Document ID: FDA-2014-N-0998-0008
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Posted Date: 2021-04-14T04:00Z

[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19622-19623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07639]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0998]

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) 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 May 14, 2021.

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, 
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.

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 (BLA) 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. This information collection supports part 315, which is currently 
approved under OMB control number 0910-0409.
    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

[[Page 19623]]

radiopharmaceuticals, or both, we estimate that six submissions will be 
received annually 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 12,000 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 studies.
    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 nine submissions 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 6,750. 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 November 12, 2020 (85 FR 71923), we 
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 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, 315.5,               6               1               6           2,000          12,000
 and 315.6).....................
Supplements to Approved NDAs                   9               1               9             750           6,750
 (Sec.  Sec.   315.4, 315.5, and
 315.6).........................
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    Total.......................  ..............  ..............  ..............  ..............          18,750
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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 increase of 13 responses with a corresponding increase of 
14,750 burden hours, including submissions involving NDAs. We attribute 
this adjustment to an increase in the number of submissions for NDAs 
for diagnostic radiopharmaceuticals we received over the past few years 
and because we are now capturing supplements to approved NDAs for 
diagnostic radiopharmaceuticals.

    Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07639 Filed 4-13-21; 8:45 am]
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