Center for Scientific Review; Notice of Closed Meetings, 33269-33270 [2019-14805]

Download as PDF Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–2153 for ‘‘Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. VerDate Sep<11>2014 16:55 Jul 11, 2019 Jkt 247001 Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 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 Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Jennifer Mercier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5390, Silver Spring, MD 20993–0002, 301– 796–0957. SUPPLEMENTARY INFORMATION: 33269 information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information under 21 CFR part 312 (investigational new drug regulations) have been approved at OMB control number 0910–0014. The collections of information in 21 CFR parts 50 and 56 (Protection of Human Subjects: Informed Consent; Institutional Review Boards) have been approved under OMB control number 0910–0755. The collection of information in 21 CFR part 314, including the submission of labeling under 21 CFR 314.50(e)(2)(ii) and (l)(1)(i), has been approved under OMB control number 0910–0001. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. Dated: July 8, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14855 Filed 7–11–19; 8:45 am] BILLING CODE 4164–01–P I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.’’ This draft guidance summarizes FDA’s recommendations for key design features for clinical trials intended to establish effectiveness and safety for hormonal drug products intended to prevent pregnancy. This draft guidance does not address development of contraceptive devices for this indication. 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 ‘‘Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy.’’ 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. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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: Bioengineering, Surgery, Anesthesiology and Trauma. Date: August 6, 2019. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\12JYN1.SGM 12JYN1 33270 Federal Register / Vol. 84, No. 134 / Friday, July 12, 2019 / Notices Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Mehrdad Mohseni, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301–435– 0484, mohsenim@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA–AI– 18–057: Long-acting Drug Delivery Systems for ART Optimization in HIV–1 Infected Children. Date: August 9, 2019. Time: 10:00 a.m. to 1:00 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: Shiv A. Prasad, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301–443– 5779, prasads@csr.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: July 8, 2019. Natasha M. Copeland, Deputy Director, Office of Federal Advisory Committee Policy. [FR Doc. 2019–14805 Filed 7–11–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20 AGENCY: National Institutes of Health, HHS. ACTION: Notice. 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 Kite Pharma, Inc. (‘‘Kite’’) located in Santa Monica, CA. DATES: Only written comments and/or complete applications for a license which are received by the National Cancer Institute’s Technology Transfer Center on or before July 29, 2019 will be considered. jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:55 Jul 11, 2019 Jkt 247001 Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: David A Lambertson, Ph.D., Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E530 MSC 9702, Bethesda, MD 20892–9702 (for business mail), Rockville, MD 20850– 9702 Telephone: (240)-276–5530; Facsimile: (240)-276–5504 Email: david.lambertson@nih.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: Intellectual Property United States Provisional Patent Application No. 62/732,263, filed 17 September 2018 and entitled ‘‘Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20 and Their Uses’’ [HHS Reference No. E–205– 2018–0–US–01]; and U.S. and foreign patent applications claiming priority to the aforementioned application. The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the following: ‘‘The development, production and commercialization of an anti-CD19 antiCD20 dual targeting chimeric antigen receptor (CAR)-based immunotherapy using allogeneic (where the donor and the recipient are different) immune cells, wherein the genome editing is meditated only by zinc-finger nucleases, and where the CAR has at least: (1) A dual antigen specificity; (2) the complementary determining region (CDR) sequences of the anti-CD19 antibody known as Hu19; (3) the complementary determining region (CDR) sequences of the anti-CD20 antibody known as 2.1.2; and (4) a T cell signaling domain; for the treatment of B-cell derived human cancers.’’ This technology discloses the development of chimeric antigen receptors that recognize both the CD19 and CD20 cell surface proteins. CD19 and CD20 are expressed on the cell surface of several hematological malignancies, including Non-Hodgkins Lymphoma (NHL), acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). Although the FDA has recently approved CARbased therapies which target only CD19 (Yescarta, Kymriah), tumors are capable of undergoing tumor antigen escape (the downregulation of target antigen expression on tumor cells), which PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 results in gradual resistance to ‘‘single target therapies.’’ As a result, patients receiving single target CAR therapies are susceptible to relapse. This has prompted investigators to pursue dual targeting CAR therapies to provide as a means of overcoming tumor antigen escape, thereby providing a more comprehensive therapeutic alternative. The development of a new therapeutic targeting both CD19 and CD20 will benefit public health by offering up an improved treatment for patients that would otherwise be subject to relapse due to tumor antigen escape. This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404. In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552. Dated: July 2, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–14822 Filed 7–11–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director) AGENCY: National Institutes of Health, HHS. ACTION: Notice. In compliance with the requirement of the Paperwork SUMMARY: E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Pages 33269-33270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14805]


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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: Bioengineering, Surgery, Anesthesiology and 
Trauma.
    Date: August 6, 2019.
    Time: 10:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.

[[Page 33270]]

    Place: National Institutes of Health, Rockledge II, 6701 
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
    Contact Person: Mehrdad Mohseni, MD, Scientific Review Officer, 
Center for Scientific Review, National Institutes of Health, 6701 
Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-
0484, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis 
Panel; RFA-AI-18-057: Long-acting Drug Delivery Systems for ART 
Optimization in HIV-1 Infected Children.
    Date: August 9, 2019.
    Time: 10:00 a.m. to 1:00 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: Shiv A. Prasad, Ph.D., Scientific Review 
Officer, Center for Scientific Review, National Institutes of 
Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 
20892, 301-443-5779, [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: July 8, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-14805 Filed 7-11-19; 8:45 am]
 BILLING CODE 4140-01-P
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