SOURCES SOUGHT
R -- Unapproved Dug Products Drug Efficacy Study
- Notice Date
- 6/28/2007
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-FDA1031337
- Response Due
- 7/12/2007
- Archive Date
- 7/27/2007
- Description
- This is a Sources Sought announcement to seek potential vendors that could fulfill this requirement for Center for the Drug Evaluation and Research (US FDA). The objective of this Sources Sought announcement is to obtain capabilities statements, based on the requirements outlined in the requirements stated in this document,from all interested businesses (large and small). The applicable NAICS code is 541690 Other Scientific and Technical Consulting Services and the size standard is $6.5M. Statement of Services Required Being Sought The ?VENDOR?has specialized knowledge, expertise, and extensive experience in the following: ? The Drug Efficacy Study Implementation program (DESI); and experience working with the Center of Medicare and Medicaid Services (CMS) and the FDA. ? Resolving scientific and administrative issues pertaining to DESI drug products. ? Reviewing and updating the list of DESI less-than-effective (LTE)/identical, related or similar (IRS) drugs provided quarterly by CMS ? Providing expert witness support in regard to disallowance of DESI LTE/IRS drug product reimbursement under state Medicaid programs and how IRS determinations are made. ? Developing, compiling, and updating the ?Compliance Report of Unapproved Products Sorted by DESI Compliance Codes.? ? Determining drug status as it relates to DESI and pre-1938/pre-1962 drug issues. ? Providing information to CMS, the Office of the Inspector General, state Medicaid offices, state agencies, drug firms, third party drug plans, private database firms, the Veterans Administration, and practicing pharmacists concerning DESI, pre-1938/pre-1962 drug issues, and CMS reimbursement and drug rebate issues. ? Classifying DESI/LTE or DESI/IRS drug products with the referenced justification why a drug product was evaluated as LTE or why a drug product is IRS to a DESI/LTE drug product. ? Interpreting DESI codes and determine correct code for the firm?s drug products. ? Using various tools, methods, and processes in order to identify all marketed drug products, including those not in the DRLS data base, in order to insure regulatory listing requirements and to expand its drug intelligence. ? Using of CDER?s Drug Registration and Listing System (DRLS) database ? ? Developing and recommending strategies to identify, notify, and take regulatory action against firms that use the National Drug Code (NDC) numbers improperly. ? Interpreting the Drug Listing Act (510) and the Drug Registration and listing regulations 21 CFR 207 for all marketed drug products. ? Differentiating drug products from non-drug products (i.e., devices, nutritional supplements, etc). ? Identifying prescription drug products marketed without approved applications and develops enforcement strategies for these products. ? Developing and recommending enforcement strategies for prescription cough cold products that should be marked as Over-the-Counter (OTC) drug products. ? Identifying drug products marketed without approved applications or that do not comply with OTC monographs both in conventional and extended release dosage forms and develops enforcement strategies for these products. ? Identifying non-drug products from the Drug Listing Database and remove them from the database. ? Identifying universe of unapproved drug products and DESI drug products. Additional Knowledge / Experience Requirements Understanding the Federal Food, Drug, and Cosmetic Act, Title 21, Code of Federal Regulations and policies and guidelines applicable to the Drug Efficacy Study Implementation program in order to make determinations as to whether a drug product is identical, related, or similar to a DESI drug product Has comprehensive knowledge of the Centers for Medicare & Medicaid Services regulations and policies on their reimbursement and Drug Rebate programs, and Medicare Part D program. Has comprehensive knowledge of precedents established by prior FDA and CMS actions in similar and related matters and has the ability to apply that knowledge to the issues at hand. Has comprehensive knowledge of the Drug Listing Act and its regulation. Responses to this Sources Sought will assist the Government in determining the acquisition strategy. All interested businesses are hereby invited to submit a capabilities statement of no more than 10 pages. The capabilities statement should be tailored to this request and specifically address the company's capabilities to provide the services outlined in the SOW. The statement should also include information on corporate experience on programs of similar size and scope. The response should include past performance information including (1) Contract Name; (2) Point of Contact (POC); (3) Phone Number; (4) email address; and, (5) Description of Services Provided. The response should address basic corporate information including annual gross revenue, number of employees in the company, number of years in business, and the primary focus of the business and associated NAICS code(s). The cover letter submitted in response to this request should include the following information: (1) Company Name; (2) Primary Point of Contact; (3) Address; (4) Telephone Number; (5) Fax Number; (6) E-mail address for POC; and, (7) Interest as Prime Contractor or Subcontractor. The cover letter should also indicate the Socioeconomic status of the company as one or more of the following: (1) small business; (2) 8(a) business; (3) HUBZone small business; (4) small disadvantaged business; (5) woman-owned small business; (6) veteran-owned small business; (7) service-disabled veteran-owned small business; or (8) large business. Please Note: This sources sought notice is not a Request for Quote (RFQ). This sources sought notice is not to be construed as a commitment by the Government to issue a solicitation, to ultimately award a contract, or to otherwise pay for the information solicited herein. Response to this request will not serve as a proposal, bid, or quote, and will not be used by the Government to form a binding contract. Interested parties shall respond with one hard copy of their capabilities statement. The response shall be sent to : Roberta.richardson@fda.hhs.gov or the following address: Food and Drug Administration; 5630 Fishers Lane, HFA -500; Room 2079; Rockville, MD 20857 All responses must be received by 3:00 PM, EST, July 12, 2007.
- Place of Performance
- Address: 11919 Rockville Pike, Rockville, MD
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01330166-W 20070630/070628220658 (fbodaily.com)
- Source
-
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