Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects; Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability, 34535-34536 [2017-15539]
Download as PDF
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
received, go to https://
www.regulations.gov/ and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
I. Background
In the Federal Register of November
2, 2016 (81 FR 76360), FDA published
the notice of availability for a draft
revised guidance entitled ‘‘Animal Drug
User Fees and Fee Waivers and
Reductions’’ giving interested persons
until January 3, 2017, to comment on
the draft revised guidance. FDA
received no comments on the draft
revised guidance. The guidance
announced in this notice finalizes the
draft guidance dated November 2016.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on Animal Drug User
Fees and Fee Waivers and Reductions.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
mstockstill on DSK30JT082PROD with NOTICES
III. Paperwork Reduction Act of 1995
This revised guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information referred to in
the guidance entitled ‘‘Animal Drug
User Fees and Fee Waivers and
Reductions’’ have been approved under
OMB control number 0910–540.
19:30 Jul 24, 2017
Jkt 241001
Dated: July 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15536 Filed 7–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–3235]
Diane Heinz, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5692,
diane.heinz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Institutional Review Board Waiver or
Alteration of Informed Consent for
Clinical Investigations Involving No
More Than Minimal Risk to Human
Subjects; Guidance for Sponsors,
Investigators, and Institutional Review
Boards; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the availability of a
guidance for sponsors, investigators,
and institutional review boards (IRBs)
entitled ‘‘IRB Waiver or Alteration of
Informed Consent for Clinical
Investigations Involving No More Than
Minimal Risk to Human Subjects.’’ This
guidance informs sponsors,
investigators, IRBs, and other interested
parties that FDA does not intend to
object to an IRB waiving or altering
informed consent requirements, as
described in the guidance, for certain
minimal risk clinical investigations. In
addition, this guidance explains that
FDA does not intend to object to a
sponsor initiating, or an investigator
conducting, a minimal risk clinical
investigation for which an IRB waives or
alters the informed consent
requirements as described in the
guidance.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
34535
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–D–3235 for ‘‘IRB Waiver or
Alteration of Informed Consent for
Clinical Investigations Involving No
More Than Minimal Risk to Human
Subjects; Guidance for Sponsors,
Investigators, and Institutional Review
Boards.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
office of Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
E:\FR\FM\25JYN1.SGM
25JYN1
34536
Federal Register / Vol. 82, No. 141 / Tuesday, July 25, 2017 / Notices
mstockstill on DSK30JT082PROD with NOTICES
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
Submit written requests for single
copies of the guidance to the Office of
Good Clinical Practice, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5169, Silver Spring,
MD 20993. Send one self-addressed
adhesive label to assist that office in
processing your requests. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Janet Norden, Office of Good Clinical
Practice, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–1127.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for sponsors, investigators
and IRBs entitled ‘‘IRB Waiver or
Alteration of Informed Consent for
Clinical Investigations Involving No
More Than Minimal Risk to Human
Subjects.’’ We are issuing this guidance
consistent with our good guidance
practices (GGP) regulation (§ 10.115 (21
CFR 10.115)). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
VerDate Sep<11>2014
19:30 Jul 24, 2017
Jkt 241001
appropriate (§ 10.115(g)(2)). We made
this determination because this
guidance presents a less burdensome
policy that is consistent with the public
health. FDA believes this guidance will
facilitate the conduct of certain minimal
risk clinical investigations that are
important to addressing significant
public health needs without
compromising the rights, safety, or
welfare of human subjects. Although
this guidance is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation.
FDA will consider all comments
received and will revise this guidance
when appropriate.
On December 13, 2016, the 21st
Century Cures Act (Cures Act) (Pub. L.
114–255) was signed into law. Title III,
section 3024 of the Cures Act amended
sections 520(g)(3) and 505(i)(4) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to provide authority for
FDA to permit an exception from
informed consent requirements when
the proposed clinical testing poses no
more than minimal risk to the human
subject and includes appropriate
safeguards to protect the rights, safety,
and welfare of the human subject. This
statutory amendment became effective
on December 13, 2016.
Currently, FDA’s regulations
governing the protection of human
subjects (21 CFR parts 50 and 56) allow
exception from the general requirements
for informed consent only in lifethreatening situations when certain
conditions are met (21 CFR 50.23) or
when the requirements for emergency
research are met (21 CFR 50.24), but do
not include an exception from informed
consent for minimal risk clinical
investigations. In light of the Cures Act
amendment to the FD&C Act described
previously, FDA intends to revise its
informed consent regulations to add a
waiver or alteration for minimal risk
clinical investigations, under
appropriate human subject protection
safeguards, to the two existing
exceptions from informed consent.
This guidance informs sponsors,
investigators, and IRBs that until FDA
issues these regulations, we do not
intend to object to an IRB approving a
consent procedure that does not
include, or that alters, some or all of the
elements of informed consent set forth
in 21 CFR 50.25, or waiving the
requirements to obtain informed
consent as described in the guidance. In
addition, we do not intend to object to
a sponsor initiating, or an investigator
conducting, a minimal risk clinical
investigation for which an IRB waives or
alters the informed consent
requirements as described in the
PO 00000
Frm 00065
Fmt 4703
Sfmt 9990
guidance. We believe that this guidance
will facilitate investigators’ ability to
conduct studies that may contribute
substantially to the development of
products to diagnose or treat diseases or
conditions, or address unmet medical
needs, without compromising the rights,
safety, or welfare of human subjects.
