83 FR 15844 - Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

Page Range		15844-15845
FR Document		2018-07544

The Reagan-Udall Foundation (the Foundation) for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Administration Amendments Act of 2007, is announcing its annual public meeting. The Foundation will discuss its activities and how it supports FDA.

Federal Register, Volume 83 Issue 71 (Thursday, April 12, 2018)

[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15844-15845]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Annual Public Meeting; Reagan-Udall Foundation for the Food and 
Drug Administration

AGENCY: Reagan-Udall Foundation for the Food and Drug Administration.

ACTION: Notice of annual meeting.

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SUMMARY: The Reagan-Udall Foundation (the Foundation) for the Food and 
Drug Administration (FDA), which was created by Title VI of the Food 
and Drug Administration Amendments Act of 2007, is announcing its 
annual public meeting. The Foundation will discuss its activities and 
how it supports FDA.

DATES: The public meeting will be held on May 4, 2018, from 10 a.m. 
until 12 noon. Registration to attend the meeting must be received by 
May 3, 2018, at 5 p.m. Eastern Time. Requests for oral presentations 
must be received before May 2, 2018, at 5 p.m. Eastern Time. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information. The public is also invited to submit written comments by 
sending them via email to Elisabeth Shaefer (see FOR FURTHER 
INFORMATION CONTACT) before May 3, 2018, at 5 p.m. Eastern Time.

ADDRESSES: The public meeting will be held at Alston & Bird, 950 F St. 
NW, Washington, DC 20006.

FOR FURTHER INFORMATION CONTACT: Elisabeth Shaefer, Executive Assistant 
to the Executive Director, Reagan-Udall Foundation for the FDA, 202-
849-2255, eshaefer@reaganudall.org.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Reagan-Udall Foundation for the FDA is an independent 501(c)(3) 
not-for-profit, organization created by Congress to advance the mission 
of FDA to modernize medical, veterinary, food, food ingredient, and 
cosmetic product development; accelerate innovation, and enhance 
product safety. With the ultimate goal of improving public health, the 
Foundation provides a unique opportunity for different sectors (FDA, 
patient groups, academia, other government entities, and industry) to 
work together in a transparent way to create exciting new research and 
engagement projects to advance regulatory science.
    The Foundation acts as a neutral third party to establish novel, 
scientific collaborations. Much like any other independently developed 
information, FDA evaluates the scientific information from these 
collaborations to determine how the Foundation projects can help the 
Agency to fulfill its mission.
    Foundation projects currently include: Innovation in Medical 
Evidence Development and Surveillance, a public-private partnership 
that allows researchers to study drug safety concerns of interest to 
public health; an Expanded Access Navigator that offers instructional 
material and resources for physicians, patients, and their caregivers 
on how to access investigational drugs outside of clinical trials; and 
a new joint Foundation and FDA regulatory science fellowship program.

II. Topics for Discussion at the Public Meeting

    FDA Commissioner, Dr. Scott Gottlieb, will deliver a keynote 
address, followed by a panel discussion on the ``Evolution of FDA 
Science and Engagement'' and the role of the Foundation. Panelists will 
include the current FDA Commissioner, Dr. Scott Gottlieb, and former 
FDA Commissioners Drs. Robert Califf and Andrew C. von Eschenbach. The 
panel moderator will be Susan Dentzer, President and Chief Executive 
Officer of the Network for Excellence in Health Innovation. Find the 
meeting agenda at https://reaganudall.org/public-meeting.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website to register: https://reaganudall.org/public-meeting. 
Persons interested in attending this public meeting must register 
online by May 3, 2018, at 5 p.m. Eastern Time.
    If you need special accommodations due to a disability, please 
contact Elisabeth Shaefer (see FOR FURTHER INFORMATION CONTACT) no 
later than May 1, 2018.
    Requests for Oral Presentations: Interested persons may present 
comments at the public meeting. Comments will be scheduled to begin 
approximately at 11:30 a.m. Time allotted for comments may be limited 
to 3 minutes, dependent on the number of requests received. Those 
desiring to make oral comments should notify Elisabeth Shaefer (see FOR 
FURTHER INFORMATION CONTACT) by May 2, 2018. Please include a brief 
statement of the general nature of the comments you wish to present 
along with your name, address, telephone number, and email address. The 
contact person will notify individuals regarding their request to speak 
by May 3, 2018.


