Notice: Agency Information Collection Activities; Proposed Collection; 
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for 
Diagnosis and Monitoring

Federal Register: April 28, 2008 (Volume 73, Number 82)        
                  Page 22955-22956

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the 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 regulations for in vivo 
radiopharmaceuticals used for diagnosis and monitoring.

DATES:  Submit written comments on the collection of information by 
June 27, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 
Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 collection of information, including each 
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 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--(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 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 PublicHealth

[[Page 22956]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                      No. of       Annual Frequency per     Total Annual        Hours per
21 CFR Section     Respondents           Response            Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
315.4, 315.5,                   2                     1                  2              2,000              4,000
 and 315.6
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      4,000
----------------------------------------------------------------------------------------------------------------

    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

    Dated: April 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9159 Filed 4-25-08; 8:45 am]

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