Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents

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). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on Draft Toxicological Profiles for Dinitrophenols, 2-Butanone, Mirex and Chlordecone, 1,2- Diphenylhydrazine, 1,2,3-Trichloropropane, Lead, and Endrin. ATSDR has updated these profiles based on availability of new health effects information since their initial release. On March 21, 2016 ATSDR announced that it was preparing to develop Draft Toxicological Profiles for public comment release (81 FR 15110), which include those profiles mentioned above. All toxicological profiles issued as ``Drafts for Public Comment'' represent the result of ATSDR's evidence-based evaluations to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of dinitrophenols, 2-butanone, mirex and chlordecone, 1,2- diphenylhydrazine, 1,2,3-trichloropropane, lead, and endrin for review and potential inclusion in the profiles. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.'' This draft guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of their regulatory submissions to provide certain information to FDA so that FDA can internally track the submissions. The purpose of this guidance is to provide instructions on how to document that a submission includes RWE.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postapproval Pregnancy Safety Studies.'' When finalized, the purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA (i.e., pregnancy safety studies). This draft guidance, when finalized, will represent the current thinking of FDA on postapproval pregnancy safety studies. This draft guidance is intended to help industry develop more comprehensive and scientifically sound studies to assess the safety of drug and biological products during pregnancy in the postmarketing setting. The previous guidance for industry entitled ``Establishing Pregnancy Exposure Registries,'' issued on August 23, 2002, has been withdrawn.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Progress and Monitoring Report (PPMR). This collection of information assists CDC in being responsible for the stewardship of funds provided via contracts, grants, and cooperative agreements, from CDC to partners throughout the world, while providing excellent, professional services to our partners and stakeholders.

The Department of Health and Human Services (HHS) is updating a portion of one office, the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary (OS). ASFR is modifying its structure to streamline and improve operational functionality by replacing the Office of Grants and Acquisition Policy and Accountability (AMT) and establishing in its place the Office of Acquisitions (AMV), and the Office of Grants (AMU).

The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) meeting has been rescheduled due to unforeseen circumstances and will now be held on Tuesday, July 2, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACBSCT website at https:// bloodcell.transplant.hrsa.gov/about/advisory_council/meetings / index.html.

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 Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by CooperVision, Inc., proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Medical X- Ray Imaging Devices Conformance with IEC Standards.'' This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the 2019 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update cruise industry representatives and other interested persons on work completed in 2018 and plans for future activities. HHS/CDC is also opening a public docket so that written comments and materials regarding VSP's 2018 and future work may be submitted. The official record of this meeting will remain open through July 26, 2019, so that comments related to the topics discussed at the meeting may be submitted and made part of the record.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).'' This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (De Novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver by Application Submissions, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs).

The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging 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 Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 18, 2021.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult patients. Specifically, this draft guidance addresses the Agency's current recommendations regarding the development programs for methylphenidate and amphetamine products, as well as for novel (i.e., new molecular entity (NME)) stimulant drugs.

This final rule removes the regulatory text that allows a state to make Medicaid payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We have concluded that this provision is neither explicitly nor implicitly authorized by the statute, which identifies the only permissible exceptions to the rule that only a provider may receive Medicaid payments. As we noted in our prior rulemaking, section 1902(a)(32) of the Social Security Act (the Act) provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.

To help inform the development of the Sexually Transmitted Diseases (STD) Federal Action Plan, HHS seeks input from stakeholders on what strategies can be implemented by federal agencies to improve the efficiency, effectiveness, coordination, accountability, and impact of our national response to increasing rates of STDs.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.

The National Institute of Mental Health (NIMH), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Repurposed Therapeutics, Inc. (``Repurposed Therapeutics'') located in Tampa, Florida, to practice the inventions embodied in the patent application listed in the Supplementary Information section of this notice.

The Administration for Children and Families (ACF) is requesting proposed revisions with a three-year extension to an approved information collection: Procedures for Requests from Tribal Lead Agencies to use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities (OMB #: 0970- 0160, expiration date: 9/30/2019).

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule'' Office of Management and Budget (OMB) Control Number 0917-0030. This previously approved information collection project was last published in the Federal Register (81 FR 15347) on March 22, 2016, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit the collection, which expires August 31, 2019, to OMB for approval of an extension, and to solicit comments on specific aspects of the information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2016-1). Title of Collection: 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Type of Information Collection Request: Extension of the currently approved information collection, 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Form(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913, and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, creates national standards to protect individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the information collection requirements contained in the Rule. 45 CFR 164.508: This provision generally requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information, unless otherwise permitted or required by the Privacy Rule. (See, e.g., 45 CFR 164.506 for a common exception to this general rule, which involves uses and disclosure for treatment, payment, or healthcare operations.) Individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810 ``Authorization for Use or Disclosure of Protected Health Information'' is used to document an individual's authorization to use or disclose their protected health information. 45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction, and with a limited exception, a covered entity is not required to agree to a requested restriction. 45 CFR 164.522(a)(1)(vi). The form IHS-912-1 ``Request for Restrictions(s)'' is used to document an individual's request for restriction of their protected health information, and whether the IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction under certain conditions. For example, termination may occur if the individual agrees to or requests the termination in writing. 45 CFR 164.522(a)(2)(i). The form IHS-912-2 ``Request for Revocation of Restriction(s)'' is used to document the individual's request, the individual's agreement, and/or the agency's decision to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. 45 CFR 164.528: This provision requires covered entities to provide an accounting of certain disclosures of protected health information made by the covered entity. See also, 45 CFR 5b.9(c). The form IHS-913 ``Request for an Accounting of Disclosures'' is used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request. 45 CFR 164.526: Under this provision, individuals have a right to amend protected health information or a record about the individual in a designated record set, under certain conditions. 45 CFR 164.526(a). This provision further requires covered entities to permit an individual to request that the covered entity amend protected health information. 45 CFR 164.526(b). The covered entity must inform the individual if the covered entity accepts the requested amendment, in whole or in part. The covered entity must provide the individual with a written denial containing certain information if the covered entity denies the requested amendment, in whole or in part. 45 CFR 164.526(d)(1). The form IHS-917 ``Request for Correction/Amendment of Protected Health Information'' will be used to document an individual's request to amend his/her protected health information and the agency's decision to accept or deny the request. Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides for this information collection: types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hour(s).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).

The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on June 12-13, 2019, in Atlanta, Georgia.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients.'' The purpose of the public workshop is to discuss the scientific and clinical trial design considerations for development of antiviral products to treat adenoviral infection.

This proposed rule would add requirements and a specified process to address changes of ownership as they relate to the sale, transfer, and/or purchase of assets of Accrediting Organizations (AOs) with the Centers for Medicare & Medicaid Services (CMS)-approved accreditation programs. This change is intended to provide CMS the ability to receive notice when an AO is contemplating undergoing or negotiating a change of ownership and the ability to review the AO's capability to perform its tasks after a change of ownership has occurred, in order to insure the ongoing effectiveness of the approved accreditation program(s) and to minimize risk to patient safety.

HRSA announces the award of a supplement for $700,000 to the University of Nebraska Medical Center/Board of Regents of the University of Nebraska for the Partnership for Urban MCH Leadership Community Cooperative Agreement. The supplement will allow the current recipient, during the period of May 1, 2019-April 30, 2020, to assess the outcomes and impact of its collective impact learning collaborative with urban health departments.

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 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 ``Safety Program in Perinatal Care (SPPC)-II Demonstration Project.''

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will commence in open session before closing to the public for the duration of the meeting.

This document extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on April 30, 2019, is extended by 120 days until August 28, 2019. This document also announces that CMS will be releasing additional data underlying the FFS Adjuster Study released October 26, 2018.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2019 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation, which offers important programmatic opportunities for persons with disabilities and older adults. The PRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY2019 will be in the amount of $1,000,000, bring the total award for FY 19 to $7,761,661. Program Name: National Paralysis Resource Center. Recipient: Christopher and Dana Reeve Foundation. Period of Performance: The supplement award will be issued for the second year of a three year project a project period, July 1, 2019 through June 30, 2020. Award Amount: $1,000,000. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 317 of the Public Health Service Act (42 U.S.C. 247(b-4)); Consolidated and Further Continuing Appropriations Act, 2016, Public Law 114-113 (Dec. 18, 2015). CFDA Number: 93.325 Discretionary Projects.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on 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) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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). 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.'' The unique device identification system regulations require that the label and device package of a device must bear a unique device identifier (UDI), unless an exception or alternative applies. An exception is provided for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI. This guidance document describes FDA's interpretation of the definition of ``convenience kit.'' This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements nor does it apply to combination products.

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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.'' The guidance identifies the types of UHMWPE commonly in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

In compliance with 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.

This document corrects the regulatory identification number (RIN) that appeared in the heading of a notice of proposed rulemaking published in the Federal Register of December 18, 2018. Through that document, OCSE proposed to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document provides guidance to government stakeholders on testing to extend the expiration dateunder the Federal Food, Drug, and Cosmetic Act (FD&C Act)of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other nonemergency purpose. This guidance finalizes the draft guidance issued in April 2017.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also propose minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, we propose to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. We are also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.

