81 FR 8078 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 31 (February 17, 2016)

Page Range		8078-8079
FR Document		2016-03152

Federal Register, Volume 81 Issue 31 (Wednesday, February 17, 2016)

[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Notices]
[Pages 8078-8079]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Science Board to the Food and Drug Administration Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Science Board to the Food and Drug 
Administration (Science Board).
    General Function of the Committee: The Science Board provides 
advice to the Commissioner of Food and Drugs and other appropriate 
officials on specific, complex scientific and technical issues 
important to the FDA and its mission, including emerging issues within 
the scientific community. Additionally, the Science Board provides 
advice to the Agency on keeping pace with technical and scientific 
developments including in regulatory science, input into the Agency's 
research agenda and on upgrading its scientific and research facilities 
and training opportunities. It will also provide, where requested, 
expert review of Agency-sponsored intramural and extramural scientific 
research programs.
    Date and Time: The meeting will be held on March 1, 2016, from 8:30 
a.m. until 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503, Section A), Silver 
Spring, MD 20993-0002. For those unable to attend in person, the 
meeting will also be webcast. The link for the webcast is available at 
https://collaboration.fda.gov/scienceboard0316/. Answers to commonly 
asked questions including information regarding special accommodations 
due to a disability, visitor parking, and transportation may be 
accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Rakesh Raghuwanshi, Office of the Chief Scientist, 
Office of the Commissioner, Food and Drug Administration, Bldg. 1 Rm. 
3309, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4769, 
[email protected], or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A 
notice in the Federal Register about last minute modifications that 
impact a previously announced advisory committee meeting cannot always 
be published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The Science Board will hear about and discuss: (1) The role 
of opioids in pain management; (2) scientific challenges facing FDA in 
supporting the development of pain medications, including opioids, that 
have reduced risks of being abused; (3) scientific challenges facing 
FDA in seeking to understand the real-world use of opioids to treat 
pain, including the impact of opioids with potentially less risk for 
abuse; (4) the role that FDA plays as a part of a larger Federal, 
State, and local response to the challenges of providing appropriate 
pain treatment while reducing opioid abuse; and (5) postmarket 
surveillance activities related to opioids. The Science Board will also 
receive a final report from the Centers of Excellence in Regulatory 
Science and Innovation Program Evaluation Subcommittee.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
February 23, 2016. Oral presentations from the public will be scheduled 
between approximately 3:15 and 4:15 p.m. Those individuals interested 
in making formal oral presentations should notify the contact person 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before February 23, 2016. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to February 25, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Mr. Rakesh Raghuwanshi at least 7 days in advance of the 
meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 1, 2016, meeting of the Science Board. Because the Agency 
believes there is some urgency to bring these issues to public 
discussion and qualified members of the Science Board were available at 
this time, the Commissioner of Food and Drugs concluded that it was in 
the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).


[[Page 8079]]


    Dated: February 10, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-03152 Filed 2-16-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 31 / Wednesday, February 17, 2016 / Notices 8079

Dated: February 10, 2016. manufacture, marketing, and interested in hearing from small tobacco
Jill Hartzler Warner, distribution of tobacco products to product manufacturers (STPMs) and
Associate Commissioner for Special Medical protect the public health generally and tobacco product manufacturers that use
Programs. to reduce tobacco use by minors. Among an authorized agent.
[FR Doc. 2016–03152 Filed 2–16–16; 8:45 am] its many provisions, the Tobacco
III. Applications for Participation
BILLING CODE 4164–01–P Control Act created requirements for
tobacco product manufacturers and Applications to participate in the
importers, among others, to submit pilot program should be sent
DEPARTMENT OF HEALTH AND certain regulatory documents and electronically to CTPeSub@fda.hhs.gov.
HUMAN SERVICES information to FDA, including, but not Applications should include the
limited to, new tobacco product following information: Company and
Food and Drug Administration applications, documents relating to contact name; contact phone number;
certain research activities and research contact email address; and whether you
[Docket No. FDA–2016–N–0160]
findings, and documents relating to are an STPM. Once applications for
Pilot Program for Tobacco Product tobacco product ingredients, including participation are received, FDA will
Manufacturers; Center for Tobacco harmful and potentially harmful contact interested applicants to discuss
Products eSubmissions Portal constituents. While certain of these the pilot program. FDA is seeking a
documents must be submitted limited number of participants (no more
AGENCY: Food and Drug Administration, electronically, for others an electronic than six) to participate in this pilot
HHS. format for submission currently is not program. The pilot program is expected
ACTION: Notice. required but is strongly encouraged to to last approximately 3 months.
facilitate efficiency and timeliness of Dated: February 10, 2016.
SUMMARY: The Center for Tobacco data submission and management. Also, Leslie Kux,
Products (CTP) in the Food and Drug in June 2013, CTP announced a Associate Commissioner for Policy.
Administration (FDA) is soliciting workshop to obtain public input on
applications from regulated tobacco [FR Doc. 2016–03145 Filed 2–16–16; 8:45 am]
topics related to the potential electronic
product manufacturers to participate in submission of tobacco product
BILLING CODE 4164–01–P

