO OFFEROR): OFFERORS INTERESTED IN RESPONDING TO
THIS RFP ARE ENCOURAGED TO REQUEST A HARD COPY OF THE 1996
"NIH AIDS RESEARCH AND REFERENCE REAGENT PROGRAM CATALOG"
AND A COPY OF A RECENT NEWSLETTER ("COURIER"). THE CATALOG
INCLUDES A CURRENT LISTING OF REAGENTS IN THE AIDS REAGENT
PROGRAM, AND INCLUDES FORMS FOR: 1) REGISTRATION FOR
RECEIVING REAGENTS IN 1996; 2) INDEMNIFICATION AGREEMENTS;
3) ACKNOWLEDGMENT OF COMMERCIAL RIGHTS; AND 4) REQUEST FOR
ORDERING REAGENTS. REQUESTS FOR CATALOG AND NEWSLETTER
SHOULD BE ADDRESSED TO: BRUCE E. ANDERSON CONTRACTING
OFFICER, CMB, NIAID, SOLAR BUILDING, ROOM 3C07, 6003
EXECUTIVE BOULEVARD (MSC 7610), ROCKVILLE, MARYLAND 20892-
7610.)
Specifically, the Contractor shall:
1. IDENTIFY, ACQUIRE, AND PRODUCE/EXPAND (AS NECESSARY) REAGENTS:
The Contractor shall actively and independently identify
novel reagents that are not readily available, and
prioritize their acquisition based upon the needs of the AIDS
research community, availability and cost. The Contractor
shall acquire reagents after receiving approval by the
Project Officer. The acquisition of reagents, including
radioactive reagents (either by purchase or donation) shall
be an ongoing endeavor. Reagents purchased shall be
acquired through a competitive process whenever practicable
in accordance with FAR Part 13 Small Purchase Procedures and
also in accordance with the prior consent requirements of
FAR Part 44. The contractor shall keep proper documentation
on file supporting: (1) the price reasonableness for all
acquisitions; and (2) the criteria for evaluation and
selection of all sources for reagent acquisitions.
The Contractor shall produce reagents as needed after
receiving approval by the Project Officer. Production of
reagents includes expansion of renewable reagents, e.g.,
includes cell lines, viruses, microorganisms and recombinant
DNA.
For the purposes of this contract, reagents include but are
not limited to the following biological materials: HIV and
other related viruses, uninfected and infected and/or
genetically manipulated prokaryotic/eukaryotic cell lines,
DNA libraries, DNA clones, body fluids and cells, proteins
and synthetic peptides, monoclonal and polyclonal
antibodies, and opportunistic infectious agents associated
with HIV infections. Reagents also refer to but are not
limited to antiviral and antiinfective drugs and
therapeutics, chemicals that modulate the immune system, and
other materials used to treat HIV or opportunistic
infections associated with AIDS. The Contractor may be
requested to acquire/distribute specialized animal models
(e.g. transgenic mice) to be used as a live source of
reagents for investigators (no housing of animals required).
The list provided above is for illustrative purposes and is
not comprehensive.
(NOTE 3 TO THE OFFEROR: THE SELECTED CONTRACTOR WILL
CONTINUE TO IDENTIFY AND RECOMMEND NEW SOURCES OF REAGENTS
THROUGHOUT THE TERM OF THIS CONTRACT. A DETAILED PLAN FOR
IDENTIFYING, PRIORITIZING AND ACQUIRING REAGENTS FROM
DOMESTIC AND INTERNATIONAL SOURCES, AND THE OFFEROR'S
KNOWLEDGE, EXPERIENCE AND QUALIFICATIONS TO DO SO SHOULD BE
SUBMITTED AS PART OF THE TECHNICAL PROPOSAL. AS AN
INDICATION OF THE OFFERORþS KNOWLEDGE OF THE FIELD, OUTLINE
WHAT REAGENTS NEED TO BE ACQUIRED AND HOW YOU WOULD PREPARE
TO DO THIS; PRIORITIZE THE MOST IMPORTANT ACQUISITIONS.
BASED UPON EXPERIENCE GAINED UNDER THE CURRENT AIDS REAGENT
PROGRAM CONTRACT, IT IS SOMEWHAT DIFFICULT TO PREDICT OR
IDENTIFY IN ADVANCE THE TYPES AND AMOUNTS OF REAGENTS, AND
THE NUMBERS OF EXPANSIONS, QUALITY CONTROL ANALYSES OF
REAGENTS THAT WILL BE REQUIRED DURING THIS CONTRACT TERM.
THEREFORE, BASED UPON HISTORICAL EXPERIENCE, AND FOR THE
PURPOSES OF PREPARING A BUDGET, THE GOVERNMENT ESTIMATES THE
FOLLOWING PROJECTED REAGENT ACQUISITION EXPENSES: $546,770
(YEAR 1), $4,190,000 (TOTAL FOR SEVEN YEARS-THIS INCLUDES
3% INFLATIONARY ADJUSTMENTS). THIS AMOUNT INCLUDES REAGENT
PURCHASE, PRODUCTION/EXPANSION, AND QUALITY CONTROL OF
REAGENTS.
IN THE PAST, 87% OF THE ACQUIRED REAGENTS WERE DONATED BY
INVESTIGATORS (50% OF WHICH WERE EXPANDED WITH CONTRACT
FUNDS); ALL OTHER "ACQUISITION" OF REAGENTS WAS ACCOMPLISHED
THROUGH PURCHASE AND/OR SERVICES. THE ACQUISITION EFFORT
THEREFORE INCLUDES SOLICITATION OF DONATIONS, PURCHASE ORDERS/
SUBCONTRACTS FOR PRODUCING REAGENTS, AND EXPANSION OF REAGENTS
(RENEWABLE REAGENTS PROVIDED TO THE AIDS REAGENT PROGRAM IN SMALL
AMOUNTS WILL REQUIRE EXPANSION).
FOR ANY PROPOSED SUBCONTRACTOR (OR SUBCONTRACTORS) TO
PRODUCE/EXPAND REAGENTS SIMILAR TECHNICAL INFORMATION SHOULD
BE PROVIDED AS PART OF THE PROPOSAL AS THAT REQUIRED FROM
THE PRIME CONTRACTOR, I.E., TECHNICAL APPROACH, METHODS,
KNOWLEDGE, EXPERIENCE, PERSONNEL QUALIFICATIONS, FACILITIES,
RESOURCES, ETC. COST DETAILS SHOULD ALSO BE PROVIDED BY THE
SUBCONTRACTOR AND SUBMITTED WITH THE BUSINESS PROPOSAL.)
(NOTE 4 TO THE OFFEROR: THE HANDLING AND TRANSPORTATION OF
ALL REAGENTS AND GOVERNMENT-OWNED PROPERTY UNDER THIS
CONTRACT SHALL BE IN ACCORDANCE WITH ALL APPLICABLE LOCAL,
STATE AND FEDERAL REGULATIONS INCLUDING SAFETY CONTROLS AND
STANDARDS. SEE ATTACHMENT A-2 TO THE WORK STATEMENT FOR
DETAILS ON HEALTH AND SAFETY STANDARDS.)
(NOTE 5 TO THE OFFEROR: IF THE OFFEROR IS A COMMERCIAL FIRM
SELLING OR DISTRIBUTING AIDS-RELATED REAGENTS, THE OFFEROR
SHOULD ADDRESS IN DETAIL IN THE TECHNICAL PROPOSAL HOW
POTENTIAL CONFLICTS OF INTEREST WILL BE RESOLVED BETWEEN
COMMERCIAL ACQUISITION AND DISTRIBUTION OF REAGENTS AND AIDS
REAGENT PROGRAM ACQUISITION AND DISTRIBUTION OF SIMILAR
REAGENTS. FOR EXAMPLE, THE OFFEROR MUST ADDRESS HOW THE
OFFEROR WILL IDENTIFY AND OBTAIN POTENTIALLY COMMERCIALLY
VALUABLE REAGENTS FOR AIDS REAGENT PROGRAM DISTRIBUTION
INSTEAD OF FOR THE OFFEROR'S COMMERCIAL USE.)
2. PROVIDE FOR QUALITY CONTROL OF REAGENTS:
The Contractor shall provide for quality control of
reagents. Quality control includes assay and evaluation of
reagents. Assays shall include but are not limited to
sterility, stability, solubility, neutralization and
infectivity assays, HPLC, restriction enzyme analysis,
polymerase chain reactions, immunoblotting, IN SITU
hybridizations, tritiated thymidine incorporation, and
biological activity. The number and types of assays to be
performed will require the prior approval by the Project
Officer. The Contractor shall anticipate assays for, but not
limited to the following:
a. Biological reagents, including but not limited to body
fluids, cells, tissues, cell lines, lysates, nucleic acids,
viruses, protein and peptide preparations including
antibodies.
b. Chemical reagents, including but not limited to
nucleoside analogs, chemicals and other compounds or natural
products which may be used for developing therapies, and
topical microbicides against HIV or opportunistic pathogens
associated with AIDS. .
(NOTE 6 TO THE OFFEROR: THE OFFEROR MUST DESCRIBE A PLAN
FOR HOW THE QUALITY AND ACTIVITY OF THE ACQUIRED REAGENTS
WILL BE VERIFIED.)
