Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration-Regulated Products: Export Certificates, 2674 [C1-2020-28064]
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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Extralabel Drug Use for Animals—21
CFR 530
OMB Control Number 0910–0325—
Extension
The Animal Medicinal Drug Use
Clarification Act of 1994 (Pub. L. 103–
396) allows a veterinarian to prescribe
the extralabel use of approved new
animal drugs. Also, it permits FDA, if it
finds that there is a reasonable
probability that the extralabel use of an
animal drug may prevent the risk to the
public health, to establish a safe level
for a residue from the extralabel use of
the drug and to require the development
of an analytical method for the detection
of residues above that established safe
level (21 CFR 530.22(b)). Although to
date, we have not established a safe
level for a residue from the extralabel
use of any new animal drug and,
therefore, have not required the
development of analytical methodology,
we believe that there may be instances
when analytical methodology will be
required. We are, therefore, estimating
the reporting burden based on two
methods being required annually. The
requirement to establish an analytical
method may be fulfilled by any
interested person. We believe that the
sponsor of the drug will be willing to
develop the method in most cases.
Alternatively, FDA, the sponsor, and
perhaps a third party may cooperatively
arrange for method development. The
respondents may be sponsors of new
animal drugs; State, Federal, and/or
State Agencies; academia; or
individuals.
In the Federal Register of August 6,
2020 (85 FR 47794), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment was received
but was not responsive to topics
solicited regarding the information
collection.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR part
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
530.22(b); Submission(s) of Analytical Method ...................
2
1
2
4,160
8,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2014–N–0913]
[FR Doc. 2021–00475 Filed 1–12–21; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; 513(g) Request for
Information
AGENCY:
Food and Drug Administration,
HHS.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
[Docket No. FDA–2010–N–0161]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Export of Food and
Drug Administration-Regulated
Products: Export Certificates
Correction
In notice document 2020–28064
appearing on pages 83091–83092 in the
issue of Monday, December 21, 2020,
make the following correction:
On page 83091, in the second column,
in the DATES section, change ‘‘January
20, 2021’’ to read ‘‘January 21, 2021.’’
[FR Doc. C1–2020–28064 Filed 1–12–21; 8:45 am]
VerDate Sep<11>2014
18:08 Jan 12, 2021
Jkt 253001
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information and to
allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection burden estimate for requests
for a written statement from FDA
regarding the classification and
regulatory requirements that may be
applicable to a particular device (513(g)
requests).
DATES: Submit either electronic or
written comments on the collection of
information by March 15, 2021.
SUMMARY:
Food and Drug Administration
BILLING CODE 1301–00–D
Notice.
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Frm 00038
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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 March 15,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 15, 2021. 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:
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
E:\FR\FM\13JAN1.SGM
13JAN1
Agencies
[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Page 2674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: C1-2020-28064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0161]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Export of Food and
Drug Administration-Regulated Products: Export Certificates
Correction
In notice document 2020-28064 appearing on pages 83091-83092 in the
issue of Monday, December 21, 2020, make the following correction:
On page 83091, in the second column, in the DATES section, change
``January 20, 2021'' to read ``January 21, 2021.''
[FR Doc. C1-2020-28064 Filed 1-12-21; 8:45 am]
BILLING CODE 1301-00-D