Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

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Draft Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy; Draft Supporting Document: Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small Children; Availability
Document Number: 05-24494
Type: Notice
Date: 2005-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement Policy.'' This draft guidance provides a recommended maximum lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The agency is also announcing the availability of a draft supporting document entitled ``Supporting Document for Recommended Maximum Level for Lead in Candy Likely To Be Consumed Frequently by Small Children.'' These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of reducing lead levels in the food supply to reduce consumers' lead exposure to the lowest level that practicably can be obtained.
Healthy Tomorrows Partnership for Children Program (HTPC)
Document Number: 05-24444
Type: Proposed Rule
Date: 2005-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.
Oral Dosage Form New Animal Drugs; Furosemide
Document Number: 05-24440
Type: Rule
Date: 2005-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for oral use of furosemide syrup for the treatment of edema in dogs.
Medicare Program; Meeting of the Advisory Panel on Medicare Education, January 26, 2006
Document Number: E5-7757
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on January 26, 2006. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting
Document Number: E5-7726
Type: Notice
Date: 2005-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
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 Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, and Distributor Reporting.
Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates; Correction
Document Number: 05-24447
Type: Rule
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 10, 2005 entitled ``Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2006 Payment Rates; Final Rule.''
Medicare Program; Establishment of the Medicare Advantage Program
Document Number: 05-24446
Type: Rule
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on January 28, 2005 entitled ``Establishment of the Medicare Advantage Program.''
Medicare Program; E-Prescribing and the Prescription Drug Program; Correction
Document Number: 05-24445
Type: Rule
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on November 7, 2005, entitled ``Medicare Program; E-Prescribing and the Prescription Drug Program.''
Simplification of the Grant Appeals Process
Document Number: 05-24442
Type: Rule
Date: 2005-12-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Department of Health and Human Services (HHS) is amending regulations to remove the Health Resources and Services Administration (HRSA) from the list of agencies which require grantees to utilize an informal appeals procedure for grant related disputes subject to the departmental appeal procedures. In doing so, HRSA will simplify the appeals procedure for aggrieved HRSA grantees by permitting them direct access to the Departmental Grant Appeals Board.
Medicare and Medicaid Programs: Reporting Outcome and Assessment Information Set Data as Part of the Conditions of Participation for Home Health Agencies
Document Number: 05-24389
Type: Rule
Date: 2005-12-23
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This final rule makes revisions in response to public comments received on the January 25, 1999 interim final rule with comment period (64 FR 3748). The interim final rule requires electronic reporting of data from the Outcome and Assessment Information Set as a Condition of Participation for home health agencies.
Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Document Number: 05-24387
Type: Rule
Date: 2005-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the regulation authorizing a health claim on the relationship between oat beta-glucan soluble fiber and reduced risk of coronary heart disease (CHD). The amendment adds barley as an additional eligible source of beta-glucan soluble fiber. We (FDA) are taking this action in response to a petition that the National Barley Foods Council submitted. We have concluded, based on the totality of publicly available scientific evidence that, in addition to certain oat products, whole grain barley and certain dry milled barley grain products are appropriate sources of beta-glucan soluble fiber for the health claim.
New Animal Drugs; Moxidectin
Document Number: 05-24386
Type: Rule
Date: 2005-12-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The NADA provides for oral use of moxidectin solution in sheep for the treatment and control of a variety of internal parasites.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-24302
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-24301
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Medicare Program: Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups-March 1, 2, and 3, 2006
Document Number: 05-24290
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first biannual meeting of the Ambulatory Payment Classification (APC) Panel (the Panel) for 2006. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking.
Consolidated Health Informatics (CHI) Initiative; Health Care and Vocabulary Standards for Use in Federal Health Information Technology Systems
Document Number: 05-24289
Type: Notice
Date: 2005-12-23
Agency: Office of the Secretary, Department of Health and Human Services
This notice identifies the 20 messaging and vocabulary standards adopted for use in Federal government health information technology systems. The first set of 5 standards was adopted on March 21, 2003. The second set of 15 standards was adopted on May 6, 2004, thus completing the initial portfolio of the Consolidated Health Informatics (CHI) initiative.
Medicare Program; Hospice Wage Index for Fiscal Year 2006
Document Number: 05-24288
Type: Rule
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2005, entitled ``Hospice Wage Index for Fiscal Year 2006.''
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2005
Document Number: 05-24023
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2005 through September 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Medicare Program; Town Hall Meeting on the Fiscal Year 2007 Applications for New Medical Services and Technologies Add-On Payments Under the Hospital Inpatient Prospective Payment System Scheduled for February 16, 2006
Document Number: 05-24022
Type: Notice
Date: 2005-12-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice, in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act), announces a Town Hall meeting to discuss fiscal year (FY) 2007 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their individual comments, recommendations, and data regarding whether the FY 2007 new medical services and technologies applications meet the substantial clinical improvement criteria.
Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs
Document Number: E5-7646
Type: Proposed Rule
Date: 2005-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.
Advisory Committees; Tentative Schedule of Meetings for 2006
Document Number: E5-7645
Type: Notice
Date: 2005-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2006. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
Document Number: E5-7644
Type: Notice
Date: 2005-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Hand-Held, Doppler Ultrasound Prenatal Listening Devices
Document Number: E5-7643
Type: Notice
Date: 2005-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey
Document Number: E5-7642
Type: Notice
Date: 2005-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
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 FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey.
National Library of Medicine; Notice of Closed Meetings
Document Number: 05-24383
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: 05-24382
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-24381
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: 05-24379
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 05-24378
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 05-24377
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 05-24376
Type: Notice
Date: 2005-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Procedures for Designating Classes of Employees as Members of the Special Exposure Cohort Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Amendments; Interim Final Rule With Request for Comments
Document Number: 05-24358
Type: Rule
Date: 2005-12-22
Agency: Department of Health and Human Services
The Department of Health and Human Services (``HHS'') is amending its procedures to consider designating classes of employees to be added to the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000 (``EEOICPA''), 42 U.S.C. 7384-7385. HHS must change these procedures to implement amendments to EEOICPA enacted on October 28, 2004, as part of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Public Law 108-375 (codified as amended in scattered sections of 42 U.S.C.).
Agency Information Collection Activities; Proposed Collection; Comment Request; State Annual Long-Term Care Ombudsman Report and Instructions for Older Americans Act Title VII
Document Number: 05-24356
Type: Notice
Date: 2005-12-22
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) 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 information collection requirements relating to State Annual Long-Term Care Ombudsman Report and instructions for Older Americans Act Title VII.
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Plans for Future Expert Panel Evaluations of Bisphenol A and Hydroxyurea; Request for Comments and Nominations of Scientists Qualified To Serve on These Expert Panels
Document Number: E5-7617
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The CERHR plans to convene two expert panels to evaluate the scientific evidence regarding the potential reproductive and developmental toxicities of bisphenol A and hydroxyurea. Each expert panel will consist of approximately 12 scientists, selected for their expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. The CERHR invites the submission of public comments on these chemicals and the nomination of scientists to serve on the expert panels for their evaluation (see SUPPLEMENTARY INFORMATION below). These meetings are tentatively scheduled for late 2006, although the exact dates and locations have not yet been established. As plans are finalized, they will be announced in the Federal Register and posted on the NTP Web site (http://ntp-server.niehs.nih.gov). CERHR expert panel meetings are open to the public with time scheduled for oral public comment.
Native American Programs
Document Number: E5-7592
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) as amended by 42 U.S.C. 2991 et seq., ANA herein describes its issuance of final interpretive rules, general statements of policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. The notice also provides additional information about ANA's plan for administering the programs.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 05-24318
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-24317
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 05-24316
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 05-24315
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 05-24314
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 05-24313
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Intelligence Reform and Terrorism Prevention Act of 2004 Delegation of Authority
Document Number: 05-24312
Type: Notice
Date: 2005-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 05-24311
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 05-24310
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 05-24309
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 05-24308
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 05-24307
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; Comment Request; A Process/Outcome Evaluation of Parkinson's Disease Research Centers
Document Number: 05-24306
Type: Notice
Date: 2005-12-21
Agency: Department of Health and Human Services, National Institutes of Health
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 Institute of Neurological Disorders and Stroke (NINDS) Office of Science Policy and Planning, the National Institute 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: A Process/Outcome Evaluation of Parkinson's Disease Research Centers. Type of Information Collection Request: New. Need and Use of Information Collection: This study is primarily an outcome evaluation, designed to assess the extent to which the NINDS-funded Morris K. Udall Centers for Excellence in Parkinson's Disease Research have achieved the program's short-term and long-term goals. The study also includes elements of a process evaluation in its examination of the major activities conducted by the Udall Centers, the relationship between Center activities and the achievement of program goals, and the NINDS management of the program. The results of the full-scale evaluation should be very helpful to NINDS in identifying the most relevant measures for tracking the future progress of the Centers, developing strategies to enhance the program's effectiveness, and improving program management. NINDS will also use the findings to inform its National Advisory Neurological Disorders and Stroke Council, and to address inquiries from the public regarding the impact of the Udall Centers Program. Lastly, Udall Center awardees will be able to use the evaluation results to improve the performance of their Centers; and other NIH Institutes and Centers may use the methodology and results of this evaluation to guide their own centers assessments. Frequency of Response: Once or twice. Affected Public: Researchers, Not-for-profit institutions; Federal Government; individuals or households. Type of Respondents: Adult professionals. The annual reporting burden is represented in the following table:
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E5-7542
Type: Notice
Date: 2005-12-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration