[Federal Register Volume 73, Number 176 (Wednesday, September 10, 2008)]
[Notices]
[Pages 52663-52664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0239]


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: Fax written comments on the collection of information by October 
10, 2008.

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: 202-395-6974, or e-mailed 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: Elizabeth Berbakos, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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

    FDA is requesting OMB approval of the information collection 
requirements contained in 21 CFR 315.4, 315.5, and 315.6. 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.
    In response to the requirements of section 122 of the Food and Drug 
Administration Modernization Act of 1997 (Public Law 105-115), FDA 
published a final rule in the Federal

[[Page 52664]]

Register of May 17, 1999 (64 FR 26657) amending its regulations by 
adding provisions that clarify the agency's evaluation and approval of 
in vivo radiopharmaceuticals used in the diagnosis or monitoring of 
diseases. The regulation describes the kinds of indications of 
diagnostic radiopharmaceuticals and some of the criteria that the 
agency would use to evaluate the safety and effectiveness of a 
diagnostic radiopharmaceutical under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) and section 351 of the 
Public Health Service Act (the PHS Act) (42 U.S.C. 262). 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 rule clarifies existing FDA requirements for approval and 
evaluation of drug and biological products already in place under the 
authorities of the 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). Under 21 CFR part 315, information 
required under the act and needed by FDA to evaluate the safety and 
effectiveness of in vivo radiopharmaceuticals still needs to be 
reported.
    Based on the number of submissions (that is, human drug 
applications and/or new indication supplements for diagnostic 
radiopharmaceuticals) that FDA receives, the agency estimates that it 
will receive approximately two submissions annually from two 
applicants. The hours per response refers to the estimated number of 
hours that an applicant would spend preparing the information required 
by the regulations. Based on FDA's experience, the agency estimates 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 regulation 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 by Sec.  
314.50 (collection of information approved by OMB under OMB control 
number 0910-0001). In fact, clarification in these regulations of FDA's 
standards 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. Table 1 of this 
document contains estimates of the annual reporting burden for the 
preparation of the safety and effectiveness sections of an application 
that are imposed by existing regulations. This estimate does not 
include the actual time needed to conduct studies and trials or other 
research from which the reported information is obtained.
    In the Federal Register of April 28, 2008 (73 FR 22955), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.-- Estimated Annual Reporting Burden\1\
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                                                   Annual
       21 CFR Section             No. of       Frequency per     Total Annual      Hours Per       Total Hours
                               Respondents        Response        Responses         Response
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315.4, 315.5, and 315.6                    2                1                2            2,000            4,000
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Total                                                                                            ...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20933 Filed 9-9-08; 8:45 am]
BILLING CODE 4160-01-S