Department of Health and Human Services April 30, 2020 – Federal Register Recent Federal Regulation Documents
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Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is welcome to listen to the meeting by teleconference; 200 teleconference lines are available, and registration is required.
Ophthalmic Devices Panel of the Medical Devices Advisory Committee: Notice of Meeting; Postponement
The Food and Drug Administration (FDA) is postponing the meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee scheduled for June 9, 2020. The meeting was announced in the Federal Register of April 1, 2020. 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 postponing this meeting and will reassess on an ongoing basis for future months. A future meeting date will be announced in the Federal Register.
Correction to Establishment and Solicitation of Nominations for Tribal Advisory Council
HRSA is soliciting comments and recommendations regarding HRSA's intent to establish the HRSA Tribal Advisory Council (TAC) and is seeking nominations of qualified tribal officials as candidates for consideration for appointment as voluntary delegate members of the HRSA TAC. Due to delays caused by the global impact of the Coronavirus Disease 2019 (COVID-19), HRSA is extending the deadline for the submissions of nominations of qualified tribal officials for consideration for appointment as voluntary delegate members of the HRSA TAC. Nominations for membership must now be received on or before July 6, 2020. This 60-day extension will allow tribes and tribal serving organizations the additional time needed to identify qualified tribal officials as candidates and submit comprehensive nomination packages.
Submission for OMB Review; Personal Responsibility Education Program (PREP) Performance Measures and Adulthood Preparation Subjects (PMAPS) Studies-Data Collection Related to the Performance Measures Study-Revision (OMB #0970-0497)
A goal of the Performance Measures and Adulthood Preparation Subjects (PMAPS) studies project is to collect, analyze, and report on performance measures data for the Personal Responsibility Education Program (PREP) programs. The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau (FYSB) in the Administration for Children and Families (ACF) request a revision to a currently approved information collection (OMB No. 0970-0497; expiration date: 04/30/2020). The purpose of the request is to make adaptions to the participant entry and exit surveys, and continue the ongoing data collection of the performance measures from PREP grantees.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Information Sharing by Constituent Part Applicants for Combination Products
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 requirements under the Postmarketing Safety Reporting Rule for Combination Product for Constituent Part Applicants to share specified adverse event information with one another.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Teaching Health Centers Graduate Medical Education Program Cost Evaluation, OMB No. 0906-XXXX-New
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; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
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.
Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.'' Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.
Fiscal Year 2020 Generic Drug Regulatory Science Initiatives; Public Workshop; Remote Only
The Food and Drug Administration is announcing that the following public workshop entitled ``FY 2020 Generic Drug Regulatory Science Initiatives'' announced in the Federal Register on March 10, 2020, is being modified to take place remotely.
Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market Without Premarket Authorization (Revised); Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).'' This is a revision to the guidance which describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS products that do not have premarket authorization. FDA is revising this guidance to change the date required to submit premarket authorization applications to the Agency from May 12, 2020, to September 9, 2020.
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule; Withdrawal of Guidance
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,'' which was issued in 2017. The guidance was intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations. FDA is withdrawing the guidance because the compliance deadlines contained therein have passed, have been vacated or stayed, or are otherwise described in other guidance.
Proposed Collection; 60-day Comment Request; Chimpanzee Research Use Form (Office of the Director)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; Bench to Bedside: Integrating Sex and Gender To Improve Human Health & Sex as a Biological Variable: A Primer (Office of the Director)
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 Office of Research on Women's Health (ORWH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) hereby announces updates to the Best Pharmaceuticals for Children Act (BPCA) Program priorities for 2020-2021. The Best Pharmaceuticals for Children Act (BPCA) seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations, publish a list of drugs/needs in pediatric therapeutics, and fund studies in the prioritized areas. This notice will provide a brief update on the current progress of the BPCA Program and provide the current Priority List of Needs in Pediatric Therapeutics.
Advisory Council for the Elimination of Tuberculosis Meeting (ACET); Notice of Meeting and Request for Comment
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by audio and web conference lines (100 audio and web conference lines are available) by accessing the following telephone number at 1-877-927-1433; the passcode is 12016435. The web conference access is https://adobeconnect.cdc.gov/r5p8l2tytpq/.
Healthcare Infection Control Practices Advisory Committee (HICPAC); Notice of Meeting and Request for Comment
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, limited only by audio phone lines available. The public is welcome to listen to the meeting by teleconference at 1-800-369-1817, and the passcode is 5200122; 200 teleconference lines are available. Registration is required. Interested parties may register at https:// www.cdc.gov/hicpac.
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