83 FR 12582 - 2018 Center for Biologics Evaluation and Research Science Symposium

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 56 (March 22, 2018)

Page Range		12582-12582
FR Document		2018-05805

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public symposium entitled ``2018 Center for Biologics Evaluation and Research Science Symposium.'' The purpose of the public symposium is to discuss scientific topics related to the regulation of biologics and highlight science conducted at the Center for Biologics Evaluation and Research (CBER) by showcasing how scientific research informs regulatory decision making and to provide a forum for developing collaborations within FDA and with external organizations. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

Federal Register, Volume 83 Issue 56 (Thursday, March 22, 2018)

[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Notices]
[Page 12582]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05805]



[[Page 12582]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1094]


2018 Center for Biologics Evaluation and Research Science 
Symposium

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public symposium.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public symposium entitled ``2018 Center for 
Biologics Evaluation and Research Science Symposium.'' The purpose of 
the public symposium is to discuss scientific topics related to the 
regulation of biologics and highlight science conducted at the Center 
for Biologics Evaluation and Research (CBER) by showcasing how 
scientific research informs regulatory decision making and to provide a 
forum for developing collaborations within FDA and with external 
organizations. The symposium will include presentations by experts from 
academic institutions, government agencies, and research institutions.

DATES: The public symposium will be held on June 25 and 26, 2018, from 
9 a.m. to 3 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public symposium will be held at FDA's White Oak campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public symposium 
participants (non-FDA employees) is through Bldg. 1, where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Sherri Revell or Loni Warren 
Henderson, Food and Drug Administration, Center for Biologics 
Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, 
Silver Spring, MD 20993, 240-402-8010, email: 
[email protected] (subject line: CBER Science Symposium).

SUPPLEMENTARY INFORMATION: 

I. Background

    The purpose of the public symposium is to discuss scientific topics 
related to the regulation of biologics and highlight science conducted 
at CBER by showcasing how scientific research informs regulatory 
decision making and to provide a forum for developing collaborations 
within FDA and with external organizations.

II. Topics for Discussion at the Public Symposium

    The public symposium will include presentations on the following 
topics: (1) Emerging and re-emerging diseases; (2) diverse types of 
data in regulatory decision making; (3) immune response to vaccination; 
(4) immunotherapy; (5) new technologies for research and treatments; 
(6) the role of the microbiome in human disease; and (7) regenerative 
medicine.

III. Participating in the Public Symposium

    Registration: To register for the public symposium, please visit 
the following website: https://www.eventbrite.com/e/2018-center-for-biologics-evaluation-and-research-cber-science-symposium-tickets-39525851887. Please provide complete contact information for each 
attendee, including name, title, affiliation, address, email, and 
telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
symposium (either in person or by webcast) (see Streaming Webcast of 
the Public Symposium) must register online by June 18, 2018, midnight 
Eastern Time. Early registration is recommended because seating is 
limited. There will be no onsite registration; therefore, FDA may limit 
the number of participants from each organization. Registrants will 
receive confirmation when they have been accepted.
    If you need special accommodations, due to a disability, please 
contact Sherri Revell or Loni Warren Henderson no later than June 11, 
2018.
    Streaming Webcast of the Public Symposium: This public symposium 
will also be webcast. A link to the live webcast of this symposium will 
be provided upon registration at https://www.eventbrite.com/e/2018-center-for-biologics-evaluation-and-research-cber-science-symposium-tickets-39525851887. Persons interested in viewing the live webcast 
must register online by June 18, 2018. Early registration is 
recommended because webcast connections are limited. A video record of 
the public symposium will be available at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/default.htm for 1 year.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.

    Dated: March 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05805 Filed 3-21-18; 8:45 am]
 BILLING CODE 4164-01-P

