Center for Scientific Review; Notice of Closed Meetings, 59405-59406 [2021-23382]

Download as PDF Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices an approved drug from sale under § 314.81(b)(3)(iii). We estimate 1,000 firms will expend 40 hours to prepare, review, and approve a standard operating procedure (SOP), for a total of 40,000 hours annually. Although we expect most respondents will have already prepared and implemented an SOP for the electronic submission of drug establishment registration and drug listing information, we retain an estimate for new firms that will do so, as recommended in the guidance. Finally, we estimate 12,800 respondents are now subject to the reporting provisions introduced by the CARES Act under section 3112(e), and assume it will take 15 minutes to prepare and submit the requisite information, as shown in our 60-day notice. However, we have reduced this figure by 1,780 to 11,020 to reflect proposed reporting exemptions pertaining to: (1) Blood and blood components for transfusion and (2) cell and gene therapy products, where one lot treats a single patient. Consistent with section 510(j)(3)(B) of the FD&C Act, we have proposed to exempt these biological product categories from the reporting requirements in section 510(j)(3)(A) of the FD&C Act. If our proposed order is not finalized, we will adjust our estimate accordingly upon reevaluation of the information collection. Overall, the information collection reflects an increase which we attribute to the new reporting required by section 510(j) of the FD&C Act, as amended by the CARES Act. We have otherwise retained the currently approved burden estimates for the provisions in part 207. Dated: October 21, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23395 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–0026] lotter on DSK11XQN23PROD with NOTICES1 Issuance of Priority Review Voucher; Rare Pediatric Disease Product AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease SUMMARY: VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Myrna Hanna, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that RETHYMIC (allogeneic processed thymus tissue-agdc), manufactured by Enzyvant Therapeutics, GmbH, meets the criteria for a priority review voucher. RETHYMIC (allogeneic processed thymus tissue-agdc) is indicated for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC (allogeneic processed thymus tissue-agdc) is not indicated for the treatment of patients with severe combined immunodeficiency (SCID). For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/industry/ developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For further information about RETHYMIC (allogeneic processed thymus tissueagdc), go to the Center for Biologics Evaluation and Research Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-bloodbiologics/cellular-gene-therapyproducts/approved-cellular-and-genetherapy-products. SUPPLEMENTARY INFORMATION: Dated: October 19, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–23336 Filed 10–26–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 59405 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: In Toxicology, Pharmacology and Hepatology. Date: December 2, 2021. Time: 9:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Santanu Banerjee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301) 435–5947, banerjees5@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Special Topics in Nephrology and Urology. Date: December 2, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Stacey Nicole Williams, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301–867–5309, stacey.williams@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Genomics. Date: December 2, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jian Cao, M.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Room 4196, MSC 7844, Bethesda, MD 20892, (301) 827–5902, caojn@csr.nih.gov. E:\FR\FM\27OCN1.SGM 27OCN1 59406 Federal Register / Vol. 86, No. 205 / Wednesday, October 27, 2021 / Notices Name of Committee: Center for Scientific Review Special Emphasis Panel; Pain Management and Substance Use Disorder Research. Date: December 2, 2021. Time: 2:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Abu Saleh Mohammad Abdullah, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1003–L, Bethesda, MD 20892, (301) 827–4043, abuabdullah.abdullah@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 22, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–23382 Filed 10–26–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings lotter on DSK11XQN23PROD with NOTICES1 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Workforce Diversity in Basic Cancer Research. Date: November 30, 2021. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301–495– 1718, jakobir@mail.nih.gov. VerDate Sep<11>2014 16:47 Oct 26, 2021 Jkt 256001 Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Infectious Diseases and Immunology Panel C. Date: December 1–2, 2021. Time: 10:00 a.m. to 8:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kumud Singh, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301–761–7830, kumud.singh@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Sleep, Circadian Rhythms, Glucose Regulation, and Cognition. Date: December 1, 2021. Time: 1:00 p.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Janita N. Turchi, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 402–4005, turchij@mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cancer Prevention and Immunotherapy. Date: December 1, 2021. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Laura Asnaghi, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Room 6200, MSC 7804, Bethesda, MD 20892, (301) 443–1196, laura.asnaghi@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 22, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–23383 Filed 10–26–21; 8:45 am] meeting of the National Advisory Environmental Health Sciences Council. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Special Open Session of the National Advisory Environmental Health Sciences Council. Date: November 29, 2021. Time: 3:30 p.m. to 5:00 p.m. Agenda: Concept: Climate Change and Health Initiative. Place: National Institute of Environmental Health Science, Research Triangle Park, NC, https://www.niehs.nih.gov/news/webcasts/ (Virtual Meeting). Contact Person: J. Patrick Mastin, Ph.D., Deputy Division Director, Division of Extramural Research and Training, National Institute of Environmental Health Science, Research Triangle Park, NC 27709, (984) 287– 3285, mastin@niehs.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute’s/Center’s home page: https:// www.niehs.nih.gov/about/boards/naehsc/ index.cfm, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: October 21, 2021. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–23371 Filed 10–26–21; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HOMELAND SECURITY National Institutes of Health U.S. Customs and Border Protection National Institute of Environmental Health Sciences; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 [1651–0127] Guarantee of Payment U.S. Customs and Border Protection (CBP), Department of Homeland Security. AGENCY: E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[Federal Register Volume 86, Number 205 (Wednesday, October 27, 2021)]
[Notices]
[Pages 59405-59406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23382]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meetings.
    The meetings will be closed to the public in accordance with the 
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: In Toxicology, Pharmacology and Hepatology.
    Date: December 2, 2021.
    Time: 9:00 a.m. to 7:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Santanu Banerjee, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 2106, Bethesda, MD 20892, (301) 
435-5947, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Special Topics in Nephrology and Urology.
    Date: December 2, 2021.
    Time: 9:00 a.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Stacey Nicole Williams, Ph.D., Scientific Review 
Officer, Center for Scientific Review, 6701 Rockledge Drive, 
Bethesda, MD 20892, 301-867-5309, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Member Conflict: Cancer Genomics.
    Date: December 2, 2021.
    Time: 10:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Jian Cao, M.D., Scientific Review Officer, 
Center for Scientific Review, 6701 Rockledge Drive, Room 4196, MSC 
7844, Bethesda, MD 20892, (301) 827-5902, [email protected].


[[Page 59406]]


    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; Pain Management and Substance Use Disorder Research.
    Date: December 2, 2021.
    Time: 2:00 p.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Abu Saleh Mohammad Abdullah, Ph.D., Scientific 
Review Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 1003-L, Bethesda, MD 20892, (301) 
827-4043, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.306, 
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, 
National Institutes of Health, HHS)

    Dated: October 22, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-23382 Filed 10-26-21; 8:45 am]
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