Department of Health and Human Services July 15, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc.

This notice sets forth estimated FY 2012 individual allotments and estimated percentages of the total allotments to States administering the State Developmental Disabilities Councils and Protection and Advocacy Systems programs, pursuant to section 122 and section 142 of the Developmental Disabilities Assistance and Bill of Rights Act (the Act) [Pub. L. 106-402, October 30, 2000]. The estimated allotment amounts are based on the FY 2012 President's Budget request and are contingent on Congressional appropriations for FY 2012. Once Congress enacts an appropriation for FY 2012 and after ADD updates the data elements listed in the SUPPLEMENTARY INFORMATION section below, the estimated allotments will be adjusted accordingly. The estimated allotments contained herein will be adjusted for FY2012. The final State allotments will be available on the ADD homepage after a final 2012 Continuing Resolution or HHS appropriations bill is passed by Congress.

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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 20, 2011 (76 FR 22108) and allowed 60 days for public comment. One public comment was received on April 20, 2011 which commented on the government spending money to support NIH. An email response was sent on May 18, 2011 stating, ``Thank you for your comments and we will take it under advisement.'' 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: 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.

This proposed rule would implement standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. These programs will mitigate the impact of potential adverse selection and stabilize premiums in the individual and small group markets as insurance reforms and the Affordable Insurance Exchanges (``Exchanges'') are implemented, starting in 2014. The transitional State-based reinsurance program serves to reduce the uncertainty of insurance risk in the individual market by making payments for high- cost cases. The temporary Federally-administered risk corridor program serves to protect against uncertainty in the Exchange by limiting the extent of issuer losses (and gains). On an ongoing basis, the State- based risk adjustment program is intended to provide adequate payments to health insurance issuers that attract high-risk populations (such as individuals with chronic conditions).