Notices. Notice; request for comments
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/register/2006/06/29/06-5804·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1998N-0359] (formerly 98N-0359) Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is requesting comments concerning the establishment of program priorities in the Center for Food Safety and Applied Nutrition (CFSAN) for fiscal year
(FY)2007. As part of its annual planning, budgeting, and resource allocation process, CFSAN is reviewing its programs to set priorities and establish work product expectations. This notice is being published to give the public an opportunity to provide input into the priority-setting process. DATES: Submit written or electronic comments by August 28, 2006. ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Tracy Summers, Center for Food Safety and Applied Nutrition (HFS-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20740, e-mail: *tsummers@.fda.hhs.gov* , 301-827-6733. SUPPLEMENTARY INFORMATION: I. Background On May 3, 2006, CFSAN released a document entitled “FY 2006 CFSAN Program Priorities.” The document, a copy of which is available on CFSAN's Web page ( *http://www.cfsan.fda.gov* ) or from the contact person listed in the FOR FURTHER INFORMATION CONTACT section of this document, constitutes the center's priority workplan for FY 2006 (i.e., October 1, 2005, through September 30, 2006). The FY 2006 workplan is based on input we received from our stakeholders (see 70 FR 29328, May 20, 2005), as well as input generated internally. Throughout the priority-setting process, we focused on one central question: “Where do we do the most good for consumers and the overall public health?” The FY 2006 workplan was developed in recognition of a diminished budget, including projected reductions and redeployment of resources to achieve funding for priorities outlined in the President's FY 2007 budget. The FY 2006 workplan is structured differently than previous years. It contains only those activities previously listed as “A” list items. Our goal is to fully complete at least 90 percent of the activities listed under sections 1 through 4 of the FY 2006 workplan by the end of the fiscal year, September 30, 2006. The FY 2006 workplan also includes a fifth section entitled “Priority Ongoing Activities.” Many of these activities are core functions that we perform on a regular basis and are among our very highest priorities. II. 2007 CFSAN Program Priorities FDA is requesting comments on what program priorities CFSAN should consider establishing for FY 2007. The input will be used to develop CFSAN's FY 2007 workplan. The workplan will set forth the center's program priorities for the period of October 1, 2006, through September 30, 2007. FDA intends to make the FY 2007 workplan available in the fall of 2006. The format of the FY 2007 workplan will be similar to the FY 2006 workplan in that it will be divided into the following five sections:
(1)Ensuring Food Defense,
(2)Ensuring Food Safety,
(3)Improving Nutrition,
(4)Improving Dietary Supplement Safety, and
(5)Ensuring Cosmetic Safety. While there will likely be continuity and follow-through on many activities between the 2006 and 2007 workplans, the final FY 2007 Congressional Appropriation will unquestionably affect what we will be able to commit to accomplish in FY 2007. Accordingly, FDA requests comments on broad program areas that should continue to be a priority as well as new program areas or activities that should be added as a high priority for FY 2007. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: June 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-10241 Filed 6-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0191] The Use of Bayesian Statistics in Medical Device Clinical Trials; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. SUMMARY: The Food and Drug Administration
(FDA)is announcing the following public meeting: The Use of Bayesian Statistics in Medical Device Clinical Trials. The draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. DATES: The public meeting will be held on July 27, 2006, from 8:30 a.m. to 5 p.m. Registration for this meeting is required (see the Registration section of this document for details). Submit written or electronic comments on the draft guidance by August 21, 2006. ADDRESSES: The public meeting will be held at The Universities at Shady Grove, 9630 Gudelsky Dr., Rockville, MD. Additional information about and directions to the facility are available on the Internet at *http://www.fda.gov/cdrh/meetings/072706-bayesian.html* . Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Cindy Garris, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3150, ext. 121, FAX: 240-276-3151, e-mail: *Cynthia.garris@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Bayesian statistics is a theory and approach to data analysis that provides a coherent method for learning from evidence as evidence accumulates. In situations where good information on clinical use of a device already exists, the Bayesian approach may enable FDA to reach the same decision on a device with a smaller-sized or shorter-duration pivotal trial. In other instances, a Bayesian approach can provide flexible methods for handling interim analyses and other modifications to trials. The draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” describes FDA's current thinking on statistical aspects of the design and analysis of medical device clinical trials that use Bayesian statistical methods. FDA announced the availability of the draft guidance on May 23, 2006 (71 FR 29651). The draft guidance is available at *http://www.fda.gov/cdrh/osb/guidance/1601.html* . II. Agenda FDA will provide presentations on the draft guidance entitled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials” in the morning. In the afternoon, panels will discuss the draft guidance. There will be opportunities for public participation throughout the day. III. Registration Online registration for the meeting is required. Acceptance will be on a first-registered, first-served basis. There are no assurances of onsite registration. Please register online at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfsud/bayesian_meeting.cfm* . FDA is pleased to provide the opportunity for interested persons to listen from a remote location to the live proceedings of the meeting. In order to ensure that a sufficient number of call-in lines are available, please register to listen to the meeting at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfsud/bayesian_meeting.cfm* by July 21, 2006. Persons without Internet access may call 240-276-3150, ext. 121, by July 21, 2006, to register for onsite meeting attendance or to register to listen to the meeting by phone. If you need special accommodations due to a disability, please contact Cindy Garris (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting. IV. Request for Input and Materials FDA is interested in receiving input from stakeholders on the draft guidance. Send suggestions or recommendations to the Division of Dockets Management (see ADDRESSES ). FDA will place an additional copy of any material it receives on the docket (Docket No. 2006D-0191). Suggestions, recommendations, and materials may be seen at the Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday. V. Transcripts Following the meeting, transcripts will be available for review at the Division of Dockets Management (see ADDRESSES ). Dated: June 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-5804 Filed 6-26-06; 12:30 pm]