Department of Health and Human Services July 2, 2021 – Federal Register Recent Federal Regulation Documents

National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2021-14238
Type: Notice
Date: 2021-07-02
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is a virtual meeting and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14227
Type: Notice
Date: 2021-07-02
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14226
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14225
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14224
Type: Notice
Date: 2021-07-02
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 Performance Monitoring of CDC's Core State Injury Prevention Program. The proposed study is designed to collect performance monitoring data, via a web-based tool, from recipients funded under the Core State Injury Prevention Program cooperative agreement (Core SIPP).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14223
Type: Notice
Date: 2021-07-02
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 proposal to allow CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Division of Adolescent and School Health (DASH) to conduct a research information collection project titled ``Teen and Parents Surveys of Health (TAPS)''. This project serves to inform the CDC's Division of Adolescent and School Health's (DASH) key school- based programmatic strategies of improving family- and school-level protective factors, bolstering health education, and increasing adolescent access to quality health services.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-14222
Type: Notice
Date: 2021-07-02
Agency: Department of Health and Human Services, National Institutes of Health
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-14212
Type: Notice
Date: 2021-07-02
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 Circulatory System 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.
Center for State, Tribal, Local, and Territorial Support (CSTLTS), CDC/ATSDR Tribal Consultation Session
Document Number: 2021-14205
Type: Notice
Date: 2021-07-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC)/Agency for Toxic Substances and Disease Registry (ATSDR), announces the 2021 CDC/ATSDR Tribal Consultation Session. CDC/ATSDR will host American Indian and Alaska Native (AI/AN) Federally Recognized Tribes for the virtual tribal consultation session. The proceedings will be open to the public.
Solicitation of Nominations for Appointment to the Advisory Board on Radiation and Worker Health for the Energy Employees Occupational Illness Compensation Program Act of 2000
Document Number: 2021-14204
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the Advisory Board on Radiation and Worker Health (ABRWH) for the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). The ABRWH consists of not more than 20 members appointed by the President of the United States, and shall reflect a balance of scientific, medical, and worker perspectives. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the ABRWH's objectives. Nominees will be appointed based on their demonstrated qualifications, professional experience, and knowledge of issues the ABRWH may be asked to consider. Federal employees will not be considered for membership.
Advisory Committee on Immunization Practices (ACIP); Amended Notice of Meeting
Document Number: 2021-14203
Type: Notice
Date: 2021-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2021-14202
Type: Notice
Date: 2021-07-02
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 ``Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications.'' Transdermal delivery systems are designed to deliver a drug across the skin and into systemic circulation, whereas topical delivery systems are designed to deliver the drug to local tissue. There is pharmaceutical and other stakeholder interest in the development of new transdermal and topical products, and this guidance provides recommendations on the clinical assessment of adhesion for such products that will be submitted as new drug applications (NDAs) or supplemental new drug applications. This guidance provides additional study design and methodology recommendations on conducting in vivo adhesion studies. This guidance takes these developments into consideration. When final, this draft guidance will expand upon the recommendation for in vivo adhesion studies in section V., Special Topics, subsection A., Product Adhesion Considerations, in the draft guidance for industry Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations issued on November 21, 2019.
Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry; Availability
Document Number: 2021-14201
Type: Notice
Date: 2021-07-02
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 ``Providing Regulatory Submissions in Alternate Electronic Format.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress granted FDA the authority to implement the statutory electronic submission requirements in guidance. In response, FDA implemented binding guidance requiring that new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) be submitted to the Agency in electronic common technical document format. Recognizing that some submissions are exempt from this requirement and that waivers of the requirement may be granted on a case-by-case basis, the Agency is issuing this guidance to provide recommendations on an alternate electronic format for submissions covered under such exemptions and waivers. This guidance replaces the draft guidance of the same title issued on March 11, 2020.
Evaluating Cancer Drugs in Patients With Central Nervous System Metastases; Guidance for Industry; Availability
Document Number: 2021-14194
Type: Notice
Date: 2021-07-02
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 ``Evaluating Cancer Drugs in Patients with Central Nervous System Metastases; Guidance for Industry.'' The guidance document provides recommendations regarding the design of clinical trials of drugs and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. The guidance includes study design recommendations regarding the patient population, available therapy, prior therapies, assessment of CNS disease, study endpoints, and leptomeningeal disease. The guidance announced in this notice finalizes the draft guidance of the same title dated August 2020.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2021-14191
Type: Notice
Date: 2021-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RYPLAZIM (plasminogen, human-tvmh), manufactured by Prometic Bioproduction, Inc., meets the criteria for a priority review voucher.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-14173
Type: Notice
Date: 2021-07-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-14162
Type: Notice
Date: 2021-07-02
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; Assessing the Implementation and Cost of High-Quality Early Care and Education: Field Test, OMB 0970-0499
Document Number: 2021-14148
Type: Notice
Date: 2021-07-02
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 to collect new information to use in testing measures of the implementation and costs of high-quality early care and education as part of the project, Assessing the Implementation and Cost of High-Quality Early Care and Education (ECE-ICHQ). The study received approval for a field test to validate and improve the psychometric properties of these measures in November 2019. This request is to add a measure to the approved field test to help further assess the associations between measures of implementation, cost, and quality.