(NOTE 7 TO THE OFFEROR: THE OFFEROR SHOULD SUBMIT, WITH THE
TECHNICAL PROPOSAL, DOCUMENTATION DEMONSTRATING: KNOWLEDGE,
EXPERIENCE AND COMPETENCE IN THE QUALITY CONTROL ANALYSES OF
BIOLOGICAL AND CHEMICAL REAGENTS. FOR ANY PROPOSED
SUBCONTRACTOR (OR SUBCONTRACTORS) SIMILAR TECHNICAL
INFORMATION SHOULD BE PROVIDED AS PART OF THE PROPOSAL AS
THAT REQUIRED FROM THE PRIME CONTRACTOR, I.E., TECHNICAL
APPROACH, METHODS, KNOWLEDGE, EXPERIENCE, PERSONNEL
QUALIFICATIONS, FACILITIES, RESOURCES, ETC. COST DETAILS
SHOULD ALSO BE PROVIDED BY THE SUBCONTRACTOR AND SUBMITTED
WITH THE BUSINESS PROPOSAL. UNDER THE CURRENT CONTRACT
APPROXIMATELY 10% OF THE REAGENT ACQUISITION EXPANSIONS ARE
FOR THE QUALITY CONTROL OF REAGENTS.)
3. PROVIDE STORAGE, PROCESSING FACILITIES AND RESOURCES:
The Contractor shall provide facilities and equipment to
receive, weigh and store potentially hazardous reagents and
maintain their activity or viability (Biosafety Level 2
Containment). The facilities must provide aseptic and/or
sterile conditions as appropriate. Drugs which may be
destined for pre-clinical use, as specified by Project
Officer, will be stored in a room separate from infectious
biologics. The Contractor shall provide appropriate storage
for radioactive material per local, state and federal
regulations.
a. Provide suitable air-conditioned floor space sufficient
for the installation, storage and maintenance of equipment
and all items necessary for the AIDS Reagent Program and
distribution operation.
b. Provide, maintain and operate facilities for the
storage of bulk and packaged reagents at 2 to 8 degrees C.,
at -10 to -20 degrees C., at -70 to -90 degrees C., liquid
nitrogen conditions; and all other items necessary for the
AIDS Reagent Program. The Contractor shall supply
uninterruptible power to accommodate the
refrigerators/freezers and other equipment. In addition,
the Contractor shall house the units in an air-conditioned
facility with the capacity to maintain a room temperature of
66 degrees to 72 degrees F, when all equipment is
operational. Freezers shall be connected to a central alarm
system monitored 24 hours per day. Emergency stand-by
refrigerators and freezers shall be available in case of
mechanical failure of storage space. The facility must have
an auxiliary electric generator capable of operating all
storage equipment for at least 48 hours for back-up in the
event of utility company power failure. Back-up generator
must be tested monthly.
(NOTE 8 TO THE OFFEROR: THE NUMBER OF REAGENT SAMPLES
STORED IN THE AIDS REAGENT PROGRAM HAS GROWN FROM
APPROXIMATELY 55,000 SAMPLES IN 1992 TO 127,000 SAMPLES IN
1996. THESE SAMPLES INCLUDE 2,500 UNIQUE REAGENTS OF WHICH
1,000 REAGENTS ARE AVAILABLE FOR PUBLIC DISTRIBUTION. IT IS
ANTICIPATED THAT NEW REAGENTS WILL ENTER THE PROGRAM ON A
REGULAR BASIS, AT AN ESTIMATED RATE OF 30-50 REAGENTS (500-
2000 REAGENTS SAMPLES) RECEIVED MONTHLY FROM DOMESTIC AND
INTERNATIONAL SUPPLIERS DURING EACH YEAR OF THIS CONTRACT.
THE OFFEROR SHOULD ANTICIPATE A 15% INCREASE ANNUALLY IN THE
NUMBER OF REAGENTS SAMPLES STORED IN THE AIDS REAGENT
PROGRAM TO AN ESTIMATED TOTAL OF 385,000 SAMPLES DURING THE
TERM OF THE CONTRACT. CURRENTLY, THE AIDS REAGENT PROGRAM
HAS 300 CUBIC FEET OF LOW-TEMPERATURE STORAGE SPACE. IT IS
ESTIMATED THAT THE CONTRACT WILL REQUIRE EXPANSION OF LOW-
TEMPERATURE STORAGE SPACE TO ABOUT 500 CUBIC FEET BY THE END
OF THIS CONTRACT. SEE ALSO ATTACHMENT A-1 TO THE WORK
STATEMENT FOR A LIST OF GOVERNMENT FURNISHED PROPERTY, AND
DETAILS ON REAGENTS SAMPLES STORED AT DIFFERENT
TEMPERATURES.
THE OFFEROR SHOULD PROVIDE IN THE TECHNICAL PROPOSAL A PLAN
FOR STORAGE AND PROCESSING OF REAGENTS, FLOOR PLAN OF THE
PROPOSED FACILITY AND LIST EQUIPMENT AND RESOURCES DEDICATED
TO THE PROJECT.)
c. Provide protective garments, equipment and sufficient
monitoring to assure safe handling of toxic and potentially
hazardous materials, including radioactive materials.
Specifically, the Contractor shall comply with all
applicable health and safety regulations while conducting
the work set forth herein and follow the standards listed
under Attachment A-2 to the Work Statement.
(NOTE 9 TO THE OFFEROR: THE OFFEROR SHOULD INCLUDE A SAFETY
AND HEALTH PLAN IN THE TECHNICAL PROPOSAL AND INCLUDE A COPY
OF OFFEROR'S SAFETY AND HEALTH OPERATING PROCEDURES MANUAL.
STANDARD OPERATING PROCEDURES FOR THE SAFE HANDLING,
STORAGE, AND SHIPPING OF THE TYPES OF REAGENTS LISTED IN THE
1996 CATALOG, INCLUDING THE RADIOACTIVE REAGENTS, SHALL BE
PROVIDED. THE OFFEROR SHOULD INCLUDE IN THE TECHNICAL
PROPOSAL: EVIDENCE OF ADEQUATE TRAINING OF PERSONNEL
HANDLING INFECTIOUS AGENTS INCLUDING HIV AND OPPORTUNISTIC
PATHOGENS ASSOCIATED WITH HIV INFECTION, RADIOACTIVE
SUBSTANCES, DEALING WITH ACCIDENTS, AND MONITORING FOR
INFECTION, AS WELL AS THE ABILITY TO IDENTIFY SAFETY
STANDARDS APPLICABLE TO PARTICULAR REAGENTS LIKELY TO BE
ACQUIRED.)
d. Provide facilities to weigh or dispense solid and
liquid reagents into aliquots and labeled vials. Because of
the nature of some of the reagents, facilities should be
available for the appropriate handling of infectious agents
and for hazardous materials, including radioactive
materials.
e. Provide a separate, locked, storage space (i.e., safe,
approximately 15 cubic foot) at the appropriate temperature
for hallucinogens, narcotics and any other reagent
designated by the Drug Enforcement Administration as a
dangerous and/or controlled substance compound.
f. Maintain 24 hour security that provide a secure
environment for employees and materials within the facility.
g. Provide an automated temperature monitoring system
composed of individual temperature probes monitored 24 hours
a day and controlled by a master computer, and measures to
ensure that necessary personnel are notified in the event of
a refrigerator/freezer malfunction. The Contractor shall be
responsible for promptly repairing malfunctioning equipment
or for arranging for the prompt repair.
(NOTE 10 TO THE OFFEROR: THE OFFEROR SHOULD DESCRIBE AN
ACTION PLAN FOR IDENTIFYING MALFUNCTIONS, A PROCESS TO TEST
CAPABILITY, AND A PROCESS FOR TRANSFER OF REAGENTS FROM
MALFUNCTIONING REFRIGERATORS/FREEZERS.)
h. The personnel assigned to this project must be bonded
prior to beginning work on this contract.
4. OBTAIN APPROVALS AND ASSURANCES NECESSARY TO DISTRIBUTE
REAGENTS:
a. Distribute reagents to approved investigators and
institutions in accordance with operating procedures
approved by the Project Officer. The Contractor shall
consult with the Project Officer in questionable cases.
b. As requested by the Project Officer, develop form
letters to be used for refusal or acceptance of reagent
requests.
c. Distribute materials only to institutions which, in
addition to other assurances, execute agreements to comply
with the following:
(1) All relevant standards for safe handling and use
of the research reagents.
(2) Agreement not to use the reagents in any
unauthorized or unsafe way including compliance with
Protection of Human Subjects, Title 45, Code of Federal
Regulations, Part 26; and Public Health Service Policy on
Human Care and Use of Laboratory Animals, implementing 1996
revisions of the Guide for the Care and Use of Laboratory
Animals.
(3) Agreement that if commercial use is planned or
commercial discoveries result through the use of a reagent,
such use will occur only according to the donor-assigned
Release Category for the reagent.
(4) Agreement by reagent recipient investigators and
their institutions to indemnify and hold harmless the United
States, its Contractor, their suppliers, and contributors of
reagents from any claims, costs, damages, or expenses. The
Contractor shall secure and update/modify these agreements
as required by the Project Officer.
