Department of Health and Human Services April 2017 – Federal Register Recent Federal Regulation Documents

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 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.

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: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.''

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.''

The invention listed in this document is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development.

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The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Through this notice, FDA is hoping to stimulate the economy and increase the regulatory certainty with respect to generic versions of these drug products by confirming that generic versions of the subject drug products may continue to be marketed.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.

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 proposed information collection project titled ``Awardee Lead Profile Assessment (ALPA).'' The information collection project includes a questionnaire to collect information to identify jurisdictional legal frameworks governing funded childhood lead poisoning prevention programs in the United States, and strategies for implementing childhood lead poisoning prevention activities in the United States.

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 revision to the information collection project titled ``Information Collection on Cause-Specific Absenteeism in Schools.'' Changes include a revised title. The proposed title is ``Information Collection on Cause-Specific Absenteeism in Schools and Evaluation of Influenza Transmission within Student Households.'' The project will continue to address the original aim of improving our understanding of the role of influenza-like illness (ILI)specific absenteeism in schools in predicting community-wide influenza transmission.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to a Revision of a Currently Approved Collection (ICR Rev).

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing 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.

The Food and Drug Administration (FDA or we) 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 (PRA).

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EMFLAZA (deflazacort) oral tablets, and oral suspension manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that two collections of information: ``Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' and ``Blood Establishment Registration and Product Listing'' have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is making available to the public a report, submitted by Duke Clinical Research Institute on December 15, 2015, of the pediatric studies of ampicillin that were conducted in accordance with the Public Health Service Act (PHS Act) and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs. This notice is to announce the 30-day open public comment period on the report.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The general function of the committees is to provide advice and make recommendations to the Agency on pediatric ethical issues. The meeting will be open to the public. FDA is establishing a docket for public comments on this document.

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.

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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for revision of the approved information collection assigned OMB control number 0990-0452, scheduled to expire on January 31, 2020. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.

The Food and Drug Administration (FDA or we) 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's (FDA) Center for Drug Evaluation and Research (CDER), Professional Affairs and Stakeholder Engagement Staff (PASES), is announcing a 1-day public workshop entitled ``Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population.'' The purpose of this workshop is to discuss the importance of individualized glycemic control targets for older patients with diabetes; to reduce the risk of serious hypoglycemia; identify and discuss medication safety efforts, both those that are part of the Safe Use Initiative and those external to FDA, that are of direct relevance and importance to older patients living with the disease; discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia in older diabetic patients; and disseminate the results of this discussion to inform patients, patient advocates, and health care practitioners.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). 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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act,, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ ohrp/sachrp-committee/meetings/.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).

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 (PRA).

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 revision of the National Disease Surveillance Program II Disease Summaries information collection. These surveillance data are essential on the local, state, and federal levels for measuring trends in diseases, evaluating the effectiveness of current preventive strategies, and determining the need to modify current preventive measures.

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 project titled ``Zika Postpartum Emergency Response Survey (ZPER), Puerto Rico, 2017.''

NIH seeks input from the biomedical research community, biotechnology and pharmaceutical companies and other members of the public on interest and opportunities of engagement with the Illuminating the Druggable Genome (IDG) Program. The purpose of this Request for Information (RFI) is to identify and obtain comments on strategies for sharing potential data, tools, and other resources of common interest generated by the IDG Program and by external stakeholders to maximize the impact of the IDG Program.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting 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. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or we) is announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the petition proposes that the existing regulations be amended to provide for the safe use of silicon dioxide and diatomaceous earth for use as components of spent beaching clay.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 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 regarding exception from the general requirements for informed consent.

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, in co-sponsorship with the Critical Path Institute's (C-Path) Patient-Reported Outcome (PRO) Consortium, is announcing a public workshop entitled ``Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials.'' The purpose of the public workshop is to provide a forum for collaborative multidisciplinary discussion to identify opportunities and address challenges for clinical outcome assessments, particularly patient- reported outcome (PRO) assessments, in oncology drug development. In this public workshop, a broad array of international stakeholders involved in oncology drug development and PRO measurement will provide perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anti-cancer agents. Speakers and panelists will explore the utility of information derived from existing and emerging PRO measures and discuss potential ways to improve the collection, analysis, and presentation of the data to support drug development and better inform treatment decisions. In addition, workshop participants will discuss possible approaches to the patient-reported assessment of an investigational drug's overall side effect burden as a clinical trial endpoint. This public workshop will include speakers and panelists from regulatory agencies, academia, patient advocacy groups, and the medical product industry.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the Web site https://www.hhs.gov/ash/carb/ and must be completed by April 25, 2017; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/ash/carb/ on the Meetings page.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On April 11, 2017, the Secretary determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves nerve agents or certain insecticides (organophosphorus and/or carbamate). On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

This publication corrects a notice that was published in the Federal Register on April 4, 2017, Volume 82, Number 63, page 16403. The meeting announcement, meeting date, and matters for discussion should read as follows: The meeting announced below concerns the Centers for Disease Control and Prevention (CDC) initial review of applications in response to Funding Opportunity Announcements GH17-002, Program Development and Research to Establish and Evaluate Innovative and Emerging Best Practices in Clinical and Community Services through the President's Emergency Plan for AIDS Relief (PEPFAR); and GH17-003, Conducting Public Health Research in South Africa. Time and Date: 9:00 a.m.-2:00 p.m., EDT, April 25, 2017, Panel A (Closed). Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ``Program Development and Research to Establish and Evaluate Innovative and Emerging Best Practices in Clinical and Community Services through the President's Emergency Plan for AIDS Relief (PEPFAR)'', FOA GH17-002; and ``Conducting Public Health Research in South Africa'', FOA GH17-003. For Further Information Contact: Hylan Shoob, Scientific Review Officer, Center for Global Health (CGH) Science Office, CGH, CDC, 1600 Clifton Road NE., Mailstop D-69, Atlanta, Georgia 30033, Telephone: (404) 639-4796, HSHOOB@CDC.GOV. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

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 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.

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Idaho National Laboratory Idaho Chemical Processing Plant in Scoville, Idaho, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA or we) is extending the comment period for a docket to receive information and comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food. We established the docket through a notice that appeared in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

NIOSH announces the availability of the following publication: ``NIOSH Center for Motor Vehicle Safety: Results from 2016 Midcourse Review'' [DHHS (NIOSH) Publication Number 2017-139].

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 Lower Limb Prosthesis, which is currently being conducted by the AHRQ's Evidence- based Practice Centers Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

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 ``AHRQ Research Reporting System (ARRS).'' This proposed information collection was previously published in the Federal Register on January 11, 2017 and allowed 60 days for public comment. AHRQ did not receive any substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0419, scheduled to expire on June 30, 2017. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing 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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will hold a public teleconference on May 5, 2017.

This document corrects an error that appeared in the notice published in the June 8, 2016, Federal Register entitled ``Findings of Research Misconduct.''