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

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Ms. Chatman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Ms. Chatman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Chatman failed to respond. Ms. Chatman's failure to respond constitutes a waiver of her right to a hearing concerning this action.

Section 1899(f) of the Social Security Act (of the Act), as added by the Affordable Care Act (ACA) authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act (the Medicare Shared Savings Program). This notice with comment period describes and solicits public input regarding possible waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involving accountable care organizations (ACOs) under the Medicare Shared Savings Program. In addition, section 1115A(d)(1) of the Act, as added by section 3021 of the ACA, authorizes the Secretary to waive the same fraud and abuse laws, among others, as necessary solely for the purposes of carrying out the provisions of section 1115A of the Act with respect to the testing of certain innovative payment and service delivery models by the Center for Medicare and Medicaid Innovation. This notice with comment period also solicits public input regarding that separate waiver authority.

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 February 4, 2011 (76 FR 6485) 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: Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of this short 2-page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 485,909 participants of the NIH-AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. A pilot mailing to 1,600 randomly selected NIH-AARP Diet and Health study participants confirmed the feasibility of the methodology and willingness of respondents to participate in this data collection effort. This questionnaire adheres to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-85). The annual reporting burden is displayed in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Maria Carmen Palazzo, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Palazzo was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of any drug product under the FD&C Act. Dr. Palazzo was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Palazzo failed to respond. Dr. Palazzo's failure to respond constitutes a waiver of her right to a hearing concerning this action.

To implement the vending machine labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing calorie information for certain articles of food sold from vending machines. The Affordable Care Act, in part, amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to, among other things, require that for an article of food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase, and is operated by a person engaged in the business of owning or operating 20 or more vending machines, the vending machine operator must disclose the number of calories for the article of food. Vending machine operators not subject to the requirements of the Affordable Care Act may elect to be subject to the Federal requirements by registering with FDA. Providing calorie disclosures for food sold from vending machines would assist consumers in making healthier dietary choices.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application No. PCT/US03/37208 [HHS Ref. No. E-339-2002/0-PCT- 02], filed November 20, 2003, which published as WO 2004/048928 on June 10, 2004, now expired, entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two- Dimensional Array;'' U.S. Patent Application No. 10/535,521 [HHS Ref. No. E-339-2002/0-US-03], filed May 18, 2005, now abandoned, which published as US-2006-0147926 A1 on July 6, 2006 entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two-Dimensional Array;'' U.S. Patent Application No. 12/587,976 [HHS Ref. No. E-339-2002/0-US-04], filed October 14, 2009, which published as US-2010-010506 on April 29, 2010 entitled ``Device for External Movement Manipulation of Nucleic Acids and/or Proteins;'' U.S. Provisional Patent Application No. 61/206,458 [HHS Ref. No. E-130- 2006/0-US-01] filed January 30, 2009, entitled, ``Amplification Platform and Methods of Use Thereof, now expired, and PCT Patent Application No. PCT/US10/022586 [HHS Ref. No. E-130-2006/0-PCT-02] filed January 29, 2010 and which published as WO 2010/088517 on August 5, 2010, entitled, ``Methods and Systems for Purifying, Transferring and/or Manipulating Nucleic Acids;'' and all continuing applications and foreign counterparts to 2-D Bio, LLC, having a place of business in Gaithersburg, Maryland. The patent rights in these inventions have been assigned to the United States of America. However, the patent rights for HHS Ref. No. E-130-2006/0-US-01 and HHS Ref. No. E-130-2006/0-PCT- 02 are co-owned and co-assigned to the University of Maryland. The United States of America has obtained an exclusive license to the University of Maryland's rights in the invention. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``development of devices for sale and services for high throughput parallel analysis and two dimensional analyses of molecules for all uses.''

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of robenacoxib tablets in cats for the control of postoperative pain and inflammation.

The Children's Bureau is interested in improving the process by which we review title IV-B and IV-E plan requirements. CB currently reviews a State's compliance through Child and Family Service Reviews (CFSRs). Following two rounds of CFSRs in every State and the passage of several amendments to Federal child welfare laws since the CFSRs began, we believe it is time to reassess how CB reviews title IV-B and IV-E programs through the CFSR and identify enhancements and system improvements we could make.

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2011. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

This notice announces that CMS is exercising its authority under section 1102(f) of the Affordable Care Act to stop accepting applications for the Early Retiree Reinsurance Program, due to the availability of funds, as of May 5, 2011.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This proposed rule would remove the definition of and modify requirements regarding ``direct solicitation;'' allow DMEPOS suppliers, including DMEPOS competitive bidding program contract suppliers, to contract with licensed agents to provide DMEPOS supplies unless prohibited by State law; remove the requirement for compliance with local zoning laws; and modify certain State licensing requirement exceptions.