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

Results 151 - 200 of 273
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: E8-21169
Type: Notice
Date: 2008-09-15
Agency: Department of Health and Human Services, National Institutes of Health
Testimony by Employees and the Production of Documents in Proceedings Where the United States Is Not a Party
Document Number: E8-21113
Type: Rule
Date: 2008-09-15
Agency: Office of the Secretary, Department of Health and Human Services
This rule amends Part 2 of Title 45 of the Code of Federal Regulations, which provides that employees and former employees of the Department of Health and Human Services (HHS or Department) may not provide testimony as part of their official duties in litigation where the United States or a federal agency is not a party, without the approval of the head of the agency. The purpose of these amendments is to modify the definition of ``employee'' contained in 45 CFR part 2. Under these amendments, the definition of employee will be revised to reflect changes in Medicare contracting, including changes brought about by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). In addition, the definition of employee will be modified to include employees of a state agency performing survey, certification, or enforcement functions under Title XVIII of the Social Security Act or Section 353 of the Public Health Service Act. Further, the definition of employee with respect to employees of entities covered by the Federally Supported Health Centers Assistance Act, as amended, 42 U.S.C. 233(g)-(n) (FSHCAA), will be limited to testimony requested in medical malpractice tort litigation which relates to medical functions performed at a time when the center was covered under FSHCAA.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2009
Document Number: Z8-17797
Type: Rule
Date: 2008-09-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-21366
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
Document Number: E8-21353
Type: Notice
Date: 2008-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ
Document Number: E8-21339
Type: Notice
Date: 2008-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK). We are opening the docket to gather additional information from interested persons on the post market experience associated with the use of LASIK devices.
National Institute of Child Health and Human Development; Proposed Collection; Comment Request; Health Behaviors in School-Age Children
Document Number: E8-21327
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data
Document Number: E8-21291
Type: Notice
Date: 2008-09-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is announcing a call-for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations of up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients that are generally recognized as safe and effective (GRASE) and are found in the sunscreen monograph regulations. FDA reviewed a time and extent application (TEA) for ecamsule and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether ecamsule can be generally recognized as safe and effective (GRASE) for its proposed OTC use.
The National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; Interagency Committee on Smoking and Health
Document Number: E8-21280
Type: Notice
Date: 2008-09-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-21173
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-21159
Type: Notice
Date: 2008-09-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-21157
Type: Notice
Date: 2008-09-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request; Proposed Projects
Document Number: E8-21129
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-21039
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-21037
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-21036
Type: Notice
Date: 2008-09-12
Agency: Department of Health and Human Services, National Institutes of Health
General and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period
Document Number: E8-21200
Type: Proposed Rule
Date: 2008-09-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register of October 31, 2006 (71 FR 63728) to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls). FDA is reopening the comment period to update comments and to receive any new information. Elsewhere in this issue of the Federal Register, FDA is also reopening the comment period on a notice of availability of a draft guidance document that would serve as the special control if FDA reclassifies this device.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period
Document Number: E8-21197
Type: Notice
Date: 2008-09-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a draft guidance entitled ``Class II Special Controls Guidance Document: Absorbable Hemostatic Device.'' The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirements of special controls if it is reclassified. FDA is reopening the comment period to update comments and to receive any new information. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls).
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-21119
Type: Notice
Date: 2008-09-11
Agency: Department of Health and Human Services
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-21041
Type: Notice
Date: 2008-09-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: E8-21040
Type: Notice
Date: 2008-09-11
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Amended Notice of Meeting
Document Number: E8-21038
Type: Notice
Date: 2008-09-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; State Petitions for Exemption from Preemption
Document Number: E8-21020
Type: Notice
Date: 2008-09-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption from Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Panels or Committees and Request for Nonvoting Industry Representatives on Public Advisory Panels or Committees
Document Number: E8-21016
Type: Notice
Date: 2008-09-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Devices Good Manufacturing Practice Advisory Committee (DGMPAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Proposed Information Collection Activity; Comment Request
Document Number: E8-21007
Type: Notice
Date: 2008-09-11
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Ethics Subcommittee, Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC); Meeting
Document Number: E8-20967
Type: Notice
Date: 2008-09-10
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; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Document Number: E8-20933
Type: Notice
Date: 2008-09-10
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-20913
Type: Notice
Date: 2008-09-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-20909
Type: Notice
Date: 2008-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-20908
Type: Notice
Date: 2008-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Statutorily Mandated Single Source Award; Quentin N. Burdick American Indians Into Nursing Program
Document Number: E8-20907
Type: Notice
Date: 2008-09-10
Agency: Department of Health and Human Services, Indian Health Service
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020
Document Number: E8-20939
Type: Notice
Date: 2008-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 020'' (Recognition List Number: 020), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E8-20938
Type: Notice
Date: 2008-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that TEQUIN (gatifloxacin) Tablets, Injection, and Oral Suspension, were withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not accept or approve abbreviated new drug applications (ANDAs) for gatifloxacin oral tablets, injection, or oral suspension that refer to any previously approved dosage forms and strengths of TEQUIN (gatifloxacin).
Memorandum of Understanding Between the Food and Drug Administration and the University of Pennsylvania
Document Number: E8-20932
Type: Notice
Date: 2008-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University of Pennsylvania (Penn). The purpose of this MOU is to establish terms of collaboration between FDA and Penn focused primarily but not exclusively, in the areas of translational therapeutics, diagnostics, bioinformatics, new clinical trial models, drug/device co-development, and pharmacoepidemiology. Beyond the collaborations in the traditional academic programs for training, research, and outreach, this MOU will also include collaborations with Penn extended partnerships such as the Institute for Translational Medicine and Therapeutics which includes the Children's Hospital of Philadelphia, the Wistar Institute, and the University of Sciences in Philadelphia.
National Institute of Mental Health; Amended Notice of Meeting
Document Number: E8-20902
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-20901
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, Health Resources and Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-20900
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-20884
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-20837
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-20836
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Amended Notice of Meeting
Document Number: E8-20835
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-20648
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-20645
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: E8-20643
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meetings
Document Number: E8-20642
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-20641
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-20640
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-20639
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: E8-20638
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-20637
Type: Notice
Date: 2008-09-09
Agency: Department of Health and Human Services, National Institutes of Health