SOLICITATION NOTICE
A -- PLAQUE REGROWTH STUDY
- Notice Date
- 7/30/2015
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH15R0076
- Response Due
- 8/10/2015
- Archive Date
- 9/28/2015
- Point of Contact
- Katrina Nelson, 301-619-2458
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(katrina.l.nelson19.civ@mail.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- The U.S. Army Institute of Surgical Research (USAISR) Dental and Trauma Research Detachment (DTRD) has a requirement for a short-term, efficacy trial of an anti-plaque chewing gum. Primary outcome measures will focus on reduction of dental plaque growth. The projected sample size is 30 healthy subjects across three arms: placebo, single dose, and multiple (2) doses over a four-day time period. At present, the Army has an existing IND 77532 for performing Phase I (safety) and IIa (proof-of-concept efficacy in reducing gingivitis, plaque index, and bleeding on probing) trials. The plaque regrowth study will be submitted and conducted under the current IND using the same investigational product described in the IND. Activities described in this Performance Work Statement include clinical document development, project management, clinical trial monitoring, U.S. Food and Drug Administration (FDA) regulatory support needed to update the new protocol to the existing IND, and statistical analyses and support for the trial.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH15R0076/listing.html)
- Place of Performance
- Address: United States Army Medical Research Acquisition Activity 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03817483-W 20150801/150731000238-733f8de443c5e00571d929a00da8c433 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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