MODIFICATION
R -- "Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)" - Solicitation 1
- Notice Date
- 11/29/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHSNIHNIMH10024
- Archive Date
- 1/28/2011
- Point of Contact
- Marla J. Jacobson, Phone: 3014433775, Bruce E. Anderson, Phone: 3014432234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, ba9i@nih.gov
(jacobsonmj@mail.nih.gov, ba9i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Request for Proposal (Solicitation document) 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHSNIHNIMH10024/listing.html)
- Place of Performance
- Address: None specified, United States
- Record
- SN02334365-W 20101201/101129233802-a748afe505349c4821425bb5311f05bc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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