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

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on ``Prevent Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of this study is to address the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties.

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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

In compliance with the requirements 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.

The Food and Drug Administration (FDA or Agency) is seeking public comment on whether the uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), in certain FDA-regulated products currently designated essential are no longer essential under the Clean Air Act due to the availability of alternatives that do not use CFCs or because the products are no longer being marketed. Essential-use products are exempt from FDA's ban on the use of CFC propellants in FDA-regulated products and the Environmental Protection Agency's (EPA's) ban on the use of CFCs in pressurized dispensers. FDA is seeking public comment because it is responsible for determining which FDA-regulated products that release CFCs or other ODSs are essential uses under the Clean Air Act. FDA is soliciting comments to assist the Agency in striking an appropriate balance that will best protect the public health, both by ensuring the availability of an adequate number of alternatives and by curtailing the release of ODSs.

Notice is hereby given of a preliminary determination that funds from the Federal Fiscal Year (FY) 2014 Low Income Home Energy Assistance Program (LIHEAP) are available for reallotment to states, territories, tribes, and tribal organizations that receive FY 2015 direct LIHEAP grants. No subgrantees or other entities may apply for these funds. Section 2607(b)(1) of the Low Income Home Energy Assistance Act (the Act), (42 U.S.C. 8626(b)(1)) requires that, if the Secretary of the U.S. Department of Health and Human Services (HHS) determines that, as of September 1 of any fiscal year, an amount in excess of 10 percent of the amount awarded to a grantee for that fiscal year (excluding Leveraging, REACH, and reallotted funds) will not be used by the grantee during that fiscal year, then the Secretary must notify the grantee and publish a notice in the Federal Register that such funds may be reallotted to LIHEAP grantees during the following fiscal year. If reallotted, the LIHEAP block grant allocation formula will be used to distribute the funds. No funds may be allotted to entities that are not direct LIHEAP grantees during FY 2015.

The National Practitioner Data Bank (NPDB) announces the release of the revised user Guidebook. The NPDB is a confidential information clearinghouse created by Congress and intended to facilitate a comprehensive review of the professional credentials of health care practitioners, entities, and suppliers. The Guidebook is the primary policy document explaining the statutes and regulations behind and operation of the NPDB. It serves as an essential reference for NPDB users, offering reporting and querying examples, explanations, definitions, and frequently asked questions. The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the NPDB's merger with the Healthcare Integrity and Protection Data Bank. In November 2013, the Health Resources and Services Administration (HRSA) released a draft Guidebook to the public for review and comment by NPDB stakeholders and other interested parties. It announced the draft Guidebook's availability in the Federal Register. HRSA received more than 360 separate comments, consisting of analyses of issues raised by the draft Guidebook. The NPDB carefully studied all comments received, and many led to detailed analyses of how NPDB explains its policies to its audiences. The final Guidebook is now available at www.npdb.hrsa.gov and replaces previous Guidebooks.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.

The Administrator of the Administration for Community Living announces 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, we announce a priority for an RRTC on Self-Directed Care to Promote Recovery, Health, and Wellness for Individuals with Serious Mental Illness (SMI). The Administrator of the Administration for Community Living may use this priority for competitions in fiscal year (FY) 2015 and later years. We take this action to focus research attention on an area of national need. We intend for this priority to contribute to improved health and wellness for individuals with serious mental illness.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' Direct marking is an important feature of FDA's unique device identification system. This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of ``reprocessing'' for purposes of UDI direct marking requirements.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Provisional Patent Application 62/006,313 entitled ``Chimeric Antigen Receptors Targeting CD-19'' [HHS Ref. E-042-2014/0-US-01], and all related continuing and foreign patents/patent applications for the technology family, to Kite Pharma, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive licensed territory may be worldwide, and the field of use may be limited to: ``All prophylactic and therapeutic uses for CD19-associated diseases, states and conditions in humans.''

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license agreement to practice the inventions embodied in US Provisional Application No. 61/418,550 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed December 1, 2010 [HHS Ref. E-039-2011/0-US-01]; PCT Application No. PCT/US2011/062670 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-PCT- 02]; Australian Patent Application No. 2011336650 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039- 2011/0-AU-03]; Canadian Patent Application No. 2818992 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-CA-04]; European Patent Application No. 11791733.6 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed November 30, 2011 [HHS Ref. E-039-2011/0-EP-05]; and U.S. Patent Application No. 13/ 990,977 entitled, ``Chimeric rabbit/human ROR1 antibodies'' filed May 31, 2013 [HHS Ref. E-039-2011/0-US-06] and all related continuing and foreign patents/patent applications for the technology family to Emergent BioSolutions. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights to develop, make, have made, sell, have sold, import and export bi-specific and multi-specific fusion proteins that are capable of eliciting redirected T-cell cytotoxicity for the treatment of human receptor tyrosine kinase-like orphan receptor 1 (ROR1) expressing cancers, wherein said fusion proteins comprise one or more single-chain variable fragment (scFv) ROR1 binding domains from the anti-ROR1 antibodies designated as R11 or R12, one or more of Licensee's proprietary scFv CD3 binding domains, and optionally a fragment crystallizable (Fc) domain.

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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' It replaces the draft of the same name that was published on March 14, 2014. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.