81 FR 7549 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 29 (February 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 29 (February 12, 2016)
| Page Range | 7549-7549 | |
| FR Document | 2016-02889 |
[Federal Register Volume 81, Number 29 (Friday, February 12, 2016)] [Notices] [Page 7549] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02889] ----------------------------------------------------------------------- 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, [email protected]. 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 http://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
![Federal Register / Vol. 81, No. 29 / Friday, February 12, 2016 / Notices 7549
technology providers in specific areas to II. Registration and Accommodations To register, please complete the
collaborate on computational science, A. Registration registration form online at (https://
describe best practices in challenging www.phuse.eu/PhUSE–CSS–2016-
areas, and propose methods for All registrants (with the exception of Registration.aspx. (FDA has verified the
addressing knowledge gaps. A a limited number of speakers and/or Web site address, but is not responsible
description of the project groups and organizers who will have a for subsequent changes to the Web site
complimentary registration) will pay a
planned activities can be found at after this document publishes in the
fee for this meeting to help defray the
http://www.phuse.eu/css.aspx. Federal Register). The costs of
costs of facilities, materials, and food.
Seats are limited, and registration will registration for the different categories
be on a first-come, first-served basis. of attendees are as follows:
Fee
Attendee category ($)
Government/nonprofit/academia .......................................................................................................................................................... 300
Industry Organizing Committee & PhUSE Board of Directors (password required) .......................................................................... 350
Poster presenter (includes the printing of the poster by PhUSE, password required) ....................................................................... 375
Industry ................................................................................................................................................................................................ 750
Single-day ............................................................................................................................................................................................ 650
Registering after the conference begins ............................................................................................................................................. 1250
Government and nonprofit attendees DEPARTMENT OF HEALTH AND number. OMB has now approved the
and exhibitors will need an invitation HUMAN SERVICES information collection and has assigned
code to register at the discounted rate. OMB control number 0910–0429. The
An invitation code can be obtained by Food and Drug Administration approval expires on December 31, 2018.
sending an email to: office@phuse.eu. [Docket No. FDA–2012–N–0247] A copy of the supporting statement for
this information collection is available
B. Accommodations Agency Information Collection on the Internet at http://
Activities; Announcement of Office of www.reginfo.gov/public/do/PRAMain.
Attendees are responsible for their
own hotel accommodations. Attendees Management and Budget Approval; Dated: February 8, 2016.
making reservations at the DoubleTree Guidance for Industry on Formal Leslie Kux,
by Hilton Silver Spring Hotel are Meetings With Sponsors and Associate Commissioner for Policy.
Applicants for Prescription Drug User
eligible for a reduced rate of $189 not [FR Doc. 2016–02889 Filed 2–11–16; 8:45 am]
Fee Act Products
including applicable taxes. Those BILLING CODE 4164–01–P
making reservations online should use AGENCY: Food and Drug Administration,
the following link to receive the reduced HHS.
rate: http://doubletree.hilton.com/en/dt/ ACTION: Notice. DEPARTMENT OF HEALTH AND
groups/personalized/D/DCASSDT-PHU- HUMAN SERVICES
20160312/index.jhtml?WT.mc_id=POG. SUMMARY: The Food and Drug
Administration (FDA) is announcing National Institutes of Health
If you need special accommodations
that a collection of information entitled National Institute of General Medical
because of disability, please contact ‘‘Guidance for Industry on Formal
Chris Decker (see FOR FURTHER Sciences; Notice of Closed Meeting
Meetings With Sponsors and Applicants
INFORMATION CONTACT) at least 14 days in for Prescription Drug User Fee Act Pursuant to section 10(d) of the
advance. Products’’ has been approved by the Federal Advisory Committee Act, as
III. Transcripts Office of Management and Budget amended (5 U.S.C. App.), notice is
(OMB) under the Paperwork Reduction hereby given of the following meeting.
We expect that transcripts will be Act of 1995. The meeting will be closed to the
available approximately 30 days after FOR FURTHER INFORMATION CONTACT: FDA public in accordance with the
the meeting. A transcript can be PRA Staff, Office of Operations, Food provisions set forth in sections
obtained either in hard copy or on CD– and Drug Administration, 8455 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
ROM, after submission of a Freedom of Colesville Rd., COLE–14526, Silver as amended. The grant applications and
Information request. Send written Spring, MD 20993–0002, PRAStaff@ the discussions could disclose
requests to the Division of Freedom of fda.hhs.gov. confidential trade secrets or commercial
Information (ELEM–1029), Food and property such as patentable material,
SUPPLEMENTARY INFORMATION: On and personal information concerning
Drug Administration, 12420 Parklawn October 21, 2015, the Agency submitted individuals associated with the grant
Dr., Element Bldg., Rockville, MD a proposed collection of information applications, the disclosure of which
20857. Send faxed requests to 301–827–
asabaliauskas on DSK9F6TC42PROD with NOTICES2
entitled ‘‘Guidance for Industry on would constitute a clearly unwarranted
9267. Formal Meetings With Sponsors and invasion of personal privacy.
Dated: February 8, 2016. Applicants for Prescription Drug User
Fee Act Products’’ to OMB for review Name of Committee: NIGMS Initial Review
Leslie Kux, Group, Training and Workforce Development
and clearance under 44 U.S.C. 3507. An Subcommittee—D.
Associate Commissioner for Policy. Agency may not conduct or sponsor, Date: March 11, 2016.
[FR Doc. 2016–02877 Filed 2–11–16; 8:45 am] and a person is not required to respond Time: 8:30 a.m. to 5:00 p.m.
BILLING CODE 4164–01–P to, a collection of information unless it Agenda: To review and evaluate grant
displays a currently valid OMB control applications.
VerDate Sep<11>2014 17:38 Feb 11, 2016 Jkt 238001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/81_FR_7578/page/1.svg)
Document Created: 2016-02-12 01:24:40
Document Modified: 2016-02-12 01:24:40
| 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. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 7549 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR