Emergency Use Authorization Declaration
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.'' Due to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the United States. The guidance is intended to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products. 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. In addition, this guidance is intended to remain in effect for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS). However, the recommendations and processes described in the guidance are expected to assist the Agency more broadly in its efforts to prevent and mitigate shortages, including under circumstances outside of the COVID-19 public health emergency and reflect the Agency's current thinking on this issue. Therefore, within 60 days following the termination of the public health emergency, FDA intends to revise and replace this guidance with any appropriate changes following the public health emergency and in consideration of comments received on this guidance and the Agency's experience with implementation.
Medicare Program; Approval of Application by the Utilization Review Accreditation Commission for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
This final notice announces our decision to approve the Utilization Review Accreditation Commission (URAC) for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage (CfCs).
Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of Its Home Health Agency Accreditation Program
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. A HHA that participates in Medicaid must also meet the Medicare conditions of participation (CoPs).
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) GH20-001, Develop, Implement, and Evaluate Evidence-Based, Innovative Approaches To Prevent, Find, and Cure Tuberculosis in High-Burden Settings; GH20-002, Malaria Operations Research To Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya; GH20-003, Conducting Public Health Research in Colombia; GH20-004, Conducting Public Health Research in Georgia; and GH20-005, Conducting Public Health Research in South America; Amended Notice of Meeting
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic 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.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses
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 2019. 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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https://www.samhsa.gov/workplace/ resources/drug-testing/certified-lab-list.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program Eligibility Guidelines
HRSA published the final eligibility guidelines for the Reimbursement of Travel and Subsistence Expenses toward Living Organ Donation Program (herein referred to as Program) in the Federal Register on October 5, 2007. HRSA is requesting public comment concerning proposed changes to the guidelines to: increase the household income eligibility threshold to 350% (currently, the threshold is 300%) for living organ donors and organ recipients, clarify the use of the existing preference categories in relation to the proposed household income eligibility threshold, and clarify that travel and subsistence expenses incurred by non-directed living organ donors qualify as reimbursable expenses under the Program. HRSA is also proposing to revise the Program eligibility guideline's background section to ensure that the information aligns with the Program's legislative authority. These proposed guidelines would apply to the Program regardless of the awardee of the cooperative agreement that administers the Program.
Notice of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures
The Department of Health and Human Services (HHS) announces the issuance of a Notice under Executive Order 13910 (Executive order) and section 102 of the Defense Production Act of 1950 (the Act), as amended, designating health and medical resources necessary to respond to the spread of Coronavirus Disease 2019 (COVID-19) that are scarce or the supply of which would be threatened by excessive accumulation. These designated materials are subject to the hoarding prevention measures authorized under the Executive order and the Act. The Notice was issued on March 25, 2020.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 Managing Unhealthy Alcohol Use in Primary Care Initiative.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
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.
Submission for OMB Review: ACF Program Instruction-Children's Justice Act (OMB #0970-0425)
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (OMB #0970-0425, expiration 4/30/2020). There are no changes requested to the form.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 053'' (Recognition List Number: 053), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Allergenic Products Advisory Committee; Cancellation of Meeting
The meeting of the Allergenic Products Advisory Committee scheduled for May 15, 2020, is canceled. The Allergenic Products Advisory Committee meeting scheduled for May 15, 2020, to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A, has been canceled to allow time for the FDA to review outstanding issues. The Agency intends to continue evaluating the product and will schedule an Advisory Committee meeting in the future, as needed. The meeting was announced in the Federal Register on February 24, 2020.
Proposed Information Collection Activity; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for a one- time study to examine familial outcomes 8 or more years 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.
Emergency Use Authorization Declaration
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
Ryan White HIV/AIDS Treatment Extension Act of 2009: Update to the List of Potentially Life-Threatening Infectious Diseases to Which Emergency Response Employees May Be Exposed To Include Coronavirus Disease 2019 (COVID-19), the Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), to the List of Potentially Life-Threatening Infectious Diseases to Which Emergency Response Employees May be Exposed. The list and companion guidelines are published by NIOSH pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009. NIOSH encourages medical facilities to review the agency's guidelines describing the manner in which medical facilities should make determinations on whether an emergency response employee was exposed to COVID-19, the disease caused by SARS-CoV-2.
