Department of Health and Human Services July 2014 – Federal Register Recent Federal Regulation Documents

The Office of Population Affairs (OPA) announces that $714,000 in fiscal year 2014 funds are being awarded for a replacement family planning service grant to the Massachusetts Department of Public Health for Berkshire, Franklin, Hampshire, and Hampden counties. This grant will establish and operate voluntary family planning service projects, which shall provide family planning services to all persons desiring such services, with priority for services to persons from low-income families.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current or upcoming vacancies effective with this notice.

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 goal of the EHR Innovations for Improving Hypertension Challenge is to seek practices that have used clinical decision support (CDS) to implement the most clinically successful examples of an evidence-based blood pressure treatment protocol, gather details about these tools and their implementation, and then drive widespread implementation of those tools by other providers. In Phase 1 (three months), practices will document the CDS tools they used to implement an evidence-based BP control protocol, as well as describe the details and results of the implementation. Practices must demonstrate high BP control levels and/ or improvement to ensure that tools and strategies merit replication across practice settings. In Phase 2 (nine months), practices and their partners will conduct, evaluate and document dissemination strategies for tools identified in Phase 1, emphasizing widespread, effective use of these tools by other practices. Submitters must demonstrate successful use of these tools in at least 2 additional practices. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. No 111-358).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products'' dated July 2014. The draft guidance document provides sponsors of virus or bacteria-based gene therapy products (VBGT products) and oncolytic viruses or bacteria (oncolytic products) with recommendations on how to conduct shedding studies during preclinical and clinical development.

The Food and Drug Administration (FDA or we) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (``FDA Recognized Consensus Standards''). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 036'' (``Recognition List Number: 036''), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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: ``Improving Hospital Informed Consent With an Informed Consent Toolkit.'' In accordance with the Paperwork Reduction Act, AHRQ invites the public to comment on this proposed information collection.

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 or request more information on the proposed project, contact: Annette Galassi, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W250, Rockville, MD 20850 or call non-toll-free number 240-276-6632 or Email your request, including your address to: agalassi@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: Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for OMB to approve the Assessment of Oncology Nursing Education and Training in Low and Middle Income Countries (LMICs). NCI-Designated Cancer Centers have a range of international activities, some of which are funded by NCI, but many of which are not. These international activities may include oncology nursing education and training in LMICs, but the extent of these activities across cancer centers is unknown. The proposed assessment requests information about oncology nursing education and training projects including: Descriptions of projects, partner organizations, types of activities, cost, and impact. NCI's Center for Global Health (CGH) is in the process of developing its strategic plan for oncology nursing education in LMICs. This information will help inform this strategic planning process and provide evidence to inform decisions on potential investments in grants for oncology nursing education in LMICs. Additionally, this information will be used in an online, interactive map that is being developed by CGH which will allow external organizations, such as cancer centers, to explore what projects are being done in which countries, which will facilitate collaborations and minimize duplication. The frequency of the data collection will be once per year although respondents may have more than one response if they have up to three projects. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 51.

The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA), Office of International Programs (OIP) is announcing the availability of grant funds for the support of a single source cooperative agreement to the Pan American Health Organization (PAHO) for fostering cooperation and strengthening medical product regulatory systems in the Americas. The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas.

The Food and Drug Administration (FDA) published a document in the Federal Register of March 10, 2014 (79 FR 13263), providing notice of a petition filed by Kemin Industries, Inc., that proposed the food additive regulations be amended to provide for the safe use of chromium propionate as a source of chromium in broiler feed. That petition included an environmental assessment which was not noted in the March 10 notice of petition.

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 proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.

This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective January 1, 2015. As required by the Affordable Care Act, this rule implements the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments and the Affordable Care Act mandated face-to-face encounter requirement. This rule also proposes: Changes to simplify the face-to- face encounter regulatory requirements; changes to the HH PPS case-mix weights; changes to the home health quality reporting program requirements; changes to simplify the therapy reassessment timeframes; a revision to the Speech-Language Pathology (SLP) personnel qualifications; minor technical regulations text changes; and limitations on the reviewability of the civil monetary penalty provisions. Finally, this proposed rule also discusses Medicare coverage of insulin injections under the HH PPS, the delay in the implementation of ICD-10-CM, and solicits comments on a HH value-based purchasing (HH VBP) model.

HRSA will be issuing non-competitive awards under the Ryan White HIV/AIDS Program, AETC/GME Program. Approximately $450,000 will be made available in the form of a grant to current grantees (listed in chart below) during the budget period of July 1, 2014, through June 30, 2015. This will: (1) Continue the current cohort and provide support for one additional cohort of graduate medical residents; (2) continue to provide workforce development that is integral to the national interest through meeting National HIV/AIDS Strategy goals, and that enhances the implementation of the Affordable Care Act; and (3) provide a more robust program evaluation that will yield sufficient data; and aid HRSA/HAB in future decisions regarding the replication and the viability of a subsequent GME competition. The scope of work does not change.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following web-based public meeting and request for public comment on the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) and also announces the availability of a report entitled ``NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) Progress Report and Proposed Future Directions2014'' which is now available for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2014- 0010 in the search field and click ``Search.''

Eunice Kennedy Shriver National Institute of Child Health and Human Development, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. 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: Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-1877 or Email your request, including your address to glavins@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: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD), 0925-0643, Expiration Date 10/31/2014, EXTENSION, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: There are no changes being requested for this submission. The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide information about the NICHD's customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the NICHD and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the NICHD's services will be unavailable. The NICHD will only submit a collection for approval under this generic clearance if it meets the following conditions: The collections are voluntary; The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; The collections are non-controversial and do not raise issues of concern to other Federal agencies; Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; Personally identifiable information (PII) is collected only to the extent necessary and is not retained; Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency; Information gathered will not be used for the purpose of substantially informing influential policy decisions; and Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4,950.

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 (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 export notification and recordkeeping requirements for persons exporting human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco that may not be marketed or sold in the United States.

The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.