Agency Emergency Processing Under Office of Management and Budget Review; Implementation of Sections 222, 223, and 224 of the Food and Drug Administration Amendments Act of 2007
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the requirement established by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that device establishments must submit registration and listing information by electronic means using FDA Form 3673, unless the Secretary of Health and Human Services (the Secretary) grants them a waiver from the electronic submission requirement.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
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 collection of information associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the U.S. Government.
Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Administrative Procedures for CLIA Categorization.'' The guidance describes FDA's current practices concerning the administrative aspects of categorizing commercially available in vitro diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The guidance discusses what manufacturers should submit to help expedite CLIA categorization by FDA.
Certain Other Dosage Form New Animal Drugs; Sevoflurane
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 Minrad, Inc. The ANADA provides for the use of sevoflurane inhalant anesthetic in dogs.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 18-19, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709. The meeting is scheduled from 8:30 a.m. to 5:30 p.m. on June 18 and 8:30 a.m. until adjournment on June 19. The meeting is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2009
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2009. In addition, it would recalibrate the case-mix indexes so that they more accurately reflect parity in expenditures related to the implementation of case-mix refinements in January 2006. It also discusses our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification (STRIVE) project. Finally, the proposed rule would make technical corrections in the regulations text with respect to Medicare bad debt payments to SNFs and the reference to the definition of urban and rural as applied to SNFs.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2008 (RY 2009)
This notice updates the prospective payment rates for Medicare inpatient psychiatric hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the rate year beginning July 1, 2008 through June 30, 2009.