Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 6866 [2018-03128]
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6866
Federal Register / Vol. 83, No. 32 / Thursday, February 15, 2018 / Notices
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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
SUMMARY:
Food and Drug Administration
[Docket Nos. FDA–2011–N–0424; FDA–
2014–N–0192; FDA–2008–N–0094; FDA–
2010–N–0062; FDA–2010–N–0588; FDA–
2010–N–0110; FDA–2010–N–0493; FDA–
2017–N–1095; FDA–2013–D–0349; FDA–
2016–N–2683]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Notice.
Food and Drug Administration,
HHS.
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 No.
Title of collection
Temporary Marketing Permit Applications ..............................................................................................................
Establishing and Maintaining Lists of U.S. Milk Product Manufacturers/Processors with Interest in Exporting ....
Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have
been Revoked, Suspended, or Modified by the EPA ..........................................................................................
Medical Devices; Exception from General Requirements for Informed Consent ...................................................
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile ......
Prescription Drug Advertisements ...........................................................................................................................
Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe
and Effective and Not Misbranded ......................................................................................................................
Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical Devices ......................
Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market
Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format ...........................
Data To Support Social and Behavioral Research as Used by the Food and Drug Administration ......................
Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
extension of a patent which claims that
human biological product.
[FR Doc. 2018–03128 Filed 2–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–E–2362 and FDA–
2014–E–2363]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SYLVANT
AGENCY:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SYLVANT and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:01 Feb 14, 2018
Jkt 244001
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 16, 2018. 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.
ADDRESSES:
Food and Drug Administration,
HHS.
ACTION:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 16, 2018.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 14, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
DATES:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Date approval
expires
0910–0133
0910–0509
11/30/2020
11/30/2020
0910–0562
0910–0586
0910–0614
0910–0686
11/30/2020
11/30/2020
11/30/2020
11/30/2020
0910–0688
0910–0769
11/30/2020
11/30/2020
0910–0771
0910–0847
11/30/2020
11/30/2020
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
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Page 6866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03128]
[[Page 6866]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-N-0424; FDA-2014-N-0192; FDA-2008-N-0094; FDA-
2010-N-0062; FDA-2010-N-0588; FDA-2010-N-0110; FDA-2010-N-0493; FDA-
2017-N-1095; FDA-2013-D-0349; FDA-2016-N-2683]
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
------------------------------------------------------------------------
Temporary Marketing Permit Applications. 0910-0133 11/30/2020
Establishing and Maintaining Lists of 0910-0509 11/30/2020
U.S. Milk Product Manufacturers/
Processors with Interest in Exporting..
Channels of Trade Policy for Commodities 0910-0562 11/30/2020
with Residues of Pesticide Chemicals
for Which Tolerances Have been Revoked,
Suspended, or Modified by the EPA......
Medical Devices; Exception from General 0910-0586 11/30/2020
Requirements for Informed Consent......
Exceptions or Alternatives to Labeling 0910-0614 11/30/2020
Requirements for Products Held by the
Strategic National Stockpile...........
Prescription Drug Advertisements........ 0910-0686 11/30/2020
Additional Criteria and Procedures for 0910-0688 11/30/2020
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded...........
Electronic Submission of Allegations of 0910-0769 11/30/2020
Regulatory Misconduct Associated with
Medical Devices........................
Providing Waiver-Related Materials in 0910-0771 11/30/2020
Accordance With the Guidance for
Industry on Providing Post-Market
Periodic Safety Reports in the
International Conference on
Harmonisation E2C(R2) Format...........
Data To Support Social and Behavioral 0910-0847 11/30/2020
Research as Used by the Food and Drug
Administration.........................
------------------------------------------------------------------------
Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03128 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P
