Sexually Transmitted Infections (STI) Impact Research Consortium
Title: Sexually Transmitted Infections (STI) Impact Research Consortium
This is a Pre-Solicitation Notice for a full and open competitive requirement under North American Industrial Classification System (NAICS) Code of 541990 – All Other Professional, Scientific, and Technical Services, with a small business size standard of S16.5M. The Centers for Disease Control and Prevention (CDC), National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) is contemplating an Indefinite Delivery Indefinite Quantity (IDIQ) multiple award for a research support services project entitled, "Sexually Transmitted Infections Impact Research Consortium." The anticipated period of performance for the contract is sixty months. Place of Performance will be determined on individual task orders. The solicitation Request for Proposal (RFP) will be made available on the Internet at www.sam.gov on or about April 15, 2022. Requests for Proposals in hard copy form will not be available to interested parties. Telephone requests will not be honored. Interested parties are responsible for checking the website regularly for release of the RFP and for other procurement-related documents. The information provided in this pre-solicitation is for information purposes only. If there are any differences in the information provided here and the actual solicitation when released, the information provided in the actual solicitation shall govern.
Background for the Acquisition: As the nation’s leading health protection agency, CDC focuses on the public’s health and safety. To accomplish this mission, CDC conducts critical scientific research to increase public health prevention impact. On March 11, 2021, the President signed into law the American Rescue Plan Act of 2021 (H.R. 1319). The Division of STD Prevention (DSTDP) received funding to strengthen the capacity of state, tribal, local, and territorial (STLT) public health departments to mitigate the spread of COVID and other infections, including sexually transmitted infections (STI). This investment included funding to support innovations to increase the impact of STI prevention and control approaches. These approaches include adaptation and evaluation of promising practices and tools from SARS-CoV-2 response efforts, development of new technology and diagnostic tests, and other interventions to increase impact through improving the efficacy, effectiveness and efficiency of public health disease intervention services pertaining to the detection, mitigation, and prevention of onward transmission of STI.
Reported cases of STI in the United States have increased substantially in the past decade, doubling for gonorrhea and chlamydia, and tripling for infectious syphilis and congenital syphilis. Prior to the onset of COVID-19, STI comprised over 80% of all notifiable infections and diseases. To reduce transmission and prevalence of STI in populations, essential public health approaches have used assessment (including surveillance and screening), treatment, case investigation and contact tracing, as well as primary prevention interventions to reach individuals and populations with high morbidity or vulnerable to transmission. Core public health functions in 2022 include acting to protect and promote health of people in all communities, including removal of barriers that have resulted in health inequities. Experience with STI prevention during the COVID-19 pandemic as well as approaches to COVID-19 management has stimulated new approaches that need to be investigated further and developed for public health STI prevention and control programs. Research conducted via this contract is therefore intended to increase the impact of disease intervention services through testing innovative strategies and tool and implementing effective approaches at population scale. Such research, addressing the core functions of public health and the public health workforce, will also strengthen public health capacity to manage infectious diseases more broadly and therefore is consistent with the goals of the American Rescue Plan Act (2021).
Project Objectives: The objective of this procurement is to establish a consortium of research centers to provide The Division of STD Prevention, of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (DSTDP/NCHHSTP) with a ready source of research, scientific and technical expertise to (a) increase the population-level impact of STI prevention and control through public health programs and (b) improve health equity for populations disproportionately affected by STI. STI of particular focus are those causing substantial national morbidity or mortality, including substantial endemic threats (e.g., HIV, syphilis, hepatitis), or as emerging threats (e.g., antimicrobial-resistant gonorrhea).
General Scope of Work: The four categories of services to be acquired under this contract provide a mechanism to conduct research, scientific and technical expertise and support services pertinent to STI prevention intervention impact and STI-related health equity to DSTDP/NCHHSTP.
As an independent organization and not as an agent of the Government, the contractor shall furnish all necessary personnel, facilities, supplies, and equipment, as appropriate, to provide DSTDP/NCHHSTP with required research support services within the general work parameters set forth in the Statement of Work. Contractor performance and all resulting deliverables must adhere to all Federal, HHS, and/or CDC IT security policies and procedures.
