83_FR_1630 83 FR 1621 - National Institute on Drug Abuse; Notice of Closed Meeting

83 FR 1621 - National Institute on Drug Abuse; Notice of Closed Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 9 (January 12, 2018)

Page Range1621-1622
FR Document2018-00445

Federal Register, Volume 83 Issue 9 (Friday, January 12, 2018) 
[Federal Register Volume 83, Number 9 (Friday, January 12, 2018)]
[Notices]
[Pages 1621-1622]
From the Federal Register Online  [www.thefederalregister.org]
[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, 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

Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices 1621 Restoration Act (Pub. L. 100–670) II. Determination of Regulatory Review CFR 60.30), any interested person may generally provide that a patent may be Period petition FDA for a determination extended for a period of up to 5 years FDA has determined that the regarding whether the applicant for so long as the patented item (human applicable regulatory review period for extension acted with due diligence drug product, animal drug product, PROACT ADJUSTABLE CONTINENCE during the regulatory review period. To medical device, food additive, or color THERAPY FOR MEN is 3,892 days. Of meet its burden, the petition must additive) was subject to regulatory this time, 3,179 days occurred during comply with all the requirements of review by FDA before the item was the testing phase of the regulatory § 60.30, including but not limited to: marketed. Under these acts, a product’s review period, while 713 days occurred must be timely (see DATES), must be regulatory review period forms the basis during the approval phase. These filed in accordance with § 10.20, must for determining the amount of extension periods of time were derived from the contain sufficient facts to merit an FDA an applicant may receive. following dates: investigation, and must certify that a 1. The date an exemption under true and complete copy of the petition A regulatory review period consists of has been served upon the patent two periods of time: A testing phase and section 520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. applicant. (See H. Rept. 857, part 1, 98th an approval phase. For medical devices, Cong., 2d sess., pp. 41–42, 1984.) 360j(g)) involving this device became the testing phase begins with a clinical Petitions should be in the format effective: March 31, 2005. The applicant investigation of the device and runs specified in 21 CFR 10.30. claims that the investigational device until the approval phase begins. The exemption (IDE) required under section Submit petitions electronically to approval phase starts with the initial 520(g) of the FD&C Act for human tests https://www.regulations.gov at Docket submission of an application to market to begin became effective on August 29, No. FDA–2013–S–0610. Submit written the device and continues until 2005. However, FDA records indicate petitions (two copies are required) to the permission to market the device is that the IDE was determined Dockets Management Staff (HFA–305), granted. Although only a portion of a substantially complete for clinical Food and Drug Administration, 5630 regulatory review period may count studies to have begun on March 31, Fishers Lane, Rm. 1061, Rockville, MD toward the actual amount of extension 2005, which represents the IDE effective 20852. that the Director of USPTO may award date. Dated: January 8, 2018. (half the testing phase must be 2. The date an application was Leslie Kux, subtracted as well as any time that may initially submitted with respect to the Associate Commissioner for Policy. have occurred before the patent was device under section 515 of the FD&C [FR Doc. 2018–00404 Filed 1–11–18; 8:45 am] issued), FDA’s determination