a voluntary pilot program to help CTP applications and other information and
evaluate a potential new portal, the CTP opened a docket for public comment on
eSubmissions Portal (CTP Portal), that is DEPARTMENT OF HEALTH AND
this topic. (For more information about HUMAN SERVICES
being designed to improve the process this workshop, please see ‘‘Electronic
in connection with providing certain Submission of Tobacco Product Food and Drug Administration
regulatory submissions electronically to Applications and Other Information;
CTP. CTP plans to accept up to six Public Workshop; Request for [Docket No. FDA–2015–N–4462]
participants for the pilot program. The Comments’’ (78 FR 34393, June 7, 2013).
pilot program is intended to provide Point of Care Prothrombin Time/
CTP has reviewed the input received
CTP regulatory review staff with an International Normalized Ratio Devices
from the comments and other sources
opportunity to evaluate the CTP Portal, for Monitoring Warfarin Therapy;
and is committed to improving the
Public Workshop; Request for
including its capability for sending and processes for providing regulatory
Comments
receiving secure messages and submissions electronically to FDA.
providing information as to the Consequently, CTP is announcing a AGENCY: Food and Drug Administration,
documents submitted to it (for example, pilot program to test the functionality of HHS.
receipt date and tracking number). the CTP Portal, an electronic submission ACTION: Notice of public workshop;
DATES: Interested parties should submit and communication tool that should request for comments.
an electronic application to participate enhance efficiency, communication, and
in this pilot program by March 2, 2016. timeliness. SUMMARY: The Food and Drug
We plan to conduct user testing Administration (FDA) is announcing the
II. Pilot Program Participation following public workshop entitled
beginning on or about March 18, 2016.
See section III of this document for The pilot program to evaluate the CTP ‘‘Point of Care Prothrombin Time/
information on applications for Portal is to last approximately 3 months. International Normalized Ratio Devices
participation. During the pilot program, CTP staff will for Monitoring Warfarin Therapy.’’ The
be available to answer any questions or purpose of this workshop is to discuss
ADDRESSES: If you are interested in concerns that may arise. Pilot program and receive input from stakeholders
participating in this pilot program, participants will receive training and regarding approaches to the analytical
please submit an electronic application will be asked to submit regulatory and clinical validation of point of care
to CTPeSub@fda.hhs.gov. submissions using data provided to (POC) Prothrombin Time/International
FOR FURTHER INFORMATION CONTACT: Ann them by CTP for testing purposes. Pilot Normalized Ratio (PT/INR) in vitro
Staten, Center for Tobacco Products, program participants also will be asked diagnostic devices for improved clinical
Food and Drug Administration, 10903 to provide written and verbal feedback management of warfarin therapy in
New Hampshire Ave., Bldg. 75, Rm. during their training and after their addition to describing the FDA’s process
G402, Silver Spring, MD 20993–0002, participation in the pilot program is for facilitating the development of safe
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ann.staten@fda.hhs.gov. over. These comments and discussions and effective POC and patient self-
SUPPLEMENTARY INFORMATION: will assist CTP in its development of the testing PT/INR devices. The goal of the
CTP Portal. CTP estimates that each workshop is to seek and identify
I. Background individual participant’s involvement potential solutions to address the
The Family Smoking Prevention and should take about 15 hours. scientific and regulatory challenges
Tobacco Control Act of 2009 (Tobacco CTP is soliciting applications from associated with POC PT/INR devices to
Control Act) (Pub. L. 111–31) grants regulated tobacco product ensure safety and effectiveness. The
FDA important authority to regulate the manufacturers and, in particular, is public workshop on ‘‘Point of Care

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Document Created: 2016-02-17 01:16:25
Document Modified: 2016-02-17 01:16:25

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.
FR Citation		81 FR 8078

81 FR 8078 - Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 31 (February 17, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration