80_FR_53332 80 FR 53162 - Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015

80 FR 53162 - Food and Drug Administration/Drug Information Association Oligonucleotide-Based Therapeutics Conference 2015

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 170 (September 2, 2015)

Page Range53162-53163
FR Document2015-21639

The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research, in cosponsorship with the Drug Information Association (DIA), is announcing a meeting entitled ``FDA/DIA Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 conference). The purpose of the meeting is to discuss advances, safety, and challenges in the field of oligonucleotide-based therapeutics.

Federal Register, Volume 80 Issue 170 (Wednesday, September 2, 2015) 
[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53162-53163]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Food and Drug Administration/Drug Information Association 
Oligonucleotide-Based Therapeutics Conference 2015

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for Drug 
Evaluation and Research, in cosponsorship with the Drug Information 
Association (DIA), is announcing a meeting entitled ``FDA/DIA 
Oligonucleotide-Based Therapeutics Conference 2015'' (FDA/DIA 2015 
conference). The purpose of the meeting is to discuss advances, safety, 
and challenges in the field of oligonucleotide-based therapeutics.

DATES: The meeting will be held on September 9 to September 10, 2015, 
from 7 a.m. to 5 p.m. and September 11, 2015, from 7 a.m. to 12 noon.

ADDRESSES: The meeting will be held at the Grand Hyatt Washington, 1000 
H St. NW., Washington, DC 20001.

FOR FURTHER INFORMATION CONTACT: Meredith Kaganovskiy, Drug Information 
Association (DIA), 800 Enterprise Rd., Horsham, PA 19044, 215-442-6117, 
FAX: 215-293-5923, email: [email protected]; or Robert 
T. Dorsam, Food and Drug Administration, Center for Drug Evaluation and 
Research (CDER), 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002; 301-796-1623, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Oligonucleotide therapeutics constitute a diverse and evolving 
class of drug products that are being developed for a wide variety of 
indications. The FDA/DIA 2015 conference is a forum where regulators, 
academics, and members of industry will discuss the advances, 
challenges, and opportunities in the field of oligonucleotide 
therapeutics. This is the sixth meeting in approximately eight years 
where attendees will discuss oligonucleotide therapeutics in clinical, 
nonclinical, and chemistry tracks. The meeting will provide updates on 
advancements in this field, and will also present time for stakeholders 
to discuss challenges in the development and regulation of 
oligonucleotide therapeutics. Topics will be addressed using 
presentations, panel discussions, case studies, and a poster session to 
facilitate discipline-specific and multidisciplinary discussions. The 
goal of the meeting is to provide a current view of oligonucleotide 
therapeutics and foster advancement in the field through discussions 
among regulators, academics, and industry members.

II. Registration and Accommodations

A. Registration

    There is a registration fee to attend this meeting. The 
registration fee is charged to help defray the costs of facilities, 
meeting materials, and food. Seats are limited, and registration will 
be on a first-come, first-served basis.
    To register, please complete registration online at http://www.diaglobal.org/. (FDA has verified the Web address, but FDA is not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register.) The costs of registration for the 
different categories of attendees are as follows:

------------------------------------------------------------------------
                          Category                               Cost
------------------------------------------------------------------------
Industry Representatives...................................       $1,350
Charitable Nonprofit/Academic..............................          675
Government.................................................          405
------------------------------------------------------------------------

B. Accommodations

    Attendees are responsible for their own hotel accommodations. 
Attendees making reservations at the Grand Hyatt Washington are 
eligible for a reduced rate of $209, not including applicable taxes. 
This rate is available for a limited number of rooms. To receive the 
reduced rate, hotel reservations must be made with onPeak and not 
directly with the hotel. Contact information for onPeak is as follows: 
Toll free in the United States 1-855-355-0302 or 1-212-532-1660. When 
calling, please select option 1 for ``Hotel Reservations,'' and inform 
the phone agent that you are making a reservation for Event #15011.
    If you need special accommodations due to a disability, please 
contact Meredith Kaganovskiy (DIA) or Robert.

