SOURCES SOUGHT
R -- Drug Product Content Management (Best Practices)
- Notice Date
- 5/8/2009
- Notice Type
- Synopsis
- NAICS
- 511140
— Directory and Mailing List Publishers
- Contracting Office
- 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1056057-09
- Response Due
- 5/14/2009
- Point of Contact
- Patricia Wright, Contract Specialist, Phone 301-827-7217, Fax 301-827-7151
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses to provide services for the project titled: Drug Product Content Risk Management and Surveillance (DCRMS) The NAICS Code is 511140. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to provide the required services. The FDA needs drug data content management support because it has neither the expertise nor the skills to maintain content at the optimal accuracy, comprehensiveness, and timeliness to support its needs. The FDA currently does not have access to thousands of unlisted products on the market, so it cannot confront establishments regarding the drugs they do not list. Thousands of commercial [drug content] manager clients and customers, including government drug programs, have access to significantly more complete drug product content. However, FDA’s current drug registration and listing system, DRLS, is incomplete and inaccurate. The FDA will soon replace the Drug Registration and Listing System (DRLS), which requires establishments to submit paper forms 2656 and 2657 to register and list (R&L). A system that will allow establishments to R&L directly by electronic transaction is our goal. The Food and Drug Administration (FDA) requires establishments to register and list their drugs (21 CFR 207). The Drug Registration and Listing System (DRLS) serves as the repository of registered drug establishments and their listed drug products. 21 CFR 207 instructs industry to use Forms 2656 and 2657 to register and list, and considers unlisted drugs to be “misbranded.” Non-compliant firms may be subject to criminal or regulatory action. Years of industry non-compliance have taken their toll. The Health and Human Services Office of the Inspector General (OIG) found numerous discrepancies in DRLS content as compared to that of a private industry drug product database. Over 36% of DRLS’ drug product listings were no longer on the market. Many drug products on the market were not listed in DRLS. OIG concluded that FDA should routinely compare their drug product list with a commercial database to identify drugs that have not been listed and drugs which have been taken off the market. Today, leadership among this group of private drug product databases boasts quality [accuracy and completeness] at the six sigma level1. These are industry’s best practices group. Establishments must register under the new electronic system and relist all of their drug products. But as the IG suggested, FDA neither has the expertise or the staff to manage accurate drug product content. We seek to contract this and other services to a firm that maintains its own up to date list of accurate and complete drug products to insure FDA knows which drug products on the market have not been listed, and to provide its expertise, experience and professional resources to provide quality control for drug product content, labeling review, and other services to monitor compliance with FDA requirements. Drug Registration and Listing (DRLS) provides the following or is critical for a number of FDA and other Government Programs:  locations for foreign & domestic establishments and ingredient information on all drugs  information for initial establishment inspections (Sec 704)  products affiliated with sites used in Risk Models guiding selection of GMP and ADE inspections  information on drug products identical, related, or similar to DESI and NDA/ANDA drugs  information that may be useful in identifying counterfeit, stolen, or diverted drugs.  a searchable data base to accomplish establishment and drug research.  a means by which to code unlisted drug products identified through external sources  Imports – In daily use at the Port Authority, officials use the DRLS database “Import Query” portal to determine if the foreign-made product is listed and has a [legitimate] NDC number (21 CFR 207.40 (b). Includes finished dose products, API’s, investigational drugs, homeopathics, OTCs, and veterinarian products.  Centers for Medicaid/Medicare Services (CMS) – These government drug programs refer to DRLS and are the most adversely affected by inaccurate content on an almost daily basis and through the expertise/consultation of DRLS data base management services as an advisory, acquire information essential to enforcing their drug reimbursement policies.  The Office of Compliance and other FDA activities depend on the DRLS database for high profile programs that depend on data base extractions and reports are the Risk Management Survey Samples, DQRS, ADE inspections, and the Unapproved Universe Problem Solving Working Group.  DEA – Refers to the DRLS as an adjunct to other policy guidance to determine which drugs are controlled substances and how they are classified (schedule assignment). Note: With no professional oversight for label review at DRLS, we rely on the manufacturer’s determination regarding controlled substances designation.  NIH – Utilizes DRLS for research purpose. They have recently requested additional information on all drug history including OTCs and homeopathic  VA and DoD Tricare Drug Programs – Recent focus on unapproved drugs has resulted in interest from other government agencies with formulary programs that will refer to the DRLS in the future to assist in determining candidate drug products that qualify for formulary inclusion.  Commercial drug database vendors frequently update their own databases by down-loading FDA approved drugs from the NDC Directory.  Standard-Making Organizations – National Provider Organizations (NPOs) such as NCPDP download from the NDC Directory to gather data to support national standard initiatives (HIPAA, Drug Protocols for Reimbursement).  Pharmaceutical Manufacturers, Distributors (Wholesalers, etc), pharmacies and pharmacy chains download NDC Directory data for various purposes to verify drug listing info and to gain advantage in the marketplace.  Import Agents and Mediators – access DRLS data base to verify drug listing data The primary objectives to be accomplished under this contract include: To provide the support necessary to maintain a high degree of accuracy and completeness of drug products entered and listed in DRLS and eLIST. With this focus, the FDA will make strides toward establishing itself along with private drug product databases, as an accurate and comprehensive source for prescription and over-the-counter (OTC) drugs on the US market. Also, FDA will have at its disposal a consistent source of expertise and skills to identify and manage not only listed drug products, but have substantial information on all drug products on the US market. Responses to this notice shall be limited to 15 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS xxxxxx (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice 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 this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received to the attention: Patricia Wright, email: patricia.wright@fda.hhs.gov not later than 4:30 PM Eastern Standard time on May 14, 2009 for consideration. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-MAY-2009); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1056057-09/listing.html)
- Record
- SN01812578-F 20090510/090509165619 (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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