[[Page 15845]]


    Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07544 Filed 4-11-18; 8:45 am]
 BILLING CODE 4161-01-P

15844 Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices

ANNUAL BURDEN ESTIMATES
Number of Average
Annual responses Total burden hours Total annual
Instrument number of per responses per burden hours
respondents respondent response

Annual/Final Report to the Secretary (depending on re-
porting period) .................................................................. 25 1 1 50 1,250

Estimated Total Annual Burden DATES: The public meeting will be held material and resources for physicians,
Hours: 1,250. on May 4, 2018, from 10 a.m. until 12 patients, and their caregivers on how to
Additional Information: Copies of the noon. Registration to attend the meeting access investigational drugs outside of
proposed collection may be obtained by must be received by May 3, 2018, at 5 clinical trials; and a new joint
writing to the Administration for p.m. Eastern Time. Requests for oral Foundation and FDA regulatory science
Children and Families, Office of presentations must be received before fellowship program.
Planning, Research and Evaluation, 370 May 2, 2018, at 5 p.m. Eastern Time. See
L’Enfant Promenade SW, Washington, the SUPPLEMENTARY INFORMATION section II. Topics for Discussion at the Public
DC 20447, Attn: ACF Reports Clearance for registration date and information. Meeting
Officer. All requests should be The public is also invited to submit
FDA Commissioner, Dr. Scott
identified by the title of the information written comments by sending them via
Gottlieb, will deliver a keynote address,
collection. Email address: email to Elisabeth Shaefer (see FOR
FURTHER INFORMATION CONTACT) before
followed by a panel discussion on the
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to May 3, 2018, at 5 p.m. Eastern Time. ‘‘Evolution of FDA Science and
make a decision concerning the Engagement’’ and the role of the
ADDRESSES: The public meeting will be
collection of information between 30 Foundation. Panelists will include the
held at Alston & Bird, 950 F St. NW,
and 60 days after publication of this current FDA Commissioner, Dr. Scott
Washington, DC 20006.
document in the Federal Register. Gottlieb, and former FDA
FOR FURTHER INFORMATION CONTACT:
Therefore, a comment is best assured of Commissioners Drs. Robert Califf and
Elisabeth Shaefer, Executive Assistant to
having its full effect if OMB receives it Andrew C. von Eschenbach. The panel
the Executive Director, Reagan-Udall
within 30 days of publication. Written moderator will be Susan Dentzer,
Foundation for the FDA, 202–849–2255,
comments and recommendations for the President and Chief Executive Officer of
eshaefer@reaganudall.org.
proposed information collection should the Network for Excellence in Health
SUPPLEMENTARY INFORMATION:
be sent directly to the following: Office Innovation. Find the meeting agenda at
of Management and Budget, Paperwork I. Background https://reaganudall.org/public-meeting.
Reduction Project, Fax: 202–395–7285, The Reagan-Udall Foundation for the III. Participating in the Public Meeting
Email: OIRA_SUBMISSION@ FDA is an independent 501(c)(3) not-
OMB.EOP.GOV, Attn: Desk Officer for for-profit, organization created by Registration: To register for the public
the Administration for Children and Congress to advance the mission of FDA meeting, please visit the following
Families. to modernize medical, veterinary, food, website to register: https://
Robert Sargis, food ingredient, and cosmetic product reaganudall.org/public-meeting. Persons
development; accelerate innovation, and interested in attending this public
Reports Clearance Officer.
enhance product safety. With the meeting must register online by May 3,
[FR Doc. 2018–07522 Filed 4–11–18; 8:45 am]
ultimate goal of improving public 2018, at 5 p.m. Eastern Time.
BILLING CODE 4184–01–P
health, the Foundation provides a If you need special accommodations
unique opportunity for different sectors due to a disability, please contact
(FDA, patient groups, academia, other Elisabeth Shaefer (see FOR FURTHER
DEPARTMENT OF HEALTH AND
government entities, and industry) to INFORMATION CONTACT) no later than May
HUMAN SERVICES
work together in a transparent way to 1, 2018.
Food and Drug Administration create exciting new research and
engagement projects to advance Requests for Oral Presentations:
[Docket No. FDA–2018–N–0001] regulatory science. Interested persons may present
The Foundation acts as a neutral third comments at the public meeting.
Annual Public Meeting; Reagan-Udall party to establish novel, scientific Comments will be scheduled to begin
Foundation for the Food and Drug collaborations. Much like any other approximately at 11:30 a.m. Time
Administration independently developed information, allotted for comments may be limited to
AGENCY: Reagan-Udall Foundation for FDA evaluates the scientific information 3 minutes, dependent on the number of
the Food and Drug Administration. from these collaborations to determine requests received. Those desiring to
ACTION: Notice of annual meeting. how the Foundation projects can help make oral comments should notify
the Agency to fulfill its mission. Elisabeth Shaefer (see FOR FURTHER
SUMMARY: The Reagan-Udall Foundation Foundation projects currently INFORMATION CONTACT) by May 2, 2018.
sradovich on DSK3GMQ082PROD with NOTICES

