81 FR 12499 - Tenth Annual Drug Information Association/Food and Drug Administration Statistics Forum-2016; Public Conference
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12499-12500 | |
| FR Document | 2016-05219 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12499-12500] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-05219] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2016-N-0001] Tenth Annual Drug Information Association/Food and Drug Administration Statistics Forum--2016; Public Conference AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public conference. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), in co-sponsorship with the Drug Information Association (DIA), is announcing a public conference entitled ``Tenth Annual DIA/Food and Drug Administration Statistics Forum--2016.'' This public conference is intended to be an open forum for the timely discussion of topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop and review new drugs and biologics. A primary focus for this public conference will be to establish an ongoing dialogue between industry and regulatory Agencies--emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials and measuring the progress being made in designing and implementing innovative solutions. DATES: The main meeting will be held over 3 days: April 25, 2016, from 1 p.m. to 5:30 p.m.; April 26, 2016, from 8:30 a.m. to 5 p.m.; and April 27, 2016, from 8:30 a.m. to 3:30 p.m. On April 25, there will also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a scientific working group session from 5:40 p.m. to 7 p.m. ADDRESSES: The meeting 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: Meredith Kaganovskiy, DIA, 800 Enterprise Rd., Horsham, PA 19044, 215-442-6117, [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 FDA and DIA will sponsor an open public discussion between industry, academia, contract research organizations, regulatory scientists, and other parties on topics related to the innovative statistical methodologies and quantitative approaches used by sponsors to provide evidence for the approval of new therapies. The forum will provide a unique opportunity for all of the relevant stakeholders to collaboratively describe the issues and discuss appropriate solutions. It is important that all of the stakeholders examine their roles in making the necessary changes and improvements in the framework used to develop evidence for the regulatory decisions and work to foster a mutual understanding of relevant scientific issues and challenges. The conference will benefit FDA by enhancing communication with the broader statistical community. The goals of the program are as follows:Explore and implement innovative statistical solutions to important issues associated with the quantitative evidence needed for the regulatory review of therapeutic drugs and biologics Describe the application of statistical methodologies and thinking regarding 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 regulatory reviewers A description of the planned activities of the working groups can be found at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum. II. Registration and Accommodations A. Registration There is a registration fee to attend this meeting. The registration fee is to help defray the costs of the event; including meeting facilities, program materials, refreshments, staff time and administrative overhead, and costs involved in getting speakers to the events; and will not result in any profits. Seats are limited, and registration will be on a first-come, first-served basis. On-site registration will be available to the extent that space is available on the day of the conference. Please note: Registration will open at 7:30 a.m. each day. To register, please complete registration online at http://www.diaglobal.org/en/conference-listing/meetings/2016/04/dia-fda-statistics-2016-forum/register. (FDA has verified the Web address, but 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 (Full time)..................... 675 Government (Full time)........................................ 405 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. B. Accommodations Attendees are responsible for their own hotel accommodations. Attendees making reservations at the Bethesda North Marriot Hotel and Conference Center, 5701 Marinelli Rd., North Bethesda, MD 20852 are eligible for a reduced rate of $199, not including applicable taxes. The Marriott Bethesda North Hotel and Conference Center has a limited [[Page 12500]] number of rooms available at the discounted rate of $199 per night until April 1, 2016, or until the block is filled. To receive the reduced rate, hotel reservations must be made with onPeak, https://compass.onpeak.com/e/72FOR16, and not directly with the hotel. If you need special accommodations due to a disability, please contact [email protected] at least 7 days in advance. Dated: March 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-05219 Filed 3-8-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices 12499
draft guidance and those comments ongoing dialogue between industry and • Describe the application of statistical
were considered as the guidance was regulatory Agencies—emphasizing the methodologies and thinking regarding
finalized. The guidance announced in regulatory and statistical challenges the development of new therapeutic
this notice finalizes the draft guidance associated with innovative approaches biologics and drugs
dated March 2015. to the design and analysis of clinical • Assess the impact of regulations and
trials and measuring the progress being guidance on statistical practice
II. Significance of Guidance • Discuss ideas for improving the
made in designing and implementing
This level 1 guidance is being issued innovative solutions. communication between industry
consistent with FDA’s good guidance DATES: The main meeting will be held statisticians and regulatory reviewers
practices regulation (21 CFR 10.115). over 3 days: April 25, 2016, from 1 p.m. A description of the planned activities
The guidance represents the current to 5:30 p.m.; April 26, 2016, from 8:30 of the working groups can be found at
thinking of FDA on ensuring safety of a.m. to 5 p.m.; and April 27, 2016, from http://www.diaglobal.org/en/
animal feed maintained and fed on- 8:30 a.m. to 3:30 p.m. On April 25, there conference-listing/meetings/2016/04/
farm. It does not establish any rights for will also be pre-meeting tutorials from dia-fda-statistics-2016-forum.
