Developing Guidance and Regulations

This second and final modification is to extend the response date until 8/10/2010 at 11:00 PM ET. This is the final extension. _________________________ The modification has been made to extend the response date to 8/10/2010 at 1:00 PM Eastern. _______________ This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide services to help develop guidance and regulations for the Center of Devices and Radiological Health. Guidance and regulation development eases interactions with industry and ensures effective implementation of the 2007 Medical Device User Fee Act (MDUFA or "MDUFMA II"). Availability of guidance and regulations results better submissions and makes for a more transparent and efficient review. Contractor will be required to provide the following service (brief description): General Requirements: CDRH has in place a plan to implement high priority guidance and regulations documents. Guidance documents provide information to FDA and stakeholders on a number of internal and external processes and regulatory decisions. The Center CDRH requires additional contract support for activities such as the following: - Analyzing Stakeholder Input: As part of the guidance and regulation development, CDRH holds meetings with stakeholders (industry, hospitals, and other federal partners) and asks the public to provide comment via a public docket. These fully activities require preparing presentations and reports for stakeholders and analyzing stakeholder's responses. For the public docket, this means analyzing numerous, in some cases thousands, of written comments. CDRH need summaries and reports to ensure stakeholder input is taken into account when writing related guidance documents. This written assignment is to provide summaries and analysis of meeting materials and dockets comments. In cases were number of items to be summarized is in the hundreds (and thousands), these summaries are better provide in simple searchable database form. - Developing Concept Papers: A concept paper analyzes the issues related to the a specific guidance or regulation under development, identifies FDA's short and long term goals, justifies why FDA is proposing the actions described in the guidance or regulation, and determines what steps must be taken to achieve the desired goals. This is written assignment to explain current thinking and approach to writing a guidance or regulation document. - Converting a Concept paper into a Guidance or Regulation: After the concept paper has been developed and approved, the guidance or regulation is written. This is a writing assignment to expand on the concept paper into draft guidance documents. - Writing New and Editing Guidance and Regulations: This assignment is to write and/or edit a new guidance or regulation using provided background materials. This includes ensuring that plain language and standard or specialized formatting is used throughout the document. - Writing Plain Language Summaries: After guidance documents are completed, it is sometimes necessary to develop simple summaries that are easily understood that can be used to communicate to key stakeholders. This is written assignment to summarize and inform stakeholders of the availability and purpose of a guidance or regulation. - Writing Reports: Reports provide information to stakeholders on guidance and regulation developments, describe recent accomplishments and teach stakeholders how to better use the resources CDRH has to offer. This is a written assignment to consolidate significant accomplishment into a report to stakeholders. - Developing and printing publication-quality documents: Certain documents require specialized layout, the use of graphs and images and a publishing style formatting in order to make the information accessible to FDA staff and other stakeholders. This is an assignment to convert reports, summaries and guidance into publication quality documents. This includes both paper and web-quality publications. Contractors must satisfy the following requirements. Provide a detailed description of your company's (including its teammates, if applicable) experience and demonstrated abilities to deliver the type of instrument described above. A firm fixed price 5 year contract will be awarded. The NAICS Code is 541690 ($5MIL). Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to provide the specific instrument(s) as required. Responses must directly demonstrate the company's ability to effectively provide the service(s) described above. Responses to this notice shall be limited to 10 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541690 and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received by the Contract Specialist named below not later than 1:00 PM Eastern time on Monday August 10, 2010 for consideration. The acceptable method of transmitting responses is via email to Jaclyn.Stielper@FDA.HHS.GOV. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.