SOURCES SOUGHT
R -- Strategic Enforcement of Homeopathic Drug Products
- Notice Date
- 4/8/2008
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- FDA-SOL-08-00601
- Point of Contact
- ReginaWilliams,, Phone: (870) 543-7012, Sandra K. Davis,, Phone: (870) 543-7469
- E-Mail Address
-
regina.williams@fda.hhs.gov, sandra.davis@fda.hhs.gov
- Description
- In accordance with FAR 15.201(e), this request is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in the announcement. This is a Sources Sought regarding potential sources. The intent of this Sources Sought announcement is to conduct market research to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, HUBZone, Service-Disabled Veteran Owned, Veteran Owned, Women-Owned) to provide the Food and Administration with Strategic Enforcement of Homeopathic Drug Products. Objectives: FDA wishes to procure services of a professional who has proven experience, expertise, knowledge, and abilities in the following areas: 1. Thorough knowledge of FDA laws, regulations, policies, enforcement procedures, and guidelines applicable in determining the regulatory status of homeopathic drug products. 2. Thorough knowledge of FDA's Compliance Policy Guide 7132.15 entitled "Conditions Under Which Homeopathic Drugs May be Marketed." 3. Experience and knowledge in determining compliance with drug labeling requirements of homeopathic drug products versus conventional OTC and prescription drug products. 4. Experience and knowledge in evaluating active and inactive homeopathic ingredients to determine if they meet scientific and legal standards for marketing. 5. Experience in resolving FDA policy, scientific, and administrative issues pertaining to homeopathic drug products. 6. Experience and knowledge in developing new approaches and policies to resolve new drug and/or misbranding issues when no previous guidance or policy exists. 7. Experience and knowledge in recognizing the need for, and in developing enforcement strategies, based on independent research of new drug and misbranding issues affecting homeopathic drug products. 8. Experience in communicating and drafting responses to inquires from various government agencies, industry, health care professionals and consumers to answer questions and to resolve compliance issues relating to homeopathic drug products. Statement of Work 1. Suggest compliance and enforcement strategies to resolve FDA policy, scientific, and administrative issues pertaining to the regulation of homeopathic drug products. 2. Provide expertise in interpreting complex and innovative scientific and legal conclusions regarding homeopathic drug products. 3. Provide support for solving complicated administrative and legal problems relating to regulating homeopathic drug products. 4. Provide support in establishing new concepts, and contributing to the drafting and development of policies and procedures relating to the regulation of homeopathic drug products. 5. Provide expert support in communicating and drafting responses to inquiries from various government agencies, industry, health care professionals and consumer on compliance and enforcement issues relating to homeopathic drug products. 6. Provide research and expert consultation to the Office of Compliance and others within FDA as needed on specific issues relating to homeopathic drug products. We anticipate awarding a contract for 1 base year plus four (4) option years. This is a new requirement. The applicable North American Industry Classification System (NAICS) Code is 541990 with a size standard of $6.5 million. Interested Contractors must demonstrate their experience and capability by submitting a capability statement addressing their experience, expertise, knowledge and abilities and include the following: Company name and address, phone number, point of contact, email address, business size, solicitation number and identify references directly related to the SOW. Capability statements are due April 18, 2008, by 15:00 hours (Central Time in Jefferson, Arkansas) by postal mail, fax, or email to the Food and Drug Administration, Office of Field Financial and Acquisition Services, Attn: Regina Williams, HFT-320, 3900 NCTR Road, Jefferson, AR 72079.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=5f75cceb666afdf87d06e7af23ac1c66&tab=core&_cview=1)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Springs, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01549368-W 20080410/080408221730-5f75cceb666afdf87d06e7af23ac1c66 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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