Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 12954 [2018-06041]
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12954
Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Regulations for In Vivo
Radiopharmaceuticals Used for
Diagnosis and Monitoring
[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.
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: Fax written comments on the
collection of information by April 25,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 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
SUMMARY:
OMB Control Number 0910–0409—
Extension
This information collection supports
FDA regulations found in part 315 (21
CFR part 315). These regulations require
manufacturers of diagnostic
radiopharmaceuticals to submit
information that demonstrates the safety
and effectiveness of a new diagnostic
radiopharmaceutical or of a new
indication for use of an approved
diagnostic radiopharmaceutical. The
regulations also describe the types of
indications for diagnostic
radiopharmaceuticals and some of the
criteria the Agency uses to evaluate the
safety and effectiveness of a diagnostic
radiopharmaceutical under section 505
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) (FD&C Act) and
section 351 of the Public Health Service
Act (42 U.S.C. 262) (the PHS Act).
Information about the safety or
effectiveness of a diagnostic
radiopharmaceutical enables FDA to
properly evaluate the safety and
effectiveness profiles of a new
diagnostic radiopharmaceutical or a
new indication for use of an approved
diagnostic radiopharmaceutical.
The regulations clarify existing FDA
requirements for approval and
evaluation of drug and biological
products already in place under the
authorities of the FD&C Act and the PHS
Act. The information, which is usually
submitted as part of a new drug
application 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 § 314.50 (21 CFR 314.50),
and approved under OMB control
number 0910–0001. This information
collection supports part 315, currently
approved under OMB control number
0910–0409.
Based on past submissions (human
drug applications and/or new indication
supplements for diagnostic
radiopharmaceuticals), we estimate two
submissions will be received annually.
We estimate the time needed to prepare
a complete application for a diagnostic
radiopharmaceutical to be
approximately 10,000 hours, roughly
one-fifth of which, or 2,000 hours, is
estimated to be spent preparing the
portions of the application that would
be affected by these regulations. The
regulations do 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 by
§ 314.50 (collection of information
approved under OMB control number
0910–0001). In fact, clarification in
these regulations of FDA’s criteria for
evaluation of diagnostic
radiopharmaceuticals 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 the Federal Register of November
2, 2017 (82 FR 50885), we published a
notice requesting public comment on
the proposed information collection. No
comments were received. We therefore
retain the following estimated burden
for the information collection.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Diagnostic Radiopharmaceuticals §§ 315.4, 315.5, and
315.6 .................................................................................
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section
2
Average
burden per
response
Total annual
responses
1
2
Total hours
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 contains estimates of the
annual reporting burden for the
preparation of the safety and
effectiveness sections of an application
that are imposed by the applicable
regulations. This estimate does not
VerDate Sep<11>2014
16:38 Mar 23, 2018
Jkt 244001
include time needed to conduct studies
and clinical trials or other research from
which the reported information is
obtained.
The burden estimate has not changed
since prior OMB approval.
PO 00000
Frm 00017
Fmt 4703
Sfmt 9990
Dated: March 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06041 Filed 3–23–18; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\26MRN1.SGM
26MRN1
4,000
]]>Agencies
[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Page 12954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06041]
[[Page 12954]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by April
25, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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
OMB Control Number 0910-0409--Extension
This information collection supports FDA regulations found in part
315 (21 CFR part 315). These regulations require manufacturers of
diagnostic radiopharmaceuticals to submit information that demonstrates
the safety and effectiveness of a new diagnostic radiopharmaceutical or
of a new indication for use of an approved diagnostic
radiopharmaceutical. The regulations also describe the types of
indications for diagnostic radiopharmaceuticals and some of the
criteria the Agency uses to evaluate the safety and effectiveness of a
diagnostic radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) (FD&C Act) and section 351 of
the Public Health Service Act (42 U.S.C. 262) (the PHS Act).
Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables FDA to properly evaluate the safety and
effectiveness profiles of a new diagnostic radiopharmaceutical or a new
indication for use of an approved diagnostic radiopharmaceutical.
The regulations clarify existing FDA requirements for approval and
evaluation of drug and biological products already in place under the
authorities of the FD&C Act and the PHS Act. The information, which is
usually submitted as part of a new drug application 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 approved under OMB control number
0910-0001. This information collection supports part 315, currently
approved under OMB control number 0910-0409.
Based on past submissions (human drug applications and/or new
indication supplements for diagnostic radiopharmaceuticals), we
estimate two submissions will be received annually. We estimate the
time needed to prepare a complete application for a diagnostic
radiopharmaceutical to be approximately 10,000 hours, roughly one-fifth
of which, or 2,000 hours, is estimated to be spent preparing the
portions of the application that would be affected by these
regulations. The regulations do 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 by Sec.
[thinsp]314.50 (collection of information approved under OMB control
number 0910-0001). In fact, clarification in these regulations of FDA's
criteria for evaluation of diagnostic radiopharmaceuticals 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 the Federal Register of November 2, 2017 (82 FR 50885), we
published a notice requesting public comment on the proposed
information collection. No comments were received. We therefore retain
the following estimated burden for the information collection.
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Diagnostic Radiopharmaceuticals 2 1 2 2,000 4,000
Sec. Sec. 315.4, 315.5, and
315.6..........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 1 contains estimates of the annual reporting burden for the
preparation of the safety and effectiveness sections of an application
that are imposed by the applicable regulations. This estimate does not
include time needed to conduct studies and clinical trials or other
research from which the reported information is obtained.
The burden estimate has not changed since prior OMB approval.
Dated: March 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06041 Filed 3-23-18; 8:45 am]
BILLING CODE 4164-01-P
