Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013; Public Conference, 13072-13073 [2013-04331]

Download as PDF 13072 Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices The guidance may also be obtained by mail by calling CBER at 1–800–835– 4709 or 301–827–1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a document entitled ‘‘Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma’’ dated February 2013. The guidance document recognizes the standardized full-length and abbreviated donor history questionnaires and accompanying materials, version 1.2 dated September 2012, prepared by the PPTA, as an acceptable mechanism that is consistent with FDA’s requirements and recommendations for collecting Source Plasma donor history information. The SPDHQ documents will provide blood establishments that collect Source Plasma with a specific process for administering questions to Source Plasma donors to determine their eligibility to donate. The guidance also advises Source Plasma manufacturers who choose to implement the acceptable SPDHQ documents on how to report the manufacturing change consisting of the implementation of the SPDHQ under 21 CFR 601.12. In the Federal Register of July 22, 2011 (76 FR 44013), FDA announced the availability of the draft guidance of the same title dated July 2011. FDA received no comments on the draft guidance. A summary of changes includes: Referencing the most current version of the acceptable SPDHQ documents, clarifying that the fulllength and abbreviated questionnaires are designed to be implemented together, and making a few editorial changes to improve clarity. The guidance announced in this notice finalizes the draft guidance dated July 2011. VerDate Mar<15>2010 16:35 Feb 25, 2013 Jkt 229001 The guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. DEPARTMENT OF HEALTH AND HUMAN SERVICES II. Paperwork Reduction Act of 1995 HHS. This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR 601.12 have been approved under OMB control number 0910–0338 and the collections of information in 21 CFR 640.63 have been approved under OMB control number 0910–0116. III. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBlood Vaccines/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// www.regulations.gov. Dated: February 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04384 Filed 2–25–13; 8:45 am] BILLING CODE 4160–01–P PO 00000 Food and Drug Administration [Docket No. FDA–2013–N–0001] Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum— 2013; Public Conference AGENCY: ACTION: Food and Drug Administration, 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 ‘‘Seventh Annual DIA/FDA Statistics Forum—2013.’’ The purpose of the conference is to discuss relevant statistical issues associated with the development and review of therapeutic drugs and biologics. This meeting is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical investigators who are involved in the development of new 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 trials data and measuring the progress being made in designing and implementing innovative solutions. DATES: The public conference will be held on April 28, 2013, to May 1, 2013, from 8:30 a.m. to 5 p.m. ADDRESSES: The public conference will be held at the Marriott Bethesda North Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852, 1– 301–822–9200. FOR FURTHER INFORMATION CONTACT: Constance Burnett, Drug Information Association, 800 Enterprise Rd., Horsham, PA 19044, 1–215–293– 5800, email: Constance.Burnett@diahome.org; or Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–0579, email: Stephen.Wilson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background This annual FDA/DIA statistics forum will establish a unique, open, international forum for statisticians and clinicians from industry, academia, contract research organizations, and Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\26FEN1.SGM 26FEN1 Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices 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/Meetingsand-Training/Find-Meetings-andTraining/Meeting-Details.aspx? ProductID=30457&EventType=Meeting. B. Accommodations Attendees are responsible for their own accommodations. Attendees making reservations at the Marriott Bethesda North Hotel and Conference Center, Bethesda, MD, are eligible for a reduced conference rate of $209, not including applicable taxes. Those making reservations online should use the group code ‘‘13008’’ to receive the special rate. If you need special accommodations because of disability, please contact Constance.Burnett@diahome.org at least 7 days before the meeting. Dated: February 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–04331 Filed 2–25–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HOMELAND SECURITY II. Registration and Accommodations [Docket No. USCG–2012–1049] A. Registration To register, please submit the registration form online at http:// www.diahome.org/en/Meetings-andTraining/Find-Meetings-and-Training/ Meeting-Details.aspx?ProductID=30457 &EventType=Meeting (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Registration fees cover the cost of facilities, materials, and food functions. Seats are limited, and conference space will be filled in the order in which registrations are received. Onsite 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 attendee are as follows: Interim Guidance for Revised Implementation of the International Convention for the Prevention of Pollution From Ships (MARPOL), Annex V Cost Industry Representatives .................. Charitable Nonprofit/Academic (Full time) .............................................. Government (Full time) ..................... Tutorial Fees ..................................... tkelley on DSK3SPTVN1PROD with NOTICES Category $1,400 700 420 405 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: Constance.Burnett@diahome.org. All registrants will pay a fee with the exception of a limited number of speakers/organizers who will have a complimentary registration. VerDate Mar<15>2010 16:35 Feb 25, 2013 Jkt 229001 Coast Guard, DHS. Notice of availability. AGENCY: SUMMARY: The Coast Guard announces the availability of CG–CVC Policy Letter 13–01, ‘‘Interim Guidance for Revised MARPOL Annex V Implementation.’’ On July 15, 2011, the International Maritime Organization’s (IMO) Marine Environment Protection Committee (MEPC) formally adopted Resolution MEPC.201(62), which amends the International Convention for the Prevention of Pollution from Ships (MARPOL) Annex V, by establishing a general prohibition on discharges of garbage into the sea. The amendments in Resolution MEPC.201(62) entered into force on January 1, 2013. CG–CVC Policy Letter 13–01 provides interim guidance to assist U.S. flagged and foreign flagged oceangoing ships regarding compliance with the amendments in Resolution MEPC.201(62) until the Coast Guard updates the applicable regulations in 33 CFR part 151. DATES: The effective date for the amendments in Resolution MEPC.201(62) was January 1, 2013. CG– CVC Policy Letter 13–01 is effective as of February 26, 2013. ADDRESSES: This notice and the documents referenced within are PO 00000 Frm 00060 available in the docket and can be viewed by going to www.regulations.gov and using ‘‘USCG–2012–1049’’ as your search term. CG–CVC Policy Letter 13– 01 can also be viewed on the Coast Guard’s Web site at http:// homeport.uscg.mil by referring to the left side menu and following the links to ‘‘Domestic Vessels,’’ ‘‘Domestic Vessel Policy,’’ and ‘‘Office of Commercial Vessel Compliance (CG– CVC) Policy Letters.’’ FOR FURTHER INFORMATION CONTACT: If you have questions on this notice or CG–CVC Policy Letter 13–01, call or email LT John Peterson, U.S. Coast Guard, Office of Commercial Vessel Compliance (CG–CVC–1), telephone (202) 372–1226, or email CG-CVC1@uscg.mil. If you have questions on viewing material in the docket, call Docket Operations, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: Background and Purpose Coast Guard ACTION: 13073 Fmt 4703 Sfmt 4703 The United States implements MARPOL Annex V through the Act to Prevent Pollution from Ships (33 U.S.C. 1901, et. seq.). On July 15, 2011, the IMO’s MEPC formally adopted Resolution MEPC.201(62), which amends MARPOL Annex V by establishing a general prohibition on discharges of garbage into the sea. Under prescribed conditions, exceptions are provided for food wastes, cargo residues, cleaning agents or additives contained in cargo hold, deck, and external surface wash waters, and animal carcasses. The amendments in Resolution MEPC.201(62) entered into force on January 1, 2013. The Coast Guard intends to revise its regulations in 33 CFR part 151 to conform with the amendments in Resolution MEPC.201(62). These conforming regulatory provisions were not finalized prior to January 1, 2013. The lack of updated regulations does not exempt ships from meeting the requirements of the amended MARPOL Annex V. CG–CVC Policy Letter 13–01 provides interim guidance to assist U.S. flagged and foreign flagged oceangoing ships regarding compliance with the amendments in Resolution MEPC.201(62) until the Coast Guard updates the applicable regulations. As of January 1, 2013, all U.S. flagged ships and fixed or floating platforms are expected to meet the requirements of the amended MARPOL Annex V. This is particularly important for U.S. flagged ships (including recreational and uninspected ships) on international voyages that want to avoid Port State control actions. For U.S. ships operating E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13072-13073]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Seventh Annual Drug Information Association/Food and Drug 
Administration Statistics Forum--2013; 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 ``Seventh Annual DIA/FDA Statistics Forum--2013.'' 
The purpose of the conference is to discuss relevant statistical issues 
associated with the development and review of therapeutic drugs and 
biologics. This meeting is intended to be an open forum for the timely 
discussion of topics of mutual theoretical and practical interest to 
statisticians and clinical investigators who are involved in the 
development of new 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 trials data and measuring the progress 
being made in designing and implementing innovative solutions.

