Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic Testing; Availability, 27331-27332 [2011-11532]
Download as PDF
<![CDATA[
27331
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICS 1
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
(in hours) 2
Total annual
responses
Total hours
312.7(d) ..............................................................................
312.23(a) through (f) and 312.120(b), (c)(2), and (c)(3) ...
312.30(a) through (e) .........................................................
312.31(b) ............................................................................
312.32(c) and (d) and 312.56(c) ........................................
312.33(a) through (f) and 312.56(c) ..................................
312.35(a) and (b) ...............................................................
312.36 ................................................................................
312.38(b) and (c) ...............................................................
312.42(e) ............................................................................
312.44(c) and (d) ...............................................................
312.45(a) and (b) ...............................................................
312.47(b) ............................................................................
312.53(c) ............................................................................
312.54(a) and (b) ...............................................................
312.55(b) ............................................................................
312.56(b) and (d) ...............................................................
312.58(a) ............................................................................
312.64(a) through (d) .........................................................
312.70(a) ............................................................................
312.110(b) ..........................................................................
312.130(d) ..........................................................................
41
433
590
263
294
647
1
6
117
74
17
60
43
348
1
138
14
8
6,003
6
21
1
1.4
1.3
6.8
29.3
13.7
2.3
1
1
1.3
1.5
1.1
1.8
1.5
6.6
1
2.5
1.6
1
3.5
1
1
1
57
563
4,012
7,706
4,028
1,488
1
6
152
111
18
108
65
2,297
1
345
22
8
21,010
6
21
1
24
1,808
284
100
32
360
300
16
28
284
16
12
160
80
48
48
80
8
24
40
75
8
1,368
1,017,904
1,139,408
770,600
128,896
535,680
300
96
4,256
31,524
304
1,296
10,400
183,760
48
16,560
1,760
64
504,240
240
1,575
8
Total ............................................................................
........................
..........................
........................
........................
4,350,287
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN FOR BIOLOGICS 1
Number of
recordkeepers
Number of
records per
recordkeeper
312.52(a) ............................................................................
312.57(a) and (b) ...............................................................
312.62(a) ............................................................................
312.62(b) ............................................................................
312.160(a)(3) .....................................................................
312.160(c) ..........................................................................
139
433
5,570
5,570
146
146
1.4
2.6
1
10
1.4
1.4
Total ............................................................................
........................
21 CFR Section
1 There
..........................
Total annual
records
Average
burden per
recordkeeping
(in hours) 2
Total hours
195
1,126
5,570
55,700
204
204
2
100
40
40
30/60
30/60
390
112,600
222,800
2,228,000
102
102
........................
........................
2,563,994
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
2 Burden
Dated: May 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11540 Filed 5–10–11; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0272]
Draft Guidance for Industry and Food
and Drug Administration Staff;
Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis
and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
17:18 May 10, 2011
Jkt 223001
PO 00000
Notice.
Frm 00031
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis
and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing.’’ This
draft guidance document provides
industry and Agency staff with
recommendations for studies to
establish the analytical and clinical
performance of in vitro diagnostic
devices (IVDs) intended for C.
trachomatis and/or N. gonorrhoeae
screening and diagnostic testing using
nucleic acid based assays. This draft
guidance is not final nor is it in effect
at this time.
SUMMARY:
E:\FR\FM\11MYN1.SGM
11MYN1
27332
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 9, 2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Establishing the
Performance Characteristics of In Vitro
Diagnostic Devices for Chlamydia
Trachomatis and/or Neisseria
Gonorrhoeae: Screening and Diagnostic
Testing’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Kathleen Whitaker, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5500, Silver Spring,
MD 20993–0002, 301–796–6208.
SUPPLEMENTARY INFORMATION:
mstockstill on DSKH9S0YB1PROD with NOTICES
DATES:
I. Background
FDA is issuing this draft guidance to
provide industry and Agency staff with
recommendations for studies to
establish the analytical and clinical
performance of IVDs intended for C.
trachomatis and/or N. gonorrhoeae
screening and diagnostic testing using
nucleic acid based assays. These devices
are used to aid in the diagnosis of
urogenital C. trachomatis and N.
gonorrhoeae infection. They include
devices that detect one specific
organism, as well as devices that may
detect both organisms with or without
further differentiation.
This draft guidance provides detailed
information on the types of studies FDA
recommends to support class I and class
II premarket submissions for these
devices. The draft guidance includes a
list of C. trachomatis and N.
VerDate Mar<15>2010
17:18 May 10, 2011
Jkt 223001
gonorrhoeae strains recommended for
analytical sensitivity studies and a list
of micro-organisms recommended for
analytical specificity studies. This
document also addresses
recommendations for fulfilling labeling
requirements applicable to all in vitro
diagnostic devices intended to screen
for, or aid in the diagnosis of, C.
trachomatis and/or N. gonorrhoeae
directly from human specimens.
