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

Development of Anti-Infective Drug Products for the Pediatric Population; Draft Guidance for Industry; Availability
Document Number: 2020-14085
Type: Notice
Date: 2020-06-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-14059
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-14058
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30 Day Comment Request Application Process for Clinical Research Training and Medical Education at the Clinical Center and Its Impact on Course and Training Program Enrollment and Effectiveness (Clinical Center)
Document Number: 2020-14057
Type: Notice
Date: 2020-06-30
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Data System for Organ Procurement and Transplantation Network, OMB No. 0915-0157-Extension
Document Number: 2020-14046
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Request for Letters of Interest (LOI) for NCI-MATCH Laboratories
Document Number: 2020-14044
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020 to allow candidate more time to submit LOIs. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next-Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.
Request for Letters of Interest (LOI) for Pediatric Focused NCI-MATCH Laboratories
Document Number: 2020-14043
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020, to allow candidate more time to submit LOIs.
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
Document Number: 2020-14040
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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).
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2020-14023
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14022
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-14021
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-14020
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-13986
Type: Notice
Date: 2020-06-30
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Services Requirements
Document Number: 2020-13792
Type: Proposed Rule
Date: 2020-06-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This proposed rule also proposes to make permanent the changes to the home health regulations regarding the use of technology in providing services under the Medicare home health benefit as described in the Medicare and Medicaid Programs; Revisions in Response to the COVID-19 Public Health Emergency interim final rule with comment period. This proposed rule also proposes to remove provisions related to test transmission of OASIS data by a new HHA, because the provision is now obsolete due to changes in our data submission system. This proposed rule discusses policies finalized in the CY 2020 HH PPS final rule with comment period regarding the permanent home infusion therapy services benefit for CY 2021, and proposes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. Additionally, this proposed rule discusses Medicare enrollment policies for qualified home infusion therapy suppliers.
Health Information Technology Advisory Committee 2020 Schedule-Revised; Meeting
Document Number: 2020-13978
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services
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.
Use of Codeine-Containing Analgesics in Children Under 12 Years of Age Subsequent to CYP2D6 Genetic Testing; Establishment of a Public Docket; Request for Comments
Document Number: 2020-13974
Type: Notice
Date: 2020-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in children under 12 years of age, and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with codeine-containing analgesics. These questions are posed in section II.
Review and Update of Device Establishment Inspection Processes and Standards; Guidance for Industry; Availability
Document Number: 2020-13972
Type: Notice
Date: 2020-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Review and Update of Device Establishment Inspection Processes and Standards.'' FDA is issuing this guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for- cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This guidance describes how FDA will implement uniform inspection processes and standards. The guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.
Submission for OMB Review; Office of Refugee Resettlement Annual Survey of Refugees (OMB #0907-0033)
Document Number: 2020-13941
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous five fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 30 to 48 minutes per respondent.
Submission for OMB Review; Survey of the National Survey of Child and Adolescent Well-Being (NSCAW) Adopted Youth, Young Adults, and Adoptive Parents (New Collection)
Document Number: 2020-13939
Type: Notice
Date: 2020-06-29
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 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.
Proposed Information Collection Activity; Cost Study of Trauma-Specific Evidence-Based Programs Used in the Regional Partnership Grants Program (New Collection)
Document Number: 2020-13935
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive studythe Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13884
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; National Survey of Child and Adolescent Well-Being-Third Cohort (NSCAW III) (OMB #0970-0202)
Document Number: 2020-13856
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), is proposing to collect data on the child welfare workforce as part of the third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW III). Previous and current data collections for NSCAW have been approved by OMB under OMB #0970-0202. This request is for additional data collection.
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-13835
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2020-13834
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Award a Sole Source Supplement to the Christopher and Dana Reeve Foundation
Document Number: 2020-13577
Type: Notice
Date: 2020-06-29
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2020 Congressional budget appropriations.
Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Document Number: 2020-13829
Type: Notice
Date: 2020-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2020-13828
Type: Notice
Date: 2020-06-26
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 to OMB for Review and Approval; Public Comment; Information Collection Request Title: Ryan White HIV/AIDS Program: Allocation and Expenditure Forms, OMB No. 0915-0318-Revision
Document Number: 2020-13794
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Membership Forms for Organ Procurement and Transplantation Network OMB No. 0915-0184-Revision
Document Number: 2020-13793
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.
Proposed Information Collection Activity; Identifying and Addressing Human Trafficking in Child Welfare Agencies (New Collection)
Document Number: 2020-13779
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on child welfare agencies' efforts to identify human trafficking and subsequent service delivery. The goal of the study is to better understand child welfare practice in screening for human trafficking, and the degree to which screening is related to subsequent referrals for, access to, and delivery of specialized services for children identified as trafficking victims or at high-risk of trafficking.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-13757
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-13756
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-13755
Type: Notice
Date: 2020-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Generic Drug User Fee Amendments; Public Meeting; Request for Comments
Document Number: 2020-13749
Type: Notice
Date: 2020-06-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Generic Drug User Fee Amendments (GDUFA) of 2017.'' At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2020-13746
Type: Notice
Date: 2020-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of antibacterial drugs for the treatment of community- acquired bacterial pneumonia (CABP) based on comments that were received and current recommendations. This guidance finalizes the draft guidance of the same title issued on January 10, 2014.
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Guidance for Industry; Availability
Document Number: 2020-13745
Type: Notice
Date: 2020-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this final guidance is to help sponsors and investigators in the clinical development of antibacterial drugs for the treatment of hospital- acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) based on comments that were received and current recommendations. This guidance finalizes the draft guidance of the same title issued on May 7, 2014.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2020-13702
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13701
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13700
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13699
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13698
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-13697
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-13696
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Case Plan Requirement, Title IV-E of the Social Security Act, (OMB #0970-0428)
Document Number: 2020-13684
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a 3-year extension of the information collectionCase Plan Requirement, Title IV-E of the Social Security Act, (OMB #0970-0428, expiration 3/31/2021). ACF is reporting a change to the information collectionthe burden estimates in the previously-approved request were based on the number of children in foster care as the respondent instead of the agency completing the case plan. The burden estimates, therefore, are adjusted accordingly.
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
Document Number: 2020-13672
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. This SACATM meeting will be held by webcast only and available to the public for remote viewing. Registration is required to access the webcast and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.
National Advisory Committee on Rural Health and Human Services
Document Number: 2020-13670
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory- committees/rural-health/.
Pfizer Inc., et.al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Document Number: 2020-13661
Type: Notice
Date: 2020-06-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-13656
Type: Notice
Date: 2020-06-25
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Determination That TENEX (Guanfacine Hydrochloride) Tablets, 1 Milligram, 2 Milligrams, and 3 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-13594
Type: Notice
Date: 2020-06-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram (mg), 2 mg, and 3 mg, 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.
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