Notice2022-21852
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61032-61033]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21852]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0576]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational
Device Exemptions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by November 7, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0078. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#da8a889b89aebbbcbc9abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="8ededccfddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>.
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.
Investigational Device Exemptions--21 CFR Part 812
OMB Control Number 0910-0078--Extension
This information collection supports implementation of section
520(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360j(g)), which governs exemption for devices for
investigational use. An investigational device exemption (IDE) allows a
device to be used in investigations involving human subjects in which
the safety and effectiveness of the device is being studied. For more
information regarding IDE, please visit our website at <a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide">https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide</a>.
FDA has promulgated regulations in part 812 (21 CFR part 812)
intended to encourage the discovery and development of useful devices
intended for human use. The regulations set forth the scope and
applicability of exemption requirements for devices for investigational
use, as well as establish application procedures, corresponding
instruction, and provisions for emergency research. The regulations
also provide for requesting waivers from the requirements and explain
sponsor responsibilities, including requirements for institutional
review board (IRB) review and approval. Finally, the regulations in
part 812, subpart G (21 CFR 812.140, 812.145, and 812.150) provide for
required recordkeeping, the inspection of records, and the preparation
and submission of reports to FDA and/or IRBs that oversee medical
device investigations.
In the Federal Register of May 6, 2022 (87 FR 27168), we published
a 60-day notice requesting public comment on the proposed collection of
information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
Activity/21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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812.10; waivers................. 1 1 1 1 1
812.20, 812.25, and 812.27; 229 1 229 80 18,320
applications, investigational
plans, and supplements.........
812.27(b)(4)(i); prior 400 1 400 1 400
investigations within the
United States..................
812.27(b)(4)(ii); prior 100 1 100 0.25 (15 25
investigations outside the minutes)
United States..................
812.28; acceptance of data from 1,500 1 1,500 10.25 15,375
clinical investigations
conducted outside the United
States, and supporting
information....................
812.28(c); waivers.............. 10 1 10 1 10
812.35 and 812.150; application 654 5 3,270 6 19,620
supplements....................
812.36(c); treatment IDE 1 1 1 120 120
applications...................
[[Page 61033]]
812.36(f); treatment IDE reports 1 1 1 20 20
812.150; non-significant risk 1 1 1 6 6
study reports..................
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Total....................... .............. .............. 5,513 .............. 53,897
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate of the average reporting burden is based on our
continued experience with the information collection. We have adjusted
the currently approved burden to reflect an increase we attribute to
Agency rulemaking that has become effective (OMB control number 0910-
AG48) since our last evaluation. Regulations in part 812 were amended
to provide for reporting associated with the acceptance of data from
clinical investigations conducted outside the United States.
Table 2--Estimated Annual Recordkeeping Burden 1
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Number of Average burden
Activity/21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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812.2(c)(3); records regarding 700 1 700 4 2,800
leftover specimens not
individually identifiable used
in certain studies.............
812.28(d); records for clinical 1,500 1 1,500 1 1,500
investigations conducted
outside United States..........
812.140; retention of records... 1,249 3.09 3,865 1.9937 7,706
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Total....................... .............. .............. .............. .............. 12,006
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.
In the guidance document ``Informed Consent For In Vitro Diagnostic
Device Studies Using Leftover Human Specimens That Are Not Individually
Identifiable'' (April 2006), available for download at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-are-not">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-informed-consent-vitro-diagnostic-device-studies-using-leftover-human-specimens-are-not</a>, FDA communicates its enforcement
policy with regard to the informed consent regulations (as required by
section 520(g) of the FD&C Act and 21 CFR part 50) for in vitro
diagnostic device studies that are conducted using leftover specimens
and that meet the criteria for exemption from IDE regulation at 21 CFR
812.2(c)(3). We include burden that may be attributable to FDA
recommendations that sponsors of studies document certain information,
in table 2, row 1. We have otherwise adjusted our estimate upward of
the average recordkeeping burden attributable to provisions in part 812
to reflect those requirements associated with clinical investigations
conducted outside the United States, and in recognition of the required
retention period for records.
Dated: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21852 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P
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