Department of Health and Human Services April 7, 2020 – Federal Register Recent Federal Regulation Documents
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Ryan White HIV/AIDS Program Part F; AIDS Education and Training Centers; National HIV Curriculum e-Learning Platform: Technology Operations and Maintenance Project
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.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:/ /www.cdc.gov/niosh/bsc/nfrs/registration.html or call (513-841-4203) at least five business days in advance of the meeting. Adobe Connect webcast will be available at https://niosh-connect.adobeconnect.com/ nfrs/event/event_info.html for participants wanting to connect remotely, teleconference is available toll-free at (855) 644-0229, and the participant pass code is 9777483. This meeting is open to the public, limited only by the number of adobe license seats available, which is 1,000. The public is welcome to participate during the public comment period, from 11:15 a.m. to 12:00 p.m., EDT, on May 15, 2020. Please note that the public comment period ends at the time indicated above.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
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.
Enforcement Discretion Under HIPAA To Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19
This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current regulations allow a HIPAA business associate to use and disclose protected health information for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction
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.
Pulmonary-Allergy Drugs Advisory Committee; Postponed
The meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) scheduled for April 21, 2020, is postponed. The Food and Drug Administration (FDA), like other government agencies, is taking the necessary steps to ensure the Agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Therefore, this meeting is being postponed. The meeting was announced in the Federal Register on February 20, 2020.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; AIDS Drug Assistance Program Data Report ADR, OMB No. 0915-0345-Revision
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.
Ryan White HIV/AIDS Program Part F; AIDS Education and Training Centers; Enhancement and Update of the National HIV Curriculum e-Learning Platform
HRSA's HIV/AIDS Bureau will award $100,000 in supplemental funding to the University of Washington. This award is to support the Ryan White HIV/AIDS Program Part F AIDS Education and Training Centers (AETC) Enhancement and Update of the National HIV Curriculum e-Learning Platform project in Fiscal Year (FY) 2020 and in each succeeding year of their periods of performance, pending the availability of funds. This supplemental funding will enable the University of Washington to make critical content enhancements to the National HIV Curriculum e- Learning Platform that respond to the specific training and technical assistance needs of HIV treatment professionals located in the jurisdictions targeted by the Ending the HIV Epidemic: A Plan for America (EHE) initiative. Further, it will ensure that more health professionals in EHE jurisdictions have access to the most up-to-date HIV treatment interventions and protocols, thus increasing their competency to provide high-quality care for people with HIV and in so doing, advance the goals of the EHE.
Ryan White HIV/AIDS Program Part F Regional AIDS Education and Training Centers
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.
Rescheduling National Advisory Council on Migrant Health Meeting
This is to notify the public that the National Advisory Council on Migrant Health (NACMH) meeting, originally scheduled for May 5-6, 2020, is re-scheduled to July 29-30, 2020. The May 5-6, 2020, NACMH meeting was announced in the Federal Register, Vol. 85, No. 41, on Monday, March 2, 2020 (FR Doc. 2020-04169 Filed 2-28-20). The decision to re-schedule the NACMH meeting has been made after carefully examining the Centers for Disease Control and Prevention's recommendations to restrict all non-essential travel, and the widespread health risks posed by COVID-19 to the American public. The location and agenda for the re-scheduled NACMH meeting remains as posted in the Federal Register, Vol. 85, No. 41, on Monday, March 2, 2020. For calendar year 2020 meetings, agenda items may include, but are not limited to, topics and issues related to migratory and seasonal agricultural worker health. Refer to the NACMH website listed below for all current and updated information concerning the calendar year 2020 NACMH meetings, including draft agendas and meeting materials, which will be posted 30 calendar days before the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
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