RFP No. NIH-NIAID-DMID-97-07
Title: "SEXUALLY TRANSMITTED DISEASES CLINICAL TRIALS UNIT
(STD CTU)"
Issued by: Carl R. Henn
Contracting Officer
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
DATE ISSUED: AUGUST 27, 1996
PROPOSAL DATE DUE: JANUARY 15, 1997, 4:30 P.M. (EST)
Ladies and Gentlemen:
You are invited to submit a proposal in accordance with the
requirements of this RFP (NIH-NIAID-DMID-97-07) for a "SEXUALLY
TRANSMITTED DISEASES CLINICAL TRIALS UNIT (STD CTU)." The
Government contemplates the award of one (1), five (5) year, cost-
reimbursement, completion type contract as a result of this RFP.
The documents included with this electronic RFP package are as
follows:
I. Streamlined RFP
a. Introduction, Background, Work Statement and Work Statement
Attachments, dated August 27, 1996 (Attachment 1)
b. Deliverables and Reporting Requirements, dated August 27,
1996 (Attachment 2)
c. Evaluation Factors for Award, dated August 27, 1996
(Attachment 3)
II. Specific RFP Instructions and Provisions, dated August 27, 1996
(Attachment 4)
III. Applicable RFP References, dated August 27, 1996 (Attachment 5)
In addition to this directory which provides access to this
streamlined RFP, there are five other subdirectories in the Gopher
System (under C. RFP References) which must be retrieved, in whole
or in part, in order to submit a proposal. The identity of these
additional documents are detailed in Attachment 5 (Applicable RFP
References) of this RFP. If you are unable to download any of these
documents, please contact Sara M. Southard, Contract Specialist, by
phone/fax/internet at the numbers/addresses listed below.
The attachments listed above represent all the necessary information
required for the submission of a proposal for this acquisition.
Following proposal submission and review, additional information
will be requested by the Contracting Officer from all offerors which
comprise the competitive range.
The original and twenty (20) copies of your technical proposal and
the original and five (5) copies of your business proposal must be
received by the Contract Specialist no later than January 15, 1997,
at 4:30 p.m. local time at the address listed in Attachment 4, Item
4.
Due to the National Institute of Allergy and Infectious Diseases'
current budget restrictions, it is recommended that any proposed
annual increase in costs for inflation be limited to no more than 4%
of total costs per year which is also the maximum currently allowed
by the NIH for research projects. Final inflation increases will be
subject to negotiation, taking into consideration the most current
consumer price index (CPI).
BE ADVISED THAT PORTIONS OF YOUR TECHNICAL PROPOSAL ARE SUBJECT TO
PAGE LIMITATIONS. The format and content of your TECHNICAL PROPOSAL
along with page limitation information is detailed in the "Technical
Proposal Table of Contents/Format", Attachment 4, Item 9.
In addition, you are reminded that the "Technical Proposal Cover
Sheet" must be completed in full detail and used as the cover sheet
for each copy of your technical proposal. (A copy of this form is
contained in the NIH Gopher under the FORMS, FORMATS, AND
ATTACHMENTS subdirectory found in C. RFP REFERENCES.) New policies
require submission of more detailed information than what has been
previously required. It is important that you list all professional
personnel and organizations named in the proposal who have any role
in the proposed work, including: staff of the primary organization
(offeror), subcontractors, collaborating organizations, and
consultants. Organizational affiliation(s) must be indicated for
every person named. You may use additional sheets, as needed,
following the format shown in the Technical Proposal Cover Sheet.
This information will be used to ensure that there will be no
conflicts of interest when selecting review committee members.
Your attention is further directed to the "Proposal Intent" form
contained in Attachment 4, Item 10. Please complete this form and
return it to this office on or before December 20, 1996. This will
allow us to expedite preparations for the peer review of proposals.
Funds are not presently available for this requirement. The
Government's obligation under a resulting contract is contingent
upon availability of appropriated funds from which payment for
contract purposes can be made.
If you intend to submit a proposal in response to this RFP, IT IS
ESSENTIAL THAT YOU IMMEDIATELY NOTIFY MS. SARA SOUTHARD, CONTRACT
SPECIALIST, OF THE NIAID CONTRACTING OFFICE AT THE FOLLOWING
INTERNET ADDRESS:
ss63e@nih.gov
IF YOU FAIL TO NOTIFY THE CONTRACTING OFFICE OF YOUR INTEREST, YOU
WILL NOT RECEIVE NOTIFICATION OF AMENDMENTS ISSUED TO THE RFP.
HOWEVER, ALL AMENDMENTS WILL BE POSTED ON THE NIH GOPHER AND/OR NIH
HOME PAGE.
Questions concerning any areas of uncertainty which in your opinion
require clarification or correction, must be furnished in writing to
Sara Southard. Your questions should be received no later than
October 18, 1996, at the address indicated in Attachment 4, Item 4
(Fax or E-mail is also acceptable.) and marked "Offeror's Questions,
RFP-NIH-NIAID-DMID-97-07."
If you have any additional questions regarding this RFP, please
contact Sara Southard at the internet electronic mail address
ss63e@nih.gov , by phone at 301/402-6289, or by fax at 301/480-5253. Collect calls will NOT be accepted.
Sincerely,
/s/
Rosemary McCabe Hamill
Chief, IAD Contract Section
Contract Management Branch
National Institute of Allergy
and Infectious Diseases
Attachments: 1 - 5
*****************************************************************
*****************************************************************
RFP-NIH-NIAID-DMID-97-07
I. STREAMLINED RFP
ATTACHMENT 1
8/27/96
INTRODUCTION
------------
The objective of the acquisition is to support clinical trials to
test safety and efficacy of biomedical and behavioral interventions
aimed at prevention and control of sexually transmitted diseases
(STDs). Diseases or pathogens of interest include, but are not
limited to: chlamydial infection; gonorrhea; syphilis; chancroid;
human papillomavirus (HPV) infection; genital herpes (herpes simplex
virus 1 & 2 infections), human herpes virus 8 (Kaposi's sarcoma
virus) and human immunodeficiency virus (HIV) infection as it is
associated with other STDs (both in terms of increased transmission
rates of HIV and alteration of the natural history of STDs). The
syndromes of interest include, but are not limited to: pelvic
inflammatory disease (and sequelae - infertility, ectopic pregnancy
and chronic pelvic pain); adverse outcomes of pregnancy; and
cervical cancer as well as other genital cancers associated with HPV
infection. Viral hepatitis and cytomegalovirus infection are
addressed in other programs of the National Institute of Allergy
and Infectious Diseases (NIAID) and are not of interest in this
solicitation.
These prevention and control strategies encompass primary, secondary
and tertiary prevention. The interventions of interest include, but
are not limited to: topical microbicides, vaccines, diagnostics
tests, screening tests, therapeutics and behavior change. Although
the scope of interventions is broad, the number of microbicides,
vaccines, diagnostic tests, behavioral interventions, that are
appropriate for clinical trials is finite. That said, a
prioritization process with respect to category of intervention and
specific intervention will be implemented and those interventions of
highest priority will be selected for study in the STD CTU.
It is anticipated that one completion type contract will be awarded.
BACKGROUND
----------
The mission of the NIAID's STD program is to foster, develop, and
administer a research program that will contribute to the
reproductive health of people and specifically lead to prevention
and control of STDs. The broad, public health goals of the research
program are:
- prevention of STDs;
- prevention of infertility;
- prevention of adverse outcomes of pregnancy;
- prevention of reproductive tract neoplasia;
- prevention of human immunodeficiency virus (HIV) infection; and
- prevention of other chronic STD sequelae.
In order to accomplish our mission, strategies for primary,
secondary and tertiary prevention of STDs must be evaluated.
Strategies for primary prevention (prevent infection) would include,
but are not limited to, topical microbicides, vaccines or behavior
change, e.g. increased use of male condoms; secondary prevention
strategies (prevent transmission of the infection to others) might
include diagnostic screening and treatment; diagnosis and use of
single-dose therapies; or behavior change, e.g. self-screening based
on mild symptoms or risk behaviors; tertiary prevention strategies
(interventions to prevent disease progression and chronic sequelae)
might focus on pelvic inflammatory disease and infertility; adverse
outcomes of pregnancy; HPV and cervical cancer; or HIV infection.
