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

Results 201 - 250 of 270
Proposed Collection; 30-Day Comment Request: Generic Clearance To Collect Stakeholder Feedback on the Research Domain Criteria (RDoC) Initiative, (NIMH)
Document Number: 2021-14630
Type: Notice
Date: 2021-07-09
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14617
Type: Notice
Date: 2021-07-09
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
Document Number: 2021-14250
Type: Proposed Rule
Date: 2021-07-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rulemaking also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rulemaking proposes to update requirements for the ESRD Quality Incentive Program (QIP), including a proposed measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) and as well as proposals to suppress individual ESRD QIP measures under that proposed measure suppression policy. This proposed rule also announces an extension of time for facilities to report September through December 2020 ESRD QIP data under our Extraordinary Circumstances Exception (ECE) policy due to CMS operational issues, and proposes to not score facilities or reduce payment to any facility in PY 2022. In addition, this proposed rule includes requests for information on topics that are relevant to the ESRD QIP. Further, this rule also proposes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries. Finally, this proposed rule includes several requests for information to inform payment reform under the ESRD PPS.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards; Correction
Document Number: 2021-14545
Type: Rule
Date: 2021-07-08
Agency: Department of Health and Human Services
This document corrects technical errors in the final rule that appeared in the May 5, 2021, Federal Register entitled, ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Manager Standards''.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-14531
Type: Notice
Date: 2021-07-08
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2021-14496
Type: Notice
Date: 2021-07-08
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 71st full Council meeting utilizing virtual technology on Tuesday, August 3-Wednesday, August 4, 2021 from 1:00-5:00 p.m. (ET) on both days. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Monday, July 26, 2021. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Wednesday, August 11, 2021. The meeting agenda will be posted on the PACHA page on HIV.gov at https://www.hiv.gov/federal-response/pacha/about-pacha prior to the meeting.
Determination of Regulatory Review Period for Purposes of Patent Extension; PIQRAY
Document Number: 2021-14490
Type: Notice
Date: 2021-07-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIQRAY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Zephyr Endobronchial Valve Implant
Document Number: 2021-14482
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zephyr Endobronchial Valve Implant and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEOVU
Document Number: 2021-14473
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BEOVU and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Biomin Holding GmbH; Filing of Food Additive Petition (Animal Use)
Document Number: 2021-14465
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Biomin Holding GmbH, proposing that the food additive regulations be amended to provide for the safe use of fumonisin esterase to degrade fumonisins in poultry feed.
Unique Device Identification System: Form and Content of the Unique Device Identifier; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2021-14462
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled ``Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI).'' This document describes the requirements for, and FDA's recommendations regarding, the form and content of the UDI to help ensure that the UDIs developed under systems for the issuance of UDIs meet the objectives of the Unique Device Identification System Final Rule.
Determination of Regulatory Review Period for Purposes of Patent Extension; BARHEMSYS
Document Number: 2021-14461
Type: Notice
Date: 2021-07-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BARHEMSYS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institutes of Health (NIH)
Document Number: 2021-14449
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; Request for Assistance for Child Victims of Human Trafficking
Document Number: 2021-14448
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office on Trafficking in Persons (OTIP) is requesting a three-year extension of the form: Request for Assistance (RFA) for Child Victims of Human Trafficking (OMB #0970-0362, expiration 07/31/2021). Minor revisions have been made to the form, including the addition of a few fields that will enable the OTIP Child Protection Specialist team to better understand the child's specific needs, connect the child to appropriate services, and help ensure the safety of the child.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14441
Type: Notice
Date: 2021-07-07
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 an information collection project titled National Quitline Data Warehouse. The National Quitline Data Warehouse (NQDW) collects a core set of information from all U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smoker's Quitline, regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14439
Type: Notice
Date: 2021-07-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14437
Type: Notice
Date: 2021-07-07
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 Muscular Dystrophy Surveillance, Tracking, and Research Network (MD STARnet) Muscular Dystrophy Questionnaire: Understanding the impact of COVID-19, flu, pain, fatigue, pregnancy and infertility, on adults with muscular dystrophy. The purpose of the proposed study is to describe the epidemiology of COVID-19 and flu and the experience with pain, fatigue, pregnancy, and infertility for adults living with muscular dystrophy who are identified through the Muscular Dystrophy Surveillance Tracking and Research Network (MD STARnet). Information will be used to develop interventions that improve the lives of people with muscular dystrophy and their families.