[[Page 53163]]

T. Dorsam (FDA) (see FOR FURTHER INFORMATION CONTACT).

    Dated: August 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21639 Filed 9-1-15; 8:45 am]
BILLING CODE 4164-01-P

53162 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices response to a safety labeling change estimates that approximately 407 and that the posting of the labeling will notification should be available on the application holders will post new take approximately 4 hours to prepare. application holder’s Web site within 10 labeling one time each year in response FDA estimates the burden of this calendar days of approval. FDA to a safety labeling change notification collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual responses per burden per Total hours respondents responses respondent response Rebuttal statement ............................................................... 42 1 42 6 252 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of Average Number of disclosures Total annual Type of submission burden per Total hours respondents per disclosures disclosure respondent Posting approved labeling on application holder’s Web site 407 1 407 4 1,628 1 There are no capital costs or operating and maintenance costs associated with this collect of information. Dated: August 27, 2015. Enterprise Rd., Horsham, PA 19044, II. Registration and Accommodations Leslie Kux, 215–442–6117, FAX: 215–293–5923, A. Registration Associate Commissioner for Policy. email: Meredith.kaganovskiy@ [FR Doc. 2015–21645 Filed 9–1–15; 8:45 am] diaglobal.org; or Robert T. Dorsam, Food There is a registration fee to attend and Drug Administration, Center for this meeting. The registration fee is BILLING CODE 4164–01–P Drug Evaluation and Research (CDER), charged to help defray the costs of 10903 New Hampshire Ave., Silver facilities, meeting materials, and food. DEPARTMENT OF HEALTH AND Seats are limited, and registration will Spring, MD 20993–0002; 301–796–1623, HUMAN SERVICES be on a first-come, first-served basis. email: robert.dorsam@fda.hhs.gov. To register, please complete Food and Drug Administration SUPPLEMENTARY INFORMATION: registration online at http:// www.diaglobal.org/. (FDA has verified [Docket No. FDA–2015–N–0001] I. Background the Web address, but FDA is not Oligonucleotide therapeutics responsible for subsequent changes to Food and Drug Administration/Drug the Web site after this document Information Association constitute a diverse and evolving class publishes in the Federal Register.) The Oligonucleotide-Based Therapeutics of drug products that are being costs of registration for the different Conference 2015 developed for a wide variety of categories of attendees are as follows: indications. The FDA/DIA 2015 AGENCY: Food and Drug Administration, conference is a forum where regulators, Category Cost HHS. academics, and members of industry ACTION: Notice of meeting. will discuss the advances, challenges, Industry Representatives .......... $1,350 and opportunities in the field of Charitable Nonprofit/Academic 675 SUMMARY: The Food and Drug Government .............................. 405 Administration’s (FDA’s) Center for oligonucleotide therapeutics. This is the Drug Evaluation and Research, in sixth meeting in approximately eight years where attendees will discuss B. Accommodations cosponsorship with the Drug Information Association (DIA), is oligonucleotide therapeutics in clinical, Attendees are responsible for their announcing a meeting entitled ‘‘FDA/ nonclinical, and chemistry tracks. The own hotel accommodations. Attendees DIA Oligonucleotide-Based meeting will provide updates on making reservations at the Grand Hyatt Therapeutics Conference 2015’’ (FDA/ advancements in this field, and will also Washington are eligible for a reduced DIA 2015 conference). The purpose of present time for stakeholders to discuss rate of $209, not including applicable the meeting is to discuss advances, challenges in the development and taxes. This rate is available for a limited safety, and challenges in the field of regulation of oligonucleotide number of rooms. To receive the oligonucleotide-based therapeutics. therapeutics. Topics will be addressed reduced rate, hotel reservations must be made with onPeak and not directly with DATES: The meeting will be held on using presentations, panel discussions, the hotel. Contact information for September 9 to September 10, 2015, case studies, and a poster session to onPeak is as follows: Toll free in the from 7 a.m. to 5 p.m. and September 11, facilitate discipline-specific and mstockstill on DSK4VPTVN1PROD with NOTICES United States 1–855–355–0302 or 1– 2015, from 7 a.m. to 12 noon. multidisciplinary discussions. The goal 212–532–1660. When calling, please ADDRESSES: The meeting will be held at of the meeting is to provide a current select option 1 for ‘‘Hotel Reservations,’’ the Grand Hyatt Washington, 1000 H St. view of oligonucleotide therapeutics and inform the phone agent that you are NW., Washington, DC 20001. and foster advancement in the field making a reservation for Event #15011. FOR FURTHER INFORMATION CONTACT: through discussions among regulators, If you need special accommodations Meredith Kaganovskiy, Drug academics, and industry members. due to a disability, please contact Information Association (DIA), 800 Meredith Kaganovskiy (DIA) or Robert. VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1

Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53163 T. Dorsam (FDA) (see FOR FURTHER Drug Discovery and for Pathophysiological Name of Committee: National Institute of INFORMATION CONTACT). Studies of CNS Disorders (R21/R33). Allergy and Infectious Diseases Special Date: October 6, 2015. Emphasis Panel; NIAID Investigator Initiated Dated: August 27, 2015. Time: 12:00 p.m. to 5:00 p.m. Program Project Applications (P01). Leslie Kux, Agenda: To review and evaluate grant Date: September 29, 2015. Associate Commissioner for Policy. applications. Time: 11:00 a.m. to 5:00 p.m. [FR Doc. 2015–21639 Filed 9–1–15; 8:45 am] Place: Hilton Alexandria Mark Center; Agenda: To review and evaluate grant 5000 Seminary Road; Alexandria, VA 22311. applications. BILLING CODE 4164–01–P Contact Person: David L Williams, Ph.D.; Place: National Institutes of Health, Room Scientific Review Officer; Center for 8F100, 5601 Fishers Lane, Rockville, MD Scientific Review; National Institutes of 20892, (Telephone Conference Call). DEPARTMENT OF HEALTH AND Health; 6701 Rockledge Drive, Room 5110, Contact Person: Thomas F. Conway, HUMAN SERVICES MSC 7854; Bethesda, MD 20892; (301)435– Scientific Review Officer, Scientific Review 1174; williamsdl2@csr.nih.gov. Program, Division of Extramural Activities, National Institutes of Health (Catalogue of Federal Domestic Assistance Room 3G51, National Institutes of Health, Program Nos. 93.306, Comparative Medicine; NIAID, 5601 Fishers Lane, MSC 9823, Center for Scientific Review; Notice of 93.333, Clinical Research, 93.306, 93.333, Bethesda, MD 20892–9823, 240–507–9685, Closed Meetings 93.337, 93.393–93.396, 93.837–93.844, thomas.conway@nih.gov. 93.846–93.878, 93.892, 93.893, National (Catalogue of Federal Domestic Assistance Pursuant to section 10(d) of the Institutes of Health, HHS) Program Nos. 93.855, Allergy, Immunology, Federal Advisory Committee Act, as and Transplantation Research; 93.856, Dated: August 27, 2015. amended (5 U.S.C. App.), notice is Microbiology and Infectious Diseases hereby given of the following meetings. Carolyn Baum, Research, National Institutes of Health, HHS) Program Analyst, Office of Federal Advisory The meetings will be closed to the Committee Policy. Dated: August 27, 2015. public in accordance with the David Clary, [FR Doc. 2015–21705 Filed 9–1–15; 8:45 am] provisions set forth in sections Program Analyst, Office of Federal Advisory BILLING CODE 4140–01–P 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Committee Policy. as amended. The grant applications and [FR Doc. 2015–21704 Filed 9–1–15; 8:45 am] the discussions could disclose DEPARTMENT OF HEALTH AND BILLING CODE 4140–01–P confidential trade secrets or commercial HUMAN SERVICES property such as patentable material, and personal information concerning National Institutes of Health DEPARTMENT OF HEALTH AND individuals associated with the grant HUMAN SERVICES applications, the disclosure of which National Institute of Allergy and would constitute a clearly unwarranted Infectious Diseases; Notice of Closed National Institutes of Health invasion of personal privacy. Meetings Prospective Grant of Co-Exclusive Name of Committee: Healthcare Delivery Pursuant to section 10(d) of the and Methodologies Integrated Review Group; License: Biomarkers for Acute Federal Advisory Committee Act, as Ischemic Stroke Health Services Organization and Delivery Study Section. amended (5 U.S.C. App.), notice is hereby given of the following meetings. AGENCY: National Institutes of Health, Date: September 28–29, 2015. HHS. Time: 9:30 a.m. to 5:00 p.m. The meetings will be closed to the Agenda: To review and evaluate grant public in accordance with the ACTION: Notice. applications. provisions set forth in sections Place: Wyndham Grand Chicago 