Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

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Advisory Committees; Tentative Schedule of Meetings for 2007
Document Number: E6-22389
Type: Notice
Date: 2006-12-29
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 2007. 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.
Update to ATSDR Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil
Document Number: E6-22388
Type: Notice
Date: 2006-12-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
ATSDR is seeking public comment on the draft revision of its 1998 Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil. The policy is intended to assist health assessors who must evaluate the public health implications of dioxin and dioxin-like compounds (e.g., 2,3,7,8-tetrachlorodibenzo-p-dioxin [TCDD], chlorinated dibenzodioxins [CDDs], chlorinated dibenzofurans [CDFs], and other structurally related groups of chemicals from the family of halogenated aromatic hydrocarbons) in residential soils near or on hazardous waste sites. The 1998 policy established a screening level of 0.05 ppb TEQ (50 ppt), an evaluation level (>0.05 ppb TEQ,
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E6-22381
Type: Notice
Date: 2006-12-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Collection; Comment Request; Genetic Studies in a Cohort of U.S. Radiologic Technologists
Document Number: E6-22348
Type: Notice
Date: 2006-12-29
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 Cancer Institute, 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-22233
Type: Notice
Date: 2006-12-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
Document Number: 06-9931
Type: Notice
Date: 2006-12-29
Agency: Department of Health and Human Services
This notice announces the 11th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 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).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension of Current Program Announcement and Grant Application Template for Older Americans Act Title IV Discretionary Grants Program
Document Number: E6-22276
Type: Notice
Date: 2006-12-28
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below 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; Submission for OMB Review; Comment Request; Title III and VII State Program Report
Document Number: E6-22273
Type: Notice
Date: 2006-12-28
Agency: Aging Administration, Department of Health and Human Services
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Privacy Act of 1974; CMS Computer Match No. 2006-06, HHS Computer Match No. 0603
Document Number: E6-22253
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with various Participating States. We have provided information about the matching program in the ``Supplementary Information'' section below. The Privacy Act provides an opportunity for interested persons to comment on the matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.
Prospective Grant of Exclusive License: Convection Enhanced Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to the Central Nervous System
Document Number: E6-22187
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS. Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic Agents,'' Provisional Patent Application, 60/413,673; International Patent Application PCT/US03/30155, U.S. Patent Application Serial No. 10/528,310; European Patent Application Serial No. 03756863.1; Australian Patent Application No. 2003299140; Canadian Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and /1 ``Method for Increasing the Distribution of Therapeutic Agents;'' and ``Method for Increasing the Distribution of Nucleic Acids;'' Provisional Patent Application 60/250,286; Provisional Patent Application No. 60/286,308; U.S. Patent Application No. 09/999,203; U.S. Patent Application No. 10/132,681; and Canadian Patent Application No. 2327208, to Medtronic Neurological, a Division of the Medtronic Corporation, having its headquarters in Minneapolis, Minnesota. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in a field of use limited to the development and sales of a clinical grade surrogate tracer for tracking the distribution of convection enhanced delivered central nervous system therapeutics, excluding lipid based systems.
Submission of Information Collection to the Office of Management and Budget
Document Number: 06-9907
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, Indian Health Service, Department of the Interior, Bureau of Indian Affairs, Indian Affairs Bureau
The Bureau of Indian Affairs and Indian Health Service are submitting the information collection, titled ``Indian Self- Determination and Education Assistance Act Programs, 25 CFR 900'' to the Office of Management and Budget for renewal. The information collection, OMB Control 1076-0136, is used to process contracts, grants or cooperative agreements for award by the Bureau of Indian Affairs and the Indian Health Service as authorized by the Indian Self-Determination and Education Assistance Act, as amended. The Department of the Interior and the Department of Health and Human Services invite you to submit comments to the OMB on the information collection described below.
National Institutes of Child Health and Human Development; Notice of Closed Meeting
Document Number: 06-9889
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute, Amended Notice of Meeting
Document Number: 06-9888
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 06-9887
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 06-9886
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 06-9885
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 06-9884
Type: Notice
Date: 2006-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Report of a Modified or Altered System of Records
Document Number: E6-22139
Type: Notice
Date: 2006-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR, ``CMS Fraud Investigation Database (FID), System No. 09-70-0527,'' most recently modified at 67 FR 65795 (October 28, 2002). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remained as routine use number 1. We will delete routine use number 2 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of information to another Federal and state agencies to: (1) Contribute to the accuracy of CMS' proper payment of Medicare benefits; (2) enable such agency to administer a Federal health benefits program, and/or (3) assist Federal/state Medicaid programs within the state. We will broaden the scope of routine uses number 4 and 5 authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to collect and maintain information to: (1) Identify if a violation(s) of a provision of the Social Security Act (the Act) or a related penal or civil provision of the United States Code (U.S.C.) related to Medicare (Title XVIII), Medicaid (Title XIX), HMO/Managed Care (Title XX), and Children's Health Insurance Program (Title XXI) have been committed; (2) determine if HHS has made a proper payment as prescribed under applicable sections of the Act; (3) determine whether these programs have been abused; and (4) coordinate investigations related to Medicare, Medicaid, HMO/Managed Care, and Children's Health Insurance Program; (5) prevent duplications investigatory efforts; and (5) provide case file material to the HHS Office of the Inspector General when a case is referred for fraud investigation. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support litigation involving the Agency related to this system of records; and (4) combat fraud, waste, and abuse in certain health care programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period. Effective Dates: CMS filed a modified or altered system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on December 20, 2006. To ensure that all parties have adequate time in which to comment, the modified system, including routine uses, will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless CMS receives comments that require alterations to this notice.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-22138
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Privacy Act of 1974; Deletion of System of Records
Document Number: E6-22125
Type: Notice
Date: 2006-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice supersedes the Federal Register Notice (FR)71 FR 70971 (December 7, 2006) that contained Centers Medicare & Medicaid Services (CMS) identification numbers that do not properly identify the CMS systems of records to be deleted.
