Department of Health and Human Services March 2015 – Federal Register Recent Federal Regulation Documents

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing from the Premerus PSO, LLC has expired and AHRQ has delisted the PSO accordingly.

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: ``Nursing Home 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.

This document corrects technical errors that appeared in the final rule with comment period published in the November 13, 2014 Federal Register (79 FR 67547-68092) entitled, ``Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015.'' The effective date for the rule was January 1, 2015.

The Food and Drug Administration (FDA) is announcing the termination of the Antiviral Drugs Advisory Committee. This document removes the Antiviral Drugs Advisory Committee from the Agency's list of standing advisory committees.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 proposed information collection was previously published in the Federal Register on November 25, 2014 (79 FR 70194), 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 Office of the Director (OD), 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. 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: NIH Desk Officer.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of an emergency single- source grant in the amount of $804,075 to the U.S. Committee for Refugees and Immigrants (USCRI) in Arlington, VA, to support resettlement services to Iranian refugee parolees.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

This notice announces an administrative hearing to be held on April 30, 2015, at the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Division of Medicaid & Children's Health, Dallas Regional Office, 1301 Young Street, Room 730, Dallas, TX 75202, to reconsider CMS' decision to disapprove Louisiana's Medicaid SPA 12-66-B. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by April 2, 2015.

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. 209 and 37 CFR part 404 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.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. 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 and to allow 60 days for public comment in response to the notice. This notice invites comments on the information collection provisions of the draft guidance entitled ``Draft Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.''

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 Human Genome Research Institute (NHGRI), 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: Carla L. Easter, Ph.D., Chief, Education and Community Involvement Branch, NHGRI, Building 31, Room B1B55, 31 Center Drive, MSC 2070, Bethesda, MD 20892 or call non-toll-free number (301) 594-1364 or Email your request, including your address to: easterc@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: Surveys to Support an Evaluation of the NHGRI Summer Workshop in Genomics (Short Course), 0925-NEW, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed data collection activity is to complete a full-scale outcome evaluation of NHGRI's Summer Workshop in Genomics (a.k.a., the ``Short Course'') focusing on program participants between 2004 and 2012. This training program is an intensive multi-day course that updates instructors and researchers of biology and nursing (and other related disciplines) on the latest research trends and topics in genomic science. The course focuses on the continuing effort to find the genetic basis of various diseases and disorders, and current topics on the ethical, legal and social implications of genomics. The Education and Community Involvement Branch (ECIB) designed the program to accomplish the following goals, which align with elements of both the NIH and NHGRI missions: Expand NIH and NHGRI's professional network to reach out to diverse communities, and to create new partnership opportunities. Prepare the next generation of genomics professionals for an era of genomic medicine. Train and diversify the pipeline of genome professionals in alignment with the NIH and US Department of Health and Human Services diversity efforts. The ECIB has systematically collected feedback annually after the program from participants since inception of the Short Course in 2003, and then used the data to tweak the program, but it has not conducted a long-term, cumulative and substantive outcome evaluation. NHGRI and the ECIB propose to conduct such an outcome evaluation, focusing on three main objectives: (1) To understand the degree of genetic and genomic curriculum integration by faculty participants; (2) To explore the barriers and supports faculty experience and changes when integrating curriculum; and (3) To investigate the influence of the program on the participants' career path. Survey findings will provide valuable information about the various methods and pathways instructors use to disseminate new knowledge (and the associated timelines), the barriers and supports experienced by faculty as they integrate new knowledge into their teaching, and insights about additional avenues of support that NHGRI could provide teaching faculty from the types of institutions identified. Key indicators will also provide evidence about the degree to which the Short Course is meeting its goals. Collectively, the outcome evaluation will inform future program design and budget allocations. OMB approval is requested for 2 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 155.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Center for Advancing Translational Sciences (NCATS), the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 21, 2014, page 69499 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 Center for Advancing Translational Sciences (NCATS), 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. 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: NIH Desk Officer. Comment 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.