Positron Emission Tomography (PET) Consulting Services

THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice 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 notice. The Government does 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 sources sought. Any responses received will not be used as a proposal. Statement of Work: 1.1 Background On November 21, 1997, the President signed the Food and Drug Administration Modernization Act of 1997 (FDAMA). Section 121 of FDAMA included provisions that directed the Food and Drug Administration (FDA) to establish appropriate procedures for the approval of positron emission tomography (PET) drugs and appropriate current good manufacturing practice requirements for such drugs. On December 9, 2009, FDA issued the final current good manufacturing practices (CGMP) regulation for the production of PET drugs. Under the requirements of section 121 of FDAMA, within two years following this publication date, a new drug application (NDA) or abbreviated new drug application (ANDA) must be submitted for any PET drug marketed for clinical use in the United States. A Final Rule providing regulations on cGMP for Positron Emission Tomography (PET) drugs was published in December 2009. The rule applies to approved PET drugs. A guidance entitled, "PET Drugs -Current Good Manufacturing Practice (CGMP) was also released to help producers better understand the FDA's thinking about compliance issues. This regulation is effective December 12, 2011. 1.2 Scope of Work The contractor shall have the necessary expertise to provide technical expertise and consultation on regulatory issues as a result of an FDA inspection of a PET facility. This may encompass input on case development, case findings, and recommendations on inspectional matters as relevant to PET facilities. The capabilities necessary for this contract include contractors with academic training and experience in the area of radiopharmaceuticals, experience in the areas of aseptic processing, hemodialysis water systems, depyrogenation, endotoxin testing, development of analytical test methods, quality systems and CGMP for the production of radiopharmaceuticals. Small businesses are encouraged to respond if they have the capability and capacity to provide the identified services. 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 perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform the task described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 10 pages, and must include: 1. Demonstrated experience of performance and/or ability to supply all required services and materials. 2. 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. 3. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 4. If qualified as an 8(a) firm (must be certified by the Small Business Administration (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). 5. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 6. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 7. 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). 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. Interested offerors should submit their capability statement not exceeding ten (10) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: emily.hunt@fda.hhs.gov or US Food and Drug Administration Emily Hunt 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2080 Rockville, MD 20857 All responses are due no later than 5:00 PM Eastern Time Friday, August 5, 2011.