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

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be conducted as a telephone conference call. The meeting will be open to the public through a conference call phone number.

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).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for reinstatement of approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23608-23609, and allowed 60 days for public comment. Two written comments and two verbal comments were received. The verbal comments expressed support for the broad scope of the study. The written comments were identical and questioned the cost and utility of the study. 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: Formative Research Studies for the National Children's Study (NCS) Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

The Food and Drug Administration (FDA) is proposing to remove a section of the Prescription Drug Marketing Act (PDMA) regulations requiring that prior to the completion of any wholesale distribution of a prescription drug, an unauthorized distributor must provide to the purchaser ``a statement identifying each prior sale, purchase, or trade of such drug,'' starting with the manufacturer, and that the identifying statement (also known as the ``pedigree'') must include certain information about the drug and each prior sale, purchase, or trade. This action is being taken in response to longstanding issues, including an injunction currently in effect, regarding the application of and compliance with this requirement. FDA is also announcing that it intends to exercise enforcement discretion with respect to certain requirements of the regulation while the rulemaking is pending and with respect to the statutory pedigree requirements of the PDMA, as long as the pedigree identifies the names and addresses of the last authorized distributor of record that handled the drug and the associated dates of transactions involving that last authorized distributor of record and the drug, as well as the names and addresses of all subsequent unauthorized distributors that handled the drug and the corresponding dates of those transactions.

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.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors planning to develop a therapeutic product that depends on the use of an in vitro companion diagnostic device for its safe and effective use or an in vitro diagnostic device that is intended for use with a corresponding therapeutic product and included in the instructions for use in the labeling of those products. This guidance defines in vitro companion diagnostic devices; explains the need for FDA oversight of companion diagnostic devices; clarifies that, in most circumstances, if use of a companion diagnostic device is essential for the safe and effective use of a therapeutic product, the diagnostic device and therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling; provides guidance for industry and FDA staff on possible premarket regulatory pathways and FDA's regulatory enforcement policy; and describes certain statutory and regulatory approval requirements relevant to therapeutic product labeling that stipulate concomitant use of a companion diagnostic device to ensure safety and effectiveness of the therapeutic product. This draft guidance is not final, nor is it in effect at this time.

This document corrects technical errors that occurred in Tables 2 and 4J, that were referenced in the proposed rule entitled ``Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2012 Rates'' which appeared in the May 5, 2011 Federal Register.

This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the following grantee: National Association for Health Data Organizations (NAHDO) to collaborate with CDC to identify and overcome barriers that limit access to hospital and emergency department data, including identifying and resolving issues of access to secure records. These activities are proposed by the above-mentioned grantee in their FY 2011 application submitted under funding opportunity EH10-1003, ``National Environmental Public Health Tracking Program (EPHT),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.070. Approximately $124,995.00 in ACA funding will be awarded to the grantee for network expansion and enhancement. Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Section 4002 [42 U.S.C. 300u-11]; (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement of EH10-1003:

The Administration on Aging is announcing the intent to provide supplemental grant funds for the support of the Senior Medicare Patrol (SMP) program. The goal of this supplemental grant funding is to address the increased need of SMP project grantees for technical assistance and support from the National Consumer Protection Technical Resource Center (the Center). This need has been generated by CMS program expansion grants which have recently doubled the size of the SMP program.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cosmetic Labeling Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 for appeals of science-based decisions above the division level at the Center for Veterinary Medicine (CVM).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the draft guidance). The draft guidance provides guidance to egg producers and other persons who are covered by FDA's final rule entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the final rule). The draft guidance contains questions FDA has received on the final rule since its publication and responses to those questions.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance on ``Data to Support Communications to Educate Consumers on How to Safely Purchase Drugs Online.'' This data collection will obtain baseline knowledge of the Internet users' knowledge, attitudes, and practices with regard to online pharmacies, and then will collect ongoing data for tracking changes in knowledge, attitudes, and practices as a function of an integrated public outreach campaign FDA will roll out to educate consumers on how to safely purchase drugs online.