Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable, 29158-29159 [E6-7617]
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29158
Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
annual frequency of response was
calculated as the total annual responses
divided by the number of respondents.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
FDA Form
No.
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
514.80(b)(1)
1932
190
0.50
95
1
95
514.80(b)(2)(i)
1932
190
64.65
12,283
1
12,283
514.80(b)(2)(ii)
1932
190
31.62
6,007
1
6,007
514.80(b)(3)
1932
340
2.94
1,000
1
1,000
1923a
250
1
250
1
250
514.80(b)(4)
2301
190
6.45
1,226
11
13,486
514.80(b)(5)(i)
2301
190
0.13
25
2
50
514.80(b)(5)(ii)
2301
190
4.06
772
2
1544
514.80(b)(5)(iii)
2301
530
0.11
56
2
112
Voluntary reporting FDA
Form 1932a for public
Total Hours
1There
34827
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
21 CFR Section
No. of
Recordkeepers
514.80(e)2
514.80(e)3
Total
1There
Annual Frequency
per Recordkeeping
530
530
Total Annual Records
36.58
4.49
Hours per Record
19,385
2,379
Total Hours
0.5
10.35
9,693
24,623
34,316
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates for 514.80(b)(1), (b)(2)(i), (b)(2)(ii), (b)(3), and Form FDA 1932.
estimates for 514.80(b)(2)(iii), (b)(4), (c), (b)(5), and Form FDA 2301.
2Recordkeeping
3Recordkeeping
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7616 Filed 5–18–06; 8:45 am]
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
guidance on informed consent for in
vitro diagnostic device studies using
leftover human specimens that are not
individually identifiable.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N–0185]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance on
Informed Consent for In Vitro
Diagnostic Device Studies Using
Leftover Human Specimens That are
Not Individually Identifiable
wwhite on PROD1PC61 with NOTICES
AGENCY:
Submit written or electronic
comments on the collection of
information by July 18, 2006.
DATES:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
VerDate Aug<31>2005
17:37 May 18, 2006
Jkt 208001
Submit electronic
comments on the collection of
information to: https://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
ADDRESSES:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1472.
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,
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19MYN1.SGM
19MYN1
Federal Register / Vol. 71, No. 97 / Friday, May 19, 2006 / Notices
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.
Guidance on Informed Consent for In
Vitro Diagnostic Device Studies Using
Leftover Human Specimens That are
Not Individually Identifiable—(OMB
Control Number 0910–0582)—Extension
FDA’s investigational device
regulations are intended to encourage
the development of new, useful devices
in a manner that is consistent with
public health, safety, and with ethical
standards. Investigators should have
freedom to pursue the least burdensome
means of accomplishing this goal.
However, to ensure that the balance is
maintained between product
development and the protection of
public health, safety, and ethical
standards, FDA has established human
subject protection regulations
addressing requirements for informed
consent and institutional review board
(IRB) review that apply to all FDAregulated clinical investigations
involving human subjects. In particular,
informed consent requirements further
both safety and ethical considerations
by allowing potential subjects to
consider both the physical and privacy
risks they face if they agree to
participate in a trial.
Under FDA regulations, clinical
investigations using human specimens
conducted in support of premarket
submissions to FDA are considered
human subject investigations (see 21
CFR 812.3(p)). Many investigational
device studies are exempt from most
provisions of part 812 (21 CFR part 812),
Investigational Device Exemptions,
29159
under § 812.2(c)(3), but FDA’s
regulations for the protection of human
subjects (21 CFR parts 50 and 56) apply
to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21
CFR 56.101; 21 U.S.C. 360j(g)(3)(A), and
21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain
exceptions from the requirements of
informed consent on the grounds that
the specimens are not identifiable or
that they are remnants of human
specimens collected for routine clinical
care or analysis that would otherwise
have been discarded. Nor do FDA
regulations allow IRBs to decide
whether or not to waive informed
consent for research involving leftover
or unidentifiable specimens.
In a level one guidance document
issued under the Good Guidances
Practices regulation, 21 CFR 10.115,
FDA outlines the circumstances in
which it intends to exercise
enforcement discretion as to the
informed consent regulations for
clinical investigators, sponsors, and
IRBs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN
No. of Recordkeepers
Annual Frequency
per Recordkeeping
wwhite on PROD1PC61 with NOTICES
700
1
The recommendations of this
guidance impose a minimal burden on
industry. FDA estimates that 700 studies
will be affected annually. Each study
will result in one recordkeeping per
year, estimated to take 4 hours to
complete. This results in a total
recordkeeping burden of 2,400 hours
(700 x 4 = 2,800). FDA estimates that the
cost of developing standard operating
procedures for each record keeper is
$300 (6 hours of work at $50/hour (h)).
