SPECIAL NOTICE
R -- Audit Services - Special Notice-Synopsis
- Notice Date
- 5/12/2017
- Notice Type
- Special Notice
- NAICS
- 541618
— Other Management Consulting Services
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Acquisitions Management, Contracts, & Grants (AMCG), Office of the Assistant Secretary for Preparedness & Response (ASPR), Department of Health and Human Services, 330 Independence Ave. SW, G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- BARDA-RQA-17_AuditSvs
- Archive Date
- 6/14/2017
- Point of Contact
- Sherica Teshome, Phone: 202-205-5919, Kyle Roberts, Phone: 202-260-0747
- E-Mail Address
-
sherica.teshome@hhs.gov, kyle.roberts@hhs.gov
(sherica.teshome@hhs.gov, kyle.roberts@hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Special Notice No.: BARDA-RQA-17_AUDIT SERVICES The United States Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response(ASPR), Biomedical Advanced Research and Development Authority (BARDA), Regulatory Quality Affairs (RQA) Division seeks to establish a network of GXP (GMP, GLP, GCP) auditing services that supplements quality oversight for the development, acquisition, stockpiling and use of medical products that are needed to effectively respond to a variety of high-consequence public health emergencies, whether naturally occurring or intentional. The mission and priorities of the PHEMCE are articulated in the PHEMCE SIP https://www.phe.gov. The Pandemic and All-Hazards Preparedness Act, signed into law on December 19, 2006, and reauthorized in March 2013, codifies HHS as the lead of Federal public health and medical response to public health emergencies and National Response Plan incidents and specified that one of the duties of the HHS Assistant Secretary for Preparedness and Response is to oversee advanced research, development, and procurement of qualified countermeasures and qualified pandemic or epidemic products. Title III, Enhancing Medical Countermeasure Review and Title IV, Accelerating Medical Countermeasure Advanced Research and Development calls for the successful lifecycle management of medical countermeasure through development, acquisition, stockpiling and use. This acquisition is for audit services to work with RQA and BARDA partners in industry and academia, and regulatory agencies like FDA to help minimize the inherent risks with development, regulatory review, and approval processes. Medical countermeasures could be biological products, devices, drugs or combination products. The development and regulatory process would be under the requirements of the Food, Drug and Cosmetic Act and Public Health Service Act as well as the amendments, regulations, and applicable guidance(s) to that Act. SEE ATTACHED
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/BARDA-RQA-17_AuditSvs/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, 330 Independence Avenue, S.W., Suite G640, Washington, District of Columbia, 20201, United States
- Zip Code: 20201
- Zip Code: 20201
- Record
- SN04506529-W 20170514/170512234613-ed8a11076db2197780b1448f34dbf015 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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