"Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)"

The Request For Proposal document HHS-NIH-NIMH-10-024 is hereby amended to extend the due date of proposals and to answer questions of perspective offerors.

All questions regarding this RFP or amendments must be submitted in writing to jacobsonmj@mail.nih.gov.

The Request for Proposal is hereby amended with Amendment 0001.  The Amendment is attached as are a revised Statement of Work (Attachment 3), Revised Additional Instructions (Attachment 4), and Revised Technical Evaluation Criteria (Section M). Within the Amendment document questions from proposed offerors and respective answers are included. 

The proposal response due date remains unchanged.

The National Institute of Mental Health (NIMH) is issuing a Request for Proposals (RFP) No. HHS-NIH-NIMH-10-024 entitled "Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)" under Full and Open Competition.

This is a Research and Development initiative which is anticipated to leverage the development of rapid treatments (demonstrable clinical improvement within 72 hours of administration) for severe, treatment-resistant depression.

1. The primary objectives of resultant contract(s) are:

     a. To establish a network of sites to study "Rapidly-Acting Treatments for Depression" (i.e. the "RAPID-network") that will focus on identifying and testing promising interventions (pharmacological and/or non-pharmacological) that produce a substantial anti-depressant effect within 72 hours of initial administration.

     b. To perform randomized clinical trials testing such promising interventions (other than Ketamine Hydrochloride or sleep deprivation (total or partial)) in a well-characterizedcohort of adult patients (age 18-60) diagnosed with treatment-resistant depression.

2. A secondary objective of resultant contract(s) would be:

     a. To further study and evaluate interventions that showed efficacy in a RAPID-network Proof of Concept trial in a larger clinical trial.

Important Considerations:

1. The Contractor(s) are responsible for identifying, recommending, and accessing (if a 3rd party is involved) all interventions to be tested during the contract period.

2. In order to be competitive for an award, Offerors should propose, with the initial offer, a trial of promising intervention with a detailed protocol that the network would be capable of initiating without delay after the infrastructure is established and after gaining all regulatory approvals.

3. The Contractor(s) should either already have access to and permission to develop the intervention (from a 3rd party supplier, if applicable), or provide evidence that there would not be delay involved in conducting the 1st trial due to access problems.

4.  The peer reviewed evaluation of the scientific merit of the 1st recommended intervention, and access to develop that intervention, will be an important factor in determining which Offerors may be awarded a contract.

The Offeror should also have the capability to:

1. Perform clinical trials of both pharmacological and non-pharmacological interventions in treatment-resistant depression specifically.

2.  Provide scientific oversight, facilitate collaboration among the investigators, integrate complex protocol management, data acquisition, bio-statistical data analysis and reporting of results from clinical trials involving subjects with treatment-resistant depression.

3.  Collaborate with multiple experts and stakeholders (investigators, clinicians, advocates, and consumers) in treatment-resistant depression research.

General Information:

This RFP, HHS-NIH-NIMH-10-024, details the specifics of the project as well as information pertinent to the development of an Offeror's proposal.

The solicitation document may be accessed through the Internet at the Federal Business Opportunities website at: http://www.fedbizopps.gov.  No paper copies will be available.  Offerors are responsible for downloading their own copy of the solicitation and amendments that may be issued by the Government.  Proposals will be due on or about January 13, 2011.  It is anticipated that one or more cost-reimbursement contract awards will be made for a period of five years beginning on or about June 30, 2011.  Contract(s) will be Indefinite Delivery Indefinite Quantity (IDIQ) and the number of interventions to be tested over the contract period is indefinite beyond the 1st intervention. 

This modification/amendment to the Pre-solicitation notice HHSNIHNIMH10024 corresponds to the Small Business Sources Sought notice: #HHS-NIMH-SBSS-10-001 previously posted on August 11, 2010 and Research and Development Sources Sought notice#: HHSNIHNIMHRDSS10024 posted on September 16, 2010.