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: 2021-14436
Type: Notice
Date: 2021-07-07
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14434
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-14421
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Charter Renewal
Document Number: 2021-14420
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-14419
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14418
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14417
Type: Notice
Date: 2021-07-07
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: 2021-14416
Type: Notice
Date: 2021-07-07
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 Quarterly Performance Report, OMB No. 0906-0016, Revision
Document Number: 2021-14412
Type: Notice
Date: 2021-07-07
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.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2021-14408
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs) as of April 30, 2021. The lists are available on the shortage area topic page on HRSA's data.hrsa.gov website.
Basic Health Program; Federal Funding Methodology for Program Year 2022
Document Number: 2021-14393
Type: Rule
Date: 2021-07-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges, and incorporates the effects on such payment amounts the American Rescue Plan Act of 2021 (ARP).
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications
Document Number: 2021-14383
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Humans Services (HHS) provides notice of the extension of the designation issued on February 1, 2021, under Executive Order 13910 (Executive Order) and section 102 of the Defense Production Act of 1950 (the Act), as amended, designating health and medical resources necessary to respond to the spread of the virus associated with Coronavirus Disease 2019 (COVID-19) that are scarce or the supply of which would be threatened by excessive accumulation by people or entities not needing the excess supplies. These designated materials are subject to the hoarding prevention measures authorized under the Executive Order and the Act.
Office of the Director Notice of Charter Renewal
Document Number: 2021-14368
Type: Notice
Date: 2021-07-07
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Proposed Model Expansion; Home Health Quality Reporting Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; Inpatient Rehabilitation Facility Quality Reporting Program Requirements; and Long-Term Care Hospital Quality Reporting Program Requirements
Document Number: 2021-13763
Type: Proposed Rule
Date: 2021-07-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would set forth routine updates to the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also provides monitoring and analysis of the Patient-Driven Groupings Model (PDGM); solicits comments on a methodology for determining the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the PDGM case-mix adjustment methodology; and proposes to recalibrate the PDGM case-mix weights, functional levels, and comorbidity adjustment subgroups while maintaining the low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rulemaking proposes to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts; and make conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. This rulemaking also proposes changes to the Home Health Quality Reporting Program (QRP) to remove one measure, remove two claims-based measures and replace them with one claims-based measure, publicly report two measures, propose a modification to the effective date for the reporting of the Transfer of Health to Provider-Post Acute Care and Transfer of Health to Patient-Post Acute Care (TOH) measures and Standardized Patient Assessment Data Elements and requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements. Additionally, this proposed rule requests information on two topics: Advancing to digital quality measurement through the use of Fast Healthcare Interoperability Resources and our efforts surrounding closing the health equity gap. It also proposes modifications to the effective date for the reporting of TOH measures and certain Standardized Patient Assessment Data Elements in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this proposed rule would incorporate into regulation certain Medicare provider and supplier enrollment policies. In addition, this rulemaking proposes to make permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and would update the home health conditions of participation to implement Division CC, section 115 of the Consolidated Appropriations Act, 2021 (CAA 2021) regarding occupational therapists completing the initial and comprehensive assessments reflect these changes. This proposed rule also would expand the Home Health Value-Based Purchasing (HHVBP) Model, beginning January 1, 2022, to the 50 States, territories, and District of Columbia. This rulemaking also proposes to end the original HHVBP Model one year early for the home health agencies (HHAs) in the nine original Model States, such that CY 2020 performance data would not be used to calculate a payment adjustment for CY 2022 under the original Model. Additionally, this proposed rule establishes survey and enforcement requirements for hospice programs as set forth in Division CC, section 407, of the CAA 2021.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2021-14341
Type: Notice
Date: 2021-07-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Reallotment of FY 2021 Funds: Puerto Rico
Document Number: 2021-14314
Type: Notice
Date: 2021-07-06
Agency: Department of Health and Human Services
The Administration on Disabilities (AoD) intends to reallot funds under the authority of the Development Disabilities Assistance and Bill of Rights Act of 2000 which states: ``If the Secretary determines that an amount of an allotment to a State for a period (of a fiscal year or longer) will not be required by the State during the period for the purpose for which the allotment was made, the Secretary may reallot the amount.''
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2021-14283
Type: Notice
Date: 2021-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-14282
Type: Notice
Date: 2021-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-14281
Type: Notice
Date: 2021-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-14279
Type: Notice
Date: 2021-07-06
Agency: Department of Health and Human Services, National Institutes of Health
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.