Department of Health and Human Services September 2005 – Federal Register Recent Federal Regulation Documents
Results 251 - 281 of 281
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for an approved new animal drug application (NADA) from Alpharma Inc., to Pharmaq AS. The drug labeler code for Pharmaq AS is also being listed.
Proposed Collection: Comment Request; Extension of OMB No. 0925-0417/exp. 08/31/05, Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors-42 CFR Part 50, Subpart F
In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. Proposed information collection was previously published in the Federal Register on May 12, 2005, Volume 70, No. 91, page 25095 and allowed 60 days for public comment. No public comments were received. 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: Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors42 CFR Part 50, Subpart F; Type of Information Collection Request: Extension, OMB 0925-0417, Expiration Date 8/31/05. Need and Use of Information Collection: This is a request for OMB approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR Part 50 Subpart F and Responsible Contractors: 45 CFR Part 94. Frequency of response: On occasion. Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; and State, Local or Tribal Government. Type of Respondents: Any public or private entity or organization. The annual reporting burden is as follows: Estimated Number of Respondents: 42,800; Estimated Number of Responses per Respondent: 1.60; Average Burden Hours Per Response: 3.40; and Estimated Total Annual Burden Hours Request: 232,000. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time should be directed to the Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIR. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Diane Dean, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3525, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0930, or E-mail your request, including your address to: hahnm@od.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Government-Owned Inventions; Availability for Licensing: Selected Technologies From the NIH Cancer Therapeutics Portfolio
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.
Final Notice for FY 2005 Formula Allocation for Targeted Assistance Grants to States for Services to Refugees
This final notice announces the availability of funds and award procedures for FY 2005 Targeted Assistance Program (TAP) grants to States for services to refugees under the Refugee Resettlement Program (RRP). These grants are for service provision in localities with large refugee populations, high refugee concentrations, and where specific needs exist for supplementation of currently available resources. Qualification of counties for eligibility for targeted assistance program grants is determined once every three years as stated in the FY 1999 Notice of Proposed Availability of Targeted Assistance Allocations to States which was published in the Federal Register on March 10, 1999 (64 FR 11927). The FY 2002-FY 2004 three-year project cycle has expired. FY 2005 is the year for the re-qualification of counties for the three-year project cycle, FY 2005, FY 2006, and FY 2007 for TAP funds. Qualifications of counties are based on the arrivals of refugees (see Footnote 1, eligible population) during the 5-year period from FY 2000 through FY 2004, and on the concentration of the arrivals population as a percentage of the general population. Counties that qualify for TAP FY 2005 funds on the basis of the most current 5-year population are listed in this proposed notice in Table 1, Table 2, Table 4, and Table 6. Under this final notice, a total of 48 counties (Table 1) qualify for targeted assistance grants. Of these, 6 new counties (Table 2) qualify for targeted assistance grants, and 11 counties (Table 3) which previously received targeted assistance grants no longer qualify for targeted assistance program funding. Application Deadline: Application deadline for targeted assistance program funding will be September 12, 2005. A full application is required this qualifying year, FY 2005. Six (6) new counties are eligible for targeted assistance. Counties that have received TAP funds in the past and will continue to qualify for TAP have not been required to submit a full application since FY 2002. Application requirements in the second and third of a 3-year project cycle will be less extensive.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
National Library of Medicine; Request for Nominations
The National Institutes of Health (NIH) is issuing this notice to invite private sector providers and users of chemical information to indicate their interest in participating in a new working group of the Board of Scientific Counselors of the National Center for Biotechnology Information (NCBI), National Library of Medicine (NLM), to advise on interactions with private sector information providers in the development of PubChem. PubChem is a publicly available NIH database that includes information about the biological activities of chemical compounds. It is designed to facilitate more integrated access to these information resources for biomedical researchers. The working group will advise on such issues as improving connections with private sector chemical information providers in order to enhance linkages and interoperability among resources and avoid unnecessary duplication with commercial information services. Response Date: Persons, groups, or organizations interested in participating in the working group should send an e-mail indicating their expertise in issues related to PubChem, along with their contact information, to: Christine Ireland, Committee Management Officer, NLM, irelanc@mail.nih.gov. Emails must be received on or before October 3, 2005. Supplementary Information: In 2004, as part of the NIH's Roadmap Initiative to speed new medical treatments and improved health care to all Americans, NIH launched an on-line database called PubChem as part of an integrated suite of databases supporting the New Pathways to Discovery component of the Roadmap effort. New Pathways focuses on very basic biomedical research, and especially focuses on understanding the molecular biology of health and illnesses. Bioinformatics is a critical component of that effort and PubChem provides the free, publicly available database that links chemical information with biomedical research and clinical information. Drawing from many public sources, PubChem organizes information about the biological activities of chemical compounds into a comprehensive biomedical database. All of this supports the part of the Roadmap called the Molecular Libraries initiative. This includes nine different componentsa compound repository, the NIH Chemical Genomics Center, the Molecular Libraries Screening Center Network, PubChem, a series of Cheminformatics Research Centers, and technology development for chemical diversity synthesis, assay development, instrumentation, and toxicology. PubChem is the informatics backbone for virtually all of these components, and is intended to empower the scientific community to use small molecule chemical