Department of Health and Human Services September 23, 2011 – Federal Register Recent Federal Regulation Documents

This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2012. The calendar year 2012 AIC threshold amounts are $130 for ALJ hearings and $1,350 for judicial review.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This information collection was previously published in the Federal Register on June 16, 2011, page 35221 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. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source (Survey of Authors). Type of Information Collection Request: NEW. Need and Use of Information Collection: The NINR End-of-Life Science Palliative Care (EOL PC) Needs Assessment: Funding Source Questionnaire will obtain information on funding sources of EOL PC research published studies for which a funding source is not cited or the information is unclear. Target participants are authors of publicly-available EOL PC research studies published between 1997-2010 for whom a funding source is unknown or unclear. The questionnaire inquires about the funding source of the published study, type of funding received, year of funding, and duration of funded study. This is a 7-item questionnaire that takes approximately 5 minutes to complete. Data collected is part of a needs assessment to address the breadth and depth of EOL PC scientific issues for use in stimulating research capacity in the field. Frequency of Response: One time. Affected Public: Individual authors of publicly available EOL PC research publications who do not list a funding source or the source is unclear within their publication. Type of Respondents: EOL PC researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1840; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .08; and Estimated Total Annual Burden Hours Requested: 147. There are no Capital Costs, Operating or Maintenance Costs to report. Request for comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Amanda Greene, Office of Science Policy and Public Liaison, NINR, NIH, Democracy One, 6701 Democracy Blvd., Suite 710, Bethesda, MD 20892 or call non-toll-free number (301) 496-9601 or E-mail your request, including your address to: amanda.greene@nih.gov. Comments due date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Reproductive and Developmental ToxicitiesIntegrating Study Results to Assess Concerns.'' This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. The guidance is intended for drug developers planning to submit new drug applications (NDAs) and biologics licensing applications (BLAs), and who are assessing nonclinical toxicity information.

The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.