Department of Health and Human Services July 30, 2020 – Federal Register Recent Federal Regulation Documents
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Proposed Information Collection Activity; National Survey of Early Care and Education COVID-19 Follow-Up (OMB #0970-0391)
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a two-wave data collection as part of the National Survey of Early Care and Education (NSECE) (OMB #0970-0391), which will be conducted October 2020 through June 2021. The objective of the NSECE COVID-19 Follow-up is to document the nation's current supply of early care and education (ECE) services that is home-based providers, center-based providers, and the center-based provider workforce. In the context of the COVID-19 pandemic, the NSECE COVID-19 Follow-up will deepen our understanding of the state of ECE supply and the ECE workforce following the initial period of crisis, including changes in supply or departures from and re-entries to the workforce.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public via webex and teleconference; a pre- registered public comment session will be held during the meeting. Pre- registration is required for members of the public who wish to attend the meeting via webex/teleconference. Individuals who wish to send in their pre-recorded or written public comments should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by September 2, 2020. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Meetings page.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Records Access Requirements for Food Facilities
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping
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.
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is intended to assist applicants in complying with the content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products. This draft guidance revises the draft guidance issued in December 2014. This revision provides clarification and additional information on recommendations to applicants submitting new drug applications (NDAs), biologics license applications (BLAs) (for biological products that are regulated as drugs), and efficacy supplements to approved NDAs or BLAs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded-Time and Extent Applications for Nonprescription Drug 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 collection of information associated with the criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded.
Proposed Information Collection Activity: State Personal Responsibility Education Program (PREP) (OMB #0970-0380)
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) requires mandatory formula grant applications, state plans, and performance progress reports from states and territories for the development of and implementation of their State Personal Responsibility Education Program (PREP). The State PREP Funding Opportunity Announcement sets forth the application and state plan requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report. ACYF/FYSB are requesting a reinstatement with no changes to the previously approved information collections under OMB #0970-0380.
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.'' The guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form drug products and appropriate expiration dates under those circumstances. This guidance finalizes the revised draft guidance for industry issued in August 2017.
Clinical Development and Commercialization of CD22-Targeting Chimeric Antigen Receptor (CAR) T-Cell Therapies for Children and Young Adults With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (ALL)
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is seeking statements of capability and interest from prospective licensees and potential Collaborators interested in participating in collaborative research under a Cooperative Research and Development Agreement (CRADA) to develop autologous CD22 CAR T-cells (m971BBZ lentivirus transduced) for the treatment of B-cell ALL.
Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Chimeric Antigen Receptors Targeting GPC3
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Cytovia Therapeutics (``Cytovia'') located in New York, NY.
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures Under Executive Order 13910 and Section 102 of the Defense Production Act of 1950
The Department of Health and Human Services (HHS) provides notice of the extension of the designation issued March 25, 2020 under Executive Order 13910 (Executive Order) and section 102 of the Defense Production Act of 1950 (the Act), 50 U.S.C. 4512, as amended, designating health and medical resources necessary to respond to the spread of the virus associated with Coronavirus Disease 2019 (COVID-19) that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies (March 25 Designation Notice). These designated materials are subject to the hoarding prevention measures authorized under the Executive Order and the Act. The March 25 Designation Notice was subsequently published in the Federal Register on March 30, 2020. See 85 FR 17592. On June 30, 2020, HHS updated the March 25 Designation Notice to change the information contact and to remove chloroquine phosphate and hydroxychloroquine HCl as a scarce or threated material. This update was published in the Federal Register on July 7, 2020. See 85 FR 40667. Without extension, the March 25 Designation Notice would terminate 120 days from publication. This notice, issued on July 23, 2020, extends the March 25 Designation Notice for an additional 120 days. This notice also includes modifications and additions to the original list of scarce or threatened materials.
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