The guidance represents the current
thinking of FDA on this topic. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
is not a significant regulatory action
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information
referenced in this guidance that are
related to IRB recordkeeping
requirements under 21 CFR part 56 have
been approved under OMB control
numbers 0910–0755 and 0910–0130.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/ScienceResearch/Special
Topics/RunningClinicalTrials/
GuidancesInformationSheetsandNotices
/ucm219433.htm, or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15539 Filed 7–24–17; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\25JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Notices]
[Pages 34535-34536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15539]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-3235]
Institutional Review Board Waiver or Alteration of Informed
Consent for Clinical Investigations Involving No More Than Minimal Risk
to Human Subjects; Guidance for Sponsors, Investigators, and
Institutional Review Boards; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for sponsors, investigators,
and institutional review boards (IRBs) entitled ``IRB Waiver or
Alteration of Informed Consent for Clinical Investigations Involving No
More Than Minimal Risk to Human Subjects.'' This guidance informs
sponsors, investigators, IRBs, and other interested parties that FDA
does not intend to object to an IRB waiving or altering informed
consent requirements, as described in the guidance, for certain minimal
risk clinical investigations. In addition, this guidance explains that
FDA does not intend to object to a sponsor initiating, or an
investigator conducting, a minimal risk clinical investigation for
which an IRB waives or alters the informed consent requirements as
described in the guidance.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-D-3235 for ``IRB Waiver or Alteration of Informed Consent for
Clinical Investigations Involving No More Than Minimal Risk to Human
Subjects; Guidance for Sponsors, Investigators, and Institutional
Review Boards.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the office of Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
[[Page 34536]]
Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the guidance to the
Office of Good Clinical Practice, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm. 5169, Silver Spring, MD 20993. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Janet Norden, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-1127.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for sponsors,
investigators and IRBs entitled ``IRB Waiver or Alteration of Informed
Consent for Clinical Investigations Involving No More Than Minimal Risk
to Human Subjects.'' We are issuing this guidance consistent with our
good guidance practices (GGP) regulation (Sec. 10.115 (21 CFR
10.115)). We are implementing this guidance without prior public
comment because we have determined that prior public participation is
not feasible or appropriate (Sec. 10.115(g)(2)). We made this
determination because this guidance presents a less burdensome policy
that is consistent with the public health. FDA believes this guidance
will facilitate the conduct of certain minimal risk clinical
investigations that are important to addressing significant public
health needs without compromising the rights, safety, or welfare of
human subjects. Although this guidance is immediately in effect, it
remains subject to comment in accordance with FDA's GGP regulation. FDA
will consider all comments received and will revise this guidance when
appropriate.
On December 13, 2016, the 21st Century Cures Act (Cures Act) (Pub.
L. 114-255) was signed into law. Title III, section 3024 of the Cures
Act amended sections 520(g)(3) and 505(i)(4) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) to provide authority for FDA to permit
an exception from informed consent requirements when the proposed
clinical testing poses no more than minimal risk to the human subject
and includes appropriate safeguards to protect the rights, safety, and
welfare of the human subject. This statutory amendment became effective
on December 13, 2016.
Currently, FDA's regulations governing the protection of human
subjects (21 CFR parts 50 and 56) allow exception from the general
requirements for informed consent only in life-threatening situations
when certain conditions are met (21 CFR 50.23) or when the requirements
for emergency research are met (21 CFR 50.24), but do not include an
exception from informed consent for minimal risk clinical
investigations. In light of the Cures Act amendment to the FD&C Act
described previously, FDA intends to revise its informed consent
regulations to add a waiver or alteration for minimal risk clinical
investigations, under appropriate human subject protection safeguards,
to the two existing exceptions from informed consent.
This guidance informs sponsors, investigators, and IRBs that until
FDA issues these regulations, we do not intend to object to an IRB
approving a consent procedure that does not include, or that alters,
some or all of the elements of informed consent set forth in 21 CFR
50.25, or waiving the requirements to obtain informed consent as
described in the guidance. In addition, we do not intend to object to a
sponsor initiating, or an investigator conducting, a minimal risk
clinical investigation for which an IRB waives or alters the informed
consent requirements as described in the guidance. We believe that this
guidance will facilitate investigators' ability to conduct studies that
may contribute substantially to the development of products to diagnose
or treat diseases or conditions, or address unmet medical needs,
without compromising the rights, safety, or welfare of human subjects.
The guidance represents the current thinking of FDA on this topic.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This is
not a significant regulatory action subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information referenced in this guidance that are related
to IRB recordkeeping requirements under 21 CFR part 56 have been
approved under OMB control numbers 0910-0755 and 0910-0130.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm,
https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm, or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15539 Filed 7-24-17; 8:45 am]
BILLING CODE 4164-01-P