[Federal Register Volume 67, Number 136 (Tuesday, July 16, 2002)]
[Notices]
[Pages 46679-46680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17784]



[[Page 46679]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0070]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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 
August 15, 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.

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 (FDAMA) (Public Law 105-115), FDA published a 
final rule in the Federal Register (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) 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.
---------------------------------------------------------------------------

    \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 number 0901-0124.
---------------------------------------------------------------------------

    Based on the number of submissions (that is, human drug 
applications and/or new indication supplements for diagnostic 
radiopharmaceuticals) that FDA received during fiscal year 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 March 31, 2005, 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. 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.
    In the Federal Register of March 14, 2002 (67 FR 11512), the agency 
requested comments on the proposed collections of information. No 
comments were received.

             Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
                                Annual
    21 CFR       Number of     Frequency     Total    Hours per   Total
   Section      Respondents       per       Annual     Response   Hours
                               Response    Responses
------------------------------------------------------------------------
315.4, 315.5,  2              1           2           2,000      4,000
 and 315.6

[[Page 46680]]

 
Total                                                            4,000
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.


    Dated: July 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17784 Filed 7-15-02; 8:45 am]
BILLING CODE 4160-01-S