[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)....................
                                --------------------------------------------------------------------------------
    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