Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 324
Possession, Use, and Transfer of Select Agents and Toxins
This document establishes a final rule regarding possession, use, and transfer of select agents and toxins. The final rule implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and is designed to protect public health and safety. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture has established corresponding final rules designed to protect animal and plant health and animal and plant products.
Proposed Collection; Comment Request; Revision of OMB# 0925-0002 Ruth L. Kirschstein NRSA Individual Fellowship Application
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Ruth L. Kirschstein NRSA Individual Fellowship Application. Type of Information Collection Request: Revision of a currently approved collection. Form Numbers: The PHS 416- 1, 416-9, 416-5, 416-6031, 6031-1, Need and Use of Information Collection: The PHS 416-1 and 416-9 are used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The other related forms (PHS 416-5, 416-7, 6031, 6031-1) are used by these individuals to activate, terminate, and provide for payback of a National Research Service Award. Affected Public: Individuals or households; business or other for profit; not-for-profit institutions; Federal Government; and State, Local or Tribal government. Type of Respondents: Adult scientific trainees and professionals. The annual reporting burden is represented in the following table:
National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Expert Panel Reports on Amphetamines and Methylphenidate; Request for Public Comments
The CERHR announces the availability of the final expert panel reports on amphetamines and on methylphenidate on March 21, 2005, from the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on these expert panel reports (see SUPPLEMENTARY INFORMATION below). The expert panel reports are evaluations on the reproductive and developmental toxicities of amphetamines and methylphenidate conducted by a 13-member expert panel composed of scientists from the Federal government, universities, and private companies. The CERHR previously solicited public comment on draft versions of each expert panel report (Federal Register volume 69, number 208, pages 62906-62907). Public deliberations by the panel took place on January 10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel reports and reach conclusions regarding whether exposure to amphetamines or methylphenidate is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. The final revisions on these reports have been reviewed for accuracy of content and presentation by the amphetamines and methylphenidate expert panel, NTP scientists, and CERHR personnel.
Government-Owned Inventions; Availability for Licensing
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
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 Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Final Guidance for Industry on Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
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.
Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting and Announcement of Members
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. This notice also announces the newly appointed members of the EMTALA TAG. Interested parties are invited to this meeting to present their comments on the EMTALA regulations and implementation.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h and 2567
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 information collection requirements relating to the general licensing provisions regarding biologics license application, changes to an approved application, labeling, and revocation and suspension, and the use of Forms FDA 356h and 2567.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Gary M. Kammer, M.D., Wake Forest University: Based on the Wake Forest University (WFU) Investigation Report, the respondent's admission, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Gary M. Kammer, M.D., former Professor, Division of Rheumatology, Department of Internal Medicine, and Department of Microbiology and Immunology at the WFU School of Medicine, engaged in scientific misconduct by falsification and fabrication of research in grant application 2 R01 AR39501-12A1, ``T Lymphocyte Dysfunction in Lupus Erythematosus,'' submitted to the National Institute of Arthritis and Musculoskeletal Skin Diseases (NIAMS), National Institutes of Health (NIH), and in 1 R01 AI46526-01A2, ``Protein Kinase A-II in the Pathogenesis of Lupus,'' submitted to the National Institute of Allergy and Infectious Diseases (NIAID), NIH. Specifically, PHS found that: The respondent fabricated Families 2 and 3 in Figure 6 and related text in application 2 R01 AR39501-12A1 (pp. 29-30), entitled (``T Lymphocyte Dysfunction in Lupus Erythematosus'') by: a. Making up both of the pedigrees, b. Fabricating 13 PKA-I and 13 PKA-II values for these non-existent affected and unaffected family members, and c. Composing the false text describing these two fabricated families. The respondent falsified the text describing the results in Figure 20 (``Inhibition of c-fos luciferase activity in S49 T cells transiently transfected with pIRES2-RIIb-EGFP and treated with 8-Cl- cAMP'') in application 1 R01 AI46526-01A2 (p. 27), by falsely reporting N = 4, P less than 0.002, when the experiment had been performed only one time at the time that the application was submitted. PHS also concluded that the respondent further demonstrated a lack of present responsibility as a Principal Investigator by submitting NIH grant proposals with additional unsupported experimental results: The pedigree and data for the family reported in grant application 2 R01 AR39501-12 and for Family 1 in grant application 2 R01 AR39501-12A1 are incorrect and the data pertaining to this family that Dr. Kammer subsequently provided to WFU after the inquiry were not the data reported in the applications. Dr. Kammer stated that he did not recall who in his laboratory gave him this pedigree. ORI noted that the actual PKA data for the ``proof-of-principle'' family, while suggesting that low PKA values may be hereditary (the presence of low PKA-I values in three generations), do not support the claims of the fabricated and mixed up pedigree and data that show that low PKA-I values were associated with Systematic Lupus Erythematosus (SLE) (application 2R01 AR39501-12). In application, R01 AI39501-12A1, the following unsupported statement was also included: ``In both normal and disease controls, all T cells express CD59+ and there is no significant difference in its cell surface expression on CD4+, CD45RA+, CD4+, CD45RO+, CD8+, CD45RA+, CD8+, CD45RO+ subsets (n=4 each control group; data not shown).'' No data could be produced to support the information in the grant application about these control experiments. Dr. Kammer has entered into a Voluntary Exclusion Agreement (Agreement ) in which he has voluntarily agreed for a period of three (3) years, beginning on February 15, 2005: (1) To exclude himself 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, and (2) To exclude himself 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'' as defined in the debarment regulations at 45 CFR part 76. This voluntary exclusion precludes the respondent from receiving Federal research, research training, or other research related funds from the Federal Government for three (3) years, but shall not apply to the respondent's participation in a Federal health care program as defined in section 1128B(f) of the Social Security Act and shall not apply to Federal funds used solely for purposes of teaching or training medical students, residents, or fellows in clinical medical matters.
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA) is establishing January 1, 2008, as the uniform compliance date for food labeling regulations that are issued between March 14, 2005, and December 31, 2006. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 31, 2002, FDA established January 1, 2006, as the uniform compliance date for food labeling regulations that issued between January 1, 2003, and December 31, 2004.
Solicitation of Nomination for Appointment to the Chronic Fatigue Syndrome Advisory Committee
The Office of Public Health and Science, DHHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of six Committee members are scheduled to end on September 30, 2005. Nominations of qualified candidates are being sought to fill these scheduled vacancies.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
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