Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products, 7549 [2016-02889]
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Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices
technology providers in specific areas to
collaborate on computational science,
describe best practices in challenging
areas, and propose methods for
addressing knowledge gaps. A
description of the project groups and
planned activities can be found at
https://www.phuse.eu/css.aspx.
II. Registration and Accommodations
A. Registration
All registrants (with the exception of
a limited number of speakers and/or
organizers who will have a
complimentary registration) will pay a
fee for this meeting to help defray the
costs of facilities, materials, and food.
Seats are limited, and registration will
be on a first-come, first-served basis.
To register, please complete the
registration form online at (https://
www.phuse.eu/PhUSE–CSS–2016Registration.aspx. (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). The costs of
registration for the different categories
of attendees are as follows:
Fee
($)
Attendee category
Government/nonprofit/academia ..........................................................................................................................................................
Industry Organizing Committee & PhUSE Board of Directors (password required) ..........................................................................
Poster presenter (includes the printing of the poster by PhUSE, password required) .......................................................................
Industry ................................................................................................................................................................................................
Single-day ............................................................................................................................................................................................
Registering after the conference begins .............................................................................................................................................
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: office@phuse.eu.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
B. Accommodations
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on Formal
Meetings With Sponsors and
Applicants for Prescription Drug User
Fee Act Products
Attendees are responsible for their
own hotel accommodations. Attendees
making reservations at the DoubleTree
by Hilton Silver Spring Hotel are
eligible for a reduced rate of $189 not
including applicable taxes. Those
making reservations online should use
the following link to receive the reduced
rate: https://doubletree.hilton.com/en/dt/
groups/personalized/D/DCASSDT-PHU20160312/index.jhtml?WT.mc_id=POG.
If you need special accommodations
because of disability, please contact
Chris Decker (see FOR FURTHER
INFORMATION CONTACT) at least 14 days in
advance.
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III. Transcripts
We expect that transcripts will be
available approximately 30 days after
the meeting. A transcript can be
obtained either in hard copy or on CD–
ROM, after submission of a Freedom of
Information request. Send written
requests to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857. Send faxed requests to 301–827–
9267.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02877 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:38 Feb 11, 2016
Jkt 238001
Food and Drug Administration
[Docket No. FDA–2012–N–0247]
AGENCY:
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–02889 Filed 2–11–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on Formal
Meetings With Sponsors and Applicants
for Prescription Drug User Fee Act
Products’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On
October 21, 2015, the Agency submitted
a proposed collection of information
entitled ‘‘Guidance for Industry on
Formal Meetings With Sponsors and
Applicants for Prescription Drug User
Fee Act Products’’ to OMB for review
and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
SUPPLEMENTARY INFORMATION:
PO 00000
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0429. The
approval expires on December 31, 2018.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Food and Drug Administration,
HHS.
ACTION:
300
350
375
750
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1250
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National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: NIGMS Initial Review
Group, Training and Workforce Development
Subcommittee—D.
Date: March 11, 2016.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)]
[Notices]
[Page 7549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02889]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0247]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance for Industry on Formal
Meetings With Sponsors and Applicants for Prescription Drug User Fee
Act Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance for Industry on Formal
Meetings With Sponsors and Applicants for Prescription Drug User Fee
Act Products'' has been approved by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On October 21, 2015, the Agency submitted a
proposed collection of information entitled ``Guidance for Industry on
Formal Meetings With Sponsors and Applicants for Prescription Drug User
Fee Act Products'' to OMB for review and clearance under 44 U.S.C.
3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0429.
The approval expires on December 31, 2018. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: February 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02889 Filed 2-11-16; 8:45 am]
BILLING CODE 4164-01-P
