SOURCES SOUGHT
B -- Quality Audit Services - ASPR/BARDA - Sources Sought Notice
- Notice Date
- 5/20/2016
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical 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
- 16-BARDA-RQA_QualityAuditServices
- Archive Date
- 6/18/2016
- Point of Contact
- Sherica Teshome, Phone: 2022055919, Kevin Nilles, Phone: 2022601457
- E-Mail Address
-
sherica.teshome@hhs.gov, kevin.nilles@hhs.gov
(sherica.teshome@hhs.gov, kevin.nilles@hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice No.: 16-BARDA-RQA_Quality Audit Services SMALL BUSIENSS SOURCES SOUGHT NOTICE DATE: May 20, 2016 TITLE: Quality Audit Services - ASPR/BARDA NOTICE No. 16-BARDA-RQA_Quality Audit Services INTRODUCTION The Government is seeking qualified small business concerns and seeks to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUB Zone, service-disabled, veteran-owned, 8(a), woman-owned small businesses, or small disadvantaged businesses; and (3) size classification relative to the North American Industry Classification System (NAICS) code 541690. Your response to the information requested will assist the Government in determining the appropriate acquisition strategy, including whether a small business set-aside is a possibility. This Sources Sought Notice (SSN) is not a Request for Proposal (RFP) and does not constitute a commitment by the United States Government (USG). The USG is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential small business sources to fulfill the requirement and gather information on current capabilities within the market. All information submitted in response to this sources sought notice is voluntary and the USG will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the USG. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the USG and will not be returned. BACKGROUND The Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) requires quality oversight through the Division Regulatory and Quality Affairs (RQA) for the development, acquisition, stockpiling and the use of medical products that are needed to effectively respond to variety of high-consequences public health emergencies, whether naturally occurring or intentional. The mission and priorities of the HHS Public Health Emergency Medical Countermeasures, Enterprise (PHEMCE) are articulated in the PHEMCE Strategy Implementation Plan (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. To that end, RQA will work with regulatory agencies like the FDA and BARDA, partners in industry and academia, to help minimize the inherent risks with development, regulatory review and approval processes. Medical countermeasures could be a biological product, device, drug or a combination product. The development and regulatory process would be under the requirements of the Food and Drug Act and the amendments, regulations, and applicable guidance(s) to that Act. Biological and combination biological products will also be under the requirements of the Public Health Service Act amendments, regulations and applicable guidance (s) to the Act. REQUIREMENT The Office of the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) intends to use responses to this Small Business Sources Sought Notice (SBSSN) for planning purposes towards the future requirement of services from technical consultants providing audit services. This notice seeks organizations that are capable conducting audit services covering end to end lifecycle of pharmaceutical products (drugs, biologics, devices and combination products regulated by the Food and Drug Administration). There are a number of audit types, which are noted as GXP; specific audits include but are not limited to: • Good Manufacturing Practices (GMP), • Good Tissue Practices (GTP) • Good Laboratory Practices (GLP) • Good Clinical Practices (GLP) • Quality Systems • Logistics BARDA requires quality oversight through the Division Regulatory and Quality Affairs (RQA) for the development, acquisition, stockpiling and the use of medical products that are needed to effectively respond to variety of high-consequences public health emergencies, whether naturally occurring or intentional. BARDA will not award any contracts under this Notice, but rather availabilities, capabilities, and other pertinent marketplace data to strengthen BARDA's understanding of the current and future marketplace, enhance its ability to obtain quality services economically, efficiently and lawfully and establish potential vendor source files and listings. The USG seeks an organization with access to highly qualified people with extensive experience, proven track record in auditing for compliance to GXP, and a proven record of achieving successful results with quality and compliance. The USG seeks an organization that has a proven record of identification of gaps in GXP compliance audits and recommendations of best practices for successful quality and compliance. The USG seeks an organization that has a proven record of identification of risks and is able to assess risk -based plans and make recommendation for avoiding, managing, and /or mitigating risks. The USG seeks an organization that has a proven record