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

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Ebola Zaire virus in response to the 2014 Ebola virus outbreak in West Africa. FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Roche Molecular Systems, Inc. (Roche). The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Health Resources and Services Administration (HRSA) is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act. The Department periodically publishes in the Federal Register low- income levels to be used by institutions receiving grants and cooperative agreements in order to determine individual eligibility for programs providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.

The Administrator of the Administration for Community Living proposes a priority for the Rehabilitation Research and Training Center (RRTC) Program administered by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR). Specifically, this notice proposes a priority for an RRTC on Outcomes Measurement for Home and Community Based Services. We take this action to focus research attention on an area of national need. We intend this priority to contribute to improved home and community based services for individuals with disabilities.

Overview Information: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)Research Fellowships Program, Notice inviting applications for new awards for fiscal year (FY) 2015.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Children's Environmental Health Network, Center for Science in the Public Interest, Breast Cancer Fund, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment, proposing that we amend our regulation to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers, revoke the Threshold of Regulation exemption No. 2005- 006 to no longer exempt the use of sodium perchlorate monohydrate as a conductivity enhancer in antistatic agents for use in finished articles in contact with dry foods, and issue a new regulation to prohibit the use of perchlorate in antistatic agents for use in food-contact articles. We are requesting comments on the petition and establishing a comment period of 60 days from the date of publication of this notice.

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 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: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301-435-0941 or Email your request, including your address to ProjectClearanceBranch@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: Public Health Service (PHS) Applications and Pre-Award Reporting Requirements. Revision, OMB 0925-0001, Expiration Date 8/31/2015. Form numbers: PHS 398, PHS 416-1, PHS 416-5, and PHS 6031. This collection represents a consolidation of PHS applications and pre-award reporting requirements into a revised data collection under the PRA. Need and Use of Information Collection: This collection includes PHS applications and pre-award reporting requirements: PHS 398 [paper] Public Health Service Grant Application forms and instructions; PHS 398 [electronic] PHS Grant Application component forms and agency specific instructions used in combination with the SF424 (R&R); PHS Fellowship Supplemental Form and agency specific instructions used in combination with the SF424 (R&R) forms/instructions for Fellowships [electronic]; PHS 416-1 Ruth L. Kirschstein National Research Service Award Individual Fellowship Application Instructions and Forms used only for a change of sponsoring institution application [paper]; Instructions for a Change of Sponsoring Institution for NRSA Fellowships (F30, F31, F32 and F33) and non-NRSA Fellowships; PHS 416-5 Ruth L. Kirschstein National Research Service Award Individual Fellowship Activation Notice; and PHS 6031 Payback Agreement. The PHS 398 (paper and electronic), PHS 416-1, 416-5, and PHS 6031 are currently approved under 0925-0001. All forms expire 8/31/2015. Post-award reporting requirements are simultaneously consolidated under 0925-0002, and include the Research Performance Progress Report (RPPR). The PHS 398 and SF424 applications are used by applicants to request federal assistance funds for traditional investigator-initiated research projects and to request access to databases and other PHS resources. The PHS 416-1 is used only for a change of sponsoring institution application. PHS Fellowship Supplemental Form and agency specific instructions is used in combination with the SF424 (R&R) forms/ instructions for Fellowships and is used by individuals to apply for direct research training support. Awards are made to individual applicants for specified training proposals in biomedical and behavioral research, selected as a result of a national competition. The PHS 416-5 is used by individuals to indicate the start of their NRSA awards. The PHS 6031 Payback Agreement is used by individuals at the time of activation to certify agreement to fulfill the payback provisions. Frequency of response: Applicants may submit applications for published receipt dates. For NRSA awards, fellowships are activated and trainees appointed. Affected Public: Universities and other research institutions; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. Type of Respondents: University administrators and principal professionals. The annual reporting burden is as follows: Total Estimated Number of Respondents: 94,326; Estimated Number of Responses per Respondent: 1, Average Burden Hours per Response: 21.75; Estimated Total Annual Burden Hours Requested: 2,051,794. The estimated annualized cost to respondents is $71,812,769. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,051,794.

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 Institute of Environmental Health Sciences, the 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 to 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) The quality, utility, and clarity of the information to be collected; and (4) 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*: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-toll-free number (919) 541-7752 or Email your request, including your address to: pettibonekg@niehs.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 DERT Extramural Grantee Data Collection, 0925- 0657, Expiration Date 06/30/2015REVISION, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per research portfolio. Affected Public: Current or past grantees from: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Deafness and Other Communication Disorders (NIDCD); National Institute of Mental Health (NIMH); National Institute of Neurological Disorders and Stroke (NINDS); National Institute of Environmental Health Sciences (NIEHS); and National Cancer Institute (NCI). OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 700.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Pursuant to the Rehabilitation Act of 1973, Section 205(a), as amended (29 U.S.C. 765), Public Law 92-463 as amended (5 U.S.C., App) and the Federal Advisory Committee Act, the Administration for Community Living (ACL), announces the establishment of the Disability, Independent Living and Rehabilitation Research Advisory Council (DILRRAC). The DILRRAC will provide the following duties: (1) Advise the Director of the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR) in the development, implementation and revision of the 5-year plan, ensuring priorities and activities are aligned with the tenets of the Plan; (2) provide input regarding the activities relative to the prioritization and integration of funding priorities, goals and timetables for implementation of activities to be conducted under Section 205 of the Rehabilitation Act; (3) ensure that the Director considers input of individuals with disabilities, organizations representing individuals with disabilities, providers of services furnished under this chapter, researchers in the rehabilitation field, and any other appropriate persons or entitles; (4) review accomplishments and results of covered activities, and recommend and facilitate strategies for widespread dissemination in accessible formats, to rehabilitation practitioners, providers of independent living and other community-based services, individuals with disabilities, and the individuals' representatives, and individuals with disabilities who are members of minority groups or of populations that are unserved or underserved by programs.

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.

This document corrects technical errors that appeared in the final rule published in the Federal Register on November 6, 2014 entitled ``End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies.''