of the Act (21 U.S.C. 360e): December 12, BILLING CODE 4164–01–P length of a regulatory review period for 2013. The applicant claims June 19, a medical device will include all of the 2013, as the date the premarket approval testing phase and approval phase as application (PMA) for PROACT DEPARTMENT OF HEALTH AND specified in 35 U.S.C. 156(g)(3)(B). ADJUSTABLE CONTINENCE THERAPY HUMAN SERVICES FOR MEN (PMA 130018) was initially FDA has approved for marketing the submitted. However, FDA records National Institutes of Health medical device PROACT ADJUSTABLE indicate that the PMA as submitted was CONTINENCE THERAPY FOR MEN. not administratively complete for the National Institute on Drug Abuse; PROACT ADJUSTABLE CONTINENCE Agency to undertake a substantive Notice of Closed Meeting THERAPY FOR MEN is indicated for review. FDA did not file this application the treatment of adult men who have Pursuant to section 10(d) of the and notified the applicant of this fact by stress incontinence arising from Federal Advisory Committee Act, as letter dated September 13, 2013. The intrinsic sphincter deficiency of at least amended, notice is hereby given of the complete PMA was then submitted on 12 months duration following radical following meeting. December 12, 2013, which is considered prostatectomy or transurethral resection The meeting will be closed to the to be the initially submitted date. of the prostate and who have failed to 3. The date the application was public in accordance with the approved: November 24, 2015. FDA has provisions set forth in sections respond adequately to conservative verified the applicant’s claim that PMA 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., therapy. Subsequent to this approval, 130018 was approved on November 24, as amended. The contract proposals and the USPTO received patent term the discussions could disclose restoration applications for PROACT 2015. This determination of the regulatory confidential trade secrets or commercial ADJUSTABLE CONTINENCE THERAPY property such as patentable material, FOR MEN (U.S. Patent Nos. 7,014,606 review period establishes the maximum potential length of a patent extension. and personal information concerning and 7,828,716) from Uromedica, Inc., individuals associated with the contract and the USPTO requested FDA’s However, the USPTO applies several statutory limitations in its calculations proposals, the disclosure of which assistance in determining this patent’s would constitute a clearly unwarranted eligibility for patent term restoration. In of the actual period for patent extension. In its applications for patent extension, invasion of personal privacy. a letter dated November 10, 2016, FDA Name of Committee: National Institute on this applicant seeks 1,827 days of patent advised the USPTO that this medical Drug Abuse Special Emphasis Panel, Digital term extension. device had undergone a regulatory Markers for Marijuana Intoxication (1218). sradovich on DSK3GMQ082PROD with NOTICES review period and that the approval of III. Petitions Date: January 30, 2018. PROACT ADJUSTABLE CONTINENCE Time: 11:00 a.m. to 4:00 p.m. Anyone with knowledge that any of THERAPY FOR MEN represented the Agenda: To review and evaluate contract the dates as published are incorrect may proposals. first permitted commercial marketing or submit either electronic or written Place: National Institutes of Health, use of the product. Thereafter, the comments and, under 21 CFR 60.24, ask Neuroscience Center, 6001 Executive USPTO requested that FDA determine for a redetermination (see DATES). Boulevard, Rockville, MD 20852, (Telephone the product’s regulatory review period. Furthermore, as specified in § 60.30 (21 Conference Call). VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1

