Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 70667-70669 [2023-22460]
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
FDA published a 60-day notice for
public comment in the Federal Register
of June 12, 2023 (88 FR 38061) and
received comments. While one
comment appeared to question the
purpose of the information collection,
another comment supported FDA
activities regarding the reporting of
information covered by the collection.
No comment suggested that we revise
our burden estimate.
We also received suggestions on how
our submission form might be
improved. In response to this comment,
we are revising the submission form
using asterisks to more clearly indicate
which fields are required for submission
versus non-required fields. The form
also has been updated to allow
submission of the company’s website.
Similarly, one comment noted that
current procedures do not allow for
complete anonymity when submitting
allegations of regulatory misconduct to
FDA. The comment suggests changing
the submission process to allow
submission of attachments to the form,
rather than via separate email. While we
have not made changes regarding the
submission process at this time, we
appreciate these suggestions and
continue to consider enhancements and
updates to our systems as our limited
resources permit. We recognize that
confidentiality is an important concern.
Under the Freedom of Information Act
(FOIA) (5 U.S.C. 552), the public has
broad access to government documents.
However, FOIA provides certain
exemptions from mandatory public
disclosure of government records (5
U.S.C. 552(b)(1–9)). FDA will make the
fullest possible disclosure of records to
the public, consistent with the rights of
individuals to privacy, the property
rights of persons in trade and
confidential commercial or financial
information.
70667
Finally, one comment expressed
concern regarding verification by FDA
of the accuracy and validity of the
information (allegations) submitted.
Allegations of regulatory misconduct
related to medical devices are reviewed
by CDRH. CDRH prioritizes the review
of allegations based on the level of
potential risks, within the context of an
overall benefit-risk profile, to patients,
and takes responsive action accordingly.
We note, however, that subsequent
questions or inquiry intended to clarify
information submitted is not considered
a collection of information under the
PRA (see 5 CFR 1320.3(h)(9)) subject to
OMB review and approval. To learn
more about CDRH’s process for handling
allegations, please visit: https://
www.fda.gov/medical-devices/medicaldevice-safety/reporting-allegationsregulatory-misconduct.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per
response
Total hours
Electronic submission of voluntary allegations to
CDRH.
2,500
1
2,500
0.25 (15 minutes)
625
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We recently consolidated the intake of
allegations across CDRH Offices. This
has improved our estimate and we have
adjusted the number of responses
accordingly. The number of responses is
based on the voluntary allegations
received by CDRH in 2022. The adjusted
estimated burden for the information
collection reflects an increase of 900
responses and a corresponding increase
of 225 hours.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22463 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–N–3848]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY:
Food and Drug Administration,
HHS.
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17:34 Oct 11, 2023
Jkt 262001
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 the collections of
information in the regulations for in
vivo radiopharmaceuticals used for
diagnosis and monitoring.
DATES: Submit either electronic or
written comments on the collection of
information by December 11, 2023.
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 December 11,
2023. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of December 11, 2023.
Comments received by mail/hand
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\12OCN1.SGM
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
ddrumheller on DSK120RN23PROD with NOTICES1
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–3848 for ‘‘Regulations for In
Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring.’’ 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, 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://
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
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Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring—21 CFR Part
315
OMB Control Number 0910–0409—
Extension
This information collection supports
our regulations in part 315 (21 CFR part
315) that require manufacturers of
diagnostic radiopharmaceuticals to
submit information that demonstrates
the safety and effectiveness of: (1) a new
diagnostic radiopharmaceutical or (2) a
new indication for use of an approved
diagnostic radiopharmaceutical.
Information about the safety or
effectiveness of a diagnostic
radiopharmaceutical enables us to
properly evaluate the safety and
effectiveness profiles of such
radiopharmaceuticals.
The information, which is usually
submitted as part of a new drug
application (NDA) or biologics license
application or as a supplement to an
approved application typically includes,
but is not limited to: (1) nonclinical and
clinical data on the pharmacology; (2)
toxicology; (3) adverse events; (4)
radiation safety assessments; and (5)
chemistry, manufacturing, and controls.
The content and format of an
application for approval of a new drug
are set forth in § 314.50 (21 CFR 314.50)
and have been approved under OMB
control number 0910–0001.
In table 1, row 1, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
an application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
radiopharmaceuticals, or both, we
estimate that three submissions will be
received annually from three applicants
and that 2,000 hours would be spent
preparing the portions of the application
that would be affected by this
information collection. We further
estimate the total time needed to
prepare complete applications for
diagnostic radiopharmaceuticals as
approximately 6,000 hours. This
information collection does not impose
any additional reporting burden for
safety and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 2,000 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001. In
fact, clarification of our criteria for the
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Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
evaluation of diagnostic
radiopharmaceuticals in this
information collection is intended to
streamline overall information
collection burdens, particularly for
diagnostic radiopharmaceuticals that
may have well-established, low-risk
safety profiles by enabling
manufacturers to tailor information
submissions and avoid unnecessary
clinical trials.
In table 1, row 2, we estimate the
annual reporting burden for preparing
the safety and effectiveness sections of
a supplement to an approved
application. This estimate does not
include the time needed to conduct
studies and clinical trials or other
research from which the reported
information is obtained.
Based on past submissions of human
drug applications, new indication
supplements for diagnostic
radiopharmaceuticals, or both, we
estimate that one submission will be
received annually. We estimate the total
time needed to prepare complete
applications for supplements to new
applications for diagnostic
radiopharmaceuticals as approximately
between 500 and 1,000 hours. We
calculated the median of this estimate to
arrive at approximately 750 hours. We
further estimate that the total time
needed to prepare the portions of the
application that would be affected by
this information collection as 750 hours.
As previously stated, this information
collection does not impose any
additional reporting burden for safety
and effectiveness information on
diagnostic radiopharmaceuticals beyond
the estimated burden of 750 hours,
because safety and effectiveness
information is already required in
§ 314.50 and has been approved under
OMB control number 0910–0001.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR NDAS AND SUPPLEMENTS TO APPROVED NDAS FOR
DIAGNOSTIC RADIOPHARMACEUTICALS 1
Manufacturers’ activity
(21 CFR section)
Average
burden per
response
Total annual
responses
Total hours
NDAs (§§ 315.4, 315.5, and 315.6) .....................................
Supplements to Approved NDAs (§§ 315.4, 315.5, and
315.6) ...............................................................................
3
1
3
2,000
6,000
1
1
1
750
750
Total ..............................................................................
........................
........................
........................
........................
6,750
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Since our last OMB approval, our
estimated burden for the information
collection reflects an overall decrease of
11 responses with a corresponding
decrease of 12,000 burden hours. We
attribute this adjustment to a decrease in
the number of submissions for NDAs for
diagnostic radiopharmaceuticals and
new indication supplements for
diagnostic radiopharmaceuticals we
received over the past few years.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–22460 Filed 10–11–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3768]
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adherence
Potential and Patient Preference in
Prescription Drug Promotion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
SUMMARY:
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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 and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed study
entitled ‘‘Adherence Potential and
Patient Preference in Prescription Drug
Promotion.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
December 11, 2023.
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
December 11, 2023. Comments received
by mail/hand delivery/courier (for
written/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.
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70667-70669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22460]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3848]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 the collections of information in the
regulations for in vivo radiopharmaceuticals used for diagnosis and
monitoring.
DATES: Submit either electronic or written comments on the collection
of information by December 11, 2023.
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 December 11, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. 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
[[Page 70668]]
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-3848 for ``Regulations for In Vivo Radiopharmaceuticals Used
for Diagnosis and Monitoring.'' 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, 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-2015-09-18/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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315
OMB Control Number 0910-0409--Extension
This information collection supports our regulations in part 315
(21 CFR part 315) that require manufacturers of diagnostic
radiopharmaceuticals to submit information that demonstrates the safety
and effectiveness of: (1) a new diagnostic radiopharmaceutical or (2) a
new indication for use of an approved diagnostic radiopharmaceutical.
Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables us to properly evaluate the safety and
effectiveness profiles of such radiopharmaceuticals.
The information, which is usually submitted as part of a new drug
application (NDA) or biologics license application or as a supplement
to an approved application typically includes, but is not limited to:
(1) nonclinical and clinical data on the pharmacology; (2) toxicology;
(3) adverse events; (4) radiation safety assessments; and (5)
chemistry, manufacturing, and controls. The content and format of an
application for approval of a new drug are set forth in Sec. 314.50
(21 CFR 314.50) and have been approved under OMB control number 0910-
0001.
In table 1, row 1, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of an application. This
estimate does not include the time needed to conduct studies and
clinical trials or other research from which the reported information
is obtained.
Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that three submissions will be received annually from three
applicants and that 2,000 hours would be spent preparing the portions
of the application that would be affected by this information
collection. We further estimate the total time needed to prepare
complete applications for diagnostic radiopharmaceuticals as
approximately 6,000 hours. This information collection does not impose
any additional reporting burden for safety and effectiveness
information on diagnostic radiopharmaceuticals beyond the estimated
burden of 2,000 hours, because safety and effectiveness information is
already required in Sec. 314.50 and has been approved under OMB
control number 0910-0001. In fact, clarification of our criteria for
the
[[Page 70669]]
evaluation of diagnostic radiopharmaceuticals in this information
collection is intended to streamline overall information collection
burdens, particularly for diagnostic radiopharmaceuticals that may have
well-established, low-risk safety profiles by enabling manufacturers to
tailor information submissions and avoid unnecessary clinical trials.
In table 1, row 2, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of a supplement to an
approved application. This estimate does not include the time needed to
conduct studies and clinical trials or other research from which the
reported information is obtained.
Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that one submission will be received annually. We estimate the
total time needed to prepare complete applications for supplements to
new applications for diagnostic radiopharmaceuticals as approximately
between 500 and 1,000 hours. We calculated the median of this estimate
to arrive at approximately 750 hours. We further estimate that the
total time needed to prepare the portions of the application that would
be affected by this information collection as 750 hours. As previously
stated, this information collection does not impose any additional
reporting burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 750 hours, because
safety and effectiveness information is already required in Sec.
314.50 and has been approved under OMB control number 0910-0001.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden for NDAs and Supplements to Approved NDAs for Diagnostic
Radiopharmaceuticals \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Manufacturers' activity (21 CFR Number of responses per Total annual burden per Total hours
section) respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
NDAs (Sec. Sec. 315.4, 315.5, 3 1 3 2,000 6,000
and 315.6).....................
Supplements to Approved NDAs 1 1 1 750 750
(Sec. Sec. 315.4, 315.5, and
315.6).........................
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Total....................... .............. .............. .............. .............. 6,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Since our last OMB approval, our estimated burden for the
information collection reflects an overall decrease of 11 responses
with a corresponding decrease of 12,000 burden hours. We attribute this
adjustment to a decrease in the number of submissions for NDAs for
diagnostic radiopharmaceuticals and new indication supplements for
diagnostic radiopharmaceuticals we received over the past few years.
Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22460 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
