DOCUMENT
R -- Fellowship - NPI agreement
- Notice Date
- 8/27/2008
- Notice Type
- NPI agreement
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-08-1046046-OM
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 611310, is to notify contractors that the government is seeking competition in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. STATEMENT OF WORK: Background The purpose of the fellowship program is to develop a cohort of trained fellows who will be especially prepared to take up the challenges of drug information and risk communication. This program is being undertaken to introduce participants to the various medical and regulatory aspects of drug development. I.Objectives: •The primary objective of the program is to introduce participants to various medical and regulatory aspects of drug development. •Train health care professionals for a career in the drug development industry by allowing them “hands on” experience. •Understand regulations regarding human drug products. •Understand the value of drug information to heath care providers and to consumers. II.Structure and Content of Program: The Fellowship requires two years of on-site participation administered through an accredited College of Pharmacy. The fellow will be a PharmD. graduate and will have rotational experiences at an academic institution, the Food and Drug Administration, Center for Drug Evaluation and Research, and either pharmaceutical company identified above. The fellow is expected to complete a project that incorporates viewpoints and aspects of the rotational experience. III.Training Tracks Within the Pharmaceuticals Drug Development Fellowship Program Although certain training elements are common to all fellows the three distinct training tracks identified within the program will allow tailoring of training to the career goals of the individual trainee. The training tracks are as follows: 1) Drug Information Track Division of Drug Information •Utilize drug information references to facilitate communication through dissemination of timely and clinically significant information for drug products, and CDER’s role, etc. •Respond to inquiries regarding approved drugs •Become familiar with drug products, regulations, guidance documents and timely issues 2)Prescription Drug Advertising Track Division of Post marketing Advertisement and Communication (DDMAC) •Reviews and evaluates promotional materials for compliance with regulations. These include materials from the Internet and exhibit halls of medical meetings and materials used by pharmaceutical sales representatives. •Reviews and evaluates promotional claims to determine if they are substantiated by the labeling and/or medical journal articles. IV.Candidate Qualifications Candidates must be a PharmD. Graduate from an accredited institution. Highly Qualified candidates will possess the following competencies and skills: •Knowledge of the drug development and review process •Knowledge of the risk management framework •Knowledge of Post-marketing epidemiological assessment •Knowledge of basic health promotion-health education concepts •Knowledge of basic social marketing perspective and strategies •Excellent oral and verbal communication skills •Excellent written communication skills •PowerPoint presentation skills •Interest in computer and web-based communication tools V.Roles and Responsibilities The Center for Drug Evaluation and Research (CDER) will: •Appoint a Coordinator for the Joint Academic/FDA/Industry fellowship Program in Pharmaceutical Drug Development. •Appoint mentor(s) who will guide the fellow during their stay at CDER •Jointly with the participating organizations periodically review and revise the objectives and programmatic assignments of the fellows. •Authorize the Coordinator to serve as a liaison between the Food and Drug Administration, Center for Drug Evaluation and Research and the Academic institution. •Accept one fellow per programmatic area per fellowship cycle. Additional fellows will be accepted at CDER’s sole discretion. •Inform the academic institution when CDER recommends withdrawal of any fellow from the Fellowship Program whose performance is unsatisfactory. The Contractor shall: •Provide a stipend to the person selected for the fellowship. •Maintain completion of records and reports necessary for the conduct and verification of student participation. •Monitor the progress of the fellow and establish criteria for the successful completion of the fellowship. •Designate a faculty member to coordinate with a designee from the specific programmatic area the fellow is assigned. •Coordinate the educational experience. •Serves as central resource for fellow regarding their development. •Coordinates recruitment and candidate selection. VI.At no time during the course of the fellowship will the participant be considered an employee of the Food and Drug Administration, Center for Drug Evaluation and Research. Fellows shall, however, adhere to the rules, regulations, procedures, and policies of the Food and Drug Administration, Center for Drug Evaluation and Research while of the premises and during that portion of the fellowship, including but not limited to completion of a Confidentiality and Nondisclosure Acknowledgement. The Food and Drug Administration, center for Drug Evaluation and Research has the right to terminate the use of its facilities and its resources by any Fellow for violation of its rules, regulations, procedures and policies. This agreement may be amended by mutual consent by the officials executing this agreement or their successor after giving written notice to the other party at least 30 days prior to the proposed amendment date. This agreement shall become effective upon execution by the signatories. Either party may terminate this Agreement upon sixty- (60) days written notice to the other. Subject to mutual agreement of the parties, such termination may not prevent those students already participating in the Fellowship program from completing their assignment at the FDA, Center for Drug Evaluation and Research. Offerors are advised that award will be made to that offeror whose quotation provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to karen.petty@fda.hhs.gov no later than August 29, 2008, 12:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: karen.petty@fda.hhs.gov, no later than 3:00pm, EST on Wednesday, September 3, 2008. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Karen.petty@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=64d7d7a72a2b0bc4cd3d102c664a9da5&tab=core&_cview=1)
- Document(s)
- NPI agreement
- File Name: NPI agreement (NPI Agreement.doc)
- Link: https://www.fbo.gov//utils/view?id=8b2802566732313879145cd8b50e331f
- Bytes: 33.00 Kb
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: NPI agreement (NPI Agreement.doc)
- Record
- SN01653254-W 20080829/080827222357-64d7d7a72a2b0bc4cd3d102c664a9da5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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