of interacting with other contractors in a supportive and mentoring manner while identifying quality and compliance gaps. The USG seeks an organization that has a proven record of identification of gaps in Quality Systems such as Deviation and Investigation, Corrective and Preventive Action, and Change Control as well as experience in recommending best practices. The USG seeks an organization that will have availability to perform a quality compliance audit within 30 days' notice and provide a written report within 15 days of the completion of the audit. The USG seeks an organization that can provide highly qualified personnel experienced with aseptic processing that may serve as a quality auditor in plant as needed and can comply with dress (gowning) requirements for up to Biosafety Level 2. In all cases described above, the USG seeks organization with the availability and capability to perform regulatory and compliance audits to assess compliance to Food, Drug and Cosmetic Act (FDCA) and Public Health Service (PHS Act, the Code of Federal Regulations (CFR), BARDA Standard Operating Procedures (SOPs), and policies. *Please note that potential offerors are expected to be independently proficient or have access to experts proficient in all areas mentioned above. The following outline shall be used in the response document: 1) Capability to perform quality audits in compliance with the FDCA and PHS Act for the development, manufacturing and stockpiling of medical countermeasures. The USG seeks to conduct work in accordance with all applicable Federal, state and local laws, codes, ordinances and regulations (or if foreign, equivalent regulatory oversight). 2) Capability to perform GXP compliance audits in compliance to 21 CFR 210, 211 Current Good Manufacturing Practices, 21 CFR 58, Good Laboratory Practices, 21 CFR 312 Investigational New Products and 21 CFR 820, Quality Systems Regulations and foreign regulations as applicable, all relevant guidance documents and recommend best practices for successful quality and compliance. 3) Available to perform a quality compliance audit within 30 days' notice and provide a written report within 15 days of the completion of the audit. 4) Capabilities to assess risk management plans and identify risks and make recommendations for avoiding, managing or mitigating risks. 5) Capability to interact in a supportive and mentoring manner during the performance of regulatory audits. 6) Evidence to evaluate quality systems such as Deviation and Investigation Management, Corrective Action and Preventive Action, and Change Control. 7) Evidence to support GXP capability and experience (List number and type of compliance audits conducted in the past three years). 8) List of proposed staff (Subject matter in aseptic processing, risk management, quality systems, GXP, and Organizational Chart). In all cases described above, the USG seeks an organization with highly qualified and experienced professionals to conduct regulatory compliance audits as needed to assess compliance and regulatory gaps to GXP regulations and recommend best practices to the lifecycle management of medical countermeasure used for stockpiling, delivery and use. Respondents to this sources sought notice may identify their interest by submitting a capability statement, including primary contact information at the organization (name, email, address and telephone number) handling this sources sought notice, in the event HHS has additional questions or requires clarification of the submitted information. Responses are limited to 15 pages including appendices and attachments. All respondents and comments to this sources sought notice shall reference HHS-BARDA-Sources Sought - Audit Capability. Respondents shall provide capability statements and all information, data, and materials in Microsoft Office ®, or Adobe® Acrobat® format, no later than: 4:00 PM EST on Friday June 3, 2016 Capability packages shall be submitted to the following: Sherica Teshome, Contracting Officer, Sherica.Teshome@hhs.gov and Kevin Nilles, Contracting Officer, Kevin.Nilles@hhs.gov OTHER INFORMATION ASPR/BARDA encourages respondents to submit currently available marketing or extant information, or to notify ASPR/BARDA of the publicly available location; thereof to the maximum extent consistent with this notice's requirements and limitations. Respondents shall mark confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends. ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an "unlimited rights" license, as FAR subpart 27.4 defines that term, and ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials. DISCLAIMER AND IMPORTANT NOTES This Notice does not obligate the Government to award a contract or otherwise pay for information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/16-BARDA-RQA_QualityAuditServices/listing.html)
- Place of Performance
- Address: Washington, District of Columbia, 20201, United States
- Zip Code: 20201
- Zip Code: 20201
- Record
- SN04124138-W 20160522/160520234314-6ae45951580f70d88aecc1099fa8a543 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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