Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle, 41410-41411 [2012-17080]
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41410
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
610.2 ....................................................................................
660.6(b) ................................................................................
660.36(a) (2) and (b) ...........................................................
660.46(b) ..............................................................................
73
2
1
1
92.9
21.5
1
1
6,782
43
1
1
3
5
6
5
20,346
215
6
5
Total ..............................................................................
77
........................
6,827
........................
20,572
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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.
[FR Doc. 2012–17079 Filed 7–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0115]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request: Guidance for
Industry and Food and Drug
Administration Staff; Class II Special
Controls Guidance Document;
Automated Blood Cell Separator
Device Operating by Centrifugal or
Filtration Separation Principle
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 August 13,
2012.
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 0910–0594. Also
include the FDA docket number found
in brackets in the heading of this
document.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
S. Mizrachi, Office of Information
Management, Food and Drug
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
Ila
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Automated Blood Cell Separator Device
Operating by Centrifugal or Filtration
Separation Principle (OMB Control
Number 0910–0594)—Extension
Under the Safe Medical Devices Act
of 1990 (Pub. L. 101–629), FDA may
establish special controls, including
performance standards, postmarket
surveillance, patient registries,
guidelines, and other appropriate
actions it believes necessary to provide
reasonable assurance of the safety and
effectiveness of the device.
The special control guidance serves to
support the reclassification from class
III to class II of the automated blood cell
separator device operating on a
centrifugal separation principle
intended for the routine collection of
blood and blood components as well as
the special control for the automated
blood cell separator device operating on
a filtration separation principle
intended for the routine collection of
blood and blood components
reclassified as class II (§ 864.9245 (21
CFR 864.9245)).
For currently marketed products not
approved under the premarket approval
process, the manufacturer should file
with FDA for 3 consecutive years an
annual report on the anniversary date of
the device reclassification from class III
to class II or, on the anniversary date of
the 510(k) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360) clearance. Any subsequent
change to the device requiring the
submission of a premarket notification
in accordance with section 510(k) of the
FD&C Act should be included in the
annual report. Also, a manufacturer of a
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
device determined to be substantially
equivalent to the centrifugal or
filtration-based automated cell separator
device intended for the routine
collection of blood and blood
components, should comply with the
same general and special controls.
The annual report should include, at
a minimum, a summary of anticipated
and unanticipated adverse events that
have occurred and that are not required
to be reported by manufacturers under
Medical Device Reporting (MDR) (part
803 (21 CFR part 803)). The reporting of
adverse device events summarized in an
annual report will alert FDA to trends
or clusters of events that might be a
safety issue otherwise unreported under
the MDR regulation.
Reclassification of this device from
class III to class II for the intended use
of routine collection of blood and blood
components relieves manufacturers of
the burden of complying with the
premarket approval requirements of
section 515 of the FD&C Act (21 U.S.C.
360e), and may permit small potential
competitors to enter the marketplace by
reducing the burden. Although the
special control guidance recommends
that manufacturers of these devices file
with FDA an annual report for 3
consecutive years, this would be less
burdensome than the current
postapproval requirements under part
814, subpart E (21 CFR part 814, subpart
E), including the submission of periodic
reports under § 814.84.
Collecting or transfusing facilities,
and manufacturers have certain
responsibilities under the Federal
regulations. For example, collecting or
transfusing facilities are required to
maintain records of any reports of
complaints of adverse reactions (21 CFR
606.170), while the manufacturer is
responsible for conducting an
investigation of each event that is
reasonably known to the manufacturer
and evaluating the cause of the event
(§ 803.50(b)). In addition, manufacturers
of medical devices are required to
submit to FDA individual adverse event
E:\FR\FM\13JYN1.SGM
13JYN1
41411
Federal Register / Vol. 77, No. 135 / Friday, July 13, 2012 / Notices
reports of death, serious injury, and
malfunctions (§ 803.50).
In the special control guidance
document, FDA recommends that
manufacturers include in their three
annual reports a summary of adverse
reactions maintained by the collecting
or transfusing facility or similar reports
of adverse events collected in addition
to those required under the MDR
regulation. The MedWatch medical
device reporting code instructions
(https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm106737.htm)
contains a comprehensive list of adverse
events associated with device use,
including most of those events that we
recommend summarizing in the annual
report.
In the Federal Register of February
15, 2012 (77 FR 8879), 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
Reporting activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Annual Reporting .................................................................
4
1
4
5
20
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are
approximately four manufactures of
automated blood cell separator devices.
We estimate that the manufacturers will
spend approximately 5 hours preparing
and submitting the annual report.
