Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable, 2868-2869 [2010-791]
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2868
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency of
Response
Total Annual
Responses
Hours
per Response
Total Hours
571.1(c) moderate category
1
1
1
3,000
3,000
571.1(c) complex category
1
1
1
10,000
10,000
571.6 amendment of petition
2
2
4
1300
5,200
Total Hours
1There
18,200
are no capital costs or operating and maintenance costs associated with this collection of information.
571.1(c) moderate category: For food
additive petition without complex
chemistry, manufacturing, efficacy or
safety issues, the estimated time
requirement per petition is
approximately 3,000 hours. An average
of one petitions of this type is received
on an annual basis, resulting in a
burden of 3,000 hours.
571.1(c) complex category: For a food
additive petition with complex
chemistry, manufacturing, efficacy and/
or safety issues, the estimated time
requirement per petition is
approximately 10,000 hours. An average
of one petition of this type is received
on an annual basis, resulting in a
burden of 10,000 hours.
571.6: For a food additive petition
amendment, the estimated time
requirement per petition is
approximately 1,300 hours. An average
of four petitions of this type is received
on an annual basis, resulting in a
burden of 5,200 hours.
Thus, the estimated total annual
burden for this information collection is
18,200 hours.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–783 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2009–N–0487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0582. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@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 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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
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,
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.
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
E:\FR\FM\19JAN1.SGM
19JAN1
2869
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
recordkeeping burden of 2,800 hours
(700 x 4 = 2,800). FDA estimates that the
cost of developing standard operating
procedures for each recordkeeper 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
recordkeeper (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.
In the Federal Register of October 20,
2009 (74 FR 53749), 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 RECORDKEEPING BURDEN1
No. of
Recordkeepers
Section of the Act
520(g)
Annual Frequency
per Recordkeeping
700
Total Annual
Records
1
Hours per
Record
700
Total Hours
4
2,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information. Due to a clerical error, the capital costs and operating and maintenance costs that appeared in a notice issued in the FEDERAL REGISTER of October 20, 2009 (74 FR 53749 at
53750) were incorrect. The costs were actually salary costs; Table 1 of this document contains the correct cost burden.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@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. 2010–791 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0480]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0078. Also
include the FDA docket number found
in brackets in the heading of this
document.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
Investigational Device Exemptions
Reports and Records—21 CFR Part 812
(OMB Control Number 0910–0078)—
Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 360j(g)) establishes the statutory
authority to collect information
regarding investigational devices, and
establishes rules under which new
medical devices may be tested using
human subjects in a clinical setting. The
Food and Drug Administration
Modernization Act of 1997 added
section 520(g)(6) to the act and
permitted changes to be made to either
the investigational device or to the
clinical protocol without FDA approval
of an investigational device exemption
(IDE) supplement. An IDE allows a
device, which would otherwise be
subject to provisions of the act, such as
premarket notification or premarket
approval, to be used in investigations
involving human subjects in which the
safety and effectiveness of the device is
being studied. The purpose of part 812
(21 CFR part 812) is to encourage, to the
extent consistent with the protection of
public health and safety and with
ethical standards, the discovery and
development of useful devices intended
for human use. The IDE regulation is
designed to encourage the development
of useful medical devices, and allow
investigators the maximum freedom
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
possible, without jeopardizing the
health and safety of the public or
violating ethical standards. To do this,
the regulation provides for different
levels of regulatory control depending
on the level of potential risk the
investigational device presents to
human subjects. Investigations of
significant risk devices, ones that
present a potential for serious harm to
the rights, safety or welfare of human
subjects, are subject to the full
requirements of the IDE regulation. Nonsignificant risk device investigations,
ones that do not present a potential for
serious harm, are subject to the reduced
burden of the abbreviated requirements.
The regulation also includes provisions
for treatment IDEs. The purpose of these
provisions is to facilitate the
availability, as early in the device
development process as possible, of
promising new devices to patients with
life-threatening or serious conditions for
which no comparable or satisfactory
alternative therapy is available. Section
812.10 of the act, permits the sponsor of
the IDE to request a waiver to all of the
requirements of part 812. This
information is needed for FDA to
determine if waiver of the requirements
of part 812 will impact the public’s
health and safety. Sections 812.20,
812.25, and 812.27 consist of the
information necessary to file an IDE
application with FDA. The submission
of an IDE application to FDA is required
only for significant risk device
investigations.
Section 812.20 lists the data
requirements for the original IDE
application; § 812.25 lists the contents
of the investigational plan; and § 812.27
lists the data relating to previous
investigations or testing. The
information in the original IDE
application is evaluated by the Center
for Devices and Radiological Health to
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2868-2869]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0487]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
February 18, 2010.
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 e-mailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0582.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-5156,
Daniel.Gittleson@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 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.
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
[[Page 2869]]
recordkeeping burden of 2,800 hours (700 x 4 = 2,800). FDA estimates
that the cost of developing standard operating procedures for each
recordkeeper 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 recordkeeper (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.
In the Federal Register of October 20, 2009 (74 FR 53749), 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 Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Section of the Act Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g) 700 1 700 4 2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Due to a clerical error, the capital
costs and operating and maintenance costs that appeared in a notice issued in the Federal Register of October 20, 2009 (74 FR 53749 at 53750) were
incorrect. The costs were actually salary costs; Table 1 of this document contains the correct cost burden.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-791 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
