Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents
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National Biodefense Science Board; Notification of a Public Teleconference
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public teleconference. The meeting is open to the public.
Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph; Corrections
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 29, 2009. The document requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDs). The document was published with an incorrect Analysis of Impacts section and omitted a reference from the reference section of the final rule. The document was also published with an error in the codified text regarding the introductory sentence to the stomach bleeding warning for NSAIDs. This document replaces the incorrect Analysis of Impacts section with the correct Analysis of Impacts section, adds a reference to the reference section of the final rule, and corrects the codified text.
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees for Area IV of the Santa Susana Field Laboratory, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees for the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Medicaid Program; Health Care-Related Taxes
This rule finalizes our proposal to delay enforcement of certain clarifications regarding standards for determining hold harmless arrangements in the final rule entitled, ``Medicaid Program; Health Care-Related Taxes'' from the expiration of a Congressional moratorium on enforcement from July 1, 2009 to June 30, 2010.
Medicaid Program: Rescission of School-Based Administration/Transportation Final Rule, Outpatient Hospital Services Final Rule, and Partial Rescission of Case Management Interim Final Rule
This rule finalizes our proposal to rescind the December 28, 2007 final rule entitled, ``Elimination of Reimbursement under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School;'' the November 7, 2008 final rule entitled, ``Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition;'' and certain provisions of the December 4, 2007 interim final rule entitled, ``Optional State Plan Case Management Services.'' These regulations have been the subject of Congressional moratoria and have not yet been implemented (or, with respect to the case management interim final rule, have only been partially implemented) by CMS. In light of concerns raised about the adverse effects that could result from these regulations, in particular, the potential restrictions on services available to beneficiaries and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted, CMS is rescinding the two final rules in full, and partially rescinding the interim final rule. Rescinding these provisions will permit further opportunity to determine the best approach to further the objectives of the Medicaid program in providing necessary health benefits coverage to needy individuals.
Meeting of the National Advisory Council for Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare in Medicaid and Children's Health Insurance Programs (CHIP)
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare in Medicaid and Children's Health Insurance Programs (CHIP).
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: ``Health IT Community Tracking Study 2009.'' 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.
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: ``Building an Implementation Toolset for E-Prescribing.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Privacy Act of 1974, as Amended; Computer Matching Program
In accordance with the Privacy Act of 1974, as amended, OCSE is publishing notice of a new computer matching program between OCSE and State Agencies administering the Supplemental Nutrition Assistance Program (SNAP).
Draft Guidance for Industry on Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for
Privacy Act of 1974; Addition of a New Routine Use
CMS proposes to add a new routine use to its inventory of SOR subject to the Privacy Act of 1974 (Title 5 United States Code (U.S.C.) 552a) authorizing disclosure of individually identifiable information to assist in efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in these systems of records. The new routine use will be prioritized in the next consecutive numbered order of routine uses in each system notice and will be included in the next published notice as part of our normal SOR review process. The new routine use will read as follows:
Medicare and Medicaid Programs; Application by the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Deeming Authority for Ambulatory Surgical Centers
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period.
President's Advisory Council for Faith-based and Neighborhood Partnerships
The President's Advisory Council for Faith-based and Neighborhood Partnerships will hold a Council meeting. Topics to be discussed include updates from Council subcommittees on Reform of the Office, Economic Recovery, Fatherhood and Healthy Families, Inter- religious Dialogue and Cooperation, Environment and Climate Change and Global Poverty and Development.
Medicare and Medicaid Programs; Application by the Joint Commission for Continued Deeming Authority for Hospitals
This proposed notice acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Oral Dosage Form New Animal Drugs; Trilostane
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the supplemental approval of a new animal drug application (NADA) filed by Dechra, Ltd. The supplemental NADA provides for the addition of a 10-milligram capsule size of trilostane, used in dogs for treatment of hyperadrenocorticism.
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