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

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Qualification of BiomarkerPlasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease.'' This guidance provides a qualified context of use (COU) for plasma fibrinogen in interventional clinical trials of chronic obstructive pulmonary disease (COPD) subjects at high risk for exacerbations and/or all-cause mortality. This guidance also describes the experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program. This biomarker can be used by drug developers for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.

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 action removes the outmoded regulations for the Smallpox Vaccine Injury Compensation Program. The program and its implementing regulation have been rendered obsolete by the expiration of the Declaration Regarding Administration of Smallpox Countermeasures under the Smallpox Emergency Personnel Protection Act of 2003 and incorporation of the smallpox countermeasure injury coverage under the Public Readiness and Emergency Preparedness Act of 2005 and its authorization of the Countermeasures Injury Compensation Program.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 25, 2016 for public comment.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In an effort to encourage harmonization, this guidance proposes to refer to, for the purpose of the TP Review Program, where appropriate and consistent with the FD&C Act and other applicable laws and regulations, the elements from the International Medical Device Regulators Forum's regulatory assessment program called the Medical Device Single Audit Program. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to establish and publish in the Federal Register criteria to reaccredit and deny reaccreditation of TP Review Organizations. Those criteria, including others, are described in this draft guidance. This draft guidance is not final nor is it in effect at this time.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.'' The draft guidance, when finalized, will describe the type and quality of evidence that we recommend that infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling. This draft guidance is intended to help infant formula manufacturers making structure/function claims comply with the statutory requirement that all claims in infant formula labeling must be truthful and not misleading under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

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 Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E17 General Principles for Planning and Design of Multi-Regional Clinical Trials.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance describes general principles for planning and designing multi-regional clinical trials (MRCT). MRCTs conducted according to the guidance will investigate treatment effects in overall populations with multiple ethnic factors (intrinsic and extrinsic factors as described in the ICH guidance entitled ``E5 Ethnic Factors in the Acceptability of Foreign Clinical Data'' (E5 guidance)) and evaluate the consistency of treatment effects across populations. The draft guidance is intended to increase the acceptability of data from MRCTs as the primary source of evidence supporting marketing approval in global regulatory submissions and to thereby facilitate more efficient drug development and earlier access to medicines.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products 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 Health and Human Services Department (HHS) is correcting a final rule that appeared in the Federal Register on July 8, 2016. The final rule increased the maximum number of patients to whom an individual practitioner may dispense or prescribe certain medications, including buprenorphine, from 100 to 275. Practitioners are eligible for the increased patient limit if they have prescribed covered medications to up to 100 patients for at least one year pursuant to secretarial approval, provided that they meet certain criteria and adhere to several additional requirements aimed at ensuring that patients receive the full array of services that comprise evidence- based medication-assisted treatment (MAT) and minimize the risks that medications provided for treatment are misused or diverted. One pathway through which practitioners may become eligible to increase their patient limit is by obtaining additional credentialing from one of several credentialing bodies. In the final rule, the name of one of the credentialing bodies listed was incorrect. This action provides the correct name.

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 requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention Pediatric Audiology Links to Services (EDHI- PALS)

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from https:// www.cdc.gov/vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed.

Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On February 8, 2016, CDC published a notice in the Federal Register (81 FR 6520) seeking public comments on proposed updated vaccine information materials for hepatitis A and hepatitis B vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for hepatitis A and hepatitis B vaccines. Copies of the final vaccine information materials for hepatitis A and hepatitis B vaccines are available to download from https://www.cdc.gov/vaccines/ hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2016-0015).

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 recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).

The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are met.

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 June 17, 2016 page 39679 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.

