Document ID: FDA-2012-N-0560-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance on Informed Consent for In Vitro Diagnostic Device
Posted Date: 2013-02-08T05:00Z

[Federal Register Volume 78, Number 27 (Friday, February 8, 2013)]
[Notices]
[Pages 9395-9396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0560]

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.

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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 March 
11, 2013.

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 0910-0582. 
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, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 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, Investigational Device Exemptions, under 21 CFR 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 1 guidance document, entitled ``Guidance on Informed 
Consent for In Vitro Diagnostic Device Studies Using Leftover Human 
Specimens That Are Not Individually Identifiable,'' 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 the guidance impose a minimal burden on 
industry. FDA estimates that 700 studies will be affected annually. 
Each study will result in one annual record, estimated to take 4 hours 
to complete. This results in a total recordkeeping burden of 2,800 
hours (700 x 4 = 2,800).
    In the Federal Register of June 12, 2012 (77 FR 34954), 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\
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                                                                                         Number of                      Average  burden
            Federal Food, Drug, and Cosmetic Act Section                Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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520(g) (21 U.S.C. 360j(g)).........................................             700                1              700                4            2,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 9396]]

    Dated: February 4, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02858 Filed 2-7-13; 8:45 am]
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