National Institute of Environmental Health Sciences; Notice of Closed Meetings, 6869-6870 [2018-03110]

Download as PDF Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices USPTO requested that FDA determine the product’s regulatory review period. 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES 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 ORKAMBI (lumacaftor and ivacaftor). ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene. Subsequent to this approval, the USPTO received patent term restoration applications for ORKAMBI (U.S. Patent Nos. 8,653,103; 8,741,933; and 8,846,718) from Vertex Pharmaceuticals Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated July 12, 2016, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ORKAMBI represented the first permitted commercial marketing or use of the product. Thereafter, the VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for ORKAMBI is 2,785 days. Of this time, 2,545 days occurred during the testing phase of the regulatory review period, while 240 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 (the FD&C Act) (21 U.S.C. 355(i)) became effective: November 18, 2007. FDA has verified the applicant’s claim that November 18, 2007, is the date the investigational new drug application (IND) became effective. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: November 5, 2014. FDA has verified the applicant’s claim that the new drug application (NDA) for ORKAMBI (NDA 206038) was initially submitted on November 5, 2014. 3. The date the application was approved: July 2, 2015. FDA has verified the applicant’s claim that NDA 206038 was approved on July 2, 2015. 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 applications for patent extension, this applicant seeks 210 or 317 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 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. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 6869 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 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–03127 Filed 2–14–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; 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: National Institute of Environmental Health Sciences Special Emphasis Panel; K99/R00 Career Development in Environmental Research. Date: March 1, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Environmental Health Sciences, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 (Virtual Meeting). Contact Person: Laura A. Thomas, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, National Institute of Environmental Health Sciences, Research Triangle Park, NC 27709 919–541–2824, laura.thomas@nih.gov. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Evaluation of U01 Grant Applications: DNA Repair Capacity (DRC) Assay Measures in Population-Based Studies. Date: March 6, 2018. Time: 8:30 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: Fairfield Inn & Suites Durham Southpoint, 7807 Leonardo Drive, Durham, NC 27713. E:\FR\FM\15FEN1.SGM 15FEN1 6870 Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, (919) 541–0670, worth@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: February 9, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–03110 Filed 2–14–18; 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 sradovich on DSK3GMQ082PROD with NOTICES 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 Training in Comparative and Veterinary Medicine. Date: March 8, 2018. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alexander Gubin, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6046B, MSC 7892, Bethesda, MD 20892, 301–408– 9655, gubina@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel PAR Panel: Perception and Cognition Research to Inform Cancer Image Interpretation. VerDate Sep<11>2014 19:01 Feb 14, 2018 Jkt 244001 Date: March 9, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). Contact Person: Maribeth Champoux, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892, 301–594– 3163, champoum@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel PAR–17– 144: Limited Competition: National Primate Research Centers (P51). Date: March 11–14, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Bourbon Orleans Hotel, 717 Orleans Street, New Orleans, LA 70116. Contact Person: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3089B, MSC 7848, Bethesda, MD 20892, (301) 402–4411, tianbi@ csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Small Business: Cancer Diagnostics and Treatments. Date: March 12–13, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW, Washington, DC 20015. Contact Person: Zhang-Zhi Hu, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6186, MSC 7804, Bethesda, MD 20892, (301) 437– 8135, huzhuang@csr.nih.gov. Name of Committee: AIDS and Related Research Integrated Review Group AIDS Clinical Studies and Epidemiology Study Section. Date: March 13–14, 2018. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Zoe, 425 North Point, San Francisco, CA 94133. Contact Person: Dimitrios Nikolaos Vatakis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3190, Bethesda, MD 20892, 301–827– 7480, dimitrios.vatakis@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Small Business: HIV/AIDS Innovative Research Applications. Date: March 13, 2018. Time: 3:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hotel Nikko San Francisco, 222 Mason Street, San Francisco, CA 94102. Contact Person: Mark P Rubert, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD 20892, 301–435– 1775, rubertm@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel Member Conflict: Child Psychopathology and Developmental Disorders. Date: March 13, 2018. Time: 12:00 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Serena Chu, Ph.D., Scientific Review Officer, BBBP IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD 20892, 301–500– 5829, sechu@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: February 9, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–03108 Filed 2–14–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel PHS 2018–1: Small Business Innovation Research (SBIR) Program Contract Solicitation (Topic 57). Date: March 1, 2018. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892 (Telephone Conference Call). E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6869-6870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; 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: National Institute of Environmental Health 
Sciences Special Emphasis Panel; K99/R00 Career Development in 
Environmental Research.
    Date: March 1, 2018.
    Time: 8:00 a.m. to 5:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institute of Environmental Health Sciences, 
Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 
(Virtual Meeting).
    Contact Person: Laura A. Thomas, Ph.D., Scientific Review 
Officer, Scientific Review Branch, Division of Extramural Research 
and Training, National Institute of Environmental Health Sciences, 
Research Triangle Park, NC 27709 919-541-2824, [email protected].

    Name of Committee: National Institute of Environmental Health 
Sciences Special Emphasis Panel; Evaluation of U01 Grant 
Applications: DNA Repair Capacity (DRC) Assay Measures in 
Population-Based Studies.
    Date: March 6, 2018.
    Time: 8:30 a.m. to 3:00 p.m.
    Agenda: To review and evaluate grant applications.
    Place: Fairfield Inn & Suites Durham Southpoint, 7807 Leonardo 
Drive, Durham, NC 27713.

[[Page 6870]]

    Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, 
Scientific Review Branch, Division of Extramural Research and 
Training, Nat. Institute of Environmental Health Sciences, P.O. Box 
12233, MD EC-30/Room 3171, Research Triangle Park, NC 27709, (919) 
541-0670, [email protected].

(Catalogue of Federal Domestic Assistance Program Nos. 93.115, 
Biometry and Risk Estimation--Health Risks from Environmental 
Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety 
Training; 93.143, NIEHS Superfund Hazardous Substances--Basic 
Research and Education; 93.894, Resources and Manpower Development 
in the Environmental Health Sciences; 93.113, Biological Response to 
Environmental Health Hazards; 93.114, Applied Toxicological Research 
and Testing, National Institutes of Health, HHS)

    Dated: February 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-03110 Filed 2-14-18; 8:45 am]
BILLING CODE 4140-01-P
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