any person and is not binding on FDA 8:30 a.m. to 12 p.m. and a scientific
or the public. You can use an alternative II. Registration and Accommodations
working group session from 5:40 p.m. to
approach if it satisfies the requirements 7 p.m. A. Registration
of the applicable statutes and
ADDRESSES: The meeting will be held at There is a registration fee to attend
regulations.
the Marriott Bethesda North Hotel and this meeting. The registration fee is to
III. Paperwork Reduction Act of 1995 Conference Center, 5701 Marinelli Rd., help defray the costs of the event;
FDA concludes that there are no North Bethesda, MD 20852, 301–822– including meeting facilities, program
collections of information under the 9200. materials, refreshments, staff time and
Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT:
administrative overhead, and costs
Meredith Kaganovskiy, DIA, 800 involved in getting speakers to the
IV. Electronic Access events; and will not result in any
Enterprise Rd., Horsham, PA 19044,
Persons with access to the Internet 215–442–6117, profits. Seats are limited, and
may obtain the guidance at either http:// Meredith.Kaganovskiy@DIAglobal.orgM; registration will be on a first-come, first-
www.fda.gov/AnimalVeterinary/ or Stephen Wilson, Food and Drug served basis. On-site registration will be
GuidanceComplianceEnforcement/ Administration, 10903 New Hampshire available to the extent that space is
GuidanceforIndustry/default.htm or Ave., Bldg. 21, Rm. 3630, Silver Spring, available on the day of the conference.
http://www.regulations.gov. MD 20993–0002, 301–796–0579, Please note: Registration will open at
Dated: March 2, 2016. Stephen.Wilson@fda.hhs.gov. 7:30 a.m. each day.
To register, please complete
Leslie Kux, SUPPLEMENTARY INFORMATION: registration online at http://
Associate Commissioner for Policy. www.diaglobal.org/en/conference-
[FR Doc. 2016–05222 Filed 3–8–16; 8:45 am] I. Background
listing/meetings/2016/04/dia-fda-
BILLING CODE 4164–01–P FDA and DIA will sponsor an open statistics-2016-forum/register. (FDA has
public discussion between industry, verified the Web address, but is not
academia, contract research responsible for subsequent changes to
DEPARTMENT OF HEALTH AND organizations, regulatory scientists, and the Web site after this document
HUMAN SERVICES other parties on topics related to the publishes in the Federal Register.) The
innovative statistical methodologies and costs of registration for the different
Food and Drug Administration quantitative approaches used by categories of attendees are as follows:
[Docket No. FDA 2016–N–0001] sponsors to provide evidence for the
approval of new therapies. Category Cost
Tenth Annual Drug Information The forum will provide a unique
Association/Food and Drug opportunity for all of the relevant Industry Representatives ................ $1,350
Administration Statistics Forum— stakeholders to collaboratively describe Charitable Nonprofit/Academic (Full
2016; Public Conference the issues and discuss appropriate time) ............................................ 675
Government (Full time) ................... 405
AGENCY: Food and Drug Administration, solutions. It is important that all of the
Tutorial Fees ................................... 405
HHS. stakeholders examine their roles in
making the necessary changes and All registrants will be required to pay
ACTION: Notice of public conference.
improvements in the framework used to the applicable fee, with the exception of
SUMMARY: The Food and Drug develop evidence for the regulatory a limited number of speakers/organizers
Administration (FDA), in co- decisions and work to foster a mutual who will have a complimentary
sponsorship with the Drug Information understanding of relevant scientific registration.
