SOLICITATION NOTICE
R -- Paperwork Reduction Act Compliance Services
- Notice Date
- 2/9/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541611
— Administrative Management and General Management 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-1052493-09
- Response Due
- 2/17/2009 2:00:00 PM
- Point of Contact
- ZetherineGore ,, Phone: (301) 827-5093, Kimberly m Davis,, Phone: 301-827-7179
- E-Mail Address
-
zetherine.gore@fda.hhs.gov, kimberly.davis@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- MODIFICATION NO. 02 CHANGES 1) THE LEVEL OF EFFORT FROM FULL TIME TO PART TIME. SEE LEVEL OF EFFORT BELOW FOR FULL TEXT OF THE CHANGES, AND 2) ADDS THAT TWO (2) WRITTEN COPIES OF ALL OFFERS MUST BE SUBMITTED TO: Food and Drug Administration, OAGS/DAO/SCT, Attn: Zetherine Gore, 5630 Fishers Lane, Room 2075, HFA-500, Rockville MD 20857 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-24. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code (541611) is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a total 100% small business set-aside. 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. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that discussions after initial offer(s) is/are provided are not necessary. This announcement is issued as a Request for Quote (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for expert consultant services to assist the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) in meeting Paperwork Reduction Act compliance requirements. This requirement identified as FDA-SOL-09-1052493, is to notify contractors that the government intends to issue a purchase order in accordance with FAR Part 13 for the following statement of work: STATEMENT OF WORK Purpose The purpose of this project is to ensure that the Center for Devices and Radiological Health (CDRH) complies with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The PRA requires that federal agencies estimate and justify the time and economic burden placed on those entities asked to supply information to the government and applies to CDRH documents that involve a collection of information by those outside the Federal government. PRA is implicated in many CDRH documents, which may include guidance documents, regulations and letters to device manufacturers. The PRA process is complex and involves numerous steps. Steps include drafting and submission of an information collection request (ICR), which includes a Supporting Statement that addresses between 18 and 23 specific issues and a worksheet that certifies that the ICR complies with the PRA; drafting and publishing two Federal Register notices requesting public comment on the agency’s intent to collect the information, and working with the Office of Management and Budget to resolve any questions or concerns about the collection. CDRH has developed a list of 2009 high priority guidance documents and regulations, and a general list of guidance documents to be revised, many of which may involve the collection of information. The list of guidances that the agency is considering publishing in FY2009 can be found at http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy09.html. CDRH also frequently develops documents in response to emerging public health concerns that involve information collections. Under the PRA, persons do not need to respond to a collection of information unless the collection displays a currently valid Office of Management and Budget (OMB) control number. CDRH needs to ensure that it is able to expeditiously identify information collections in its documents and, if necessary, obtain approval from OMB. Background CDRH issues numerous documents related to device and radiological product issues each year. Many of these documents include recommendations or requirements related to the collection of information. For example, CDRH may request reports and recordkeeping from device manufacturers; these generally constitute collections of information. CDRH must ensure that its documents that include any information collection comply with the PRA. Complying with the PRA involves identifying and analyzing the extent of information collected in the document; researching whether existing paperwork approval covers the information collection; drafting/editing documents necessary to comply with the PRA which includes Federal Register notices and supporting documents submitted to OMB; determining whether emergency clearance for information collection is necessary and undertaking any steps necessary to obtain that emergency clearance from OMB; discussing and responding to questions from OMB and the public; and updating existing approvals to ensure they do not expire. To meet the demand for expert knowledge of the Paper Reduction Act the Agency relies on knowledgeable staff. The Office and Staff’s in-house resources, though proficient, are often exceeded by the demand for this kind of expertise. The approval of this contract will greatly enhance the ability to address and respond to the often complex issues that arise with these compliance requirements; as establishing a professional services contract is a cost effective method, designed to allow us to provide the required expertise of an individual with the needed knowledge and skills. Scope of Work 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 may 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. Tasks: The contractor shall attend all meetings (in person or by phone) as requested