Department of Health and Human Services April 9, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 26 of 26
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations by establishing a new maximum permitted energy level of x-rays for treating food of 7.5 million electron volts (MeV) provided that the x- rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for removing the amendment to the regulation.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines
HRSA is soliciting comments on the proposed eligibility criteria for the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donations Program. Eligibility criteria were proposed by the program grantee, the Regents of the University of Michigan, to HRSA. HRSA has determined that the proposed eligibility criteria constitute a proper interpretation of the authorizing statute's requirements, including determinations as to which individuals would otherwise be unable to meet the eligible expenses authorized under this Program. HRSA is soliciting public comment on the criteria outlined in this notice. HRSA will consider the comments in light of the authorizing statute and seek feedback from the Regents of the University of Michigan concerning the comments. HRSA will then approve final criteria. The final program eligibility criteria will be posted on the Reimbursement of Travel and Subsistence Expenses for Living Organ Donation Web site, https://www.livingdonorassistance.org.
Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting-Improving Human Subject Protection; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Clinical Investigators, Sponsors, and IRBs; Adverse Event Reporting Improving Human Subject Protection.'' This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the Institutional Review Board (IRB). FDA developed this draft guidance in response to concerns raised by the IRB community that increasingly large volumes of individual adverse event reports are inhibiting rather than enhancing IRBs' ability to adequately protect human subjects. The guidance provides recommendations to IRBs, sponsors, and investigators on improving the usefulness of the adverse event information submitted to IRBs.
Trimethobenzamide Hydrochloride Suppositories; Withdrawal of Approval
The Food and Drug Administration (FDA) is announcing the resolution of issues concerning trimethobenzamide hydrochloride suppositories. This notice announces the withdrawal of approval of the new drug application (NDA) for Tigan (trimethobenzamide hydrochloride) Suppositories. The notice also declares that the marketing of unapproved trimethobenzamide hydrochloride suppository products is unlawful and subject to FDA regulatory action. FDA is taking these actions because trimethobenzamide hydrochloride suppositories lack substantial evidence of effectiveness.
Draft Guidance for Industry on Orally Disintegrating Tablets; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Orally Disintegrating Tablets.'' The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate a proposed product as an ODT.
Draft Guidance for Industry on the Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in drafting prescription drug labeling in which prescribing information is clear and accessible and complying with the new requirements in the final rule on the content and format of labeling for prescription drug and biological products (71 FR 3922, January 24, 2006). This draft guidance is intended to help applicants select information for inclusion in the ``Dosage and Administration'' section of labeling and to help them organize that information.
Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a public hearing to obtain feedback on FDA's Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients. Dates and Times: The public hearing will be held on June 12 and 13, 2007, from 8:30 a.m. to 4:30 p.m. on both days. Submit written or electronic notices of participation by 4:30 p.m. on May 12, 2007. Written and electronic comments will be accepted until July 12, 2007. Location: The public hearing will be held at the National Transportation and Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (Metro: L'Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines). Addresses: Submit written or electronic notices of participation to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Submit written or electronic comments to https://www.accessdata.fda.gov/scripts/oc/dockets/commentdocke t.cfm or to the Division of Dockets Management. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ohrms/dockets approximately 21 days after the hearing. For Registration to Attend and/or to Participate in the Meeting: Seating at the meeting is limited. People interested in attending should register at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm or submit a written request for registration to the Division of Dockets Management (see Addresses) by 4:30 p.m. on May 12, 2007. Registration is free and will be on a first-come, first- served basis. If you wish to make an oral presentation during the open session of the meeting, you must state this intention on your notice of participation (see Addresses) and provide an abstract of your presentation by May 12, 2007. In the notice, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. FDA has identified questions and subject matter of special interest in section II of this document. You should also identify the subject matter and question number you wish to address in your presentation, and the approximate time requested for your presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. We will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. You must submit final electronic presentations, if any, to Mary Gross (see Contacts) by no later than June 6, 2007. Contacts: Mary C. Gross, Safety Policy and Communication Staff (HFD-001), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5421, e-mail: mary.gross@fda.hhs.gov.
Medical Devices; Technical Amendment
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.
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