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

The Indian Health Service published a document in the Federal Register on June 3, 2016, for the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service. The notice contained the incorrect U.S. Code regarding consultation.

The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are announcing a 2-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Although we have learned a lot about conducting pediatric trials over the past two decades, there are still challenges that need to be addressed. The training course is intended to provide investigators with: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: Pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Use of International Standard ISO 10993-1, `Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process.' '' FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993- 1, ``Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process'' to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing.' ''

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing an invitation for participation in its Tobacco Product Manufacturing Facility Visits. This program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory testing, and to observe the manufacturing operations of the tobacco industry. The purpose of this document is to invite parties interested in participating in Tobacco Product Manufacturing Facility Visits to submit requests to CTP.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.

The Department of Health and Human Services (HHS) is proposing to revise and republish its regulations implementing the Freedom of Information Act (FOIA). The regulations are being revised in order to incorporate changes made to the FOIA by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the Electronic FOIA Act of 1996 (E-FOIA Act). Additionally, the regulations are being updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer. Because of the numerous changes to the organization and to the headings, the regulations are being republished in their entirety.

The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as ``stand-alone symbols'') if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement ``Rx only'' or ``[rx] only'' in the labeling for prescription devices.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort 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 the CDC I- Catalyst program. The I-Catalyst program is intended to help CDC employees get their ideas out of the starting blocks and down the track through a discovery, ideation, and prototyping process. The expected result is that CDC staff will be empowered to implement innovative strategies and solutions that create value for a set of beneficiaries.

The National Institute on Drug Abuse (NIDA), one of the components of the National Institutes of Health (NIH), announces the ``$100,000 for Start a SUD Startup'' Challenge. The Challenge goal is to support research ideas that would further an understanding of neurobiology as it relates to Substance Use Disorders (SUD) and that are intended to be the basis for the development of a new and potentially successful start-up. NIDA hopes that participation in the contest will enable scientists to test the hypothesis that their research idea can be fostered into a biotech startup, and that eventually any newly created startups will contribute to the pool of innovative small business companies that can successfully compete for NIDA's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) funding. Each Challenge winner will receive $10,000. The Challenge total purse is up to $100,000.

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 Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces an amendment to its notice entitled, Announcement of Requirements and Registration for Healthcare Associated Venous Thromboembolism Prevention Challenge. This amendment is being made to reflect an increase in the number of Champions and change the maximum total prize disbursement. There are no other changes to the September 22, 2015 notice.

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 a proposed information collection entitled ``TRAUMATIC BRAIN INJURY (TBI) SURVEILLANCE SYSTEM.'' CDC will use the information collected to determine how many children and adults experience a traumatic brain injury (TBI) each year in the United States, and to collect information about the circumstances that identifies groups most at risk for TBI.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

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: ``Survey of Hospital Quality Leaders.'' 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 proposed information collection was previously published in the Federal Register on February 10, 2016 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The Food and Drug Administration (FDA) has determined the regulatory review period for POMALYST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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 the availability of a draft guidance for industry (GFI) #237 entitled ``Oncology Drugs for Companion Animals.'' The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application (NADA) for certain oncology drugs, and provides recommendations on how to address human user safety concerns.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Dissemination of Patient-Specific Information from Devices by Device Manufacturers.'' The FDA developed this draft guidance to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. This draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients. This draft guidance is not final nor is it in effect at this time.

HRSA announces the award of an extension in the amount of $1,100,000 for the Reproductive and Environmental Health Network (REHN) cooperative agreement. The purpose of the REHN is to improve maternal and fetal health outcomes by providing evidence-based information on the safety of exposures in pregnancy and lactation. The extension will permit the Organization of Teratology Information Specialists (OTIS), the cooperative agreement awardee, during the budget period of 9/1/ 2016-8/31/2017, to continue to provide evidence-based information on the safety of exposures in pregnancy and lactation through individualized risk-assessments and counseling services, developing and disseminating the most current education to providers and the public, improving access to information for hard-to-reach populations, and supporting a national network of resources with centers accessible to each of the 10 HRSA regions.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Treatment Strategies for Patients with Lower Extremity Chronic Venous Disease (LECVD), which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Programs. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).

