Department of Health and Human Services March 5, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-4269
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: E8-4213
Type: Notice
Date: 2008-03-05
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 If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing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 https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-4200
Type: Notice
Date: 2008-03-05
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: The Development of Human Therapeutics for the Treatment of Cancer
Document Number: E8-4198
Type: Notice
Date: 2008-03-05
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 part 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 5,167,956 entitled ``Immunotoxin with in-vivo T-Cell suppressant activity and Methods of Use'' [HHS Ref. E-012-1991/0-US-01], U.S. Patent Application 60/037,196 entitled ``Novel Vectors and Expression Methods for Producing Mutant Proteins'' [HHS Ref. E-043-1997/0-US-01], U.S. Patent Application 60/039,987 entitled ``Novel Immunotoxins and Methods of Inducing Immune Tolerance'' [HHS Ref. E-044-1997/0-US-01], U.S. Patent Application 09/064,413 entitled ``Use of Immunotoxins to Induce Immune Tolerance to Pancreatic Islet Transplantation'' [HHS Ref. E-059-1998/0-US-01], U.S. Patent Application 09/291,712 entitled ``Methods Related to the Combined Use of Immunotoxins and Agents that Inhibit Dendritic Cell Maturation'' [HHS Ref. E-168-1999/0-US-01], and all continuing applications and foreign counterparts, to CK Life Sciences International, Inc., which has offices in Hong Kong. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to: The production and use of the immunotoxins covered by the licensed patent rights for the treatment of T-cell mediated diseases, including but not limited to T-cell lymphoma and autoimmune diseases.
National Institute of Allergy and Infectious Diseases: Licensing Opportunity and Cooperative Research and Development Agreement (“CRADA”) Opportunity; Live Attenuated Vaccine To Prevent Disease Caused by West Nile Virus
Document Number: E8-4193
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases (NIAID) of the NIH is seeking licensees and/or CRADA partners to further develop, evaluate, and commercialize modified West Nile virus (WNV) chimeras as a live attenuated vaccine against infections of WNV in humans. NIAID is also seeking licensees to commercialize modified WNV chimeras as live attenuated veterinary vaccines against infections of WNV in animals.
State Median Income Estimate for a Four-Person Family: Notice of the Federal Fiscal Year (FFY) 2009 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) (CFDA Number 93.568) Administered by the U.S. Department of Health and Human Services (HHS), Administration for Children and Families, Office of Community Services, Division of Energy Assistance
Document Number: E8-4190
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2009 (October 1, 2008 to September 30, 2009). LIHEAP grantees may adopt the State median income estimates beginning with the date of publication in the Federal Register or at a later date as discussed below. This enables LIHEAP grantees to choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2008, or the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2009 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-4187
Type: Notice
Date: 2008-03-05
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.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
Document Number: E8-4185
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expense Program in the Federal Register on October 5, 2007 (72 FR 57049). The purpose of this notice was to inform the public of the eligibility requirements for participation in the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program. HRSA is requesting public comments concerning recommended change to a specific section of the reimbursement program eligibility guidelines.
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
Document Number: E8-4158
Type: Notice
Date: 2008-03-05
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 certification to accompany human drug, biological product, and device applications or submissions (Form FDA 3674).
Oncologic Drugs Advisory Committee; Amendment of Notice
Document Number: E8-4157
Type: Notice
Date: 2008-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
Pediatric Advisory Committee; Amendment of Notice
Document Number: E8-4156
Type: Notice
Date: 2008-03-05
Agency: Food and Drug Administration, Department of Health and Human Services
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 08-938
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 08-937
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-936
Type: Notice
Date: 2008-03-05
Agency: Department of Health and Human Services, National Institutes of Health
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