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

Results 251 - 300 of 304
National Cancer Institute; Notice of Meeting
Document Number: E8-9875
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: E8-9874
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: Antibody Therapeutics for the Treatment of Cancer in Humans
Document Number: E8-9873
Type: Notice
Date: 2008-05-06
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 invention embodied in U.S. Patent Application Number 11/895,326, filed August 24, 2007, entitled ``Tumor Markers in Ovarian Cancer'' [E-138-2000/0-US-05]; to Morphotek, Incorporated, having a place of business at Exton, PA. 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 antibodies developed by Licensee's proprietary Human MORPHODOMA[supreg] antibody technology or via humanization for anti-claudin-3 antibody therapeutics for ovarian cancer.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-9871
Type: Notice
Date: 2008-05-06
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.
Findings of Scientific Misconduct
Document Number: E8-9858
Type: Notice
Date: 2008-05-06
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Lois Bartsch, Ph.D., University of Nebraska Medical Center: Based on the report of an investigation conducted by the University of Nebraska Medical Center (UNMC) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Lois Bartsch, Ph.D., former postdoctoral research trainee, Department of Genetics, Cell Biology, and Anatomy, UNMC, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants P30 CA36727 and R01 CA77876 and National Center for Research Resources (NCRR), NIH, grant P20 RR016469. Specifically, PHS found that Dr. Bartsch: Falsified DNA sequence files by deleting a nucleotide and changing nucleotide designations and reported the altered file as the ACI rat p16Cdkn2a sequence with a CpG dinucleotide polymorphism in the upstream region to GenBank, in grant application CA118151, and in the poster presented to Cold Spring Harbor Laboratory (CSHL); Fabricated the claim in grant application CA118151 that GenBank entries for the human p16Cdkn2a gene had a CpG polymorphism near the transcription start site; Falsified the differential methylation of CpG dinucleotides near the transcription start site of p16Cdkn2a DNA and reported that tumor tissue was more methylated than normal tissue in ACI rats treated with estrogen and that the ACI allele was more methylated than the BN allele in tumor tissue from (BN x ACI)F1 animals treated with estrogen in grant application CA118151. Dr. Bartsch has entered into a Voluntary Exclusion Agreement (Agreement) in which she neither admits nor denies ORI's finding of scientific misconduct; the settlement is not an admission of liability on the part of the respondent. In accordance with the terms of the Agreement, she has voluntarily agreed, beginning on April 15, 2008: (1) To exclude herself from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government- wide Debarment and Suspension (2 CFR Part 180) for a period of two (2) years; and (2) To exclude herself permanently from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant or contractor to PHS for a period of three (3) years.
Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Delay in the Application of Payment Adjustments for Short Stay Outliers and Changes to the Standard Federal Rate
Document Number: 08-1217
Type: Rule
Date: 2008-05-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period implements certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long term care hospitals (LTCHs). These provisions include a 3-year delay in the application of certain provisions of the payment adjustment for short-stay outliers and revisions to the RY 2008 standard Federal rate.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-9791
Type: Notice
Date: 2008-05-05
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: E8-9788
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: E8-9762
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: E8-9759
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: E8-9758
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-9757
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-9756
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-9755
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: E8-9751
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The 11th Annual Food and Drug Administration-Orange County Regulatory Affairs Educational Conference
Document Number: E8-9728
Type: Notice
Date: 2008-05-05
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
Document Number: E8-9726
Type: Notice
Date: 2008-05-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft drug safety 5-year plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five- Year Plan.'' This plan is intended to communicate FDA's strategy for meeting the commitments for enhancing and modernizing the drug safety system within the context of the PDUFA IV program.
Submission for OMB Review; Comment Request
Document Number: E8-9640
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute of Child Health and Human Development; Notice of Meeting
Document Number: E8-9639
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: E8-9638
Type: Notice
Date: 2008-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E8-9746
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
Availability of the Draft Report “Selected Information on Chemical Releases Within Great Lakes Counties Containing Areas of Concern (AOC) (Public Comment Draft 2008)”
Document Number: E8-9742
Type: Notice
Date: 2008-05-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This report responds to a request from the International Joint Commission (IJC), the binational organization that works to implement the Great Lakes Water Quality Agreement (GLWQA) between the U.S. and Canada. The GLWQA calls for the two nations to define ``the threat to human health from critical pollutants'' found in the Great Lakes basin. This notice announces the availability of the draft report entitled ``Selected Information on Chemical Releases Within Great Lakes Counties Containing Areas of Concern (AOC) (Public Comment Draft 2008)''. This report summarizes previously-published public health assessment products and chemical release information for the 26 U.S. AOCs and 54 counties that are in close geographic proximity to those AOCs. This is a descriptive report that does not make associations between health outcomes and chemical exposures. The compilation of environmental data, gathered by ATSDR and the Environmental Protection Agency (EPA), is intended to help decision-makers set future priorities.
Determination of Regulatory Review Period for Purposes of Patent Extension; TEKTURNA
Document Number: E8-9699
Type: Notice
Date: 2008-05-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TEKTURNA 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 Center for Environmental Health/Agency for Toxic Substances and Disease Registry
Document Number: E8-9668
Type: Notice
Date: 2008-05-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-9637
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Delegation of Authority
Document Number: E8-9634
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Institute on Aging; Notice of Closed Meetings
Document Number: E8-9563
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-9562
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-9561
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: E8-9560
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: E8-9559
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: E8-9558
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: E8-9557
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: E8-9556
Type: Notice
Date: 2008-05-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-9503
Type: Notice
Date: 2008-05-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; ARTEFILL
Document Number: E8-9592
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ARTEFILL 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; AZILECT
Document Number: E8-9591
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for AZILECT 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.
Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
Document Number: E8-9590
Type: Rule
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment exempts certain foods from the nutrient content requirement of ``low fat.'' The exemption will apply if the food exceeds the ``low fat'' requirement due to fat content derived from whole oat sources. The amendment expands the use of this health claim to some whole oat products that are currently ineligible for the health claim. FDA is taking this action in response to a petition submitted by the Quaker Oats Co.
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-9549
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9546
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Combustion Engineering, Windsor, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9545
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Lawrence Livermore National Laboratory, Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9544
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Mound Plant, near Dayton, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-9537
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-9535
Type: Notice
Date: 2008-05-01
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.