Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 323
Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia): Debarment Order
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.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2011 Final Wage Indices Implementing the Medicare and Medicaid Extenders Act
This notice contains the final fiscal year (FY) 2011 wage indices and hospital reclassifications and other related tables which reflect changes required by or resulting from the implementation of section 102 of the Medicare and Medicaid Extenders Act of 2010. MMEA requires the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2011.
Medicare Program; Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center
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.
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations
This proposed rule would implement section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs). Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additional payments based on meeting specified quality and savings requirements.
Submission for OMB Review; Comment Request; Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (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 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.
Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment
This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule for renal dialysis services provided on April 1, 2011 through December 31, 2011. We are revising the transition budget-neutrality adjustment to reflect the actual election decision to receive payment under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011 made by ESRD facilities, rather than projected elections using the same methodology as described in the ESRD PPS proposed and final rules. This results in a zero percent adjustment for renal dialysis services furnished April 1, 2011 through December 31, 2011.
Maria Carmen Palazzo: Debarment Order
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.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Allergenic Products Advisory Committee notify FDA in writing. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
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.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
To implement the menu 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 certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The Affordable Care Act, in part, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the Affordable Care Act, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with the FDA. Providing calorie and other nutrition information in restaurants and similar retail food establishments would assist consumers in making healthier dietary choices.
Prospective Grant of Exclusive License: Device and System for Two Dimensional Analysis of Biomolecules From Tissue and Other Samples
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.''
Oral Dosage Form New Animal Drugs; Robenacoxib
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.
Federal Monitoring of Child and Family Service Programs; Request for Public Comment and Consultation Meetings
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.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
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.
Current List of Laboratories and Instrumented Initial Testing Facilities 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 and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF 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 https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Preparation for International Cooperation on Cosmetics Regulations; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR-5 Meeting in Paris, France'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Paris, France. The topics to be discussed are the topics for discussion at the forthcoming ICCR Steering Committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Paris, France scheduled on June 28 through July 1, 2011.
Early Retiree Reinsurance Program
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.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Safeguards
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.
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