[Federal Register Volume 85, Number 219 (Thursday, November 12, 2020)]
[Notices]
[Pages 71923-71924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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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 January 11, 2021.

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 January 11, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 11, 2021. 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 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-2014-N-0998 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 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

[[Page 71924]]

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 (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 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.
    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
 Manufacturers' activity (21 CFR     Number of     responses per   Total annual   Average burden    Total hours
            section)                respondents     respondent       responses     per 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: November 5, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25023 Filed 11-10-20; 8:45 am]
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