SPECIAL NOTICE
R -- Professional Services
- Notice Date
- 5/5/2009
- Notice Type
- Special Notice
- NAICS
- 541611
— Administrative Management and General Management Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Administration, 6011 Executive Blvd, 5th Floor, Rockville, Maryland, 20852-3804, United States
- ZIP Code
- 20852-3804
- Solicitation Number
- 263-2009-AR-05-05
- Archive Date
- 5/13/2009
- Point of Contact
- Aleise D Roberts,, Phone: 301-402-3342
- E-Mail Address
-
aleiser@mail.nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of H (NIH) intends to negotiate unde the authority of Federal Acquisiton Regulation (FAR) 13.106-1 (b) sole source with Robert Lanman 1678 Wainwright Drive reston VA, 20190-3433 to provide reviewing and rewriting services of the NIH guidelines for research involving Recombinant DNA Molecules, within the Office of Biotechnology Activities (OBA), Office of the Director. The contractor shall perform the following duties as stated in the below statement of work: Background The Office of Biotechnology Activities (OBA) is a component of the Office of the Director (OD), National Institutes of Health (NIH). OBA is the policy focal point within the U.S. Department of Health and Human Services (DHHS) for addressing the scientific, clinical, safety, ethical, legal, and societal impacts of pioneering biologic research programs in the areas of recombinant DNA and gene transfer, xenotransplantation, genetic testing, and biosecurity. With regard to these areas of research, OBA helps establish principles and standards of research excellence, conducts comprehensive assessment of risks and benefits, and assesses its societal impacts. In coordination with other DHHS agencies and offices, OBA also develops and implements federal policies and procedures for the oversight and safe and ethical conduct of this research. Scope of Work The Contractor shall serve as consultant for reviewing and rewriting the NIH guidelines for research involving Recombinant DNA Molecules, within the Office of Biotechnology Activities (OBA), Office of the Director, NIH. The contractor shall also serve as legal consultant for the genetic modified organisms’ policy. This policy and/or sections of policy will need to be updated and sections possibly revised. This is an ongoing project that will extend for the length of the contract. The contractor shall be providing expert analytical and writing support for the development of a policy on conflict of interest screening for the NIH Data Safety Monitoring Board (DSMB) members, the development of a contract for DSMB logistical support services, and the development of a Notice of Proposed Rulemaking (NPRM) for clinical trial registration and results reporting to NIH. This project is ongoing for the length of the contract. The contractor shall also work on enhancing the guideline compliance within the research community. The contractor may be called upon to provide other high level advisory services related to the Office of Biotechnology Activities. This will require an individual with an in-depth knowledge of the NIH guidelines and policies and a vast knowledge of the legal ramifications and implications. This project is ongoing to the end of the contract. Deliverables The Contractor shall provide ongoing revisions and reviews of the NIH guidelines for research involving Recombinant DNA Molecules, within the Office of Biotechnology Activities (OBA), Office of the Director, NIH. The contractor shall serve as a legal consultant for the genetic modified organisms’ policy. This policy and/or sections of policy will need to be updated and sections possibly rewritten. This is an ongoing project that will extend to the end of the contract. The contractor shall provide expert analytical and writing support for the development of a policy on conflict of interest screening for NIH DSMB members, the development of a contract for DSMB logistical support services, and the development of an NPRM for clinical trial registration and results reporting to NIH.. The contractor shall provide other high level advisory services related to the Office of Biotechnology Activities, as needed. Period of Performance The period of performance of this task shall be for the peiod of one year from date of award. Again, this is a NOTICE OF INTENT to negotiate on a sole source basis with Robert Lanman for services as sateted not a request for competitive proposals. The Government intends to issue a firm-fixed price purchase order for the services utilizing simplified acquisitions procedures. Interested parties may identify their interest and capability to respond to the requirement or submit capability statements by email to aleiser@od.nih.gov, Contract Specialist by May11th, 1PM EST. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=9bad550c444d912d1ef8e232cf887c9f&tab=core&_cview=1)
- Place of Performance
- Address: Rockledge 1, 6705 Rockledge Drive, Bethesda, Maryland, 20817, United States
- Zip Code: 20817
- Zip Code: 20817
- Record
- SN01808912-W 20090507/090505220429-7f6fd3aa249d2ca0ee956b4b68c07670 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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