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

Results 51 - 100 of 291
Medicare Program; Request for Nominations for Members of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
Document Number: E8-1345
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services, Centers for Medicare & Medicaid Services
This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). We are requesting nominations for both voting and nonvoting members to serve on the MedCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We have a special interest in ensuring that women, minority groups, and physically challenged individuals are adequately represented on the MedCAC. Therefore, we encourage nominations of qualified candidates from these groups. The MedCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare. The MedCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare and Medicaid Services (CMS), as requested by the Secretary, whether medical items and services are reasonable and necessary under Title XVIII of the Social Security Act.
Submission for OMB Review; Comment Request
Document Number: 08-324
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
National Cancer Institute; Amended Notice of Meeting
Document Number: 08-318
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 08-317
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 08-316
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 08-315
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 08-314
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 08-313
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 08-312
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 08-311
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 08-310
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 08-309
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 08-308
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 08-307
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 08-306
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 08-305
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 08-304
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 08-303
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 08-302
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 08-301
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 08-300
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 08-299
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 08-298
Type: Notice
Date: 2008-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Supplier Enrollment Safeguards
Document Number: E8-1346
Type: Proposed Rule
Date: 2008-01-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule clarifies, expands, and adds to the existing enrollment requirements that Durable Medical Equipment and Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers must meet to establish and maintain billing privileges in the Medicare program.
Strategy To Support Health Information Technology Among HRSA's Safety Net Providers
Document Number: E8-1301
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
The following represents a series of respondents' comments and the Health Resources and Services Administration's (HRSA) responses to the comments regarding the Federal Register notice (FRN): September 19, 2006 (71 FR 54829). The FRN proposed strategies to support health information technology (HIT) among safety net providers, and requested comments on HIT topic areas addressing quality improvement, collaboration, general network-related issues, specific health center controlled network (HCCN) related issues, sustainability and building HIT capacity. HRSA received a total of 53 comments from a broad range of stakeholders, including State health departments, non-profit organizations, individual healthcare providers and the health information technology industry. HRSA's responses reflect activities within the Office of Health Information Technology (OHIT) that include, but are not limited to, the development of an HRSA HIT strategic plan, technical assistance resources including the establishment of the HRSA HIT virtual community, the development of HIT online toolboxes tailored to the needs of various HRSA programs, a TA resource center, and the development of funding opportunities. The comments have helped, in part, to shape the direction and activities of OHIT.
Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E8-1298
Type: Notice
Date: 2008-01-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all other legal and regulatory requirements are met.
Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees
Document Number: E8-1297
Type: Notice
Date: 2008-01-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee and the Allergenic Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will occur through August 31, 2008.
Pediatric Advisory Committee; Notice of Meeting
Document Number: E8-1296
Type: Notice
Date: 2008-01-25
Agency: Food and Drug Administration, Department of Health and Human Services
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-1295
Type: Notice
Date: 2008-01-25
Agency: Food and Drug Administration, Department of Health and Human Services
Notice of Opportunity for Public to Provide NIOSH with Comment: Positive-Pressure Closed-Circuit Self-Contained Breathing Apparatus
Document Number: E8-1273
Type: Notice
Date: 2008-01-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The NIOSH, National Personal Protective Technology Laboratory (NPPTL), is currently reevaluating its limitations on and precaution for safe use of positive-pressure closed-circuit self-contained breathing apparatus. As stated in the Federal Register (Vol. 50, No. 222, pages 47456-47457 dated Monday, November 18, 1985) NIOSH's position on this topic is that:
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-1260
Type: Notice
Date: 2008-01-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-1259
Type: Notice
Date: 2008-01-25
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: Human Monoclonal Antibodies, Their Fragments and Derivatives as Biotherapeutics for the Treatment of HIV Infections
Document Number: E8-1258
Type: Notice
Date: 2008-01-25
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), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: 1. U.S. Provisional Patent Application S/N 60/329,709 (E-130-2001/ 0-US-01). PCT/US02/33165 was filed on October 16, 2002 (E-130-2001/0- PCT-01) and converted into 02773789.9 (E-130-2001/0-EP-03) filed in Europe on May 12, 2004, 2002337885 (E-130-2001/0-AU-02) filed in Australia on March 29, 2004, 10/492,729 (E-130-2001/0-US-05) filed in the U.S. on April 15, 2004, divisional application 11/748,992 (E-130- 2001/0-US-07) filed in the U.S. on May 15, 2007, and 2,463,931(E-130- 2001/0-CA-04) filed in Canada on April 15, 2004; entitled ``Broadly Cross-Reactive Neutralizing Antibodies Against Human Immunodeficiency Virus Selected By Env-CD4-Co-Receptor Complex.'' Inventor(s): Dimiter S. Dimitrov (NCI), Maxime Moulard (EM), Xiadong Xiao (NCI), Yuuei Shu (NCI), Sanjay K. Phogat (IAVI), Mei-Yun Zhang (NCI), and Dennis Burton (Scripps Inst.) 2. U.S. Provisional Patent Application S/N 60/623,394 (E-251-2004/ 0-US-01). PCT/US2005/39175 (E-251-2004/0-PCT-02) filed on October 28, 2005 and converted into 2,585,574 (E-251-2004/0-CA-04) filed in Canada on October 28, 2005, 05819487.9 (E-251-2004/0-EP-05) filed in Europe on April 27, 2007, 2005302416 (E-251-2004/0-AU-06) filed in Australia on October 28, 2005, and 11/718,202 (E-251-2004/0-US-03) filed in the U.S. on August 10, 2007; entitled ``Novel Broadly Cross-Reactive HIV Neutralizing Human Monoclonal Antibodies Selected From Phage Display Libraries Using Novel Strategy Based On Competitive Antigen Panning.'' Inventor(s): Dimiter S. Dimitrov (NCI) and Mei-Yun Zhang (SAIC) to Profectus Biosciences, Inc. (hereafter Profectus) having a place of business in Baltimore, Maryland. The patent rights in these inventions have been assigned to the United States of America.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-1257
Type: Notice
Date: 2008-01-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Complementary and Alternative Medicine Announcement of Grantsmanship Workshop
Document Number: E8-1251
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Center for Complementary and Alternative Medicine (NCCAM) invites the research community to apply to attend a grantsmanship workshop. This workshop will provide researchers, fellows, and graduate students with an in-depth understanding of the NIH grants and review processes, clarify Federal regulations and policies, and highlight areas of special interest and concern. Emphasis will be placed on complementary and alternative medicine (CAM) research. The workshop will include time to interact and discuss research ideas with NCCAM staff. The Workshop will take place on June 3-5, 2008, in Rockville, Maryland. Those interested in CAM research are particularly encouraged to attend. Background: The National Center for Complementary and Alternative Medicine (NCCAM) was established in 1999 with the mission of exploring complementary and alternative healing practices in the context of rigorous science, training CAM researchers, and disseminating authoritative information to the public and professionals. NCCAM funds research grants that explore the science of CAM. For more information, see http://nccam.nih.gov/research/nccamfunds.htm. Request for Applications: The research community is invited to submit an application to attend the grantsmanship workshop. For more information about what will be covered at the workshop, see http:// nccam.nih.gov/news/2007/110707.htm. Applications will be accepted until February 29, 2008. Accepted participants will be notified via e-mail by March 31, 2008. The Dialogue will be held: June 3-5, 2008, Neuroscience Building, National Institutes of Health, Rockville, Maryland.
Submission for OMB Review; Comment Request; NIH-American Association for Retired Persons (AARP) Short Follow-Up Questionnaire 2008 (NCI)
Document Number: E8-1249
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 6, 2007 (Vol. 72, No. 214, p. 62660) and allowed 60-days for public comment. One public comment was received on November 6, 2007 which questioned why AARP was not funding this study as opposed to using NIH funds. An e-mail response was sent on January 14, 2008 stating, ``We received your comment. We will take your comments into consideration''. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NIH-American Association for Retired Persons (AARP) Short Follow-Up Questionnaire 2008 (NCI). Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this short 2-page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 513,225 participants of the NIH-AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. This questionnaire adheres to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-85). The annual reporting burden is as follows: Estimated Number of Respondents: 513,225; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .0668; and Estimated Total Annual Burden Hours Requested: 34,283. The annualized cost to respondents is estimated at: $302,158. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee; Amended Notice
Document Number: E8-1248
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services
The February 27-28, 2008, meeting of the NTP Board of Scientific Counselors was announced in the Federal Register (72FR70863) on December 13, 2007. The agenda for the subcommittee meeting has changed. The draft NTP Technical Report on [beta]-myrcene (TR 557) will not be reviewed. The guidelines published in the December 13 notice for submitting public comments or making an oral presentation at the meeting still apply. Any updates to the agenda or additional information and background materials will be posted on the NTP Web site (http://ntp.niehs.nih.gov/go/15833) and provided upon request from the Executive Secretary (see ADDRESSES below).
Government-Owned Inventions; Availability for Licensing
Document Number: E8-1247
Type: Notice
Date: 2008-01-25
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: E8-1244
Type: Notice
Date: 2008-01-25
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.
Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting
Document Number: E8-1239
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, Food and Drug Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-1235
Type: Notice
Date: 2008-01-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing: Flavivirus Technologies
Document Number: E8-1234
Type: Notice
Date: 2008-01-25
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: E8-1233
Type: Notice
Date: 2008-01-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-1232
Type: Notice
Date: 2008-01-25
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 08-282
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 08-281
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 08-280
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 08-279
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 08-278
Type: Notice
Date: 2008-01-25
Agency: Department of Health and Human Services, National Institutes of Health