The Contractor is advised that it is not possible to determine the precise types or amounts of services, supplies, and/or equipment that will be ordered during the term of the contract. The Contractor shall be obligated to perform within the minimum and maximum order limitations set forth in clauses 52.216-19, Order Limitations. The time of issuance and amount of work in task orders cannot be accurately predicted. The Government will make every effort to give the Contractor advance notice of requirements, but the services for which this contract will be used could address an immediate need involving an emergency or short notice requirement. Services to be performed shall be non-personal and not inherently governmental services. Supplies and equipment are incidental to the required services to be performed.
Follow-On Requirement: This is a new requirement; this is not a follow-on contract requirement.
75D301-22-R-72168 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
3/31/22, 4:36 PM Sexually Transmitted Infections (STI) Impact Research Consortium
Small Business Sources Sought Notice
Title of Project: Sexually Transmitted Infections (STI) Impact Research Consortium
Introduction. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this Sources Sought Notice is 541690 – Other Scientific and Technical Consulting Services, Size Standard: $16.5 million.
Background. As the nation’s leading health protection agency, CDC focuses on the public’s health and safety. To accomplish this mission, CDC conducts critical scientific research to increase public health prevention impact. On March 11, 2021, the President signed into law the American Rescue Plan Act of 2021 (H.R. 1319). The Division of STD Prevention (DSTDP) received funding to strengthen the capacity of state, tribal, local, and territorial (STLT) public health departments to mitigate the spread of COVID and other infections, including sexually transmitted infections (STI). This investment included funding to support innovations to increase the impact of STI prevention and control approaches. These approaches include adaptation and evaluation of promising practices and tools from SARS-CoV-2 response efforts, development of new technology and diagnostic tests, and other interventions to increase impact through improving the efficacy, effectiveness and efficiency of public health disease intervention services pertaining to the detection, mitigation, and prevention of onward transmission of STI.
Reported cases of STI in the United States have increased substantially in the past decade, doubling for gonorrhea and chlamydia, and tripling for infectious syphilis and congenital syphilis. Prior to the onset of COVID-19, STI comprised over 80% of all notifiable infections and diseases. To reduce transmission and prevalence of STI in populations, essential public health approaches have used assessment (including surveillance and screening), treatment, case investigation and contact tracing, as well as primary prevention interventions to reach individuals and populations with high morbidity or vulnerable to transmission. Core public health functions in 2022 include acting to protect and promote health of people in all communities, including removal of barriers that have resulted in health inequities. Experience with STI prevention during the COVID-19 pandemic as well as approaches to COVID-19 management has stimulated new approaches that need to be investigated further and developed for public health STI prevention and control programs. Research conducted via this contract is therefore intended to increase the impact of disease intervention services through testing innovative strategies and tool and implementing effective approaches at population scale. Such research, addressing the core functions of public health and the public health workforce, will also strengthen public health capacity to manage infectious diseases more broadly and therefore is consistent with the goals of the American Rescue Plan Act (2021).
Purpose and Objectives. The Division of STD Prevention, of the National Center for HIV, Viral Hepatitis, STD, and TB Prevention (DSTDP/NCHHSTP) in the Centers for Disease Control and Prevention intends to establish a consortium of research centers to (a) increase the population-level impact of STI prevention and control through public health programs and (b) improve health equity for populations disproportionately affected by STI.
These two purposes will be met by conducting research and associated activities in two substantive and overlapping areas. These areas are (1) clinical trials (see NIH's Definition of a Clinical Trial | grants.nih.gov for guidance on what constitutes a clinical trial) and (2) population-focused implementation science. Although contractors are not required to follow any specific research templates given the broad scope of this contract, they are encouraged to follow research principles grounded in population-level impact and in health equity, for example WHO ’s Implementation Research in Health and National Institute on Minority Health and Health Disparities (NIMHD) Research Framework Details (nih.gov).