(5) State-Institution Compliance Agreement by reagent
recipient investigators at public institutions that are
unable to accept the terms of the Standard Indemnification
Agreement stated above c(4), the recipient institution
agrees to be responsible for any claims, costs or expenses
that may arise from the possession and use of reagents to
the extent permitted under the law of the State.
(NOTE 11 TO THE OFFEROR: SAMPLES OF CURRENT INDEMNIFICATION
AGREEMENTS FOR BIOHAZARDOUS REAGENTS ARE IN THE HARD COPY OF
THE 1996 CATALOG).
5. SHIP AND RECEIVE REAGENTS:
a. Ship and receive reagents, ensuring the assumption of
shipping costs by the recipient whenever possible.
b. The Contractor shall ship available reagents within 7
working days from the date requests are received.
(NOTE 12 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A
BUDGET, ASSUME THAT APPROXIMATELY 700 REAGENTS WILL BE
SHIPPED MONTHLY FROM THE AIDS REAGENT PROGRAM, INVOLVING
APPROXIMATELY 170 SHIPMENTS, OF WHICH 15% MAY BE TO OVERSEAS
LOCATIONS IN INDUSTRIALIZED AND DEVELOPING COUNTRIES. THE
OFFEROR SHOULD ANTICIPATE APPROXIMATELY 25 INCOMING
SHIPMENTS OF REAGENTS PER MONTH INCLUDING THOSE FROM
OVERSEAS.)
c. Provide, packaged with outgoing reagents, data sheets
containing technical information, references and citations
of the relevant information for safe handling and use of the
reagents, and applicable safety standards. Specific safety
standards for the safe handling and use of specific reagents
in compliance with the guidelines/regulations shall be
specified by the Contractor.
d. Provide for safe packaging, shipping and distribution
of reagents and drugs approved by the Project Officer to
eligible research investigators in the U.S. and abroad so
that such shipments are coordinated for timely receipt.
e. Obtain the appropriate licenses and permits required by
local, state and Federal authorities for the safe import,
storage and distribution of reagents and drugs.
Additionally, the Contractor shall obtain the appropriate
interstate, intrastate and foreign import/export shipping
licenses and permits for transporting
biohazardous/radioactive reagents and drugs.
(NOTE 13 TO THE OFFEROR: THE OFFEROR SHOULD DEMONSTRATE
KNOWLEDGE AND EXPERIENCE IN PACKAGING/SHIPPING BIOHAZARDOUS
AND ETIOLOGIC AGENTS NATIONALLY AND INTERNATIONALLY. THE
OFFEROR SHOULD ALSO DEMONSTRATE KNOWLEDGE AND EXPERIENCE IN
PROCURING THE APPROPRIATE IMPORT/EXPORT LICENSES AND
PERMITS. THE OFFEROR SHOULD DESCRIBE: (A) A PLAN FOR
PACKAGING AND SHIPPING OF REAGENT REQUESTS, AND RECEIVING
INCOMING REAGENTS; AND (B) LIST EQUIPMENT, RESOURCES AND
FACILITIES DEDICATED TO THE PROJECT.)
f. Provide 24-hour, seven days a week availability of
personnel to pick up and store incoming shipments of
reagents from a specified airport or other contract site in
a timely manner in order to assure that reagents are
maintained at necessary temperature until placed in the AIDS
Reagent Program. Because the incoming shipments usually
represent a substantial financial investment, it is
essential that shipments be coordinated by the Contractor so
that personnel will be available to receive the arriving
package whenever delivered and transport shipment to the
AIDS Reagent Program for storage at the required
temperature. All shipments when received should be
maintained for stability and viability by providing the
necessary temperature in transit from the airport or other
site to the AIDS Reagent Program.
g. Coordinate all shipments so that viability, biological
activity or purity of the reagents will not be adversely
affected. Send notification by World Wide
Web/facsimile/telegram to all foreign investigators to
coordinate shipping and receiving of frozen and refrigerated
reagents. Advise domestic investigators in the most suitable
manner of shipments and arrival dates.
(NOTE 14 TO THE OFFEROR: THE OFFEROR SHOULD DESCRIBE A PLAN
FOR HOW THE INCOMING REAGENTS WILL BE DELIVERED TO THE AIDS
REAGENT PROGRAM IN A TIMELY MANNER. FOR SHIPMENTS OUT OF
THE AIDS REAGENT PROGRAM, THE OFFEROR SHALL ESTABLISH A
MECHANISM FOR BEING NOTIFIED BY REQUESTER OF DATE REAGENTS
WERE RECEIVED AND CONDITION OF REAGENTS UPON RECEIPT. THE
OFFEROR SHOULD INCLUDE DETAILS OF PROPOSED NOTIFICATION
MECHANISM/PLAN IN THE TECHNICAL PROPOSAL.)
h. Use shipping containers for reagents which will comply
with current domestic and international transport
regulations and pertinent International Air Transport
Association/International Civil Aviation Organization
Dangerous Goods regulations. The shipping containers must
provide a sufficient margin of safety for maintaining
appropriate environmental safeguards and desired
refrigeration levels for specific products in transit,
depending on the mode of transportation employed.
6. DISSEMINATE PUBLIC INFORMATION CONCERNING REAGENT AVAILABILITY:
a. Promote awareness of the AIDS Reagent Program's
services throughout the scientific community using
electronic and print media, and as determined by the Project
Officer, leased booths or poster presentations at scientific
meetings, symposia and workshops. World Wide Web-based
advertisements shall include links to all relevant pages.
(NOTE 15 TO THE OFFEROR: THE OFFEROR SHOULD ANTICIPATE
MAKING TWO PRESENTATIONS ANNUALLY AT SCIENTIFIC MEETINGS.
FOR THE PURPOSE OF PREPARING A BUDGET ASSUME ONE MEETING IN
WASHINGTON D.C. METROPOLITAN AREA AND OTHER IN SAN
FRANCISCO, CALIFORNIA. THE OFFEROR SHOULD OUTLINE THEIR
EXPERIENCE IN INTERACTIONS WITH THE AIDS RESEARCH COMMUNITY,
BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES (WORLDWIDE),
TECHNOLOGY TRANSFER OFFICIALS, AND THE DIVISION OF AIDS,
INCLUDING SPONSORING WORKSHOPS AND AWARENESS-PROMOTING
ACTIVITIES.)
b. Provide HTML copy to publish and periodically update
the AIDS Reagent Program information on the NIAID Home Page
on the World Wide Web including but not limited to the AIDS
Reagent Program catalog, a newsletter (the "Courier"), articles
on new reagents, protocols, and NIH initiatives. These should
be of quality comparable to the information currently
available on the NIAID Home Page.
c. Develop and maintain an electronic World Wide Web-based
reagent ordering/donating system, LISTSERV news groups and
an electronic bulletin board.
(NOTE 16 TO THE OFFEROR: CURRENTLY A FOLIO INFOBASE IS
ACCESSED VIA A NIAID FILE SERVER AND IS ACCESSIBLE TO USERS
ON THE WORLD WIDE WEB. THE
INFOBASE WAS CREATED WITH FOLIO VIEWS 3.1 (FOLIO
CORPORATION, 2155 NORTH FREEDOM BLVD., SUITE 150, PROVO,
UT). THE OFFEROR SHOULD DESCRIBE A PLAN TO CONTINUE TO PROVIDE
AIDS REAGENT PROGRAM INFORMATION ON THE WORLD WIDE WEB AND
HOW THE OFFEROR WILL KEEP CURRENT WITH THE ADVANCING
TECHNOLOGY OF THE WORLD WIDE WEB.)
d. With approval of the Project Officer, prepare camera-
ready hard copy of a catalog of available reagents. The
Government may print these catalogs, or the Project Officer
and the Contracting Officer may direct the Contractor to
arrange for printing through the contract. The catalog
shall be prepared annually with a publication date of
January of each year. The first catalog shall be published
in January 1999, and shall be of quality comparable to the
January 1998 catalog. It is anticipated that approximately
4,000 copies will be printed and distributed annually. The
Contractor shall distribute the catalogs to the scientific
community on the AIDS Reagent Program mailing list
(approximately 3,000 copies), and to others on request.
e. With approval of Project Officer, publish three to four
hard copy editions of a newsletter ("Courier"), including
information on new reagents, protocols, and NIH research
initiatives. It is anticipated that approximately 4,000
copies will be published with each edition. The Contractor
shall distribute catalog updates/newsletters to the
scientific community on the AIDS Reagent Program mailing
list and to others on request.
f. Publish descriptions of portions of the AIDS Reagent
Program collection in relevant scientific journals as
determined by the Project Officer.
(NOTE 17 TO THE OFFEROR: THE OFFEROR SHOULD INDICATE IN THE
TECHNICAL PROPOSAL HOW THE EDITORIAL AND TECHNICAL SUPPORT
FOR THE ABOVE PUBLICATIONS WILL BE PROVIDED BY THE
CONTRACTOR'S STAFF. IF A SUBCONTRACT IS PROPOSED, THE
OFFEROR SHOULD PROVIDE THE CRITERIA FOR SELECTION OF THE
SUBCONTRACTOR WITH THE TECHNICAL PROPOSAL, AND THE COSTS IN
THE BUSINESS PROPOSAL.)
