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

Results 151 - 200 of 270
Intent To Award One Single-Source Supplement for Current Senior Medicare Patrol National Resource Center (SMPNRC) Grantee
Document Number: 2021-15023
Type: Notice
Date: 2021-07-15
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award one administrative supplement in the form of cooperative agreement to existing SMP National Resource Center (SMPNRC) grantee to support the expansion and enhancement of virtual capacity for the SMP program. This effort will benefit the SMPNRC, and the 54 SMP project grantees which are located in each state, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. The purpose of the existing SMPNRC grantee's work is to support SMP projects nationally in empowering and assisting Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education. As a result of the COVID-19 pandemic and related travel and congregation limitations and public health concerns, it has been identified that focus on expansion of virtual capacity is crucial at this time. The administrative supplement to the SMNPRC for FY 2021 will be distributed according to identified need and will total $405,312.
Intent To Award 54 Single-Source Supplements for Current Senior Medicare Patrol (SMP) State Grantees
Document Number: 2021-15022
Type: Notice
Date: 2021-07-15
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award 54 administrative supplements in the form of cooperative agreements to existing SMP project grantees to support the expansion and enhancement of virtual capacity of the program. This effort will benefit the SMP programs in each state, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. The purpose of existing grantees' work is to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education with an emphasis on reaching Medicare beneficiaries with limited income and those residing in rural areas. As a result of the COVID-19 pandemic and related travel and congregation limitations and public health concerns, it has been identified that focus on expansion of virtual capacity is crucial at this time. The administrative supplements for FY 2021 will be distributed at a flat rate of $18,000 to each of the existing 54 state grantees, bringing the total for the supplement awards to $972,000.
Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
Document Number: 2021-15072
Type: Rule
Date: 2021-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle. This action is in response to a food additive petition filed by Adisseo France S.A.S.
Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
Document Number: 2021-15070
Type: Rule
Date: 2021-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds. This action is in response to a food additive petition filed by Alzchem Trostberg GmbH.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-15005
Type: Notice
Date: 2021-07-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Friday, July 9, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request.'' That notice invited public comments on three separate information collection requests specific to document identifiers: CMS-10215, CMS- 10249, and CMS-10341. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled ``Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428.'' Form number CMS-10341 (OMB control number 0938-1162). The withdrawn information collection request will be replaced by another 30-day notice in July or August of this year.
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs; Guidance for Industry; Availability
Document Number: 2021-14938
Type: Notice
Date: 2021-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of final guidance for industry (GFI) #261 entitled ``Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.'' This guidance is intended for sponsors and potential sponsors who may be interested in pursuing conditional approval of new animal drugs for certain major uses in major species. Eligibility for conditional approval has been expanded beyond minor uses in major species and use in minor species (MUMS) to include certain major uses in major species. The Center for Veterinary Medicine (CVM or we) refers to the process for conditionally approving new animal drugs that are not intended for MUMS indications as ``expanded conditional approval.'' The purpose of expanded conditional approval is to incentivize development of new animal drugs for serious or life-threatening conditions or unmet animal or human health needs under circumstances where a demonstration of effectiveness would require a complex or particularly difficult study or studies. This guidance defines certain terms, clarifies the eligibility criteria for expanded conditional approval, and describes the criteria CVM intends to consider when determining expanded conditional approval eligibility.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Conference Attendees' Observations About Prescription Drug Promotion
Document Number: 2021-14936
Type: Notice
Date: 2021-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Determination That STROMECTOL (Ivermectin) Tablets, 6 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-14935
Type: Notice
Date: 2021-07-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that STROMECTOL (ivermectin) tablets, 6 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for STROMECTOL (ivermectin) tablets, 6 mg, if all other legal and regulatory requirements are met.
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-14931
Type: Notice
Date: 2021-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-14930
Type: Notice
Date: 2021-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Approaches to Effective Therapeutic Management of Pain for People With Sickle Cell Disease
Document Number: 2021-14921
Type: Notice
Date: 2021-07-14
Agency: Department of Health and Human Services, National Institutes of Health
This NCCIH/NHLBI-led Trans-NIH workshop on Sickle Cell Disease Pain aims to explore critical gaps and research challenges, as well as to brainstorm potential solutions for this understudied pain condition in a highly underserved population. This fits into the NIH mission of seeking fundamental knowledge to enhance health.
National Eye Institute; Notice of Closed Meeting
Document Number: 2021-14920
Type: Notice
Date: 2021-07-14
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2021-14894
Type: Notice
Date: 2021-07-14
Agency: Department of Health and Human Services, National Institutes of Health
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2021-14866
Type: Notice
Date: 2021-07-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is requesting that this information collection request (ICR), for revisions to the form CMS-2567 be processed under the emergency Paperwork Reduction Act of 1995 (PRA) clearance process.