Other burden hours required for
§ 864.9245 are reported and approved
under OMB control number 0910–0120
(premarket notification submission
501(k), 21 CFR part 807, subpart E), and
OMB control number 0910–0437 (MDR,
21 CFR part 803).
Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–17080 Filed 7–12–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–P–0271]
Determination That TOPOTECAN
INJECTION (Topotecan Hydrochloride)
1 Milligram (Base)/1 Milliliter, 3
Milligram (Base)/3 Milliliter, 4 Milligram
(Base)/4 Milliliter, Was Not Withdrawn
From Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that TOPOTECAN INJECTION
(topotecan hydrochloride) 1 milligram
(mg) (base)/1 milliliter (mL), 3 mg
(base)/3 mL, 4 mg (base)/4 mL, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:08 Jul 12, 2012
Jkt 226001
applications (ANDAs) for topotecan
hydrochloride intravenous solution 1
mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg
(base)/4 mL, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Rachel Turow, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6236,
Silver Spring, MD 20993–0002, 301–
796–5094.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA). The only clinical data required
in an ANDA are data to show that the
drug that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
TOPOTECAN INJECTION (topotecan
hydrochloride) 1 mg (base)/1 mL, 3 mg
(base)/3 mL, 4 mg (base)/4 mL, is the
subject of NDA 200199, held by Sandoz
Inc., and initially approved on February
25, 2011. TOPOTECAN INJECTION is
indicated for the treatment of small cell
lung cancer sensitive disease after
failure of first-line chemotherapy. In
clinical studies submitted to support
approval, sensitive disease was defined
as disease responding to chemotherapy
but subsequently progressing at least 60
days (in the phase 3 study) or at least
90 days (in the phase 2 studies) after
chemotherapy. TOPOTECAN
INJECTION in combination with
cisplatin is indicated for the treatment
of stage IV–B, recurrent, or persistent
carcinoma of the cervix, which is not
amenable to curative treatment with
surgery and/or radiation therapy.
Sandoz Inc. has never marketed
TOPOTECAN INJECTION (topotecan
hydrochloride) 1 mg (base)/1 mL, 3 mg
(base)/3 mL, 4 mg (base)/4 mL. In
previous instances (see, e.g., 72 FR
9763, March 5, 2007; 61 FR 25497, May
21, 1996), the Agency has determined
that, for purposes of §§ 314.161 and
314.162, never marketing an approved
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Notices]
[Pages 41410-41411]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17080]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0115]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request: Guidance for Industry
and Food and Drug Administration Staff; Class II Special Controls
Guidance Document; Automated Blood Cell Separator Device Operating by
Centrifugal or Filtration Separation Principle
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 August
13, 2012.
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 0910-0594.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@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.
Guidance for Industry and Food and Drug Administration Staff; Class II
Special Controls Guidance Document: Automated Blood Cell Separator
Device Operating by Centrifugal or Filtration Separation Principle (OMB
Control Number 0910-0594)--Extension
Under the Safe Medical Devices Act of 1990 (Pub. L. 101-629), FDA
may establish special controls, including performance standards,
postmarket surveillance, patient registries, guidelines, and other
appropriate actions it believes necessary to provide reasonable
assurance of the safety and effectiveness of the device.
The special control guidance serves to support the reclassification
from class III to class II of the automated blood cell separator device
operating on a centrifugal separation principle intended for the
routine collection of blood and blood components as well as the special
control for the automated blood cell separator device operating on a
filtration separation principle intended for the routine collection of
blood and blood components reclassified as class II (Sec. 864.9245 (21
CFR 864.9245)).
For currently marketed products not approved under the premarket
approval process, the manufacturer should file with FDA for 3
consecutive years an annual report on the anniversary date of the
device reclassification from class III to class II or, on the
anniversary date of the 510(k) of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360) clearance. Any subsequent change to
the device requiring the submission of a premarket notification in
accordance with section 510(k) of the FD&C Act should be included in
the annual report. Also, a manufacturer of a device determined to be
substantially equivalent to the centrifugal or filtration-based
automated cell separator device intended for the routine collection of
blood and blood components, should comply with the same general and
special controls.
The annual report should include, at a minimum, a summary of
anticipated and unanticipated adverse events that have occurred and
that are not required to be reported by manufacturers under Medical
Device Reporting (MDR) (part 803 (21 CFR part 803)). The reporting of
adverse device events summarized in an annual report will alert FDA to
trends or clusters of events that might be a safety issue otherwise
unreported under the MDR regulation.
Reclassification of this device from class III to class II for the
intended use of routine collection of blood and blood components
relieves manufacturers of the burden of complying with the premarket
approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e),
and may permit small potential competitors to enter the marketplace by
reducing the burden. Although the special control guidance recommends
that manufacturers of these devices file with FDA an annual report for
3 consecutive years, this would be less burdensome than the current
postapproval requirements under part 814, subpart E (21 CFR part 814,
subpart E), including the submission of periodic reports under Sec.
814.84.
Collecting or transfusing facilities, and manufacturers have
certain responsibilities under the Federal regulations. For example,
collecting or transfusing facilities are required to maintain records
of any reports of complaints of adverse reactions (21 CFR 606.170),
while the manufacturer is responsible for conducting an investigation
of each event that is reasonably known to the manufacturer and
evaluating the cause of the event (Sec. 803.50(b)). In addition,
manufacturers of medical devices are required to submit to FDA
individual adverse event
[[Page 41411]]
reports of death, serious injury, and malfunctions (Sec. 803.50).
In the special control guidance document, FDA recommends that
manufacturers include in their three annual reports a summary of
adverse reactions maintained by the collecting or transfusing facility
or similar reports of adverse events collected in addition to those
required under the MDR regulation. The MedWatch medical device
reporting code instructions (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm106737.htm) contains a
comprehensive list of adverse events associated with device use,
including most of those events that we recommend summarizing in the
annual report.
In the Federal Register of February 15, 2012 (77 FR 8879), 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 Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Reporting activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Reporting................................................... 4 1 4 5 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on FDA records, there are approximately four manufactures of
automated blood cell separator devices. We estimate that the
manufacturers will spend approximately 5 hours preparing and submitting
the annual report.
Other burden hours required for Sec. 864.9245 are reported and
approved under OMB control number 0910-0120 (premarket notification
submission 501(k), 21 CFR part 807, subpart E), and OMB control number
0910-0437 (MDR, 21 CFR part 803).
Dated: July 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-17080 Filed 7-12-12; 8:45 am]
BILLING CODE 4160-01-P
