Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

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Government-Owned Inventions; Availability for Licensing
Document Number: E9-31075
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: E9-31074
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: E9-31072
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
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.
Submission for OMB Review; Comment Request; A Generic Submission for Formative Research, Pretesting, and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: E9-31071
Type: Notice
Date: 2009-12-31
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 Cancer Institute (NCI), 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 October 28, 2009 (74 FR 55558) and allowed 60 days for public comment. One comment in regards to NCI's communication on October 28, 2009, and we responded on October 28, 2009, ``We received your comment. We will take your comments into consideration''. 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 valid OMB control number.
Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates
Document Number: E9-30967
Type: Rule
Date: 2009-12-31
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 found in the Federal Register (FR) on November 20, 2009, entitled ``Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E9-30957
Type: Notice
Date: 2009-12-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Development and Evaluation of AHRQ's Quality Indicators Improvement Toolkit.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Notice of Meeting
Document Number: E9-30956
Type: Notice
Date: 2009-12-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
National Library of Medicine; Notice of Meeting
Document Number: E9-30949
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
Request for Public Comment: 30-Day Proposed Information Collection: Application for Participation in the IHS Scholarship Program
Document Number: E9-30947
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 30-day advance opportunity for public comment on the proposed information collection project, the Indian Health Service (IHS) 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 project was previously published in the Federal Register (74 FR 36714) on July 24, 2009 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E9-30743
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E9-30742
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E9-30741
Type: Notice
Date: 2009-12-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E9-31014
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E9-31012
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E9-30989
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees at Brookhaven National Laboratory in Upton, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 10, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E9-30988
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees at the Piqua Organic Moderated Reactor site, Piqua, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 10, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E9-30987
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees at the Oak Ridge 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 December 10, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E9-30986
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees at Metals and Controls Corp. in Attleboro, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 10, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E9-30985
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees at the Hanford site in Richland, Washington, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 10, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Decision To Evaluate a Petition To Designate a Class of Employees for the Lawrence Berkeley National Laboratory, Berkeley, CA, To Be Included in the Special Exposure Cohort
Document Number: E9-30984
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Lawrence Berkeley National Laboratory, Berkeley, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Decision To Evaluate a Petition To Designate a Class of Employees for the Westinghouse Electric Corporation, Bloomfield, NJ, To Be Included in the Special Exposure Cohort
Document Number: E9-30983
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Westinghouse Electric Corporation, Bloomfield, New Jersey, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Advisory Committees; Tentative Schedule of Meetings for 2010
Document Number: E9-30973
Type: Notice
Date: 2009-12-30
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 2010. 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.
Second Annual Sentinel Initiative Public Workshop
Document Number: E9-30971
Type: Notice
Date: 2009-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
List of Recipients of Indian Health Scholarships Under the Indian Health Scholarship Program
Document Number: E9-30945
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, Indian Health Service
National Cancer Institute; Notice of Closed Meetings
Document Number: E9-30923
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E9-30922
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: E9-30921
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: E9-30907
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Vaccine Advisory Committee
Document Number: E9-30897
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-30890
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: E9-30889
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-30888
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E9-30882
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Pet Food Early Warning Recall Rational Questionnaire as Part of the MedWatchPlus
Document Number: E9-30872
Type: Notice
Date: 2009-12-30
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 and to allow for public comment in response to the notice. This notice solicits comments on the data elements for the Rational Questionnaire which is being rolled out as part of the ongoing MedWatch\Plus\ Portal and Rational Questionnaire initiative.
Medical Device Interoperability; Public Workshop
Document Number: E9-30871
Type: Notice
Date: 2009-12-30
Agency: Food and Drug Administration, Department of Health and Human Services
National Center for Research Resources; Notice of Meeting
Document Number: E9-30870
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E9-30868
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: E9-30865
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E9-30862
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E9-30859
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: E9-30856
Type: Notice
Date: 2009-12-30
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Adoption of ANA Program Policies and Procedures
Document Number: E9-30826
Type: Notice
Date: 2009-12-29
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 (NAPA), as amended, the Administration for Native Americans is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2010 Funding Opportunity Announcements (FOA) for the following programs: Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development StrategiesSpecial Initiative (hereinafter referred to as SEDS-SI), Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation), Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as Language-EMI), and Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice also provides additional information about ANA's plan for administering the programs.
Medicaid and CHIP Programs; Initial Core Set of Children's Healthcare Quality Measures for Voluntary Use by Medicaid and CHIP Programs
Document Number: E9-30802
Type: Notice
Date: 2009-12-29
Agency: Department of Health and Human Services, Office of the Secretary, Centers for Medicare & Medicaid Services
This notice identifies and solicits public comments on the initial, recommended core set of children's health care quality measures for voluntary use by State programs administered under titles XIX and XXI of the Social Security Act, health insurance issuers and managed care entities that enter into contracts with Medicaid and Children's Health Insurance Programs, and providers of items and services under these programs, in accordance with the Children's Health Insurance Program Reauthorization Act of 2009 (Pub. L. 111-3). This notice also discusses steps already underway to facilitate the programs' voluntary use of the children's health care quality measures. In addition, this notice solicits comments on how the steps might be enhanced, and recommendations for additional steps to facilitate use of the measures.
Informed Consent Elements
Document Number: E9-30751
Type: Proposed Rule
Date: 2009-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or agency) is issuing a proposed rule that, if finalized, would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA update its informed consent regulations to require that the informed consent documents and processes for certain clinical investigations include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank.
Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions; Availability
Document Number: E9-30750
Type: Notice
Date: 2009-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance to Pharmacies on Advance Compounding of Tamiflu Oral Suspension to Provide for Multiple Prescriptions.'' This guidance describes the circumstances in which FDA will not object to certain compounding of Tamiflu Oral Suspension in advance of receiving prescriptions.
Economic Analysis of Nutrition Interventions: Methods, Research and Policy
Document Number: E9-30683
Type: Notice
Date: 2009-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: E9-30680
Type: Notice
Date: 2009-12-29
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: E9-30560
Type: Proposed Rule
Date: 2009-12-29
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E9-30677
Type: Notice
Date: 2009-12-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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