WORK STATEMENT
--------------
The Contractor, independently and not as an agent of the government,
shall furnish all services, qualified professional and technical
personnel, volunteer populations, materials, equipment and
facilities not otherwise provided by the government under the terms
of this contract, as needed to evaluate biomedical and behavioral
interventions to prevent and control sexually transmitted diseases
(STDs).
Specifically the contractor shall:
I. Conduct clinical trials to evaluate interventions to prevent and
control STDs, including human challenge studies as appropriate.
Contract efforts may include, but are not limited to, clinical
trials to evaluate topical microbicides, vaccines, diagnostic tests,
therapeutics and behavioral interventions.
{NOTES TO OFFEROR:
1. The offeror should describe how an existing clinical and
laboratory facility can support the various studies, or
describe the establishment of such facilities or
collaborations to support the various studies.
2. A well-trained, experienced, and balanced staff to
conduct clinical trials is required. The primary
investigator (PI) should have an M.D. and/or Ph.D. degree
and should have demonstrated expertise in clinical trials
related to STDs involving appropriate populations. The team
of experts in the diseases of interest should include a
nursing staff, experts in adolescent medicine; behavioral
science; infectious diseases including STDs, pelvic
inflammatory disease and adverse outcomes of pregnancy;
obstetrics/gynecology, including colposcopy; clinical trials
evaluating vaccines, diagnostic tests, therapeutics,
behavioral interventions; epidemiology and biometry.
Effective nursing staff are critical to the success of
intervention trials and a Research Nurse Coordinator should
be identified. Technical personnel, trained and experienced
in collecting specimens, and performing assays and
laboratory procedures should be included. The offeror
should describe coverage of administrative responsibilities.
3. A two page biosketch of each proposed professional
should be included in the proposal.}
II. Provide and retain patients as required for all clinical trials
to ensure timely completion of protocols.
{NOTES TO OFFEROR:
4. The availability of appropriate populations is critical
to the effective testing of candidate interventions.
Offeror's technical proposal should include a detailed
description of the types of populations available;
consideration should be given to incidence and prevalence of
STDs. Estimates of the target populations for the clinical
trials efforts are as follows: adolescents, 14-17 years
old, (50%); young adults, 18-24 years (30%); adults 25 years
and older (20%). Studies may require testing in healthy
volunteers at low risk for STDs as well as populations at
high risk for STDs. Depending upon the study, monogamous,
contracepting women may be required. In other studies sero-
positive and/or sero-negative volunteers may be required.
5. For contracts dealing with clinical research, it is NIH
policy that women and members of minority groups and their
sub-populations must be included in all NIH supported
biomedical and behavioral research projects involving human
subjects, unless a clear and compelling rationale and
justification is provided that inclusion is inappropriate
with respect to the health of the subjects or the purpose of
the research. All investigators proposing research
involving human subjects should read the "NIH Guidelines For
Inclusion of Women and Minorities as Subjects in Clinical
Research". A copy of this publication is contained in this
RFP Gopher under the RFP REFERENCES - FORMS, FORMATS and
INSTRUCTIONS directory.}
III. Conduct rigorously designed clinical trials to evaluate safety
and effectiveness of topical microbicides, diagnostic tests,
therapeutics and behavioral interventions for the prevention of
STDs. ALL STUDIES ARE SUBJECT TO PROJECT OFFICER APPROVAL.
{NOTES TO OFFEROR:
6. Two sample, detailed, protocols and consent forms
should be submitted with the proposal and should demonstrate
a thorough understanding of clinical evaluation of the
interventions described.
i. One Phase I protocol should focus on an approach to
the diagnosis of subclinical pelvic inflammatory
disease; the offeror should first describe the
characteristics of the diagnostic approach followed
by an appropriate protocol. The protocol need not
describe the use of a currently available product.
If a theoretical product or approach is described,
the offeror should include sufficient detail to
permit determination of the appropriateness of the
protocol. The Offeror should consider the Meeting
Summary of the NIAID Workshop on Pelvic Inflammatory
Disease, December 1994, Attachment 1.A.
ii. One Phase II protocol should address the safety/
efficacy of a vaginal topical microbicide to prevent
chlamydial infection in an adolescent population. The
microbicide protocol need not involve the use of a
currently available product. The offeror should
describe the "theoretical product" in sufficient
detail so as to enable determination of the protocol's
appropriateness. The Offeror should consider the
International Working Group on Vaginal Microbicides'
Recommendations for the Development of Vaginal
Microbicides (a copy of this document is available
from the NIAID Contracting Officer upon request) and
the World Health Organization's (WHO) Manual for
Colposcopy, copies of which are available through the
WHO, Geneva, Switzerland.
iii. The protocols should neither be underway presently nor
have been sponsored or reviewed by the NIAID
previously. The protocols should document how the
Offeror can best address the intent of this RFP.
7. It is anticipated that a representative Phase I study
might involve 12-20 patients for a two week time period or a
2-4 month time period depending upon the nature of the
intervention being tested; a representative Phase II study
would involve 100 patients for a 2-6 month time period.
However, the Offeror should justify the number of
participants and the study duration proposed in the sample
protocols.}
IV. Conduct rigorously designed clinical trials to determine
vaccine safety, immunogenicity, reactogenicity, optimal dose and
schedule; where appropriate, conduct challenge studies in human
volunteers immunized with candidate vaccines for gonorrhea or
chancroid. Both vaccines and controls shall be challenged with
virulent pathogens to assess protection. ALL STUDIES ARE SUBJECT TO
PROJECT OFFICER APPROVAL.
{NOTES TO OFFEROR:
8. Two sample, detailed, protocols and consent forms should
be submitted with the proposal and should demonstrate a
thorough understanding of clinical evaluation of the
interventions described.
i. One Phase I protocol should address the safety of a
vaccine for human papillomavirus infection designed to
ameliorate disease by inducing regression of genital
warts. This protocol need not involve the use of a
currently available or "under-development" vaccine.
The offeror should describe the "theoretical vaccine"
in sufficient detail so as to enable determination of
the protocol's appropriateness. If the protocol
submitted has been conducted previously it must be so
identified. The protocol should document how the
Offeror can best address the intent of this RFP.
ii. One Phase II protocol should describe a study to
assess the safety/effectiveness of a prophylactic
vaccine for gonorrhea or chancroid, using the human
challenge model of experimental urethritis or skin
infection, respectively. This protocol need not
involve the use of a currently available or
"under-development" vaccine. The offeror should
describe the "theoretical vaccine" in sufficient
detail so as to enable determination of the
protocol's appropriateness. If the protocol submitted
has been conducted previously it must be so
identified. The protocol should document how the
Offeror can best address the intent of this RFP.
9. It is anticipated that a representative Phase I study
would involve 12-20 patients for a two week time period or a
2-4 month time period depending upon the nature of the
intervention being tested; a representative Phase II study
would involve 100 patients for a 2-6 month time period. A
representative human challenge experiment would involve 25-
50 people for a two week period. However, the Offeror
should justify the number of participants and the study
duration proposed in the sample protocols.}
V. Collect, appropriately store and conduct assays on sera and
other clinical specimens to determine volunteer eligibility and from
study participants, as required in the protocol.
{NOTE TO OFFEROR:
10. The Offerer should include a complete description of
the clinical and laboratory facilities and capabilities
required to run assays, in order to document the 1)
appropriateness of the population; 2) the safety of the
intervention; and 3) the effect of the intervention. A plan
for long term follow-up (up to, but not to exceed, monthly
evaluations for one year) should be included. Should non-
routine or "special" assays be necessary, testing may be
arranged by the government, and the offeror will be asked to
ship specimens to the appropriate site for assay.}
VI. Organize and administer the clinical and associated laboratory
research activities of the contract:
a. Receive and process concepts for proposed studies.
b. Develop and implement a protocol review process that ensures
scientific needs are met and that individual protocols are
prioritized across the spectrum of existing protocols.
c. Write protocols and case report forms and submit to the NIAID
Project Officer for review and approval.
d. Track the current status of concepts, protocols, active trials,
abstracts and publications.
e. Prepare clinical trials agreement which includes a delineation
of responsibilities of industry, the STD clinical trials unit
and the NIAID in the implementation of each trial. The list of
responsibilities should be submitted for review to the Project
Officer prior to the initiation of each trial.
