[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34079-34080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14418]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0405]
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 information collection for in
vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.
DATES: Submit either electronic or written comments on the collection
of information by August 9, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
[email protected].
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 these topics: (1) Whether the proposed 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--21 CFR Part 315 (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 (Pub. L. 105-115), FDA
published a final rule in the Federal 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 FD&C 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 FD&C 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 FD&C 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, or 2,000 hours, of which 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
[[Page 34080]]
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.
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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315.4, 315.5, and 315.6.................................. 2 1 2 2,000 4,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-14418 Filed 6-9-11; 8:45 am]
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