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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult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 Specifically, this draft guidance addresses the Agency's current recommendations regarding the development programs for methylphenidate and amphetamine products, as well as for novel (i.e.,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