Through the ``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' Challenge (the ``Challenge''), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings. The goal of the challenge is to identify a diagnostic test that when utilized would lead to more rapid clinical decision making such that antibiotic use and/or outcomes of patients infected with resistant pathogens are fundamentally improved compared to current standard of care, and/or reduce transmission of resistant pathogens such that population infection rates significantly decrease. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators to develop diagnostic tests that would enable health care providers to make more informed decisions on appropriate antibiotic use and infection prevention. This Challenge, structured in three steps, will complement existing BARDA and NIH research portfolios by reaching out to a diverse population of innovators and solvers, including not only those from academic institutions, but also those from research and development communities in the private sector and others who are outside biomedical disciplines. The NIH and the BARDA believe this Challenge will stimulate investment from both public and private sectors in rapid, point-of-need in vitro diagnostic assay research and product development, which, in turn, could lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis.

This document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner.

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 we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.

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 (Vol. 81, No. 93, page 29877) on May 13, 2016 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.

In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA.

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.

This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally- facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health plans; consumer assistance tools; network adequacy; the Small Business Health Options Program; stand-alone dental plans; fair health insurance premiums; guaranteed renewability; the medical loss ratio program; eligibility and enrollment; appeals; and other related topics.

The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: 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.

In compliance with the Paperwork Reduction Act of 1995, 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.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Cancer Institute (NCI) and the Clinical Center (CC), National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive license to Advanced Imaging Projects, LLC, a company having a place of business in Boca Raton, FL, to practice the inventions embodied in the following patent applications:

This notice acknowledges the Secretary of the Department of Health and Human Services' (HHS) receipt and review of the 2016 National Quality Forum Annual Report to Congress and the Secretary submitted by the consensus-based entity (CBE) under a contract with the Secretary as mandated by section 1890(b)(5) of the Social Security Act, established by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) and amended by section 3014 of the Patient Protection and Affordable Care Act of 2010. The statute requires the Secretary to review and publish the report in the Federal Register together with any comments of the Secretary on the report not later than six months after receiving the report. This notice fulfills the statutory requirements.

The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on issues related to communications by manufacturers, packers, and distributors, including their representatives (collectively ``firms''), regarding FDA-regulated drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively, ``medical products''). FDA is engaged in a comprehensive review of its regulations and policies governing firms' communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA's policy development in this area. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension for this collection, titled, ``Application for Participation in the IHS Scholarship Program (OMB Control Number 0917- 0006),'' with an expiration date of September 30, 2016. This proposed information collection project was previously published in the Federal Register (81 FR 44030) on July 6, 2016, and allowed 60 days for public comment, as required by 3506(c)(2)(A). The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: ``Application for Participation in the IHS Scholarship Program,'' OMB Control No. 0917-0006. Type of Information Collection Request: Extension of the currently approved information collection ``Application for Participation in the IHS Scholarship Program,'' OMB Control No. 0917-0006. Form Number(s): IHS- 856-3, IHS-856-5 through 856-19, IHS-856-21 through 856-24, IHS-817, and IHS-818 are retained for use by the IHS Scholarship Program (IHSSP) as part of this current information collection request. Reporting forms are found on the IHS Web site at www.ihs.gov/scholarship. Need and Use of Information Collection: The IHS Scholarship Branch needs this information for program administration and uses the information to: solicit, process, and award IHS Pre-graduate, Preparatory, and/or Health Professions Scholarship recipients; monitor the academic performance of recipients; and to place recipients at payback sites. The IHSSP application is electronically available on the internet at the IHS Web site at: https://www.ihs.gov/scholarship/applynow/. Affected Public: Individuals, not-for-profit institutions and State, local or Tribal Governments. Type of Respondents: Students pursuing health care professions. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hours.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.'' The purpose of the workshop is to describe the Sentinel Initiative and PRISM program, illustrate how PRISM is used by FDA for regulatory responsibilities (including how it has been integrated into FDA's regulatory review process and case examples), and discuss the future direction of PRISM in terms of expansion and further integration into the regulatory review process.

The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2018.

The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is requesting public comment on the draft 2017-2021 NIDCD Strategic Plan. The Strategic Plan serves as a guide to the NIDCD in prioritizing its research investment, illustrates the current state-of-the-science, and highlights recent advances in the communication sciences. The draft Plan presents a series of goals and objectives that represent the most promising research needs within the NIDCD's mission areas.