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

Results 101 - 150 of 204
Diseases Transmitted Through the Food Supply
Document Number: E8-27165
Type: Notice
Date: 2008-11-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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
Document Number: E8-27122
Type: Notice
Date: 2008-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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
Document Number: E8-27120
Type: Notice
Date: 2008-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Pediatric Ethics Subcommittee; Notice of Meeting
Document Number: E8-27118
Type: Notice
Date: 2008-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
Pediatric Advisory Committee; Notice of Meeting
Document Number: E8-27117
Type: Notice
Date: 2008-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-27115
Type: Notice
Date: 2008-11-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-27113
Type: Notice
Date: 2008-11-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-27084
Type: Notice
Date: 2008-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-27061
Type: Notice
Date: 2008-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27060
Type: Notice
Date: 2008-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: E8-27052
Type: Notice
Date: 2008-11-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs: Clarification of Compensation Plans
Document Number: E8-27041
Type: Rule
Date: 2008-11-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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
Document Number: E8-27008
Type: Notice
Date: 2008-11-13
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 information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-27006
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-27004
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: E8-27001
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Hearing: Reconsideration of Disapproval of Michigan State Plan Amendment (SPA) 07-21
Document Number: E8-26993
Type: Notice
Date: 2008-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Health and Human Services (hhs)
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.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-26988
Type: Notice
Date: 2008-11-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-26965
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees
Document Number: E8-26963
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CBER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.
Grants Awarded: Program Titles and Funding Opportunity Announcements for Fiscal Year 2009
Document Number: E8-26889
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF) hereby gives notice to the public that certain programs within the Agency will administratively impose a matching requirement on grants awarded under the following program titles and funding opportunity announcements for Fiscal Year 2009:
Notice of a Safety Symposium Sponsored by the NIH Recombinant DNA Advisory Committee (RAC) and the Intragovernmental Select Agent and Toxin Technical Advisory Committee (ISATTAC)
Document Number: E8-26886
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health, Office of the Director, Office of Biotechnology Activities, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-26881
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability
Document Number: E8-26869
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans.'' The interim safety/risk assessment evaluated exposure to melamine and its analogues (cyanuric acid, ammelide and ammeline) in infant formula and other foods to identify, where possible, a level of exposure that would not raise public health concerns. FDA is seeking public comment on the interim safety/risk assessment.
National Library of Medicine; Notice of Meetings
Document Number: E8-26791
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Document Number: E8-26868
Type: Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, September 29, 2008 (73 FR 56477). The final rule was published with an inadvertent error in the ``Analysis of Economic Impacts'' section. This document corrects that error.
Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act
Document Number: E8-26866
Type: Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a new regulation to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. In the proposed rule section of this issue of the Federal Register, we are concurrently proposing and soliciting comments on this rule. If significant adverse comments are received, we will withdraw this final rule and address the comments in a subsequent final rule. FDA will not provide additional opportunity for comment.
Maximum Civil Money Penalty Amounts and Compliance With the Federal Civil Penalties Inflation Adjustment Act
Document Number: E8-26864
Type: Proposed Rule
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the Federal Register, which is intended to amend our regulations to adjust for inflation the maximum civil money penalty amounts for the various civil money penalty authorities within our jurisdiction. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended. The last adjustment was published in the Federal Register of July 20, 2004 (69 FR 43299), and the FCPIAA requires Federal agencies to adjust their civil money penalties at least once every 4 years. This proposed rule does not adjust the civil money provisions enacted by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
Document Number: E8-26863
Type: Notice
Date: 2008-11-12
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 Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-26816
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
Board of Scientific Counselors, National Center for Health Marketing (BSC, NCHM)
Document Number: E8-26803
Type: Notice
Date: 2008-11-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Injury Prevention and Control, Initial Review Group, (NCIPC, IRG)
Document Number: E8-26801
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-26796
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Board of Scientific Counselors, Coordinating Center for Infectious Diseases (CCID)
Document Number: E8-26795
Type: Notice
Date: 2008-11-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26794
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Notice of Approval of Original Abbreviated New Animal Drug Application; Phenylbutazone Tablets
Document Number: E8-26793
Type: Notice
Date: 2008-11-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for veterinary prescription use of phenylbutazone tablets in horses for the relief of inflammatory conditions associated with the musculoskeletal system.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26790
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-26789
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Non-Invasive Diabetes Diagnostics
Document Number: E8-26788
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), a federal agency under the Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. Nos. E-091-1998 ``Method For Non- Invasive Identification Of Individuals At Risk For Diabetes;'' U.S. Patent No. 6,721,583; and HHS Ref. No. E-079-1998 ``Optical Fiber Probe and Methods for Measuring Optical Properties;'' U.S. Patent No. 6,678,541; to Eyelight Diagnostics, Inc., a corporation formed under the laws of the state of Connecticut and having a principle place of business therein. The United States of America is the assignee of the patent rights in the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and integrated systems for non-invasive ocular clinical diagnostics for diabetes.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26787
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-26786
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-26779
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-26684
Type: Notice
Date: 2008-11-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”
Document Number: E8-26828
Type: Notice
Date: 2008-11-10
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 (the PRA).
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex
Document Number: E8-26825
Type: Rule
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.
Privacy Act of 1974; New OIG Privacy Act System of Records: Consolidated Data Repository
Document Number: E8-26725
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
The Privacy Act of 1974 (5 U.S.C. 552(e)(4)) requires that all agencies publish in the Federal Register a notice of the existence and character of their system of records. Notice is hereby given that OIG is adding a new system of records entitled ``Consolidated Data RepositoryHHS-OIG'' (09-90-1000).
Determination of Regulatory Review Period for Purposes of Patent Extension; TYKERB
Document Number: E8-26679
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TYKERB 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; IXEMPRA
Document Number: E8-26678
Type: Notice
Date: 2008-11-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for IXEMPRA 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 Mental Health; Notice of Closed Meeting
Document Number: E8-26638
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: E8-26637
Type: Notice
Date: 2008-11-10
Agency: Department of Health and Human Services, National Institutes of Health