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

Results 51 - 100 of 3,354
Proposed Information Collection Activity; National and Tribal Evaluation of the 2nd Generation of the Health Profession Opportunity Grants
Document Number: 2020-28246
Type: Notice
Date: 2020-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Health Profession Opportunity Grants (HPOG) Program provides healthcare occupational training for Temporary Assistance for Needy Families recipients and other low-income people. The Office of Management and Budget (OMB) has approved various data collection activities for the National and Tribal Evaluation of the 2nd Generation of HPOG (HPOG 2.0 National and Tribal Evaluation) under OMB #0970-0462. Due to the profound effects the COVID-19 pandemic has had on the U.S. economy, on families nationwide and on HPOG 2.0 programs, the Office of Planning, Research, and Evaluation (OPRE) is considering surveying study participants who applied to the HPOG Program after the onset of the pandemic. This notice provides a summary for public review and comment of the use and burden associated with a new information collection for this ``COVID Cohort'' Survey.
Fogarty International Center; Notice of Meeting
Document Number: 2020-28169
Type: Notice
Date: 2020-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2020-28163
Type: Notice
Date: 2020-12-22
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 Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https:// www.hrsa.gov/advisory-committees/infant-mortality/.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Title III Supplemental Form to Financial Status Report (SF-425), OMB #0985-0004
Document Number: 2020-28157
Type: Notice
Date: 2020-12-22
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed information collection, Title III Supplemental Form to Financial Status Report (SF-425) OMB 0985-0004.
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
Document Number: 2020-28131
Type: Notice
Date: 2020-12-22
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-28114
Type: Notice
Date: 2020-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-28113
Type: Notice
Date: 2020-12-21
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 GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs). GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing.
National Cancer Institute; Notice of Meeting
Document Number: 2020-28100
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2020-28099
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-28098
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2020-28097
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP); Correction
Document Number: 2020-28091
Type: Notice
Date: 2020-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications; Correction
Document Number: 2020-28081
Type: Notice
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice entitled ``Wockhardt Ltd., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications'' that appeared in the Federal Register on October 9, 2020. The document announced the withdrawal of approval (as of November 9, 2020) of nine abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771: ANDA 077788, Albuterol Sulfate Syrup, Equivalent to 2 milligrams base/5 milliliters. Before FDA withdrew the approval of this ANDA, VistaPharm, Inc., informed FDA that it did not want the approval of the ANDA withdrawn. Because VistaPharm, Inc., timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077788 is still in effect.
Determination That DOBUTREX (Dobutamine Hydrochloride), Equivalent 12.5 Milligram Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-28080
Type: Notice
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that DOBUTREX (dobutamine hydrochloride), equivalent (eq) 12.5 milligram (mg) base/milliliter (mL), 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.
Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director Notice of Proposed Reorganization
Document Number: 2020-28074
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) in the Office of the Director, National Institutes of Health (NIH) is seeking public comment regarding its proposal to transfer the Office of Nutrition Research (ONR) from the National Institute of Diabetes and Digestive and Kidney Diseases to DPCPSI in the Office of the Director, NIH. The program offices in DPCPSI share a common mission of identifying emerging scientific opportunities, rising public health challenges, or scientific knowledge gaps that deserve special emphasis. The proposed reorganization would align this important office with offices having similar trans-NIH functions.
Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials; Public Meeting
Document Number: 2020-28069
Type: Notice
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing a public meeting that will be convened by Duke University's Robert J. Margolis Center for Health Policy and supported by a cooperative agreement with FDA. The meeting, entitled ``Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials,'' is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
Document Number: 2020-28068
Type: Notice
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 reporting and recordkeeping requirements of our regulations concerning new animal drugs for investigational use.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates
Document Number: 2020-28064
Type: Notice
Date: 2020-12-21
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.
Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee
Document Number: 2020-28054
Type: Notice
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective February 1, 2021, with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Meeting of the National Vaccine Advisory Committee
Document Number: 2020-28046
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.
