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

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 Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed new information collection requirements related to the Outcome Evaluation for ACL's Long-term Ombudsman Program (LTCOP).

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public limited only by the audio (via teleconference) lines available. The public is welcome to listen to the meeting by joining the teleconference (information below).

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.

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.

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.

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.

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.

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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff.'' This final guidance provides FDA's regulatory approach for device products with multiple functions including at least one device function and includes such device products that are part of combination products, in accordance with the 21st Century Cures Act (Cures Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products.'' This guidance describes FDA's current recommendations about endotoxin limits in certain investigational oncology drugs and biological products. This guidance looks at a risk- based approach of weighing the potential risks of not evaluating endotoxin levels in all components of a multidrug regimen against the potential benefits to patients with serious and life-threatening diseases.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ Safety Program for Improving Surgical Care and Recovery.''

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Pilot Implementation of the Violence Against Children and Youth Survey (VACS) in the United States.'' This study is designed to conduct a pilot implementation of the Violence Against Children and Youth Survey (VACS) in the United States, which CDC has conducted in 24 countries globally.

NIOSH announces the availability of IDLH Value Profiles for Bromine Trifluoride, Chlorine Trifluoride, and Ethylene Dibromide.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the form OCS-0024: Low Income Home Energy Assistance Program (LIHEAP) Model Plan Application (OMB #0970-0075, expiration 9/30/2020). There are no changes requested to the form.