NIOSH Proposed Revision of the “Occupational Exposure Sampling Strategies Manual (OESSM)”
Document Number: E6-22120
Type: Notice
Date: 2006-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) is considering updating the Occupational Exposure Sampling Strategies Manual(OESSM), NIOSH Document Number: DHHS (NIOSH) Publication Number 77-173; and requests user feedback to maximize the relevancy of any revisions to the document. Specifically, NIOSH seeks input in the following areas: 1. The relevance, currency, and appropriateness of the OESSM; identification of the most useful components of the OESSM; information on the disciplines and jobs of current users; and other useful resources related to sampling strategies. 2. The need for an updated/revised OESSM; the types of information needed but not currently included in the OESSM; the revisions needed to make the OESSM more useful; the gaps, unmet needs for guidance, or needs for new information; and the topics that do not need to be updated or addressed in the OESSM to avoid duplicating already existing materials. 3. Information needs relative to exposure assessment and sampling strategies (e.g., qualitative vs. quantitative, control banding approaches, etc.). 4. The Action Level approach (decision statistics, utility of the decision logic chart in the current OESSM [p. 11]). 5. Statistical issues, including the need for new sampling strategy statistics, the existing sampling strategy applications, and the need for specific sampling strategies that are currently not addressed. 6. The most appropriate (needed or preferred) dissemination medium for an updated/revised OESSM (hard copy, CD, Web-based, etc.), including the preferred organizational format (e.g., one large document, one overview document with several monographs on specific topics, etc). NIOSH expects to hold a public meeting (date, time, and location to be announced in the Federal Register on a later date) for additional input on future occupational exposure sampling strategies guidance. A copy of the current Occupational Exposure Sampling Strategies Manual and additional information related to this announcement can be found at: http://www.cdc.gov/niosh/review/public/77-173.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-22119
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-22118
Type: Notice
Date: 2006-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-22117
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the special Exposure Cohort
Document Number: 06-9877
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Oak Ridge Thermal Diffusion Plant (S-50), Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 06-9876
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Los Alamos National Laboratory, Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, as provided for under 42 U.S.C. 7834q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the special Exposure Cohort
Document Number: 06-9875
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Oak Ridge Institute of Nuclear Studies Cancer Research Hospital, Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 9, 2006, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Submission for OMB Review; Comment request; The Atherosclerosis Risk in Communities Study (ARIC)
Document Number: 06-9874
Type: Notice
Date: 2006-12-27
Agency: Department of Health and Human Services, National Institutes of Health
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 for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 28, 2006, pages 50924-50925, and allowed 60-days for public comments. Only one comment was 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, 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 currently OMB control number. Proposed Collection: Title: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0281. Need and Use of Information Collection: This project involves annual follow-up by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in middle aged and older men and women. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households: Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 12,845; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours per Response: 0.242; and Estimated Total Annual Burden Hours Requested: 3,108. The annualized cost to respondents is estimated at $60,525, assuming respondents' time at the rate of $16.5 per hour for family and patient respondents, and $75 per hour for physicians. There are not Capital Costs to report. There are no Operation or Maintenance Costs to report.
Medical Devices; Exemptions from Premarket Notification; Class II Devices
Document Number: E6-22072
Type: Notice
Date: 2006-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption for cranial orthosis type devices from the premarket notification requirements for certain class II devices. A cranial orthosis device is a device intended to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry or shape. FDA is publishing this notice in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E6-22049
Type: Notice
Date: 2006-12-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory 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 http:// workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice
Document Number: E6-21995
Type: Notice
Date: 2006-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Required Warnings and Other Labeling
Document Number: E6-21855
Type: Proposed Rule
Date: 2006-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to amend its over-the-counter (OTC) labeling regulations and the tentative final monograph (TFM) for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include new warnings and other labeling requirements advising consumers about potential risks and when to consult a doctor. FDA is also proposing to remove the alcohol warning in its regulations and add new warnings and other labeling for all OTC IAAA drug products. The new labeling would be required for all OTC drug products containing an IAAA active ingredient whether marketed under an OTC drug monograph or an approved new drug application (NDA). FDA is issuing this proposal as part of its ongoing review of OTC drug products after considering the advice of its Nonprescription Drugs Advisory Committee (NDAC) and other available information. FDA is proposing these labeling changes because it has tentatively concluded they are necessary for these ingredients to be considered generally recognized as safe and effective and not misbranded for OTC use. FDA will address information about the cardiovascular risks of nonsteroidal anti-inflammatory drugs (NSAIDs) that was discussed at a February 16- 18, 2005, FDA advisory committee meeting, and the ``Allergy alert'' warning for NSAID products, in a future issue of the Federal Register.