Proposed Information Collection Activity; Follow-up Study of Coaching Practices in Early Care and Education Settings (OMB #0970-0515)
Document Number: 2020-28043
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
This is a primary data collection request for the Follow-up Study of Coaching Practices in Early Care and Education Settings (3), a follow-up to the previously approved Study of Coaching Practices in Early Care and Education Settings (SCOPE) survey (OMB #0970-0515). The study aims to examine, using surveys and qualitative interviews, the practice and processes of coaching and professional development in supporting early care and education (ECE) settings in their provision of care for preschool children and their families as COVID-19 has progressed. The study will focus on both centers and family child care (FCC) homes that serve low-income children, with a primary target of settings that serve children supported by Child Care and Development Fund subsidies or a Head Start grant.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients; Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034-Extension
Document Number: 2020-28017
Type: Notice
Date: 2020-12-21
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 on Aging; Notice of Closed Meeting
Document Number: 2020-28005
Type: Notice
Date: 2020-12-21
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: 2020-28004
Type: Notice
Date: 2020-12-21
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: 2020-28003
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-28002
Type: Notice
Date: 2020-12-21
Agency: Department of Health and Human Services, National Institutes of Health
Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
Document Number: 2020-27828
Type: Proposed Rule
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposed revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. FDA is proposing this action because these regulations are obsolete or no longer necessary to achieve public health goals. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive Orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
French Dressing; Proposed Revocation of a Standard of Identity
Document Number: 2020-27822
Type: Proposed Rule
Date: 2020-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) proposes to revoke the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS). We tentatively conclude that this standard no longer promotes honesty and fair dealing in the interest of consumers. Revocation of the standard of identity for French dressing could provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
Advisory Committee on Immunization Practices (ACIP); Correction
Document Number: 2020-28090
Type: Notice
Date: 2020-12-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting.
Document Number: 2020-27980
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting.
Document Number: 2020-27979
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-27978
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-27977
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2020-27976
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
Document Number: 2020-27963
Type: Notice
Date: 2020-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-27947
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-27943
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB No. 0906-0017, Revision
Document Number: 2020-27919
Type: Notice
Date: 2020-12-18
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.
Submission for OMB Review; Advance Planning Document (APD) Process (OMB #0970-0417)
Document Number: 2020-27916
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting an update to the Advance Planning Document (APD) process (OMB #0970-0417). OCSE proposes revisions to the annual burden estimates to reflect an increase in the number of states seeking approval to implement modernization solutions in efforts to replace antiquated legacy child support enforcement systems and to address an excess demand for emergency funding requests due to the impacts of the COVID-19 pandemic.
Submission for OMB Review; Placement and Transfer of Unaccompanied Alien Children Into ORR Care Provider (0970-0554)
Document Number: 2020-27901
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR) Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow Unaccompanied Alien Children (UAC) Program to place UAC referred to ORR by Federal agencies into care provider facilities and to transfer UAC within the ORR care provider network. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.
Submission for OMB Review; Services Provided to Unaccompanied Alien Children (0970-0553)
Document Number: 2020-27898
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR) Administration for Children and Families (ACF), Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow Unaccompanied Alien Children (UAC) Program to provide services to UAC as required by statute and ORR policy. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.
Submission for OMB Review; Release of Unaccompanied Alien Children From ORR Custody (0970-0552)
Document Number: 2020-27896
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS), is proposing to continue to collect information that will allow Unaccompanied Alien Children (UAC) Program to process release of UAC from ORR custody and provide services after release. These information collections were originally approved under emergency approval for 6 months. This request is to continue data collection. Information collections related to other aspects of the UAC Programs, such as sponsorship and health care, are covered under OMB Numbers 0970-0278, 0970-0385, 0970-0466, 0970-0490, 0970-0498, 0970-0509, and 0970-0543.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-27885
Type: Notice
Date: 2020-12-18
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.
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2020-27861
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-27860
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2020-27859
Type: Notice
Date: 2020-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Requirements for Additional Traceability Records for Certain Foods; Extension of Comment Period; Reopening of the Comment Period
Document Number: 2020-27829
Type: Proposed Rule
Date: 2020-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the proposed rule and reopening the comment period for the information collection related to the proposed rule entitled ``Requirements for Additional Traceability Records for Certain Foods'' that appeared in the Federal Register of September 23, 2020. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested persons to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Frozen Cherry Pie; Proposed Revocation of a Standard of Identity and a Standard of Quality
Document Number: 2020-27823
Type: Proposed Rule
Date: 2020-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) proposes to revoke the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association (ABA). We tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. We also tentatively conclude that revoking the standards of identity and quality for frozen cherry pie would provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
Announcement and Request for comment on Non-Substantive Changes to Three Data Collections
Document Number: 2020-27820
Type: Notice
Date: 2020-12-18
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 (HHS) announces the opening of a public docket to obtain comment on non-substantive changes to three data collections conducted by CDC's National Center for Health Statistics (NCHS). Although CDC has already obtained approval from the Office of Management and Budget (OMB) under the Paperwork Reduction Act on these non-substantive changes, CDC is requesting public comment on these non-substantive changes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-27819
Type: Notice
Date: 2020-12-18
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 Prevention Research Centers (PRC) National Program Evaluation Reporting System (PERS). The purposes of the information collection system are to monitor progress on PRC program inputs, activities, outputs, and outcomes; support program management, evaluation, and improvement; facilitate internal and external reporting; and demonstrate accountability for Congressional funding. CDC has received and incorporated feedback from PRCs on the current version of PERS.
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