[Federal Register Volume 67, Number 50 (Thursday, March 14, 2002)]
[Notices]
[Pages 11512-11513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0070]


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.

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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 May 13, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit 
written comments on the collection of information to the Dockets 
Management Branch (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 L. Nelson, Office of Information 
Resources Management (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 proposed collection of information, including 
each proposed 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 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 No. 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 (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 (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 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) or biologics 
license application (BLA) 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.
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    \1\ The information collection requirements for biological 
products are no longer submitted for approval to OMB in this 
package, but are included under OMB Control No. 0910-0124.
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    Based on the number of submissions (that is, human drug 
applications and/or new indication supplements for diagnostic 
radiopharmaceuticals) that FDA received during fiscal years 2000 and 
2001, FDA 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 until February 28, 2002, 
under OMB Control No. 0910-

[[Page 11513]]

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. 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\
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                                                      Annual
         21 CFR section              Number 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.......................  ..............  ..............  ..............  ..............           4,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: March 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6095 Filed 3-13-02; 8:45 am]
BILLING CODE 4160-01-P