MODIFICATION
B -- Unapproved Drug Products Efficay Study
- Notice Date
- 8/17/2007
- Notice Type
- Modification
- 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
- FDA-SOL-07-00323
- Response Due
- 8/17/2007
- Archive Date
- 9/30/2007
- Point of Contact
- Roberta Richardson, Contract Specialist , Phone 301-827-7175, Fax 301-827-7106, - Sharon Bradshaw , Contracting Officer, Phone 301-827-8774, Fax 301-827-7106,
- E-Mail Address
-
roberta.richardson@fda.hhs.gov, Sharon.Bradshaw@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This modification is to upload the soliciation and SF1449 documents. Questions must be submitted in writing to: Roberta.richardson@fda.hhs.gov no later than Aug 31, 2007, at 2:00 PM EST. No phone calls will be accepted The Food and Drug Administration intends to award a Sole Source contract for consultative services to CDER as it relates to Unapproved Drug Products Efficay Studies as referenced in the SOW below.. It is anticipated the one award will be made for a 12 month contract period and two twelve month option periods for a total contract period of 36 (thirty-six) months. A Sources sought notice was posted on Fed Bizz Opps on Jun 28, 2007. The solicitation will be available on or about Aug 17, 2007, on the FedBizOpps website at http://fedbizopps.gov. Prospective Offerors are responsible for downloading the solicitation and amendments. It is the offeror?s responsibility to monitor the FedBizOpps website for release of the solicitation and amendments. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The proposed contract actions are for services for which the Government intends to solicit and negotiate with only one source under authority of FAR 6.302-1. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 15 days from the date of this announcement. A determination by the Government not to compete the proposed contract based on responses from this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be sent via email to Roberta.richardson@fda.hhs.gov and sharon.bradshaw@fda.hhs.gov. No phone calls will be accepted. STATEMENT OF WORK Unapproved Drug Efficacy Studies July 23, 2007 The contractor will independently perform the tasks below: ? Assist in resolving FDA policy, scientific, and administrative issues pertaining to the Drug Efficacy Study Implementation (DESI) Program drug products ? Review and update the list of DESI less-than-effective (LTE)/identical, related or similar (IRS) drugs provided quarterly by CMS to determine if this list is accurate ? Provide support for complex innovative decisions interpreting medical conclusions, solving complicated administrative and legal problems, as well as establishing new concepts, and contributing to the development of policies and procedures. ? Determine legal and regulatory status of these products, if compliance action is needed, and determine their compliance codes to maintain this report. Assist in interpretation of the Drug Listing Act (510) and revision, implementation, and interpretation of the Drug Registration and listing regulations 21 CFR 207 for all marketed drug products ? Provide expertise to various government agencies and public organizations, including the FDA, CMS, Office of the Inspector General, and State agencies, on DESI, unapproved drug products, drug listing, reimbursement, and drug rebates issues. ? Provide expertise testimony witness before government department and agencies regarding the DESI process, how IRS determinations are made, and product reimbursement issues. ? Provides reports and other services to support the government and the public on issues regarding Unapproved Drug Products, associated DESI Compliance Codes, Federal Register Notice content, and determination of drug status as governed by FDA laws and regulations. ? Research the FDA Drug Listing Database and provide expertise as to the appropriate use and application of the National Drug Code, and historical significance and interpretation of FDA Law and its implications for drug products. ? Draft responses for the FDA in resolving requests from drug firms, State agencies, private databases, and pharmacists in regard to the determination of the correct DESI code for drug products enrolled in the Omnibus Budget Reconciliation Act of 1991 Drug Rebate Agreement. ? Assistance in the identification of prescription drug products marketed without approved applications and development of enforcement strategies for these products; identification of cough cold drug products marketed without approved applications or not complying with OTC monographs both in conventional and extended release dosage forms and development of enforcement strategies for these products; identification of all non-drug products from the Drug Listing Database and remove them from the database. Deliverables The contractor will provide monthly status reports on the accomplishment of specific activities each month, various stages of work in progress and be available to discuss with members of the Program Office. Delivery Schedule: ? Technical Reports The Contractor shall meet (by conference call or face-to-face) with the FDA Project Officer and designee(s) once per week during the first year of the contract, and at least once every two weeks thereafter. Deliveries of this contract: 1. Monthly Progress/Activity Report Monthly progress/activity reports shall be brief reports in letter format and may include: ? work accomplished during the period; ? planned activities for the upcoming period; and ? a description of any problems experienced during the month or anticipated in the upcoming period, solutions or recommended plan for addressing issues. One copy of this report will go to the FDA/CDER Project Officer and one copy to the Contracting Officer within 15 days following the end of each contract month. 2. Annual Progress/Activity Report This report shall include a summation of the results of the entire contract work for the period covered. An Annual Report will not be required for the period when the Final Report is due. A Monthly Report shall not be submitted when an Annual Report is due. 3. Final Report This report is to include a summation of the work performed for the entire contract period of performance. An annual report will not be required for the period when the Final Report is due. All reports are to be in Microsoft Word or Excel format and accompanied by an electronic version. Criteria for Acceptance FDA/CDER will review contractor deliverables in accordance with specifications and standards stated in the criteria established during the task kick-off meeting, and any directives issued during the life of this contract. Only the Project Officer that initiated the tasking or designated manager has the authority to accept or reject deliverables.
- Place of Performance
- Address: Contractor Site and, FDA/CDER, 11919 Rockville Pike, Rockville, MD
- Zip Code: 20852
- Country: UNITED STATES
- Zip Code: 20852
- Record
- SN01376199-W 20070819/070817220623 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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