Document ID: FDA-2012-N-0560-0014
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2019-08-08T04:00Z

[Federal Register Volume 84, Number 153 (Thursday, August 8, 2019)]
[Notices]
[Pages 38992-38993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17026]

[[Page 38992]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 
September 9, 2019.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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 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 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, and 21 U.S.C. 360j(g)(3)(A) and (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 the 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 March 5, 2019 (84 FR 7906), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received the following comments:
    (Comment 1) Some comments strongly support further harmonization 
between the updated Common Rule and FDA regulations. Although the 
comments support FDA's 2006 Guidance and discretionary enforcement, the 
comments suggested that scientists would welcome expanded efforts to 
remove investigations using de-identified human tissues from FDA's 
human subject regulations, consistent with the Common Rule. The 
comments suggest there is little practical utility in FDA maintaining 
de-identified specimens as part of human subject investigations. The 
comments suggest that removing de-identified specimens from these 
requirements would allow for safety and ethical considerations while 
reducing administrative burden for investigators, ensuring consistency 
with the Common Rule and streamlining effectiveness. The comments 
suggest there is a longstanding tradition of research using de-
identified human tissue in a way that demonstrates adherence to the 
Belmont principles of justice, beneficence, and respect for persons. 
Further the comments express the belief that requiring consent for 
tissue routinely archived would render a very large and crucial 
resource essentially off limits for research because most institutions/
hospitals, particularly outside academia, do not include consent for 
surplus tissue use prior to surgery or tissue biopsy. The comments 
suggested that asking for consent retrospectively is very cumbersome, 
costly, and may be perceived as intrusive by patients.
    (Response) These comments are not related to the information 
collection or burden estimate. However, we have forwarded the comment 
to the appropriate program office for consideration.
    (Comment 2) A comment suggested that 4 hours per recordkeeper may 
be a significant underestimation of the burden of the information 
collection. The comment referenced Section V of the 2006 Guidance and 
stated that the two-step process in that section amounts to both a 
general review of policies and procedures and a study-by-study IRB 
review to ensure compliance. The comment suggested that requiring 
reviews at the level of individual FDA investigations will lead to an 
aggregate of more than 4 hours per year per recordkeeper.
    (Response) The comment was considered but FDA does not believe that 
the 4-hour estimate is a significant

[[Page 38993]]

underestimation given that these actions should not be a burdensome 
process for the recordkeeper.
    (Comment 3) The commenter opposed changing the default from ``opt-
in'' to ``opt-out'' for patients to consent to their tissue being used 
for research. Although simple malformations, such as warts and tumors, 
may be useful to labs to fine-tune their tests, and although many (even 
most) patients might be willing to share this tissue, a significant 
minority of Americans hold beliefs about the human body that would 
prevent them from consenting, and all Americans likely assume that 
their tissue is destroyed (burned as medical waste) after procedures 
have been performed. The commenter believes that changing what happens 
without changing the public understanding of what happens is 
fundamentally dishonest. The commenter recognizes that obtaining 
consent is time-consuming, particularly when the patient does not speak 
English as a first language, or has other comprehension issues; 
however, the commenter believes no lab has a right to the tissue of an 
American citizen for its private, profit-making use.
    (Response) The subject of the comment deals with sample 
acquisition, a step that happens in advance of the information 
communicated in this guidance. Therefore, patient ``opt-in'' versus 
``opt-out'' is out of scope. This guidance describes the enforcement 
discretion policy FDA uses when sponsors choose to use de-identified 
samples for IVD medical device clinical trials.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                      Average  burden
                              Activity                                  Number of       records per     Total  annual         per          Total  hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping regarding leftover human specimens that are not                   700                1              700                4            2,800
 individually identifiable that are used in certain IVD studies....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.

    Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17026 Filed 8-7-19; 8:45 am]
BILLING CODE 4164-01-P