{NOTE TO OFFEROR:
11. With respect to VI.e., the list of responsibilities is
to be included, regardless of who has primary responsibility.
A sample list is given in Attachment 1.B.}
VII. Coordinate submission of protocols, consent forms (including
parental assent forms, where applicable), site registration
information, local Institutional Review Board (IRB) approval
documents, and other Investigative New Drug (IND) or New Drug
Application (NDA) information to the Clinical and Regulatory Affairs
Branch, Division of Microbiology and Infectious Diseases, NIAID, for
those protocols in which the NIAID holds the IND. Ensure that
documents are revised and finalized as necessary after review by the
Project Officer, the NIAID Clinical and Regulatory Affairs Branch,
the local IRB and the regulatory authorities.
a. Serve as coordinator for the conduct of clinical trials in the
case of multi-site trials.
b. Receive and ship reagents and samples, code patients, reagents,
and samples, and coordinate all of the subcontractors'
activities (if applicable).
c. Develop and follow a detailed plan for on-site monitoring;
offeror shall monitor according to the plan to ensure
completeness and accuracy of study data and adherence with
established research standards and protocol requirements and
regulatory guidelines.
VIII. Develop policies and standard operating procedures for the
conduct of the clinical trails, site evaluation criteria,
publication criteria, and manuals of operation. All policies and
standard operating procedures are subject to approval by the Project
Officer.
IX. The Principal Investigator shall attend and participate in the
semi-annual meetings of the Directors of the STD Cooperative
Research Centers (STD CRCs) held in Bethesda, MD, to discuss on-
going protocols and future clinical trials agenda with the STD CRC
Directors.
{NOTES TO OFFEROR:
12. Offerors should include travel costs for the Principal
Investigator to attend these 1-day semi-annual meetings in
their cost proposal.
13. The STD CRC Directors will act as consultants to the
Project Officer and the Principal Investigator of the STD
CTU. Additional consultants and advisory activities may be
sought and arranged on an as needed basis, by the Project
Officer.}
X. Organize and conduct an annual, 1-2 day investigators' meeting
involving STD CTU and NIH staff. This meeting shall include
presentation and review of data, progress updates on all studies,
discussion of proposed protocols and establishment of the group's
standard operating procedures and research priorities to update the
proposed scientific agenda for subsequent submission to the Project
Officer.
{NOTE TO OFFEROR:
14. The location of these annual meetings will rotate
between the Contractor's site and the NIH, Bethesda, MD.
The Offeror should assume that there will be approximately
ten (10) meeting participants. The Offeror's cost proposal
should include travel expenses for the STD CTU Principal
Investigator, two STD CTU Investigators, and the Nurse
Coordinator to attend the meetings held at the NIH. For
meetings held at the Contractor's site, all STD CTU doctoral
level staff and the Nurse Coordinator should attend.}
XI. Collect, store, manage and analyze data from the conduct of the
clinical trials. Prepare and publish all manuscripts and
presentations involving data from the clinical trials, including
those sponsored by pharmaceutical trials. The Project Officer shall
have access to all data generated with the support of this contract
and shall review and approve all resulting manuscripts and abstracts
before publication.
{NOTE TO OFFEROR:
15. The current guidelines for publications resulting from
work sponsored by this contract are provided in Attachment
1.C.}
{GENERAL NOTES TO THE OFFEROR:
16. Award of the contract does not commit the government to
approve the studies outlined or the proposed protocols. The
Project Officer will determine which studies are actually
undertaken.
17. In general, direct patient costs will not be reimbursed as
allowable costs under this contract, except for the cost to house
participants in the human challenge studies. Exception for other
direct patient costs, on a case by case basis, may be made by the
Project Officer. The Offeror should present a plan to indicate
how the patient costs associated with the submitted protocols can
be covered. Typically this has involved industrial support or
co-sponsorship by a General Clinical Research Center.
18. For the purposes of planning and budgeting, assume that
fourteen (14) clinical trials will be initiated over the life of
the contract with approximately 50% being Phase I and 50% being
Phase II.
19. A detailed organizational chart should be provided that
shows the administrative structure, reporting structure,
supervisory roles, the interactions between the groups and
projects, etc.
20. The technical proposals submitted in response to this RFP
are subject to page limitations. Please see the RFP Attachment
4, Item 9, "Technical Proposal - Table of Contents", for
additional details.}
********************************************************************
Attachment 1.A
SUMMARY OF A WORKSHOP ON PELVIC INFLAMMATORY DISEASE
____________________________________________________
March 31, 1995 DRAFT
Prepared by: P. Hitchcock & J. Gomez
OBJECTIVES AND STRUCTURE OF THE MEETING
---------------------------------------
On December 16, 1994, the STD Branch of the National Institutes of
Allergy and Infectious Diseases convened a Workshop on Pelvic
Inflammatory Disease to discuss and recommend appropriate research
strategies for the Institute to pursue that would lead to a
reduction of PID and associated sequelae. Based on the Institute's
long standing interest in conducting clinical trials to test
interventions that would prevent PID associated sequelae - one
question that we specifically wanted to address was, "Are we in a
position to do such a trial and if not what issues need to be
resolved before such a trial could be undertaken?". Other critical
questions included: Do we know enough to do a clinical study on
diagnosis of PID? What is the current working hypothesis with
respect to the development of PID? What are the possible
determinants of PID?
The meeting was divided into two parts; the first part consisted of
four brief background presentations, the second part consisted of
informal discussion. The first presentation, by Dr. Jorma
Paavonen, focused on the PID prevention and control efforts in
Northern Europe. The purpose was to demonstrate and discuss a
successful PID prevention model that has been implemented using
existing technology. The second presentation, by Dr. Roberta Ness,
summarized the clinical challenges facing PID researchers. The
purpose was to focus on the opportunities for and impediments to doing
treatment trials for PID. The third and fourth presentations, by Dr.
Peter Rice and Dr. Walter Stamm, were summaries of research efforts in
the PID Program Projects at Boston University and University of
Washington, respectively. The purpose was to assess the progress of
our current PID research efforts as a prelude to deliberating on
appropriate future directions.
HIGHLIGHTS OF PRESENTATIONS
---------------------------
The Northern European Model:
Dr. Paavonen presented data from Norway and Finland that indicated the
declining trends of gonorrhea. In 1991 there were 92 cases of
gonorrhea in Norway and 600 in Finland. (A similar trend has occurred
in Sweden as well.) The decline of chlamydial infections is similar
but not as dramatic. He speculated that this may be due to the
asymptomatic nature of the infection (25% of men and 75% of women are
asymptomatic); specifically the criteria for screening may be
differentially affected. In both countries, declines in rates of PID
have followed, as has ectopic pregnancy rates in Finland.
Concurrently, there has been a change in the epidemiology and
clinical manifestations of PID. When detected, the disease seems
to be milder; he speculated that this may be due to decreased IUD use
and increased use of hormonal contraceptives. Given the trend towards
milder disease, diagnostic problems have been exacerbated and the
apparent number of cases may be lower than the actual number.
