[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]
[Page 22887-22888]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0153]
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 regulations for in vivo
radiopharmaceuticals used for diagnosis and monitoring.
DATES: Submit written or electronic comments on the collection of
information by July 5, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Karen Nelson, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1482.
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 collection of information, including each
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: (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 (OMB Control Number 0910-0409)--Extension
FDA is requesting OMB approval of the information collection
requirements contained in Sec. Sec. 315.4, 315.5, and 315.6 (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 (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), 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.
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\1\ The information collection requirements for biological
products are no longer submitted to OMB for approval in this
package, but are included under OMB control number 0910-0338.
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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
[[Page 22888]]
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\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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315.4, 315.5, and 2 1 2 2,000 4,000
315.6
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Total 4,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8818 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S