SOLICITATION NOTICE
R -- Paperwork Reduction Act (PRA) Compliance
- Notice Date
- 2/13/2007
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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-07-00171
- Response Due
- 2/23/2007
- Archive Date
- 3/10/2007
- Small Business Set-Aside
- Total Small Business
- Description
- The Food and Drug Administration intends to award a firm fixed price hourly contract to Margaret Robbins of Bethesda, MD. This is NOT a request for competitive quotes. The Purchase Order will be made on a sole source basis in accordance with FAR Part 13 - Simplified Acquisition Procedures - Sole source acquisitions for the following, full-time, services to be performed at 1350 Piccard Drive, Rockville, MD 20850, under the simplified acquisition procedures. WORK TO BE PERFORMED: A) Objective: To analyze CDRH documents that might implicate the PRA and determine whether any approval under the PRA is necessary. In addition, if approval is necessary, the objective is to ensure that CDRH obtains that approval in a timely way by developing the necessary documents and working with the appropriate parties within CDRH, FDA, and OMB to obtain approval for the information collection. B) Scope of Work: Independently and not as an agent of the Government, the consultant shall furnish the necessary personnel, material, services, facilities, and otherwise do all things necessary for or incident to the performance of the work described below: The consultant will work with CDRH in identifying documents that involve information collection. The consultant will analyze documents to determine what information is necessary to comply with PRA, including documents necessary to obtain new approvals and documents necessary to update existing approvals. The consultant will assist CDRH in developing training materials related to the PRA for CDRH staff. The consultant will provide expertise to CDRH staff on the application of various statutes, regulations, and Executive Orders, on regulatory issues concerning medical devices and radiological health within the Paperwork Reduction Act, as well as the Federal Food, Drug and Cosmetic Act, the Administrative Procedures Act as needed. The consultant will also provide assistance on other projects, such as drafting standard operating procedures for the CDRH Regulations Staff which includes identifying issues that need to be resolved before the process can proceed and who the decision making authority should be on those issues, as directed by the CDRH Center and/or Office Directors. Deliverables The consultant will analyze documents identified by the Project Officer or Liaison, including any 2006/2007 high priority guidance documents and regulations that might implicate the PRA, and develop the documents required under the PRA (or requested by OMB) necessary to obtain paperwork approval. The contractor: Will attend all meetings (in person or by phone) as requested by the liaison, Director of Regulations Staff, or CDRH Deputy Director. Will assist CDRH in the development of a PRA training CD and other PRA training materials. Will assist with the development of Regulations Staff standard operating procedures. Will provide additional counsel or services related to PRA as directed by the liaison, Regulations Staff Director or CDRH Deputy Director. Will be required to commit to scheduled and ad hoc telephone interaction with Regulations and/or Senior Office Staff. Will participate telephonically at meetings, and conferences as necessary, as a representative of FDA. Ms. Robbins has worked on the FDA?s Paperwork Reduction Act (PRA) staff that is part of the PRA and Records Management Branch under the Office of Management Systems, Office of Management Programs, Division of Management Systems staff for 17 years. Ms. Robbins has extensive expertise in PRA issues, particularly PRA issues relating to CDRH documents. The consultant has expertise in analyzing PRA issues and developing the documents required under the PRA regulations. In addition, the consultant has extensive background working with the Office of Management and Budget (OMB) the Office of Chief Counseled and the Office Regulations Policy Managements Systems in the processing of PRA issues. PERIOD OF PERFORMANCE: March 1, 2007 - February 28, 2008 PAYMENT: payment should be made within 30 days of Government receipt of a proper invoice. 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. The anticipated award date is 02/27/2007; however, all dates in this announcement are subject to change. This action is proposed on a sole source basis because it is a follow-on contract where the vendor has developed procedures that help expedite critical requests and there being a substantial duplication of cost to the government that is not expected to be recovered through competition. Interested parties may identify their interest by responding to this requirement within 5 calendar days after the date of publication of this notice. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. 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 and Bradstreet number and banking information. The following FAR clauses apply to this combined synopsis/solicitation. 52.212-1 Instructions to Offers-Commercial Items, 52.212-3 Offer Representations and Certifications-Commercial Items, 52.212-4 Contract Terms and Conditions-Commercial Items, 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items,52.217-8 Option to Extend Services (Nov 1999), 52.217-9 Option to Extend the Term of the Contract (Mar 2000). All information received by 2:00pm EST on February 23, 2007 will be considered by the Government. All questions must be emailed no later than February 15, 2007 to kimberly.davila@fda.hhs.gov.
- Place of Performance
- Address: 1350 Piccard Drive, Suite 200, Rockville, MD
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01231049-W 20070215/070213220208 (fbodaily.com)
- Source
-
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