This results in a total cost to industry of
$210,000 ($300 x 700 recordkeepers).
FDA estimates that operating costs for
collecting this information is $300 per
record keeper (6 hours of work at $50/
h). This results in a total operational
and maintenance cost to industry of
$210,000 ($300 x 700 recordkeepers).
The total cost of this recordkeeping,
capital plus operational and
maintenance cost, is estimated to be
$420,000.
VerDate Aug<31>2005
Total Annual
Records
17:37 May 18, 2006
Jkt 208001
Hours per
Record
700
Total Hours
4
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–7617 Filed 5–18–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources And Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to OMB under the
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
2,800
Total Capital
Costs
$210,000
Total Operating and
Maintenance Costs
420,000
Paperwork Reduction Act of 1995. To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, call the HRSA Reports
Clearance Officer on (301) 443–1891.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 71, Number 97 (Friday, May 19, 2006)]
[Notices]
[Pages 29158-29159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-7617]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0185]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Informed Consent for In Vitro Diagnostic
Device Studies Using Leftover Human Specimens That are Not Individually
Identifiable
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 guidance on informed consent
for in vitro diagnostic device studies using leftover human specimens
that are not individually identifiable.
DATES: Submit written or electronic comments on the collection of
information by July 18, 2006.
ADDRESSES: Submit electronic comments on the collection of information
to: https://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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
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,
[[Page 29159]]
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.
Guidance on Informed Consent for In Vitro Diagnostic Device Studies
Using Leftover Human Specimens That are Not Individually Identifiable--
(OMB Control Number 0910-0582)--Extension
FDA's investigational device regulations are intended to encourage
the development of new, useful devices in a manner that is consistent
with public health, safety, and with ethical standards. Investigators
should have freedom to pursue the least burdensome means of
accomplishing this goal. However, to ensure that the balance is
maintained between product development and the protection of public
health, safety, and ethical standards, FDA has established human
subject protection regulations addressing requirements for informed
consent and institutional review board (IRB) review that apply to all
FDA-regulated clinical investigations involving human subjects. In
particular, informed consent requirements further both safety and
ethical considerations by allowing potential subjects to consider both
the physical and privacy risks they face if they agree to participate
in a trial.
Under FDA regulations, clinical investigations using human
specimens conducted in support of premarket submissions to FDA are
considered human subject investigations (see 21 CFR 812.3(p)). Many
investigational device studies are exempt from most provisions of part
812 (21 CFR part 812), Investigational Device Exemptions, under Sec.
812.2(c)(3), but FDA's regulations for the protection of human subjects
(21 CFR parts 50 and 56) apply to all clinical investigations that are
regulated by FDA (see 21 CFR 50.1; 21 CFR 56.101; 21 U.S.C.
360j(g)(3)(A), and 21 U.S.C. 360j(g)(3)(D)).
FDA regulations do not contain exceptions from the requirements of
informed consent on the grounds that the specimens are not identifiable
or that they are remnants of human specimens collected for routine
clinical care or analysis that would otherwise have been discarded. Nor
do FDA regulations allow IRBs to decide whether or not to waive
informed consent for research involving leftover or unidentifiable
specimens.
In a level one guidance document issued under the Good Guidances
Practices regulation, 21 CFR 10.115, FDA outlines the circumstances in
which it intends to exercise enforcement discretion as to the informed
consent regulations for clinical investigators, sponsors, and IRBs.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per Total Capital Total Operating and
No. of Recordkeepers per Recordkeeping Records Record Total Hours Costs Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
700 1 700 4 2,800 $210,000 420,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
The recommendations of this guidance impose a minimal burden on
industry. FDA estimates that 700 studies will be affected annually.
Each study will result in one recordkeeping per year, estimated to take
4 hours to complete. This results in a total recordkeeping burden of
2,400 hours (700 x 4 = 2,800). FDA estimates that the cost of
developing standard operating procedures for each record keeper is $300
(6 hours of work at $50/hour (h)). This results in a total cost to
industry of $210,000 ($300 x 700 recordkeepers). FDA estimates that
operating costs for collecting this information is $300 per record
keeper (6 hours of work at $50/h). This results in a total operational
and maintenance cost to industry of $210,000 ($300 x 700
recordkeepers). The total cost of this recordkeeping, capital plus
operational and maintenance cost, is estimated to be $420,000.
Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7617 Filed 5-18-06; 8:45 am]
BILLING CODE 4160-01-S
