[Federal Register: September 10, 2008 (Volume 73, Number 176)]
[Notices]
[Page 52663-52664]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se08-48]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0239]
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.
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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 October
10, 2008.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0409. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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 (Public Law 105-115), FDA
published a final rule in the Federal
[[Page 52664]]
Register of May 17, 1999 (64 FR 26657) amending its regulations by
adding provisions that clarify the agency'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 or 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
reported.
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 (collection of information approved by OMB 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. 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 April 28, 2008 (73 FR 22955), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.-- Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. 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 ...............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: August 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20933 Filed 9-9-08; 8:45 am]
BILLING CODE 4160-01-S