Notice2023-19951
Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals; Draft Guidance for Industry; Availability
Primary source
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Published
September 15, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #282 entitled "Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals." As used in this guidance, informed consent is a documented process by which an owner or owner's agent voluntarily confirms the owner's willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that may be relevant to the owner's decision to participate. A sponsor or investigator should ensure the owner is provided with adequate information and time to allow for an informed decision about voluntary participation in a clinical investigation. This draft guidance provides recommendations on informed consent forms (ICF) used for studies that enroll client-owned companion animals (dogs, cats, and horses). FDA's Center for Veterinary Medicine (CVM) recommends all studies conducted with client-owned companion animals use an ICF and be conducted in accordance with Good Clinical Practice (GCP) guidelines.
Full Text
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<title>Federal Register, Volume 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63586-63587]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19951]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2654]
Informed Consent Forms for Studies that Enroll Client-Owned
Companion Animals; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #282 entitled
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' As used in this guidance, informed consent is a documented
process by which an owner or owner's agent voluntarily confirms the
owner's willingness to allow their animal(s) to participate in a
particular study, after having been informed of all aspects of the
study that may be relevant to the owner's decision to participate. A
sponsor or investigator should ensure the owner is provided with
adequate information and time to allow for an informed decision about
voluntary participation in a clinical investigation. This draft
guidance provides recommendations on informed consent forms (ICF) used
for studies that enroll client-owned companion animals (dogs, cats, and
horses). FDA's Center for Veterinary Medicine (CVM) recommends all
studies conducted with client-owned companion animals use an ICF and be
conducted in accordance with Good Clinical Practice (GCP) guidelines.
DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-D-2654 for ``Informed Consent Forms for Studies that Enroll
Client-Owned Companion Animals.'' Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See
[[Page 63587]]
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.
FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0809,
<a href="/cdn-cgi/l/email-protection#b1e2c5d4c7d4df9ff7ddd4d8c2d2d9d4c3f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="6e3d1a0b180b004028020b071d0d060b1c2e080a0f4006061d40090118">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #282 entitled
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' As used in this guidance, informed consent is a documented
process by which an owner or owner's agent voluntarily confirms the
owner's willingness to allow their animal(s) to participate in a
particular study, after having been informed of all aspects of the
study that may be relevant to the owner's decision to participate. A
sponsor or investigator should ensure the owner is provided with
adequate information and time to allow for an informed decision about
voluntary participation in a clinical investigation. This draft
guidance provides recommendations on ICFs used for studies that enroll
client-owned companion animals (dogs, cats, and horses). CVM recommends
all studies conducted with client-owned companion animals use an ICF
and be conducted in accordance with GCP guidelines.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Informed Consent Forms for Studies that Enroll Client-Owned Companion
Animals.'' 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 and section 571 of the Federal Food,
Drug, and Cosmetic Act have been approved under OMB control number
0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19951 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P
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