Regulation and Guidance Writing

General Information: Document Type: Sources Sought Release Date: March 23, 2012 Response Date: April 6, 2012 at 10:00 am EST via e-mail to Contract Specialist: Vida Niles at Vida.Niles@fda.hhs.gov Description: Development of Food Safety Guidance Writing This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses). This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quote, or an indication the Government will contract for the items or services 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 source sought. Any response received will not be used as a proposal. NAICS CODES: 541690 No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience in developing Food Safety Guidance Writing. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned. Project Title: Food Safety Guidance Writing Background On January 4, 2011, President Barack Obama signed into law the FDA Food Safety Modernization Act (FSMA; Pub. L. 111- 353), which requires the owner, operator, or agent in charge of a facility required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to take certain actions, including to evaluate the hazards that could affect food manufactured, processed, packed, or held and to implement preventive controls to significantly minimize or prevent the occurrence of such hazards. A written plan must be prepared to describe the procedures used by the facility to comply. FSMA also mandates that FDA establish science- and risk-based standards for growing, harvesting, packing, and holding produce on farms. FDA plans to issue proposed regulations on hazard analysis and preventive controls for human foods and standards for produce safety. FDA is required to issue guidance that will explain the requirements of the proposed preventive controls regulation with respect to the various components of the food safety plan, including how to do a hazard analysis and determine appropriate preventive controls. Guidance to industry is most useful when those using it can apply the guidance to the specific foods being produced and processes used to produce those foods. FDA is also required to issue an updated good agricultural practices guidance and guidance for the safe production and harvesting of produce. The updated good agricultural practices guidance would take into account the science and technology developments in the area of produce safety since the Agency issued its Good Agricultural Practices Guidance in 1998. This broad-based guidance would serve to encourage safe practices by fresh produce firms, including those that will be exempted either entirely or in part from compliance with the produce safety regulation. Scope Given the diversity of registered facilities and regulated foods, FDA is seeking assistance in the development of such food type-specific guidance documents to assist the food industry in complying with the preventive controls regulations, when finalized. FDA is interested in information on how to group foods subject to the regulation into categories with similar hazards and controls, as well as guidance specific to those food categories. FDA is seeking assistance in the development of guidance for safe production and harvesting of produce. The guidance for safe would serve as companion guidance to the produce rule and include recommendations to facilitate industry implementation and compliance with the regulation. This guidance would include information about hazards associated with growing, harvesting, packing, and holding of all produce covered by the produce safety regulation. Responses must include capability statements and duns number be sent to this notice no later than 10:00 a.m. EST on April 6, 2012 submitted by email to vida.niles@fda.hhs.gov,Vida Niles, Contract Specialist for consideration. 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. NO TELEPHONE CALLS WILL BE ACCEPTED.