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, 38992-38993 [2019-17026]
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38992
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
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.
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.
SUMMARY:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
jbell on DSK3GLQ082PROD with NOTICES
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
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
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 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, 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 × 4 = 2,800).
In the Federal Register of March 5,
2019 (84 FR 7906), FDA published a 60-
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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-bystudy 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
E:\FR\FM\08AUN1.SGM
08AUN1
38993
Federal Register / Vol. 84, No. 153 / Thursday, August 8, 2019 / Notices
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
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Recordkeeping regarding leftover human specimens that
are not individually identifiable that are used in certain
IVD studies .......................................................................
700
1
700
4
2,800
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2019–N–0006]
Advisory Committees; Filing of Closed
Meeting Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing that, as required by the
Federal Advisory Committee Act, the
Agency has filed with the Library of
Congress the annual reports of those
FDA advisory committees that held
closed meetings during fiscal year 2018.
ADDRESSES: Copies are available at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500. You also may
access the docket at https://
www.regulations.gov for the annual
reports of those FDA advisory
committees that held closed meetings
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:51 Aug 07, 2019
Jkt 247001
during fiscal year 2018. Insert the
docket number found in brackets in the
heading of this document at https://
www.regulations.gov into the ‘‘Search’’
box, clear filter under Document Type
(left side of screen), and check
‘‘Supporting and Related Material,’’
then Sort By Best Match (from the dropdown menu; top right side of screen),
‘‘ID Number (Z–A)’’ or Sort By Best
Match (from the drop-down menu)
‘‘Title (A–Z),’’ also found in the heading
of this document.
Russell Fortney, Director, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–1068.
Under
section 10(d) of the Federal Advisory
Committee Act (5 U.S.C. app.) and 21
CFR 14.60(d), FDA has filed with the
Library of Congress the annual reports
for the following FDA advisory
committees that held closed meetings
during the period October 1, 2017,
through September 30, 2018:
SUPPLEMENTARY INFORMATION:
Center for Biologics Evaluation and
Research:
Blood Products Advisory Committee
Vaccine and Related Biological Products
Advisory Committee
Center for Drug Evaluation and
Research:
Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee
Office of Commissioner
Joint Meeting of the Pediatric Advisory
Committee and the Endocrinologic
and Metabolic Drugs Advisory
Committee
Annual Reports are available for public
inspections between 9 a.m. and 4 p.m.,
Monday through Friday, at:
(1) The Library of Congress, Madison
Building, Newspaper and Current
Periodical Reading Room, 101
Independence Ave. SE, Rm. 133,
Washington, DC; 20540; and
(2) Dockets Management Staff (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16992 Filed 8–7–19; 8:45 am]
BILLING CODE 4164–01–P
National Center for Toxicological
Research:
Science Board to the National Center for
Toxicological Research
PO 00000
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]]>Agencies
[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 [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: 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,
[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 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
