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

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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2020-12100
Type: Notice
Date: 2020-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Substance Use Disorder Treatment and Recovery Loan Repayment Program, OMB No. 0906-xxxx-New
Document Number: 2020-12040
Type: Notice
Date: 2020-06-04
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-12031
Type: Notice
Date: 2020-06-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-12005
Type: Notice
Date: 2020-06-04
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 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-12002
Type: Notice
Date: 2020-06-04
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 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Privacy Act of 1974; Matching Program
Document Number: 2020-11996
Type: Notice
Date: 2020-06-04
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE), is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs) participating in the Public Assistance Reporting Information System (PARIS) Program. The matching program provides the SPAAs with VA compensation and pension data on a periodic basis to use in determining public assistance applicants' and recipients' eligibility for certain public assistance benefits. HHS/ACF/OPRE facilitates the matching program, and the Department of Defense (DoD), Defense Manpower Data Center (DMDC) conducts the matches of SPAA and VA data and provides associated support.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-11992
Type: Notice
Date: 2020-06-03
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.
Submission for OMB Review; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (New Collection)
Document Number: 2020-11985
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) seeks approval for a new information collection requesting Refugee Support Services (RSS) grantees and RSS Set Aside grantees to provide the agency name, city, state, phone number, and funding amount for each contracted sub-grantee.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2020-11982
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2020-11980
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-11913
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2020-11911
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11910
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions and Delegations of Authority
Document Number: 2020-11769
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019
Document Number: 2020-11898
Type: Notice
Date: 2020-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the process for publishing FDA Emergency Use Authorizations (EUAs) for medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA believes that this process will allow the Agency to rapidly publish EUAs that have been issued for medical devices under the Federal Food, Drug, and Cosmetic Act.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-11883
Type: Notice
Date: 2020-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2020-11880
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11879
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-11878
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11876
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2020-11875
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2020-11862
Type: Notice
Date: 2020-06-02
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; Information Collection Request Title: Ryan White HIV/AIDS Program Part F Dental Services Report, OMB No. 0915-0151-Extension
Document Number: 2020-11834
Type: Notice
Date: 2020-06-02
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11815
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11814
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11813
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11812
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2020-11811
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2020-11810
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-11809
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2020-11808
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-11804
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11803
Type: Notice
Date: 2020-06-02
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the ``Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)'' (OMB Control No. 0920-1204, expiration date 11/30/2020). The ACBS is an in-depth asthma survey conducted on a subset of BRFSS respondents with an asthma diagnosis. The goal of this survey is to strengthen the existing body of asthma data and to address critical questions surrounding the health and experiences of persons with asthma.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11802
Type: Notice
Date: 2020-06-02
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 Pulmonary Function Test Course Approval Application. The program consists of an application submitted by potential sponsors (universities, hospitals, and private consulting firms) who seek NIOSH approval to conduct courses, and if approved, notification to NIOSH of any course or faculty changes during the approval period, which is limited to five years.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11801
Type: Notice
Date: 2020-06-02
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 the Medical Monitoring Project Facility Survey, a one-time survey of the characteristics of HIV care facilities in order to collect information on the nation's existing HIV care infrastructure and the capacity of facilities to implement the strategies of the U.S. Ending the HIV Epidemic Federal Initiative.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11800
Type: Notice
Date: 2020-06-02
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 National YRBS Test-Retest Reliability Study. This study is designed to test the reliability of the data collected through the Youth Risk Behavior Survey (YRBS) questionnaires. The YRBS is a biennially school-based survey of high school students in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11799
Type: Notice
Date: 2020-06-02
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 ``Assessments of adults' professional experiences for improving programs to decrease sexual risk and related behaviors and adverse health outcomes among youth,'' a generic information collection package that supports qualitative and quantitative data collection from adults who help implement programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy or influence related risk and protective factors; data will be collected for needs assessment and program refinement.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11798
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11797
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11796
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11795
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11794
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-11793
Type: Notice
Date: 2020-06-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2020-11774
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice announces a correction to the time of the Secretary's Advisory Committee on Infant Mortality (ACIM) scheduled public meeting. The ACIM meeting, originally scheduled for June 17, 2020, 11:00 a.m.-6:00 p.m. Eastern Time (ET) and June 18, 2020, 11:00 a.m.-3:00 p.m. ET, has been extended by 30 minutes on June 18, 2020. The meeting will now end at 3:30 p.m. on June 18, 2020. This meeting was originally announced in the Federal Register, Vol. 85, No. 95, on Friday, May 15, 2020 (FR Doc. 2020-10447 Filed 5-14-20; 8:45 a.m.). The location and agenda for the re-scheduled ACIM meeting remains the same as posted. Information about ACIM and the agenda for this meeting will be available on the ACIM website at https://www.hrsa.gov/advisory- committees/infant-mortality/index.html.
Amendments to the HHS-Operated Risk Adjustment Data Validation Under the Patient Protection and Affordable Care Act's HHS-Operated Risk Adjustment Program
Document Number: 2020-11703
Type: Proposed Rule
Date: 2020-06-02
Agency: Department of Health and Human Services
This rule proposes to adopt certain changes to the risk adjustment data validation error estimation methodology starting with the 2019 benefit year and beyond for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. The Patient Protection and Affordable Care Act (PPACA) established a permanent risk adjustment program under which payments are made to health insurance issuers that attract higher-than-average risk populations funded by payments from health insurance issuers that attract lower-than-average risk populations. To ensure the integrity of the HHS-operated risk adjustment program, CMS, on behalf of HHS, performs risk adjustment data validation, also known as HHS-RADV, to validate the accuracy of data submitted by issuers for the purposes of risk adjustment transfer calculations. Based on lessons learned from the first payment year of HHS-RADV, this rule proposes changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also proposes to change the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied starting with 2021 benefit year HHS-RADV. These proposals seek to further the integrity of the HHS-RADV program, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.
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: 2020-11695
Type: Notice
Date: 2020-06-02
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).
Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
Document Number: 2020-11342
Type: Rule
Date: 2020-06-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.
Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide
Document Number: 2020-10033
Type: Rule
Date: 2020-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates). This action is in response to a food additive petition filed by Evonik Corp.
Notice of Closed Meeting
Document Number: 2020-11736
Type: Notice
Date: 2020-06-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Commission on Childhood Vaccines Meeting Cancellation
Document Number: 2020-11705
Type: Notice
Date: 2020-06-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
This is to notify the public that the June 4, 2020, and June 5, 2020, meeting of the Advisory Commission on Childhood Vaccines (ACCV) is canceled.