Clinical Challenges:
Dr. Ness began by identifying the current clinical perceptions about
PID and focused remarks on her assessment of the current clinical
realities. The perceptions are: 1) we have made little diagnostic
progress on PID; 2) we cannot do treatment trials because we cannot
diagnose the disease; 3) we cannot do treatment trials because we
cannot follow the patients; and 4) we do not need to do treatment
trials because once the disease is diagnosed, the damage is done. The
realities are: 1) laparoscopy is the most specific test; the positive
predictive value increases if used in combination with other
signs/symptoms; 2) treatment trials do depend upon the diagnostic
capabilities but laparoscopy will identify damaged tubes in women who
have no recollection of PID episodes; 3) studies are being done with
PID patients, follow up issues are challenging but the patients'
mothers have proven to be a good way to track them; 4) the treatment
trials that have showed no impact on infertility did not employ
optimal therapies. In the discussion period that followed, most of
the participants felt that there were a number of caveats associated
with the current realities, these are reflected in the
recommendations. Dr. Holmes added that the use of ligase chain
reaction (LCR) to diagnose chlamydial infection in cervical and tubal
samples is clearly going to increase the sensitivity of laparoscopy
for the diagnosis of PID. In the monkey model, rates of positive
results using culture compared to LCR were as follows: cervical 82%,
tubal 47% and cervical 100%, tubal 87% respectively.
Boston University PID Program Project:
Dr. Rice presented an overview of their ongoing research which is
based on combining clinical and laboratory investigations. They are
conducting a clinical study which is focused on identifying and
characterizing factors that influence transmission from males to
females and then determining whether the women have evidence of PID.
The index cases are male STD clinic patients, with culture proven
gonorrhea or chlamydial infection, that have had two or more contacts
in 30 days; the clinic population is 80% African American, and 90% of
individuals are of low socioeconomic status. The female partners are
enrolled and evaluated; virtually all of them are asymptomatic.
Analysis of the number of exposures and the infection status revealed
a surprising finding: there is no increase in infection with multiple
exposures; about 25% of the women appear to be immune to gonorrhea.
Cultures and molecular analysis of the strains from partners revealed
98% concordance. Analysis of the immunological features of the
susceptible and resistant contacts revealed that antibodies to Protein
I and LPS were protective and antibodies to Protein III were
associated with susceptibility. Studies of chlamydial infection
revealed similar pattern of resistance with only 50-60% of the women
being susceptible. Interestingly there were multiple serovars found
in both the men and the women; most, but not all, were concordant. In
terms of evidence for PID in the contacts of infected men, 25% of
women had a positive endometrial culture and biopsy (plasma cell
endometritis).
University of Washington PID Program Project:
Because of the region X chlamydial control program, the population in
the Seattle area has a low prevalence of chlamydial infection (4%).
In this study, women who were members of a group health cooperative
were surveyed for demographic, behavioral and clinical characteristics
that have been proven, by the Seattle group, to identify women at risk
for chlamydial infection. High risk women were randomized to an
intervention or a control group. The intervention group was screened
and treated for chlamydial infections whereas symptom driven diagnosis
and treatment was provided in the control group. The incidence of PID
was 8% in the intervention group compared to 18% in the controls. The
conclusion is that selective screening and treatment of chlamydial
cervicitis can contribute to PID control efforts even in a low risk
populations. It is estimated that treatment of 44 cases of chlamydial
infection would prevent 15 cases of PID. A cost effective analysis is
now in progress. When urine-based diagnostic tests for chlamydial
infection become available, different kinds of screening programs can
be considered.
SUMMARY OF CRITICAL RESEARCH ISSUES
-----------------------------------
Based on a series of discussions, prior to and during the workshop,
a number of critical research issues were identified.
Behavioral Research
-------------------
Important behavioral research issues focused on two broad
categories: host and provider.
HOST (includes both patient and partner)
-----------------------------------------
- sexual behavior
- contraceptive practices
- douching
- organism-specific risks
- risks associated with type/stage of PID
- male partner characteristics and behaviors
- screening and treatment
- symptom recognition
- treatment compliance
- partner notification
- awareness of link between PID and infertility
- other behaviors to prevent PID and sequelae
PROVIDER
--------
- bias in perception of at-risk women
- screening/prevention
- diagnosis
- treatment recommendations
- health care setting
- physician training
Clinical/Epidemiological Research
---------------------------------
Important clinical/epidemiological research issues fell into four
broad categories: diagnostics, treatment, natural history, and
management.
DIAGNOSTICS
- methods for diagnosis of acute PID, silent PID, and
long term sequelae
- significance of cervicitis and endometritis
- development of serological diagnostic capabilities
- role of LCR and PCR in detecting organisms in upper tract
- significance of non-STD microbiological findings
- role of screening and case-finding in PID prevention
TREATMENT
- broad spectrum therapy for chlamydial infection, gonorrhea,
anaerobes, ureaplasma, and mycoplasmas
- role of anti-inflammatory therapy
- role of single dose therapies
- long term outcome measures associated with current
treatment regimens
NATURAL HISTORY
- persistence versus recurrent infection
- immunology
- PID in HIV-infected women male partner
- risk factors for PID, acute PID, silent PID, tubal
scarring
MANAGEMENT
- in-patient versus out-patient management
- development of more effective algorithms using new
diagnostic methods as adjuncts
- development of prototypes for PID case management
- cost effectiveness analyses of current practices
- development of follow-up strategies for at-risk women
Basic Research
--------------
Basic research issues were categorized as either pathogen or host
related.
PATHOGEN
- virulence factors for gonococcal and chlamydial PID:
factors which influence invasion, ascension, scarring,
persistence, immunopathogenesis, and symptomatic versus
asymptomatic infections
- non-STD organisms: virulence factors (as above) and
requisite conditions for pathogenesis
- pathogenesis: interplay with host factors, including
elicitation of "auto antibodies", deleterious cytokines or
steroid hormones, and complement-mediated damage
- PID vaccine development correlates of protection,
avoiding vaccine induced damage to the reproductive tract;
significance of antigenic variation/MOMP polymorphism
HUMAN HOST
- genetics: immuno-genetics, cyto-genetics
- normal defenses: flora, pH, mucin, defensins, etc.
- reproductive hormones: role in protection,
pathogenesis; relevance in puberty, during menses,
contraceptives
- immunity: role in protection, pathogenesis;
characterization of mucosal and systemic immunity in
infection; role of cellular and antibody constituents;
- study of chlamydial heat shock protein 60
ANIMAL MODELS
- development
- characterization
- relevance (strengths and weaknesses)
- study of chlamydial heat shock protein 60
GROUP CONSENSUS
---------------
The group considered whether or not it was appropriate, at this time,
to conduct a clinical trial testing interventions to prevent the
acquisition of PID and the long term sequelae of PID, specifically
tubal scarring, ectopic pregnancy and infertility.
The consensus was that a clinical trial is not feasible at this point
in time. There was uniform agreement that the major obstacle to a
trial is the absence of diagnostic capabilities for asymptomatic or
silent PID. Furthermore, there was remarkable agreement about the
critical gaps in our knowledge of PID, including the ideas that
vaginitis/cervicitis is necessary but perhaps not sufficient to cause
PID and that the microbes, the host (the patient and the partner) and
the provider all play key roles in the development of PID. Two cross
cutting themes were apparent in the deliberations and final
recommendations: the application of medical advances to the problem
and the consideration of the ethical-issues in PID clinical research.
ADDITIONAL DISCUSSION ISSUES
----------------------------
During the informal discussion period a number of new issues as well
as confirmation of issues generated in the pre-meeting activities were
addressed.
Behavior:
- Patient/Partner Behaviors: Perception of normal will
influence symptom recognition (e.g, is a vaginal discharge
normal, how much how often, what kind?) . In the absence of
a gold standard for diagnosing PID, surrogate measures such
as cervicitis or infertility, might be used. The outcome
measures will influence identification of risk associated
behaviors.
- Provider Behaviors: Clinical research is needed to determine
if practitioners are using CDC treatment guidelines for PID.
The variations in health care settings and provider
specialty should be evaluated. The role (and type) of
medical education in enhancing the ability of the provider
to recognize and treat PID needs to be studied.
Clinical:
- Endometrial Biopsy: Clinical research (including application
of modern technology for evaluation) is needed to better
characterize the chronology, prevalence and significance of
endometritis as a part of PID and as an indicator of tubal
infection.
- Laparoscopy: Doing a second procedure (second look) after
treatment may be an effective way to measure tubal damage as
opposed to longer term clinical manifestations of tubal
damage.
- Magnetic Resonance Imaging (MRI): Clinical research is
needed on the capabilities of MRI to detect uterine or
endometrial changes. The goal would be to use this as a
gold standard in order to identify reliable and reproducible
markers of PID that would be inexpensive and more
appropriate for resource limited settings.
