Request for Nominations for Voting Members on the Food Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Food Advisory Committee, Office of Regulations, Policy, and Social Sciences, Center for Food Safety and Applied Nutrition. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Guidance for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' The recommendations in this guidance are intended to assist applicants in developing the ``Patient Counseling Information'' section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory scheduled for December 12, 2014. The meeting was announced in the Federal Register of September 22, 2014 (79 FR 56589). The meeting is postponed from December 12, 2014, until February 20, 2015. The location of the meeting has also changed. Date and Time: The meeting will be held February 20, 2015, from 8 a.m. to 6 p.m. Location: Hilton/Washington DC North, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 13, 2015. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 4, 2015. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 6, 2015. Contact Person: Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Ebola Virus Disease Vaccines
The Secretary is issuing a declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to Ebola Virus Disease Vaccines consistent with the terms of the declaration.
Office of the National Coordinator for Health Information Technology; Federal Health IT Strategic Plan: 2015-2020 Open Comment Period
Section 3001(c)(3) of the Public Health Service Act, as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires the National Coordinator for Health Information Technology (ONC) to update the Federal Health IT Strategic Plan (developed June 3, 2008; last updated on September 15, 2011) in consultation with other appropriate federal agencies and in collaboration with private and public entities. The Plan was developed in collaboration across multiple federal agencies, and ONC will seek input on the draft Plan from the private sector through the Health IT Policy Committee. This notice serves to announce that the public comment period for the Federal Health IT Strategic Plan is open through Tuesday, February 6 at 5:00 p.m. (Eastern). ONC welcomes and encourages all comments from the public regarding the Plan. In order for your comments to be read and considered, you must submit your comment via http://www.healthit.gov/policy-researchers- implementers/strategic-plan-public-comments.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #214) entitled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data'' (VICH GL35). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit VICH GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products. Please note that VICH GL42 has been harmonized in GFI #188, ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.''
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014.
Patient-Focused Drug Development Public Meeting on Chagas Disease
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Chagas disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The meeting is intended to allow FDA to obtain patients' perspectives on the impact that Chagas disease has on their daily lives, as well as their perspectives on the available therapies for Chagas disease. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat Chagas disease. In the afternoon, FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease. The input from this public meeting will help in developing topics for further discussion.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements contained in current FDA regulations: Administrative Practices and Procedures; Formal Evidentiary Public Hearing.