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

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum.

The U.S. Department of Health and Human Services solicits written comments regarding a new objective proposed to be added to Healthy People 2020 since the fall 2015 public comment period. Public participation helps shape Healthy People 2020, its framework, objectives, organization, and targets. Healthy People provides opportunities for public input periodically throughout the decade to ensure that Healthy People 2020 reflects current public health priorities and public input. The updated set of Healthy People 2020 objectives will be incorporated on www.HealthyPeople.gov. This set will reflect further review and deliberation by the topic area workgroups, Federal Interagency Workgroup on Healthy People 2020, and other Healthy People 2020 stakeholders.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Head Lice Infestation: Developing Drugs for Topical Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of head lice infestation. This guidance addresses the Agency's current thinking regarding the overall development program and clinical trial designs of drugs to support approval of an indication for topical treatment of head lice infestation. The information presented will help sponsors plan clinical trials, design clinical protocols, and conduct and appropriately monitor clinical trials. This guidance finalizes the draft guidance of the same name issued on December 15, 2015.

In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Council on Graduate Medical Education (COGME). This meeting will be open to the public. Information about COGME and the agenda for this meeting can be obtained by accessing the COGME Web site at https://www.hrsa.gov/ advisorycommittees/bhpradvisory/COGME.

The National Cancer Institute, an institute of the 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 U.S. Patents and Patent Applications listed in the Summary Information section of this notice to Inova Health System located in Falls Church, VA.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding, as well as any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public.

This document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and 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; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals.''

The Food and Drug Administration (FDA or we) is extending the comment period for the revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,'' that appeared in the Federal Register of August 12, 2016. We are taking this action in response to requests to extend the comment period to allow interested persons additional time to submit comments.

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 study project entitled ``Survey of Sexually Transmitted Disease (STD) Provider Practices in the United States''. The primary goal of this study is to better understand policies and practices for STD care delivery among medical providers who typically see patients for STDs. Another goal is to assess awareness and use of CDC's STD treatment guidelines.

The Administration for Children and Families (ACF), Administration for Children Youth and Families (ACYF), Children's Bureau announces the award of a single-source supplement grant in the amount of $547,000 to the National Child Welfare Capacity Building Center for Tribes (CBCT), operated by the University of Denver (Colorado Seminary). The primary goal of this grant is to provide capacity-building services to title IV-E and IV-B American Indian and Alaska Native Nations (AI/AN), and to promote intergovernmental collaboration between tribes and state child welfare agencies in system improvement work.

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for ``method, metallic reduction, glucose (urinary, nonquantitative)'' devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ``copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

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 Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) are announcing the following public workshop entitled ``CDC/FDA/NLM/ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The purpose of this public workshop is to receive and discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Peace Corps (PC).

This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016 [2016-161].

The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp.

The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to the sponsors of rare pediatric disease product applications that meet all of the requirements of this program, are submitted 90 days or more after July 9, 2012, and upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2017 and outlines the payment procedures for such fees.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information collection request regarding risk factors associated with transfusion-transmissible infections (TTI) in blood donors.

This final rule makes regulatory changes to the Child Care and Development Fund (CCDF) based on the Child Care and Development Block Grant Act of 2014. These changes strengthen requirements to protect the health and safety of children in child care; help parents make informed consumer choices and access information to support child development; provide equal access to stable, high-quality child care for low-income children; and enhance the quality of child care and the early childhood workforce.

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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and 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 we) 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 invites comments on the information collection provisions of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements.

NHLBI, with input from federal and nonfederal partners, is developing the COPD National Action Plan to help guide stakeholders nationwide in their efforts to reduce the burden of Chronic Obstructive Pulmonary Disease (COPD). The purpose of this notice is to seek public input on the current draft of the COPD National Action Plan.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.'' The guidance advises manufacturers who wish to use the implied nutrient content claim ``healthy'' to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim ``healthy'' on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ``low fat'', or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that a meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public.

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 Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), which authorizes FDA to collect fees and use them for the review of certain generic human drug applications and associated Type II active pharmaceutical ingredient (API) drug master files (DMFs), and for conducting associated inspections for fiscal years (FYs) 2018 through 2022. The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to present the recommendations to the relevant Congressional committees, publish the recommendations for the reauthorized program in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.

HRSA announces the award of a supplement in the amount of $350,000 for the National Center for Medical Home Implementation (NCMHI) cooperative agreement. The purpose of the NCMHI cooperative agreement is to support a national resource and assistance effort to implement and spread the medical home model to all children and youth, particularly children with special health care needs (CSHCN), children who are vulnerable and/or medically underserved, and pediatric populations served by state public health programs, the Maternal and Child Health Bureau (MCHB), and HRSA. The supplement will permit the American Academy of Pediatrics (AAP), the cooperative agreement awardee, during the budget period of July 1, 2016-June 30, 2017, to enhance their capacity to provide technical assistance and health professional education to increase the clinical expertise of pediatric health care professionals, including safety net providers, to more effectively serve as the medical home and provide family-centered, comprehensive, coordinated, and culturally-effective care for Zika- affected children and their families.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 July 12, 2016, page 45169 (81 FR 45169) 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Self- Identification of Generic Drug Facilities, Sites, and Organizations.'' On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President. GDUFA, designed to speed the delivery of safe and effective generic drugs to the public and reduce costs to industry, requires that generic drug facilities, sites, and organizations around the world provide identification information annually to FDA. This guidance is intended to assist industry to meet the self-identification requirement. It explains who is required to self-identify, what information must be requested, how the information should be submitted to FDA, and what the penalty is for failure to self-identify.

The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of June 29, 2016. In the notice, FDA requested comments on ``Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees; Guidance for the Public, FDA Advisory Committee Members, and FDA Staff'' and on whether FDA should request that each advisory committee member, who receives an authorization from FDA on an appearance issue so that they may participate in an advisory committee meeting, voluntarily publicly disclose the authorization. The Agency is taking this action due to errors displayed on the FDA Web site pertaining to this guidance.

The Food and Drug Administration (FDA) has determined the regulatory review period for FYCOMPA 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.

This document extends the comment period in the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service announcement that was published in the Federal Register on June 3, 2016.

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 Cogentis Therapeutics, Inc. which is located in Maryland, 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 Frontotemporal dementia, Alzheimer's disease excluding intranasal delivery, Neuronal injury (stroke, traumatic brain injury (TBI) and epilepsy), and Progressive Supranuclear Palsy.

This notice announces the meeting date for the second Technical Advisory Panel on Medicare Trustee Reports on Friday, September 30, 2016 in Washington, DC.

HRSA is giving notice that the Advisory Committee on Organ Transplantation (ACOT) has been rechartered. The effective date of the renewed charter is September 1, 2016.

The Food and Drug Administration (FDA) is classifying the strabismus detection device 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 strabismus detection device's 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 or Agency) is announcing the availability of a draft guidance entitled ``Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.'' This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System 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 magnetic surgical instrument system's 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 or Agency) is announcing the availability of a draft guidance for industry entitled ``FDA's Application of Statutory Factors in Determining When a REMS Is Necessary.'' This draft guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several being developed to fulfill performance goals that FDA agreed to satisfy in the context of the fifth reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act V).

The Food and Drug Administration (FDA or Agency) is suspending approval of abbreviated new drug application (ANDA) 060851 for chloramphenicol capsules, 250 milligrams (mg), held by Armenpharm, Ltd. (Armenpharm), 49 South Ridge Rd., P.O. Box D1400, Pomona, NY 10970. FDA has also determined that CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 milliliters (mL), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL.

This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA.