[Federal Register: August 23, 2005 (Volume 70, Number 162)]
[Page 49294-49295]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0153]

Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 22, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management 
Programs (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

    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 26675, 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 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 
    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 (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

[[Page 49295]]

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

    In the Federal Register of May 3, 2005 (70 FR 22887), FDA published 
a 60-day notice requesting public comment on the information collection 
provisions. No comments were received.

    Dated: August 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16656 Filed 8-22-05; 8:45 am]