The contractor shall conduct population-level prevention research and implementation studies. The consortium shall be named the Sexually Transmitted Infections Impact Research Consortium (hereafter STIIRC). STI of particular focus are those causing substantial national morbidity or mortality, including substantial endemic threats (e.g., HIV, syphilis, hepatitis), or as emerging threats (e.g., antimicrobial-resistant gonorrhea).
Project Scope. The Contractor shall conduct research and provide scientific and technical expertise and related services in research pertinent to STI prevention intervention impact and STI-related health equity.
The potential requirements will include a mix of planning, assessment, development, management, support, and execution tasks in line with CDC’s missions and activities.
The Contractor shall participate in a research consortium (STIIRC) comprising CDC staff and principal investigators from contracted sites. The consortium is managed by CDC’s Division of STD Prevention (DSTDP). The chair of the consortium shall be a staff member of DSTDP, leading discussions and making final study protocol decisions considering input from consortium members. Consortium members will provide expert input and advice into the research projects undertaken to meet the terms of the contract, and consortium membership will operate in an open and collaborative framework. Final decisions on the conduct of research remain within the purview of CDC via the Director of DSTDP.
Functional Research Areas. Contractor(s) shall represent a mixture of entities responsible for public health prevention activities in STI prevention and control (e.g., state, tribal and health departments) and entities with extensive clinical and implementation research experience and capacities related to public health prevention (e.g., academic institutions, research non-profit organizations). This contract will specialize in four interrelated and cross-cutting functional research areas relating to STI prevention and control and incorporating primary and secondary prevention research:
1) STI service delivery research involving prevention content: Research, including clinical trials, to develop, test and implement interventions that include efficacious STI prevention content, including STI treatment options, vaccination, biomedical and socio-behavioral interventions, and management of comorbid factors (i.e., syndemic approach)
2) STI service delivery research into prevention methods/approaches: Research to develop, test and implement interventions to increase access to, and efficient use of, STI services, including home testing, specimen collection and other “out of clinic” models, express visit models, telehealth models, and collaborative networks at different levels of clinical and prevention capacity.
3) Field-based prevention research: Research to integrate novel interventions into field investigations, including improved case and contact monitoring and support, access to and use of remote services during field investigations, and novel approaches to isolation, quarantine and other strategies to prevent onward transmission of infection.
4) Diagnostic research approaches: Research into new STD diagnostic approaches to develop, test and implement diagnostic tools that increase the proportion of infected persons tested and diagnosed; clinical trials of new diagnostic tools and methods; implementation research to increase use of efficacious and effective diagnostic tools.
Other Important Considerations. For all functional research areas, contractors must demonstrate:
STI prevention and control expertise aimed at population-level prevention impact.
Clinical trial research expertise.
Capacity related to research design and planning, including:
Scientific and technical support for research design and planning
Community engagement and acceptability testing
Protocol development and pilot testing
Data system development and implementation
Data modeling, management, analysis, and informatics expertise
Preparation of OMB, IRB, and other Regulatory and Safety packages as required
Capacity to provide consultation and technical assistance to CDC in selected topics of interest related to STI prevention and control research development, to include expertise in select pathogens, diagnostics (including point of care diagnostics), research syntheses, research methodology, mathematical modeling, and cost analyses. In addition, DSTDP is frequently required to make policy, programmatic, administrative, and budgetary decisions relative to program activities in a timely manner. The efficiency of decision making will be greatly promoted by the ability to access expert consultation and technical assistance in a wide variety of topics.
Preferably, contractors will have expertise and capacity to address STI prevention and control research design tasks in resource-limited or policy-constrained settings.
Functional Research Areas 1 through 4: STI service delivery research: prevention interventions and prevention methods; field-based prevention research; diagnostics research. All parts below apply to all three functional research areas except as noted in parts b, c, d, e and f.
Contractors will have centralized Institutional Review Board (IRB) capacity for conducting human subjects reviews for both single and multicenter studies. Contractors should also have STI prevention and control expertise, demonstrable access to focus populations and clinical settings serving those populations, capacity to conduct interventions for population impact, and experience developing protocols and intervention tools. Contractors should also have demonstrable capacity to conduct formative research, community assessment and engagement research, and pilot efficacy and implementation studies.