Announcement of the Advisory Panel on Outreach and Education (APOE) July 28, 2021 Virtual Meeting
Document Number: 2021-14830
Type: Notice
Date: 2021-07-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-14820
Type: Notice
Date: 2021-07-13
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Advanced Nursing Education Program Specific Form OMB No. 0915-0375-Revision
Document Number: 2021-14804
Type: Notice
Date: 2021-07-13
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.
Draft-Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report
Document Number: 2021-14801
Type: Notice
Date: 2021-07-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of a draft technical report entitled Approaches to Developing Occupational Exposure Limits or Bands for Engineered Nanomaterials: User Guide and Technical Report now available for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2021-0067 in the search field and click ``Search.''
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Document Number: 2021-14779
Type: Notice
Date: 2021-07-13
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 material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that STRATAGRAFT (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagendsat), manufactured by Stratatech, a Mallinckrodt Company, meets the criteria for a priority review voucher.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
Document Number: 2021-14768
Type: Notice
Date: 2021-07-13
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 information collection associated with medical device labeling regulations.
Requirements Related to Surprise Billing; Part I
Document Number: 2021-14379
Type: Rule
Date: 2021-07-13
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules amend and add provisions to existing rules under the Internal Revenue Code, the Employee Retirement Income Security Act, the Public Health Service Act, and the Federal Employees Health Benefits Act. These interim final rules implement provisions of the No Surprises Act that protect participants, beneficiaries, and enrollees in group health plans and group and individual health insurance coverage from surprise medical bills when they receive emergency services, non-emergency services from nonparticipating providers at participating facilities, and air ambulance services from nonparticipating providers of air ambulance services, under certain circumstances. In this rulemaking, the Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage. HHS is also issuing in this rulemaking additional interim final rules that apply to emergency departments of hospitals and independent freestanding emergency departments, health care providers and facilities, and providers of air ambulance services related to the protections against surprise billing. The Office of Personnel Management (OPM) is issuing in this rulemaking interim final rules that specify how certain provisions of the No Surprises Act apply to health benefits plans offered by carriers under the Federal Employees Health Benefits Act (FEHBA).
Food and Drug Administration Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for Food and Drug Administration Staff; Availability
Document Number: 2021-14789
Type: Notice
Date: 2021-07-12
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 FDA staff entitled ``FDA Oversight of Food Products Covered by Systems Recognition Arrangements.'' This draft guidance provides recommendations related to the FDA's regulatory oversight activities for food products imported from countries whose food safety systems the FDA has recognized in Systems Recognition Arrangements (SRAs).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14754
Type: Notice
Date: 2021-07-12
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 Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT), which collects information from people testing for HIV in order to compare the performance characteristics of new point of care HIV tests for detection of early HIV infection and to identify behavioral and clinical predictors of early HIV infection.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14753
Type: Notice
Date: 2021-07-12
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 Energy Employees Occupational Illness Compensation Program Act (EEOICPA) Dose Reconstruction Interviews and Forms. This data collection permits claimants under EEOICPA to provide information potentially useful in reconstructing radiation doses, and to confirm that they have no further information to submit.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-14752
Type: Notice
Date: 2021-07-12
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 Using Real-time Prescription and Insurance Claims Data to Support the HIV Care Continuum. This proposed collection will collect data to evaluate the efficacy of using administrative insurance and prescription claims (billing) data to identify and intervene upon persons with HIV who fail to fill antiretroviral (ARV) prescriptions.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-14751
Type: Notice
Date: 2021-07-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2021-14739
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-14738
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2021-14737
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of Intent To Issue One Operating Division (OPDIV)-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Alien Children, HHS-2017-ACF-ORR-ZU-1132
Document Number: 2021-14722
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS HHS, San Antonio, Texas in the amount of up to $475,868,102. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of UAC at the Southwest Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for UAC referred to its care by the Department of Homeland Security. To ensure sufficient capacity to provide shelter to UAC referred to HHS, ORR is requesting that BCFS HHS continue the use of up to 1008 hard-sided beds at Carrizo Springs, Texas.
Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction
Document Number: 2021-14717
Type: Notice
Date: 2021-07-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 2, 2019. The document announced the withdrawal of approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants, effective January 2, 2020. The document erroneously included ANDA 076709 for Fentanyl Extended-Release Film, 25 micrograms (mcg)/hour (hr), 50 mcg/hr, 75 mcg/hr, 100 mcg/hr, held by Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt Lake City, UT 84108, and ANDA 077062 for Fentanyl Extended-Release Film, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr, held by Mayne Pharma LLC, 1240 Sugg Parkway, Greenville, NC 27834. This correction is being made because FDA previously withdrew the approval of ANDAs 076709 and 077062 in the Federal Register of November 18, 2019. This notice corrects that error.