This document is limited to studies
intended to establish the performance
characteristics of devices that detect
chlamydial and/or gonococcal nucleic
acid. It does not address detection of
serological response from the host to
bacterial antigens, nor does it address
establishing performance of nonchlamydial or non-gonococcal
components of multianalyte or
multiplex devices.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on establishing the performance
characteristics of in vitro diagnostic
devices for C. trachomatis and/or N.
gonorrhoeae screening and diagnostic
testing. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Establishing the Performance
Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis
and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing,’’ you
may either send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
a hard copy. Please use the document
number 1733 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance documents. These
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; the collections of
information in 21 CFR parts 56.115 have
been approved under OMB control
number 0910–0130; and the collections
of information in 21 CFR part 801 and
21 CFR 809.10 have been approved
under OMB control number 0910–0485.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 6, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–11532 Filed 5–10–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0621]
Proposal To Withdraw Approval for the
Breast Cancer Indication for
Bevacizumab; Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of hearing.
The Food and Drug
Administration (FDA) is granting a
hearing to Genentech, Inc. (Genentech),
on the Center for Drug Evaluation and
Research’s (CDER’s) proposal to
withdraw approval of the breast cancer
indication for bevacizumab (Avastin).
Genentech is the sponsor for Avastin.
Genentech and CDER are the parties to
the hearing. The issues to be discussed
and resolved at the hearing relate
directly to the statutory and regulatory
standard for FDA to withdraw
accelerated approval of the metastatic
SUMMARY:
E:\FR\FM\11MYN1.SGM
11MYN1
]]>Agencies
[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27331-27332]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11532]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0272]
Draft Guidance for Industry and Food and Drug Administration
Staff; Establishing the Performance Characteristics of In Vitro
Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria
Gonorrhoeae: Screening and Diagnostic Testing; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Establishing the
Performance Characteristics of In Vitro Diagnostic Devices for
Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening and
Diagnostic Testing.'' This draft guidance document provides industry
and Agency staff with recommendations for studies to establish the
analytical and clinical performance of in vitro diagnostic devices
(IVDs) intended for C. trachomatis and/or N. gonorrhoeae screening and
diagnostic testing using nucleic acid based assays. This draft guidance
is not final nor is it in effect at this time.
[[Page 27332]]
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 9, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for Chlamydia
Trachomatis and/or Neisseria Gonorrhoeae: Screening and Diagnostic
Testing'' to the Division of Small Manufacturers, International, and
Consumer Assistance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-847-8149. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Kathleen Whitaker, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5500, Silver Spring, MD 20993-0002, 301-
796-6208.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing this draft guidance to provide industry and Agency
staff with recommendations for studies to establish the analytical and
clinical performance of IVDs intended for C. trachomatis and/or N.
gonorrhoeae screening and diagnostic testing using nucleic acid based
assays. These devices are used to aid in the diagnosis of urogenital C.
trachomatis and N. gonorrhoeae infection. They include devices that
detect one specific organism, as well as devices that may detect both
organisms with or without further differentiation.
This draft guidance provides detailed information on the types of
studies FDA recommends to support class I and class II premarket
submissions for these devices. The draft guidance includes a list of C.
trachomatis and N. gonorrhoeae strains recommended for analytical
sensitivity studies and a list of micro-organisms recommended for
analytical specificity studies. This document also addresses
recommendations for fulfilling labeling requirements applicable to all
in vitro diagnostic devices intended to screen for, or aid in the
diagnosis of, C. trachomatis and/or N. gonorrhoeae directly from human
specimens.
This document is limited to studies intended to establish the
performance characteristics of devices that detect chlamydial and/or
gonococcal nucleic acid. It does not address detection of serological
response from the host to bacterial antigens, nor does it address
establishing performance of non-chlamydial or non-gonococcal components
of multianalyte or multiplex devices.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on establishing
the performance characteristics of in vitro diagnostic devices for C.
trachomatis and/or N. gonorrhoeae screening and diagnostic testing. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``Establishing the Performance Characteristics of In Vitro Diagnostic
Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae:
Screening and Diagnostic Testing,'' you may either send an e-mail
request to dsmica@fda.hhs.gov to receive an electronic copy of the
document or send a fax request to 301-847-8149 to receive a hard copy.
Please use the document number 1733 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance documents. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR part
807, subpart E have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078; the collections of information in
21 CFR parts 56.115 have been approved under OMB control number 0910-
0130; and the collections of information in 21 CFR part 801 and 21 CFR
809.10 have been approved under OMB control number 0910-0485.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 6, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-11532 Filed 5-10-11; 8:45 am]
BILLING CODE 4160-01-P