7. PROVIDE NECESSARY AIDS REAGENT PROGRAM SUPPORT:
a. Support collaborative efforts of the Division of AIDS
to develop/evaluate and expand access to reagents, including
but not limited to reference standards and panels of
reagents, such as PCR standards, DNA libraries, drug
resistant viral isolates, antibodies, and drugs.
b. Periodically evaluate services provided by the AIDS
Reagent Program, including the status and use of reagents,
and other services provided by the contract.
c. The Contractor shall provide other related services
within the scope of this contract as may be deemed necessary
by the Project Officer.
8. PROVIDE SUPPORT FOR THE AIDS REAGENT PROGRAM SPONSORED WORKSHOPS:
Under the guidance of the Project Officer, the AIDS Reagent
Program shall sponsor workshops: to develop reagents and/or
protocols; to prioritize reagent acquisitions; to promote
technology transfer; and to promote compliance with
regulations for packaging and shipping of infectious
substances. The Contractor shall provide support for
invited participants, including travel and per diem expenses
and honoraria.
(NOTE 18 TO THE OFFEROR: FOR THE PURPOSES OF PREPARING A
BUDGET, ASSUME TWO, ONE-DAY WORKSHOPS ANNUALLY, FOR 10
INVITEES TO BE HELD IN THE WASHINGTON, D.C. AREA.)
9. PROVIDE AN INVENTORY AND DISTRIBUTION DATABASE AND MANAGEMENT
SYSTEM:
Provide and maintain an on-going computerized inventory and
distribution database and processing system on an IBM/IBM
compatible system which will track and assist in the
coordination of the activities under this contract.
(NOTE 19 TO THE OFFEROR: THIS CONTRACT SHALL NOT SUPPORT
THE PURCHASE OF GENERAL PURPOSE ADP EQUIPMENT. THE OFFEROR
SHOULD ASSUME THAT THE GOVERNMENT WILL PROVIDE TO THE NEW
CONTRACTOR THE EXISTING DATA BASE AND MANAGEMENT SYSTEM, THE
AIDS REAGENT MANAGEMENT SYSTEM CONTAINING INFORMATION ON
REAGENT INVENTORY, INCLUDING ACTIVITIES OF THE AIDS REAGENT
PROGRAM, ALONG WITH NECESSARY DOCUMENTATION. THE AIDS
REAGENT MANAGEMENT SYSTEM CURRENTLY RESIDES ON AN IBM
COMPATIBLE 486 COMPUTER, IS WRITTEN IN FOXPRO FOR DOS 2.6
(FOX SOFTWARE INC., PERRYSBURG, OH 43551), A MENU-DRIVEN
COMMERCIALLY AVAILABLE RELATIONAL DATABASE MANAGEMENT
SYSTEM. A MAJOR COMPONENT OF THE SYSTEM IS THE MODULE TO
TRACK INDIVIDUAL INVESTIGATORS' REAGENT ACQUISITION AND
RECEIPT. OTHER MODULES SUPPORT PRODUCTION OF STANDARD
REPORTS, SUCH AS RECEIVING AND SHIPPING. MORE SPECIALIZED
REPORTS INCLUDING THE REAGENT INVENTORY, INVESTIGATOR
AFFILIATIONS AND MAILING LISTS ARE ALSO AVAILABLE THROUGH
THIS DATABASE. THE AIDS REAGENT MANAGEMENT SYSTEM AND
COMPUTER FILES WILL BE TRANSFERRED TO THE NEW CONTRACTOR,
WITHOUT ANY COMPUTERS. THE OFFEROR SHOULD PROPOSE APPROPRIATE
COMPUTER HARDWARE AND SOFTWARE FOR THIS REQUIREMENT, AND A
PLAN FOR MAINTENANCE, DATA INPUT AND DATA BACK-UP.)
a. Keep records for each reagent, including but not
limited to the following: the source/donor of the reagent;
a description of the reagent; category of reagent (e.g. not
of human origin, human derived, biohazardous, radioactive,
donor assigned category for commercial use); lot number;
date of receipt; quality control information; storage
conditions; solubility of the reagent when appropriate;
storage location; restrictions, if any, on disposition and
uses; how dispensed and to whom; when the reagent was
shipped; and documentation from the recipient that the
reagent was received.
b. Have the capability to read and generate bar coded
labels for 1.8 ml reagent vials in different formats
including numeric, alpha numeric and colored bar codes.
Software and hardware for maintaining these records shall be
provided by the Contractor.
c. Ensure protection against the loss of data by the
duplication of data base files and programs for storage
outside of the AIDS Reagent Program. The system in its
entirety shall be completely documented and capable of being
transferred to the Government without interruption.
d. Provide for the security and safety of data on the
reagents and information related to the evaluation and use
of the reagents. All information regarding the evaluation
of the reagents shall be proprietary and treated as such.
The Project Officer shall be responsible for determining the
level of information regarding a particular reagent that
will be made available for dissemination and to whom the
information will be made available.
10. MEET WITH THE PROJECT OFFICER:
The Contractor's key personnel, including the Principal
Investigator, shall meet with the Project Officer at
periodic intervals to be scheduled after contract award, to
review the project and discuss the work to be performed.
(NOTE 20 TO THE OFFEROR: FOR THE PURPOSE OF PREPARING A
BUDGET, ASSUME A MINIMUM OF 12 VISITS PER YEAR TO 6003
EXECUTIVE BOULEVARD, ROCKVILLE, MD 20892, TO MEET WITH THE
PROJECT OFFICER.)
11. ENSURE AN ORDERLY TRANSITION OF THE AIDS REAGENT PROGRAM TO A
SUCCESSOR CONTRACTOR:
a. The Contractor shall coordinate an orderly and safe
transition from the current incumbent Contractor to the new
awardee, and an orderly transition to the successor of this
contract, including the movement of stored reagent samples,
data, and all Government furnished property to a subsequent
Contractor or to the Government.
The Contractor shall safely and effectively coordinate the
transfer of the contents of the current AIDS Reagent Program
with the current Contractor and begin operation of the AIDS
Reagent Program within 90 calendar days from the award of
the new contract. The Contractor, subject to Project Officer
approval, shall deliver to the Government or its designee by
the expiration date of this contract, the following items:
1) preserved reagent samples; 2) data files and program
comprising the AIDS Reagent Management System; 3)
computerized listings of accurate and updated information on
reagent inventory, data files, data bases, original data and
any necessary information related thereto; 4) labeled and
inventoried paper files; and 5) Government owned equipment
and property.
b. The Contractor shall commence operation in accordance
with approved Standard Operating Procedures.
(NOTE 21 TO THE OFFEROR: THE OFFEROR SHOULD INCLUDE TWO (2)
"TRANSITION" PLANS" IN THE TECHNICAL PROPOSAL (AND COSTS IN
THE BUSINESS PROPOSAL):
1) IN THE EVENT AN ORGANIZATION OTHER THAN THE CURRENT CONTRACTOR
IS SELECTED, THE CURRENT INCUMBENT CONTRACTOR SHALL BEGIN TO MOVE
THE AIDS REAGENT PROGRAM COLLECTION (CURRENTLY LOCATED IN
ROCKVILLE, MD), AND ALL GOVERNMENT FURNISHED PROPERTY LISTED
UNDER ATTACHMENT A-1 TO THE STATEMENT OF WORK, TO THE NEW SITE ON
OR ABOUT NOVEMBER 20, 1997; IT IS ESTIMATED THAT THIS WILL BE
ACCOMPLISHED NO LATER THAN 90 CALENDAR DAYS FROM THE AWARD
OF THE "NEW" CONTRACT; THEREFORE, THE OFFEROR SHOULD PROVIDE,
IN THE TECHNICAL PROPOSAL, A TRANSITION PLAN FOR COORDINATING
BETWEEN THE INCUMBENT CONTRACTOR AND THE OFFEROR THAT WILL
INCLUDE ALL TASKS ASSOCIATED WITH THIS RELOCATION EFFORT AND
THE MANNER OF OPERATIONS BY THE OFFEROR DURING THE TRANSITION
PERIOD; INCLUDE ANY PROPOSED TRAINING TIME ASSOCIATED WITH
TRANSFER AND OPERATION OF THE CURRENT AIDS REAGENT MANAGEMENT
SYSTEM;
2) PROVIDE WITH THE TECHNICAL PROPOSAL A PLAN FOR MOVEMENT OF THE
AIDS REAGENT PROGRAM AT THE CONCLUSION OF "THIS" CONTRACT TO A
NEW SITE; INCLUDE COSTS IN THE BUSINESS PROPOSAL FOR THIS MOVE.)
(NOTE 22 TO THE OFFEROR: THE OFFEROR SHOULD FURNISH ITS
PROPOSED STANDARD OPERATING PROCEDURES RELATING TO THE
CONDUCT OF THIS CONTRACT AS PART OF THE TECHNICAL PROPOSAL.)
