Department of Health and Human Services March 2012 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 301
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Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.'' This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER's) current thinking on the potential human health risks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 In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER- regulated drug and biologic products,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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of “Health Care Providers' Responses to Medical Device Labeling”
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Decision To Evaluate a Petition To Designate a Class of Employees From the Rocky Flats Plant in Golden, CO, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Rocky Flats Plant in Golden, Colorado, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Rocky Flats Plant. Location: Golden, Colorado. Job Titles and/or Job Duties: All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors. Period of Employment: January 1, 1972 through December 31, 1989.
Decision To Evaluate a Petition To Designate a Class of Employees From the Ventron Corporation Site in Beverly, MA, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Ventron Corporation site in Beverly, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Ventron Corporation. Location: Beverly, Massachusetts. Job Titles and/or Job Duties: All Atomic Weapons Employees. Period of Employment: January 1, 1942 through December 31, 1948.
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