Meeting of the COVID-19 Health Equity Task Force, 36562-36563 [2021-14703]

Download as PDF 36562 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices the Eastern District of Texas.1 On May 8, 2020, the Court granted a joint motion to govern proceedings in that case and postpone the effective date of the final rule by 120 days.2 On December 2, 2020, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days.3 On March 2, 2021, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days.4 On May 21, 2021, the same Court granted a new motion by Plaintiffs in the same case to postpone the effective date of the final rule by an additional 90 days.5 The new effective date of the final rule is July 13, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date of the final rule is similarly postponed, and those obligations and deadlines are now tied to the postponed effective date. As such, 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 September 13, 2021. FDA is issuing this guidance consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA regarding the submission of plans for cigarette packages and cigarette advertisements. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of khammond on DSKJM1Z7X2PROD with NOTICES 1 R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20–cv– 00176 (E.D. Tex. filed April 3, 2020). 2 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. May 8, 2020) (order granting joint motion and establishing schedule), Doc. No. 33. 3 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. December 2, 2020) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 80. 4 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. March 2, 2021) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 89. 5 R.J. Reynolds Tobacco Co. et al., No. 6:20–cv– 00176 (E.D. Tex. May 21, 2021) (order granting Plaintiffs’ motion and postponing effective date), Doc. No. 91. VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 information are subject to review by OMB under the PRA. The collections of information in 21 CFR 1141.10 have been approved under 0910–0877. III. Electronic Access Persons with access to the internet may obtain an electronic version of the guidance at https:// www.regulations.gov, https:// www.fda.gov/tobacco-products/ products-guidance-regulations/rulesregulations-and-guidance, and https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents. Dated: June 24, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14674 Filed 7–9–21; 8:45 am] Silver Spring, MD 20993–0002, 240– 402–6980, Martha.Nguyen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, December 2, 2019, 84 FR 65986, appearing on page 65986 in FR Doc. 2019–25946, the following correction is made: On page 65986, in the table, the entries for ANDAs 076709 and 077062 are removed. Dated: July 6, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021–14717 Filed 7–9–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–4590] Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. 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 ExtendedRelease 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. FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1676, SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Meeting of the COVID–19 Health Equity Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: 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. SUMMARY: The Task Force meeting will be held on Friday, July 30, 2021, from 2 p.m. to approximately 6 p.m. ET (date and time are tentative and subject to change). The confirmed time and agenda will be posted on the COVID–19 Health Equity Task Force web page: www.minorityhealth.hhs.gov/ healthequitytaskforce/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: Samuel Wu, Designated Federal Officer for the Task Force; Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 100, Rockville, DATES: E:\FR\FM\12JYN1.SGM 12JYN1 Federal Register / Vol. 86, No. 130 / Monday, July 12, 2021 / Notices Maryland 20852. Phone: 240–453–6173; email: COVID19HETF@hhs.gov. SUPPLEMENTARY INFORMATION: Background: The COVID–19 Health Equity Task Force (Task Force) was established by Executive Order 13995, dated January 21, 2021. The Task Force is tasked with providing specific recommendations to the President, through the Coordinator of the COVID– 19 Response and Counselor to the President (COVID–19 Response Coordinator), for mitigating the health inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequities in the future. The Task Force shall submit a final report to the COVID–19 Response Coordinator addressing any ongoing health inequities faced by COVID–19 survivors that may merit a public health response, describing the factors that contributed to disparities in COVID–19 outcomes, and recommending actions to combat such disparities in future pandemic responses. The meeting is open to the public and will be live-streamed at www.hhs.gov/ live. No registration is required. A public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register, please send an email to COVID19HETF@hhs.gov and include your name, title, and organization by close of business on Friday, July 23, 2021. Comments will be limited to no more than three minutes per speaker Dated: July 6, 2021. Samuel Wu, Designated Federal Officer, COVID–19 Health Equity Task Force. [FR Doc. 2021–14703 Filed 7–9–21; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Oligonucleotides Analogues Targeting Human LMNA ‘‘lamin A’’ Gene AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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. SUMMARY: Only written comments and/or applications for a license that are received by the NHGRI Office of Technology Transfer Office on or before July 27, 2021 will be considered. DATES: Requests for a copy of the patent application(s), inquiries, and comments relating to the contemplated license should be directed to: Eggerton Campbell, License and Patent Manager, NHGRI Technology Transfer Office, Telephone: 301–402–1648; email: eggerton.campbell@nih.gov. ADDRESSES: The following and all continuing U.S. and foreign patents/patent applications thereof are the intellectual properties to be licensed under the prospective agreement: SUPPLEMENTARY INFORMATION: Country Title United States ......... Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–US–01. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–PCT–03. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–GB–12. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–US–02. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–US–06. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–US–07. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–EP–04. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–JP–15. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–FR–11. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–DE–10. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–IE–13. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–JP–05. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–JP–08. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–NL–14. Methods For Treating Progeroid Laminopathies Using Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–0–CH–09. Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–US–01 ...................................... Oligonucleotide Analogues Targeting Human LMNA NIH E–044–2013–1–PCT–02 .................................... WIPO ..................... United Kingdom ..... United States ......... United States ......... United States ......... Europe ................... Japan ..................... France .................... Germany ................ Ireland .................... Japan ..................... khammond on DSKJM1Z7X2PROD with NOTICES and should be pertinent to the meeting discussion. Individuals are encouraged to provide a written statement of any public comment(s) for accurate minutetaking purposes. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing COVID19HETF@hhs.gov no later than close of business on Thursday, August 5, 2021. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact: COVID19HETF@hhs.gov and reference this meeting. Requests for special accommodations should be made at least 10 business days prior to the meeting. Japan ..................... Netherlands ............ Switzerland ............ United States ......... WIPO ..................... VerDate Sep<11>2014 17:26 Jul 09, 2021 Jkt 253001 PO 00000 Frm 00042 Fmt 4703 Application No. Sfmt 4703 36563 E:\FR\FM\12JYN1.SGM 12JYN1 Patent No. 61/568,590. PCT/US12/068609 WO 2013/086444. 12806796.4 .......... 2788488 13/708,709 ........... 9,326,992 15/084,255 ........... 9,833,468 15/727,483 CON .. 10,398,721 12806796.4 .......... 2788488 2019–109410. 12806796.4 .......... 2788488 12806796.4 .......... 2788488 12806796.4 .......... 2788488 2014–546152 ....... 6132849 2017–41744. 12806796.4 .......... 2788488 12806796.4 .......... 2788488 62/330,027. PCT/US17/30174 WO 2017/190041.