*****************************************************************
ATTACHMENT A-1
LIST OF GOVERNMENT FURNISHED PROPERTY
______________________________________
Dates Purchased:
1. Equipment:
(i) LKB Gamma Counter, Model 1272-001. 10/88
(ii) LKB Rackbeta Liquid Scintillation Counter, 10/88
Model 1209-005.
(iii) Cryo-Frig -90 degree Centigrade Freezer, 05/90
Model C2090-DNS (20 cu.ft.).
(iv) American Scientific Upright Refrigerator, 11/88
Model LR234-ANK (22.5 cu.ft.)
(v) American Scientific Refrigerator/Freezer, 11/88
Model GCS141-A0A (10.9 cu.ft./3.1 cu.ft.).
(vi) Taylor Wharton Liquid Nitrogen Tank, 01/93
Model 33KCT (33,000 vial capacity)
The above listed new equipment provided to the AIDS Reagent
Program is under preventive maintenance contract and is in
good working condition.
2. Computer Software:
(i) AIDS Reagent Management System: 38 information files,
approximately 18 Megabytes; 253 programming files, approximately
8.5 Megabytes.
(ii) Annual catalog of reagents: 170 files, 4.0 Megabytes; data
sheets, 689 files, 14 Megabytes.
(iii) One Folio file (.nfo) of catalog information, approximately 7.9
Megabytes.
(iv) Thirty Folio Search and Replace (FSR) files, approximately 188
Megabytes.
3. Paper Files:
Ten, 4-drawer file cabinets for accumulated paperwork.
Four, 5-drawer file cabinets for accumulated paperwork.
4. Journals:
Five, 7'X 4'(wide) and 18" deep bookshelves stacked with
scientific journals.
5. Shipping Materials:
Nine, 6-ft shelving units containing packing and shipping
materials.
6. Reagents:
Majority of the approximately 127,000 reagents samples, including
drugs, are stored in 1.0 or 2.0 ml Nunc tube type vials as
follows:
Storage Temperature Storage Space Number of Samples
(degree Centigrade) (cubic foot)
24 21 1,200
2-8 82 7,500
-20 40 11,000
-90 94 52,000
-135 61 55,000
Total 298 cu ft 126,700
**********************************************************
ATTACHMENT A-2
SAFETY CONTROLS AND STANDARDS
___________________________
PHS 352.223-70 SAFETY AND HEALTH (APRIL 1984)
a. In order to provide safety controls for protection to the
life and health of employees and other persons; for
prevention of damage to all property; and for avoidance of
work interruptions in the performance of the contract; the
Contractor will consult, comply with, and include in all
applicable subcontracts, the following standards, as
appropriate:
(1) Biosafety in Microbiological and Biomedical
Laboratories, U.S. Department of Health and Human Services,
Centers for Disease Control (CDC) and the NIH, DHHS Pub. No.
(CDC) 93-8395.
(2) Recommendations for Prevention of HIV Transmission in
Health-Care Settings, Morbidity and Mortality Report, August
21, 1987, Vol. 35, No. 2S.
(3) Update: Universal Precautions for Prevention of
Transmission of Human Immunodeficiency Virus, Hepatitis B
Virus, and Other Bloodborne Pathogens in Health-Care
Settings. Morbidity and Mortality Weekly Report, June 24,
1988, Vol. 37, No. 24.
(4) Agent Summary Statement for Human Immunodeficiency
Viruses (HIV); Included are GTLV-III, LAV, HIV-1, and HIV-2.
Morbidity and Mortality Weekly Report, April 1, 1988, Vol.
37, No. S4.
(5) Recommendations for the Safe Handling of Parentoral
Antineoplastic Drugs, NIH Publication No. 83-2621.
(6) NIH Guidelines for the Laboratory Use of Chemical
Carcinogens, NIH Publication No. 81-2385.
The above, (1) - (6), may be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building 31, Room 1C02
31 CENTER DR MSC 2260
BETHESDA MD 20892-2260
(7) Occuupational Safety and Health Administration (OSHA)
Publications: 1) 29 CFR Part 1910.1030, Occupational Exposure
to Blood Borne Pathogens, Final Rule, and; 2) 29 CFR Part 1910,
Occupational Exposure to hazardous chemicals in Laboratories,
Final Rule.
The above 1 and 2 can be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building 31, Room 1C02
31 CENTER DR MSC 2260
BETHESDA MD 20892-2260
(8) Guidelines for Research Involving Recombinant DNA
Molecules (49 FR 46266 or latest revision) and
Administrative Practices Supplement. These may be obtained
from:
Office of Recombinant DNA Activities
Office of Science Policy and Legislation
National Institutes of Health
Building 31, Room B1C34
31 CENTER DR MSC 2250
BETHESDA MD 20892-2250
(9) Procedures for the Domestic handling and Transport of
Diagnostic Specimens and Etiologic Agents, National
Committee for Clinical Laboratory Standards, July 17, 1985,
Vol. 5. This may be obtained from
National Committee for Clinical Laboratory Standards
771 East Lancaster Avenue
Villanova, Pennsylvania 19085
Further, the Contractor shall take or cause to be taken such
additional safety measures as the Contracting Officer may
determine to be reasonably necessary; provided, that if
compliance with such additional safety measures results in
a material increase in the cost or time of performance of
the contract, an equitable adjustment will be made in
accordance with the clause of this contract entitled
"Changes."
b. Prior to commencement of work, the Contractor
will submit in writing its plan for complying with the safety
and health provisions of this contract, and will meet with the
Contracting Officer or his/her designated representative to
discuss and develop a mutual understanding relative to
administration of the overall safety program.
c. During the performance of work under this contract, the
Contractor shall comply with all procedures prescribed by
the Contracting Officer for the control and safety of
persons visiting the job site and will comply with such
requirements to prevent accidents as may be prescribed by
the Contracting Officer.
d. The Contractor will maintain an accurate record of, and
report to the Contracting Officer in such manner as the
Contracting Officer may prescribe, all accidents and
incidents resulting in death, traumatic injury, occupational
disease, and/or damage to all property incident to work
performed under the contract.
e. The Contracting Officer shall notify (if otherwise,
confirm in writing) the Contractor of any noncompliance with
the provisions of this clause and corrective action to be
taken. After receipt of such notice, the Contractor shall
immediately take such corrective action. (Such notice, when
delivered to the Contractor or its representative at the
site of the work, shall be deemed sufficient for the
purpose.) If the Contractor fails or refuses to comply
promptly, the Contracting Officer may issue an order
stopping all or part of the work until satisfactory
corrective action has been taken. No part of the time lost
due to any such stop order shall be the subject of claim for
extension of time or for costs or damages by the Contractor.
f. The Contractor shall insert the substance of this clause
in each subcontract involving the use of hazardous materials
or operations. Compliance with the provisions of this
clause by subcontractors will be the responsibility of the
Contractor.
(End of clause)
***********************************************************************
ATTACHMENT B
REPORTING REQUIREMENTS AND DELIVERABLES
The Contractor shall submit to the Contracting Officer and to the
Project officer technical progress reports covering the work
accomplished during each reporting period as stated below:
A. QUARTERLY REPORTS. By the fifteenth working day after completion
of each quarter, the Contractor shall submit 3 copies of a report of
work performed in the previous quarter. Each quarterly 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. Information which shall include a brief summary of the work
performed during the reporting period but not be limited to the
following:
(a) An inventory report of the quantity and types of each
reagent stored as of the last day of each quarter;
(b) A list of reagents assayed during the quarter, type of assay
and results of the assay;
(c) A summary of reagents shipped which will have the following
information for each reagent:
(i) Quantity of the reagent
(ii) Date of shipment
(iii) Date of receipt of shipment
(iv) Name and address of the recipient
(v) Problems associated with any shipment
(d) A summary of reagents that were acquired during the quarter
which will list the following information for each:
(i) Quantity of reagent,
(ii) Source of reagent,
(iii) Description of reagent,
(iv) Quality control information, and
(v) Restrictions on disposition and use.
(vi) Unit and total cost of reagent.
(e) Cumulative list of publications by registrants
acknowledging AIDS Reagent Program as a source of reagents.
(f) Feedback on reagents use.
(g) Maintenance problems encountered and corrective action
taken.
(h) Need for replacement or repair of Government furnished
equipment.
(i) Description of current technical or administrative
problems encountered, their resolution or the proposed
corrective action.
B. FINAL REPORT
The Contractor shall submit 3 copies of the final report
which documents and summarizes the results of the entire
contract for the period of performance. This report will
provide a final inventory and contain a cover page described
in A.1. above and the information required in A.2. above.
1. The final report shall be submitted by the expiration
date of the contract.
2. If the Contractor is unable to deliver the reports specified
hereunder within the period of performance because of unforeseen
difficulties, notwithstanding the exercise of good faith and
diligent efforts in performance of the work, the Contractor shall
give the Contracting Officer immediate written notice of
anticipated delays with reasons therefor.
C. OTHER DELIVERABLES. The Contractor, subject to the Contracting
Officer, approval shall deliver to the Government or its designee
by the expiration date of the Contract, the following items:
(1) Preserved reagent samples;
(2) AIDS Reagent Management System and documentation on the
computer systems/files;
(3) Computerized listing of accurate and updated
information on reagent inventory, including activities of
the AIDS Reagent Program, data files, data bases, original
data and any necessary information related thereto;
(4) Labeled and inventoried paper files; and
(5) Government-owned equipment and property.
