[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4313-4314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01237]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3848]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Regulations for In
Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA 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.
DATES: Submit written comments (including recommendations) on the
collection of information by February 22, 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 0910-0409. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 FDA to evaluate properly 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,
nonclinical and clinical data on the pharmacology; toxicology; adverse
events; radiation safety assessments; and 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
[[Page 4314]]
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 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.
In the Federal Register of October 12, 2023 (88 FR 70667), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates 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\
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Number of Average
Manufacturers' activity (21 CFR Number of responses per Total annual burden per Total hours
section) respondents respondent responses response
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NDAs (Sec. Sec. 315.4, 3 1 3 2,000 6,000
315.5, 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.
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: January 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01237 Filed 1-22-24; 8:45 am]
BILLING CODE 4164-01-P