compounds in their research. Small molecules include many of the chemicals commonly used as medicines. They affect genes, proteins, cells, and people. Identification of small molecule tools is a compelling next step following on the success of the Human Genome Project. It offers a new paradigm to transform basic biomedical research, speeding development of new therapies and finding solutions to America's most important health problems. NIH's goals are to rapidly translate the discoveries of the genome into new therapeutics and to integrate small molecule chemistry into biomedical research. PubChem facilitates these efforts by linking genome, chemistry, protein, and biomedical literature information. This seamless integration of resources is essential for providing information about potential starting points for the development of new medications. Without PubChem, the work of NIH funded scientists will be greatly hampered and progress in biomedical research will be slowed. NIH intends to continue to operate PubChem as a free, publicly available resource that is an integral part of the NIH Roadmap Initiative. This is consistent with the principles of publicly funded science. NLM has had extensive and valuable private sector interactions for developing and maintaining other major information resources, such as sequence databases and PubMed/Medline. NIH believes that the private sector has expertise that will be helpful in the further development of PubChem and will help to ensure coordinated and integrated access by researchers to the full range of resources useful for advancing scientific discovery. Therefore, NIH is asking private sector providers and users of chemical information to indicate their interest in participating in a working group of the NLM/NCBI Board of Scientific Counselors, which is established under the Federal Advisory Committee Act. All members of such a working group would be required to disclose their potential conflicts. This new working group of outside experts would be separate from the existing PubChem Working Group, which provides advice about details of the operation of the PubChem database and also reports to the NCBI Board of Scientific Counselors. Specifically, this working group would advise the NCBI Board of Scientific Counselors on such issues as: Establishing a process for retrospective evaluation of the biomedical relevance of compounds entered into PubChem Ensuring the provenance of the data (i.e., whether private data are being improperly deposited in PubChem) Ensuring the high quality of data in PubChem Monitoring the effect of PubChem on scientific progress Improving/integrating interactions with commercial information providers Avoiding unnecessary duplication with commercial information providers
Medicare Program; Medicare Prescription Drug Discount Card; Revision of Marketing Rules for Endorsed Drug Card Sponsors
This final rule will revise the current limitations prohibiting an endorsed drug card sponsor from marketing its Part D plans to its drug card enrollees. This revised rule will give the current drug card sponsors the ability to market to their enrollees Part D plans that are either offered by the same endorsed drug card sponsor or an affiliated organization of the same endorsed drug card sponsor. We are making these changes after considering the public comments received regarding the need to ensure a smooth transition from the drug card to the Medicare Prescription Drug Benefit.
Agency Emergency Processing Under Office of Management and Budget Review; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). FDA is preparing a guidance document to notify the public of procedures being implemented by the agency to assist firms that wish to request, on a case-by-case basis upon an appropriate showing, an extension to use existing label stock after the effective date of the trans fat labeling final rule. This notice solicits comments on the proposed collection of information associated with the guidance document entitled ``Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006.''
Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking to request comment on whether to initiate a rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), regarding when an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug product.
Advisory Commission on Childhood Vaccines; Notice of Meeting
The Health Resources and Services Administration is amending a notice that appeared in the Federal Register of August 22, 2005 (70 FR 48962-48963) announcing an Advisory Commission on Childhood Vaccines meeting on September 14, 2005. The document announced that the public can join the meeting by attending in person or by audio conference call. The meeting will now be held by audio conference call only. This document amends the notice by changing the place of the meeting.
Office of Refugee Resettlement; Final Notice of Allocations to States of FY 2005 Funds for Refugee Social Services
This notice establishes the final allocations to States of FY 2005 funds for refugee \1\ social services under the Refugee Resettlement Program (RRP). The final notice reflects amounts adjusted based upon final adjustments to FY 2002, FY 2003 and FY 2004 (0ctober 1, 2001 through September 30, 2004) data submitted to ORR by States.
Family and Youth Services Bureau; Positive Youth Development State and Local Collaboration Demonstration Projects
Notice is hereby given that a noncompetitive grant supplement is being made to the following state agencies: State of Nebraska Health & Human Services, University of Kentucky Research Foundation, State of Oregon, New York Office of Children & Family Services, State of Louisiana, Iowa Dept. of Human Rights Criminal & Juvenile Justice, Commonwealth of Massachusetts, Illinois Department of Human Services, Governor's Office for Children Youth & Families. The purpose of this supplement is to support collaborations between state-level agencies and local community jurisdictions regarding positive development opportunities available to young people as approved in their original planning grant.
Medicare Program; Establishment of the Medicare Advantage Program
This document corrects technical errors that appeared in the final rule published in the Federal Register on January 28, 2005 entitled ``Establishment of the Medicare Advantage Program.'' It also stays several amendments made in the previous rule.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006; Corrections
This document corrects errors in the proposed rule that appeared in the Federal Register on August 8, 2005 entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006.''
Medicare Program; Withdrawal of Ambulance Fee Schedule Issued in Accordance With Federal District Court Order in Lifestar Ambulance, Inc.
This notice with comment period withdraws the fee schedule that was put in place in 2003 to effect compliance with the Order in Lifestar Ambulance, Inc. v. United States. [211 F.R.D. 688 (M.D. Ga. 2003)] That Order was vacated on January 10, 2005 by the U.S. Court of Appeals for the Eleventh Circuit and is no longer in force.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
