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

HRSA announces a request for comments and notice of a public meeting to receive feedback on proposed updates to the list of testing services and scores for foreign health care workers to demonstrate English language proficiency pursuant to section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly related to embryo-fetal development (EFD)) for anticancer pharmaceuticals and to provide recommendations to applicants for pharmaceutical labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. The guidance also clarifies FDA's current thinking on when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). The intended outcome of this guidance is to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles, and to provide a consistent approach to labeling recommendations for the duration of contraception after completion of therapy. This guidance finalizes the guidance of the same name issued September 29, 2017.

In compliance with the requirement for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the State Temporary Assistance for Needy Families (TANF) Case Studies project. This study seeks to document innovative employment and training programs for low- income individuals including TANF recipients and examine the ways the programs provide or link families to wraparound services. Over a three- year period, the study will conduct up to 12 comprehensive qualitative case studies and up to 20 profiles of innovative programs to showcase promising approaches.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces that, effective immediately, it is temporarily suspending the importation of dogs from Egypt. This includes dogs originating in Egypt that are imported from third-party countries if the dogs have been present in those countries for less than six months. CDC is taking this action in response to an increase of imported cases of rabies in dogs from Egypt. This action is needed to prevent the reintroduction of canine rabies virus variant (CRVV), which has been eliminated from the United States. This suspension will remain in place until appropriate veterinary controls have been established in Egypt to prevent the export of rabid dogs. CDC will coordinate with other federal agencies and entities as necessary to implement this action.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.