Department of Health and Human Services April 2016 – Federal Register Recent Federal Regulation Documents

This publication corrects a notice that was published in the Federal Register on March 22, 2016, Volume 81, Number 55, page 15307. The meeting place should read as follows: Place: Atlanta Marriott Century Center, 2000 Century Blvd. NE., Atlanta, Georgia 30345.

The Food and Drug Administration (FDA or Agency) is proposing to amend its nonprescription (over-the-counter or OTC) drug regulations. The proposed rule, if finalized as proposed, would supplement the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). We are also proposing other changes to make the TEA process more efficient.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry (#156) entitled ``Comparability ProtocolsChemistry, Manufacturing, and Controls Information for New Animal Drugs.'' This document provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC) information. It is intended to provide recommendations to industry regarding comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD), and veterinary master file (VMF) submissions that are referenced in applications. FDA is providing this guidance in response to requests from those interested in using comparability protocols.

This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Ovensa, Inc. (``Ovensa'') located in Ontario, Canada.

The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a start-up exclusive license to Great Lakes Neuroscience, Inc., which is located in Illinois, to practice the inventions embodied in the following patents: U.S. Patent 8,597,660, issued December 3, 2013 (HHS reference E-144-2010/0-US-02). The patent rights in these inventions have been assigned to the United States of America. The prospective start-up exclusive license territory may be worldwide and the field of use may be limited to therapeutics for Multiple sclerosis, Acute Disseminated Encephalomyelitis (ADEM), Balo's disease, Clinically Isolated Syndrome, HTLV-1 Associated Myelopathy (HAM), Neuromyelitis optica and NMO spectrum disorder, Schilder's disease, Traverse myelitis, amyotrophic lateral sclerosis and other motor neuron diseases as follows: progressive bulbar palsy, primary lateral sclerosis, progressive muscular atrophy, spinal muscular atrophy, Kennedy's disease, and post polio syndrome.

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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects 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: Shari Ludlam, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892, or call non-toll-free number (301) 435-6667, or Email your request to: ludlams@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: The Women's Health Initiative, 0925-0414, Revision, Exp. 7/31/2016, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: This proposal is to extend the Women's Health Initiative (WHI), which comprises a group of research studies that will address critical issues about the most common causes of frailty, disability, and death among post-menopausal women aged 50 to 79 years. This Initiative is comprised of two main investigational approaches: (1) A large clinical trial (CT) to evaluate the clinical efficacy of promising, but unproven preventive approaches for specific diseases common among older women; and (2) a companion observational study (OS) comprised of women ineligible or unwilling to participate in the CT, to evaluate risk factors for chronic diseases by following this large cohort of women and relating subsequent disease development to baseline assessments of historical, physical, and physiologic characteristics. The WHI provides new information on health and risk of disease among older post-menopausal women to inform development of approaches to disease prevention. The specific objectives of the OS are to provide reliable estimates of the extent to which known risk factors predict heart disease, cancers and fractures; identify new risk factors for these and other diseases in women; compare risk factors, presence of disease at the start of the study, and new occurrences of disease during the WHI in all study components; and create a future resource to identify biological indicators of disease, especially substances and factors found in the blood. Continued follow-up of medical outcome occurrences will enhance achievement of the WHI original goals and increase the range of scientific issues that can be examined. Specific biomarkers will be assessed based on current and future hypotheses related to clinical endpoints. The WHI study/protocol allows for analysis and presentation of results in aggregate form only, thus all data including biological samples are void of personal identifiers. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,796.

The Food and Drug Administration (FDA) has determined the regulatory review period for BRINTELLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) 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: 041'' (Recognition List Number: 041), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Department of Health and Human Services published a document containing technical amendments in the Federal Register on January 20, 2016, revising the Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards. That document inadvertently failed to update the following: A provision in Appendix II; an improper citation; a recent OMB change; and a grammatical error. This document makes correcting amendments to correct these sections.

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 require; 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.

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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.

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 collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.