National Institute on Drug Abuse; Notice of Closed Meeting, 1621-1622 [2018-00445]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 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 medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (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 medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA has approved for marketing the medical device PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN. PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least 12 months duration following radical prostatectomy or transurethral resection of the prostate and who have failed to respond adequately to conservative therapy. Subsequent to this approval, the USPTO received patent term restoration applications for PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (U.S. Patent Nos. 7,014,606 and 7,828,716) from Uromedica, Inc., and the USPTO requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated November 10, 2016, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product’s regulatory review period. VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 II. Determination of Regulatory Review Period FDA has determined that the applicable regulatory review period for PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN is 3,892 days. Of this time, 3,179 days occurred during the testing phase of the regulatory review period, while 713 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(g)) involving this device became effective: March 31, 2005. The applicant claims that the investigational device exemption (IDE) required under section 520(g) of the FD&C Act for human tests to begin became effective on August 29, 2005. However, FDA records indicate that the IDE was determined substantially complete for clinical studies to have begun on March 31, 2005, which represents the IDE effective date. 2. The date an application was initially submitted with respect to the device under section 515 of the FD&C Act (21 U.S.C. 360e): December 12, 2013. The applicant claims June 19, 2013, as the date the premarket approval application (PMA) for PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN (PMA 130018) was initially submitted. However, FDA records indicate that the PMA as submitted was not administratively complete for the Agency to undertake a substantive review. FDA did not file this application and notified the applicant of this fact by letter dated September 13, 2013. The complete PMA was then submitted on December 12, 2013, which is considered to be the initially submitted date. 3. The date the application was approved: November 24, 2015. FDA has verified the applicant’s claim that PMA 130018 was approved on November 24, 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 1,827 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 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 1621 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. 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: January 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–00404 Filed 1–11–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Digital Markers for Marijuana Intoxication (1218). Date: January 30, 2018. Time: 11:00 a.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). E:\FR\FM\12JAN1.SGM 12JAN1 1622 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices Contact Person: Julia Berzhanskaya, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 20892, 301–827–5840, julia.berzhanskaya@nih.gov. (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: January 9, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–00445 Filed 1–11–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sradovich on DSK3GMQ082PROD with NOTICES Fogarty International Center; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Fogarty International Center Advisory Board. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the 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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Fogarty International Center Advisory Board. Date: February 12–13, 2018. Place: National Institutes of Health Lawton L. Chiles International House (Stone House), Building 16, Conference Room, 16 Center Drive, Bethesda, MD 20892. Closed Session: February 12, 2018, 2:00 p.m. to 5:00 p.m. Agenda: Second level review of grant applications. Date: February 13, 2018. VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 Place: National Institutes of Health. Lawton L. Chiles International House (Stone House), Building 16, Conference Room, 16 Center Drive, Bethesda, MD 20892. Open Session: February 13, 2018, 9:00 a.m. to 3:00 p.m. Agenda: Update and discussion of current and planned FIC activities. Contact Person: Kristen Weymouth, Executive Secretary, Fogarty International Center, National Institutes of Health, 31 Center Drive, Room B2C02, Bethesda, MD 20892, (301) 496– 1415, kristen.weymouth@nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: http:// www.fic.nih.gov/About/Advisory/Pages/ default.aspx, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.106, Minority International Research Training Grant in the Biomedical and Behavioral Sciences; 93.154, Special International Postdoctoral Research Program in Acquired Immunodeficiency Syndrome; 93.168, International Cooperative Biodiversity Groups Program; 93.934, Fogarty International Research Collaboration Award; 93.989, Senior International Fellowship Awards Program, National Institutes of Health, HHS) Dated: January 9, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Drug Abuse Special Emphasis Panel, Development of Portable Neuromodulatory Devices for the Treatment of Substance Use Disorders (8941). Date: January 17, 2018. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Julia Berzhanskaya, Ph.D., Scientific Review Officer, Office of Extramural Policy and Review, Division of Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 20892, 301–827–5840, julia.berzhanskaya@nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS) Dated: January 9, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–00444 Filed 1–11–18; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2018–00440 Filed 1–11–18; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00018 Fmt 4703 Sfmt 9990 E:\FR\FM\12JAN1.SGM 12JAN1

Agencies

[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1621-1622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00445]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Drug Abuse; 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 contract proposals and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the contract proposals, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Drug Abuse Special 
Emphasis Panel, Digital Markers for Marijuana Intoxication (1218).
    Date: January 30, 2018.
    Time: 11:00 a.m. to 4:00 p.m.
    Agenda: To review and evaluate contract proposals.
    Place: National Institutes of Health, Neuroscience Center, 6001 
Executive Boulevard, Rockville, MD 20852, (Telephone Conference 
Call).

[[Page 1622]]

    Contact Person: Julia Berzhanskaya, Ph.D., Scientific Review 
Officer, Office of Extramural Policy and Review, Division of 
Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 
6001 Executive Boulevard, Room 4234, MSC 9550, Bethesda, MD 20892, 
301-827-5840, [email protected].

(Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug 
Abuse and Addiction Research Programs, National Institutes of 
Health, HHS)

    Dated: January 9, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2018-00445 Filed 1-11-18; 8:45 am]
 BILLING CODE 4140-01-P