Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 34079-34080 [2011-14418]
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Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: May 31, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–14106 Filed 6–9–11; 8:45 am]
BILLING CODE 4184–22–M
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.
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 https://
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,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
34079
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 § 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
E:\FR\FM\10JNN1.SGM
10JNN1
34080
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
because safety and effectiveness
information is already required by
§ 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
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.
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
315.4, 315.5, and 315.6 ...................................
2
1
2
2,000
4,000
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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0424]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Temporary
Marketing Permit Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
reporting requirements contained in
existing FDA regulations governing
temporary marketing permit
applications.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
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 https://
www.regulations.gov. Submit written
comments on the collection of
DATES:
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
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:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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.
Temporary Marketing Permit
Applications—21 CFR 130.17(c) and (i)
(OMB Control Number 0910–0133)—
Extension
Section 401 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 341) directs FDA to issue
regulations establishing definitions and
standards of identity for food
‘‘[w]henever * * * such action will
promote honesty and fair dealing in the
interest of consumers * * *.’’ Under
section 403(g) of the FD&C Act (21
U.S.C. 343(g)), a food that is subject to
a definition and standard of identity
prescribed by regulation is misbranded
if it does not conform to such definition
and standard of identity. Section 130.17
(21 CFR 130.17) provides for the
issuance by FDA of temporary
marketing permits that enable the food
industry to test consumer acceptance
and measure the technological and
commercial feasibility in interstate
commerce of experimental packs of food
that deviate from applicable definitions
and standards of identity. Section
130.17(c) enables the Agency to monitor
the manufacture, labeling, and
distribution of experimental packs of
food that deviate from applicable
definitions and standards of identity.
The information so obtained can be
used in support of a petition to establish
or amend the applicable definition or
standard of identity to provide for the
variations. Section 130.17(i) specifies
the information that a firm must submit
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34079-34080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14418]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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,
Elizabeth.Berbakos@fda.hhs.gov.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
315.4, 315.5, and 315.6.................................. 2 1 2 2,000 4,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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]
BILLING CODE 4160-01-P