**********************************************************
RFP-NIH-NIAID-DAIDS-98-03
ATTACHMENT C
(January 28, 1997)
EVALUATION FACTORS FOR AWARD
----------------------------
1. GENERAL
Proposals submitted in response to this solicitation will be
subjected to review by an ad hoc technical review committee.
The evaluation will be based on the demonstrated
capabilities of the prospective contractors in relation to
the needs of the project as set forth in the RFP. The merit
of each proposal will be evaluated carefully, based on
responsiveness to the RFP and thoroughness and feasibility
of the technical approach taken. Offerors must submit
information sufficient to evaluate their proposal based on
the detailed criteria listed below. Failure to provide the
information required to evaluate the proposal may result in
rejection of that proposal without further consideration.
While high competency is sought, capabilities that exceed
those needed for successful performance of the contract work
statement are not requested.
2. COMPARATIVE IMPORTANCE OF PROPOSALS
You are advised that paramount consideration shall be given
to the evaluation of the technical proposals, but not to the
exclusion of past performance and cost considerations. The
past performance capability of the offeror and estimated
cost of an offer will be considered to determine which offer
provides the best or greatest overall value to the
Government. Past performance will be evaluated apart from
the technical evaluation and the cost/price analysis (See
Item 4. below for additional past performance information).
At Source Selection, the technical evaluation will count for
NINETY PERCENT (90%) of the overall evaluation and past
performance will count for TEN PERCENT (10%) of the overall
evaluation. In cases where offers are considered to be
equal based on the combined technical and past performance
evaluation, the estimated cost to the Government may be the
determining factor for award of a contract. In any event,
the Government reserves the right to make an award to the
best advantage of the Government, cost and other factors
considered.
3. PROPOSAL EVALUATION CRITERIA
Proposals submitted in response to this RFP will be
evaluated based on the following factors which are listed
and weighted in order of their relative importance.
Proposals will be judged solely on the written material
provided by the offeror. It is anticipated that one award
will be made as a result of this acquisition, dependent on
the availability of funds.
TECHNICAL EVALUATION CRITERIA POINTS
A. TECHNICAL APPROACH 55 Points
The technical adequacy, feasibility, safety and
effectiveness of the detailed and specific plans
demonstrating knowledge, experience and competence,
standard operating procedures, and quality control
measures proposed for operation of an AIDS Reagent
Program, including:
(1) Identification, prioritization, and acquisition of
reagents from domestic and international sources;(15 points)
(2) Production/expansion of reagents; evaluation of the
quality and activity of the reagents; (10 points)
(3) Coordination of the operation of the AIDS Reagent
Program through interactions with the AIDS research
community, biotechnology and pharmaceutical companies
(worldwide), technology transfer officials, and the Division
of AIDS, including sponsoring workshops and awareness-
promoting activities; plan for providing editorial and
publishing services for the catalog of reagents and the
newsletter; plan for resolving potential conflicts of
interest if a commercial organization is acquiring
potentially valuable reagents for this program instead of
for offeror's commercial use; (10 points)
(4) Maintaining and updating internal information database
systems and on the World Wide Web, to track all information
that relates to the activities of the AIDS Reagent Program,
including an inventory of reagents, shipment and receiving
of reagents, and assay information; (10 points)
(5) Effecting smooth transitions between Contractors,
including providing assistance to the incumbent Contractor
to ensure a safe and efficient move of the AIDS Reagent
Program; and coordinating an orderly transition to the
successor Contractor. Quality of the Standard Operating
Procedures submitted to BEGIN operation of the AIDS Reagent
Program. (10 points)
B. PERSONNEL QUALIFICATIONS 25 Points
(1). Documented training, experience and availability of a
Principal Investigator with technical and administrative
competence to operate an AIDS Reagent Program or a Project
of comparable size and complexity; the proposed P.I. should
have a Ph.D. or its equivalence, and postdoctoral research
experience in biological sciences; demonstrated knowledge
and research experience in retrovirology in order to
identify and prioritize HIV/AIDS reagents and to provide
technical assistance (10 points).
(2). Documented training, experience and availability of
other professional and support staff necessary to
successfully carry out proposed roles, including editorial
and demonstrated scientific writing (preferably experience
in human virology and/or retroviruses) to prepare an AIDS
Reagent Program catalog, a scientific newsletter and
promotional literature; experience with promotion of a AIDS
research service/business; laboratory competence and
familiarity with safety regulations and World Wide Web site
maintenance experience (15 points).
C. FACILITIES AND RESOURCES 20 Points
Documented availability of adequate facilities, equipment and
resources necessary to safely operate, maintain and expand this
AIDS Reagent Program; facilities to ship, receive and store
hazardous and infectious agents, and maintain their activity and
viability. The offeror offer must provide: 1) a detailed floor
plan of the proposed facility which shows location of the
equipment and resources; 2) information regarding ownership/lease
of the facility which demonstrates availability for the duration
of the proposed contract); 3) plan for compliance with all safety
guidelines and regulations, including training and monitoring of
personnel for exposure to infectious and hazardous reagents; and
4) logistic plan for storage, packaging and shipping of reagents
nationally and internationally, including notification mechanism
for date reagent received and condition of reagent upon receipt;
logistic plan for receiving, processing and storing incoming
reagent shipments.
TOTAL 100 Points
4. PAST PERFORMANCE FACTOR
The offeror's past performance will be evaluated after
completion of the technical evaluation. Only those offerors
comprising the competitive range will be evaluated. The
Government will evaluate the QUALITY of the offeror's past
performance based on information obtained from references
provided by the offeror, as well as other relevant past
performance information obtained from other sources known to
the Government.
Evaluation of past performance will be a subjective
assessment based on a consideration of all relevant facts
and circumstances. The Government is seeking to determine
whether the offeror has consistently demonstrated a
commitment to customer satisfaction and timely delivery of
services at fair and reasonable prices.
The assessment of the offeror's past performance will be
used as a means of evaluating the relative capability of the
offeror and the other competitors. Thus, an offeror with an
exceptional record of past performance may receive a more
favorable evaluation than another whose record is
acceptable, even though both may have acceptable technical
and management proposals.
Past performance will be ranked and the Government's
conclusions about overall quality of the offeror's past
performance may be influential in determining the relative
merits of the offeror's proposal and in selecting the
offeror whose proposal is considered most advantageous to
the Government.
BY PAST PERFORMANCE, THE GOVERNMENT MEANS THE OFFEROR'S
RECORD OF CONFORMING TO SPECIFICATIONS AND TO STANDARDS OF
GOOD WORKMANSHIP; THE OFFEROR'S RECORD OF FORECASTING AND
CONTROLLING COSTS; THE OFFEROR'S ADHERENCE TO CONTRACT
SCHEDULES, INCLUDING THE ADMINISTRATIVE ASPECTS OF
PERFORMANCE; THE OFFEROR'S REPUTATION FOR REASONABLE AND
COOPERATIVE BEHAVIOR AND COMMITMENT TO CUSTOMER
SATISFACTION; AND GENERALLY, THE OFFEROR'S BUSINESS-LIKE
CONCERN FOR THE INTEREST OF THE CUSTOMER.
Offerors shall submit the following information as part of
their BUSINESS PROPOSALS (for both the offeror and proposed
major subcontractors): a list of the contracts completed
during the past THREE years and ALL contracts currently in
progress for products or services similar to those being
acquired under this RFP. Contracts listed may include those
entered into with the Federal Government, agencies of state
and local governments and commercial customers. Offerors
that are newly formed entities without prior contracts
should list contracts and subcontracts as required above for
all key personnel. Include the following information for
each contract:
1. Name of Contracting Organization
2. Contract Number
3. Contract Type
4. Total Contract Value
5. Description of Requirement
6. Contracting Officer's Name and Telephone Number
7. Project Officer's Name and Telephone Number
At SOURCE SELECTION (after the initial technical review and
negotiations), past performance information from Offerors
who comprise the competitive range will be evaluated using
the following CUSTOMER SURVEY:
****************************************************
[SAMPLE-DO NOT COMPLETE]
NATIONAL INSTITUTES OF HEALTH
CONTRACTOR PERFORMANCE - RFP CUSTOMER SURVEY QUESTIONNAIRE
Please complete the following questionnaire and return via
regular mail or fax to the attention of:
(Name)
(Address)
(Fax Number)
BASELINE INFORMATION
This survey pertains to the company:
Contract Number:
Date of survey:
Name of person completing survey:
Signature of person completing survey:
Your company/Agency:
Your role in this contract (circle one):
Contracting Officer Contract Specialist
Project Officer Other
Time period covered including all option periods:
Contract value including all option and option periods: $
Type of Contract:
Approximate percentage of work being performed (or
completed) by subcontractor(s): %
Subcontracting company names (where more than__ % of work
was completed by the subcontractor).
