Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring, 78443-78444 [2014-30452]
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Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0998]
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.
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 January 29,
2015.
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:
202–395–7285, or emailed to oira_
submission@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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
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 (21 U.S.C. 355) (the
FD&C Act) and section 351 of the Public
Health Service Act (42 U.S.C. 262) (the
PHS Act). 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 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.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
78443
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
§ 314.50 (collection of information
approved 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 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 July 21,
2014 (79 FR 42337), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\30DEN1.SGM
30DEN1
78444
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
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
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: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30452 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0797]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance: Medical
Device ISO 13485:2003 Voluntary Audit
Report Submission Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0700. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
ADDRESSES:
Notice.
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 January 29,
2015.
SUMMARY:
Guidance: Medical Device ISO
13485:2003 Voluntary Audit Report
Submission Pilot Program—(OMB
Control Number 0910–0700)—Extension
Under section 228 of the Food and
Drug Administration Amendments Act
of 2007 (Pub. L. 110–85), as amended by
section 704(g)(7) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
374(g)(7)), the owner or operator of an
establishment may submit an audit
report that assesses conformance with
appropriate quality system standards set
by the International Organization for
Standardization (ISO) and identified by
the Secretary in public notice.
The ‘‘Guidance for Industry, Third
Parties and FDA Staff: Medical Device
ISO 13485:2003 Voluntary Audit Report
Submission Program’’ describes how
FDA’s Center for Devices and
Radiological Health and Center for
Biologics Evaluation and Research are
implementing this provision of the law
and providing public notice as required.
The proposed collections of information
are necessary to satisfy the previously
mentioned statutory requirements for
implementing this voluntary submission
program. The collected information is
used for setting risk-based inspectional
priorities.
In the Federal Register of June 26,
2014 (79 FR 36318), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity
(One time only burden) First year, electronic setup and verification certificate 1
(Recurring burden) Audit report submission .......................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total
operating and
maintenance
costs
1,700
1
1,700
2 42
71,400
$51,000
1,700
1
1,700
3
5,100
51,000
are no capital costs associated with this information collection.
may already have a valid WebTrader account established for other FDA electronic submissions.
mstockstill on DSK4VPTVN1PROD with NOTICES
2 Respondent
Based on FDA’s experience with the
founding regulatory members of the
Global Harmonization Task Force
(GHTF), FDA expects that the vast
majority of manufacturers who will
participate in the Voluntary Audit
Report Submission Program will be
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
manufacturers who are certified by
Health Canada under ISO 13485:2003.
In addition, FDA only expects firms
that do not have major deficiencies or
observations in their ISO 13485:2003
audits to be willing to submit their audit
reports to FDA under the Voluntary
Audit Report Submission Program. FDA
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
analyzed its inspection data from Fiscal
Year (FY) 2013 (October 1, 2012 to
October 1, 2013) and determined that
the total number of inspections finalized
in FY 2013 for medical devices was
2,404. The breakdown for the 2,404
compliance decisions is as follows:
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78443-78444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30452]
[[Page 78443]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0998]
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 January
29, 2015.
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: 202-395-7285, or emailed to oira_submission@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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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--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 (21 U.S.C. 355) (the FD&C Act)
and section 351 of the Public Health Service Act (42 U.S.C. 262) (the
PHS Act). 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 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
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 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 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 July 21, 2014 (79 FR 42337), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 78444]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30452 Filed 12-29-14; 8:45 am]
BILLING CODE 4164-01-P
