[Federal Register Volume 67, Number 26 (Thursday, February 7, 2002)]
[Notices]
[Pages 5829-5830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0785]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Revised Draft Guidance for Industry on 
Developing Medical Imaging Drugs and Biologics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
March 11, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Revised Draft Guidance for Industry on Developing Medical Imaging 
Drugs and Biologics

    In the Federal Register of October 14, 1998 (63 FR 55067), FDA 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Developing Medical Imaging Drugs and Biological 
Products.'' In response to comments and on its own initiative, FDA made 
several revisions to the draft guidance. The agency announced the 
availability of a revised draft guidance in the Federal Register of 
July 31, 2000 (65 FR 46674).
    The draft guidance is intended to assist developers of drug and 
biological products used for medical imaging in planning and 
coordinating the clinical investigations of and submitting various 
types of applications for, such products.
    The draft guidance also provides information on how the agency will 
interpret and apply provisions in the final rule, published in the 
Federal Register of May 17, 1999 (64 FR 26657), on the evaluation and 
approval of in vivo radiopharmaceuticals used in the diagnosis and 
monitoring of diseases. The final rule describes certain types of 
indications for which FDA will approve diagnostic radiopharmaceuticals 
and lists factors that the agency will consider in evaluating the 
safety and effectiveness of a diagnostic radiopharmaceutical drug or 
biological product under the Federal Food, Drug, and Cosmetic Act (the 
act) or the Public Health Service Act (the PHS Act), respectively.
    The draft guidance applies to medical imaging agents that are used 
for diagnosis and monitoring and that are administered in vivo. Such 
agents include contrast agents used with medical imaging techniques 
such as radiography, computed tomography, ultrasonography, and magnetic 
resonance imaging, as well as radiopharmaceuticals used with imaging 
procedures such as single-photon emission computed tomography and 
positron emission tomography. The draft guidance is not intended to 
apply to possible therapeutic uses of these agents or to in vitro 
diagnostic products.
    Description: The draft guidance is intended to assist developers of 
drug and biological products used for medical imaging in planning and 
coordinating the clinical investigations of, and submitting various 
types of applications for, such products. The draft guidance provides 
information on how the agency will interpret and apply provisions of 
the existing regulations regarding the content and format of an 
application for approval of a new drug (21 CFR 314.50) and the content 
of a biological product application (21 CFR 601.25). The draft guidance 
also provides information on how the agency will interpret and apply 
the final rule on the evaluation and approval of in vivo 
radiopharmaceuticals used for diagnosis and monitoring (64 FR 26657). 
The final rule, by adding part 315 (21 CFR part 315), clarifies 
requirements for the evaluation and approval of drug and biological 
radiopharmaceuticals under the authority of the act and the PHS Act.
    Existing regulations, which appear primarily in parts 314 and 601 
(21 CFR parts 314 and 601), specify the information that manufacturers 
must submit so that FDA may properly evaluate the safety and 
effectiveness of new drugs and biological products. This information is 
usually submitted as part of a new drug application (NDA) or a 
biological license application, or as a supplement to an approved 
application. Part 315 contains regulations that clarify what 
information is relevant for diagnostic radiopharmaceuticals. This 
revised draft guidance supplements these regulations. Under part 315 
and the revised draft guidance, information required under the act and 
the PHS Act to establish safety and effectiveness would still have to 
be reported.
    Description of Respondents: Developers of medical imaging drugs and 
biological products, including contrast drug products and diagnostic 
radiopharmaceuticals.
    Burden Estimate: The final rule on in vivo radiopharmaceuticals 
used for

[[Page 5830]]

diagnosis and monitoring set forth an estimated annual reporting burden 
on the industry that would result from that rulemaking (64 FR 26657). 
OMB has approved this collection of information until July 31, 2002, 
under OMB control number 0910-0409. This revised draft guidance on the 
development of medical imaging drugs and biological products is in part 
intended to explain how FDA will interpret and apply the final rule. 
Thus, the estimated annual reporting burden of the draft guidance is 
the same as that of the final rule, with one change. In addition to the 
diagnostic radiopharmaceuticals that are the subject of the final rule, 
the revised draft guidance also addresses the development of contrast 
drug products, which FDA evaluates and approves under part 314, but 
which are not affected by the final rule.
    Table 1 in this document provides an estimate of the annual 
reporting burden for contrast drug products. FDA estimates that the 
potential number of respondents who would submit applications or 
supplements for contrast drug products would be one. Although FDA did 
not approve any NDA's for contrast drugs (there are no biological 
contrast drug products) in fiscal year 1999, for purposes of estimating 
the annual reporting burden, the agency assumes that it will approve 
one contrast drug each fiscal year. The annual frequency of responses 
for contrast drugs is estimated to be one response per application or 
supplement. The hours per response, which is the estimated number of 
hours that an applicant would spend preparing the information to be 
submitted for a contrast drug in accordance with this draft guidance, 
is estimated to be approximately 2,000 hours.
    The revised draft guidance would not impose any additional 
reporting burden because safety and effectiveness information is 
already required by existing regulations. In fact, clarification by the 
guidance of FDA's standards for evaluation of medical imaging drugs and 
biological products is expected to reduce the overall burden of the 
information collection.FDA received no comments on the analysis of 
information collection burdens stated in the notice of availability of 
the draft guidance published on October 14, 1998. In the Federal 
Register of July 31, 2000 (65 FR 46674), FDA requested comments on the 
revised proposed collection of information. The agency received no 
comments.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
                                      No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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Contrast Drugs                          1               1               1           2,000           2,000
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Total                                                                                               2,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: January 31, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-3024 Filed 2-6-02; 8:45 am]
BILLING CODE 4160-01-S