Company Program Manager Phone
Company Program Manager Phone
Company Program Manager Phone
General description of products/services required under the
contract:
RATINGS
Please answer each of the following questions with a rating
that is based on objective measurable performance indicators
to the maximum extent possible. Commentary to explain
rating can be noted on an attachment.
Assign each area a rating of 0 (Unsatisfactory), 1 (Poor),
2 (Fair), 3 (Good), 4 (Excellent), or 5 (Outstanding). Use
the attached Rating Guidelines as a guidance in making these
evaluations. Circle the appropriate rating. If you do not
have enough personal knowledge or feedback from internal
customers who directly received products and services from
the contractor to make a determination on any of the
performance criteria below, please circle the þN/Aþ (not
applicable/no opinion) answer.
QUALITY OF SERVICE
1. Compliance with contract requirements:
0 1 2 3 4 5 N/A
2. Accuracy of reports:
0 1 2 3 4 5 N/A
3. Effectiveness of personnel:
0 1 2 3 4 5 N/A
4. Technical excellence:
0 1 2 3 4 5 N/A
COST CONTROL
1. Record of forecasting and controlling target costs:
0 1 2 3 4 5 N/A
2. Current, accurate and complete billings:
0 1 2 3 4 5 N/A
3. Relationship of negotiated costs to actuals:
0 1 2 3 4 5 N/A
4. Cost efficiencies:
0 1 2 3 4 5 N/A
TIMELINESS OF PERFORMANCE
1. Met interim milestones:
0 1 2 3 4 5 N/A
2. Reliability:
0 1 2 3 4 5 N/A
3. Responsive to technical direction:
0 1 2 3 4 5 N/A
4. Completed on time including wrap-up and contract
administration:
0 1 2 3 4 5 N/A
5. Met delivery schedules:
0 1 2 3 4 5 N/A
6. No liquidated damages assessed: Yes No
(circle one)
BUSINESS RELATIONS
1. Effective management, including subcontracts:
0 1 2 3 4 5 N/A
2. Reasonable/cooperative behavior:
0 1 2 3 4 5 N/A
3. Responsive to contract requirements:
0 1 2 3 4 5 N/A
4. Notification of problems:
0 1 2 3 4 5 N/A
5. Flexibility:
0 1 2 3 4 5 N/A
6. Pro-active vs reactive:
0 1 2 3 4 5 N/A
7. Effective small/small disadvantaged business
subcontracting program:
0 1 2 3 4 5 N/A
CUSTOMER SATISFACTION
1. The contractor is committed to customer
satisfaction. Yes No (circle one)
2. Would you recommend selection of this firm again? Yes
No (circle one)
ADDITIONAL COMMENTS:
********************************************************************
RATING GUIDELINES
Summarize contractor performance in each of the rating
areas. Assign each area a rating of 0 ( UNSATISFACTORY),
1 (POOR), 2 (FAIR), 3 (GOOD), 4 (EXCELLENT), OR 5
(OUTSTANDING). Use the following instructions as guidance
in making these evaluations. Ensure that this assessment is
consistent with any other Agency assessments made (i.e., for
payment of fee purposes).
CRITERIA
---------
QUALITY OF PRODUCT OR SERVICE (Compliance with contract
requirements; Accuracy of reports; Effectiveness of
personnel; Technical excellence)
0 Unsatisfactory: contractor is not in compliance and is
jeopardizing achievement of contract objectives.
1 Poor: major problems have been encountered.
2 Fair: some problems have been encountered.
3 Good: minor inefficiencies/errors have been identified.
4 Excellent: contractor is in compliance with contract
requirements and/or delivers quality products/services.
5 Outstanding: the contractor has demonstrated an
outstanding performance level in this category that
justifies adding a point to the score. It is expected
that this rating will be used in those rare
circumstances when contractor performance clearly
exceeds the performance levels described as
"Excellent."
--------------------------------------------------
COST CONTROL (Record of forecasting and controlling target
costs; Current, accurate and complete billings; Relationship
of negotiated costs to actuals; Cost efficiencies)
0 Unsatisfactory: Contractor is unable to manage costs
effectively
1 Poor: Contractor is having major difficulty in
managing costs effectively.
2 Fair: Contractor is having some problems in managing
costs effectively.
3 Good: Contractor is usually effective in managing
costs.
4 Excellent: Contractor is effective in managing costs
and submits current, accurate, and complete billings.
5 Outstanding: The contractor has demonstrated an
outstanding performance level in this category that
justifies adding a point to the score. It is expected
that this rating will be used in those rare
circumstances when contractor performance clearly
exceeds the performance levels described as
"Excellent."
-----------------------------------------------
TIMELINESS OF PERFORMANCE (Met interim milestones;
Reliability; Responsive to technical direction; Completed on
time including wrap-up and contract administration; Met
delivery schedules; No liquidated damages assessed)
0 Unsatisfactory: Contractor delays are jeopardizing
performance of contract objectives.
1 Poor: Contractor is having major difficulty meeting
milestones and delivery schedules
2 Fair: Contractor is having some problems meeting
milestones and delivery schedules.
3 Good: Contractor is usually effective in meeting
milestones and delivery schedules
4 Excellent: Contractor is effective in meeting
milestones and delivery schedules.
5 Outstanding: The contractor has demonstrated an
outstanding performance level in this category that
justifies adding a point to the score. It is expected
that this rating will be used in those rare
circumstances when contractor performance clearly
exceeds the performance levels described as þExcellent.þ
-------------------------------------------------------
BUSINESS RELATIONS (Effective management,including
subcontracts; Reasonable/cooperative behavior; Responsive to
contract requirements; Notification of problems; Flexibility;
Pro-active vs reactive; Effective small/small disadvantaged
business subcontracting program)
0 Unsatisfactory: Response to inquiries,
technical/service/administrative issues is not effective.
1 Poor: Response to inquiries,technical/service/admin-
istrative issues is marginally effective
2 Fair: Response to inquiries, technical/service/admin-
istrative issues is somewhat effective.
3 Good: Response to inquiries, technical/service/admin-
istrative issues is usually effective.
4 Excellent: Response to inquiries,
technical/service/admin-istrative issues is effective.
5 Outstanding: The contractor has demonstrated an
outstanding performance level in this category that
justifies adding a point to the score. It is expected
that this rating will be used in those rare
circumstances when contractor performance clearly
exceeds the performance levels described as "Excellent."
**********************************************************
RFP-NIH-NIAID-DAIDS-98-03
ATTACHMENT D
SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
---------------------------------------------
NOTICE TO OFFERORS: This attachment contains proposal
instructions and information which are specifically related
to this acquisition. The information provided below is only
a portion of the instructions and notices required for the
submission of a proposal. References to additional, more
general, information and forms regarding proposal
preparation are contained in Attachment E, "Applicable RFP
References."
1. NUMBER AND TYPE OF AWARD(S)(NIH 2980) (APR 1984)
It is anticipated that one (1) award will be made from this
solicitation and that award will be made on or about January
20, 1998 (NOTE: award may be made by November 20, 1997, to
allow for a transition period to a new contractor).
It is anticipated that the award from this solicitation will
be multiple-year, cost-reimbursement type level-of-effort
contract with a period of performance of 7 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 requirement for the work set forth in the
Work Statement of this solicitation is 101,920 DIRECT LABOR
HOURS over the 7-year contract. It is estimated that the
labor hours are constituted as specified below and will be
expended approximately as follows:
DIRECT LABOR HOURS*
------------------
PRINCIPAL ASSIST. P.I.
INVEST. OTHER SCIENT. SUPPORT TOTALS
----------------------------------------------------------------
YEAR 1 2,080 4,160 8,320 14,560
YEAR 2 2,080 4,160 8,320 14,560
YEAR 3 2,080 4,160 8,320 14,560
YEAR 4 2,080 4,160 8,320 14,560
YEAR 5 2,080 4,160 8,320 14,560
YEAR 6 2,080 4,160 8,320 14,560
YEAR 7 2,080 4,160 8,320 14,560
---------------------------------------------------------------
TOTALS 14,560 29,120 58,240 101,920
*EFFORT IN THE ABOVE CHART WAS BASED ON 100% EFFORT (1 FULL-TIME
EQUIVALENT = 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 OBJECTIVES OF THESE
PROGRAM, AND IT WILL BE USED AS A BASIS FOR NEGOTIATIONS. 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. Bruce Anderson
Hand-Carried Address:
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, Maryland 20852
Mailing Address:
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard (MSC 7610)
Bethesda, Maryland 20892-7610
(b) The copy of any protest shall be received IN the
office designated above on the same day a protest is filed
with the GSBCA or within one day of filing a protest with
the GAO.