All responsible sources are encouraged to submit a proposal that will be considered by the NIMH.  This advertisement does not commit the Government to award a contract.

Please contact Marla Jacobson, Contract Specialist at jacobsonmj@mail.nih.gov for further information.  All questions must be submitted in writing to jacobsonmj@mail.nih.gov.

The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposals (RFP) No. HHS-NIH-NIMH-10-024 entitled "Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)" under Full and Open Competition.

This is a Research and Development initiative which is anticipated to leverage the development of rapid treatments (demonstrable clinical improvement within 72 hours of administration) for severe, treatment-resistant depression.

1. The primary objectives of resultant contract(s) are:

     a. To establish a network of sites to study "Rapidly-Acting Treatments for Depression" (i.e. the "RAPID-network") that will focus on identifying and testing promising interventions (pharmacological and/or non-pharmacological) that produce a substantial anti-depressant effect within 72 hours of initial administration.

     b. To perform randomized clinical trials testing such promising interventions (other than Ketamine Hydrochloride or sleep deprivation (total or partial)) in a well-characterizedcohort of adult patients (age 18-60) diagnosed with treatment-resistant depression.

2. A secondary objective of resultant contract(s) would be:

     a. To further study and evaluate interventions that showed efficacy in a RAPID-network Proof of Concept trial in a larger clinical trial.

Important Considerations:

1. The Contractor(s) are responsible for identifying, recommending, and accessing (if a 3rd party is involved) all interventions to be tested during the contract period.

2. In order to be competitive for an award, Offerors should propose, with the initial offer, a trial of promising intervention with a detailed protocol that the network would be capable of initiating without delay after the infrastructure is established and after gaining all regulatory approvals.

3. The Contractor(s) should either already have access to and permission to develop the intervention (from a 3rd party supplier, if applicable), or provide evidence that there would not be delay involved in conducting the 1st trial due to access problems.

4.  The peer reviewed evaluation of the scientific merit of the 1st recommended intervention, and access to develop that intervention, will be an important factor in determining which Offerors may be awarded a contract.

The Offeror should also have the capability to:

1. Perform clinical trials of both pharmacological and non-pharmacological interventions in treatment-resistant depression specifically.

2.  Provide scientific oversight, facilitate collaboration among the investigators, integrate complex protocol management, data acquisition, bio-statistical data analysis and reporting of results from clinical trials involving subjects with treatment-resistant depression.

3.  Collaborate with multiple experts and stakeholders (investigators, clinicians, advocates, and consumers) in treatment-resistant depression research.

General Information:

This is a Pre-solicitation Notice in advance of the Request for Proposals (RFP), and the Government is not committed to award a contract pursuant to this announcement.  The RFP, HHS-NIH-NIMH-10-024, detailing the specifics of the project as well as information pertinent to the development of an Offeror's proposal will be available electronically on or about November 24, 2010 and may be accessed through the Internet at the Federal Business Opportunities website at: http://www.fedbizopps.gov.  No paper copies will be available.  Offerors are responsible for downloading their own copy of the solicitation and amendments that may be issued by the Government.  Proposals will be due on or about January 12, 2011.  It is anticipated that one or more cost-reimbursement contract awards will be made for a period of five years beginning on or about June 30, 2011.  Contract(s) will be Indefinite Delivery Indefinite Quantity (IDIQ) and the number of interventions to be tested over the contract period is indefinite beyond the 1st intervention. 

This Pre-solicitation notice corresponds to the Small Business Sources Sought notice: #HHS-NIMH-SBSS-10-001 previously posted on August 11, 2010 and Research and Development Sources Sought notice#: HHSNIHNIMHRDSS10024 posted on September 16, 2010.

All responsible sources are encouraged to submit a proposal that will be considered by the NIMH.  This advertisement does not commit the Government to award a contract.

Please contact Marla Jacobson, Contract Specialist at jacobsonmj@mail.nih.gov for further information.