Submission for OMB Review; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009 (NCI)
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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 22, 2008 (Volume 73, No. 164, p. 49685) 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: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fifth to be administered in 2009. 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 2009, the fifth bi-annual survey, is planned for administration to 55,000 adult 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, and obesity. 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 or households. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 3,436.93 (see Table A). The annualized cost to respondents is estimated at: $57,825. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Medicaid Program; Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition
Outpatient hospital services are a mandatory part of the standard Medicaid benefit package. This final rule aligns the Medicaid definition of outpatient hospital services more closely to the Medicare definition in order to: Improve the functionality of the applicable upper payment limits (which are based on a comparison to Medicare payments for the same services), provide more transparency in determining available hospital coverage in any State, and generally clarify the scope of services for which Federal financial participation (FFP) is available under the outpatient hospital services benefit category.
Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
The Food and Drug Administration (FDA) is issuing a final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The final rule implements the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which required prior notification of imported food to begin on December 12, 2003. The final rule requires that the prior notice be submitted to FDA electronically via either the U.S. Customs and Border Protection (CBP or Customs) Automated Broker Interface (ABI) of the Automated Commercial System (ACS) or the FDA Prior Notice System Interface (FDA PNSI). The information must be submitted and confirmed electronically as facially complete by FDA for review no less than 8 hours (for food arriving by water), 4 hours (for food arriving by air or land/rail), and 2 hours (for food arriving by land/road) before the food arrives at the port of arrival. Food imported or offered for import without adequate prior notice is subject to refusal and, if refused, must be held. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft compliance policy guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.''
Draft Compliance Policy Guide; “Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft Compliance Policy Guide (CPG) entitled ``Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The draft CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The final rule entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' is published elsewhere in this issue of the Federal Register.
Designating Additions to the Current List of Tropical Diseases in the Food and Drug Administration Amendments Act; Public Hearing
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on adding additional diseases to the list of tropical diseases recognized under the Food and Drug Administration Amendments Act (FDAAA), which adds a new section to the Federal Food, Drug, and Cosmetic Act (the act). The new section authorizes FDA to award priority review vouchers to sponsors of certain tropical disease product applications that meet the criteria specified by the act. The new section lists diseases considered to be ``tropical diseases'' for the purposes of this legislation, and provides for expansion of the list to include diseases meeting certain criteria. This public meeting is being held to obtain comments from the public on the criteria that should be used to determine whether an infectious disease should be added to the list, and to elicit suggestions for adding specific diseases.
Availability of Draft Toxicological Profiles
The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)], directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 22nd set of toxicological profiles, which consists of four updated drafts prepared by ATSDR for review and comment. The toxicological profiles for formaldehyde and perfluoroalkyls are on a modified schedule pending additional review.
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 http:// www.workplace.samhsa.gov and http://www.drugfreeworkplace.gov.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Linde Ceramics Plant, Tonawanda, NY, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Linde Ceramics Plant, Tonawanda, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Linde Ceramics Plant. Location: Tonawanda, New York. Job Titles and/or Job Duties: All employees. Period of Employment: January 1, 1954 through July 31, 2006 (during the applicable covered residual radiation period).
Notice of a Public Meeting
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following public meeting to discuss NIOSH's Respirator Standards Development Efforts and the Personal Protective Technology (PPT) Program Action Planning Efforts.
Notice of Meeting of the Advisory Council on Blood Stem Cell Transplantation
Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the third meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT), Department of Health and Human Services (HHS). The meeting will be held from approximately 8:30 a.m. to 5 p.m. on December 15, 2008, and from 8:30 a.m. to 3:30 p.m. on December 16, 2008, at the Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, Maryland 20814. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jusan Yang, M.S., M.D., University of Iowa: Based on the report of an investigation conducted by the University of Iowa (UI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, this settlement resolves proposed U.S. Public Health Service (PHS) findings that Dr. Jusan Yang, former Assistant Research Scientist, UI, engaged in scientific misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant R01 HL48058. PHS finds the Respondent engaged in scientific misconduct by falsifying and fabricating data that were reported in a scientific manuscript intended for publication entitled ``Increased renin transcription after inhibition of NF-YA with RNAi reveals through regulation of Ea element and Ear2'' and at two professional scientific meetings. Specifically, PHS found that: 1. Respondent falsified Figure 1 in the manuscript that purports to show the effectiveness of four plasmids targeting different parts of the NF-Y coding sequence in inhibiting NF-Y expression by (1) Claiming in Figure 1A that the loading control bands were obtained by reprobing a Western blot with antibody to GAPDH when he used a prominent background (nonspecific) band from the blot probed with antibody to NF- YA, (2) inappropriately enhancing and manipulating the NF-YA band in Figure 1A claiming decreased expression of NF-YA in cultures transfected with 2 of the 4 constructs, and (3) falsely claiming in Figure 1B that the quantitative data for NF-YA expression obtained by scanning Western blot films were based on an n of 4 and that the expression of NF-YA in cultures treated with two constructs was statistically significantly lower than the control. Versions of the same falsified blot and histogram also were reported in several of the Respondent's public presentations. 2. Respondent falsified Figures 4, 5, 6, and 8 in the manuscript by claiming in the figure legends that 4 independent repetitions contributed to each figure's results when the actual numbers of repetitions were n=3 for Figure 4, n=1 for Figure 5, n=3 for Figure 6, and n=2 for Figure 8; in Figure 5, error bars based on the Student's t test further falsely claim that n was >2. He further falsified Figures 6 and 8 by reporting smaller standard errors of the mean than were obtained from the actual data, thereby giving an enhanced impression of rigor for the reported experiments. Respondent reported Figures 5, 6, and 8 (without legends) at the American Heart Association Council for High Blood Pressure meeting in September 2003, and he reported Figures 5 and 8 at the Experimental Biology meeting in April 2004. Respondent stated that he does not intend to apply for or engage in PHS-supported research. However, if such a circumstance were to arise, Respondent agreed for a period of five (5) years, beginning on October 14, 2008: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or which uses him in any capacity on PHS supported research, or that submits a report of PHS funded research in which he is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution; Respondent agreed to ensure that a copy of the supervisory plan is also submitted to ORI by the institution; Respondent agreed that he will not participate in any PHS- supported research until such a supervision plan is approved by ORI; (2) That any institution employing the Respondent submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which he is involved, a certification that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived, and that the data, procedures, and methodology are accurately reported in the application or report; the Respondent must ensure that the institution also sends a copy of the certification to ORI; and (3) 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.
Agency Emergency Processing Under Office of Management and Budget Review; Implementation of the Animal Generic Drug User Fee Act of 2008; User Fee Cover Sheet Form FDA 3728
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). The proposed collection of information concerns the burden hours required for the Animal Generic Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C. 379j-21) for implementing the new user fee cover sheet Form FDA 3728.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009
This notice sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services, effective on January 1, 2009.