Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 48151-48152 [2019-19779]
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Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices
end users interpret zero-day withdrawal
period, or zero-day milk discard times
statements found on new animal drug
labeling. We are taking this action in
response to requests for an extension to
allow interested persons additional time
to submit comments.
DATES: FDA is extending the comment
period on the request for comments
published August 9, 2019 (84 FR
39340). Submit either electronic or
written comments by January 6, 2020.
ADDRESSES: 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 January 6,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 6, 2020. 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
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’’).
jbell on DSK3GLQ082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014
17:27 Sep 11, 2019
Jkt 247001
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3019 for ‘‘Transit Times to
Slaughter Facilities, Milking Frequency,
and Interpretation of Zero-Day
Withdrawal Periods and Zero-Day Milk
Discard Times Assigned to New Animal
Drugs.’’ Received comments, those filed
in a timely manner (see ADDRESSES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
PO 00000
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48151
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Charli M. Long-Medrano, Center for
Veterinary Medicine (HFV–150), Food
and Drug Administration, 7500 Standish
Pl., Rm. E340, Rockville, MD 20855,
240–402–0850, Charli.Long-Medrano@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 9, 2019, FDA
published a request for comments with
a 60-day comment period to request
comments on transit times to slaughter,
milking frequency, and how end users
interpret zero-day withdrawal period, or
zero-day milk discard time statements
found on new animal drug labeling.
Comments on interpretation of these
labeling statements will help to evaluate
if our current approach to assigning
zero-day withdrawal periods and zeroday milk discard times to new animal
drugs is appropriate.
The Agency has received requests for
a 90-day extension of the comment
period for the request for comments.
The requests convey concern that the
current 60-day comment period does
not allow sufficient time to develop a
meaningful or thoughtful response to
the request for comments.
FDA has considered the requests and
is extending the comment period for the
request for comments for 90 days, until
January 6, 2020. The Agency believes
that a 90-day extension allows adequate
time for interested persons to submit
comments without significantly
delaying rulemaking on these important
issues.
Dated: September 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19697 Filed 9–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–N–3516, FDA 2019–
N–0482, FDA–2012–N–0021, FDA–2018–N–
4042, FDA–2011–D–0597, FDA–2018–N–
4735, FDA–2019–N–0721, FDA–2013–N–
1425, FDA–2018–D–3631, and FDA–2011–D–
0689]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
SUMMARY:
E:\FR\FM\12SEN1.SGM
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48152
Federal Register / Vol. 84, No. 177 / Thursday, September 12, 2019 / Notices
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
FOR FURTHER INFORMATION CONTACT:
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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
Disease Awareness and Prescription Drug Promotion on Television ....................................................................
Reporting Associated with New Animal Drug Applications and Veterinary Master Files .......................................
Substances Generally Recognized as Safe: Notification Procedure ......................................................................
Establishing and Maintaining Lists of U.S. Product Manufacturers/Processors with Interest in Exporting
CFSAN-Regulated Products ................................................................................................................................
Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring ..........................................................
Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act ....................................
Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications ...........
Mitigation Strategies to Protect Food Against Intentional Adulteration ...................................................................
Standards for the Growing, Harvesting, Packaging, and Holding of Produce for Human Consumption ...............
De Novo Classification Process (Evaluation of Automatic Class III Designation) ..................................................
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–19779 Filed 9–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3936]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to FDA on regulatory issues. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this document.
DATES: The meeting will be held on
November 14, 2019, from 8 a.m. to 5
p.m.
ADDRESSES: The meeting will be held at
FDA’s White Oak Campus, 10903 New
Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (Rm. 1503),
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:27 Sep 11, 2019
Jkt 247001
Silver Spring, MD 20993–0002. Answers
to commonly asked questions including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–3936.
The docket will close on November 13,
2019. Submit either electronic or
written comments on this public
meeting by November 13, 2019. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before November 13, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 13, 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.
Comments received on or before
October 30, 2019, will be provided to
the committee. Comments received after
that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
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Date approval
expires
0910–0874
0910–0032
0910–0342
8/31/2021
7/31/2022
7/31/2022
0910–0509
0910–0733
0910–0734
0910–0750
0910–0812
0910–0816
0910–0844
7/31/2022
7/31/2022
7/31/2022
7/31/2022
7/31/2022
7/31/2022
8/31/2022
You may submit comments as
follows:
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’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
E:\FR\FM\12SEN1.SGM
12SEN1
]]>Agencies
[Federal Register Volume 84, Number 177 (Thursday, September 12, 2019)]
[Notices]
[Pages 48151-48152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-N-3516, FDA 2019-N-0482, FDA-2012-N-0021, FDA-
2018-N-4042, FDA-2011-D-0597, FDA-2018-N-4735, FDA-2019-N-0721, FDA-
2013-N-1425, FDA-2018-D-3631, and FDA-2011-D-0689]
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
[[Page 48152]]
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
------------------------------------------------------------------------
Disease Awareness and Prescription Drug 0910-0874 8/31/2021
Promotion on Television................
Reporting Associated with New Animal 0910-0032 7/31/2022
Drug Applications and Veterinary Master
Files..................................
Substances Generally Recognized as Safe: 0910-0342 7/31/2022
Notification Procedure.................
Establishing and Maintaining Lists of 0910-0509 7/31/2022
U.S. Product Manufacturers/Processors
with Interest in Exporting CFSAN-
Regulated Products.....................
Oversight of Clinical Investigations; A 0910-0733 7/31/2022
Risk-Based Approach to Monitoring......
Safety Labeling Changes; Implementation 0910-0734 7/31/2022
of the Federal Food, Drug, and Cosmetic
Act....................................
Accreditation of Third Party 0910-0750 7/31/2022
Certification Bodies to Conduct Food
Safety Audits and Issue Certifications.
Mitigation Strategies to Protect Food 0910-0812 7/31/2022
Against Intentional Adulteration.......
Standards for the Growing, Harvesting, 0910-0816 7/31/2022
Packaging, and Holding of Produce for
Human Consumption......................
De Novo Classification Process 0910-0844 8/31/2022
(Evaluation of Automatic Class III
Designation)...........................
------------------------------------------------------------------------
Dated: September 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19779 Filed 9-11-19; 8:45 am]
BILLING CODE 4164-01-P
