[Federal Register Volume 81, Number 70 (Tuesday, April 12, 2016)]
[Notices]
[Pages 21558-21559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08329]


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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

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 May 12, 
2016.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 compliant 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

[[Page 21559]]

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 October 23, 2015 (80 FR 64422), 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
                        The FD&C Act section                            Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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520(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.


    Dated: April 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08329 Filed 4-11-16; 8:45 am]
 BILLING CODE 4164-01-P