Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 56347 [2018-24609]
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Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
ACTION:
[FR Doc. 2018–24673 Filed 11–9–18; 8:45 am]
BILLING CODE 4120–01–C
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–N–0558; FDA–
2017–N–1315; FDA–2011–N–0776; FDA–
2018–N–3038; FDA–2018–N–0405; FDA–
2014–N–1048; FDA–2011–N–0908; FDA–
2011–N–0920; and FDA–2018–N–1857]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
56347
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. 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.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Disclosures in Professional and Consumer Prescription Drug Promotion ..............................................................
Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads ..........................
Reclassification Petitions for Medical Devices ........................................................................................................
Request for Samples and Protocols ........................................................................................................................
Medical Device Recall Authority ..............................................................................................................................
Food Safety, Health, and Diet Survey .....................................................................................................................
Medical Device Labeling Regulations .....................................................................................................................
GFI: Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human
Food .....................................................................................................................................................................
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals .................................................................................................................................................................
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24609 Filed 11–9–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4100]
Drug Development Tool Process Under
the 21st Century Cures Act and
Prescription Drug User Fee Act VI;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
amozie on DSK3GDR082PROD with NOTICES1
ACTION:
VerDate Sep<11>2014
17:34 Nov 09, 2018
Jkt 247001
The public meeting will be held
on December 11, 2018, from 9 a.m. to 5
p.m. Submit either electronic or written
comments on this public meeting by
January 31, 2019. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
DATES:
The public meeting will be
held at FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31, Rm.
1503A (the Great Room), Silver Spring,
MD 20993. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
ADDRESSES:
The Food and Drug
Administration (FDA or the Agency) is
announcing a public meeting entitled
‘‘Drug Development Tool Process under
the 21st Century Cures Act and PDUFA
VI.’’ This public meeting is intended to
fulfill commitments made by FDA
under the sixth authorization of the
SUMMARY:
Prescription Drug User Fee Act (PDUFA
VI) and the 21st Century Cures Act
(Cures Act) by soliciting comments on
Drug Development Tool Qualification at
FDA related to the qualification process
under section 507 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act);
discussing taxonomy for biomarkers and
related concepts used in drug
development; and planning activities to
define a framework with appropriate
standards and scientific approaches to
support qualification for a specified
context of use.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0860
0910–0861
0910–0138
0910–0206
0910–0432
0910–0345
0910–0485
0910–0581
9/30/2020
9/30/2020
9/30/2021
9/30/2021
9/30/2021
10/31/2020
10/30/2021
10/31/2021
0910–0751
10/31/2021
0910–0789
10/31/2021
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/ucm241
740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments may not be considered.
For timely consideration we request that
electronic comments be submitted on or
before January 31, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time on January 31,
2019. Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Page 56347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24609]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2017-N-0558; FDA-2017-N-1315; FDA-2011-N-0776; FDA-
2018-N-3038; FDA-2018-N-0405; FDA-2014-N-1048; FDA-2011-N-0908; FDA-
2011-N-0920; and FDA-2018-N-1857]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at https://www.reginfo.gov/public/do/PRAMain. 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.
Table 1--List of Information Collections Approved By OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Disclosures in Professional and Consumer 0910-0860 9/30/2020
Prescription Drug Promotion............
Experimental Study of Risk Information 0910-0861 9/30/2020
Amount and Location in Direct-to-
Consumer Print Ads.....................
Reclassification Petitions for Medical 0910-0138 9/30/2021
Devices................................
Request for Samples and Protocols....... 0910-0206 9/30/2021
Medical Device Recall Authority......... 0910-0432 9/30/2021
Food Safety, Health, and Diet Survey.... 0910-0345 10/31/2020
Medical Device Labeling Regulations..... 0910-0485 10/30/2021
GFI: Clinical Trial Sponsors on the 0910-0581 10/31/2021
Establishment and Operation of Clinical
Trial Data Monitoring Committees.......
Current Good Manufacturing Practice and 0910-0751 10/31/2021
Hazard Analysis and Risk-Based
Preventive Controls for Human Food.....
Current Good Manufacturing Practice and 0910-0789 10/31/2021
Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals................................
------------------------------------------------------------------------
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24609 Filed 11-9-18; 8:45 am]
BILLING CODE 4164-01-P
