National Institute of General Medical Sciences; Notice of Closed Meeting, 16274 [2019-07750]

Download as PDF jbell on DSK30RV082PROD with NOTICES 16274 Federal Register / Vol. 84, No. 75 / Thursday, April 18, 2019 / Notices approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. TRISENOX (arsenic trioxide) injection, 1 mg/mL, is the subject of NDA 021248, held by Cephalon, Inc., and initially approved on September 25, 2000. TRISENOX is indicated in combination with tretinoin for treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression; and for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RARalpha gene expression. In a letter dated February 21, 2018, the sponsor notified FDA that TRISENOX (arsenic trioxide) injection, 1 mg/mL, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Lachman Consultant Services, Inc., submitted a citizen petition dated October 17, 2018 (Docket No. FDA– 2018–P–3949), under 21 CFR 10.30, requesting that the Agency determine whether TRISENOX (arsenic trioxide) injection, 1 mg/mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that TRISENOX (arsenic trioxide) injection, 1 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that TRISENOX (arsenic trioxide) injection, 1 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of TRISENOX (arsenic trioxide) injection, 1 mg/mL, from sale. We have also VerDate Sep<11>2014 17:37 Apr 17, 2019 Jkt 247001 independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list TRISENOX (arsenic trioxide) injection, 1 mg/mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. Dated: April 15, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–07828 Filed 4–17–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences Special Emphasis Panel; Review of COBRE Phase 1 Applications. Date: July 10, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Ruth Grossman, DDS, Scientific Review Officer, Center for Scientific Review, National Institutes of PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Health, 6701 Rockledge Drive, Room 5215, Bethesda, MD 20892, (301) 435–2409, grossmanrs@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: April 12, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–07750 Filed 4–17–19; 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 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; Risk Prevention and Health Behavior AREA Review. Date: May 30, 2019. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: John H. Newman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3222, MSC 7808, Bethesda, MD 20892, (301) 435– 0628, newmanjh@csr.nih.gov. Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; Psychosocial Development, Risk and Prevention Study Section. Date: June 6–7, 2019. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\18APN1.SGM 18APN1

Agencies

[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Page 16274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07750]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of General Medical Sciences; 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 General Medical 
Sciences Special Emphasis Panel; Review of COBRE Phase 1 
Applications.
    Date: July 10, 2019.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 
Wisconsin Avenue, Bethesda, MD 20814.
    Contact Person: Ruth Grossman, DDS, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5215, Bethesda, MD 20892, (301) 435-2409, 
[email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.375, 
Minority Biomedical Research Support; 93.821, Cell Biology and 
Biophysics Research; 93.859, Pharmacology, Physiology, and 
Biological Chemistry Research; 93.862, Genetics and Developmental 
Biology Research; 93.88, Minority Access to Research Careers; 93.96, 
Special Minority Initiatives; 93.859, Biomedical Research and 
Research Training, National Institutes of Health, HHS)

    Dated: April 12, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-07750 Filed 4-17-19; 8:45 am]
 BILLING CODE 4140-01-P

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