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-DAIDS-98-03
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. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT-ORGANIZATION
OF THE TECHNICAL PROPOSAL
PLEASE USE THE FOLLOWING FORMAT TO ORGANIZE AND PRESENT YOUR
TECHNICAL PROPOSAL-THIS WILL AID IN THE REVIEW OF THE
PROPOSALS RECEIVED:
SECTION # PAGE #
--------- -------
I. TECHNICAL PROPOSAL COVER SHEET (Format in Section C
of Gopher RFP: FORMS, FORMATS, ATTACHMENTS)
II. TECHNICAL PROPOSAL TABLE OF CONTENTS
III. TECHNICAL PROPOSAL*
SUB-SECTIONS - THE OFFEROR SHOULD STRUCTURE THEIR PROPOSAL
TO MIRROR THE WORK STATEMENT AND EVALUATION CRITERIA AS
FOLLOWS (IN CASE OF ANY INCONSISTANY BETWEEN THE LANGUAGE
BELOW AND THE WORK STATEMENT/EVALUATION CRITERIA IN THIS
RFP, THE LATER RULE):
--------
SECTION A: WORK STATEMENT (DISCUSS YOUR SPECIFIC TECHNICAL
APPROACH TO):
(1) IDENTIFICATION, PRIORITIZATION, AND ACQUISITION OF
REAGENTS FROM DOMESTIC AND INTERNATIONAL SOURCES;
[qualifications and experience in the identification,
prioritization, and acquisition of reagents from domestic
and international sources; outline of what reagents need to
be acquired and how you would prepare to do this; prioritize
the most important acquisitions] [see Work Statement Note
3].
(2) PRODUCTION/EXPANSION OF REAGENTS; EVALUATION OF
THE QUALITY AND ACTIVITY OF THE REAGENTS;
[plan for production/expansion of reagents, and how the
quality and activity of the acquired reagents will be
verified] [see Work Statement Notes 3,6,7]
(3) COORDINATION OF THE OPERATION OF THE AIDS REAGENT
PROGRAM THROUGH INTERACTIONS WITH THE AIDS RESEARCH
COMMUNITY, BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES
(WORLDWIDE), TECHNOLOGY TRANSFER OFFICIALS, AND THE
DIVISION OF AIDS, INCLUDING SPONSORING WORKSHOPS AND
AWARENESS-PROMOTING ACTIVITIES;
[plan for interacting with the AIDS research community,
sponsoring workshops and awareness-promoting activities; how
the editorial and technical support for the above
publications will be provided; plan for resolving potential
conflicts of interest if a commercial organization is
acquiring potentially valuable reagents for this program
instead of for offerorþs commercial use] [see Work Statement
Notes 5,16,17]
(4) MAINTAINING AND UPDATING INTERNAL INFORMATION
DATABASE SYSTEMS AND ON THE WORLD WIDE WEB, TO TRACK
ALL INFORMATION THAT RELATES TO THE ACTIVITIES OF THE
AIDS REAGENT PROGRAM, INCLUDING AN INVENTORY OF
REAGENTS, SHIPMENT AND RECEIVING OF REAGENTS, AND ASSAY
INFORMATION.
[plan to provide an inventory and distribution database and
management system;; propose appropriate computer hardware
and software for this requirement, and a plan for
maintenance, data input and data back-up; plan to continue
to provide aids reagent program information on the world
wide web and how the offeror will keep current with the
advancing technology of the world wide web] [see Work
Statement Note 19].
(5) EFFECTING SMOOTH TRANSITIONS BETWEEN CONTRACTORS,
INCLUDING PROVIDING ASSISTANCE TO THE INCUMBENT
CONTRACTOR TO ENSURE A SAFE AND EFFICIENT MOVE OF THE
AIDS REAGENT PROGRAM; AND COORDINATING AN ORDERLY
TRANSITION TO THE SUCCESSOR CONTRACTOR. QUALITY OF THE
STANDARD OPERATING PROCEDURES SUBMITTED TO BEGIN
OPERATION OF THE AIDS REAGENT PROGRAM.
[Discussion of the two Transition Plans; proposed standard
operating procedures relating to BEGIN operation of this
contract] [see Work Statement Notes 21,22].
SECTION B: RESOURCES/OTHER CONSIDERATIONS
Documented availability of adequate facilities, equipment
and resources necessary to safely operate, maintain and
expand this AIDS Reagent Program; facilities to ship,
receive and store hazardous and infectious agents, and
maintain their activity and viability.
THE OFFEROR OFFER SHOULD PROVIDE:
(1) A DETAILED FLOOR PLAN OF THE PROPOSED FACILITY
WHICH SHOWS LOCATION OF THE EQUIPMENT AND RESOURCES TO
BE DEDICATED TO THIS EFFORT;
[see Work Statement Note [3].
(2) INFORMATION REGARDING OWNERSHIP/LEASE OF THE
FACILITY WHICH DEMONSTRATES AVAILABILITY FOR THE
DURATION OF THE PROPOSED CONTRACT;
(3) PLAN FOR COMPLIANCE WITH ALL SAFETY GUIDELINES AND
REGULATIONS, INCLUDING TRAINING AND MONITORING OF
PERSONNEL FOR EXPOSURE TO INFECTIOUS AND HAZARDOUS
REAGENTS;
[submit copy of current Safety and Health Plan; evidence of
adequate training of personnel handling infectious agents
including hiv and opportunistic pathogens associated with
hiv infection, radioactive substances, dealing with
accidents, and monitoring for infection, as well as the
ability to identify safety standards applicable to
particular reagents likely to be acquired] [see Work
Statement Note 9].
(4) LOGISTIC PLAN FOR STORAGE, PACKAGING AND SHIPPING
OF REAGENTS NATIONALLY AND INTERNATIONALLY, INCLUDING
NOTIFICATION MECHANISM FOR DATE REAGENT RECEIVED AND
CONDITION OF REAGENT UPON RECEIPT; LOGISTIC PLAN FOR
RECEIVING, PROCESSING AND STORING INCOMING REAGENT
SHIPMENTS.
[logistic plan for storage, packaging and shipping of
reagents nationally and internationally; plan for how the
incoming reagents will be delivered to the aids reagent
program in a timely manner; for shipments out of the aids
reagent program, plan for establishing a mechanism for being
notified by requester of date reagents were received and
condition of reagents upon receipt; action plan for
identifying malfunction, a process to test capability, and
a process for transfer of reagents from malfunctioning
refrigerators/freezers; experience in procuring the
appropriate import/export licenses and permits] [see Work
Statement Notes 8,10,13,14].
SECTION C: PERSONNEL
list personnel by name, title, department and organization,
and detail each person's qualifications, role, and level-
of-effort in NARRATIVE Format (ATTACH RESUMES IN SECTION D
BELOW AND A FLOWCHART SHOWING ORGANIZATIONAL LINES OF
AUTHORITY); identify any subcontractor/consultant personnel
and provide their qualifications)
(1) DOCUMENTED TRAINING, EXPERIENCE AND AVAILABILITY
OF A PRINCIPAL INVESTIGATOR
(2) DOCUMENTED TRAINING, EXPERIENCE AND AVAILABILITY
OF OTHER PROFESSIONAL AND SUPPORT STAFF
[NOTE: FOR KEY PERSONNEL, ALSO INCLUDE THE FORM ENTITLED
"SUMMARY OF CURRENT AND PROPOSED ACTIVITIES" UNDER
SECTION D BELOW]
SECTION D: APPENDICES: (list each Appendix; Appendices
should be clear and legible, and easily located)
(1) Resumes and flowchart of organizational structure
for this project (IT IS RECOMMENDED THAT RESUMES BE
REDUCED TO NO MORE THAN 2 PAGES IN LENGTH)
(2) Any policy manuals, safety manuals, SOPs for above
Technical Plan);
(3) "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)
(4) "Technical Proposal Cost Information" form (located
in Section C, Gopher RFP, FORMS, FORMATS, &
ATTACHMENTS)
** Sections III.A through III.C. above MUST NOT EXCEED 75 PAGES
(this does not include any appendices but only the NARRATIVE
description of the Technical Plan). The front side of a
page equals one page (front and back of a page equals two
pages). Type density and size must be 10 to 12 points. If
constant spacing is used, there should be no more than 15
cpi, whereas proportional spacing should provide an average
of no more than 15 cpi. There must be no more than six lines
of text within a vertical inch.
**************************************************
6. PROPOSAL INTENT RESPONSE SHEET
PROPOSAL INTENT
---------------
RFP No.:NIH-NIAID-DAIDS-98-03
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:
RFP No.:NIH-NIAID-DAIDS-98-03
NIH-AIDS RESEARCH AND REFERENCE REAGENT PROGRAM
[] 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: Bruce Anderson
RFP NIH-NIAID-DAIDS-98-03
Fax # 301/402-0972
PLEASE RETURN BY: MARCH 28, 1996
**************************************************
RFP-NIH-NIAID-DAIDS-98-03
ATTACHMENT E
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" (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) PAST PERFORMANCE INFORMATION (SINCE PAST PERFORMANCE
IS AN EVALUATION CRITERION, THIS ITEM IS APPLICABLE)
(3) SMALL BUSINESS AND SMALL DISADVANTAGED BUSINESS
SUBCONTRACTING PLAN (DOES NOT APPLY TO SMALL BUSINESSES)
(4) FACILITIES CAPITAL COST OF MONEY (FOR COMMERCIAL
ORGANIZATIONS)
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) 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
OTHER - TO BE SUBMITTED AS DIRECTED BY CONTRACTING OFFICER
---------------------------------------------------------
(11) Certificate of Current Cost or Pricing Data, NIH-
1397
4. The Representations and Certifications are applicable.
5. The "Sample Contract Format-General" is applicable.