Contractors should have direct access to facilities providing comprehensive STI services to focus populations and, for Functional Search Area 3, must have the authority and capacity to conduct field investigations of STI transmission networks based on diagnosis of STI in facilities providing comprehensive STI services. Facilities will preferably be owned and operated by a common entity (including health departments) or operating within a network structure with common information technology infrastructures within which clinical data generated during the course of patient care across multiple facilities is collected and stored using common data format and structure. Data thus gathered should be accessible through a central point of contact within the network.
Contractors should demonstrate the ability to recruit individuals, patients, healthcare and other facilities and patients within the network to participate in STI prevention research, including assessing the impact of STI prevention interventions (single interventions or interventions in combination).
Contractors will have access to integrated electronic medical systems and population-based outcomes across a spectrum of healthcare facilities providing sexual health care or STI prevention services. Access to clinical data, including administrative data from healthcare institutions that collect data in a standardized fashion, is preferable.
Contractors will have expertise in preparing and submitting IRB packages and overseeing all aspects of implementation of clinical and other research studies pertaining to STI prevention and control.
Contractors will have internal capacity for Office of Management and Budget (OMB) package development and submissions.
Contractors will have public health, STI prevention, and clinical expertise and will provide services related to assessments (individual, provider/program, community, geographic areas, social determinants); clinical trials and other research approaches; program management processes, procedures and intervention techniques. Services may include:
Background Analyzes and Syntheses
Formative Research, including community engagement studies and acceptability studies
Materials/Methods Pre-testing and/or Efficacy Evaluations
Process Evaluations
Outcome and/or Impact Evaluation
Anticipated period of performance. The period of performance will be five years.
Capability Statement/Information Sought. PAGE LIMIT 8 PAGES.
Interested offerors should submit a capability statement specifically addressing the criteria listed below ONLY. Capability statements that address requirements other than what is identified below will not be reviewed.
Your opinion about the difficulty and or feasibility of the potential requirement(s) or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts;
Your staff expertise, including your availability, experience, and formal and other training;
Your current in house capability and capacity to perform the work;
Completed projects in the last 5 years of similar size and scope;
Corporate experience and management capability;
Provide any examples of prior completed Government contracts, reference, and other related information;
Recommendations for a different NAICS code. If so, please explain?
Information Submission Instructions: Please include a cover page with the following business information. The cover page does not count against the page limit for the capability statement.
Company name and address;
DUNS number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.SAM.gov/;
Do you have a government-approved accounting system? If so, please identify the agency that approved this system;
Business Size and Type of Business (e. g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code 541690 – Other Scientific and Technical Consulting Services, Size Standard: $16.5 million;
Technical point of contact including name, title, address, telephone number, and email address of the individual(s) who can verify the demonstrated capabilities identified in the response;
Contracts’ point of contact including name, title, address, telephone number, and email address;
In your opinion, can this work fit under a GSA Schedule? If so, which GSA Schedule? Please provide the schedule number.
Page Limitation: Capability Statements shall be limited to EIGHT (8) (including references, appendices, charts, illustrations, diagrams, and or resumes) single-spaced pages not including cover page. Pages shall be formatted as follows: MS Word, 8 ½ x 11, 12 pitch, Times New Roman font with one (1) inch margins.
Response Due Date: Submit capability statements via email to Liubov Kriel, Contract Specialist at vyh1@cdc.gov. Should you have any questions concerning this sources sought, please direct your questions in writing to the Contracting Specialist Liubov Kriel at vyh1@cdc.gov. The government will not respond to oral questions. Responses must be submitted no later than 5:00 pm, Eastern Standard Time (EST) by Tuesday, February 8, 2022. Capability statements will NOT be accepted after the due date. No telephonic or facsimile responses will be accepted.
The Government will not provide feedback on capability statements and we will not return capability statements received.
Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Response is strictly voluntary. It is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this Sources Sought notice.
We appreciate your interest and thank you in advance for responding to the Sources Sought.
75D301-22-R-72168 Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services
2/1/22, 1:53 PM