Department of Health and Human Services July 12, 2021 – Federal Register Recent Federal Regulation Documents

Food and Drug Administration Oversight of Food Products Covered by Systems Recognition Arrangements; Draft Guidance for Food and Drug Administration Staff; Availability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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for FDA staff entitled ``FDA Oversight of Food Products Covered by Systems Recognition Arrangements.'' This draft guidance provides recommendations related to the FDA's regulatory oversight activities for food products imported from countries whose food safety systems the FDA has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.