Department of Health and Human Services July 9, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of a meeting of SACATM on September 5-6, 2012, at the Rodbell Auditorium, Rall Building at the NIEHS, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709. The meeting is open to the public with attendance limited only by the space available. The meeting will be webcast through a link at (https://www.niehs.nih.gov/news/video/live). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
Announcement of Requirements and Registration for Million Hearts TM
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services, in partnership with Million Hearts TM announces the launch of The Million Hearts TM Caregiver Video Challenge. We invite people who play a role in helping to prevent or control high blood pressure or maintain the heart health of a loved one to share their stories of caregiving by creating original, compelling videos that are less than 2 minutes long. The videos should include a description of how the caregiver contributes to another person's heart health and provide helpful tips related to high blood pressure prevention or control. This challenge is necessary to engage a key audience of the Million Hearts TM initiative and to recognize individuals who work hard to provide care for their family members or friends. The goal of this Challenge is to have caregivers create inspiring videos that provide other caregivers helpful tips on heart healthy practices, particularly on the prevention and control of high blood pressure. Through these personalized videos we intend to promote heart disease prevention through blood pressure control, medication adherence, and lifestyle changes to the public.
Glen R. Justice: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Glen R. Justice, M.D. from providing services in any capacity to a person that has an approved or pending drug product application for a period of 25 years. We base this order on a finding that Dr. Justice was convicted of five felony counts under Federal law for conduct involving health care fraud and that this pattern of conduct was sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Dr. Justice was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Justice failed to respond. Dr. Justice's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Wyeth Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for DURACT Capsules
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for DURACT (bromfenac sodium) Capsules, held by Wyeth Pharmaceuticals, Inc. (Wyeth), P.O. Box 8299, Philadelphia, PA 19101-8299. Wyeth, now a part of Pfizer, Inc., has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.
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