Department of Health and Human Services June 19, 2019 – Federal Register Recent Federal Regulation Documents

Medicare Program; Secure Electronic Prior Authorization for Medicare Part D
Document Number: 2019-13028
Type: Proposed Rule
Date: 2019-06-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule proposes a new transaction standard for the Medicare Prescription Drug Benefit program's (Part D) e-prescribing program as required by the ``Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act'' or the ``SUPPORT for Patients and Communities Act.'' Under the SUPPORT for Patients and Communities Act, the Secretary is required to adopt standards for Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. If finalized, the proposals in this rule would amend the Part D e-prescribing regulations to require Part D plan sponsors' support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in electronic Prior Authorization (ePA) transactions with prescribers regarding Part D covered drugs to Part D-eligible individuals.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-13027
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-13026
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13025
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2019-13024
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-13023
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance of Medical Devices
Document Number: 2019-13004
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 for postmarket surveillance of medical devices.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration
Document Number: 2019-13001
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
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 a generic clearance to collect information to support social and behavioral research used by FDA about drug products.
Agency Information Collection Activities; Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2019-12996
Type: Notice
Date: 2019-06-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2019-12986
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 64th full Council meeting in Jackson, Mississippi. Members will hear a panel presentation regarding Ending the HIV Epidemic: A Plan for America and will discuss possible recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is encouraged 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 Caroline Talev, MPA, at Caroline.Talev@hhs.gov. Pre-Registration must be complete by Monday, July 1, 2019.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Teaching Health Center Graduate Medical Education Program Eligible Resident/Fellow FTE Chart, OMB No. 0915-0367-Extension
Document Number: 2019-12961
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement of the Paperwork Reduction Act of 1995 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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Ryan White HIV/AIDS Program Recipient Compilation of Best Practice Strategies and Interventions, OMB No. 0906-xxxx-New
Document Number: 2019-12960
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Standardized Work Plan Form for Use With Applications to the Bureau of Health Workforce Research and Training Grants and Cooperative Agreements, OMB No. 0906-xxxx-New
Document Number: 2019-12959
Type: Notice
Date: 2019-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.