Lead Exposure and Prevention Advisory Committee (LEPAC); Meeting
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by web conference; however, advance registration is needed by April 15, 2020, to receive the information to join the meeting. The registration link is https://rossstrategic.zoom.us/webinar/register/ WN_I76JZ04RT5SVinnqu_tSYw. The public comment period is scheduled on April 29, 2020, from 1:45 p.m. until 2:00 p.m., EDT. Individuals wishing to make a comment during the public comment period, please email your name, organization, and phone number by April 15, 2020, to LEPAC@cdc.gov.
Agency Information Collection Activities: Proposed Collection: Public Comment Request: Office for the Advancement of Telehealth Outcome Measures, OMB No. 0915-0311-Revision
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.
Health Information Technology Advisory Committee 2020 Schedule-Revised; Meeting
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below.
Notice of Order Under Sections 362 and 365 of the Public Health Service Act Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of a an Order under Section 362 and 365 of the Public Health Service Act that suspends the introduction of certain persons from countries where an outbreak of a communicable disease exists. The Order was issued on March 20, 2020.
Preparation for International Cooperation on Cosmetics Regulation 14th Annual Meeting; Public Meeting; Cancellation
The Food and Drug Administration (FDA or we) is announcing the cancellation of following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-14 Meeting.'' The purpose of the public meeting was to invite public input on various topics pertaining to the regulation of cosmetics.
Notice To Announce Request for Information on the Development of the National Institute of Diabetes and Digestive and Kidney Diseases Strategic Plan
This Request for Information (RFI) is intended to gather broad public input to assist the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in developing the NIDDK Strategic Plan. NIDDK invites input from: The scientific research community; patients and caregivers; health care providers and health advocacy organizations; scientific and professional organizations; federal agencies; and other stakeholders, including interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.
Temporary Policy Regarding Preventive Controls and Foreign Supplier Verification Programs Food Supplier Verification Onsite Audit 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 Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency.'' The guidance communicates the Agency's intention not to enforce certain onsite audit requirements in three of our food safety regulations in certain circumstances related to the impact of the coronavirus if other supplier verification methods that are designed to provide sufficient assurance that hazards have been significantly minimized or prevented are used instead during the period of onsite audit delay.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC); Correction
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the ports available. There will be 2,000 telephone ports available. The public comment period will be at the end of the meeting from 3:00 p.m.-3:45 p.m., EDT. The public is encouraged to register to participate by telephone and/or provide public comment using the registration form available at the link provided: https://www.surveymonkey.com/r/P6ZN7QX. Written comments may also be submitted for the meeting record in advance using the registration form. Individuals registered to provide public comment will be called upon to speak based on the order of registration. After persons who have registered have spoken, any remaining time in the public comment period will be used for members of the public who have not registered, but wish to offer comment. Each individual making public comment during the meeting will have a 2-minute speaking limit to allow for as many comments as possible. Registered individuals may also request that their written comments be read during the meeting, but such comments will be subject to the same duration limit.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
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 meeting is open to the public via webcast and by teleconference. If you wish to attend, please see the NIOSH website to register (http://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (855) 644-0229, and the participant passcode 9777483. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for up to 100 participants. The public is welcome to participate during the public comment period, from 12:45 p.m., EDT to 1:00 p.m., EDT on April 28, 2020. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: http://www.cdc.gov/niosh/bsc/contact.html.
Process for Making Available Guidance Documents Related to Coronavirus Disease 2019
The Food and Drug Administration (FDA or Agency) is announcing the process for making available FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA believes that this process will allow the Agency to rapidly disseminate essential Agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.
Proposed Information Collection Activity: Title V State Sexual Risk Avoidance Education (SRAE) Program (New Collection)
The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity Announcement sets forth the application requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report.