Department of Health and Human Services April 2020 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and to give notice of the proposed changes no less than 30 days before such changes become effective. In accordance with notice requirements of NAPA, ANA herein describes proposed interpretive rules and general statements of policy that relate to ANA's new funding opportunity announcement (FOA) in Fiscal Year (FY) 2020, Social and Economic Development Strategies Growing Organizations (SEDS-GO), (HHS-2020-ACF-ANA-NN-1837).

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the work of the Public Comment and Federal Inventory Subcommittees and the chapters being developed for the 2020 report to Congress on federal tick-borne activities and research.

HRSA's HIV/AIDS Bureau will award $100,000 in supplemental funding to the University of Washington to support the AIDS Education and Training Centers' (AETC) National HIV Curriculum (NHC) e-Learning Platform: Technology Operations and Maintenance project in Fiscal Year (FY) 2020 and, pending the availability of funds, in each succeeding year of the project's period of performance. This supplemental funding will enable the recipient to implement technological enhancements to the NHC eLearning Platform to increase access and improve efficiency of new online training modules and learning activities that respond to specific needs, as identified, by Ending the HIV Epidemic: A Plan for America (EHE) initiative jurisdictions. These system enhancements will help increase the number of health professionals that have access to state of the art HIV treatment interventions and protocols.

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 provisions of our recordkeeping and records access requirements for food facilities.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of the following seven ANDAs after receiving a withdrawal request from CASI Pharmaceuticals, Inc., c/o Target Health, Inc., 261 Madison Ave., 24th Floor, New York, NY 10016: ANDA 073191, Triamterene and Hydrochlorothiazide Capsules USP, 50 milligrams (mg)/25 mg; ANDA 076075, Econazole Nitrate Cream, 1%; ANDA 076192, Ribavirin Capsules USP, 200 mg; ANDA 076514, Midodrine Hydrochloride (HCl) Tablets USP, 2.5 mg, 5 mg, and 10 mg; ANDA 086809, Spironolactone Tablets USP, 25 mg; ANDA 090288, Naratriptan Tablets USP, Equivalent to (EQ) 1 mg base and EQ 2.5 mg base; and ANDA 203384, Epinastine HCl Ophthalmic Solution, 0.05%. Before FDA withdrew the approval of these ANDAs, CASI Pharmaceuticals, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because CASI Pharmaceuticals, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 073191, 076075, 076192, 076514, 086809, 090288, and 203384 is still in effect.

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.

HRSA's HIV/AIDS Bureau will award supplemental funding to the eight current recipients of the Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Centers (AETC) in Fiscal Year (FY) 2020 and pending the availability of funds, in each succeeding fiscal year of their periods of performance. The recipients will use this supplement funding to provide critical expertise and resources to respond to the specific workforce development needs of novice and experienced health professionals who care for people with or at risk for HIV in Ending the HIV Epidemic focus areas.

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.

The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Council on Graduate Medical Education (COGME) meeting previously announced as in-person and webinar/conference call on Tuesday, April 28, 2020, and Wednesday, April 29, 2020, has changed its format, date, and time. The meeting will now be a one-day webinar and conference call only on Wednesday, April 29, 2020, from 12:00 p.m.-5:00 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and agenda will be available on the COGME website: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/meeting s/ index.html.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a writing subcommittee public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/.

This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some pre-existing Medicare payment rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. We are also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. We are also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, we are making programmatic changes to the Medicare Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint Replacement (CJR) Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. We are also modifying our under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.

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 provisions of reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.