Association (DIA), is announcing a issues and challenges.
public conference entitled ‘‘Tenth The conference will benefit FDA by B. Accommodations
Annual DIA/Food and Drug enhancing communication with the Attendees are responsible for their
Administration Statistics Forum— broader statistical community. own hotel accommodations. Attendees
2016.’’ This public conference is The goals of the program are as making reservations at the Bethesda
Lhorne on DSK5TPTVN1PROD with NOTICES
intended to be an open forum for the follows: North Marriot Hotel and Conference
timely discussion of topics of mutual • Explore and implement innovative Center, 5701 Marinelli Rd., North
theoretical and practical interest to statistical solutions to important Bethesda, MD 20852 are eligible for a
statisticians and clinical trialists who issues associated with the quantitative reduced rate of $199, not including
develop and review new drugs and evidence needed for the regulatory applicable taxes.
biologics. A primary focus for this review of therapeutic drugs and The Marriott Bethesda North Hotel
public conference will be to establish an biologics and Conference Center has a limited
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![12500 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
number of rooms available at the Human Cells, Tissues, and Cellular and 2015–D–0349 for ‘‘Investigating and
discounted rate of $199 per night until Tissue-Based Products (HCT/Ps)’’ dated Reporting Adverse Reactions Related to
April 1, 2016, or until the block is filled. December 2011 and supersedes the Human Cells, Tissues, and Cellular and
To receive the reduced rate, hotel guidance entitled ‘‘Guidance for Tissue-Based Products Regulated Solely
reservations must be made with onPeak, Industry: MedWatch Form FDA 3500A: under Section 361 of the Public Health
https://compass.onpeak.com/e/ Mandatory Reporting of Adverse Service Act and 21 CFR part 1271;
72FOR16, and not directly with the Reactions Related to Human Cells, Guidance for Industry.’’ Received
hotel. If you need special Tissues, and Cellular and Tissue-Based comments will be placed in the docket
accommodations due to a disability, Products (HCT/Ps)’’ dated November and, except for those submitted as
please contact 2005. The guidance announced in this ‘‘Confidential Submissions,’’ publicly
Stephanie.Ritter@DIAglobal.org at least notice finalizes the draft guidance of the viewable at http://www.regulations.gov
7 days in advance. same title dated February 2015. or at the Division of Dockets
Dated: March 3, 2016. DATES: Submit either electronic or Management between 9 a.m. and 4 p.m.,
written comments on Agency guidances Monday through Friday.
Leslie Kux, • Confidential Submissions—To
Associate Commissioner for Policy. at any time.
