Department of Health and Human Services May 2008 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 304
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-10679
Type: Notice
Date: 2008-05-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: E8-10677
Type: Notice
Date: 2008-05-13
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: E8-10491
Type: Notice
Date: 2008-05-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-10490
Type: Notice
Date: 2008-05-13
Agency: Department of Health and Human Services, National Institutes of Health
Pilot Program to Evaluate Proposed Name Submissions; Concept Paper; Public Meeting
Document Number: E8-10513
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) are announcing a public technical meeting in preparation for a pilot program to enable pharmaceutical firms to evaluate proposed propriety names and submit the data generated from those evaluations to FDA for review. The purpose of the public technical meeting is to discuss a concept paper that describes the logistics of the pilot program, proposed recommendations for carrying out a proprietary name review, and the way FDA intends to review submissions made under the pilot program. FDA plans to formally issue the concept paper by the end of fiscal year (FY) 2008 and expects to begin enrollment in the pilot program in FY 2009.
Determination of Regulatory Review Period for Purposes of Patent Extension; VECTIBIX
Document Number: E8-10512
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for VECTIBIX 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 biological product.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-10474
Type: Notice
Date: 2008-05-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Development of Set 22 Toxicological Profiles
Document Number: E8-10472
Type: Notice
Date: 2008-05-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the development of Set 22 Toxicological Profiles. Set 22 Toxicological Profiles consists of one new draft and five updated drafts. These profiles will be available to the public for comment on or about October 17, 2008.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-10470
Type: Notice
Date: 2008-05-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer Survey on the Impact of Perceptions of the 2006 Spinach Recall on Current Spinach Consumption
Document Number: E8-10467
Type: Notice
Date: 2008-05-12
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 60 days for public comment in response to the notice. This notice solicits comments on a proposed survey of how consumer perceptions of the 2006 spinach recall affect their current spinach consumption behaviors.
Determination of Regulatory Review Period for Purposes of Patent Extension; OMNARIS
Document Number: E8-10466
Type: Notice
Date: 2008-05-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for OMNARIS 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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: E8-10460
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: E8-10330
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: E8-10325
Type: Notice
Date: 2008-05-12
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Meeting
Document Number: E8-10329
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-10328
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: E8-10327
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: E8-10326
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-10323
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Committee on Vital and Health Statistics: Meeting
Document Number: E8-10322
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-10321
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: E8-10320
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Amended Notice of Meeting
Document Number: E8-10317
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-10285
Type: Notice
Date: 2008-05-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Office of Urban Indian Health Programs; Announcement Type: Targeted Solicitation
Document Number: E8-10218
Type: Notice
Date: 2008-05-09
Agency: Department of Health and Human Services, Indian Health Service
Medicare Program; Prospective Payment System for Long-Term Care Hospitals RY 2009: Annual Payment Rate Updates, Policy Changes, and Clarifications; and Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period
Document Number: 08-1219
Type: Rule
Date: 2008-05-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). We are also consolidating the annual July 1 update for payment rates and the October 1 update for Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) weights to a single rulemaking cycle that coincides with the Federal fiscal year (FFY). In addition, we are clarifying various policy issues. This final rule also finalizes the provisions from the Electronic Submission of Cost Reports: Revision to Effective Date of Cost Reporting Period interim final rule with comment period that was published in the May 27, 2005 Federal Register which revises the existing effective date by which all organ procurement organizations (OPOs), rural health clinics (RHCs), Federally qualified health centers (FQHCs), and community mental health centers (CMHCs) are required to submit their Medicare cost reports in a standardized electronic format from cost reporting periods ending on or after December 31, 2004 to cost reporting periods ending on or after March 31, 2005. This final rule does not affect the current cost reporting requirement for hospices and end-stage renal disease (ESRD) facilities. Hospices and ESRD facilities are required to continue to submit cost reports under the Medicare regulations in a standardized electronic format for cost reporting periods ending on or after December 31, 2004.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: E8-9870
Type: Notice
Date: 2008-05-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-9868
Type: Notice
Date: 2008-05-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-9865
Type: Notice
Date: 2008-05-08
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Meeting
Document Number: E8-9864
Type: Notice
Date: 2008-05-08
Agency: Department of Health and Human Services, National Institutes of Health
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: E8-10307
Type: Notice
Date: 2008-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-10258
Type: Notice
Date: 2008-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: E8-10257
Type: Notice
Date: 2008-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-10215
Type: Notice
Date: 2008-05-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements
Document Number: E8-10204
Type: Notice
Date: 2008-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
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
Document Number: E8-10194
Type: Notice
Date: 2008-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: E8-10180
Type: Notice
Date: 2008-05-07
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, 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
Document Number: E8-10178
Type: Notice
Date: 2008-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: E8-10153
Type: Rule
Date: 2008-05-07
Agency: Food and Drug Administration, Department of Health and Human Services
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 Cancer Institute; Notice of Meeting
Document Number: E8-10014
Type: Notice
Date: 2008-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-10013
Type: Notice
Date: 2008-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Document Number: E8-10010
Type: Notice
Date: 2008-05-07
Agency: Department of Health and Human Services, National Institutes of Health
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
Document Number: 08-1214
Type: Proposed Rule
Date: 2008-05-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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)
Document Number: 08-1213
Type: Notice
Date: 2008-05-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Statement of Organization, Functions and Delegation of Authority
Document Number: E8-9898
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Fast Track Drug Development Programs: Designation, Development, and Application Review
Document Number: E8-9882
Type: Notice
Date: 2008-05-06
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, 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 proposed collection of information concerning requests by sponsors of investigational new drugs and applicants for new drug approvals or biologics licenses for fast track designation as provided in the guidance for industry on fast track drug development programs.
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-9879
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-9877
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, National Institutes of Health