Agencies

[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36562-36563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the COVID-19 Health Equity Task Force

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

ACTION: Notice of meeting.

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SUMMARY: 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.

DATES: The Task Force meeting will be held on Friday, July 30, 2021, 
from 2 p.m. to approximately 6 p.m. ET (date and time are tentative and 
subject to change). The confirmed time and agenda will be posted on the 
COVID-19 Health Equity Task Force web page: www.minorityhealth.hhs.gov/healthequitytaskforce/ when this information becomes available.

FOR FURTHER INFORMATION CONTACT: Samuel Wu, Designated Federal Officer 
for the Task Force; Office of Minority Health, Department of Health and 
Human Services, Tower Building, 1101 Wootton Parkway, Suite 100, 
Rockville,

[[Page 36563]]

Maryland 20852. Phone: 240-453-6173; email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Background: The COVID-19 Health Equity Task Force (Task Force) was 
established by Executive Order 13995, dated January 21, 2021. The Task 
Force is tasked with providing specific recommendations to the 
President, through the Coordinator of the COVID-19 Response and 
Counselor to the President (COVID-19 Response Coordinator), for 
mitigating the health inequities caused or exacerbated by the COVID-19 
pandemic and for preventing such inequities in the future. The Task 
Force shall submit a final report to the COVID-19 Response Coordinator 
addressing any ongoing health inequities faced by COVID-19 survivors 
that may merit a public health response, describing the factors that 
contributed to disparities in COVID-19 outcomes, and recommending 
actions to combat such disparities in future pandemic responses.
    The meeting is open to the public and will be live-streamed at 
www.hhs.gov/live. No registration is required. A public comment session 
will be held during the meeting. Pre-registration is required to 
provide public comment during the meeting. To pre-register, please send 
an email to [email protected] and include your name, title, and 
organization by close of business on Friday, July 23, 2021. Comments 
will be limited to no more than three minutes per speaker and should be 
pertinent to the meeting discussion. Individuals are encouraged to 
provide a written statement of any public comment(s) for accurate 
minute-taking purposes. If you decide you would like to provide public 
comment but do not pre-register, you may submit your written statement 
by emailing [email protected] no later than close of business on 
Thursday, August 5, 2021. Individuals who plan to attend and need 
special assistance, such as sign language interpretation or other 
reasonable accommodations, should contact: [email protected] and 
reference this meeting. Requests for special accommodations should be 
made at least 10 business days prior to the meeting.

    Dated: July 6, 2021.
Samuel Wu,
Designated Federal Officer, COVID-19 Health Equity Task Force.
[FR Doc. 2021-14703 Filed 7-9-21; 8:45 am]
BILLING CODE 4150-29-P
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