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: ``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
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.
Oral Dosage Form New Animal Drugs; Amprolium; Correction
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) that appeared in the Federal Register of August 6, 2008 (73 FR 45610). FDA is correcting a paragraph designating the sponsors of approved applications for oral dosage forms of amprolium. This correction is being made to improve the accuracy of the animal drug regulations.
Global Harmonization Task Force, Study Group 1; Proposed and Final Documents; Availability
The Food and Drug Administration (FDA) is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF). These documents represent a harmonized proposal and recommendation from the GHTF Study Group that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacture of products in the United States.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)
The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is amending FDA's regulation on the use of ozone-depleting substances (ODSs) in self- pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). The Clean Air Act requires FDA, in consultation with the EPA, to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. FDA has concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs as of December 31, 2011. Epinephrine MDIs containing an ODS cannot be marketed after this date.
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
This final rule with comment period implements changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also finalizes the calendar year (CY) 2008 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2009. In addition, as required by the statute, it announces that the physician fee schedule update is 1.1 percent for CY 2009, the preliminary estimate for the sustainable growth rate for CY 2009 is 7.4 percent, and the conversion factor (CF) for CY 2009 is $36.0666. This final rule with comment period also implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). (See the Table of Contents for a listing of the specific issues addressed in this rule.)
Draft Guidance for Industry on Process Validation: General Principles and Practices; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Process Validation: General Principles and Practices.'' FDA is revising its guidance for industry entitled ``Guideline on General Principles of Process Validation,'' which issued in May 1987 (the 1987 guidance). The revised draft guidance promotes a ``lifecycle'' approach to process validation that includes scientifically sound design practices, robust qualification, and process verification. When finalized, this draft guidance will replace the 1987 guidance.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Enforcement Notifications
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.
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile; Technical Amendment
The Food and Drug Administration (FDA) is amending the biologics regulations to reincorporate a regulation that was inadvertently removed. This action is being taken to correct the regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT
The Food and Drug Administration (FDA) has determined the regulatory review period for SOMATULINE DEPOT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Compliance With the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly “Reprocessed Single-Use Device Labeling”)
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 reprocessed single-use device labeling.
Diseases Transmitted Through the Food Supply
Section 103(d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109). The final list has been reviewed in light of new information and has been revised as set forth below.
Medicare and Medicaid Programs; Approval of the Accreditation Association for Ambulatory Health Care for Continued Deeming Authority for Ambulatory Surgical Centers
This notice announces our decision to approve the Accreditation Association for Ambulatory Health Care (AAAHC) for continued recognition as a national accreditation program for ambulatory surgical centers (ASCs) seeking to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Approval of the Joint Commission for Continued Deeming Authority for Ambulatory Surgical Centers
This notice announces our decision to approve the Joint Commission for continued recognition as a national accreditation program for ambulatory surgical centers (ASCs) seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs: Clarification of Compensation Plans
This interim final rule with comment period (IFC) revises the regulations governing the Medicare Advantage (MA) program (Part C), and prescription drug benefit program (Part D). This IFC 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. The new marketing requirements, which set forth new limits on the compensation that can be paid to agents or brokers with respect to Part C and Part D plans, are based on authority under provisions in the Medicare Improvements for Patients and Providers Act (MIPPA) that became law on July 15, 2008.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
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 the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
Notice of Hearing: Reconsideration of Disapproval of Michigan State Plan Amendment (SPA) 07-21
This notice announces an administrative hearing to be held on January 6, 2009, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, Illinois 60601 to reconsider CMS' decision to disapprove Michigan SPA 07-21.