- Treatment: Research is needed on the chronology of events in
PID to determine when/if cervical infection should be
treated as if there were concurrent upper tract infection.
Basic Research:
- Immunology: Basic research is needed to delineate the cell
mediated immune response including the epitope specificity
of that response, the immuno-histopathology (e.g., the role
of cytotoxic T-cells in delayed hypersensitivity) and the
immunogenetics of the host (e.g., HLA type).
- Microbiology: Research is needed on the role of other agents
in the etiology of PID. This aspect of PID microbiology is
poorly characterized and not understood.
- Serology: Research is needed on serologic markers of tubal
damage, including antibodies and cytokines.
- Reproductive Endocrinology: Research on the influence of
natural or exogenous reproductive hormones on
susceptibility, resolution, progression or symptoms of
PID is needed.
RECOMMENDATIONS:
----------------
Based on the deliberations of the group the following recommendations
were made vis a vis research needs and opportunities for the immediate
future:
- Clinical research on the diagnosis of PID, especially
asymptomatic PID, should be given the highest priority, with
special emphasis on the positive predictive value of the
test.
- Further clinical research on screening and treating
asymptomatic cervical infections as an effective approach to
PID prevention is needed.
- Support for basic research into the pathogenesis of PID will
provide important information leading to more effective
behavioral, therapeutic and immunological interventions.
- High priority should be given to development and
characterization of an animal model of PID, especially one
that includes tubal scarring.
- Research into patient/partner and provider behaviors is
likely to provide important information needed to develop
effective interventions for PID prevention and control.
********************************************************************
Attachment 1.B
Sample List of Responsibilities
_______________________________
The Contractor shall prepare for approval by the Project Officer
a list of responsibilities to indicate who will:
Generate consent forms
Approve consent forms
Distribute consent forms to sites*
Conduct site assessment/orientation/start-up visits*
Collect pre-study regulatory documents
Sponsor IND
Submit protocol and regulatory documents to FDA
Ship study medication to repository or sites*
Generate randomization codes
Hold randomization codes
Perform CRF/drug supply/regulatory site monitoring*
Perform QA monitoring
Report serious adverse events to FDA
- 3 & 10 day reports
- annual safety reports
Monthly update of enrollment, ADE's, and waivers
Harvest completed CRFs
Conduct secondary review of CRFs
Log in CRFs, generate queries to investigators
Perform data entry and logic checks
Resolve all queries and ensure audit trail
Submit annual IND report to FDA
Submit any protocol revisions, updated 1572s to FDA
Obtain copies of annual IRB renewals from the sites
Design CRF
Print CRF
Distribute CRFs to sites*
Maintain lab samples (serum/isolate) in a repository
Serve as central lab facility for drug levels/susceptibilities
Analyze data
Present data to DSMB
* Note: Intended for multi-center studies.
********************************************************************
Attachment 1.C
GUIDELINES FOR MANUSCRIPT WRITING
_________________________________
1. For publication of the primary results from each official
study, a Writing Committee will e appointed. This
Committee will typically consist of:
a. the study principal investigator (P.I.).
b. the responsible biostatistician.
C. any other individuals, e.g., investigators,
Operations Office staff, who have contributed
substantially to the study as determined by the
study P.I.
2. The Chair of the Writing Committee will be the study P.I.
3. For a joint studies with the ACTG or other collaborative
groups the Writing Committee will be merged with a
similarly constituted Writing Committee from the
appropriate collaborative group.
4. The Writing Committee will prepare drafts of a manuscript.
Before submission of the final draft to a peer-reviewed
journal, the draft should be circulated to all
participating investigators. the Operations Office. the
Principal Investigator and representatives of industry
(where appropriate) for comments and suggestions and to
the NIAID for approval by the Project Officer.
5. If additional manuscripts result from any official study,
additional Writing Committees can be constituted. The
same general guidelines will apply.
6. Authorship and its order for a given manuscript should
reflect workload, intellectual contribution, and patient
contribution. The composition of authorship will differ
depending on the number of institutions involved, the
number of patients, and the nature of any special
assessments, such as laboratory studies.
7. The first author of the manuscript will usually be the
Study P.I. (Writing Committee Chair). The masthead for
authorship of a manuscript will be determined by journal
guidelines. For example, the number of authors may vary
from a few (3-5) to many (15-25). The ultimate order of
names on the masthead will be determined by the Writing
Committee Chair. If there is any appeal about the order
of authors, the final decision will be made by the
Principal Investigator.
8. The NIAID Contract number must be provided in the
Acknowledgement section.
9. In addition to authorship, a manuscript should acknowledge
all participating institutions (sites) enrolling evaluable
patients. The listing of institutions should be in order
of evaluable patients. The listing may include up to 4
persons per participating institution, the participating
Central Staff, and the appropriate industry participants.
10. The selection of the journal will be at the discretion of
the Chair of the Writing Committee.
11. Copies of the final draft submitted for publication should
be sent to each of the authors the administrator,
Operations Office, and the Project Officer.
12. After journal review of a manuscript has been completed.
the dialogue between Editors, Reviewers, and the Writing
Committee should be handled at the Writing Committee
level. Correspondence from the Editors including the
reviews.should be distributed to each of the authors
listed in the masthead. and to the Administrator,
Operations-Office.
13. A copy of the final revised manuscript should be sent to
each of the authors and the Administrator. Operations
Office.
GUIDELINES FOR ABSTRACTS
________________________
1. These guidelines (listed above) would apply, where
appropriate, to abstracts.
2. No presentation of primary results from any study may be
made without the approval of the P.I., biostatistics unit,
and the Project Officer.
3. A copy of all abstracts, based on official studies, must
be submitted to the Administrator, Operations Office, and
the Project Officer, simultaneously with submission for
presentation.
********************************************************************
********************************************************************
RFP-NIH-NIAID-DMID-97-07
ATTACHMENT 2
8/27/96
REPORTING REQUIREMENTS
______________________
The Contractor shall submit to the Contracting Officer and to the
Project Officer technical progress reports covering the work
accomplished during each reporting period; in addition to the number
of hard copies requested in each case, an electronic copy shall be
submitted on diskette or by electronic mail (Email). These reports
are subject to technical inspection and requests for clarification
by the Project Officer. These shall be brief and factual and
prepared in accordance with the following format:
A. TECHNICAL REPORTS
In addition to those reports required by SECTION I and other
terms of this contract, the Contractor shall prepare and submit
the following reports in the manner stated below:
(1) QUARTERLY TECHNICAL PROGRESS REPORTS - by the fifteenth
working day of the month following the end of each three month
period, the Contractor shall submit four (4) copies of the
quarterly Technical Progress Report, comprising three (3)
copies to the Project Officer and one (1) copy to the
Contracting Officer. Such reports shall include the following
specific information:
a. A cover page that lists the contract number and title,
the period of performance being reported, the
Contractor's name and address, the author(s), and the
date of submission;
b. SECTION I - An introduction covering the purpose and
scope of the contract effort;
c. SECTION II - A description of overall progress plus a
separate description for each task or other logical
segment of work on which effort was expended during
the report period. The description shall include
pertinent data and/or graphs in sufficient detail to
explain any significant results achieved and
preliminary conclusions resulting from analysis and
scientific evaluation of data accumulated to date
under the project;
d. SECTION III - Substantive performance; a description
of current technical or substantive performance and any
problems encountered and/or which may exist along with
proposed corrective action. An explanation of any
difference between planned progress and actual
progress, why the differences have occurred and if
behind planned progress what corrective steps are
planned;
e. An anticipated work plan for the next three months; and
f. Pre-prints and reprints shall be submitted along with
the report.
Quarterly Technical Progress Reports are not due for periods in
which an annual or final report is due.
