SOURCES SOUGHT
R -- Professional Services in support of the CDER Office of Compliance Import Safety Initiatives
- Notice Date
- 7/25/2008
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- RFI-1041620
- Archive Date
- 8/16/2008
- Point of Contact
- Barbara J Arnold,, Phone: (870) 543-7483
- E-Mail Address
-
barbara.arnold@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- In accordance with FAR 15.201(e), this request is for Market Research 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 Drug Administration with Professional Services in support of the CDER Office of Compliance Import Safety Initiatives. Background: CDER, Office of Compliance is assessing its drug import operational activities, and is developing various risk-based initiative(s) for implementation to promote, assure, and enhance the safety of imported drugs. The projects and initiatives may be in the form of a program, guidance, agreement and/or plan. Some of these projects include: •Initiation of a Secure Supply Chain (SSC) Pilot Program. Create incentives for drug manufacturers to develop secure routes to import finished drugs and active pharmaceutical ingredients (APIs) and allow FDA field personnel to focus on drugs imported via less secure supply routes to prevent the importation of diverted and counterfeit drugs. •Issuing for comment of draft guidances on import designed to increase safety, efficacy, quality and purity of imported drugs. Draft guidances intend to describe FDA’s policy and procedures for manufacturers seeking to import drugs, to increase compliance with requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) for imported drugs, and to allow FDA to focus resources on high-risk 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 related to the import and export of drugs including but not limited to definitions, section 201 of the Federal Food, Drug and Cosmetic Act (FDCA); adulterated drugs, section 501 of FDCA; misbranded drugs, section 502 of FDCA; new drugs, section 505 of FDCA; registration and listing section 510 of FDCA; imports and exports, section 801 of FDCA; export of unapproved drugs, section 802 of FDCA; the importation of prescription drugs, section 804 of FDCA; and FDA Guidance for Industry on Exports and Imports established under the FDA Export Reform and Enhancement Act of 1996. (2) Reviewing and drafting comments on proposed legislation impacting drug importation. (3) Developing, drafting, reviewing, and updating import and export guidance documents, and other import plans or projects. (4) Determining, in an expedited manner, the regulatory status and appropriate enforcement actions concerning drugs detained by field offices. (5) Resolving FDA policy, regulatory, scientific, and administrative issues pertaining to imported and exported drug products. (6) Knowledge and experience working with US Customs and Border Protection laws and regulations related to drug products. (7) Drafting and reviewing drug import alerts and bulletins. (8) Thorough knowledge of FDA’s Personal Importation Policy (PIP) as well as experience determining whether the importation of specific unapproved new drugs is consistent and appropriate with this policy. (9) Resolving complex regulatory issues concerning the export of unapproved new drugs; (10) Reviewing and drafting comments on draft guidance, regulations, and policies that could significantly impact import or export activities. i.Experience providing consistent and uniform guidance to FDA and CDER personnel on drug import laws and regulations. ii. Experience and knowledge in developing new approaches and policies to resolve drug importation issues when no previous guidance or policy exists. iii. Experience in communicating and drafting responses to inquiries from various government agencies, industry, health care professionals, and consumers to answer questions and to resolve compliance issues relating to the import and export of drugs. Description of Work The contractor will design, develop and ready for implementation each of the initiative(s) to meet and reflect the import safety needs and the items identified under each initiative so that the initiative is ready for implementation. (1) Initiate and ready for implementation the SSC pilot program. Review and evaluate comments received on the SSC pilot program. (2) Assist with the preparation and issuance for comment of draft guidances on import designed to increase safety, efficacy, quality and purity of imported drugs. Review and evaluate comments received on draft guidances. Assist with the preparation and issuance of the final guidances. (3) Provide support in establishing new concepts, and contributing to the drafting, development, and implementation of policies, procedures, and guidance relating to the import/export of drugs, including Good Importer Practices, pandemic influenza, and agreements with other countries. (4) Suggest compliance and enforcement strategies to resolve FDA policy, scientific, and administrative issues pertaining to the import/export of drugs. (5) Provides expertise in interpreting complex and innovative scientific and legal conclusions regarding the import/export of drugs. (6) Provide support for solving complicated administrative and legal problems relating to import/export of drugs. (7) 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 the import/export of drugs. (8) Provide research and expert consultation to the Office of Compliance and others within the FDA as needed on specific issues relating to the import/export of drugs. 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 August 1, 2008, by 3:00 PM (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: Barbara J. Arnold, HFT-320, 3900 NCTR Road, Jefferson, AR 72079.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1c00fe5cccdf82af97b202f960b4e0c8&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
- SN01623681-W 20080727/080725224320-1c00fe5cccdf82af97b202f960b4e0c8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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