Prospective Grant of an Exclusive Patent License: RP2 AAV Vectors for Treating X-Linked Retinitis Pigmentosa, 22503-22504 [2019-10285]

Download as PDF Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices Rockledge Drive, Room 1458, MSC 6902, National Institutes Of Health, Bethesda, MD 20892, 301–443–9737, bautista@ mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.niaaa.nih.gov/about-niaaa/our-work/ advisory-council where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Dated: May 13, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–10219 Filed 5–16–19; 8:45 am] BILLING CODE 4140–01–P (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS) Dated: May 13, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–10218 Filed 5–16–19; 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: RP2 AAV Vectors for Treating X-Linked Retinitis Pigmentosa AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: National Institutes of Health jbell on DSK3GLQ082PROD with NOTICES 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 on Alcohol Abuse and Alcoholism Special Emphasis Panel; RFA AA19–004 Specialized Alcohol Research Centers. Date: August 13–14, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 6700 B Rockledge Drive, Conference Rooms B & C, Bethesda, MD 20817. Contact Person: Beata Buzas, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 6700 B Rockledge Drive, Room 2116, Rockville, MD 20852, 301–443– 0800, bbuzas@mail.nih.gov. 17:05 May 16, 2019 Notice. The National Eye 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 U.S. and foreign Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to IVERIC bio, Inc. located in New York, NY. DATES: Only written comments and/or applications for a license which are received by the National Eye Institute c/o National Cancer Institute’s Technology Transfer Center on or before June 3, 2019 will be considered. ADDRESSES: Requests for copies of the patent application, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Alan Hubbs, 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, Email: hubbsa@mail.nih.gov. SUPPLEMENTARY INFORMATION: The following represents the intellectual property to be licensed under the prospective agreement: SUMMARY: National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting VerDate Sep<11>2014 National Institutes of Health, HHS. Jkt 247001 Intellectually Property 1. U.S. Provisional Patent Application No. 62/131,661, filed March 11, 2015 [HHS Reference No. E–050–2015/0–US– 01]; PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 22503 2. PCT Patent Application No. PCT/ US2016/022072 filed March 11, 2016 [HHS Reference No. E–050–2015–0– PCT–03]; 3. Australian Patent Application No. AU2016228751A, filed on March 11, 2016 [HHS Reference No. E–050–2015– 0–AU–04]; 4. Canadian Patent Application No. CA2979229A, filed on March 11, 2016 [HHS Reference No. E–050–2015–0– CA–05]; 5. European Patent Application No. EP16762623.3A, filed on March 11, 2016 [HHS Reference No. E–050–2015– 0–EP–06]; 6. Japanese Patent Application No. JP2017547425A, filed on March 11, 2016 [HHS Reference No. E–050–2015– 0–JP–07]; 7. United States Patent Application No. US15/556,746, filed on March 11, 2016 [HHS Reference No. E–050–2015– 0–US–08]. With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be world-wide, and the field of use may be limited to the use of Licensed Patent Rights for the following: ‘‘Human therapeutics for treating x-linked retinitis pigmentosa: The license will also be limited by licensed products covered by patent rights that pertain to AAV-mediated gene therapy delivering an RP2 transgene.’’ This technology discloses adenoassociated virus (AAV) vectors comprising nucleotide sequences encoding RPGR–ORF15 or RP2 and related pharmaceutical compositions. It also discloses methods of treating or preventing x-linked retinitis pigmentosa, increasing photoreceptor number in the retina of a mammal, and increasing visual acuity of a mammal using the vectors and pharmaceutical compositions. 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 Eye 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 license E:\FR\FM\17MYN1.SGM 17MYN1 22504 Federal Register / Vol. 84, No. 96 / Friday, May 17, 2019 / Notices 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: May 9, 2019. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute. [FR Doc. 2019–10285 Filed 5–16–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [1651–0053] Agency Information Collection Activities: Accreditation of Commercial Testing Laboratories and Approval of Commercial Gaugers U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day notice and request for comments; extension of an existing collection of information. AGENCY: The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies. Comments are encouraged and must be submitted (no later than July 16, 2019) to be assured of consideration. ADDRESSES: Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651–0053 in the subject line and the agency name. To avoid duplicate submissions, please use only one of the following methods to submit comments: (1) Email. Submit comments to: CBP_ PRA@cbp.dhs.gov. (2) Mail. Submit written comments to CBP Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, Economic Impact Analysis jbell on DSK3GLQ082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:28 May 16, 2019 Jkt 247001 Branch, 90 K Street NE, 10th Floor, Washington, DC 20229–1177. FOR FURTHER INFORMATION CONTACT: Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229–1177, Telephone number 202–325–0056 or via email CBP_PRA@cbp.dhs.gov. Please note that the contact information provided here is solely for questions regarding this notice. Individuals seeking information about other CBP programs should contact the CBP National Customer Service Center at 877–227–5511, (TTY) 1–800–877–8339, or CBP website at https://www.cbp. gov/. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record. Overview of This Information Collection Title: Accreditation of Commercial Testing Laboratories and Approval of Commercial Gaugers. OMB Number: 1651–0053. Form Number: Form 6478. Abstract: Commercial laboratories seeking accreditation or approval must provide the information specified in 19 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 CFR 151.12 to Customs and Border Protection (CBP), and Commercial Gaugers seeking CBP approval must provide the information specified under 19 CFR 151.13. This information may be submitted on CBP Form 6478. After the initial approval and/or accreditation, a private company may ‘‘extend’’ its approval and/or accreditation to add facilities by submitting a formal written request to CBP. This application process is authorized by Section 613 of Public Law 103–182 (NAFTA Implementation Act), codified at 19 U.S.C. 1499(b), which directs CBP to establish a procedure to accredit privately owned testing laboratories. The information collected is used by CBP in deciding whether to approve individuals or businesses desiring to measure bulk products or to analyze importations. Instructions for completing these applications are accessible at: https:// www.cbp.gov/about/labs-scientific/ commercial-gaugers-and-laboratories. CBP Form 6478 is accessible at: https:// www.cbp.gov/sites/default/files/ documents/CBP%20Form%206478_ 0.pdf. Current Actions: This submission is being made to extend the expiration date with no change to the burden hours or to the information collected. Type of Review: Extension (without change). Affected Public: Businesses. Applications for Commercial Testing and Approval of Commercial Gaugers: Estimated Number of Annual Respondents: 8. Estimated Number of Responses per Respondent: 1. Estimated Total Annual Responses: 8. Estimated Time per Response: 1.25 hours. Estimated Total Annual Burden Hours: 10. Record Keeping Associated with Applications for Commercial Testing and Approval of Commercial Gaugers: Estimated Number of Respondents: 180. Estimated Number of Responses per Respondent: 1. Estimated Total Annual Responses: 180. Estimated Time per Response: 1 hour. Estimated Total Annual Burden Hours: 180. Dated: May 14, 2019. Seth D. Renkema, Branch Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection. [FR Doc. 2019–10258 Filed 5–16–19; 8:45 am] BILLING CODE 9111–14–P E:\FR\FM\17MYN1.SGM 17MYN1

Agencies

[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Pages 22503-22504]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10285]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: RP2 AAV Vectors 
for Treating X-Linked Retinitis Pigmentosa

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Eye 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 U.S. and foreign Patents and Patent 
Applications listed in the Supplementary Information section of this 
notice to IVERIC bio, Inc. located in New York, NY.

DATES: Only written comments and/or applications for a license which 
are received by the National Eye Institute c/o National Cancer 
Institute's Technology Transfer Center on or before June 3, 2019 will 
be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated Exclusive Patent License 
should be directed to: Alan Hubbs, 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, Email: [email protected].

SUPPLEMENTARY INFORMATION:  The following represents the intellectual 
property to be licensed under the prospective agreement:

Intellectually Property

    1. U.S. Provisional Patent Application No. 62/131,661, filed March 
11, 2015 [HHS Reference No. E-050-2015/0-US-01];
    2. PCT Patent Application No. PCT/US2016/022072 filed March 11, 
2016 [HHS Reference No. E-050-2015-0-PCT-03];
    3. Australian Patent Application No. AU2016228751A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-AU-04];
    4. Canadian Patent Application No. CA2979229A, filed on March 11, 
2016 [HHS Reference No. E-050-2015-0-CA-05];
    5. European Patent Application No. EP16762623.3A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-EP-06];
    6. Japanese Patent Application No. JP2017547425A, filed on March 
11, 2016 [HHS Reference No. E-050-2015-0-JP-07];
    7. United States Patent Application No. US15/556,746, filed on 
March 11, 2016 [HHS Reference No. E-050-2015-0-US-08].
    With respect to persons who have an obligation to assign their 
right, title and interest to the Government of the United States of 
America, the patent rights in these inventions have been assigned to 
the Government of the United States of America. The prospective 
exclusive license territory may be world-wide, and the field of use may 
be limited to the use of Licensed Patent Rights for the following: 
``Human therapeutics for treating x-linked retinitis pigmentosa: The 
license will also be limited by licensed products covered by patent 
rights that pertain to AAV-mediated gene therapy delivering an RP2 
transgene.''
    This technology discloses adeno-associated virus (AAV) vectors 
comprising nucleotide sequences encoding RPGR-ORF15 or RP2 and related 
pharmaceutical compositions. It also discloses methods of treating or 
preventing x-linked retinitis pigmentosa, increasing photoreceptor 
number in the retina of a mammal, and increasing visual acuity of a 
mammal using the vectors and pharmaceutical compositions.
    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 
Eye 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 
license

[[Page 22504]]

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: May 9, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-10285 Filed 5-16-19; 8:45 am]
 BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.