DATES: The public conference will be held on April 28, 2013, to May 1, 
2013, from 8:30 a.m. to 5 p.m.

ADDRESSES: The public conference will be held at the Marriott Bethesda 
North Hotel and Conference Center, 5701 Marinelli Rd., Bethesda, MD 
20852, 1-301-822-9200.

FOR FURTHER INFORMATION CONTACT: 

Constance Burnett, Drug Information Association, 800 Enterprise Rd., 
Horsham, PA 19044, 1-215-293-5800, email: 
Constance.Burnett@diahome.org; or
Stephen Wilson, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-0579, email: 
Stephen.Wilson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    This annual FDA/DIA statistics forum will establish a unique, open, 
international forum for statisticians and clinicians from industry, 
academia, contract research organizations, and

[[Page 13073]]

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/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=30457&EventType=Meeting.

II. Registration and Accommodations

A. Registration

    To register, please submit the registration form online at http://www.diahome.org/en/Meetings-and-Training/Find-Meetings-and-Training/Meeting-Details.aspx?ProductID=30457&EventType=Meeting (FDA has 
verified the Web site address, but is not responsible for subsequent 
changes to the Web site after this document publishes in the Federal 
Register.) Registration fees cover the cost of facilities, materials, 
and food functions. Seats are limited, and conference space will be 
filled in the order in which registrations are received. Onsite 
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 attendee are as follows:

------------------------------------------------------------------------
                            Category                               Cost
------------------------------------------------------------------------
Industry Representatives.......................................   $1,400
Charitable Nonprofit/Academic (Full time)......................      700
Government (Full time).........................................      420
Tutorial Fees..................................................      405
------------------------------------------------------------------------

    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: Constance.Burnett@diahome.org. 
All registrants will pay a fee with the exception of a limited number 
of speakers/organizers who will have a complimentary registration.

B. Accommodations

    Attendees are responsible for their own accommodations. Attendees 
making reservations at the Marriott Bethesda North Hotel and Conference 
Center, Bethesda, MD, are eligible for a reduced conference rate of 
$209, not including applicable taxes. Those making reservations online 
should use the group code ``13008'' to receive the special rate. If you 
need special accommodations because of disability, please contact 
Constance.Burnett@diahome.org at least 7 days before the meeting.

    Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04331 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P