National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting, 3471-3472 [2019-02011]

Download as PDF Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved for marketing the human drug product, ZEJULA (niraparib) indicated for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Subsequent to this approval, the USPTO received a patent term restoration application for ZEJULA (U.S. Patent No. 8,071,623) from MSD Italia S.R.l., and the USPTO requested FDA’s assistance in determining the patent’s eligibility for patent term restoration. In a letter dated January 9, 2018, FDA advised the USPTO that this human drug product VerDate Sep<11>2014 18:30 Feb 11, 2019 Jkt 247001 had undergone a regulatory review period and that the approval of ZEJULA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ZEJULA is 3,234 days. Of this time, 3,086 days occurred during the testing phase of the regulatory review period, while 148 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: May 21, 2008. The applicant claims May 22, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was May 21, 2008, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: October 31, 2016. FDA has verified the applicant’s claim that the new drug application (NDA) for ZEJULA (NDA 208447) was initially submitted on October 31, 2016. 3. The date the application was approved: March 27, 2017. FDA has verified the applicant’s claim that NDA 208447 was approved on March 27, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 370 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 3471 filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: February 7, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–02036 Filed 2–11–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel. 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: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; P41 BTRC Application Review (2019/05). Date: March 5–7, 2019. Time: 6:00 p.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: DoubleTree by Hilton Memphis East, 5069 Sanderlin Avenue, Memphis, TN 38117. Contact Person: John P. Holden, Ph.D., Scientific Review Officer, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Blvd., Suite 920, Bethesda, MD 20892, (301) 496–8775 john.holden@nih.gov. E:\FR\FM\12FEN1.SGM 12FEN1 3472 Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices Dated: February 6, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–02011 Filed 2–11–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; 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 Human Genome Research Institute Special Emphasis Panel Genomic Innovator. Date: March 13, 2019. Time: 9:00 a.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Human Genome Research Institute, Greider Conference Room No. 3189, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Keith McKenney, Ph.D., Scientific Review Officer, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, Bethesda, MD 20814, 301– 594–4280, mckenneyk@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) 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: Communication Disorders Review Committee. Date: June 20–21, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institure on Deafness and Other Communication Disorders, National Institute of Health, 6001 Executive Blvd., Rockville, MD 20850, 301– 402–3587, rayk@nidcd.nih.gov. Name of Committee: Communication Disorders Review Committee. Date: October 17–18, 2019. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Bethesda, MD 20852. Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institure on Deafness and Other Communication Disorders, National Institute of Health, 6001 Executive Blvd., Rockville, MD 20850, 301– 402–3587, rayk@nidcd.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: February 6, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. 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 Deafness and Other Communication Disorders Special Emphasis Panel, P50 Clinical Trial Review. Date: March 8, 2019. Time: 1:30 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center Building (NSC), 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Kausik Ray, Ph.D., Scientific Review Officer, National Institute on Deafness and Other Communication Disorders, National Institutes of Health Rockville, MD 20850, 301–402–3587, rayk@ nidcd.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: February 6, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–01971 Filed 2–11–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; International Research Fellowship Award Program of the (National Institute on Drug Abuse) Dated: February 6, 2019. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–01973 Filed 2–11–19; 8:45 am] AGENCY: BILLING CODE 4140–01–P HHS. [FR Doc. 2019–01969 Filed 2–11–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4140–01–P ACTION: National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Sep<11>2014 18:30 Feb 11, 2019 Jkt 247001 National Institute on Deafness and Other Communication Disorders; 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 National Institutes of Health, Notice. In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. DATES: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. SUMMARY: E:\FR\FM\12FEN1.SGM 12FEN1

Agencies

[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3471-3472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Biomedical Imaging and Bioengineering; 
Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended, notice is hereby given of a meeting of the National Institute 
of Biomedical Imaging and Bioengineering Special Emphasis Panel.
    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: National Institute of Biomedical Imaging and 
Bioengineering Special Emphasis Panel; P41 BTRC Application Review 
(2019/05).
    Date: March 5-7, 2019.
    Time: 6:00 p.m. to 12:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: DoubleTree by Hilton Memphis East, 5069 Sanderlin Avenue, 
Memphis, TN 38117.
    Contact Person: John P. Holden, Ph.D., Scientific Review 
Officer, National Institute of Biomedical Imaging and 
Bioengineering, National Institutes of Health, 6707 Democracy Blvd., 
Suite 920, Bethesda, MD 20892, (301) 496-8775 john.holden@nih.gov.


[[Page 3472]]


    Dated: February 6, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2019-02011 Filed 2-11-19; 8:45 am]
 BILLING CODE 4140-01-P

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