80_FR_15854 80 FR 15797 - Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2015; Public Conference

80 FR 15797 - Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2015; Public Conference

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 57 (March 25, 2015)

Page Range15797-15798
FR Document2015-06702

The Food and Drug Administration (FDA), in cosponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Ninth Annual DIA/FDA Statistics Forum--2015''. The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. A primary focus for this meeting will be to establish an ongoing dialogue regarding FDA's ``Critical Path'' initiative-- emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trial data and measuring the progress being made in designing and implementing innovative solutions.

Federal Register, Volume 80 Issue 57 (Wednesday, March 25, 2015) 
[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15797-15798]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-06702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Ninth Annual Drug Information Association/Food and Drug 
Administration Statistics Forum--2015; Public Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
the Drug Information Association (DIA), is announcing a public 
conference entitled ``Ninth Annual DIA/FDA Statistics Forum--2015''. 
The purpose of the conference is to discuss relevant statistical issues 
associated with the development and review of therapeutic drugs and 
biologics. A primary focus for this meeting will be to establish an 
ongoing dialogue regarding FDA's ``Critical Path'' initiative--
emphasizing the regulatory and statistical challenges associated with 
innovative approaches to the design and analysis of clinical trial data 
and measuring the progress being made in designing and implementing 
innovative solutions.

DATES: The public conference will be held from April 20, 2015, to April 
22, 2015, from 8:30 a.m. to 5 p.m. each day.

ADDRESSES: The public conference will be held at the Marriott Bethesda 
North Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, 
MD 20852, 301-822-9200.

FOR FURTHER INFORMATION CONTACT: Ellen Diegel, Drug Information 
Association, 800 Enterprise Rd., Horsham, PA 19044, 215-442-6100, 
[email protected]; or Stephen Wilson, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver 
Spring, MD 20993-0002, 301-796-0579, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This annual FDA/DIA statistics forum will be a unique, open, 
international forum for statisticians and clinicians from industry, 
academia, contract research organizations, and Government Agencies. 
Meeting participants will learn, discuss, and collaborate on the 
current and emerging statistical methodologies and quantitative 
approaches used by sponsors to provide evidence for the approval of new 
therapies.
    The goals of the program are to:
     Explore and implement innovative statistical solutions to 
issues associated with the regulatory review of therapeutic drugs and 
biologics.
     Describe the application of statistical methodologies and 
thinking to the development of new therapeutic biologics and drugs.
     Assess the impact of regulations and guidance on 
statistical practice.
     Discuss ideas for improving the communication between 
industry statisticians and FDA reviewers.
    A description of the planned activities of the working groups can 
be found at http://www.diahome.org/en-US/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3630578&EventType=Meeting.

II. Registration and Accommodations

A. Registration

    To register, please submit the registration form online at http://www.diahome.org/en-US/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=3630578&EventType=Meeting. (FDA has 
verified this Web site address but is not responsible for changes to 
the Web site after this document publishes in the Federal Register.) 
Seats are limited, and conference space will be filled in the order in 
which registrations are received. On-site registration will be 
available to the extent that space is available on the day of the 
conference. The costs of registration for different categories of 
attendees are as follows:

------------------------------------------------------------------------
                        Category                               Cost
------------------------------------------------------------------------
Industry Representatives................................          $1,440
Charitable Nonprofit/Academic (Full time)...............             720
Government (Full time)..................................             430
Tutorial Fees...........................................             405
------------------------------------------------------------------------

    All registrants will be required to pay the applicable fee, with 
the exception of a limited number of speakers/organizers who will have 
a complimentary registration. (Government and nonprofit attendees and 
exhibitors will need an invitation code to register at the discounted 
rate. An invitation code can be obtained by sending an email to 
[email protected].) Registration fees cover the costs of 
facilities, materials, and food functions.

B. Accommodations

    Attendees are responsible for their own accommodations. 
Reservations may be made online via the conference hotel reservation 
page at https://www.tphousing.com/ph2/

[[Page 15798]]

startres.aspx?EICode=3132&Attcode=72.
    The Marriott Bethesda North Hotel and Conference Center has a 
limited number of rooms available at the discounted rate of $199 per 
night until April 3, 2015, or until the block is filled. To receive 
this rate, attendees are asked to make reservations using the link to 
the hotel reservation page or by calling 855-355-0302 or 212-532-1660. 
If calling, please select the first option for ``Hotel Reservations'' 
and inform the phone agent that you are making a reservation for 
``Event #15008''.
    If you need special accommodations because of disability, please 
contact [email protected] at least 7 days before the meeting.

    Dated: March 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06702 Filed 3-24-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 15797 program outcomes. The evaluation is DEPARTMENT OF HEALTH AND The goals of the program are to: used to determine how participants’ HUMAN SERVICES • Explore and implement innovative quality of life changes after transitioning statistical solutions to issues associated to the community. The semi-annual Food and Drug Administration with the regulatory review of progress report is used by the national [Docket No. FDA–2015–N–0001] therapeutic drugs and biologics. evaluation contractor and CMS to • Describe the application of monitor program implementation at the Ninth Annual Drug Information statistical methodologies and thinking grantee level. Form Number: CMS– Association/Food and Drug to the development of new therapeutic 10249 (OMB control number: 0938– Administration Statistics Forum— biologics and drugs. 2015; Public Conference • Assess the impact of regulations 1053); Frequency: Yearly, quarterly, and and guidance on statistical practice. semi-annually; Affected Public: State, AGENCY: Food and Drug Administration, • Discuss ideas for improving the Local, or Tribal Governments; Number HHS. communication between industry of Respondents: 45; Total Annual ACTION: Notice of public conference. statisticians and FDA reviewers. Responses: 28,590; Total Annual Hours: A description of the planned activities 14,225. (For policy questions regarding SUMMARY: The Food and Drug of the working groups can be found at this collection contact Michael Smith at Administration (FDA), in cosponsorship http://www.diahome.org/en-US/ 410–786–2267.) with the Drug Information Association Meetings-and-Training/Find-Meetings- 3. Type of Information Collection (DIA), is announcing a public and-Training/Meeting- conference entitled ‘‘Ninth Annual DIA/ Details.aspx?ProductID= Request: New collection (Request for a FDA Statistics Forum—2015’’. The 3630578&EventType=Meeting. new OMB control number); Title of purpose of the conference is to discuss Information Collection: Outcome and relevant statistical issues associated II. Registration and Accommodations Assessment Information Set (OASIS) with the development and review of OASIS–C1/ICD–10; Use: Home health A. Registration therapeutic drugs and biologics. A agencies (HHAs) are required to collect primary focus for this meeting will be to To register, please submit the the outcome and assessment establish an ongoing dialogue regarding registration form online at http:// information data set (OASIS) to FDA’s ‘‘Critical Path’’ initiative— www.diahome.org/en-US/Meetings-and- participate in the Medicare program. We emphasizing the regulatory and Training/Find-Meetings-and-Training/ are requesting a new OMB control statistical challenges associated with Meeting-Details.aspx?ProductID= number for the proposed revised OASIS innovative approaches to the design and 3630578&EventType=Meeting. (FDA has item set, referred to hereafter as OASIS– analysis of clinical trial data and verified this Web site address but is not C1/ICD–10. The current version of the measuring the progress being made in responsible for changes to the Web site OASIS–C1/ICD–9 data set was approved designing and implementing innovative after this document publishes in the by OMB on October 7, 2014 (0938– solutions. Federal Register.) Seats are limited, and conference space will be filled in the 0760), and will be in use until the DATES: The public conference will be order in which registrations are implementation of the ICD–10 coding held from April 20, 2015, to April 22, received. On-site registration will be system which is currently scheduled for 2015, from 8:30 a.m. to 5 p.m. each day. available to the extent that space is October 1, 2015. Subsequent to the 60- ADDRESSES: The public conference will available on the day of the conference. day Federal Register notice (80 FR be held at the Marriott Bethesda North The costs of registration for different 1419), there was a minor typographical Hotel and Conference Center, 5701 categories of attendees are as follows: correction made to the data set. Form Marinelli Rd., North Bethesda, MD Number: CMS–10545 (OMB control 20852, 301–822–9200. Category Cost number: 0938–NEW); Frequency: FOR FURTHER INFORMATION CONTACT: Occasionally; Affected Public: Private Ellen Diegel, Drug Information Industry Representatives ...... $1,440 Sector (Business or other for-profit and Association, 800 Enterprise Rd., Charitable Nonprofit/Aca- Horsham, PA 19044, 215–442–6100, demic (Full time) ............... 720 Not-for-profit institutions); Number of Government (Full time) ......... 430 Respondents: 12,014; Total Annual Ellen.Diegel@diahome.org; or Stephen Tutorial Fees ......................... 405 Responses: 17,268,890; Total Annual Wilson, Food and Drug Administration, Hours: 15,320,253. (For policy questions 10903 New Hampshire Ave., Bldg. 21, All registrants will be required to pay regarding this collection contact Cheryl Rm. 3630, Silver Spring, MD 20993– the applicable fee, with the exception of Wiseman at 410–786–1175). 0002, 301–796–0579, Stephen.Wilson@ a limited number of speakers/organizers fda.hhs.gov. who will have a complimentary Dated: March 17, 2015. SUPPLEMENTARY INFORMATION: registration. (Government and nonprofit William N. Parham, III, attendees and exhibitors will need an Director, Paperwork Reduction Staff, Office I. Background invitation code to register at the of Strategic Operations and Regulatory This annual FDA/DIA statistics forum discounted rate. An invitation code can Affairs. will be a unique, open, international be obtained by sending an email to [FR Doc. 2015–06884 Filed 3–20–15; 5:15 pm] forum for statisticians and clinicians Ellen.Diegel@diahome.org.) Registration BILLING CODE 4120–01–P from industry, academia, contract fees cover the costs of facilities, research organizations, and Government materials, and food functions. rljohnson on DSK3VPTVN1PROD with NOTICES Agencies. Meeting participants will learn, discuss, and collaborate on the B. Accommodations current and emerging statistical Attendees are responsible for their methodologies and quantitative own accommodations. Reservations may approaches used by sponsors to provide be made online via the conference hotel evidence for the approval of new reservation page at https:// therapies. www.tphousing.com/ph2/ VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1

15798 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices startres.aspx?EICode=3132& (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND Attcode=72. Program Nos. 93.853, Clinical Research HUMAN SERVICES The Marriott Bethesda North Hotel Related to Neurological Disorders; 93.854, and Conference Center has a limited Biological Basis Research in the National Institutes of Health number of rooms available at the Neurosciences, National Institutes of Health, HHS) National Institute of Allergy and discounted rate of $199 per night until April 3, 2015, or until the block is filled. Dated: March 19, 2015. Infectious Diseases; Notice of Closed To receive this rate, attendees are asked Meetings Carolyn Baum, to make reservations using the link to Pursuant to section 10(d) of the Program Analyst, Office of Federal Advisory the hotel reservation page or by calling Committee Policy. Federal Advisory Committee Act, as 855–355–0302 or 212–532–1660. If amended (5 U.S.C. App.), notice is [FR Doc. 2015–06841 Filed 3–24–15; 8:45 am] calling, please select the first option for hereby given of the following meetings. BILLING CODE 4140–01–P ‘‘Hotel Reservations’’ and inform the The meetings will be closed to the phone agent that you are making a public in accordance with the reservation for ‘‘Event #15008’’. provisions set forth in sections If you need special accommodations DEPARTMENT OF HEALTH AND HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., because of disability, please contact as amended. The grant applications and Ellen.Diegel@diahome.org at least 7 Centers for Disease Control and the discussions could disclose days before the meeting. Prevention confidential trade secrets or commercial Dated: March 19, 2015. property such as patentable material, Leslie Kux, Disease, Disability, and Injury and personal information concerning Associate Commissioner for Policy. Prevention and Control Special individuals associated with the grant [FR Doc. 2015–06702 Filed 3–24–15; 8:45 am] Emphasis Panel (SEP): Initial Review applications, the disclosure of which BILLING CODE 4164–01–P would constitute a clearly unwarranted The meeting announced below invasion of personal privacy. concerns Using Longitudinal Data to Characterize the Natural History of Name of Committee: National Institute of DEPARTMENT OF HEALTH AND Allergy and Infectious Diseases, Special HUMAN SERVICES Fragile X Syndrome to Improve Services Emphasis Panel; Loan Repayment Program and Outcomes, DD15–003, initial (LRP). National Institutes of Health review. Date: April 20–24, 2015. In accordance with Section 10(a)(2) of Time: 8:00 a.m. to 5:00 p.m. National Institute of Neurological the Federal Advisory Committee Act Agenda: To review and evaluate grant Disorders and Stroke; Notice of Closed (Pub. L. 92–463), the Centers for Disease applications. Meeting Place: National Institutes of Health, 5601 Control and Prevention (CDC) Fishers Lane, Rockville, MD 20892, (Virtual Pursuant to section 10(d) of the announces the aforementioned meeting: Meeting). Federal Advisory Committee Act, as Time and Date: 10:00 a.m.–6:00 p.m., April Contact Person: Maryam Feili-Hariri, amended (5 U.S.C. App.), notice is 14, 2015 (Closed). Ph.D., Scientific Review Officer, Scientific hereby given of the following meeting. Place: Teleconference. Review Program, Division of Extramural The meeting will be closed to the Status: The meeting will be closed to the Activities, National Institutes of Health/ public in accordance with the public in accordance with provisions set NIAID, 5601 Fishers Lane, Rockville, MD provisions set forth in sections forth in Section 552b(c)(4) and (6), Title 5 20852, 240–669–5026, haririmf@ 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., U.S.C., and the Determination of the Director, niaid.nih.gov. as amended. The grant applications and Management Analysis and Services Office, Name of Committee: National Institute of CDC, pursuant to Public Law 92–463. Allergy and Infectious Diseases, Special the discussions could disclose Matters for Discussion: The meeting will Emphasis Panel; NIAID Investigator Initiated confidential trade secrets or commercial include the initial review, discussion, and Program Project Applications (P01). property such as patentable material, evaluation of applications received in Date: April 20, 2015. and personal information concerning response to ‘‘Using Longitudinal Data to Time: 1:00 p.m. to 5:00 p.m. individuals associated with the grant Characterize the Natural History of Fragile X Agenda: To review and evaluate grant applications, the disclosure of which Syndrome to Improve Services and applications. would constitute a clearly unwarranted Outcomes, DD15–003, initial review.’’ Place: National Institutes of Health, Room invasion of personal privacy. Contact Person for More Information: M. 3F100, 5601 Fishers Lane, Rockville, MD Chris Langub, Ph.D., Scientific Review 20852, (Telephone Conference Call). Name of Committee: National Institute of Officer, CDC, 4770 Buford Highway NE., Contact Person: Jane K. Battles, Ph.D., Neurological Disorders and Stroke Special Mailstop F–80, Atlanta, Georgia 30341, Scientific Review Officer, Scientific Review Emphasis Panel; Epilepsy Clinical Trial Telephone: (770) 488–3585, EEO6@cdc.gov. Program DEA/NIAID/NIH/DHHS, 5601 Review. The Director, Management Analysis and Fishers Lane, Rockville, MD 20852, 240–669– Date: April 22, 2015. Services Office, has been delegated the 5029, battlesja@mail.nih.gov. Time: 12:00 p.m. to 5:00 p.m. authority to sign Federal Register notices Agenda: To review and evaluate grant Name of Committee: National Institute of pertaining to announcements of meetings and Allergy and Infectious Diseases, Special applications. other committee management activities, for Place: National Institutes of Health, Emphasis Panel; NIAID Peer Review Meeting. both the Centers for Disease Control and Date: April 23, 2015. Neuroscience Center, 6001 Executive Prevention and the Agency for Toxic Time: 1:00 p.m. to 4:00 p.m. Boulevard, Rockville, MD 20852, (Telephone rljohnson on DSK3VPTVN1PROD with NOTICES Substances and Disease Registry. Agenda: To review and evaluate contract Conference Call). Contact Person: William C. Benzing, Ph.D., Catherine Ramadei, proposals. Scientific Review Officer, Scientific Review Place: National Institutes of Health, 5601 Acting Director, Management Analysis and Fishers Lane, Rockville, MD 20852, Branch, Division of Extramural Research, Services Office Centers for Disease Control (Telephone Conference Call). NINDS/NIH/DHHS/Neuroscience Center, and Prevention. Contact Person: Betty Poon, Ph.D., 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– [FR Doc. 2015–06849 Filed 3–24–15; 8:45 am] Scientific Review Officer, Scientific Review 0660, benzingw@mail.nih.gov. BILLING CODE 4163–18–P Program, Division of Extramural Activities, VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\25MRN1.SGM 25MRN1


Document Created: 2018-02-21 09:48:57
Document Modified: 2018-02-21 09:48:57
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 public conference.
DatesThe public conference will be held from April 20, 2015, to April 22, 2015, from 8:30 a.m. to 5 p.m. each day.
ContactEllen Diegel, Drug Information Association, 800 Enterprise Rd., Horsham, PA 19044, 215-442-6100, [email protected]; or Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver Spring, MD 20993-0002, 301-796-0579, [email protected]
FR Citation80 FR 15797 
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