(2) ANNUAL REPORTS - On the anniversary date of the contract,
the Contractor shall submit four (4) copies of an annual
Technical Progress Report, as above, comprising three (3)
copies to the Project Officer and one (1) copy to the
Contracting Officer. Such reports shall detail, document, and
summarize the results of the entire contract work for the
period covered and shall include information regarding numbers
of women and minority subjects enrolled in trials. These
reports shall be in sufficient detail to explain
comprehensively the results achieved. Also to be included in
the report is a summary of work proposed for the next reporting
period. An annual report will not be required for the period
when the final report is due. Pre-prints and reprints not
submitted in the quarterly report shall be submitted. The
annual report will also append all relevant manufacturing
documents available for the Project Officer's confidential
review, these include, but are not limited to: quality control
(QC) documentation; formal accelerated and real-time stability
protocols; component specifications; manufacturing procedures.
(3) FINAL REPORT - By the expiration date of the contract,
the Contractor shall submit ten (10) copies of a comprehensive
Final Report, as above, comprising nine (9) copies to the
Project Officer and one (1) copy to the Contracting Officer.
These final reports shall detail, document and summarize the
results of the entire contract period of performance. These
reports shall be in sufficient detail to explain
comprehensively the results achieved. Pre-prints and reprints
not included previously shall be submitted.
(4) SUMMARY OF SALIENT RESULTS - With the annual and final
reports the Contractor shall submit a summary (not to exceed
200 words) of salient results achieved during performance of
the contract.
(5) OTHER REPORTS - To facilitate compliance with regulatory
requirements, the Contractor shall submit to the Project
Officer (10) copies of a brief summary of each ongoing and
completed protocol one year and thirty days after FDA
approvals go into effect.
B. If the Contractor becomes unable to deliver the reports
specified hereunder within the period of performance because of
unforeseen difficulties, notwithstanding the exercise of good
faith and diligent efforts in performance of the work, the
Contractor shall give the Contracting Officer immediate written
notice of any anticipated delays with reasons.
********************************************************************
********************************************************************
RFP-NIH-NIAID-DMID-97-07
ATTACHMENT 3
8/27/96
EVALUATION FACTORS FOR AWARD
____________________________
1. COMPARATIVE IMPORTANCE OF THE PROPOSALS
You are advised that paramount consideration shall be given to the
evaluation of the technical proposals, but not to the exclusion of
cost considerations. In the event that the technical evaluation
reveals that two or more offerors are approximately equal in
technical ability, then the estimated cost of performance will
become paramount. In any event the Government reserves the right to
make an award to the best advantage of the Government, cost and
other factors considered.
2. GENERAL
The technical proposal will receive paramount consideration in the
selection of the Contractor for this acquisition. The evaluation
will be based on the demonstrated capabilities of the prospective
contractor in relation to the needs of the project as set forth in
the RFP. The merit of each proposal will be evaluated carefully,
based on responsiveness to the RFP and thoroughness and feasibility
of the technical approach taken. Offerors must submit information
sufficient to evaluate their proposals based on the detailed
criteria listed below. Failure to provide the information required
to evaluate the proposal may result in rejection of that proposal
without further consideration.
3. MANDATORY QUALIFICATION FOR FACILITIES
Prior to award the offeror must document the adequacy and
suitability of the facilities for performing all of the requirements
of the Work Statement.
4. TECHNICAL EVALUATION CRITERIA
Proposals submitted in response to this RFP will be evaluated based
on the following factors which are listed and weighted in order of
their relative importance. Proposals will be judged solely on the
written material provided by the Offeror.
CRITERION ELEMENT WEIGHT
_________________ ______
1. Technical Approach 60
Documented technical adequacy and feasibility of the
proposed plans to conduct Phase I and Phase II clinical
trials of biomedical and behavioral interventions on
topical microbicides, vaccines, diagnostics tests,
screening tests, therapeutics and behavior change to
prevent and control STDs. Adequacy, suitability and
availability of necessary populations, including women and
minorities as documented in the proposal. Documented
technical adequacy and feasibility to collect store and
analyze specimens. (20 points each)
a) PHASE I AND II TRIALS OF TOPICAL
MICROBICIDES, DIAGNOSTIC TESTS, THERAPEUTICS AND
BEHAVIORAL INTERVENTIONS -- This includes the
comprehensive approach, suitability and
originality of the sample clinical protocols
cited in the Work Statement, appropriateness of
consent forms and data collection forms,
demonstrated ability to recruit, retain, monitor
and follow-up appropriate and relevant
populations.
b) PHASE I AND II TRIALS OF THERAPEUTIC AND
PREVENTIVE VACCINES -- This includes the
comprehensive approach, suitability and
originality of the sample clinical protocols
cited in the Work Statement, appropriateness of
consent forms and data collection forms,
demonstrated ability to recruit, retain, monitor
and follow-up appropriate and relevant
populations and the approach to investigating
gonorrhea or chancroid utilizing the established
human challenge models.
c) COLLECTION, APPROPRIATE STORAGE AND ANALYSIS
OF CLINICAL SPECIMENS -- This includes the
comprehensive approach and technical adequacy of
clinical and laboratory capabilities to perform
all assays.
2. Management of Work 20
Adequacy of plans for organizing, and administering the
clinical and laboratory research activities of the
contract. (10 points each)
a) PREPARATIONS FOR CLINICAL TRIALS -- This
includes the suitability of proposed processes
to review and prioritize concepts, write and
review protocols, and all attending
documentation.
b) ADMINISTRATION AND MONITORING OF CLINICAL
TRIALS -- This includes the suitability of the
plan to develop and administer policies and
standard operating procedures.
3. Personnel 20
Documented adequacy and relevance of expertise, experience,
education/skill, and availability of personnel for performing
all the requirements. (10 points each)
a) CLINICAL TRIALS STAFF -- The primary
investigator (PI) should have an M.D. and/or Ph.D.
degree with expertise in clinical trials related to
STDs involving appropriate populations. The team of
professional personnel including the nursing staff,
with documented clinical trials expertise, should
have composite experience in: 1) adolescent medicine;
2) infectious diseases including STDs, pelvic
inflammatory disease and adverse outcomes of
pregnancy; 3) obstetrics/gynecology, including
colposcopy; 4) clinical trials evaluating vaccines,
diagnostic tests, therapeutics, behavioral
interventions; 5) epidemiology and biometry. The
capabilities and expertise of the designated Research
Coordinator should be documented. The support staff
should possess the requisite experience to perform
their clerical and administrative duties.
b) LABORATORY PERSONNEL -- The technical personnel
and their supervisor(s) should be trained and
experienced in performing assay and laboratory
procedures.
TOTAL POSSIBLE POINTS.................................... 100
5. EVALUATION OF MINORITY GROUP AND GENDER REPRESENTATION
(NIH 3185) (JUL 1994)
This research project involves human subjects. NIH Policy
requires that woman and members of minority groups and their
subpopulations must be included in the study population of
research involving human subjects, unless a clear and compelling
rationale and justification is provided with respect to the
health of the subjects or the purpose of the research.
Where inclusion of women and minority populations is not
feasible, a detailed rationale and justification for exclusion of
one or both groups from the study population must be submitted
with the technical proposal. The NIH will review the exclusion
rationale to determine if it is appropriate with respect to the
health of the subjects and/or the purpose of the research. If
the rationale is not considered acceptable by the Government and
you are included in the competitive range, you will be afforded
the opportunity to further discuss and/or clarify your position
during discussions or include women and minorities in your best
and final (BAFO). If your exclusion position is still considered
unacceptable by the Government after discussions, your proposal
may not be considered further for award.
********************************************************************
********************************************************************
RFP-NIH-NIAID-DMID-97-07
ATTACHMENT 4
8/27/96
II. SPECIFIC RFP INSTRUCTIONS AND PROVISIONS
---------------------------------------------
NOTICE TO OFFERORS: This attachment contains proposal instructions
and information which are specifically related to this acquisition.
The information provided below is only a portion of the instructions
and notices required for the submission of a proposal. References
to additional, more general, information and forms regarding
proposal preparation are contained in Attachment 5, "Applicable RFP
References."
