Department of Health and Human Services May 5, 2011 – Federal Register Recent Federal Regulation Documents

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
Document Number: 2011-9644
Type: Proposed Rule
Date: 2011-05-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems and to implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. These changes would be applicable to discharges occurring on or after October 1, 2011. We also are setting forth the proposed update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2011. We are proposing to update the payment policy and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implement certain statutory changes made by the Affordable Care Act. These changes would be applicable to discharges occurring on or after October 1, 2011.
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-11055
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Center for Research Resources; Notice of Closed Meeting
Document Number: 2011-11040
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2011-11039
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-11037
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2011-11036
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2011-11034
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-11033
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2011-11031
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2011-11024
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Committee on Rural Health and Human Services; Notice of Meeting
Document Number: 2011-10983
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
Meeting of the President's Council on Fitness, Sports, and Nutrition; Correction
Document Number: 2011-10973
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services
The Department of Health and Human Services published a notice in the Federal Register of April 21, 2011 to announce a meeting of the President's Council on Fitness, Sports, and Nutrition that will be held on May 10, 2011, from 11 a.m. to 2:30 p.m., in the U.S. Capitol Visitor Center, East Capitol and First Streets, NE., Washington, DC 20001. The meeting location has changed.
Guidance for Industry on Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products; Availability
Document Number: 2011-10965
Type: Notice
Date: 2011-05-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products.'' This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing orally ingested over-the-counter (OTC) liquid drug products packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, or spoons). FDA is issuing this guidance because of ongoing concerns about potentially serious accidental drug overdoses that can result from the use of dosage delivery devices with markings that are inconsistent or incompatible with the labeled dosage directions for orally ingested OTC liquid drug products.
Information Required in Prior Notice of Imported Food
Document Number: 2011-10955
Type: Rule
Date: 2011-05-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations on prior notice of imported food. As required by the FDA Food Safety Modernization Act, FDA is issuing this interim final rule to require an additional element of information in a prior notice of imported food. This change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. The new information can help FDA make better informed decisions in managing the potential risks of imported food into the United States.
Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption
Document Number: 2011-10953
Type: Rule
Date: 2011-05-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations on administrative detention of food for human or animal consumption. As required by the FDA Food Safety Modernization Act (FSMA), FDA is issuing this interim final rule to change the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the U.S. food supply.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2011-10952
Type: Notice
Date: 2011-05-05
Agency: Department of Health and Human Services
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).
Partnerships To Advance the National Occupational Research Agenda (NORA)
Document Number: 2011-10950
Type: Notice
Date: 2011-05-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 10 a.m.-3:30 p.m. EDT, June 29, 2011. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of the Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the NORA Sector Councils on their progress, priorities, and implementation plans to date, including the NORA Manufacturing, Public Safety, Services, and Wholesale and Retail Trade Sector Councils. Updates will also be given on the Mid- Decade Review of NORA, the NORA Symposium 2011, and at least one NIOSH Program that is working on several NORA priorities, e.g., the NIOSH Economics Program. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the Internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: Computer, Internet connection, and telephone, preferably with `mute' capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-U.S. citizens are encouraged to participate in the Web meeting. Non-U.S. citizens who do not register to attend in person on or before June 6, 2011, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008-10, most of these Councils posted draft strategic plans for public comment and eight have posted finalized National Sector Agendas after considering comments on the drafts. For the National Sector Agendas, see https://www.cdc.gov/niosh/nora/.
Public Health Information Network (PHIN) Messaging Guide for Syndromic Surveillance
Document Number: 2011-10949
Type: Notice
Date: 2011-05-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is requesting public comment on the draft PHIN Messaging Guide for Syndromic Surveillance. The document translates the business requirement recommendations from the International Society for Disease Surveillance to technical specifications to support meaningful use of electronic health records for syndromic surveillance. Comments will be used to inform and finalize the Messaging Guide.
Medicare and Medicaid Programs: Changes Affecting Hospital and Critical Access Hospital Conditions of Participation: Telemedicine Credentialing and Privileging
Document Number: 2011-10875
Type: Rule
Date: 2011-05-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). The final rule will implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. This final rule will remove this undue hardship and financial burden.
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