Department of Health and Human Services June 2007 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 276
Government-Owned Inventions; Availability for Licensing
Document Number: E7-11830
Type: Notice
Date: 2007-06-20
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.
Prospective Grant of Exclusive License: Anti-Mesothelin Antibodies Useful for Immunological Assays
Document Number: E7-11828
Type: Notice
Date: 2007-06-20
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 Application No. 60/681,104, filed May 12, 2005, entitled ``Anti- Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0- US-01] and PCT Application No. PCT/US2006/018502, filed May 11, 2006, entitled ``Anti-Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0-PCT-02] 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: E7-11826
Type: Notice
Date: 2007-06-20
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: E7-11825
Type: Notice
Date: 2007-06-20
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: E7-11824
Type: Notice
Date: 2007-06-20
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.
Privacy Act of 1974: New System of Records
Document Number: 07-3052
Type: Notice
Date: 2007-06-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records titled, ``Information Center (IC) Integrated Clearinghouse System (IC/ICS),'' System No. 09-15-0067. The HRSA IC/ICS will facilitate the delivery of publications and requested information by members of the general public. The HRSA IC/ICS will also enable HRSA to deliver information efficiently through physical mailings or broadcast e-mail messages to HRSA Grantee organizations and other interested parties.
Reimbursement Rates for Calendar Year 2007
Document Number: 07-3037
Type: Notice
Date: 2007-06-20
Agency: Department of Health and Human Services, Indian Health Service
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2007 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Public Law 106-554, section 432, dated December 21, 2000, authorized IHS facilities to file Medicare Part B claims with the carrier for payment for physician and certain other practitioner services provided on or after July 1, 2001.
Establishment of the National Biodefense Science Board
Document Number: 07-3032
Type: Notice
Date: 2007-06-20
Agency: Office of the Secretary, Department of Health and Human Services
The Office of the Secretary announces establishment of the National Biodefense Science Board. The Board will provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding activities to prevent, prepare for and respond to adverse health effects of public health emergencies resulting from current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Resumes or curricula vitae from qualified individuals who wish to be considered for membership on the Board are currently being accepted. To Submit a resume or curriculum vitae, send e-mail to nbsbnominations@hhs.gov.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-3014
Type: Notice
Date: 2007-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 07-3013
Type: Notice
Date: 2007-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 07-3012
Type: Notice
Date: 2007-06-20
Agency: Department of Health and Human Services, National Institutes on Health, National Institutes of Health
Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers; Availability
Document Number: E7-11817
Type: Notice
Date: 2007-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Pharmacogenetic Tests and Genetic Tests for Heritable Markers.'' This document is intended to provide guidance on preparing and reviewing premarket approval applications (PMAs) and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests).
Listing of Color Additives Subject to Certification; D&C Black No. 3
Document Number: E7-11801
Type: Rule
Date: 2007-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the color additive regulations to provide for the safe use of D&C Black No. 3 (bone black, subject to FDA batch certification) as a color additive in eyeliner, eye shadow, mascara, and face powder. This action is in response to a petition filed by Ebonex Corp.
Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
Document Number: E7-11795
Type: Rule
Date: 2007-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT[sol]Ps), and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule.
Advisory Committee on Immunization Practices: Meeting
Document Number: E7-11789
Type: Notice
Date: 2007-06-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E7-11779
Type: Notice
Date: 2007-06-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: E7-11728
Type: Notice
Date: 2007-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
Science Board to the Food and Drug Administration; Amendment of Notice; Correction
Document Number: E7-11727
Type: Notice
Date: 2007-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of June 7, 2007 (72 FR 31587). The document announced an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. The meeting was originally announced in the Federal Register of May 21, 2007 (72 FR 28499). The document was published with an incorrect docket number. This document corrects that error.
