Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 3,314
National Cancer Institute; Notice of Closed Meetings
Document Number: 06-9816
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 06-9797
Type: Notice
Date: 2006-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Prescription Drugs
Document Number: 06-9792
Type: Proposed Rule
Date: 2006-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement the provisions of the Deficit Reduction Act of 2005 (DRA) pertaining to prescription drugs under the Medicaid program. The DRA requires the Secretary of Health and Human Services to publish a final regulation no later than July 1, 2007. In addition, we would add to existing regulations certain established Medicaid rebate policies that are currently set forth in CMS guidance. This rule would bring together existing and new regulatory requirements in one, cohesive subpart.
Uniform Compliance Date for Food Labeling Regulations
Document Number: E6-21902
Type: Rule
Date: 2006-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing January 1, 2010, as the uniform compliance date for food labeling regulations that are issued between January 1, 2007, and December 31, 2008. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On March 14, 2005, FDA established January 1, 2008, as the uniform compliance date for food labeling regulations that issued between March 14, 2005, and December 31, 2006.
Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability
Document Number: E6-21901
Type: Notice
Date: 2006-12-21
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 ``Procedures for Handling Post- Approval Studies Imposed by PMA Order.'' The guidance provides a standard format and content for submitting post-approval studies. The guidance is issued to help ensure that sponsors provide adequate information about the conduct of post-approval studies and that the Center for Devices and Radiological Health (CDRH) can properly track and evaluate post-approval studies.
Statement of Organization, Functions, and Delegations of Authority
Document Number: E6-21857
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services, Office of the Secretary, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E6-21809
Type: Notice
Date: 2006-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E6-21783
Type: Notice
Date: 2006-12-21
Agency: Office of the Secretary, Department of Health and Human Services
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup
Document Number: 06-9809
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the fifth meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
Document Number: 06-9808
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the 13th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting
Document Number: 06-9807
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the 12th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology, American Health Information Community Chronic Care Workgroup Meeting
Document Number: 06-9806
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the 12th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology, American Health Information Community Confidentiality, Privacy and Security Workgroup Meeting
Document Number: 06-9805
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the sixth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Biosurveillance Workgroup Meeting
Document Number: 06-9804
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the 13th meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup
Document Number: 06-9803
Type: Notice
Date: 2006-12-21
Agency: Department of Health and Human Services
This notice announces the first meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Marketed Unapproved Drugs; Public Workshop; Change of Meeting Location and Time
Document Number: E6-21738
Type: Notice
Date: 2006-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a change of location and time for the upcoming public workshop on marketed unapproved drugs. Registration for the public workshop is closed. A new address and time are given for those persons who have previously registered with FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: E6-21737
Type: Notice
Date: 2006-12-20
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: E6-21719
Type: Notice
Date: 2006-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21718
Type: Notice
Date: 2006-12-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Prospective Grant of Exclusive License: Immunoconjugates Having High Binding Affinity
Document Number: E6-21667
Type: Notice
Date: 2006-12-20
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 7,081,518, issued July 25, 2006, entitled ``Anti-Mesothelin Antibodies Having High-Affinity Binding'' [E-139-1999/0-US-07]; European Patent Application No. 00937925.6, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/ 0-EP-04]; Japanese Patent Application No. 2001-500670, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E- 139-1999/0-JP-05]; Mexican Patent Application No. PA/a/2001/01195, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/0-MX-06]; and Canadian Patent Application No. 2374398, filed May 26, 2000, entitled ``Immunoconjugates Having High Binding Affinity'' [E-139-1999/0-CA-03] to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the SSIP immunoconjugate and variants thereof for the treatment of mesothelin expressing cancers.
Government-Owned Inventions; Availability for Licensing
Document Number: E6-21666
Type: Notice
Date: 2006-12-20
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: E6-21665
Type: Notice
Date: 2006-12-20
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Document Number: E6-21636
Type: Notice
Date: 2006-12-20
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.
Acquisition Regulations
Document Number: E6-21505
Type: Rule
Date: 2006-12-20
Agency: Office of the Secretary, Department of Health and Human Services
The Department of Health and Human Services is amending its acquisition regulations (HHSAR) to make administrative and editorial changes to reflect organizational title changes resulting from Office of the Secretary (OS) and Operating Division (OPDIV) reorganizations and to update or remove outdated text and references. The intent of the final rule is to bring the HHSAR up to date and to make the HHSAR consistent with the latest amendments to the Federal Acquisition Regulations (FAR).