1622 Federal Register / Vol. 83, No. 9 / Friday, January 12, 2018 / Notices Contact Person: Julia Berzhanskaya, Ph.D., Place: National Institutes of Health. DEPARTMENT OF HEALTH AND Scientific Review Officer, Office of Lawton L. Chiles International House HUMAN SERVICES Extramural Policy and Review, Division of (Stone House), Building 16, Conference Extramural Research, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Room, 16 Center Drive, Bethesda, MD National Institutes of Health Boulevard, Room 4234, MSC 9550, Bethesda, 20892. MD 20892, 301–827–5840, National Institute on Drug Abuse; Open Session: February 13, 2018, 9:00 julia.berzhanskaya@nih.gov. Notice of Closed Meeting a.m. to 3:00 p.m. (Catalogue of Federal Domestic Assistance Program No.: 93.279, Drug Abuse and Agenda: Update and discussion of Pursuant to section 10(d) of the Addiction Research Programs, National current and planned FIC activities. Federal Advisory Committee Act, as Institutes of Health, HHS) Contact Person: Kristen Weymouth, amended, notice is hereby given of the Dated: January 9, 2018. Executive Secretary, Fogarty following meeting. Natasha M. Copeland, International Center, National Institutes The meeting will be closed to the Program Analyst, Office of Federal Advisory of Health, 31 Center Drive, Room public in accordance with the Committee Policy. B2C02, Bethesda, MD 20892, (301) 496– provisions set forth in sections [FR Doc. 2018–00445 Filed 1–11–18; 8:45 am] 1415, kristen.weymouth@nih.gov. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., BILLING CODE 4140–01–P as amended. The contract proposals and Any interested person may file the discussions could disclose written comments with the committee confidential trade secrets or commercial DEPARTMENT OF HEALTH AND by forwarding the statement to the property such as patentable material, HUMAN SERVICES Contact Person listed on this notice. The and personal information concerning statement should include the name, individuals associated with the contract National Institutes of Health address, telephone number and when proposals, the disclosure of which applicable, the business or professional Fogarty International Center; Notice of would constitute a clearly unwarranted affiliation of the interested person. Meeting invasion of personal privacy. In the interest of security, NIH has Pursuant to section 10(d) of the Name of Committee: National Institute on instituted stringent procedures for Federal Advisory Committee Act, as Drug Abuse Special Emphasis Panel, entrance onto the NIH campus. All amended, notice is hereby given of a Development of Portable Neuromodulatory visitor vehicles, including taxicabs, meeting of the Fogarty International Devices for the Treatment of Substance Use hotel, and airport shuttles will be Disorders (8941). Center Advisory Board. inspected before being allowed on The meeting will be open to the Date: January 17, 2018. campus. Visitors will be asked to show Time: 12:00 p.m. to 5:00 p.m. public as indicated below, with one form of identification (for example, attendance limited to space available. Agenda: To review and evaluate contract a government-issued photo ID, driver’s proposals. Individuals who plan to attend and license, or passport) and to state the Place: National Institutes of Health, need special assistance, such as sign language interpretation or other purpose of their visit. Neuroscience Center, 6001 Executive Information is also available on the Boulevard, Rockville, MD 20852, (Telephone reasonable accommodations, should Institute’s/Center’s home page: http:// Conference Call). notify the Contact Person listed below Contact Person: Julia Berzhanskaya, Ph.D., in advance of the meeting. www.fic.nih.gov/About/Advisory/Pages/ The meeting will be closed to the Scientific Review Officer, Office of default.aspx, where an agenda and any Extramural Policy and Review, Division of public in accordance with the additional information for the meeting Extramural Research, National Institute on provisions set forth in sections will be posted when available. Drug Abuse, NIH, DHHS, 6001 Executive 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., (Catalogue of Federal Domestic Boulevard, Room 4234, MSC 9550, Bethesda, as amended. The grant applications Assistance Program Nos. 93.106, MD 20892, 301–827–5840, and/or contract proposals and the Minority International Research julia.berzhanskaya@nih.gov. discussions could disclose confidential trade secrets or commercial property Training Grant in the Biomedical and This notice is being published less than 15 such as patentable material, and Behavioral Sciences; 93.154, Special days prior to the meeting due to the timing personal information concerning International Postdoctoral Research limitations imposed by the review and individuals associated with the grant Program in Acquired Immunodeficiency funding cycle. applications and/or contract proposals, Syndrome; 93.168, International (Catalogue of Federal Domestic Assistance the disclosure of which would Cooperative Biodiversity Groups Program No.: 93.279, Drug Abuse and constitute a clearly unwarranted Program; 93.934, Fogarty International Addiction Research Programs, National invasion of personal privacy. Research Collaboration Award; 93.989, Institutes of Health, HHS) Name of Committee: Fogarty Senior International Fellowship Awards Dated: January 9, 2018. International Center Advisory Board. Program, National Institutes of Health, Natasha M. Copeland, Date: February 12–13, 2018. HHS) Program Analyst, Office of Federal Advisory Place: National Institutes of Health Dated: January 9, 2018. Committee Policy. Lawton L. Chiles International House [FR Doc. 2018–00444 Filed 1–11–18; 8:45 am] Natasha M. Copeland, sradovich on DSK3GMQ082PROD with NOTICES (Stone House), Building 16, Conference Program Analyst, Office of Federal Advisory BILLING CODE 4140–01–P Room, 16 Center Drive, Bethesda, MD 20892. Committee Policy. Closed Session: February 12, 2018, [FR Doc. 2018–00440 Filed 1–11–18; 8:45 am] 2:00 p.m. to 5:00 p.m. BILLING CODE 4140–01–P Agenda: Second level review of grant applications. Date: February 13, 2018. VerDate Sep<11>2014 17:47 Jan 11, 2018 Jkt 244001 PO 00000 Frm 00018 Fmt 4703 Sfmt 9990 E:\FR\FM\12JAN1.SGM 12JAN1


Document Created: 2018-10-26 09:50:55
Document Modified: 2018-10-26 09:50:55
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesJanuary 30, 2018.
FR Citation83 FR 1621 
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