Proposed Information Collection Activity; Comment Request
Document Number: 07-3004
Type: Notice
Date: 2007-06-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 07-2998
Type: Notice
Date: 2007-06-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Proposed Information Collection Activity; Comment Request
Document Number: 07-2997
Type: Notice
Date: 2007-06-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Submission for OMB Review; Comment Request
Document Number: 07-2996
Type: Notice
Date: 2007-06-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Statement of Organization, Functions and Delegation of Authority
Document Number: E7-11707
Type: Notice
Date: 2007-06-18
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice of Request for Public To Submit Comments and Attend Public Meeting
Document Number: E7-11680
Type: Notice
Date: 2007-06-18
Agency: Department of Health and Human Services, Centers of Disease Control and Prevention, Centers for Disease Control and Prevention
Medicare and State Health Care Programs: Fraud and Abuse; Clarification of Terms and Application of Program Exclusion Authority for Submitting Claims Containing Excessive Charges
Document Number: E7-11663
Type: Proposed Rule
Date: 2007-06-18
Agency: Department of Health and Human Services, Office of Inspector General, Inspector General Office, Health and Human Services Department, Centers for Medicare & Medicaid Services
On September 15, 2003, we published a notice of proposed rulemaking (68 FR 53939) soliciting public comments regarding further guidance on OIG's exclusion authority under section 1128(b)(6)(A) of the Social Security Act and 42 CFR 1001.701 of our regulations. Having considered the public comments and for the reasons explained below, we are not promulgating a final rule.
Licensure of Apheresis Blood Products; Public Workshop
Document Number: E7-11615
Type: Notice
Date: 2007-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
Anthrax Vaccines-Bridging Correlates of Protection in Animals to Immunogenicity in Humans; Public Workshop
Document Number: E7-11613
Type: Notice
Date: 2007-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
New Animal Drugs for Use in Animal Feeds; Lincomycin
Document Number: E7-11611
Type: Rule
Date: 2007-06-18
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 a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for the use of lincomycin in feed of swine weighing greater than 250 pounds and for the addition of a reproductive cautionary statement to labeling.
Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008; Correction
Document Number: 07-2987
Type: Proposed Rule
Date: 2007-06-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the proposed rule published in the Federal Register on May 4, 2007, entitled ``Medicare Program; Home Health Prospective Payment System Refinement and Rate Update for Calendar Year 2008'' (72 FR 25356).
National Committee on Vital and Health Statistics: Meeting
Document Number: 07-2980
Type: Notice
Date: 2007-06-18
Agency: Department of Health and Human Services
National Toxicology Program (Ntp); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Second Bisphenol A Expert Panel Meeting
Document Number: E7-11590
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services
CERHR announces the second meeting of the CERHR Expert Panel on Bisphenol A on August 6-8, 2007, at the Hilton Alexandria Old Town in Alexandria, VA. This meeting is open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting space.
Agency Information Collection Activities: Proposed Collection Comment Request
Document Number: E7-11557
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
Meetings of the Advisory Committee for Injury Prevention and Control (ACIPC), and Its Subcommittee, the Science and Program Review Subcommittee
Document Number: E7-11555
Type: Notice
Date: 2007-06-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Commission of Childhood Vaccines; Request for Nominations for Voting Members
Document Number: E7-11548
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Label Comprehension Study
Document Number: E7-11528
Type: Notice
Date: 2007-06-15
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, FDA Form 3546
Document Number: E7-11527
Type: Notice
Date: 2007-06-15
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 hourly burden necessary to complete FDA Form 3546, ``Animal Drug User Fee Cover Sheet.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E7-11468
Type: Notice
Date: 2007-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E7-11467
Type: Notice
Date: 2007-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 07-2974
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 07-2973
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 07-2972
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 07-2971
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 07-2970
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 07-2969
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meetings
Document Number: 07-2968
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine, Notice of Closed Meetings
Document Number: 07-2967
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 07-2966
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meetings
Document Number: 07-2965
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society
Document Number: 07-2964
Type: Notice
Date: 2007-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society
Document Number: 07-2963
Type: Notice
Date: 2007-06-15
Agency: Office of the Secretary, Department of Health and Human Services
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