by the liaison, Director of Regulations Staff or CDRH Deputy Director. The contractor may assist CDRH in the development of a PRA training and other PRA training materials. The contractor shall assist with the development of Regulations Staff standard operating procedures. The contractor shall provide additional counsel or services related to PRA as directed by the liaison, Regulations Staff Director or CDRH Deputy Director. The contractor will be required to commit to scheduled and ad hoc telephone interaction with Regulations and/or Senior Office Staff. The contractor will participate telephonically at meetings, and conferences as necessary, as a representative of FDA. Deliverables: The contractor shall: 1) Analyze documents identified as 2009 high priority guidance documents and regulations, as assigned, to determine if they implicate the PRA, and develop the documents required under the PRA (or requested by OMB) necessary to obtain approval. Initial comments are due within 2 weeks of assignment, final comment within 1 week of receiving comments and concurrence from the Regulations Staff Director. Deadlines for preparation of approval documents, where determined necessary, will be determined as assignments are made and based on the individual complexity and implications identified. 2) Assist in development of training materials related to PRA. Initial comments are due within 2 weeks of assignment, final comment within 1 week of receiving comments and concurrence from the Regulations Staff Director. Deadlines for preparation of training documents will be determined as assignments are made. 3) Assist in development of Standard Operating Procedures related to PRA. Initial comments are due within 2 weeks of assignment, final comment within 1 week of receiving comments and concurrence from the Regulations Staff Director. Deadlines for preparation of procedures will be determined as assignments are made. 4) Will provide counsel and services related to PRA as directed by the liaison, Regulations Staff Director or CDRH Deputy Director. Level of Effort It is estimated that a Senior Policy Analyst/Reviewer will be required on an average of 15 to 25 hours per week. The number of actual hours expended each week will be determined by project need. There could be periods of lesser or greater demand. The Government anticipates that a Senior Policy Analyst/Reviewer is equivalent to a federal employee grade GS-15 with an hourly pay rate ranging from $57.90 to $73.41 per hour. This is provided for information only, should not be considered restrictive, and is not a wage determination. Payment Schedule: Offers should include a breakout of the total number of hours proposed and the applicable hourly rate. Payment will be made in monthly installments based on level of effort (hours worked). Period of Performance The period of performance shall be for one (1) year. The anticipated period of performance is from March 1, 2009 through February 28, 2010. Basis For Award Provision 52.212-1 Instructions to Offerors—Commercial Items(Nov 2007) is incorporated by reference. 52.212-2 Evaluation—Commercial Items (Jan 1999) (a) The Government will award a purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. (b) Proposals received will first be evaluated from a technical standpoint without regard to proposed cost. Those proposals considered to be technically acceptable will then be evaluated from a financial and management standpoint. (c) Technical factors are significantly more important than cost or price. It is pointed out, however, that should technical competence between offerors be considered approximately the same, then cost or price could become primary. Evaluation Criteria The following factors shall be used to evaluate offers: All submitted proposals shall not exceed 10 pages in their final submission. 1) Technical understanding of PRA requirements, congressional mandates, and all deliverables identified above. (40%) 2) Demonstrated experience in PRA and Regulations writing, editing, and submission to OMB, and or, OGC for processing.(45%) 3) Experience establishing contacts and building relationships of the client origination (regulations and policy staff). (10%) 4) Demonstrated expertise with internal Government approval processes and systems. (5%) Past Performance Evaluation FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. Offerors should provide the name, address, telephone number, contact, and e-mail address of three references to include the associated contract number. Past performance is not weighted and will receive a negative or positive rating. 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days before the end of the period of performance. (End of clause) All questions regarding this solicitation/posting must be in writing, can be sent via email to: zetherine.gore@fda.hhs.gov, and must be received no later than Friday, February 6, 2009. On all quotes, please provide a Tax Identification Number and Duns Number. All contractors must be registered in the Central Contractor Registration (CCR). No Phones Calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=e30ada4863a2267ac052b21fbd5a3b17&tab=core&_cview=1)
- Place of Performance
- Address: Food and Drug Administration, 1350 Piccard Dr, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN01747005-W 20090211/090209220329-e30ada4863a2267ac052b21fbd5a3b17 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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