Notice2023-22460
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70667-70669]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#257577647651444343654341440b4d4d560b424a53"><span class="__cf_email__" data-cfemail="a9f9fbe8faddc8cfcfe9cfcdc887c1c1da87cec6df">[email protected]</span></a>.
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).........................
-------------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 12, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.