(the Foundation) for the Food and Drug include: Innovation in Medical Please include a brief statement of the
Administration (FDA), which was Evidence Development and general nature of the comments you
created by Title VI of the Food and Drug Surveillance, a public-private wish to present along with your name,
Administration Amendments Act of partnership that allows researchers to address, telephone number, and email
2007, is announcing its annual public study drug safety concerns of interest to address. The contact person will notify
meeting. The Foundation will discuss public health; an Expanded Access individuals regarding their request to
its activities and how it supports FDA. Navigator that offers instructional speak by May 3, 2018.

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Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices 15845

Dated: April 6, 2018. FOR FURTHER INFORMATION CONTACT: to Pharmaceutical Current Good
Leslie Kux, Domini Bean, Office of Operations, Manufacturing Practice.’’ We intend the
Associate Commissioner for Policy. Food and Drug Administration, Three guidance to inform manufacturers of
[FR Doc. 2018–07544 Filed 4–11–18; 8:45 am] White Flint North, 10A–12M, 11601 veterinary and human drugs, including
BILLING CODE 4161–01–P
Landsdown St., North Bethesda, MD human biological drug products, on
20852, 301–796–5733, PRAStaff@ how to resolve disputes about scientific
fda.hhs.gov. and technical issues relating to current
DEPARTMENT OF HEALTH AND good manufacturing practice (CGMP).
SUPPLEMENTARY INFORMATION: In
HUMAN SERVICES Disputes related to scientific and
compliance with 44 U.S.C. 3507, FDA
technical issues may arise during FDA
Food and Drug Administration has submitted the following proposed
inspections of pharmaceutical
collection of information to OMB for
[Docket No. FDA–2014–N–1076] manufacturers to determine compliance
review and clearance.
with CGMP requirements or during
Agency Information Collection Guidance for Industry on Formal FDA’s assessment of corrective actions
Activities; Submission for Office of Dispute Resolution: Scientific and undertaken as a result of such
Management and Budget Review; Technical Issues Related to inspections. The guidance recommends
Comment Request; Guidance for Pharmaceutical Current Good procedures that we believe encourage
Industry on Formal Dispute Manufacturing Practice open and prompt discussion of disputes
Resolution: Scientific and Technical and lead to their resolution. The
OMB Control Number 0910–0563—
Issues Related to Pharmaceutical guidance describes procedures for
Extension
Current Good Manufacturing Practice raising such disputes to the Office of
Congress enacted section 562 of the Regulatory Affairs and Center levels and
AGENCY: Food and Drug Administration, Federal Food, Drug, and Cosmetic Act for requesting review by the dispute
HHS. (FD&C Act) (21 U.S.C. 360bbb–1), which resolution (DR) panel. The guidance is
ACTION: Notice. directed FDA to ensure that it had available on our website at: https://
adequate dispute resolution procedures www.fda.gov/downloads/drugs/
SUMMARY: The Food and Drug to provide for appropriate review of guidances/ucm070279.pdf, along with
Administration (FDA) is announcing scientific controversies between the additional information regarding the
that a proposed collection of FDA and members of regulated resolution of scientific disputes at FDA.
information has been submitted to the industry, including possible review by a In the Federal Register of October 27,
Office of Management and Budget scientific advisory committee. To 2017 (82 FR 49832), we published a
(OMB) for review and clearance under implement this provision, we amended notice soliciting public comment on the
the Paperwork Reduction Act of 1995. the general appeal regulation applicable proposed collection of information.
