Department of Health and Human Services July 2012 – Federal Register Recent Federal Regulation Documents

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.

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.

The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of that determination, and pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic Act (``FD&C Act''), the Secretary of Health and Human Services is renewing her July 20, 2011 declaration of an emergency justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb- 3(a). This notice is being issued in accordance with section 564(b)(4) of the FD&C Act, 21 U.S.C. 360bbb-3(b)(4).

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, announces plans to submit a request to extend the use of an approved Information Collection Request (ICR) to the Office of Management and Budget. The approved ICR is assigned OMB control number 4040-0005 and expires on August 31, 2012. Prior to submitting that ICR to OMB, HHS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. HHS especially requests comments on (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Deadline: Comments on the ICR must be received within 60 days of the issuance of this notice.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Sami Arshak Yanikian for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Yanikian was convicted of two counts of introducing unapproved new drugs into interstate commerce, which relates to the development or approval, including the process for development or approval, of drug products and to the regulation of drug products under the FD&C Act. In addition, the type of conduct that served as the basis for Mr. Yanikian's convictions undermine the process for the regulation of drugs. Mr. Yanikian was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Yanikian failed to respond. Mr. Yanikian's failure to respond constitutes a waiver of his right to a hearing concerning this action.