submit a comment with confidential
[FR Doc. 2016–05219 Filed 3–8–16; 8:45 am] ADDRESSES: You may submit comments information that you do not wish to be
BILLING CODE 4164–01–P
as follows: made publicly available submit your
Electronic Submissions comments only as a written/paper
submission. You should submit two
DEPARTMENT OF HEALTH AND Submit electronic comments in the copies total. One copy will include the
HUMAN SERVICES following way: information you claim to be confidential
• Federal eRulemaking Portal: http:// with a heading or cover note that states
Food and Drug Administration www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
[Docket No. FDA–2015–D–0349]
Comments submitted electronically, Agency will review this copy, including
Investigating and Reporting Adverse including attachments, to http:// the claimed confidential information, in
Reactions Related to Human Cells, www.regulations.gov will be posted to its consideration of comments. The
Tissues, and Cellular and Tissue- the docket unchanged. Because your second copy, which will have the
Based Products; Guidance for comment will be made public, you are claimed confidential information
Industry; Availability solely responsible for ensuring that your redacted/blacked out, will be available
comment does not include any for public viewing and posted on
AGENCY: Food and Drug Administration, confidential information that you or a http://www.regulations.gov. Submit
HHS. third party may not wish to be posted, both copies to the Division of Dockets
ACTION: Notice of availability. such as medical information, your or Management. If you do not wish your
anyone else’s Social Security number, or name and contact information to be
SUMMARY: The Food and Drug confidential business information, such made publicly available, you can
Administration (FDA or Agency) is as a manufacturing process. Please note provide this information on the cover
announcing the availability of a that if you include your name, contact sheet and not in the body of your
document entitled ‘‘Investigating and information, or other information that comments and you must identify this
Reporting Adverse Reactions Related to identifies you in the body of your information as ‘‘confidential.’’ Any
Human Cells, Tissues, and Cellular and comments, that information will be information marked as ‘‘confidential’’
Tissue-Based Products (HCT/Ps) posted on http://www.regulations.gov. will not be disclosed except in
Regulated Solely Under Section 361 of • If you want to submit a comment accordance with 21 CFR 10.20 and other
the Public Health Service Act and 21 with confidential information that you applicable disclosure law. For more
CFR part 1271; Guidance for Industry.’’ do not wish to be made available to the information about FDA’s posting of
The guidance document provides public submit the comment as a written/ comments to public dockets, see 80 FR
establishments that manufacture human paper submission and in the manner 56469, September 18, 2015, or access
cells, tissues, and cellular and tissue- detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
based products (HCT/Ps) for which no Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
premarket submissions are required default.htm.
because they are not also regulated as Written/Paper Submissions
Docket: For access to the docket to
drugs, devices, and/or biological Submit written/paper submissions as read background documents or the
products, with recommendations for follows: electronic and written/paper comments
complying with the requirements for • Mail/Hand delivery/Courier (for received, go to http://
investigating and reporting adverse written/paper submissions): Division of www.regulations.gov and insert the
reactions involving communicable Dockets Management (HFA–305), Food docket number, found in brackets in the
disease in recipients of these HCT/Ps. and Drug Administration, 5630 Fishers heading of this document, into the
The guidance also provides updated Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
information specific to reporting • For written/paper comments and/or go to the Division of Dockets
adverse reactions related to HCT/Ps to submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
supplement the general instructions Management, FDA will post your 1061, Rockville, MD 20852.
Lhorne on DSK5TPTVN1PROD with NOTICES
accompanying the MedWatch comment, as well as any attachments, Submit written requests for single
mandatory reporting form, Form FDA except for information submitted, copies of the guidance to the Office of
3500A. The guidance supplements marked and identified, as confidential, Communication, Outreach and
section XXII of FDA’s guidance entitled if submitted as detailed in Development, Center for Biologics
‘‘Guidance for Industry: Current Good ‘‘Instructions.’’ Evaluation and Research (CBER), Food
Tissue Practice (CGTP) and Additional Instructions: All submissions received and Drug Administration, 10903 New
Requirements for Manufacturers of must include the Docket No. FDA– Hampshire Ave., Bldg. 71, Rm. 3128,
VerDate Sep<11>2014 15:08 Mar 08, 2016 Jkt 238001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/81_FR_12545/page/2.svg)
Document Created: 2016-03-09 00:13:56
Document Modified: 2016-03-09 00:13:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public conference. | |
| Dates | The main meeting will be held over 3 days: April 25, 2016, from 1 p.m. to 5:30 p.m.; April 26, 2016, from 8:30 a.m. to 5 p.m.; and April 27, 2016, from 8:30 a.m. to 3:30 p.m. On April 25, there will also be pre-meeting tutorials from 8:30 a.m. to 12 p.m. and a scientific working group session from 5:40 p.m. to 7 p.m. | |
| Contact | Meredith Kaganovskiy, DIA, 800 Enterprise Rd., Horsham, PA 19044, 215-442-6117, [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 Citation | 81 FR 12499 |
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