Department of Health and Human Services November 21, 2008 – Federal Register Recent Federal Regulation Documents

Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E8-27714
Type: Notice
Date: 2008-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-27713
Type: Notice
Date: 2008-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs; Correcting Amendment
Document Number: E8-27712
Type: Rule
Date: 2008-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In the September 18, 2008 issue of the Federal Register (73 FR 54226), we published an interim final rule with comment period that revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. The interim final rule makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private-fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost- sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, the interim final rule sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. This correcting amendment corrects technical and typographical errors identified in the September 18, 2008 interim final rule.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27711
Type: Notice
Date: 2008-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Privacy Act of 1974; Report of Amended or Altered System; Medical, Health and Billing Records System
Document Number: E8-27708
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, Indian Health Service
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27696
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-27530
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-27529
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-27528
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27523
Type: Notice
Date: 2008-11-21
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: ``Improving implementation of the U.S. Preventive Services Task Force recommendation for prophylactic aspirin use among adults at risk for cardiovascular disease.'' 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
Document Number: E8-27522
Type: Notice
Date: 2008-11-21
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: ``Conducting Measurement Activities in Support of the AHRQ Health IT Initiative.'' 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. This proposed information collection was previously published in the Federal Register on September 19th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27521
Type: Notice
Date: 2008-11-21
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: ``Reducing Waste and Inefficiency through Process Redesign: Lean/Toyota Production System (TPS) Implementation.'' 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.
Patient Safety and Quality Improvement
Document Number: E8-27475
Type: Rule
Date: 2008-11-21
Agency: Department of Health and Human Services
The Secretary of Health and Human Services is adopting rules to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005, Pub. L. 109-41, 42 U.S.C. 299b-21b-26 (Patient Safety Act). The final rule establishes a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The final rule outlines the requirements that entities must meet to become PSOs and the processes by which the Secretary will review and accept certifications and list PSOs. It also describes the privilege and confidentiality protections for the information that is assembled and developed by providers and PSOs, the exceptions to these privilege and confidentiality protections, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.