[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