Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; Comment Request; Assessment of the Use of Special Funding for Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997, the FY 2001 Consolidated Appropriations Act, and the Public Health Service Act Amendment for Diabetes
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 10, 2005, page 11994 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Proposed Collection; Comment Request; Tobacco Use Supplement to the Current Population Survey Series: 2006-2007 Tobacco Use Supplement to the Current Population Survey
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles.'' This guidance is intended to provide information and references that can be used for the decontamination of food transport vehicles following Hurricanes Katrina and Rita in August and September 2005. The scope of this guidance is limited to decontamination of trucks, rail cars, and cold storage units that were flooded or otherwise impacted by the hurricanes, before being placed back in service to transport or store food.
Oral Dosage Form New Animal Drugs; Ivermectin and Praziquantel Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Virbac AH, Inc. The supplemental NADA provides revised labeling for ivermectin and praziquantel oral paste used in horses for the treatment and control of various internal parasites.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Prescription Drug User Fee Act; Public Meeting; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of October 18, 2005 (70 FR 60536). The document announced a public meeting on the Prescription Drug User Fee Act (PDUFA). The document was published with typographical errors in the DATES and FOR FURTHER INFORMATION CONTACT sections of the document. This document corrects those errors.
Administration for Children and Families
The Administration for Children and Families (ACF) will be holding a one-day Tribal Consultation Session on December 6, 2005, at the Wyndham Hotel (California Grand Ball Room) in Palm Springs, California.
Medicare and Medicaid Programs; Requirements for Long Term Care Facilities; Nursing Services; Posting of Nurse Staffing Information
In this rule, we finalize provisions specified in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) that establish new data collection, posting, and recordkeeping requirements for skilled nursing facilities (SNFs) and nursing facilities (NFs). It requires that on a daily basis for each shift, SNFs and NFs must post nurse staffing data for the licensed and unlicensed staff directly responsible for resident care in the facility. Facility census information must also be posted. This final rule is also part of a broader communication outreach initiative by CMS to provide beneficiaries, their families, and the public with access to updated data and other information that can assist them in making healthcare decisions.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 5, 2005
This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary). This meeting is open to the public.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Council of Healthcare Research and Quality.
Proposed Collection; Comment Request; The NIDA Primary Care Physician Outreach Project
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The NIDA Primary Care Physician Outreach Project Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a 4-year generic clearance to study the extent to which NIDA is (1) increasing awareness among primary care physicians and other medical professionals about drug addiction as a major public health issue, (2) increasing their awareness of NIDA and NIDA-funded research, and (3) providing them with the information resources needed to incorporate such research findings into their clinical practices. Primary care physicians and other medical professionals, especially those who care for adolescents, are front line individuals helping patients with drug abuse-or drug addiction-related health and mental health problems. Each has key roles in obtaining, disseminating, and applying drug abuse and addiction resource materials in clinical practice. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Formative, process, and outcome evaluations using a multi-method approach (surveys, focus, groups, case studies) will be employed to determine the most appropriate resources and also the usefulness of the materials developed for physicians and other medical professionals. Measures will include the following variables: the information needs and learning styles and preferences of physicians and other medical professionals; their knowledge/awareness of NIDA and the NIDA resources developed for physicians and other medical professionals; their attitudes toward NIDA and the NIDA resources developed for them; their use of the resources developed by NIDA; and ways to strengthen NIDA's knowledge dissemination activities. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals, organizations, and businesses. Type of Respondents: physicians, physician assistants, nurses, medical office managers, hospital/clinic based health educators, and hospital/clinic based social workers. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 1118; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 0.39. Estimated Total Annual Burden Hours Requested: 872.24. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.
Assistant Secretary for Planning & Evaluation; Medicaid Program; Announcement of the Appointment of New Individuals To Serve on the Medicaid Commission
This notice announces the appointment of three new individuals to serve on the Medicaid Commission and the release of one Commissioner from service on the Medicaid Commission. Notice of this announcement is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 2(b)(5)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high- quality health care to its beneficiaries in a financially sustainable way. New Medicaid Commission Voting Members: John Ellis ``Jeb'' Bush, Joe Manchin III, and Donald Young. Medicaid Commission Member Released from Service on the Medicaid Commission: Michael O'Grady.
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