Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents

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: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI). Type of Information Collection Request: Revision (OMB : 0925-0407, current expiry date 10/31/ 2011). Need and Use of Information Collection: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 254,570 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. OMB first approved this study in 1993 and has approved it every 3 years since then through 2011. During the first approval period a pilot study was conducted to evaluate recruitment methods and data collection procedures. Recruitment was completed in 2001 and data collection continues through 2014. When participants enrolled in the trial they agreed to be followed for at least 13 years from the time of enrollment. The current number of respondents in the study is 122,655; this is down from the initial total due to deaths. The primary endpoint of the trial is cancer specific mortality for each of the four cancer sites (prostate, lung, colorectal, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. Frequency of Response: Annually. Affected Public: Individuals. Type of Respondents: Adult men and women. The annual reporting burden is provided for each study component as shown in the Table 1 below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (CDC) announces the availability of the following publication: NIOSH Current Intelligence Bulletin 63: Occupational Exposure to Titanium Dioxide.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Ivyl W. Wells, MD from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Wells was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Wells was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Wells failed to respond. Dr. Well's failure to respond constitutes a waiver of his right to a hearing concerning this action.

This notice provides public announcement of CDC's intent to fund Approved cooperative agreement applications previously received and competed in response to CDC Funding Opportunity, CDC-RFA-IP11-010, ``Enhanced Surveillance for New Vaccine Preventable Disease.'' It is the intent of CDC to fund the applications with Patient Protection Affordable Care Act (ACA), Section 4002, appropriations. CFDA Number 93.533 is the ACA-specific CFDA number for this initiative.

This final rule will revise Medicaid regulations for Mechanized Claims Processing and Information Retrieval Systems. We are also modifying our regulations so that the enhanced Federal financial participation (FFP) is available for design, development and installation or enhancement of eligibility determination systems until December 31, 2015. This final rule also imposes certain defined standards and conditions in terms of timeliness, accuracy, efficiency, and integrity for mechanized claims processing and information retrieval systems in order to receive enhanced FFP.

The Health Resources and Services Administration (HRSA) will be issuing non-competitive supplemental funding to the Maternal Child and Health Bureau's (MCHB) Comprehensive Hemophilia Diagnostic and Treatment Centers. MCHB's Division of Children with Special Health Needs and the Genetic Services Branch are currently undergoing a strategic planning process. This will provide feasible time for the MCHB to align fiscal resources and programmatic goals as determined by this strategic planning process with the least disruption to the States, communities, and constituencies that currently receive assistance and services from these grantees.

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing a notice for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or tobacco products. These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP.

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: ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats. In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

This notice announces to LIHEAP grantees the estimated median income of four-person families in each State and the District of Columbia for FFY 2012 (October 1, 2011, to September 30, 2012). LIHEAP grantees that choose to base their income eligibility criteria on these State median income (SMI) estimates may adopt these estimates (up to 60 percent) on the estimates' date of publication in the Federal Register or on a later date as discussed below. This enables these grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2011, or the beginning of the grantees' fiscal years, whichever is later, these grantees must adjust their income eligibility criteria so that such criteria are in accord with the FFY 2012 SMI. This listing of 60 percent of SMI provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP. LIHEAP appropriations for FFY 2009 through FFY 2010 raised this criterion from 60 percent of SMI to 75 percent of SMI for those years. The Continuing Resolutions covering FFY 2011 through the date of this publication have maintained this criterion at 75 percent of SMI. This criterion will remain at 75 percent SMI for FFY 2011 unless Congress acts otherwise after the date of this publication. This criterion will return to 60 percent of SMI for FFY 2012 unless Congress acts otherwise in providing FFY 2012 appropriations after the publication of this notice. This is because no change to the LIHEAP authorizing statute has been made.

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), 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: Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The title of this collection was previously, ``24-hour Dietary Recall Method Comparison and the National Cancer Institute (NCI) Observational Feeding Studies.'' The objective of the two studies is to compare the performance of the newly developed computerized Automated Self- Administered 24-Hour Recall (ASA24) approach to collecting 24 hour recall (24HR) data with the current standard, the interviewer- administered Automated Multiple Pass Method (AMPM). The ultimate goal is to determine to what extent the new automated instrument can be used instead of the more expensive interviewer-administered instrument in the collection of dietary intake data. Frequency of Response: Twice. Affected Public: Individuals. Type of Respondents: For the FORCS study, approximately 1,200 adult members from three health maintenance organization plans (in Minnesota, California, and Michigan) between ages 20 and 70 years. For the FEAST study, approximately 90 adult residents from the Washington, DC metropolitan area between ages 20 and 70 years. The annual reporting burden is estimated at 866 hours (see table below). This amounts to an estimated 2,598 burden hours over the 3-year data collection period with a total cost to the respondents of $54,293. There are no Capital costs, Operating costs, and/or Maintenance Costs to report.

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 provisions of existing FDA regulations regarding countries seeking to be designated as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions applicable to FDA-regulated human food and cosmetics.

The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.

This notice informs interested parties of an opportunity to apply to participate in the Medicare Community-based Care Transitions Program, which was authorized by section 3026 of the Affordable Care Act.