MODIFICATION
R -- Presolicitation Notice: Research Acquisition Specialist Personnel
- Notice Date
- 6/19/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- ACC-APG - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-13-R-0072
- Response Due
- 6/28/2013
- Archive Date
- 8/18/2013
- Point of Contact
- John Conlin, 508-233-6164
- E-Mail Address
-
ACC-APG - Natick (SPS)
(john.conlin3.civ@mail.mil)
- Small Business Set-Aside
- Total Small Business
- Description
- ***Update 19 June 2013- The Government plans to issue an RFP no earlier than 28 June 2013. Once the RFP is released, instructions for obtaining it will be posted to this announcement. Please feel free to contact John Conlin with any questions (john.conlin3.civ@mail.mil, 508-233-6164) ----------------------- ***Update 11 June 2013- The Government plans to issue an RFP no earlier than 21 June 2013. Once the RFP is released, instructions for obtaining it will be posted to this announcement. Please feel free to contact John Conlin with any questions (john.conlin3.civ@mail.mil, 508-233-6164) ----------------------- SUMMARY This is a notice of a proposed contract action issued in accordance with Federal Acquisition Regulation (FAR) 5.203(a). The Government intends to issue a solicitation and award up to 1 contract for the services described below. This acquisition is set aside 100% for small businesses, as defined below. This notice is not a solicitation; information on release of the solicitation is provided below. The Government will use the procedures of FAR Part 12 quote mark Acquisition of Commercial Items quote mark for this acquisition. BACKGROUND The Naval Health Research Center (NHRC) conducts Navy Medicine Research and includes subject areas such as: (1) combat casualty care research, including traumatic brain injury, posttraumatic stress disorder, wounds from improvised explosive devices, etc.; (2) non-communicable disease research, including cancer research; and (3) infectious disease research, including respiratory or enteric disease research. NHRC performs both intramural and extramural research, the latter meaning that the work must be outsourced or contracted out to industry or academia performers. Therefore, NHRC is in need of Research Acquisition Specialist (RAS) contractor personnel who understand the aforementioned subject areas significantly enough to act on the relevant regulations and statute but can also translate the requirements of these subject areas into meaningful acquisition documents that a Contracting Officer can execute on. Of particular concern is that the RAS is knowledgeable of, experienced with, and can successfully act on regulations, statutes, and protocols such as those relevant to the FDA clinical trial process, which may include human use and/or animal use. REQUIREMENT AND TYPE OF SERVICE The RAS must be able to develop and administer acquisition documents containing human-use requirements. A contract action that involves human-use research does require assurance certification by the contractor performer. Any contract that does require research on human subjects requires that the DoD component be responsible for contractor oversight of compliance with 32 CFR Part 219, Protection of Human Subjects; and that the Government personnel responsible for such oversight is the client's Human Research Protection Official as defined by DFAR S 252.235-7004, Protection of Human Subjects. The RAS must be at a level of qualification sufficiently enough to support these Government representatives through the development and administration of acquisition documents. All research needs to be determined to be compliant with Federal and DoD regulations for protecting human subjects. All studies similarly need to be compliant with the requirements of the Health Information Portability and Accountability Act (HIPAA) Privacy Rule. Further, evolving human-subject protection regulations need to be investigated and training plans developed to educate researchers as to their human subject responsibilities. Contractor performers shall support Institutional Review Board (IRB) functions and HIPAA Privacy Office functions by reviewing all agency studies, including those in the areas of medical resource planning, enhancing performance during shipboard and ground operations, investigating and monitoring disease incidence among military personnel, development of computer systems for monitoring the physiologic status of individual patients, clinical research studies, survey administration efforts, and evaluating physiological effects of various agents found in military operational environments. Such support shall include analyzing research protocols to determine compliance with relevant human subject protection regulations and drafting administrative correspondence detailing review proceedings and findings. Support shall also include development of educational materials, monitoring of research, and database development for tracking of research protocols. Therefore, the RAS must be able to understand the aforementioned and act on such. A contract action that involves animal use does require assurance and accreditation by the contractor performer. Any contract that does require the use of animals in research shall be compliant with all applicable Federal and DoD regulations, specifically including 7 U.S.C. 2131 et. Seq. and 9 CFR 1-4, quote mark Animal Welfare Act quote mark ; DoDI 3216.01, quote mark Use of Animals in DoD Programs quote mark ; and specific DoD component management plans. Evolving animal use and care regulations need to be investigated and training plans developed to educate researchers regarding their animal use and care responsibilities. Contractor performers shall support Institutional Animal Care and Use Committee (IACUC) functions and comply with any procedures required for IACUC approval, including research protocol submission, Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation, DHHS Office of Laboratory Animal Welfare (OLAW) assurance, and USDA site inspections. Therefore, the RAS must be able to understand the aforementioned and act on such. There are many more regulations, statutes, and protocols within the medicine research sector that the RAS must be able to comprehend sufficiently enough to assure that all necessary provisions are included in the acquisition documents and that that contract administration is of sufficient caliber to assure that these medical research regulations, statutes, and protocols are being adhered to by the contractor performer. Such services are non-personal in nature and do not include inherently Governmental duties. RELEASE OF SOLICITATION The Government will set aside the entire requirement for small business concerns. The applicable NAICS code for this requirement is 541611 quote mark Administrative Management and General Management Consulting Services, quote mark which has a size standard of $7,000,000 in annual receipts. Concerns with annual receipts less than or equal to $7,000,000 will be considered small businesses for this acquisition. The Government intends to issue a Request for Proposals (RFP) no earlier than 21 June 2013. Proposals will be due 30 calendar days following release of the RFP. The Government will only consider proposals offered from responsible small businesses. The Government intends to award no more than 1 firm fixed priced, indefinite delivery/indefinite quantity contract with a term of 36 months using the procedures of FAR Part 12 quote mark Acquisition of Commercial Items. quote mark QUESTIONS Questions about this acquisition may be directed to John Conlin (john.conlin3.civ@mail.mil, 508-233-6164)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/52edc8002643446a846ee0d9ab948036)
- Place of Performance
- Address: ACC-APG - Natick Contracting Division ATTN: ACC-APG, Natick Contracting Division, Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN03093301-W 20130621/130619235530-52edc8002643446a846ee0d9ab948036 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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