Department of Health and Human Services November 15, 2010 – Federal Register Recent Federal Regulation Documents
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National Institute of Child Health and Human Development; Revision to Proposed Collection; Comment Request; the National Children's Study, Vanguard (Pilot) Study
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 National Institute of Child Health and Human Development (NICHD), 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.
Office of Biotechnology Activities Recombinant DNA Research: Proposed Actions Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
A request to certify Kluyveromyces lactis as a new host-vector system has been submitted to the NIH Office of Biotechnology Activities (OBA). The data to be considered for certifying a new host-vector system can be found in Appendix I of the NIH Guidelines. A new host- vector system may be certified only after review by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as a Major Action. Part of this request is to exempt from the NIH Guidelines certain types of research when performed in K. lactis, if K. lactis and its affiliated plasmids meet the requirements for certification as a host- vector system. Research that is exempt from the NIH Guidelines when performed with other certified host-vector systems can be found in Appendix C of the NIH Guidelines.
Advisory Committee on Training in Primary Care Medicine and Dentistry
Notice is hereby given of the cancellation of the Advisory Committee on Training in Primary Care Medicine and Dentistry, November 15, 2010, 8:30 a.m. to 4:30 p.m., and November 16, 2010, 8 a.m. to 2 p.m., at the Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20910, which was published in the Federal Register on October 19, 2010, FR Doc. 2010-26205 (75 FR 64318).
Medicare and Medicaid Programs; Approval of Det Norske Veritas Healthcare for Deeming Authority for Critical Access Hospitals
This final notice announces our decision to approve Det Norske Veritas Healthcare (DNVHC) for recognition as a national accreditation program for critical access hospitals seeking to participate in the Medicare or Medicaid programs.
Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs
This final rule withdraws two provisions from the ``Medicaid Program; Prescription Drugs'' final rule (referred to hereafter as ``AMP final rule'') published in the July 17, 2007 Federal Register. The provisions we are withdrawing are as follows: The determination of average manufacturer price, and the Federal upper limits for multiple source drugs. We are also withdrawing the definition of ``multiple source drug'' as it was revised in the ``Medicaid Program; Multiple Source Drug Definition'' final rule published in the October 7, 2008 Federal Register.
Proposed Collection; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2011 (NCI)
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 National Cancer Institute (NCI), 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: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2010. Type of Information Collection Request: Revision. Need and Use of Information Collection: The NCI has sponsored five Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a sixth to be administered in 2011. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the State. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2011 is planned for continual administration to 48,150 adults and 3,316 adolescent Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, obesity, and human papillomavirus. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 2,177 (see Table 1). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
New Animal Drugs for Minor Use and Minor Species
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the Agency's regulations. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.
New Animal Drugs for Minor Use and Minor Species
The Food and Drug Administration (FDA) is amending its regulations regarding new animal drugs for minor use and minor species to update language and to clarify the regulations consistent with the explanations in the preambles to the proposed and final rules establishing them. This action is being taken to ensure accuracy and clarity in the Agency's regulations. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and- comment rulemaking, to provide a procedural framework to finalize the rule in the event the Agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.
New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for sulfadiazine and pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC, to Pegasus Laboratories, Inc.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Development of the Guide to Patient and Family Engagement in Health Care Quality and Safety in the Hospital Setting.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Standardizing Antibiotic Use in Long-term Care Settings.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
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