SPECIAL NOTICE
99 -- This is a notice of intent to award a sole-source contract and is not a request for competitive proposals.
- Notice Date
- 3/18/2013
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWHTOPICALCREAM
- Archive Date
- 6/16/2013
- Point of Contact
- Kelly R. Green, 301-619-1346
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(kelly.r.green@det.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The United States Army Medical Research Acquisition Activity intends to solicit a proposal and enter into a contract with PPD, Middleton, WI. The statutory authority for this sole-source is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1(a)(2)(iii). The NAICS code for this action is 325412. This requirement is for continued stability testing of existing lots of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Alone. Testing will be conducted with existing PPD Methods (Numbers M2079.03, M7067.00, and M7068.01) in accordance with the PWS. Microbial limit and viscosity testing will be performed at each time point. Stability testing of current lots of product must be continued as long as the product is being used in clinical investigations. Complete stability data packages on all lots of product used in clinical investigations will be submitted to the US Food and Drug Administration (FDA) for the New Drug Application (NDA). It is paramount that the data be consistently collected from a single source using the same test methods. The required testing is currently projected for 24 months, however, an additional 12 months may be required if clinical investigations are not completed on time. Stability data that is available to date has been submitted to FDA for evaluation. Based on preliminary communication, the Agency indicated they may request further characterization of the impurities identified during stability testing, which may warrant the characterization of the active pharmaceutical ingredients Paromomycin and Gentamicin Sulfate. USAMRAA requires that all contractors doing business with the Acquisition Office must be registered with the SAM and to be eligible to receive an award from this acquisition office, all offerors must have a DUN & Bradstreet Number. A DUN & Bradstreet Number may be acquired free of charge by contacting DUN & Bradstreet on line at https://www.dnb.com or by phone at (800) 333-0505.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWHTOPICALCREAM/listing.html)
- Record
- SN03014691-W 20130320/130318235627-ffc55e6e74c9c69418a57842deaf67d0 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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