Meeting of the COVID-19 Health Equity Task Force
Document Number: 2021-14703
Type: Notice
Date: 2021-07-12
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 July 30, 2021. The purpose of this meeting is to consider interim recommendations addressing future pandemic preparedness, mitigation, and resilience needed to ensure equitable response and recovery in communities of color and other underserved populations. 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.
Prospective Grant of an Exclusive Patent License: Oligonucleotides Analogues Targeting Human LMNA “lamin A” Gene
Document Number: 2021-14702
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
The National Human Genome Research Institute (NHGRI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive, Sublicensable Patent License to consolidate co-owned rights to the inventions and the Patents and Patent Applications listed in the Supplementary Information section of this notice to The Progeria Research Foundation (``PRF''), having a place of business in 200 Lake Street, Unit 102, Peabody, MA 01960.
Agency Information Collection Activities; Proposed Collection; Comment Request; Evidence Based Program Fidelity Surveys
Document Number: 2021-14700
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 information collection requirements relating to a Grantee Survey and a Local Implementation Organization Survey that will be used by ACL to evaluate the fidelity with which ACL and its grantee organizations, under the Older Americans Act, implement the required evidence-based programs.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2021-14699
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-14698
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-14697
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
Notice To Announce Request for Information (RFI) Inviting Input on the ICCFASD 2022-2026 Strategic Plan Outline
Document Number: 2021-14689
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD) is developing an updated strategic plan to guide its efforts over the next five years. As sponsor and chair of the ICCFASD, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) will be issuing a Request for Information to seek comments on the draft outline of the ICCFASD's 2022-2026 Strategic Plan from diverse stakeholders, including scientific experts, health care providers, patients and family members, advocacy groups, other federal agencies, and non-governmental scientific, professional, and healthcare organizations.
Solicitation of Nominations for Appointment to the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT)
Document Number: 2021-14686
Type: Notice
Date: 2021-07-12
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 CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). The CHACHSPT consists of 18 experts in fields associated with public health; epidemiology; laboratory practice; immunology; infectious diseases; drug abuse; behavioral science; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing, who are selected by the Secretary of the U.S. Department of Health and Human Services (HHS).
Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2021-14685
Type: Notice
Date: 2021-07-12
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 meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, limited only by the space available. The are 200 spaces for the audio conference and computer lines combined. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining a teleconference line and/or computer connection (information below).
Prospective Grant of an Exclusive Patent License: RP2 AAV-Based Gene Human Therapy for Ocular Diseases and Disorders Including XLRP
Document Number: 2021-14682
Type: Notice
Date: 2021-07-12
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 PTC Therapeutics GT, Inc. located in 100 Corporate, Middlesex Business Center, South Plainfield, NJ 07080.
Prospective Grant of an Exclusive Patent License: High ASS1 Expressing Tumors Embody a Purine Rich Genomic Signature and Sensitivity to Purine Depletion
Document Number: 2021-14681
Type: Notice
Date: 2021-07-12
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute (NCI), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to Yeda Research & Development Co, Ltd (``YEDA''), the technology transfer company of the Weizmann Institute of Science, a non-profit research institution located in Rehovot, Israel for NCI's rights to the patent applications listed in the Supplementary Information section of this notice.
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
Document Number: 2021-14678
Type: Rule
Date: 2021-07-12
Agency: Food and Drug Administration, Department of Health and Human Services
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is July 13, 2022.
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability
Document Number: 2021-14674
Type: Notice
Date: 2021-07-12
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 revised final guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised).'' This is a revision to the third edition of this final guidance, which issued in February 2021, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled ``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements'' to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14671
Type: Notice
Date: 2021-07-09
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
Document Number: 2021-14655
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; AJOVY
Document Number: 2021-14652
Type: Notice
Date: 2021-07-09
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 AJOVY 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 biological product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificates
Document Number: 2021-14650
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation; Withdrawal
Document Number: 2021-14637
Type: Notice
Date: 2021-07-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Department of Health and Human Services (Department or HHS) is announcing the withdrawal of a notice published in the Federal Register on January 21, 2021, entitled ``Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.'' HHS also withdraws the requests for proposals issued on its website on September 24, 2020, and revised on January 13, 2021, and ends the period for submission of proposals in response to the requests for proposals.