Medical Device Regulations; Disqualification of a Clinical Investigator; Technical Amendment
Document Number: E6-21952
Type: Rule
Date: 2006-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending a medical device regulation to include references to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This regulation pertains to the disqualification of a clinical investigator. Currently, only a reference to the Center for Devices and Radiological Health is listed in this regulation. This action is being taken to ensure the accuracy of FDA's regulations.
Implantation or Injectable Dosage Form New Animal Drugs; Gentamicin
Document Number: E6-21951
Type: Rule
Date: 2006-12-22
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 Sparhawk Laboratories, Inc. The ANADA provides for use of a gentamicin sulfate injectable solution in piglets for treatment of porcine colibacillosis.
Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to Food and Drug Administration Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations
Document Number: E6-21950
Type: Notice
Date: 2006-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations.'' This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under Sec. 50.54 (21 CFR 50.54) and in reaching final determinations in accordance with these regulations. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2006.
Advisory Committee for Reproductive Health Drugs; Notice of Meeting
Document Number: E6-21949
Type: Notice
Date: 2006-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21935
Type: Notice
Date: 2006-12-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21933
Type: Notice
Date: 2006-12-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21932
Type: Notice
Date: 2006-12-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21931
Type: Notice
Date: 2006-12-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E6-21917
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-21916
Type: Notice
Date: 2006-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Prospective Grant of Exclusive License: Method of Treating or Preventing Cancer Using Radiosensitizing Agents
Document Number: E6-21905
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Provisional Patent Application No. 60/718,172, filed September 16, 2005, entitled ``Method of Treating or Preventing Cancer Using Pyridine Carboxaldehyde Pyridine Thiosemicarbazone Radiosensitizing Agents'' [E- 319-2005/0-US-01; E-319-2005/0-PCT-02], to Vion Pharmaceuticals, Inc., having a place of business in New Haven, Connecticut. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the Triapine as a radiosensitizer as claimed in the licensed patent rights for the treatment of cancer and other tumors.
Medicare Program; First Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-March 7, 8, and 9, 2007
Document Number: E6-21736
Type: Notice
Date: 2006-12-22
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 Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2007. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. CMS will consider the Panel's advice as we prepare the proposed and final rules that update the hospital Outpatient Prospective Payment System (OPPS) for CY 2008. Meeting Dates: We are scheduling the first biannual meeting in 2007 for the following dates and times: Wednesday, March 7, 2007, 1 p.m. to 5 p.m. (e.s.t.) Thursday, March 8, 2007, 8 a.m. to 5 p.m. (e.s.t.) Friday, March 9, 2007, 8 a.m. to 12 noon (e.s.t.) \1\
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2006
Document Number: E6-21735
Type: Notice
Date: 2006-12-22
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 2006 through September 2006, 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 and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. 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; Meeting of the Advisory Panel on Medicare Education, January 24, 2007
Document Number: E6-21434
Type: Notice
Date: 2006-12-22
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 24, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) 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.
Medicare Program; Town Hall Meeting on the Fiscal Year 2008 Applications for New Medical Services and Technologies and Informational Workshop on Payment for New Technologies Under the Inpatient Prospective Payment System (IPPS) and the Outpatient Prospective Payment System (OPPS), Processes for Diagnosis-Related Group (DRG) Assignment; and Requesting New International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) Codes Under the IPPS-February 22, 2007 (CMS-1382-N)
Document Number: 06-9838
Type: Notice
Date: 2006-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall Meeting to discuss fiscal year (FY) 2008 applications for add-on payments for new medical services and technologies under the Inpatient Prospective Payment System (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2008 new medical services and technologies applications meet the substantial clinical improvement criteria. Additionally, we will hold an Informational Workshop for all interested parties on the application process and criteria for new medical services and technologies add-on payments under the IPPS, the transitional pass-through payment and new technology ambulatory payment classification (APC) assignment application processes under the Outpatient Prospective Payment System (OPPS) and the processes of Diagnosis-Related Group (DRG) assignment and requesting new ICD-9 codes under the IPPS.
Administration for Children and Families
Document Number: 06-9834
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, Children and Families Administration
Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as 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), Improving the Well-Being of Children Native American Health Marriage Initiative (hereinafter referred to as Healthy Marriage) 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. This Notice also provides additional information about ANA's plan for administering the programs.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 06-9817
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, National Institutes of Health