DRAFT RFP - Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE)

Note: This is only a brief introduction. Please read the entire DRAFT RFP to ensure you have a clear understanding of the Government's intended requirement.
March 6, 2019
Dear Ladies and Gentlemen:
The Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) is requesting feedback (questions and comments) from Contract Research Organizations (CRO) and other similar entities who work in the Clinical Study area regarding the following three (3) BARDA DRAFT RFPs:
1. 19-BARDA-DRAFT-CSN-BSIP
2. 19-BARDA-DRAFT-CSN-SDCC
3. 19-BARDA-DRAFT-CSN-CTPE
Combined, these three (3) DRAFT RFPs will form the revised Clinical Studies Network (CSN) Contract Research Organizations (CROs) for CBRNE Medical Countermeasures (MCMs).
Specifically, BARDA is seeking feedback form those interested entities involved in Clinical Trial Planning and Execution, Statistical and Data Coordinating Center activities, and Biological Specimen and Investigational Product Storage. Questions and comments should be submitted by Close of Business (COB) on March 12, 2019 as outlined below, in preparation for a pre-proposal conference (see below for detailes). Feedback from all capable and qualified sources would be appreciated.
The following are notices relating to this request for feedback:
- Feedback from prospective Responders will not provide them with an advantage nor disadvantage in future solicitations.
- All Feedback will be reviewed and responses to feedback and questions will be posted on the Federal Business Opportunities Website (www.fedbizopps.gov).
- No company information will be revealed to the public to include which companies asked particular questions.
- The posting of information about this requirement does not express or imply any commitment by the Government to issue a final RFP or the promise for any contract action.
- Any information and notices concerning the release of a final RFP will be posted on the Federal Business Opportunities Website (www.fedbizopps.gov) when available.
FORMAT
Responses shall adhere to the following formatting and outline instructions:
1. Format specifications include 8.5 by 11 inch paper. All submissions must be in a format compatible with the Microsoft Office or Adobe software package and electronically submitted as follows:
To: enrique.manan@hhs.gov
Cc: marcy.grace@hhs.gov
2. Cover Page (1 page)
a. Title
b. Organization
c. Respondents' technical and administrative points of contact (names, addresses, phones and fax numbers, and email addresses)
d. Respondents' intent to participate either in person or via teleconference at the below identified pre-proposal conference.
3. Feedback to Draft RFP (19-BARDA-DRAFT-CSN-CTPE) (no page limit)
a. Questions should be numbered with at least one line space between each question.
b. Please identify the DRAFT RFP No. and the RFP Section for each question.
The posting of information about this requirement does not express or imply any commitment by the Government to issue a final RFP or the promise for any contract action.
The point(s) of contact for this DRAFT RFP are as follows:
Enrique Mañán: enrique.manan@hhs.gov
Marcy Grace: marcy.grace@hhs.gov
BARDA encourages open communication from all potential Responders.
A combined conference call (with all interested potential Responders) to discuss this DRAFT RFP has been scheduled as follows:
DATE: Friday, March 22, 2019 *DATE UPDATED*
TIME: TBD
LOCATION: Conference Call / Washington, DC
CALL IN INFO: TBD
Thank you for your interest in doing business with the Federal Government..

Note: This is only a brief introduction. Please read the entire RFP.
March 6, 2019
Dear Ladies and Gentlemen:
The Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) is requesting feedback (questions and comments) from Contract Research Organizations (CRO) and other similar entities who work in the Clinical Study area regarding the following three (3) BARDA DRAFT RFPs:
1. 19-BARDA-DRAFT-CSN-BSIP
2. 19-BARDA-DRAFT-CSN-SDCC
3. 19-BARDA-DRAFT-CSN-CTP & E
Combined, these three (3) DRAFT RFPs will form the revised Clinical Studies Network (CSN) Contract Research Organizations (CROs) for CBRNE Medical Countermeasures (MCMs).
Specifically, BARDA is seeking feedback form those interested entities involved in Clinical Trial Planning and Execution, Statistical and Data Coordinating Center activities, and Biological Specimen and Investigational Product Storage. Questions and comments should be submitted by Close of Business (COB) on March 12, 2019 as outlined below, in preparation for a pre-proposal conference on March 15 (see below). Feedback from all capable and qualified sources would be appreciated.
The following are notices relating to this request for feedback:
- Feedback from prospective Responders will not provide them with an advantage nor disadvantage in future solicitations.
- All Feedback will be reviewed and responses to feedback and questions will be posted on the Federal Business Opportunities Website (www.fedbizopps.gov).
- No company information will be revealed to the public to include which companies asked particular questions.
- The posting of information about this requirement does not express or imply any commitment by the Government to issue a final RFP or the promise for any contract action.
- Any information and notices concerning the release of a final RFP will be posted on the Federal Business Opportunities Website (www.fedbizopps.gov) when available.
FORMAT
Responses shall adhere to the following formatting and outline instructions:
1. Format specifications include 8.5 by 11 inch paper. All submissions must be in a format compatible with the Microsoft Office or Adobe software package and electronically submitted as follows:
To: marcy.grace@hhs.gov
Cc: enrique.manan@hhs.gov
2. Cover Page (1 page)
a. Title
b. Organization
c. Respondents' technical and administrative points of contact (names, addresses, phones and fax numbers, and email addresses)
d. Respondents' intent to participate either in person or via teleconference at the below identified pre-proposal conference.
3. Feedback to Draft RFP (19-BARDA-DRAFT-CSN-CTP & E) (no page limit)
a. Questions should be numbered with at least one line space between each question.
b. Please identify the DRAFT RFP No. and the RFP Section for each question.
The posting of information about this requirement does not express or imply any commitment by the Government to issue a final RFP or the promise for any contract action.
The point(s) of contact for this DRAFT RFP are as follows:
Marcy Grace: marcy.grace@hhs.gov
Enrique Manan: enrique.manan@hhs.gov
BARDA encourages open communication from all potential Responders.
A combined conference call (with all interested potential Responders) to discuss this DRAFT RFP has been scheduled as follows:
DATE: Friday March 15, 2019
TIME: TBD
LOCATION: Washington, DC
CALL IN INFO: TBD
Thank you for your interest in doing business with the Federal Government..