1. SIC CODE AND SMALL BUSINESS SIZE STANDARD (NIH 3150) (JUN 1988)
Note: The following information is to be used by the offeror in
preparing its Representations and Certifications (See Attachment 5,
Item 4. of this RFP.), specifically in completing the provision
entitled, SMALL BUSINESS PROGRAM REPRESENTATIONS (OCT 1995), FAR
52.219-1:
(a) The standard industrial classification (SIC) code for this
acquisition is 8733.
(b) (1) The small business size standard is $5,000,000.
(2) The small business size standard for a concern which
submits an offer in its own name, other than on a
construction or service contract, but which proposes
to furnish a product which it did not itself
manufacture, is $5,000,000.
(c) This requirement is NOT Set-Aside for Small Business.
However, the Federal Acquisition Regulation (FAR) requires in every
solicitation (except for foreign acquisitions) the inclusion of the
Standard Industrial Classification (SIC) Code and corresponding size
standard which best describes the nature of the requirement in the
solicitation.
2. NUMBER AND TYPE OF AWARD(S) (NIH 2980) (APR 1984)
It is anticipated that one (1) award will be made from this
solicitation and that award will be made on or about September 30,
1997.
It is anticipated that the award from this solicitation will be
multiple-year cost reimbursement, completion type contract with a
period of performance of 5 years, and that incremental funding will
be used [see paragraph (6) of Business Proposal Instructions, in the
"Standard RFP Instructions and Provisions" of the Gopher RFP].
3. ESTIMATE OF EFFORT
It is expected that a completion type contract will be awarded as a
result of this RFP. To assist you in the preparation of your
proposal, the Government considers the total direct labor effort to
be approximately 4,500% (900%/year). This estimate is furnished for
the offeror's information only and is not to be considered
restrictive for proposal purposes.
As further assistance, it is estimated that the above total labor
effort is constituted as follows:
Labor Effort* 5 YR
Category Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 TOTAL
-------- ---- ---- ---- ---- ---- -----
P.I. 30% 30% 30% 30% 30% 150%
Investigators 220% 220% 220% 220% 220% 1,100%
RNs 350% 350% 350% 350% 350% 1,750%
Biostat. Support 50% 50% 50% 50% 50% 250%
Technicians 200% 200% 200% 200% 200% 1,000%
Admin. Support 50% 50% 50% 50% 50% 250%
==== ==== ==== ==== ==== ======
TOTAL 900% 900% 900% 900% 900% 4,500%
* Effort in the above chart was based on 100%
effort = 2,080 hours per year, which includes
holidays and other paid absences. If you are
using a different base, please state the work
year used in your proposal. The above level of
effort is the Government's estimate of the
effort that will be necessary to satisfactorily
accomplish the objective of these studies, and
it will be used as a basis for negotiations.
However, you can propose deviations from this
estimated level of effort, with justification.
4. PACKAGING AND DELIVERY OF THE PROPOSAL (NIH 2995) (JUL 1994)
Shipment and marking shall be as indicated below:
External Package Marking:
-------------------------
In addition to the address cited below, mark each package as
follows:
"RFP No. NIH-NIAID-DMID-97-07"
"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. 52.233-2 SERVICE OF PROTEST (NOV 1988)
(a) Protests, as defined in Section 33.101 of the Federal
Acquisition Regulation, that are filed directly with an agency, and
copies of any protests that are filed with the General Accounting
Office (GAO) or the General Services Administration Board of
Contract Appeals (GSBCA), shall be served on the Contracting Officer
(addressed as follows) by obtaining written and dated
acknowledgement of receipt from:
Mr. Lewis S. Pollack
Hand-Carried Address:
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard
Rockville, Maryland 20852
Mailing Address:
NIH/NIAID
Contract Management Branch
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
(b) The copy of any protest shall be received in the office
designated above on the same day a protest is filed with the GSBCA
or within one day of filing a protest with the GAO.
6. PRIVACY ACT SYSTEM OF RECORDS
The Privacy Act System of Records Notice that applies to this RFP
was published in the Federal Register dated January 13, 1993, Vol.
58, No. 8, Pages 4226-4228. This notice will be incorporated into
any contract resulting from this RFP. If you would like a copy,
please contact the Contracting Officer identified in the cover
letter to this RFP.
7. PHS 352.223-70 SAFETY AND HEALTH (APRIL 1984)
(a) In order to provide safety controls for protection to the life
and health of employees and other persons; for prevention of damage
to all property; and for avoidance of work interruptions in the
performance of the contract; the Contractor will consult, comply
with, and include in all applicable subcontracts, the following
standards, as appropriate:
(1) Biosafety in Microbiological and Biomedical Laboratories, U.S.
Department of Health and Human Services, Centers for Disease
Control (CDC) and the NIH, HHS Pub. No. (CDC) 93-8395.
(2) Recommendations for Prevention of HIV Transmission in Health-
Care Settings, Morbidity and Mortality Report, August 21, 1987,
Vol. 35, No. 2S.
(3) Update: Universal Precautions for Prevention of Transmission
of Human Immunodeficiency Virus, Hepatitis B Virus, and Other
Bloodborne Pathogens in Health-Care Settings. Morbidity and
Mortality Weekly Report, June 24, 1988, Vol. 37, No. 24.
(4) Agent Summary Statement for Human Immunodeficiency Viruses
(HIV); Included are GTLV-III, LAV, HIV-1, and HIV-2. Morbidity
and Mortality Weekly Report, April 1, 1988, Vol. 37, No. S4.
(5) Recommendations for the Safe Handling of Parenteral
Antineoplastic Drugs, NIH Publication No. 83-2621.
(6) NIH Guidelines for the Laboratory Use of Chemical Carcinogens,
NIH Publication No. 81-2385.
The above, (1) - (6), may be obtained from:
Division of Safety
Office of Research Services
National Institutes of Health
Building 31, Room 1CO2
31 Center Drive, MSC 2260
Bethesda, Maryland 20892-2260
(7) Guidelines for Research Involving Recombinant DNA Molecules (49
FR 46266 or latest revision) and Administrative Practices
Supplement. These may be obtained from:
Office of Recombinant DNA Activities
Office of Science Policy and Legislation
National Institutes of Health
Building 31, Room B1C34
31 Center Drive, MSC 2250
Bethesda, Maryland 20892-2250
(8) Procedures for the Domestic handling and Transport of
Diagnostic Specimens and Etiologic Agents, National Committee
for Clinical Laboratory Standards, July 17, 1985, Vol. 5. This
may be obtained from:
National Committee for Clinical
Laboratory Standards
771 East Lancaster Avenue
Villanova, Pennsylvania 19085
Further, the Contractor shall take or cause to be taken such
additional safety measures as the Contracting Officer may
determine to be reasonably necessary; Provided, that if
compliance with such additional safety measures results in a
material increase in the cost or time of performance of the
contract, an equitable adjustment will be made in accordance
with the clause of this contract entitled "Changes."
(b) Prior to commencement of work, the Contractor will submit in
writing its plan for complying with the safety and health provisions
of this contract, and will meet with the Contracting Officer or
his/her designated representative to discuss and develop a mutual
understanding relative to administration of the overall safety
program.
(c) During the performance of work under this contract, the
Contractor shall comply with all procedures prescribed by the
Contracting Officer for the control and safety of persons visiting
the job site and will comply with such requirements to prevent
accidents as may be prescribed by the Contracting Officer.
(d) The Contractor will maintain an accurate record of, and report
to the Contracting Officer in such manner as the Contracting Officer
may prescribe, all accidents and incidents resulting in death,
traumatic injury, occupational disease, and/or damage to all
property incident to work performed under the contract.
(e) The Contracting Officer shall notify (if otherwise, confirm in
writing) the Contractor of any noncompliance with the provisions of
this clause and corrective action to be taken. After receipt of
such notice, the Contractor shall immediately take such corrective
action. (Such notice, when delivered to the Contractor or its
representative at the site of the work, shall be deemed sufficient
for the purpose.) If the Contractor fails or refuses to comply
promptly, the Contracting Officer may issue an order stopping all or
part of the work until satisfactory corrective action has been
taken. No part of the time lost due to any such stop order shall be
the subject of claim for extension of time or for costs or damages
by the Contractor.
