SPECIAL NOTICE
B -- Notice of Intent to Sole Source: Statistical Analysis Support
- Notice Date
- 7/28/2021 5:37:10 AM
- Notice Type
- Special Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES (USUHS)
- ZIP Code
- 00000
- Response Due
- 8/12/2021 9:00:00 AM
- Archive Date
- 08/27/2021
- Point of Contact
- Rebecca Mashek, Jenniffer Vazquez
- E-Mail Address
-
rebecca.mashek.ctr@usuhs.edu, jenniffer.vazquez@usuhs.edu
(rebecca.mashek.ctr@usuhs.edu, jenniffer.vazquez@usuhs.edu)
- Description
- The Uniformed Services University of the Health Sciences (USU) is the Nation's federal health sciences university and is committed to excellence in military medicine and public health during peace and war. We provide the Nation with health professionals dedicated to career service in the Department of Defense and the United States Public Health Service and with scientists who serve the common good. We serve the uniformed services and the Nation as an outstanding academic health sciences center with a worldwide perspective for education, research, service, and consultation; we are unique in relating these activities to military medicine, disaster medicine, and military medical readiness. USU is located in Bethesda, MD on the grounds of the Naval Support Activity Bethesda. The mission of the USU is to provide the highest quality education programs in the health sciences to those selected individuals who demonstrate dedication to a health profession career in the Uniformed Services. Intent to Sole-Source: USU intends to award a sole-source, firm-fixed-price contract to STATKING Clinical Services for the Statistical review for study design and statistical methodology for 17 protocols required for approval of SavvyCheckTM Vaginal Yeast Test. Intended Recipient: STATKING Clinical Services, 759 Wessel Drive Suite 6, Fairfield, OH 45014 USA Sole Source Justification: Statistical support in the form of analytical validation testing to aid the final, FDA 510K Medical Device Submission for approval of over-the-counter use of their vulvovaginal candidiasis self-test kit for military women must be provided by STATKING Clinical Services since the company is the only vendor that is capable of meeting the needs of the government. The requirement will be procured in accordance with the procedures of FAR Part 13.106-1(b)(1)(i). Please see attached Notice of Intent to Sole Source for full details.�
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/0c74935f67bf49f7948f2ea92381ee61/view)
- Place of Performance
- Address: Bethesda, MD 20814, USA
- Zip Code: 20814
- Country: USA
- Zip Code: 20814
- Record
- SN06075953-F 20210730/210728230106 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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