Department of Health and Human Services May 6, 2011 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a web meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The web meeting will be open to the public. Information about the Advisory Group can be obtained by accessing the following Web site: https:// www.healthcare.gov/center/councils/nphpphc/.
Meeting of the Advisory Committee on Blood Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.
Guidance for Industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications.'' The guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the requirements in the final rule on the submission of bioequivalence data that published in the Federal Register in January 2009 (74 FR 2849, January 16, 2009). The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs and is applicable to BE studies conducted during both preapproval and postapproval periods.
Decision To Evaluate a Petition To Designate a Class of Employees From the Y-12 Plant in Oak Ridge, TN, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Y-12 Plant in Oak Ridge, TN, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Y-12 Plant. Location: Oak Ridge, TN. Job Titles and/or Job Duties: All workers potentially exposed to radioactive materials. Period of Employment: January 1, 1948 through December 31, 1957.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Linde Ceramics Plant in Tonawanda, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 21, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)
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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
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 PRA).
Medicaid Program; Methods for Assuring Access to Covered Medicaid Services
This proposed rule would create a standardized, transparent process for States to follow as part of their broader efforts to ``assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area'' as required by section 1902(a)(30)(A) of the Social Security Act (the Act). This proposed rule would also recognize, as States have requested, electronic publication as an optional means of communicating State plan amendments (SPAs) proposed rate-setting policy changes to the public.
Medicare Program; Hospital Inpatient Value-Based Purchasing Program
This final rule implements a Hospital Inpatient Value-Based Purchasing program (Hospital VBP program or the program) under section 1886(o) of the Social Security Act (the Act), under which value-based incentive payments will be made in a fiscal year to hospitals that meet performance standards with respect to a performance period for the fiscal year involved. The program will apply to payments for discharges occurring on or after October 1, 2012, in accordance with section 1886(o) (as added by section 3001(a) of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act)). Scoring in the Hospital VBP program will be based on whether a hospital meets or exceeds the performance standards established with respect to the measures. By adopting this program, we will reward hospitals based on actual quality performance on measures, rather than simply reporting data for those measures.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Rate Year Beginning July 1, 2011 (RY 2012)
This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) for discharges occurring during the rate year (RY) beginning July 1, 2011 through September 30, 2012. The final rule also changes the IPF prospective payment system (PPS) payment rate update period to a RY that coincides with a fiscal year (FY). In addition, the rule implements policy changes affecting the IPF PPS teaching adjustment. It also rebases and revises the Rehabilitation, Psychiatric, and Long-Term Care (RPL) market basket, and makes some clarifications and corrections to terminology and regulations text.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Disclosures of Ownership and Additional Disclosable Parties Information
This proposed rule presents two options for updating the payment rates used under the prospective payment system for skilled nursing facilities (SNFs), for fiscal year 2012. In this context, it examines recent changes in provider behavior relating to the implementation of the Resource Utilization Groups, version 4 (RUG-IV) case-mix classification system and considers a possible recalibration of the case-mix indexes so that they more accurately reflect parity in expenditures between RUG-IV and the previous case-mix classification system. It also includes a discussion of a Non-Therapy Ancillary component and outlier research currently under development within CMS. In addition, this proposed rule discusses the impact of certain provisions of the Affordable Care Act. It proposes to require for fiscal year 2012 and subsequent fiscal years that the SNF market basket percentage change be reduced by the multi-factor productivity adjustment. It also proposes to require Medicare SNFs and Medicaid nursing facilities to disclose certain information to the Secretary of the United States Department of Health and Human Services (the Secretary) and other entities regarding the ownership and organizational structure of their facilities. Finally, it proposes certain changes relating to the payment of group therapy services and proposes new resident assessment policies.
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