(f) The Contractor shall insert the substance of this clause in
each subcontract involving the use of hazardous materials or
operations. Compliance with the provisions of this clause by
subcontractors will be the responsibility of the Contractor.
8. 52.227-6 ROYALTY INFORMATION (APR 1984)
(a) Cost or charges for royalties. When the response to this
solicitation contains costs or charges for royalties
totaling more than $250, the following information shall
be included in the response relating to each separate item
of royalty or license fee:
(1) Name and address of licensor.
(2) Date of license agreement.
(3) Patent numbers, patent application serial numbers,
or other basis on which the royalty is payable.
(4) Brief description, including any part or model
numbers of each contract item or component on which
the royalty is payable.
(5) Percentage or dollar rate of royalty per unit.
(6) Unit price of contract item.
(7) Number of units.
(8) Total dollar amount of royalties.
(b) Copies of current licenses. In addition, if specifically
requested by the Contracting Officer before execution of
the contract, the offeror shall furnish a copy of the
current license agreement and an identification of
applicable claims of specific patents.
9. TECHNICAL PROPOSAL TABLE OF CONTENTS/FORMAT
(NOTE: INSTRUCTIONS TO OFFERORS ARE INDICATED IN PARENTHESES OR AS
FOOTNOTES.)
SECTION # PAGE #
1. TECHNICAL PROPOSAL COVER SHEET (Format in Section C
of Gopher RFP: FORMS, FORMATS, ATTACHMENTS) .............. 1
2. TECHNICAL PROPOSAL TABLE OF CONTENTS ....................... 2
3. SUMMARY OF OBJECTIVES AND METHODS* ......................... 3
4. TECHNICAL PLAN ** (Refer to Technical Proposal
Instructions, Section C.1., Standard RFP Instructions
and Provisions, Gopher RFP for more detail)
a. WORK STATEMENT
1. Objectives .................................. 4
2. Approach .................................... ____
3. Methods ..................................... ____
4. Schedule .................................... ____
b. RESOURCES AND DIRECT COSTS (list/describe all
equipment, facilities and other resources available
for this project; attach "Technical Proposal Cost
Information" form, and marked laboratory floor
plan in Section 6, below) ........................ ____
c. PERSONNEL (List by name, title, department and
organization, and detail each person's qualifications
and role in the Project); provide narrative for:
1. Principal Investigator/Project Director ..... ____
2. Other Investigators ......................... ____
3. Additional Personnel (technical support/
subcontractors/consultants) ................. ____
[Note: For personnel, include 2 page biosketch
and the form entitled "Summary of Current and
Proposed Activities" under Sections 5 and 6
below.]
d. OTHER CONSIDERATIONS (provide brief narrative
of any unique arrangements, safety procedures
in place, animal welfare issues, human subject
and minority and gender issues, etc.)............ ____
5. APPENDICES (protocols, literature citations,
resumes/biosketches, policy manuals, etc. for above
Technical Plan); list each Appendix; Appendices must
be clear and legible, and easily located............. ____
6. OTHER ATTACHMENTS:
a. "Summary of Current and Proposed Activities" (All
key personnel must be listed on this form; it is
located in the FORMS, FORMATS, ATTACHMENTS
Directory found in Section C, Gopher RFP)......... ____
b. "Technical Proposal Cost Information" form (located
in Section C, Gopher RFP, FORMS, FORMATS, &
ATTACHMENTS)...................................... ____
c. Laboratory Design and Floor Plan (clearly indicate
the space available for this Project)............. ____
* State the proposal's broad, long-term objectives and specific
aims. Briefly and concisely describe the research design and
methods for achieving these goals (limit to one page).
** Sections 4.a. through 4.d. above MUST NOT EXCEED 200 PAGES (this
does not include copies of resumes/biosketches and any required forms or
protocols, 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.
**********************************************************
10. PROPOSAL INTENT RESPONSE SHEET
PROPOSAL INTENT
---------------
RFP No.: NIH-NIAID-DMID-97-07
PLEASE REVIEW THE ATTACHED REQUEST FOR PROPOSAL. FURNISH THE
INFORMATION REQUESTED BELOW AND RETURN THIS PAGE BY THE EARLIEST
PRACTICABLE DATE. YOUR EXPRESSION OF INTENT IS NOT BINDING BUT
WILL GREATLY ASSIST US IN PLANNING FOR PROPOSAL EVALUATION.
================================================================
[ ] DO INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING:
__________________________________________________________
__________________________________________________________
[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING
REASONS:
__________________________________________________________
__________________________________________________________
TYPED NAME AND TITLE: _______________________________
INSTITUTION: ________________________________________
SIGNATURE: __________________________________________
TELEPHONE NO.: ______________________________________
DATE: _______________________________________________
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
COLLABORATORS/CONSULTANTS - Provide name(s) and institution(s):
(Continue list on reverse if necessary)
________________________________________________________________
________________________________________________________________
RETURN TO: CMB, NIAID, NIH
Solar Building, Room 3C07
6003 Executive Boulevard MSC 7610
Bethesda, Maryland 20892-7610
Attn: Sara M. Southard
RFP NIH-NIAID-DMID-97-07
Fax # 301/480-5253
PLEASE RETURN BY DECEMBER 20, 1996
************************************************************
********************************************************************
RFP-NIH-NIAID-DMID-97-07
ATTACHMENT 5
8/27/96
III. APPLICABLE RFP REFERENCES
------------------------------
This section identifies the items located in the Gopher directory
"C. RFP REFERENCES" that are applicable to this RFP.
1. The entire file entitled "STANDARD RFP INSTRUCTIONS AND
PROVISIONS" is applicable to this RFP, except as otherwise may be
modified by the inclusion of an item from the "OPTIONAL RFP
INSTRUCTIONS AND PROVISIONS" (below).
2. The following items are applicable from the file entitled"
OPTIONAL RFP INSTRUCTIONS AND PROVISIONS":
(1) LATE PROPOSALS, MODIFICATIONS OF PROPOSAL, AND WITHDRAWALS
OF PROPOSALS, PHS 352.215-10
(2) HUMAN SUBJECTS
(3) CARE OF LIVE VERTEBRATE ANIMALS - NOTICE TO OFFERORS OF
REQUIREMENT FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE
ANIMAL SUBJECTS (SEP 1985), PHSAR 352.280-2(a)
(4) SMALL, SMALL DISADVANTAGED AND WOMEN-OWNED SMALL BUSINESS
SUBCONTRACTING PLAN, FAR 52.219-9 [NOTE: A Subcontracting Plan
is not due with the initial proposal. The Contracting Officer
will notify offerors if a plan becomes due.]
(5) INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
3. The following items are applicable from the subdirectory
entitled "FORMS, FORMATS, AND ATTACHMENTS":
Applicable to Technical Proposal
--------------------------------
(1) Technical Proposal Cover Sheet
(2) Technical Proposal Cost Information, Dec 1988
(3) Summary of Current and Proposed Activities, July 1995
Applicable to Business Proposal
-------------------------------
(4) Contract Pricing Proposal, SF-1411, (Rev. 10/95)
(5) Proposal Summary and Data record, NIH-2043 (Rev. 6/82)
(6) Business Proposal Cost Information
(7) Disclosure of Lobbying Activities, OMB SF-LLL
To Become Contract Attachments
------------------------------
(8) Invoice/Financing Requests Instructions for NIH Cost-
Reimbursement Type Contracts, NIH(RC)-1, JUN 1992
(9) Instructions for Completing Form NIH 2706 (Financial
Report
(10) Procurement of Certain Equipment, NIH(RC)-7
(11) Research Patient Care Costs, NIH(RC)-11
(12) NIH Women and Minority Policy
(13) Protection of Human Subjects - Assurance Identification/
Certification/Declaration, OF 310
Other - to be submitted as directed by Contracting Officer
----------------------------------------------------------
(11) Certificate of Current Cost or Pricing Data, NIH-1397
(12) Subcontracting Plan
4. The Representations and Certifications are applicable and a
completed copy must be submitted with offeror's business proposal.
5. The "Sample Contract Format-General" is applicable.
********************************************************************
End of document