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 06-9775
Type: Notice
Date: 2006-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 06-9774
Type: Notice
Date: 2006-12-20
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Meeting
Document Number: 06-9773
Type: Notice
Date: 2006-12-20
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E6-21641
Type: Notice
Date: 2006-12-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Document Number: E6-21591
Type: Rule
Date: 2006-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21584
Type: Notice
Date: 2006-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Partial Retraction
Document Number: 06-9786
Type: Notice
Date: 2006-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Friday, November 24, 2006 (71 FR 67873), the Centers of Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on three separate information collections. Through the publication of this document, CMS is retracting the portion of that notice requesting public comment on the Information Collection Requirement titled ``Medicaid Drug Program Monthly Quarterly Drug Reporting Format'', form number CMS-367 (OMB 0938-0578).
Proposed Information Collection Activity; Comment Request
Document Number: 06-9766
Type: Notice
Date: 2006-12-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E6-21527
Type: Notice
Date: 2006-12-18
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; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans
Document Number: E6-21486
Type: Notice
Date: 2006-12-18
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; Submission for Office of Management and Budget Review; Comment Request; Manufactured Food Regulatory Program Standards
Document Number: E6-21472
Type: Notice
Date: 2006-12-18
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: Submission for OMB Review; Comment Request
Document Number: E6-21436
Type: Notice
Date: 2006-12-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E6-21435
Type: Notice
Date: 2006-12-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: E6-21375
Type: Notice
Date: 2006-12-15
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.
Notice of Program Exclusions
Document Number: E6-21363
Type: Notice
Date: 2006-12-15
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E6-21350
Type: Notice
Date: 2006-12-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E6-21349
Type: Notice
Date: 2006-12-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization Scheduling Recommendations for Dronabinol and its Stereoisomers, and Oripavine
Document Number: E6-21318
Type: Notice
Date: 2006-12-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 12 to 16, 2007. This notice is issued under the Controlled Substances Act.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Proposed Experimental Study of Trans Fat Claims on Foods
Document Number: E6-21317
Type: Notice
Date: 2006-12-15
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.
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 06-9731
Type: Notice
Date: 2006-12-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 06-9730
Type: Notice
Date: 2006-12-15
Agency: Department of Health and Human Services, National Institutes of Health
Drug Products Containing Quinine; Enforcement Action Dates
Document Number: 06-9713
Type: Notice
Date: 2006-12-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such products or their shipment in interstate commerce. Drug products containing quinine, quinine sulfate, and any other salt of quinine are new drugs that require approved applications. One firm has an approved application to market a drug product containing quinine sulfate to treat malaria; this product has been designated an orphan drug product. Other manufacturers who wish to market a drug product containing quinine, quinine sulfate, or any other salt of quinine must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA); consideration of any such applications will be subject to the rights of the current NDA holder under the Orphan Drug Act.
Government-Owned Inventions; Availability for Licensing
Document Number: E6-21301
Type: Notice
Date: 2006-12-14
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.
Request for Information (RFI): Guidance for Prioritization of Pre-pandemic and Pandemic Influenza Vaccine
Document Number: E6-21282
Type: Notice
Date: 2006-12-14
Agency: Department of Health and Human Services
Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. It is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. Extensive information on Federal government strategic and implementation plans for pandemic flu is available at http:// www.pandemicflu.gov. A critical part of the United States Government (USG) strategy to control the spread of a pandemic and reduce its health and societal impact is through the use of vaccines. The U. S. Government is working toward a goal of expanding domestic influenza vaccine surge capacity for the production of pandemic influenza vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic influenza vaccine and pandemic influenza vaccine (which could include up to two doses) will require that the limited supply be prioritized for distribution and administration. Pre-pandemic vaccine refers to influenza vaccine that is produced against a virus strain that is believed to have pandemic potential and is maintained in a national stockpile. Depending on what influenza strain actually causes the pandemic, stockpiled pre- pandemic vaccine may provide some protection. Total quantities of pre- pandemic vaccines will be limited. Accordingly, the Federal government has initiated a process to provide guidance to assist State and local governments, communities, tribal and territorial governments, and the private sector in defining groups that should be considered for priority access to scarce vaccine. Guidance will be drafted by a Federal interagency task force that will seek information and advice from relevant individual stakeholders, a public engagement process in selected communities across the country, and through this Request for Information (RFI). The Federal government plans to issue draft guidance resulting from this process for public comment before finalization. With this RFI, the Department of Health and Human Services (HHS) requests input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre- pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Specifically, HHS is seeking input on pandemic influenza vaccine prioritization considerations from all interested and affected parties, including but not limited to public health and health care individuals and organizations, as well as those from other sectors of the economy including, for example, travel and transportation, commerce and trade, law enforcement, emergency management and responders, other critical infrastructure sectors and the general public. Previous reports relating to pandemic influenza vaccine prioritization issues are available at http:// www.pandemicflu.gov.