Department of Health and Human Services March 2, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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 If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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.
Announcement of Requirements and Registration for Surgeon General's (SG) Youth Video Contest
The Center for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Surgeon General's (SG) Youth Video Contest. This contest is sponsored by CDC in conjunction with the Office of the Surgeon General, HHS. This contest has been designed to engage youth and young adults in developing original videos in conjunction with the launch of the 2012 Surgeon General's Report, ``Preventing Tobacco Use among Youth and Young Adults.'' Specifically, the contest will engage youth and young people in considering how tobacco use impacts their health, how the tobacco industry reaches youth through marketing, and other tobacco-related influences.
Fees for Sanitation Inspections of Cruise Ships
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation inspections. These inspections are conducted by CDC's Vessel Sanitation Program (VSP). VSP assists the cruise line industry in fulfilling its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly inspections and, when necessary, re-inspection.
Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments
The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on recently issued draft guidances relating to the development of biosimilar products (draft guidances). These draft guidances were issued by FDA as part of the implementation of the Biologics Price Competition and Innovation Act of 2009 (the BPCI Act). The BPCI Act establishes an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to, or interchangeable with, a reference product. FDA will consider the information it obtains from the public hearing in the finalization of these guidances. In addition, FDA is soliciting public input regarding topics for future policies regarding biosimilars.
Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER- regulated drug and biologic products, including prescription and nonprescription products.
Office of the Assistant Secretary for Planning and Evaluation; Meeting of the Advisory Council on Alzheimer's Research, Care, and Services
This notice announces public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The chairs of the three subcommittees (Research, Clinical Care, Long-Term Services and Supports) will summarize feedback from their subcommittees on the Draft National Plan to Address Alzheimer's Disease. This feedback will be discussed among the full Advisory Council.
Office of the Secretary; Departmental Appeals Board; Statement of Organization, Functions and Delegations of Authority
The Departmental Appeals Board is announcing this reorganization which allows for greater flexibility and better reflects the current work environment and priorities within the organization.
Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Advanced Diagnostic Imaging Supplier Accreditation Program
This notice invites independent accreditation organizations who have not previously submitted applications to participate in the advanced diagnostic imaging supplier accreditation program as a designated accreditation organization, for the purpose of accrediting suppliers furnishing the technical component (TC) of advanced diagnostic imaging services. It also sets forth the application guidelines for approval of organizations wishing to accredit suppliers furnishing the TC of advanced diagnostic imaging services.
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