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

Results 1 - 50 of 56,732
Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
Document Number: 2021-07452
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of October 13, 2020. In that notice, FDA announced a public meeting, which was held on November 16, 2020, and requested public input on a potential revised approach for considering the human medical importance of antimicrobial new animal drugs when assessing and managing the antimicrobial resistance risks associated with the use of antimicrobial drugs in animals. Specifically, the Agency requested comments on the potential revised process for ranking antimicrobials according to their relative importance in human medicine, on the potential criteria for their ranking, and on the resulting ranked list of antimicrobial drugs. We are taking this action in response to technical difficulties submitting comments to the Federal eRulemaking portal.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2021-07435
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Child Care Improper Payments Data Collection Instructions
Document Number: 2021-07425
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families is proposing revisions to an approved information collection, Child Care Improper Payments Data Collection Instructions (OMB #0970-0323, expiration 10/ 31/2021). There are minor changes requested to the form.
Proposed Information Collection Activity; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (0970-0555)
Document Number: 2021-07420
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Document Number: 2021-07397
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
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 (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
Document Number: 2021-07396
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
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 (NIH) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-07379
Type: Notice
Date: 2021-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 TEMPORARY HALT IN RESIDENTIAL EVICTIONS TO PREVENT THE FURTHER SPREAD OF COVID-19. The information collection originally pertained to the September 4, 2020 CDC Order of the same name that temporarily halts residential evictions of covered persons for nonpayment of rent from September 4, 2020, through December 31, 2020. The Consolidated Appropriations Act, 2021, statutorily extended CDC's Order until January 31, 2021. On January 29, 2021, the CDC Director renewed the Order until March 31, 2021. As of March 31, the Order is further extended until June 30, 2021. The Declaration in this information collection request will serve as an attestation by a tenant, lessee, or resident that they meet the criteria therein, to prevent an eviction proceeding per the Order issued by the CDC.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2021-07378
Type: Notice
Date: 2021-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07377
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next ADUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07375
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Generic Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program. The meeting will be open to the public.
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2021-07374
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next AGDUFA program and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure consistent stakeholder representation at the consultation meetings.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2021-07373
Type: Notice
Date: 2021-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization of the ADUFA program. The meeting will be open to the public.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program
Document Number: 2021-07343
Type: Proposed Rule
Date: 2021-04-12
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. In addition, this proposed rule includes proposals for the IRF Quality Reporting Program (QRP).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-07342
Type: Notice
Date: 2021-04-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2021-07341
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Draft Recommendations for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Central Line-Associated Blood Stream Infections (CLABSI)
Document Number: 2021-07337
Type: Notice
Date: 2021-04-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the opening of a docket to obtain comment on the Draft Recommendations for Prevention and Control of Infections in Neonatal Intensive Care Unit Patients: Central Line-associated Blood Stream Infections (CLABSI). (``Draft Guideline''). The Draft Guideline provides new, evidence-based recommendations specific to the prevention and control of central line- associated blood stream infections (CLABSI) in neonatal intensive care unit (NICU) patients.
Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
Document Number: 2021-07335
Type: Notice
Date: 2021-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS).
Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
Document Number: 2021-07332
Type: Notice
Date: 2021-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug products marketed for human use with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs); CBER-regulated therapeutic biological products marketed for human use with approved Biologic License Applications (BLAs); Whole Blood or blood components; and human cells, tissues, and cellular and tissue- based products (HCT/Ps) regulated solely under the Public Health Service Act.
Prospective Grant of an Exclusive Patent License: N-butyldeoxynojirimycin To Treat Smith-Lemli Opitz Syndrome (SLOS) and Diseases That Exhibit a Similar NPC-Like Cellular Phenotype
Document Number: 2021-07316
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Child Health and Human Development, 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 U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to SubRed Pty Ltd located in Australia, registered in Victoria.
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Webcast; Request for Public Input
Document Number: 2021-07315
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may view the presentations by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is required for both webcast viewing and oral statements. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/ iccvamforum-2021.
Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Document Number: 2021-07313
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-07312
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Virtual Stakeholder Listening Session in Preparation for the 74th World Health Assembly
Document Number: 2021-07299
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
Document Number: 2021-07287
Type: Notice
Date: 2021-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2021-07286
Type: Notice
Date: 2021-04-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.
Agency Information Collection Request-60-Day Public Comment Request
Document Number: 2021-07285
Type: Notice
Date: 2021-04-09
Agency: Department of Health and Human Services
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.
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR)
Document Number: 2021-07284
Type: Notice
Date: 2021-04-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting that is open to the public, limited only by the number of net conference access available, which is 500. Pre-registration is required by accessing the link at: https://cdc.zoomgov.com/webinar/register/ WN_OwjXZIdgSRK_yea6iSTs4Q.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-07251
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-07250
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-07249
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-07248
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-07221
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-07220
Type: Notice
Date: 2021-04-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2021-07053
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-07052
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2021-07051
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2021-07049
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-07039
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
Document Number: 2021-07002
Type: Notice
Date: 2021-04-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, 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.
Intent To Award a Single-Source Supplement for the National Association of Area Agencies on Aging
Document Number: 2021-06999
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services
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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-06997
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-06996
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-06995
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine Notice of Meetings; Amended Notice of Meeting
Document Number: 2021-06992
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-06990
Type: Notice
Date: 2021-04-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
Document Number: 2021-06960
Type: Notice
Date: 2021-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2021-06940
Type: Notice
Date: 2021-04-05
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 1111(g) of the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Thursday, May 13, 2021, and Friday, May 14, 2021. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory- committees/heritable-disorders/index.html.