Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs, 1100-1101 [2024-00220]
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Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
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. This
requirement is codified at § 530.22(b)
(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. Respondents to the
information collection are private sector
drug sponsors or veterinary
associations, or veterinarians, State,
local, and tribal governments, and
Federal Agencies.
In the Federal Register of August 31,
2023 (88 FR 60213), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section; activity
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.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00219 Filed 1–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3490]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Application for
Participation in Food and Drug
Administration Fellowship and
Traineeship Programs
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by February 8,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0780. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Application for Participation in FDA
Fellowship and Traineeship Programs
OMB Control Number 0910–0780—
Extension
This information collection supports
FDA fellowship and traineeship
programs. Sections 1104, 1302, 3301,
3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code
authorize Federal Agencies to rate
applicants for Federal jobs. The
information collection involves brief
online applications completed by
applicants applying to FDA’s
Fellowship and Traineeship programs.
These voluntary online applications
will allow the Agency to easily and
efficiently elicit and review information
from students and healthcare
professionals who are interested in
becoming involved in FDA-wide
activities. The process will reduce the
time and cost of submitting written
documentation to the Agency and lessen
the likelihood of applications being
misrouted within the Agency mail
system. It will assist the Agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with FDA.
In the Federal Register of September
19, 2023 (88 FR 64438), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. We received two
comments, which were not PRA related
and will not be addressed in this
document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
Activity
Medical Device Fellowship Program ...................................
VerDate Sep<11>2014
16:38 Jan 08, 2024
Jkt 262001
PO 00000
Frm 00041
Number of
responses per
respondent
250
Fmt 4703
Sfmt 4703
Total annual
responses
1
E:\FR\FM\09JAN1.SGM
250
09JAN1
Average
burden per
response
Total hours
1
250
1101
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
respondents
Activity
Total annual
responses
Average
burden per
response
Total hours
FDA Traineeship Program ...................................................
1,000
1
1,000
1
1,000
Total ..............................................................................
........................
........................
........................
........................
1,250
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.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00220 Filed 1–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4804]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Expedited
Programs for Serious Conditions—
Drugs and Biologics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 information
collection pertaining to ‘‘Expedited
Programs for Serious Conditions—Drugs
and Biologics.’’
DATES: Submit either electronic or
written comments on the collection of
information by March 11, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 11, 2024. Comments received by
mail/hand delivery/courier (for written/
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
16:38 Jan 08, 2024
Jkt 262001
paper submissions) will be considered
timely if they are received 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’’).
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.
• 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–
2023–N–4804 for ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1100-1101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00220]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3490]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for
Participation in Food and Drug Administration Fellowship and
Traineeship Programs
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by February 8, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0780. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Application for Participation in FDA Fellowship and Traineeship
Programs
OMB Control Number 0910-0780--Extension
This information collection supports FDA fellowship and traineeship
programs. Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394
of Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. The information collection involves brief
online applications completed by applicants applying to FDA's
Fellowship and Traineeship programs. These voluntary online
applications will allow the Agency to easily and efficiently elicit and
review information from students and healthcare professionals who are
interested in becoming involved in FDA-wide activities. The process
will reduce the time and cost of submitting written documentation to
the Agency and lessen the likelihood of applications being misrouted
within the Agency mail system. It will assist the Agency in promoting
and protecting the public health by encouraging outside persons to
share their expertise with FDA.
In the Federal Register of September 19, 2023 (88 FR 64438), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments, which were not PRA
related and will not be addressed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Medical Device Fellowship 250 1 250 1 250
Program........................
[[Page 1101]]
FDA Traineeship Program......... 1,000 1 1,000 1 1,000
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,250
----------------------------------------------------------------------------------------------------------------
\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.
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00220 Filed 1-8-24; 8:45 am]
BILLING CODE 4164-01-P