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., SUMMARY: This is notice, in accordance Riverfront; 71 East Wacker Drive; Chicago, IL as amended. The grant applications and with 35 U.S.C. 209 and 37 CFR part 404, 60601. the discussions could disclose that the National Institutes of Health, Contact Person: Jacinta Bronte-Tinkew, confidential trade secrets or commercial Department of Health and Human Ph.D.; Scientific Review Officer; Center for property such as patentable material, Services, is contemplating the grant of a Scientific Review; National Institutes of and personal information concerning co-exclusive patent license to practice Health; 6701 Rockledge Drive, Room 3164, the inventions embodied in U.S. Patent MSC 7770; Bethesda, MD 20892; (301) 806– individuals associated with the grant applications, the disclosure of which Application No. 13/580,571 filed 22 0009; brontetinkewjm@csr.nih.gov. August, 2012 and entitled ‘‘Biomarkers Name of Committee: Surgical Sciences, would constitute a clearly unwarranted invasion of personal privacy. for Acute Ischemic Stroke’’ [HHS Ref. Biomedical Imaging and Bioengineering No. E–023–2010/0–US–03] to CereDx, Integrated Review Group; Clinical Molecular Name of Committee: National Institute of Imaging and Probe Development. Inc., which is located in West Virginia. Allergy and Infectious Diseases Special The patent rights in this invention have Date: October 5–6, 2015. Emphasis Panel; NIAID Investigator Initiated Time: 8:00 a.m. to 5:00 p.m. Program Project Applications (P01). been assigned to the United States of Agenda: To review and evaluate grant Date: September 28, 2015. America. applications. Time: 10:00 a.m. to 5:00 p.m. The prospective co-exclusive license Place: Hilton Alexandria Mark Center; Agenda: To review and evaluate grant territory may be worldwide and the 5000 Seminary Road; Alexandria, VA 22311. applications. field of use may be limited to the use Contact Person: David L Williams, Ph.D.; Place: National Institutes of Health, Room of the diagnostics of ischemic stroke. Scientific Review Officer; Center for 3C100, 5601 Fishers Lane, Rockville, MD mstockstill on DSK4VPTVN1PROD with NOTICES DATES: Only written comments and/or Scientific Review; National Institutes of 20892, (Telephone Conference Call). Health; 6701 Rockledge Drive, Room 5110, applications for a license which are Contact Person: Zhuqing (Charlie) Li, received by the NIH Office of MSC 7854; Bethesda, MD 20892; (301)435– Ph.D., Scientific Review Officer, Scientific 1174; williamsdl2@csr.nih.gov. Review Program, Division of Extramural Technology Transfer on or before Name of Committee: Center for Scientific Activities, Room # 3G41B, National Institutes October 2, 2015 will be considered. This Review Special Emphasis Panel; of Health/NIAID, 5601 Fishers Lane, notice updates the Federal Register Development and Application of PET and MSC9823, Bethesda, MD 20892–9823, (240) Notice published in 80 FR 28633, SPECT Imaging Ligands as Biomarkers for 669–5068, zhuqing.li@nih.gov. Tuesday May 19, 2015. VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\02SEN1.SGM 02SEN1


Document Created: 2018-02-26 10:11:11
Document Modified: 2018-02-26 10:11:11
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
ActionNotice of meeting.
DatesThe meeting will be held on September 9 to September 10, 2015, from 7 a.m. to 5 p.m. and September 11, 2015, from 7 a.m. to 12 noon.
ContactMeredith Kaganovskiy, Drug Information Association (DIA), 800 Enterprise Rd., Horsham, PA 19044, 215-442-6117, FAX: 215-293-5923, email: [email protected]; or Robert T. Dorsam, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002; 301-796-1623, email: [email protected]
FR Citation80 FR 53162 
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