SOLICITATION NOTICE
R -- Regulatory Affairs Support Services
- Notice Date
- 5/18/2010
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-R-0126
- Response Due
- 6/2/2010
- Archive Date
- 8/1/2010
- Point of Contact
- lisa.trott, 301-619-2212
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(lisa.trott@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Preparation and assembly of Investigational New Drug applications (INDs)/Investigational Device Exemption Applications (IDEs) and IND/IDE related documents; preparation and assembly of Pre-Market Notifications (510 (k)s), Pre-Market Approval applications (PMAs), Biological License Applications (BLA), New Drug Applications (NDAs), Environmental Protection Agency (EPA) registration packages, and related documents; data base management (i.e. electronic cataloging and storage capabilities of INDs, NDAs, IDEs, 510(k)s, PMAs and EPA registration packages); post marketing surveillance for NDAs and PMAs; suitability assessments of data to support regulatory filings; audit capability encompassing clinical trials, preclinical trials, assay development and validation, and product manufacturing to include compliance with current Good Clinical Practices (cGCP), current Good Laboratory Practices (cGLP), and current Good Manufacturing Practices (cGMP); capable of Common Technical Data (CTD) packages and/or electronic Technical Data Packages (eCTD); capable of in-house eCTD Readiness and Document Processing by demonstrating the ability to convert paper documents to electronic documents regarding compliance to the latest e-Submission requirements; possess a proven track record of successful submission through to the FDA; support all lifecycle management of eINDs through NDA or BLA submission; provide all documents to the Government eSubmission ready; support a secure collaborative website for the exchange of eSubmissions and collaborative work groups; and compliance with all CFR and FDA guidelines. Place of performance is both on and off a Government Facility. This action is unrestricted and will not be set-aside. The NAICS is 541990. The Government anticipates a single Firm Fixed Price award of a 1-year base period with 4 one-year options. Tasks will be directed by individually issued Task Orders; more than one Task Order may be issued concurrently. Estimated date of award is 1 September 2010. Total IDIQ contract is estimated at $32,000,000.00 for five years if option periods are exercised. This will be a performance-based statement of work; evaluation will be on a Best Value basis. Incumbent contractor: Science Applications International Corporation, Maryland. All offerors must provide a written technical proposal discussing specified technical evaluation factors. The solicitation is expected to be issued on or around 17 June 2010 and will close at least 30 days after the issuance date. Those interested in obtaining the solicitation should download it from the United States Army Medical Acquisition Activity (USAMRAA) homepage: www.usamraa.army.mil and click on Solicitation W81XWH-10-R-0126. Solicitation will be issued in electronic format only; requests by phone will not be accepted. All responsible sources may submit a proposal. No solicitations will be provided by hard copy, fax, or e-mail. All offerors are responsible for checking for amendments to the solicitation from the Internet. It is the responsibility of the recipient to ensure that the RFP is received from the Internet accurately and in its entirety. Offerors must be registered with Central Contractor Registration (CCR) (www.ccr.gov) in order to be eligible to receive an award from this solicitation. Call 1-888-227-2423 for more information or visit the CCR website at http://www.ccr.gov. Offerors must complete the on-line representations and certifications located at http://orca.bpn.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-R-0126/listing.html)
- Place of Performance
- Address: US Army Medical Material Development Agency 1430 Veterans Drive Fort Detrick MD
- Zip Code: 21702-9232
- Zip Code: 21702-9232
- Record
- SN02152541-W 20100520/100518234825-3db7d2a97be1a7a69e5aa0ffea83d5f8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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