Department of Health and Human Services April 2021 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the National Area Agencies on Aging for the Eldercare Locator. Older adults are at greater risk of requiring hospitalization or dying if diagnosed with COVID-19, therefore ensuring that this population is vaccinated in an imperative. In addition, we recognize that the COVID-19 pandemic has birthed many challenges for people with disabilities and linking this population to vaccination resources is also critically important. The purpose of this project is to increase the capacity of the current Eldercare Locator call center to assist additional older adults in obtaining information and linkages to state and local organizations for the purpose of obtaining COVID-19 vaccines. In addition, utilizing the Eldercare Locator platform to develop a call center to assist people with disabilities with state and local resources to obtain links to vaccines and community resources. Program Name: The Eldercare Locator. Recipient: The National Association of Area Agencies on Aging. Period of Performance: The supplement award will be issued for the third year of the five-year project period of June 1, 2018, through May 31, 2023. Total Award Amount: $5,140,000 FY 2021. Award Type: Cooperative Agreement Supplement. Statutory Authority: This program is authorized under Section 202 of the Older Americans Act. Basis for Award: The National Association of Area Agencies on Aging is currently funded to carry out the objectives of this program, entitled The Eldercare Locator. Older adults and their caregivers face a complicated array of decisions regarding home and community-based services. For almost 30 years, the Eldercare Locator has helped older adults and their families navigate this complex environment by connecting those needing assistance with State and local agencies on aging that serve older adults and their caregivers. The Eldercare Locator serves approximately 450,000 people a year through the call center. To ensure that the needs of those who contact the Eldercare Locator are carefully matched with the appropriate resources, information specialists are trained to listen closely to callers, identify relevant local, state and/or national resources and, when needed, provide a transfer to a particular resource. As a trusted national resource, the supplement to the Eldercare Locator will be used to expand the capacity of the service to link a larger number of older adults and their caregivers seeking COVID-19 vaccines with local organizations that can assist in making the appropriate connections and appointments. With the supplemental funding, ACL will fund the expansion of the Eldercare Locator Call Center to support an increase of 500,000 calls from older adults and their caregivers. In addition, the Call Center will utilize and maintain a list of trusted resources, such as the CDC Vaccine Finder, to assist callers in making appropriate local COVID-19 vaccine connections. Some people with disabilities might be at a higher risk of COVID-19 infection or severe illness because of their underlying medical conditions. Having to sift through countless websites and make multiple phone calls to gain education and access to vaccine resources is a significant issue. Having a one-stop call center quickly set-up to provide accurate and up-to-date state and local specific information and referrals regarding COVID-19 vaccines and information regarding local community resources for people with disabilities it critically needed. Using the established Eldercare Locator infrastructure, this supplement will be used for the rapid development of a call center to assist people with disabilities to make appropriate state and local linkages to COVID-19 vaccines and other resources. The grantee, working with appropriate national disability organizations, will establish a call center with a dedicated line and trained information specialists to serve approximately 500,000 people with disabilities. For More Information Contact: For further information or comments regarding this program supplement, contact Sherri Clark, U.S. Department of Health and Human Services, Administration for Community Living, Administration on Aging (202)-795-7327; email Sherri.Clark@acl.hhs.gov.

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 collections related to Medical Device Recall Authority.

The Food and Drug Administration (FDA or we) 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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This is a virtual meeting. It is open to the public, limited only by web conference lines (500 web conference lines are available). If you wish to attend, please register at the NIOSH website https:// www.cdc.gov/niosh/bsc/ or call (404-498-2581) no later than May 12, 2021. Time will be available for public comment.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/.

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Evaluating the Association between Serum Concentrations of Per- and Polyfluoroalkyl Substances (PFAS) and Symptoms and Diagnoses of Selected Acute Viral Illnesses.'' The proposed study will examine the relationship between PFAS serum levels and susceptibility to certain acute viral illnesses, including but not limited to COVID-19.

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. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

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 information collection requirements for consumer assessment surveys used by ACL to measure program performance for programs funded under Title III of the Older Americans Act. This notice solicits comments on a proposed revision of a currently approved collection with the addition of a new rotating module to the National Survey of Older Americans Act Participants.

The Food and Drug Administration (FDA or Agency) has determined that CUTIVATE (fluticasone propionate) ointment, 0.005 percent, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIOMIMICS 3D VASCULAR STENT SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

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 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 October, November, and December 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 improve the accuracy and readability of the regulations.

The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for TPOXX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IBSRELA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.