12582 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Notices

DEPARTMENT OF HEALTH AND science conducted at CBER by WorkshopsMeetingsConferences/
HUMAN SERVICES showcasing how scientific research default.htm for 1 year.
informs regulatory decision making and If you have never attended a Connect
Food and Drug Administration to provide a forum for developing Pro event before, test your connection at
[Docket No. FDA–2018–N–1094]
collaborations within FDA and with https://collaboration.fda.gov/common/
external organizations. help/en/support/meeting_test.htm. To
2018 Center for Biologics Evaluation get a quick overview of the Connect Pro
II. Topics for Discussion at the Public
and Research Science Symposium program, visit https://www.adobe.com/
Symposium
go/connectpro_overview. FDA has
AGENCY: Food and Drug Administration, The public symposium will include verified the website addresses in this
HHS. presentations on the following topics: document as of the date this document
ACTION: Notice of public symposium. (1) Emerging and re-emerging diseases; publishes in the Federal Register, but
(2) diverse types of data in regulatory websites are subject to change over time.
SUMMARY: The Food and Drug decision making; (3) immune response Dated: March 1, 2018.
Administration (FDA, the Agency, or to vaccination; (4) immunotherapy; (5)
we) is announcing the following public Leslie Kux,
new technologies for research and Associate Commissioner for Policy.
symposium entitled ‘‘2018 Center for treatments; (6) the role of the
Biologics Evaluation and Research [FR Doc. 2018–05805 Filed 3–21–18; 8:45 am]
microbiome in human disease; and (7)
Science Symposium.’’ The purpose of regenerative medicine. BILLING CODE 4164–01–P
the public symposium is to discuss
scientific topics related to the regulation III. Participating in the Public
of biologics and highlight science Symposium DEPARTMENT OF HEALTH AND
conducted at the Center for Biologics HUMAN SERVICES
Registration: To register for the public
Evaluation and Research (CBER) by symposium, please visit the following
showcasing how scientific research Food and Drug Administration
website: https://www.eventbrite.com/e/
informs regulatory decision making and 2018-center-for-biologics-evaluation- [Docket Nos. FDA–2014–N–1027; FDA–
to provide a forum for developing and-research-cber-science-symposium- 2017–N–1064; FDA–2014–D–0329; FDA–
collaborations within FDA and with tickets-39525851887. Please provide 2013–N–1429; FDA–2009–N–0505; and
external organizations. The symposium complete contact information for each FDA–2014–N–0192]
will include presentations by experts attendee, including name, title,
from academic institutions, government Agency Information Collection
affiliation, address, email, and Activities; Announcement of Office of
agencies, and research institutions. telephone.
DATES: The public symposium will be
Management and Budget Approvals
Registration is free and based on
held on June 25 and 26, 2018, from 9 space availability, with priority given to AGENCY: Food and Drug Administration,
a.m. to 3 p.m. See the SUPPLEMENTARY early registrants. Persons interested in HHS.
INFORMATION section for registration date attending this public symposium (either ACTION: Notice.
and information. in person or by webcast) (see Streaming
ADDRESSES: The public symposium will Webcast of the Public Symposium) must SUMMARY: The Food and Drug
be held at FDA’s White Oak campus, register online by June 18, 2018, Administration (FDA) is publishing a
10903 New Hampshire Ave., Bldg. 31 midnight Eastern Time. Early list of information collections that have
Conference Center, the Great Room (Rm. registration is recommended because been approved by the Office of
1503), Silver Spring, MD 20993. seating is limited. There will be no Management and Budget (OMB) under
Entrance for the public symposium onsite registration; therefore, FDA may the Paperwork Reduction Act of 1995.
participants (non-FDA employees) is limit the number of participants from FOR FURTHER INFORMATION CONTACT: Ila
through Bldg. 1, where routine security each organization. Registrants will S. Mizrachi, Office of Operations, Food
check procedures will be performed. For receive confirmation when they have and Drug Administration, Three White
parking and security information, please been accepted. Flint North, 10A–12M, 11601
refer to https://www.fda.gov/AboutFDA/ If you need special accommodations, Landsdown St., North Bethesda, MD
WorkingatFDA/BuildingsandFacilities/ due to a disability, please contact Sherri 20852, 301–796–7726, PRAStaff@
WhiteOakCampusInformation/ Revell or Loni Warren Henderson no fda.hhs.gov.
ucm241740.htm. later than June 11, 2018. SUPPLEMENTARY INFORMATION: The
FOR FURTHER INFORMATION CONTACT: Streaming Webcast of the Public following is a list of FDA information
Sherri Revell or Loni Warren Symposium: This public symposium collections recently approved by OMB
Henderson, Food and Drug will also be webcast. A link to the live under section 3507 of the Paperwork
Administration, Center for Biologics webcast of this symposium will be Reduction Act of 1995 (44 U.S.C. 3507).
Evaluation and Research, 10903 New provided upon registration at https:// The OMB control number and
Hampshire Ave., Bldg. 71, Rm. 1118, www.eventbrite.com/e/2018-center-for- expiration date of OMB approval for
Silver Spring, MD 20993, 240–402– biologics-evaluation-and-research-cber- each information collection are shown
8010, email: CBERPublicEvents@ science-symposium-tickets- in table 1. Copies of the supporting
fda.hhs.gov (subject line: CBER Science 39525851887. Persons interested in statements for the information
Symposium). viewing the live webcast must register collections are available on the internet
daltland on DSKBBV9HB2PROD with NOTICES

SUPPLEMENTARY INFORMATION: online by June 18, 2018. Early at https://www.reginfo.gov/public/do/
registration is recommended because PRAMain. An Agency may not conduct
I. Background webcast connections are limited. A or sponsor, and a person is not required
The purpose of the public symposium video record of the public symposium to respond to, a collection of
is to discuss scientific topics related to will be available at https://www.fda.gov/ information unless it displays a
the regulation of biologics and highlight BiologicsBloodVaccines/NewsEvents/ currently valid OMB control number.

VerDate Sep<11>2014 19:32 Mar 21, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\22MRN1.SGM 22MRN1

Document Created: 2018-03-22 01:25:15
Document Modified: 2018-03-22 01:25:15

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 symposium.
Dates		The public symposium will be held on June 25 and 26, 2018, from 9 a.m. to 3 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Sherri Revell or Loni Warren Henderson, Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 1118, Silver Spring, MD 20993, 240-402-8010, email: [email protected] (subject line: CBER Science Symposium).
FR Citation		83 FR 12582

83 FR 12582 - 2018 Center for Biologics Evaluation and Research Science Symposium

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 56 (March 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration