Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2015; Public Conference, 15797-15798 [2015-06702]

Download as PDF Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices program outcomes. The evaluation is used to determine how participants’ quality of life changes after transitioning to the community. The semi-annual progress report is used by the national evaluation contractor and CMS to monitor program implementation at the grantee level. Form Number: CMS– 10249 (OMB control number: 0938– 1053); Frequency: Yearly, quarterly, and semi-annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 45; Total Annual Responses: 28,590; Total Annual Hours: 14,225. (For policy questions regarding this collection contact Michael Smith at 410–786–2267.) 3. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Outcome and Assessment Information Set (OASIS) OASIS–C1/ICD–10; Use: Home health agencies (HHAs) are required to collect the outcome and assessment information data set (OASIS) to participate in the Medicare program. We are requesting a new OMB control number for the proposed revised OASIS item set, referred to hereafter as OASIS– C1/ICD–10. The current version of the OASIS–C1/ICD–9 data set was approved by OMB on October 7, 2014 (0938– 0760), and will be in use until the implementation of the ICD–10 coding system which is currently scheduled for October 1, 2015. Subsequent to the 60day Federal Register notice (80 FR 1419), there was a minor typographical correction made to the data set. Form Number: CMS–10545 (OMB control number: 0938–NEW); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profit and Not-for-profit institutions); Number of Respondents: 12,014; Total Annual Responses: 17,268,890; Total Annual Hours: 15,320,253. (For policy questions regarding this collection contact Cheryl Wiseman at 410–786–1175). Dated: March 17, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015–06884 Filed 3–20–15; 5:15 pm] rljohnson on DSK3VPTVN1PROD with NOTICES BILLING CODE 4120–01–P VerDate Sep<11>2014 15:26 Mar 24, 2015 Jkt 235001 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. 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, Ellen.Diegel@diahome.org; or Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver Spring, MD 20993– 0002, 301–796–0579, Stephen.Wilson@ fda.hhs.gov. SUMMARY: 15797 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 https://www.diahome.org/en-US/ Meetings-and-Training/Find-Meetingsand-Training/MeetingDetails.aspx?ProductID= 3630578&EventType=Meeting. II. Registration and Accommodations A. Registration To register, please submit the registration form online at https:// www.diahome.org/en-US/Meetings-andTraining/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 Industry Representatives ...... Charitable Nonprofit/Academic (Full time) ............... Government (Full time) ......... Tutorial Fees ......................... Cost $1,440 720 430 405 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. 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 Ellen.Diegel@diahome.org.) Registration fees cover the costs of facilities, materials, and food functions. B. Accommodations SUPPLEMENTARY INFORMATION: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Attendees are responsible for their own accommodations. Reservations may be made online via the conference hotel reservation page at https:// www.tphousing.com/ph2/ E:\FR\FM\25MRN1.SGM 25MRN1 15798 Federal Register / Vol. 80, No. 57 / Wednesday, March 25, 2015 / Notices 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 Ellen.Diegel@diahome.org at least 7 days before the meeting. Dated: March 19, 2015. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting rljohnson on DSK3VPTVN1PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 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 Neurological Disorders and Stroke Special Emphasis Panel; Epilepsy Clinical Trial Review. Date: April 22, 2015. Time: 12:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). Contact Person: William C. Benzing, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research, NINDS/NIH/DHHS/Neuroscience Center, 6001 Executive Boulevard, Suite 3208, MSC 9529, Bethesda, MD 20892–9529, 301–496– 0660, benzingw@mail.nih.gov. 15:26 Mar 24, 2015 Jkt 235001 Dated: March 19, 2015. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–06841 Filed 3–24–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review [FR Doc. 2015–06702 Filed 3–24–15; 8:45 am] VerDate Sep<11>2014 (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS) The meeting announced below concerns Using Longitudinal Data to Characterize the Natural History of Fragile X Syndrome to Improve Services and Outcomes, DD15–003, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 10:00 a.m.–6:00 p.m., April 14, 2015 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Using Longitudinal Data to Characterize the Natural History of Fragile X Syndrome to Improve Services and Outcomes, DD15–003, initial review.’’ Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F–80, Atlanta, Georgia 30341, Telephone: (770) 488–3585, EEO6@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Catherine Ramadei, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. 2015–06849 Filed 3–24–15; 8:45 am] BILLING CODE 4163–18–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 (5 U.S.C. App.), 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; Loan Repayment Program (LRP). Date: April 20–24, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20892, (Virtual Meeting). Contact Person: Maryam Feili-Hariri, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/ NIAID, 5601 Fishers Lane, Rockville, MD 20852, 240–669–5026, haririmf@ niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases, Special Emphasis Panel; NIAID Investigator Initiated Program Project Applications (P01). Date: April 20, 2015. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3F100, 5601 Fishers Lane, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Jane K. Battles, Ph.D., Scientific Review Officer, Scientific Review Program DEA/NIAID/NIH/DHHS, 5601 Fishers Lane, Rockville, MD 20852, 240–669– 5029, battlesja@mail.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases, Special Emphasis Panel; NIAID Peer Review Meeting. Date: April 23, 2015. Time: 1:00 p.m. to 4:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 5601 Fishers Lane, Rockville, MD 20852, (Telephone Conference Call). Contact Person: Betty Poon, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 80, Number 57 (Wednesday, March 25, 2015)]
[Notices]
[Pages 15797-15798]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06702]


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

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, 
Ellen.Diegel@diahome.org; or Stephen Wilson, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3630, Silver 
Spring, MD 20993-0002, 301-796-0579, Stephen.Wilson@fda.hhs.gov.

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 https://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 https://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 
Ellen.Diegel@diahome.org.) 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 Ellen.Diegel@diahome.org 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
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