DATES: Fax written comments on the across all FDA components (21 CFR Although no comments were received,
collection of information by May 14, 10.75; Internal Agency review of we are reconsidering the usefulness of
2018. decisions) to provide for advisory the guidance document in light of
ADDRESSES: To ensure that comments on committee review (§ 10.75(b)(2)). At the changing Agency procedures. Consistent
the information collection are received, same time, and also consistent with the with our regulations at 21 CFR part
OMB recommends that written mandates of section 562 of the FD&C 10.115 we invite comment on our
comments be faxed to the Office of Act, we adopted an approach whereby guidance documents at any time.
Information and Regulatory Affairs, specific implementation procedures Ultimately, as our resources permit, we
OMB, Attn: FDA Desk Officer, Fax: 202– regarding scientific controversy hope to either revise, replace, or
395–7285, or emailed to oira_ associated with review of certain FDA withdraw the subject guidance
submission@omb.eop.gov. All decisions are detailed in center-issued document, however, until that time the
comments should be identified with the guidance. guidance remains available.
OMB control number 0910–0563. Also Accordingly, FDA developed the Accordingly, we are seeking to extend
include the FDA docket number found guidance entitled, ‘‘Guidance for OMB approval of the information
in brackets in the heading of this Industry on Formal Dispute Resolution: collection and estimate the burden as
document. Scientific and Technical Issues Related follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual Total Average
Number of frequency
Activity annual burden per Total hours
respondents per responses response
response

Requests for tier-one DR 2 1 2 30 60
Requests for tier-two DR 1 1 1 8 8

Total .............................................................................. ........................ ........................ ........................ ........................ 68
1 There are no capital costs or operating and maintenance costs associated with this collection.
sradovich on DSK3GMQ082PROD with NOTICES

As reflected in table 1, we estimate that there will be one appeal to the DR approximately 8 hours to prepare and
only a nominal burden for the panel (tier-two DR); (3) that it will take submit each tier-two DR request. We
information collection and assume: (1) respondents approximately 30 hours to base this estimate on our experience
That two manufacturers will submit two prepare and submit each tier-one DR with the information collection. There
requests annually for tier-one DR; (2) request; and (4) that it will take has been no increase in the burden

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Document Created: 2018-11-02 08:14:59
Document Modified: 2018-11-02 08:14:59

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 annual meeting.
Dates		The public meeting will be held on May 4, 2018, from 10 a.m. until 12 noon. Registration to attend the meeting must be received by May 3, 2018, at 5 p.m. Eastern Time. Requests for oral presentations must be received before May 2, 2018, at 5 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for registration date and information. The public is also invited to submit written comments by sending them via email to Elisabeth Shaefer (see FOR FURTHER INFORMATION CONTACT) before May 3, 2018, at 5 p.m. Eastern Time.
Contact		Elisabeth Shaefer, Executive Assistant to the Executive Director, Reagan-Udall Foundation for the FDA, 202- 849-2255, [email protected]
FR Citation		83 FR 15844

83 FR 15844 - Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 71 (April 12, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration