83 FR 12954 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 58 (March 26, 2018)

Page Range		12954-12954
FR Document		2018-06041

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.

Federal Register, Volume 83 Issue 58 (Monday, March 26, 2018)

[Federal Register Volume 83, Number 58 (Monday, March 26, 2018)]
[Notices]
[Page 12954]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06041]



[[Page 12954]]

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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.

-----------------------------------------------------------------------

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

12954 Federal Register / Vol. 83, No. 58 / Monday, March 26, 2018 / Notices

DEPARTMENT OF HEALTH AND collection of information to OMB for and chemistry, manufacturing, and
HUMAN SERVICES review and clearance. controls. The content and format of an
application for approval of a new drug
Food and Drug Administration Regulations for In Vivo
are set forth in § 314.50 (21 CFR 314.50),
Radiopharmaceuticals Used for
[Docket No. FDA–2014–N–0998] and approved under OMB control
Diagnosis and Monitoring
number 0910–0001. This information
Agency Information Collection OMB Control Number 0910–0409— collection supports part 315, currently
Activities; Submission for Office of Extension approved under OMB control number
Management and Budget Review; 0910–0409.
This information collection supports
Comment Request; Regulations for In FDA regulations found in part 315 (21 Based on past submissions (human
Vivo Radiopharmaceuticals Used for CFR part 315). These regulations require drug applications and/or new indication
Diagnosis and Monitoring manufacturers of diagnostic supplements for diagnostic
AGENCY: Food and Drug Administration, radiopharmaceuticals to submit radiopharmaceuticals), we estimate two
HHS. information that demonstrates the safety submissions will be received annually.
and effectiveness of a new diagnostic We estimate the time needed to prepare
ACTION: Notice.
radiopharmaceutical or of a new a complete application for a diagnostic
SUMMARY: The Food and Drug indication for use of an approved radiopharmaceutical to be
Administration (FDA) is announcing diagnostic radiopharmaceutical. The approximately 10,000 hours, roughly
that a proposed collection of regulations also describe the types of one-fifth of which, or 2,000 hours, is
information has been submitted to the indications for diagnostic estimated to be spent preparing the
Office of Management and Budget radiopharmaceuticals and some of the portions of the application that would
(OMB) for review and clearance under criteria the Agency uses to evaluate the be affected by these regulations. The
the Paperwork Reduction Act of 1995. safety and effectiveness of a diagnostic regulations do not impose any
DATES: Fax written comments on the radiopharmaceutical under section 505 additional reporting burden for safety
collection of information by April 25, of the Federal Food, Drug, and Cosmetic and effectiveness information on
2018. Act (21 U.S.C. 355) (FD&C Act) and diagnostic radiopharmaceuticals beyond
section 351 of the Public Health Service the estimated burden of 2,000 hours
ADDRESSES: To ensure that comments on
Act (42 U.S.C. 262) (the PHS Act). because safety and effectiveness
the information collection are received, information is already required by
OMB recommends that written Information about the safety or
effectiveness of a diagnostic § 314.50 (collection of information
comments be faxed to the Office of approved under OMB control number
Information and Regulatory Affairs, radiopharmaceutical enables FDA to
properly evaluate the safety and 0910–0001). In fact, clarification in
OMB, Attn: FDA Desk Officer, Fax: 202– these regulations of FDA’s criteria for
395–7285, or emailed to oira_ effectiveness profiles of a new
diagnostic radiopharmaceutical or a evaluation of diagnostic
submission@omb.eop.gov. All radiopharmaceuticals is intended to
comments should be identified with the new indication for use of an approved
diagnostic radiopharmaceutical. streamline overall information
OMB control number 0910–0409. Also collection burdens, particularly for
include the FDA docket number found The regulations clarify existing FDA
requirements for approval and diagnostic radiopharmaceuticals that
in brackets in the heading of this may have well-established, low-risk
document. evaluation of drug and biological
products already in place under the safety profiles, by enabling
FOR FURTHER INFORMATION CONTACT: authorities of the FD&C Act and the PHS manufacturers to tailor information
Domini Bean, Office of Operations, Act. The information, which is usually submissions and avoid unnecessary
Food and Drug Administration, Three submitted as part of a new drug clinical studies.
White Flint North, 10A–12M, 11601 application or biologics license In the Federal Register of November
Landsdown St., North Bethesda, MD application or as a supplement to an 2, 2017 (82 FR 50885), we published a
20852, 301–796–5733, PRAStaff@ approved application, typically notice requesting public comment on
fda.hhs.gov. includes, but is not limited to, the proposed information collection. No
SUPPLEMENTARY INFORMATION: In nonclinical and clinical data on the comments were received. We therefore
compliance with 44 U.S.C. 3507, FDA pharmacology, toxicology, adverse retain the following estimated burden
has submitted the following proposed events, radiation safety assessments, for the information collection.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

Diagnostic Radiopharmaceuticals §§ 315.4, 315.5, and
315.6 ................................................................................. 2 1 2 2,000 4,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
sradovich on DSK3GMQ082PROD with NOTICES

Table 1 contains estimates of the include time needed to conduct studies Dated: March 19, 2018.
annual reporting burden for the and clinical trials or other research from Leslie Kux,
preparation of the safety and which the reported information is Associate Commissioner for Policy.
effectiveness sections of an application obtained. [FR Doc. 2018–06041 Filed 3–23–18; 8:45 am]
that are imposed by the applicable The burden estimate has not changed BILLING CODE 4164–01–P
regulations. This estimate does not since prior OMB approval.

VerDate Sep<11>2014 16:38 Mar 23, 2018 Jkt 244001 PO 00000 Frm 00017 Fmt 4703 Sfmt 9990 E:\FR\FM\26MRN1.SGM 26MRN1

Document Created: 2018-03-24 00:59:58
Document Modified: 2018-03-24 00:59:58

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by April 25, 2018.
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]
FR Citation		83 FR 12954

83 FR 12954 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 58 (March 26, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration