HIV Risk Questionnaire (HRQ) Study / Assessment of the Predictive Value of a Panel of Questions for Recent Infection with HIV
THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL BE ACCEPTED REQUESTING A BID PACKAGE OR SOLICITATION. THERE IS NO BID PACKAGE OR SOLICITATION. IN ORDER TO PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) / Office of Biostatistics and Epidemiology (OBE) who is seeking potential Small Business providers to conduct an HIV Risk Questionnaire (HRQ) Study / Assessment of the Predictive Value of a Panel of Questions for Recent Infection with HIV.
Please note that any potential Small Business must be responsible for providing at least 51% of the proposed services that it offers as a solution. Merely subcontracting or outsourcing the services to a large business is not an acceptable solution and the prime contractor would not qualify as a Small Business.
Background:
The FDA continues to review its donor deferral policies to ensure they reflect the most up-to-date scientific knowledge by conducting a study that will provide FDA with evidence by which to consider potential changes in the blood donor deferral policy for men who have sex with men (MSM) while maintaining the safety of the blood supply.
Objectives:
Public Health Policies must be data-driven, so the timeframe for future changes is not something that can be predicted. Therefore, the FDA proposes to conduct the following study to assess whether an alternative MSM donor deferral strategy that minimizes HIV risk could be a reasonable alternative to the current approach. The study was developed through a collaborative process with a Blood Equality Working Group of community stakeholders including advocacy organizations, community health centers, blood collectors, and public health agencies.
Primary Objective:
• Conduct an initial assessment of the discriminant function of revised donor history questions for predicting recent infection with HIV in MSM who wish to donate blood.
Secondary Objectives:
• Evaluate the recency of infection in those individuals who test positive for HIV by individual Nucleic Acid Testing (NAT) and antibody testing;
• Identify risk factors associated with recent HIV infection in individuals who are antibody negative yet HIV NAT positive.
Contractor Technical Tasks:
• The Contractor shall establish an Executive Committee (EC) and Steering/Monitoring Committee that will review and analyze the data and reports on a regular basis, the results of any investigation and analyses (e.g., temporal trends in incidence and prevalence), and meet as necessary to carry out the functions required under this proposal. FDA staff and analysts are available to consult and provide advice to the Contractor on items such as study design, analytic approaches, analyses and related areas.
• The Contractor shall develop and deliver a written MOP and the protocol, including the background rate of HIV for the population to be studied and coordinate with the SMC to finalize them. Procedures shall address at a minimum the following: survey implementation, specimen collection procedures and handling, laboratory procedures, shipping and storage, management and tracking, consensus definitions, security, data security and management, transfer, and data sharing considerations.
• The Contractor shall document training of all survey staff on the protocol and survey procedures, including initial questionnaire delivery and data capture, and follow-up interview and counseling techniques.
• This study will involve in-person administration of a questionnaire, preferably using electronic tools, by trained survey staff, the collection of a 7 mL blood sample by a trained phlebotomist, and when appropriate, administration of a follow-up questionnaire through an in-person subject interview combined with appropriate counseling and referral. The survey shall be administered by staff trained on the survey administration procedure, HIPAA and confidentiality of records and data. Data are to be collected through a secure survey design into a confidential data repository.
• The Contractor shall be responsible for analysis of study results including questionnaire outcomes, test results, and their integration. The Contractor shall develop an analysis plan that will include a description of all proposed analyses and will include the data specifications, the dataset structures, the table specifications for summary results, the statistical plan, any proposed data modeling, and data quality control procedures.
If you are a small business concern under NAICS CODE 541990 - All Other Professional, Scientific, and Technical Services, Small Size Standard is $15 M million, and believe that your firm would be able to provide the FDA the services as described, shall provide the below in writing by mail or e-mail within the posted date to howard.nesmith@fda.hhs.gov.
Response Shall Include:
I. Capability statement that demonstrates minimum requirements outlined in their Capability statement in 10 pages or less.
II. Provide the following Business Information:
a. Company Name
b. Company Address
c. Company Point of Contact, name, phone number, and e-mail address
d. Type of business (i.e. commercial, academia), as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov any potential government contractor must be registered on SAM located at www.sam.gov
e. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.)
f. DUNS Number
g. Shall list any Small Disadvantaged status currently hold [HUBZone, 8(a), Service Disabled Veteran Owned Small Business (SDVOSB), Women Owned Small Business (WOSB), Economically Disadvantaged Women-Owned Small Business (EDWOSB), etc.]
III. Past experience/performance through the description of completed projects which will uniquely demonstrate they have experience providing the required services.
Responses to this Sources Sought announcement will assist the Government in determining whether or not this and/or any future requirement(s) similar to this one should be set aside for small business or made available to full and open competition.
**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**
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 in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
The DEADLINE for receiving responses is 1:00 p.m. Central Time, March 29, 2019. Responses received after the deadline or without the required information shall be considered unacceptable and shall not be considered. Responses should be emailed to howard.nesmith@fda.hhs.gov and the email subject line should reference Sources Sought FDA_1209847. Since this is a Sources Sought announcement, no evaluation letters will be issued to the participants.
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).
Howard Nesmith, Contract Specialist, Phone 870-543-7459, Email howard.nesmith@fda.hhs.gov