The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices 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 draft guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period provided in the notice entitled ``Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information'' that appeared in the Federal Register of December 7, 2018. That notice announced the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. The Agency is taking this action to allow interested persons additional time to submit comments, data, or information.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to collect descriptive information for the Early Head Start Family and Child Experiences Survey 2020 (Baby FACES 2020).

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Characterizing FDA's Approach to Benefit-Risk Assessment Throughout the Medical Product Life Cycle'' and an opportunity for public comment. The meeting will be convened by Duke University's Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, researcher, and other stakeholder input on applying FDA's Benefit-Risk Framework throughout the human drug lifecycle and best approaches to communicating FDA's benefit-risk assessment. Input from this meeting will support development of a draft guidance on benefit-risk assessment for new drugs and biologics and result in a publicly available summary report from Duke-Margolis. This meeting is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).

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.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the Social Security Act (the Act), this proposed rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. We are proposing to rebase and revise the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, we are proposing to replace the previously finalized unweighted motor score with a weighted motor score to assign patients to CMGs and remove one item from the score beginning with FY 2020 and to revise the CMGs and update the CMG relative weights and average length of stay values beginning with FY 2020, based on analysis of 2 years of data (FY 2017 and FY 2018). We are proposing to update the IRF wage index to use the concurrent FY inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust IRF payments. We are proposing to amend the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), we are proposing to adopt two new measures, modify an existing measure, and adopt new standardized patient assessment data elements. We also propose to expand data collection to all patients, regardless of payer, as well as proposing updates related to the system used for the submission of data and related regulation text.

On March 4, 2019, the Department of Health and Human Services (HHS) published a proposed rule that would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. The comment period for the rule was scheduled to close on May 3, 2019. This document extends the comment period for the proposed rule by 30 days to June 3, 2019.

The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of the Health Profession Opportunity Grants (HPOG) to Serve TANF Recipients and Other Low Income Individuals. ACF has developed a multi-pronged research and evaluation approach for the HPOG Program to better understand and assess the activities conducted and their results. Two rounds of HPOG grants have been awardedthe first in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal evaluations associated with each round of grants. HPOG grants provide funding to government agencies, community- based organizations, post-secondary educational institutions, and tribal-affiliated organizations to provide education and training services to Temporary Assistance for Needy Families (TANF) recipients and other low-income individuals, including tribal members. Under HPOG 2.0, ACF provided grants to five tribal-affiliated organizations and 27 non-tribal entities. OMB previously approved data collection under OMB Control Number 0970-0462 for the HPOG 2.0 National and Tribal Evaluation. The first submission, approved in August 2015, included baseline data collection instruments and the grant performance management system. A second submission, approved in June 2017, included additional data collection for the National Evaluation impact study, the National Evaluation descriptive study, and the Tribal Evaluation. A third submission for National Evaluation impact study data collection was approved in June 2018. The proposed data collection activities described in this Federal Register Notice will provide data for the impact, descriptive, and cost benefit studies of the 27 non-tribal grantees participating in the National Evaluation of HPOG 2.0.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Surveillance System (NHSS). This data collection is for continuation of the National HIV Surveillance System which provides the primary population-based data used to describe the epidemiology of HIV in the United States including adult/adolescent and pediatric HIV case reporting, case report evaluations and updates, laboratory updates, deduplication activities, investigation reporting and evaluation, cluster reporting, perinatal HIV exposure reporting, and annual reporting of the standards evaluation report.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Human health effects of drinking water exposures to per- and polyfluoroalkyl substances (PFAS): A multi-site cross-sectional study (The Multi-site Study).'' The purpose of this research is to use sound study methods to see if drinking water exposure to PFAS is related to health outcomes.

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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Extended Evaluation of the National Tobacco Prevention and Control Public Education Campaign.'' This information collection request will enable the Centers for Disease Control and Prevention (CDC) to continue to measure exposure and awareness of the Tips From Former Smokers[supreg] campaign (Tips[supreg]) and to evaluate its impact on campaign-targeted outcomes among smokers and nonsmokers in the United States.

The Office of Child Support Enforcement is requesting a three- year extension of the application form titled, Child Access and Visitation Grant Application Form, expiration 8/31/2019. There are no changes requested to the form.

The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) is requesting letters of intent for the second annual Investigator Awards Program. The NIH Sexual and Gender Minority (SGM) Investigator Awards Program was developed to recognize early-stage investigators who have made substantial, outstanding research contributions in areas related to SGM health and who are poised to become future leaders or are already leading the field of SGM health research. The NIH SGMRO is currently soliciting nominations for the 2019 NIH SGM Investigator Awards. The NIH SGMRO will make two non-monetary awards this year.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices 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.

This document announces the addition of 12 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.