[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Page 22887-22888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0153]

Agency Information Collection Activities; Proposed Collection; 
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 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 or electronic comments on the collection of 
information by July 5, 2005.

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.fda.gov/dockets/ecomments. 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: Karen Nelson, Office of Management 
Programs (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: (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 Sec.  Sec.  315.4, 315.5, and 315.6 (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 
    In response to the requirements of section 122 of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), 
FDA published a final rule (64 FR 26657, May 17, 1999) amending its 
regulations by adding provisions that clarify FDA'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\1\ 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 (NDA), 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 

    \1\ The information collection requirements for biological 
products are no longer submitted to OMB for approval in this 
package, but are included under OMB control number 0910-0338.

    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

[[Page 22888]]

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 (OMB control number 0910-0001 approved by OMB until 
March 31, 2005). 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. The burden totals do not 
include an increase in burden. This estimate does not include the 
actual time needed to conduct studies and trials or other research from 
which the reported information is obtained.

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

    Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8818 Filed 5-2-05; 8:45 am]