Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents
Results 501 - 550 of 3,343
Medicare Program; Application by the American Association of Diabetes Educators (AADE) for Recognition as a National Accreditation Organization for Accrediting Entities To Furnish Outpatient Diabetes Self-Management Training
This proposed notice announces the receipt of an application from the American Association of Diabetes Educators (AADE) for recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training to Medicare beneficiaries. The statute requires that the Secretary publish a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period.
Medicare and Medicaid Programs; Conditional Approval of the Joint Commission's Continued Deeming Authority for Critical Access Hospitals
This notice announces our decision to conditionally approve, with a probationary period, the Joint Commission's request for continued recognition as a national accreditation program for critical access hospitals (CAHs) seeking to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``The AHRQ Data Inventory.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
Medicare Program; Plan To Transition to a Medicare Value-Based Purchasing Program for Physician and Other Professional Services: Listening Session, December 9, 2008
This notice announces a listening session being conducted as part of the development of a plan for the transition to a value-based purchasing program for physician and other professional services as required by section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The purpose of the listening session is to solicit comments on an issues paper that will present the range of issues being considered for plan development. Physicians, physician associations, and all others interested in the pursuit of new payment approaches to enhance the quality and efficiency of physician and other professional services are invited to participate, in person or by calling in to the teleconference. The issues paper will be posted on the CMS Web site Physician Center Spotlights at https://www.cms.hhs.gov/ center/physician.asp no later than November 28, 2008. The issues identified and discussed during this meeting will assist us in developing options for the plan. The meeting is open to the public, but attendance is limited to space and teleconference lines available.
Medicare Program; Meeting of the Practicing Physicians Advisory Council, December 8, 2008
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 manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services. This meeting is open to the public.
Substances Prohibited From Use in Animal Food or Feed; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2008 (73 FR 22720). The document amended the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE). The document was inadvertently published with incorrect dollar amounts in two separate areas: The summary of economic impacts and the paperwork burden table. This document corrects those errors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the record retention requirement of the soy protein/coronary heart disease health claim.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Biennial Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): NIH Publication No. 08-6529
NICEATM announces the availability of the ``Biennial Progress Report: Interagency Coordinating Committee on the Validation of Alternative Methods: 2006-2007.'' In accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), this report describes progress and activities during 2006-2007 by ICCVAM and NICEATM. The report is available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/about/ICCVAMrpts.htm. Copies can also be requested from NICEATM at the address given below.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatchPlus
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of MedWatch\Plus\ Portal and Rational Questionnaire to collect electronically all adverse event, consumer complaint/product problem and medication use error data submitted to FDA.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Final Guidance on Engagement of Institutions in Human Subjects Research
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a guidance document entitled, ``OHRP Guidance on Engagement of Institutions in Human Subjects Research.'' The guidance document describes: (1) Scenarios that, in general, would result in an institution being considered engaged in a human subjects research project; (2) scenarios that would result in an institution being considered not engaged in a human subjects research project; and (3) IRB review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance document is intended primarily for institutional review boards (IRBs), research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the Department of Health and Human Services (HHS). The guidance document announced in this notice finalizes the draft guidance with the same title that was made available for public comment in the Federal Register on December 8, 2006 (71 FR 71169). OHRP received twenty-four comments on the draft guidance document, and those comments were considered as the guidance was finalized. The final guidance document replaces two existing OHRP guidance documents on the engagement of institutions in human subjects research: (1) The January 26, 1999, document on ``Engagement of Institutions in Research,'' and (2) the December 23, 1999, document on ``Engagement of Pharmaceutical Companies in HHS Supported Research.''
Notice of Hearing: Reconsideration of Disapproval of Arkansas State Plan Amendment (SPA) 07-024
This notice announces an administrative hearing to be held on December 9, 2008, at the CMS Dallas Regional Office, 1301 Young Street, Suite 833, Room 1196, Dallas, Texas 75202, to reconsider CMS' decision to disapprove Arkansas SPA 07-024.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification for a New Dietary Ingredient
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification for a New Dietary Ingredient'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Authorization of Emergency Use of Doxycycline Hyclate Tablet Emergency Kits for Eligible United States Postal Service Participants in the Cities Readiness Initiative and Their Household Members; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible United States Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, HHS. The Authorization contains, among other things, conditions on the emergency use of doxycycline hyclate tablet emergency kits. The Authorization follows the determination by the Secretary of the Department of Homeland Security 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 such determination, Secretary of Health and Human Services Michael O. Leavitt (the Secretary) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued under 21 U.S.C. 360bbb-3(a). The Authorization, which includes an explanation of the reasons for its issuance, is reprinted in this Notice.
National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program (NTP); Request for Information (NOT-ES-09-001): Ongoing Research and Research Needs for Biological Effects of Exposure to Bisphenol A (BPA)
The NIEHS Division of Extramural Research and Training (DERT) and the NTP are seeking input on a number of key research areas that have been identified in recent evaluations of bisphenol A (BPA). Information provided will be used to help focus future research and testing activities on BPA. This Request for Information (RFI) is for planning purposes only and should not be construed as a funding opportunity or grant program. The NIEHS and NTP welcome input from the lay public, environmental health researchers, healthcare professionals, educators, policy makers, industry, and others with an interest in BPA.
Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the public meeting notice entitled ``Preparation for ICH meetings in Brussels, Belgium.'' This meeting was announced in the Federal Register of September 16, 2008 (73 FR 53428). The amendment is being made to reflect changes in the Location portion of the document. There are no other changes.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the meeting date for the 25th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Meeting Date: November 12, 2008, from 8:30 a.m. to 2:45 p.m. (Eastern)
Submission for OMB Review; Comment Request; Evaluation of Risk Factors Associated With Viral Infections in Chinese Donors: a. Risk Factors Associated With HIV; b. Risk Factors Associated With Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV).
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 31, 2008, pages 44751-44753 and allowed 60 days for public comment. 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, and 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 current valid OMB control number. Proposed Collection: Title: Evaluation of Risk Factors Associated with Viral Infections in Chinese Donors: a. Risk factors associated with Human Immunodeficiency Virus (HIV), b. Risk factors associated with Hepatitis B virus (HBV) and Hepatitis C virus (HCV). This collection will cover two protocols as stated in the title. The first protocol will aim to study risk factors associated with HIV in Chinese donors and the second protocol will study risk factors related to HBV and HCV in Chinese donors. Type of Information Collection Request: NEW. Need and Use of Information Collection: Understanding the risk factors associated with HIV, HBV and HCV infections in donors is essential for developing donor behavioral screening policies. Injection drug use, sexual transmissions, transfusion history, and medical injections are thought to be major routes of transmission in China but their relative importance in blood donors is unknown. In the U.S., risk factors have been better characterized, but questions still remain. Risk factors cannot be identified in 33% and 40% of persons with acute hepatitis B and C respectively, and risk factors may differ between the U.S. and China. This study will improve our understanding of potential transfusion transmitted viral risk factors that cannot be optimally studied in the U.S. because of their low prevalence. For example, we may be able to assess whether treatments commonly used in China, such as acupuncture and medical injections, are important routes of HBV and HCV transmission. The primary objectives of the proposed study are to assess: The primary risk factors associated with HIV, HBV and HCV. The relative importance of injection drug use, heterosexual transmission, family history, transfusion history, history of previous whole blood or plasma donation, male to male sex, medical injections, acupuncture, and tattoos as routes of transmission for HIV, HBV and HCV. Other important routes of transmission for these viruses such as sex with an injection drug user, snorting drugs, living with someone who has HBV and HCV, living with someone who injects drugs, sharing a toothbrush or a razor, having been in jail, occupational history, having surgery, etc. It is proposed to conduct a large, multi blood center case-control study to meet the study objectives. Cases for the HIV protocol will be donors with confirmed anti-HIV antibody reactivity. Blood centers will select a random group of donors with negative infectious disease test results as Controls for this study. Controls will be enrolled with a 2:1 ratio to Cases and will be matched to the Cases by blood center and donation month. Blood centers will contact potential Controls by phone and/or mail, inviting them to come back to participate in this study. Cases and Controls will be consented and interviewed using the same Risk Factor Questionnaire (RFQ) by Chinese-CDC (C-CDC) or blood center staff, either at the local C-CDC or blood center. The second protocol assessing risk factors related to HBV and HCV will have three groups of donors: ``HBV Group'': HBV (HBsAg) positive donors either from prescreening (rapid testing) or routine screening testing. Confirmatory testing for HBV will be done for these donors. ``HCV Group'': HCV (anti-HCV) positive donors from routine screening testing (blood centers do not do prescreening rapid testing for anti- HCV). Confirmatory testing for HCV will be done for these donors. The third group will be a ``Control Group'' including donors with negative results for all prescreening and routine screening tests. No additional testing is done for these donors. On a monthly basis, the blood centers will use the confirmatory testing results for HBV and HCV respectively, to generate a list of cases. For that same month, the blood center will generate a list of controls (randomly selected and matched by blood center and month of donation). The same control group will be used for HBV and HCV cases. Donors in all three groups will be mailed a Risk Factor Survey study packet. The packet will include a study information sheet (discussing the purpose and nature of this study), an informed consent document explaining the voluntary nature, the benefits and risks of this study, a RFQ, a small monetary reward for taking the survey and an envelope with paid postage for the donor to mail their completed questionnaire back to the blood center. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adult Blood Donors. The annual reporting burden is as follows: Estimated Number of Respondents: 3,920; Estimated Number of Responses per Respondent: 1; Average Burden of Hours per Response: 0.33; and Estimated Total Annual Burden Hours Requested: 1,293.5. The annualized cost to respondents is estimated at: $1,940.25 (based on $1.50 per hour). According to China's National Bureau of Statistics in 2006, the average annual wage in China is 21,001 Chinese Yuan (or $2,958 U.S. dollars based on current exchange rate of 1 U.S. dollar = 7.1). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Draft Guidance for Industry on Tropical Disease Priority Review Vouchers; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of section 1102 of the Food and Drug Administration Amendments Act (FDAAA), which adds a new section 524 to the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the act. This draft guidance explains to internal and external stakeholders how FDA intends to implement the provisions of section 524.
National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States, and recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
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