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

Results 201 - 250 of 291
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cell Therapies for Cancer
Document Number: 2021-19604
Type: Notice
Date: 2021-09-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Athenex, Inc. (``Athenex'') headquartered in Buffalo, NY.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-19599
Type: Notice
Date: 2021-09-13
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.
Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care To Produce a Therapeutic Article
Document Number: 2021-18912
Type: Notice
Date: 2021-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is consolidating regulatory oversight responsibilities in the Center for Biologics Evaluation and Research (CBER) for certain devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by the Center for Devices and Radiological Health (CDRH) will be transferred to CBER for regulation. This action affects only center assignment.
Prospective Grant of Exclusive Patent License: Chimeric Live-Attenuated Vaccine for West Nile Virus (WNV)
Document Number: 2021-19566
Type: Notice
Date: 2021-09-10
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Blue Water Vaccines, Inc. (BWV), having a place of business in Cincinnati, Ohio, U.S.A.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19560
Type: Notice
Date: 2021-09-10
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: 2021-19559
Type: Notice
Date: 2021-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-19558
Type: Notice
Date: 2021-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Stakeholder Measures and Advocate Forms at the National Cancer Institute (NCI)
Document Number: 2021-19544
Type: Notice
Date: 2021-09-10
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: 2021-19534
Type: Notice
Date: 2021-09-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-19533
Type: Notice
Date: 2021-09-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
Document Number: 2021-19480
Type: Notice
Date: 2021-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 collection of information entitled ``Generic Clearance for Quantitative Testing for the Development of FDA Communications,'' which collects individual generic quantitative information (e.g., surveys, experimental studies) to test communications or educational messages on FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed while they are being developed or are in review.
Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy in an Evolving Opioid Crisis; Public Workshop; Request for Comments
Document Number: 2021-19437
Type: Notice
Date: 2021-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis.'' Convened by the Duke-Margolis Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS. We expect interested stakeholders to include healthcare providers, healthcare professional associations, pharmacists, pharmacy benefit managers, public and private insurers, patient organizations, Federal and State Agencies, providers of continuing education for healthcare professionals, and the public. A second public workshop is being planned to solicit input on additional issues associated with a move to mandatory prescriber education under a REMS, such as operational and technical issues related to such a system and what should be included in potential mandatory prescriber education.
Allergenic Products Advisory Committee; Notice of Meeting
Document Number: 2021-19436
Type: Notice
Date: 2021-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public.
S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2021-19410
Type: Notice
Date: 2021-09-09
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 ``S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. Considerations for interpretation and application of the BD data to support a nonclinical development program and inform the design of clinical trials are also provided. The recommendations in the guidance endeavour to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles. The draft guidance is intended to promote harmonization of recommendations for BD studies for investigational GT products and facilitate a more efficient and timely nonclinical development program.
Monaghan Mushrooms Ireland Unlimited Company; Filing of Food Additive Petition
Document Number: 2021-19409
Type: Proposed Rule
Date: 2021-09-09
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 Monaghan Mushrooms Ireland Unlimited Company, proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 mushroom powder produced by exposing dried and powdered edible cultivars of Agaricus bisporus to ultraviolet light.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-19408
Type: Notice
Date: 2021-09-09
Agency: Department of Health and Human Services, National Institutes of Health
Fermentalg; Filing of Color Additive Petition
Document Number: 2021-19405
Type: Proposed Rule
Date: 2021-09-09
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 Fermentalg, proposing that the color additive regulations be amended to provide for the safe use of blue Galdieria extract, derived from unicellular red algae (Galdieria sulphuraria), as a color additive in various food categories at levels consistent with good manufacturing practice.
International Council for Harmonisation Q12: Implementation Considerations for Food and Drug Administration-Regulated Products; Draft Guidance for Industry; Reopening of the Comment Period
Document Number: 2021-19403
Type: Notice
Date: 2021-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the draft guidance for industry entitled ``ICH Q12: Implementation Considerations for FDA-Regulated Products'' published in the Federal Register of May 20, 2021. FDA is reopening the comment period to allow interested persons additional time to submit comments.
Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use; Reopening of the Comment Period
Document Number: 2021-19402
Type: Notice
Date: 2021-09-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is reopening the comment period for public scoping on the environmental impact statement (EIS) described in the notice entitled ``Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use'' that appeared in the Federal Register of May 13, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-19476
Type: Notice
Date: 2021-09-08
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 on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2021-19466
Type: Notice
Date: 2021-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; ACF-196P, TANF Pandemic Emergency Assistance Fund (PEAF) Financial Report for States, Territories and Tribes (0970-0510)
Document Number: 2021-19459
Type: Notice
Date: 2021-09-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families' (ACF) Office of Family Assistance plans to submit a generic information collection (GenIC) request under the umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970-0510). This request includes a reporting form and associated instructions for financial information to be completed by grant recipients of Temporary Assistance for Needy Families (TANF) Pandemic Emergency Assistance Funding authorized by the American Rescue Plan Act of 2021.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: MCH Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906-0042, Extension
Document Number: 2021-19447
Type: Notice
Date: 2021-09-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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, or any other aspect of the ICR related to the Maternal and Child Health (MCH) Jurisdictional Survey that is to be administered in the U.S. territories and jurisdictions (excluding the District of Columbia) for purposes of collecting information related to the well-being of all mothers, children, and their families.
Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco Products Scientific Advisory Committee
Document Number: 2021-19444
Type: Notice
Date: 2021-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products. 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.
Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
Document Number: 2021-19382
Type: Rule
Date: 2021-09-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why we did not comply with the regular publication timeline.
Center for Drug Evaluation and Research Office of New Drugs Novel Excipient Review Pilot Program
Document Number: 2021-19335
Type: Notice
Date: 2021-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing a Novel Excipient Review Pilot Program (Pilot Program). The Pilot Program is voluntary and intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients.
Submission for OMB Review; Child Care Improper Payments Data Collection Instructions; (OMB #0970-0323)
Document Number: 2021-19299
Type: Notice
Date: 2021-09-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families is proposing revisions to an approved information collection Child Care Improper Payments Data Collection Instructions (OMB #0970-0323, expiration 10/ 31/2021). There are minor changes requested to the form.
Submission for OMB Review; 30-Day Comment Request; Evaluation of Office of Acquisitions System (OASYS) and FFRDC Contract Administration System (FCAS) Vendor Portals National Cancer Institute (NCI); Correction
Document Number: 2021-19281
Type: Notice
Date: 2021-09-08
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on August 31, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-19394
Type: Notice
Date: 2021-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products 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. FDA is establishing a docket for public comment on this document. Consistent with FDA's regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission of a request to supplement the approved Biologics License Application for COMIRNATY for administration of a third dose, or ``booster'' dose, of the COVID-19 vaccine, in individuals 16 years of age and older and the need for prompt discussion of such submission given the COVID-19 pandemic.
Proposed Collection; 60-Day Comment Request; The Genetic Testing Registry
Document Number: 2021-19384
Type: Notice
Date: 2021-09-07
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), Office of the Director (OD) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Proposed Collection; 60-Day Comment Request: Federal COVID Response-Audience Feedback To Inform Ongoing Messaging and Strategies for “Combat COVID”
Document Number: 2021-19383
Type: Notice
Date: 2021-09-07
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), Clinical Center (CC) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19365
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2021-19364
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-19354
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the COVID-19 Health Equity Task Force
Document Number: 2021-19322
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on September 30, 2021. The purpose of this meeting is to present and vote on the final recommendations for mitigating inequities caused or exacerbated by the COVID-19 pandemic and for preventing such inequities in the future. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/healthequitytaskforce/ prior to the meeting.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: DoNation General Workplace Campaign Scorecard, 0906-XXXX-New
Document Number: 2021-19313
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for the 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.
National Library of Medicine; Notice of Meetings, Amended Notice of Meeting
Document Number: 2021-19233
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-19229
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19228
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC)
Document Number: 2021-19224
Type: Notice
Date: 2021-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). A notice of this WTCHP STAC meeting has also been posted on the committee website at: https://www.cdc.gov/wtc/stac_meeting.html.
Solicitation of Nominations for Membership on the Lead Exposure and Prevention Advisory Committee (LEPAC)
Document Number: 2021-19222
Type: Notice
Date: 2021-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC is composed of 15 members that are Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals with expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devices
Document Number: 2021-19221
Type: Notice
Date: 2021-09-07
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 information collection associated with reclassification of medical devices.
Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment
Document Number: 2021-19220
Type: Rule
Date: 2021-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the biologics regulation to improve clarity and revise an incorrect citation. This action is being taken to ensure the accuracy and clarity of the biologics regulation.
Food and Drug Administration New Era of Smarter Food Safety Summit on E-Commerce; Public Meeting; Request for Comments
Document Number: 2021-19219
Type: Notice
Date: 2021-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a virtual public meeting entitled ``FDA New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers.'' The purpose of the public meeting is to engage with stakeholders and invite input on various topics pertaining to the implementation of Core Element 3.1 of the New Era of Smarter Food Safety Blueprint. We intend to use information resulting from the public meeting to determine what action(s), if any, should be taken to help ensure the safe production and delivery of human and animal foods sold through new e-commerce business models.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs
Document Number: 2021-19218
Type: Notice
Date: 2021-09-07
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 information collection associated with labeling requirements for prescription drugs.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction
Document Number: 2021-19216
Type: Notice
Date: 2021-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice entitled ``Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' The document announced a meeting of the Pediatric Advisory Committee. The document was published with the incorrect docket number and end time of the meeting. This document corrects those errors.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2021-19167
Type: Notice
Date: 2021-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice of a decision to designate a class of employees from the Savannah River Site in Aiken, South Carolina, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2021-19166
Type: Notice
Date: 2021-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from Superior Steel Company, in Carnegie, Pennsylvania, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-19163
Type: Notice
Date: 2021-09-07
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 Sudden Death in the Young (SDY). The goal of the SDY Case Registry is to improve and standardize the ascertainment of deaths so that funded jurisdictions can better understand the incidence and risk factors for sudden death in youth. Per CDC's cooperative agreement, respondents agree to compile a defined set of SDY information about a defined subset of child deaths through the jurisdiction/state's existing CDR program.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-19162
Type: Notice
Date: 2021-09-07
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 Data Collection Through Web Based Surveys for Evaluating Act Against AIDS Social Marketing Campaign Phases Targeting Consumers. This proposed information collection activity includes the use of web surveys to test campaign messaging.