National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 14898-14899 [2022-05559]

Download as PDF 14898 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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. SUPPLEMENTARY INFORMATION: jspears on DSK121TN23PROD with NOTICES1 I. Background FDA is announcing the availability of a draft guidance document entitled ‘‘Human Gene Therapy Products Incorporating Human Genome Editing; Draft Guidance for Industry.’’ The draft guidance document provides recommendations to sponsors developing human gene therapy products incorporating GE of human somatic cells. Specifically, the guidance provides recommendations regarding information that should be provided in an IND application in order to assess the safety and quality of the investigational GE product as required in 21 CFR 312.23. This includes information on product design, product manufacturing, product testing, preclinical safety assessment and clinical trial design. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of another human gene therapy draft guidance document entitled ‘‘Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Draft Guidance for Industry.’’ This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Human Gene Therapy Products Incorporating Human Genome Editing.’’ 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 VerDate Sep<11>2014 17:16 Mar 15, 2022 Jkt 256001 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 information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR parts 210 and 211 have been approved under OMB control number 0910–0073; the collections of information in 21 CFR part 1271 have been approved under OMB control number 0910–0543. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics/ biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/ or https://www.regulations.gov. Dated: March 10, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–05538 Filed 3–15–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; PAR19–319: NIDDK Central Repositories Non-renewable Sample Access (X01). Date: May 6, 2022. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Democracy II, 6707 Democracy Blvd., Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Najma S. Begum, Ph.D. Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health Room, 7349, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–8894, begumn@niddk.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 11, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–05562 Filed 3–15–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Characterization of Islet-derived Extracellular Vesicles for Improved Detection, Monitoring, Classification, and Treatment of Type 1 Diabetes Special Emphasis Panel. Date: April 6, 2022. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\16MRN1.SGM 16MRN1 Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Peter J. Kozel, Ph.D., Chief, Training and Mentored Research Section, Scientific Review Branch, Division of Extramural Activities, 6707 Democracy Blvd., Room 7009, Bethesda, MD 20892, kozelp@ mail.nih.gov, 301–594–4721. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 11, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–05559 Filed 3–15–22; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Mental Health Special Emphasis Panel, March 24, 2022, 9:00 a.m. to March 24, 2022, 5:00 p.m., National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD, 20852, which was published in the Federal Register on February 28, 2022, FR DOC 2022–04158, 87 FR 11080. This notice is being amended to change the date from March 24, 2022, to April 5, 2022. Meeting time and location remain the same. The meeting is closed to the public. Dated: March 11, 2022. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–05563 Filed 3–15–22; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health jspears on DSK121TN23PROD with NOTICES1 National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 17:16 Mar 15, 2022 Jkt 256001 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32). Date: March 25, 2022. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G51, Rockville, MD 20892 (Virtual Meeting). Contact Person: Thomas F. Conway, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G51, Rockville, MD 20852, 240–507–9685, thomas.conway@ nih.gov. Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; National Center for Advancing Translational Sciences Special Emphasis Panel. Date: April 14, 2022. Time: 10:00 a.m. to 1:00 p.m. Agenda: To review and evaluate grant applications. Place: National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Suite 1037, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Alumit Ishai, Ph.D., Scientific Review Officer, Office of Grants Management and Scientific Review, National Center for Advancing Translational Sciences, National Institutes of Health, 6701 Democracy Boulevard, Suite 1037, Bethesda, MD 20892, 301–496–9539, alumit.ishai@ nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Dated: March 10, 2022. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) [FR Doc. 2022–05485 Filed 3–15–22; 8:45 am] Dated: March 11, 2022. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection BILLING CODE 4140–01–P Enhanced Transparency and Access to Information for Debtors and Sureties in the Automated Commercial Environment DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: [FR Doc. 2022–05560 Filed 3–15–22; 8:45 am] National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 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. 14899 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 U.S. Customs and Border Protection, Department of Homeland Security. ACTION: General notice. This document announces that U.S. Customs and Border Protection (CBP) is making three enhancements to CBP’s debt management processes to increase transparency and access to information for debtors and sureties. One of the enhancements will support importers of record, licensed customs brokers, and other Automated Commercial Environment (ACE) account users who owe debts to CBP by enabling the electronic viewing of bill sanction status and protest details in the unpaid, open bill details report in ACE. The other two enhancements will facilitate compliance for sureties by providing electronic access to the SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1

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[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14898-14899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Diabetes and Digestive and Kidney Diseases; 
Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of the following meeting.
    The meeting 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: National Institute of Diabetes and Digestive 
and Kidney Diseases Special Emphasis Panel; Characterization of 
Islet-derived Extracellular Vesicles for Improved Detection, 
Monitoring, Classification, and Treatment of Type 1 Diabetes Special 
Emphasis Panel.
    Date: April 6, 2022.
    Time: 12:00 p.m. to 6:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 14899]]

    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Peter J. Kozel, Ph.D., Chief, Training and 
Mentored Research Section, Scientific Review Branch, Division of 
Extramural Activities, 6707 Democracy Blvd., Room 7009, Bethesda, MD 
20892, [email protected], 301-594-4721.

(Catalogue of Federal Domestic Assistance Program Nos. 93.847, 
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive 
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology 
and Hematology Research, National Institutes of Health, HHS)

    Dated: March 11, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-05559 Filed 3-15-22; 8:45 am]
BILLING CODE 4140-01-P

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