Department of Health and Human Services May 2013 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This proposed rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also proposes to add additional DSH reporting requirements for use in implementing the DSH health reform methodology.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Product Labeling; Medication Guide Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.'' The guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic healthcare data. The guidance includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA's review of protocols and final reports that are submitted to the Agency.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on 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. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dorothy Farrell, Center for Strategic Scientific Initiatives, Office of Cancer Nanotechnology Research, National Cancer Institute, 31 Center Drive, Bldg. 31 A, Rm. 10A52, Bethesda, MD 20892 or call non-toll-free number 301-496-5652 or Email your request, including your address to: farrelld@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for Nanotechnology in Cancer, a network of awards funded by NCI to promote the application of nanotechnology to cancer research and care. The proposed guidelines request information about award performance related to trans-Alliance collaboration, scientific milestones, progress towards clinical translation and technology commercialization, and education and outreach efforts. The report also gathers information on leveraged funding, patents and publications. The information is gathered every six months. This information is needed to monitor the performance of this special program within NCI, funded through Requests for Applications (RFA CA-09-013, released May 29, 2009) using the cooperative agreement mechanism (U01). The information will be used to monitor individual award performance and the effectiveness of the program as a whole. The respondents are the Principal Investigators of the awards, along with their institutional business officials. The awards are administered by and the reports reviewed by the Office of Cancer Nanotechnology Research (OCNR), part of the Center for Strategic Scientific Initiatives within NCI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 72.

The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met.

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.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.