The Food and Drug Administration (FDA or we) is correcting a notice entitled ``Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council; Filing of Food Additive Petition'' that appeared in the Federal Register of May 20, 2016 (81 FR 31877). The document announced that Breast Cancer Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Earthjustice, Environmental Defense Fund, Improving Kids' Environment, Learning Disabilities Association of America, and Natural Resources Defense Council filed a petition proposing that we amend and/or revoke specified regulations to no longer provide for the food contact use of specified ortho- phthalates, but omitted two items. This document corrects that error.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Adolescent Pregnancy Prevention Program, announces its intent to award a single-source expansion supplement grant of up to $151,265 to Children's Hospital of Los Angeles and up to $55, 917.20 to Education Development Center, Inc.

This document contains proposed regulations on the rules for expatriate health plans, expatriate health plan issuers, and qualified expatriates under the Expatriate Health Coverage Clarification Act of 2014 (EHCCA). This document also includes proposed conforming amendments to certain regulations to implement the provisions of the EHCCA. Further, this document proposes standards for travel insurance and supplemental health insurance coverage to be considered excepted benefits and revisions to the definition of short-term, limited- duration insurance for purposes of the exclusion from the definition of individual health insurance coverage. These proposed regulations affect expatriates with health coverage under expatriate health plans and sponsors, issuers and administrators of expatriate health plans, individuals with and plan sponsors of travel insurance and supplemental health insurance coverage, and individuals with short-term, limited- duration insurance. In addition, this document proposes to amend a reference in the final regulations relating to prohibitions on lifetime and annual dollar limits and proposes to require that a notice be provided in connection with hospital indemnity and other fixed indemnity insurance in the group health insurance market for it to be considered excepted benefits.

This document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on April 27, 2016 titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports.''

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 an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number OMB No. 0937-0025, which expires on November 30, 2016. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This document corrects technical errors that appeared in the notice published in the May 10, 2016 Federal Register entitled ``Announcement of Requirements and Registration for ``A Bill You Can Understand'' Design and Innovation Challenge: Help Patients Understand Their Medical Bills and the Financial Aspect of Health.''

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), 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: Intellectual Property: U.S. Provisional Patent Application 61/477,020 entitled ``Human Monoclonal Antibody Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-01], PCT Patent Application PCT/US2012/034186 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-PCT-02], Chinese Patent Application 201280029201.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-03], European Patent 2699603 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-04], and validated in France, Germany and the United Kingdom, United States Patent 9,206,257 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-05], United States Patent Application 14/837,903 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-US-06], European Patent Application 15188264.4 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-07], United States Patent Application 15/090,873 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130- 2011/0-US-12], Chinese Patent Application 201610290837.3 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-CN-13], European Patent Application 16166924.7 entitled ``Human Monoclonal Antibodies Specific for Glypican-3 And Use Thereof'' [HHS Ref. E-130-2011/0-EP-14], and all continuing U.S. and foreign patents/patent applications for the technology family, to Lentigen Technology, Inc. The patent rights to 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 the United States, Australia, Canada, the European Union, Russia, China, Hong Kong, Japan, Taiwan, South Korea and Singapore, and the field of use may be limited to: ``The development of a glypican-3 (GPC3) chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) primary human lymphocytes (T cells or NK cells) transfected with a lentiviral or retroviral vector, wherein the vector expresses a CAR having (1) a single antigen specificity and (2) comprising at least: (a) The complementary determining region (CDR) sequences of the anti-GPC3 antibody known as HN3; and (b) a T cell signaling domain; for the prophylaxis and treatment of GPC3-expressing cancers.''

The Food and Drug Administration (FDA) has determined the regulatory review period for ALPROLIX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

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 estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.

The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), announces a single-source award in the amount of $750,000 to HFSA in San Angelo, TX for the purpose of continued participation in the federal impact evaluation. The award allows sufficient time to complete evaluation related activities of the Steps to Success program. Steps to Success is a comprehensive, culturally appropriate intervention that seeks to postpone subsequent pregnancies and increase safe sex behaviors for high-risk pregnant and parenting teens.

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 information collection requirements relating to the reporting of biological product deviations in manufacturing and human cells, tissues, and cellular and tissue- based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.

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 the National HIV Behavioral Surveillance (NHBS) system. CDC is requesting a 3-year approval for revision to the previously approved project to continue collecting standardized HIV-related behavioral data from persons at risk for HIV systematically selected from 25 Metropolitan Statistical Areas (MSAs) throughout the United States.

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 or Agency) is extending the comment period for the notice entitled ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 13, 2015 (80 FR 61426). The document announced the withdrawal of approval of 67 new drug applications (NDAs) and 128 abbreviated new drug applications from multiple applicants, effective November 12, 2015. The document indicated that FDA was withdrawing approval of the following two NDAs after receiving a request from the NDA holder, Merck Sharp & Dohme Corp. (Merck), 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889: NDA 016096, MINTEZOL (thiabendazole) Tablets, and NDA 016097, MINTEZOL (thiabendazole) Oral Suspension. Before withdrawal of these NDAs became effective, Merck informed FDA that it did not want approval of the NDAs withdrawn. Because Merck timely requested that approval of these NDAs not be withdrawn, the approval of NDAs 016096 and 016097 is still in effect.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E18 Genomic Sampling and Management of Genomic Data.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance pertains to genomic sampling and to the management of genomic data in clinical studies. The focus of this draft guidance is on the general principles of collecting, processing, transporting, storing, and disposing of genomic samples or data. The technical aspects of genomic sampling and research are also discussed when appropriate, recognizing the rapidly evolving technological advances in these areas. The draft guidance is intended to provide harmonized principles of genomic sampling and of managing genomic data in clinical studies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Charging for Investigational Drugs Under an INDQuestions and Answers.'' The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND. This guidance finalizes the draft guidance issued in May 2013.

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 Dental Craniofacial Research (NIDCR), 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: Dr. Sophia Jeon, Health Science Policy Analyst, Office of Science Policy and Planning, OSPP, NINDS, NIH, 31 Center Drive, Building 31, Room 8A03, Bethesda, MD 20892, or call non-toll-free number (301) 435-7571, or Email your request, including your address to: sophia.jeon@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, National Institute of Neurological Disorders and Stroke (NINDS), 0925-0678, Expiration Date 08/31/2016EXTENSION, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH). Need and Use of Information Collection: The information collection activity will 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 insights into 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 Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will 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 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. OMB approval extension is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5750.

The Department of Health and Human Services is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``State Health Insurance Assistance Program (SHIP).'' This final rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. Prior to the interim final rule, prior regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA), Section 4360.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development 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 and/or co-development.

This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace\SM\,\1\ Medicare, Medicaid, and Children's Health Insurance Program (CHIP) consumer education strategies. This meeting is open to the public.

The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.

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 (HHS) 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.

The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) is hosting a public webcast to address import and export permit regulations for infectious biological agents, infectious substances, and vectors; and import and export permit exemptions. Presenters for this webcast will include representatives from the U.S. Department of Transportation (DOT), United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), CDC Division of Global Migration and Quarantine, U.S. Customs and Border Protection, U.S. Department of Commerce, U.S. Food and Drug Administration, HHS/Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority (BARDA), U.S. Fish and Wildlife Service, and the Public Health Agency of Canada.

The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 collects comments on the information collection requirements relating to the continuation of an existing collection for University Centers for Excellence in Developmental Disabilities Education, Research, and Service.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Instititue, 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 March 1, 2016 and page 10638 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 Cancer Institute, NCI, 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 Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.'' The draft guidance, when finalized, will describe our views on voluntary short- term and long-term goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population and promote improvements in public health.

The Food and Drug Administration (FDA) Philadelphia District Office, in co-sponsorship with the Association of Food and Drug Officials (AFDO), and the North Central Association of Food and Drug Officials, is announcing a conference entitled ``Collaborating to Strengthen Food, Drug, and Medical Device Safety Systems.'' This conference is intended to provide information about FDA drug and device regulation to the regulated industry.

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.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Administration for Community Living (ACL), Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled ``Medicare and Medicaid Programs; Electronic Health Record Incentive ProgramStage 3 and Modifications to Meaningful Use in 2015 through 2017.''

The Food and Drug Administration (FDA) has determined the regulatory review period for OTEZLA 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) is announcing a public workshop entitled: OpenFDA Public Workshop. The purpose of the public workshop is to provide a forum for the openFDA system user community to engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform, as well as to view the demonstration of various applications (apps) specifically developed for utilization of openFDA data.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs.'' This draft guidance is intended to provide recommendations for the design and conduct of studies evaluating the adhesive performance of a Transdermal Delivery System or a topical patch (collectively, TDS). This guidance, once finalized, is intended to provide updated recommendations for the design and conduct of adhesion studies submitted in support of an Abbreviated New Drug Application (ANDA) for a TDS.

The Administration for Children and Families (ACF), Office of Community Services (OCS), Division of Energy Assistance (DEA) announces the final reallotment of $4,324,422 of FY 2014 funds for the Low Income Home Energy Assistance Program (LIHEAP).