Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability, 106510-106512 [2024-31261]
Download as PDF
106510
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
thickness thermal burns. Subsequent to
this approval, the USPTO received a
patent term restoration application for
NEXOBRID (U.S. Patent No. 8,540,983)
from MediWound, Ltd., and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
January 30, 2024, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
NEXOBRID represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
NEXOBRID is 7,427 days. Of this time,
6,514 days occurred during the testing
phase of the regulatory review period,
while 913 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: August 30, 2002. The
applicant claims August 29, 2002, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was August 30, 2002,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): June 29, 2020. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
NEXOBRID (BLA 761192) was initially
submitted on June 29, 2020.
3. The date the application was
approved: December 28, 2022. FDA has
verified the applicant’s claim that BLA
761192 was approved on December 28,
2022.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
VerDate Sep<11>2014
23:58 Dec 27, 2024
Jkt 265001
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: December 13, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–31022 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5016]
Protocol Deviations for Clinical
Investigations of Drugs, Biological
Products, and Devices; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Protocol
Deviations for Clinical Investigations of
Drugs, Biological Products, and
Devices.’’ This draft guidance provides
recommendations to assist sponsors,
clinical investigators, and institutional
review boards (IRBs) in defining,
identifying, and reporting protocol
deviations. The guidance provides
definitions for protocol deviations and
important protocol deviations. In
addition, the guidance provides a
recommended classification system for
sponsors to report protocol deviations to
FDA in clinical study reports for drugs,
biological products, and devices; for
SUMMARY:
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Fmt 4703
Sfmt 4703
investigators to report protocol
deviations to sponsors and to IRBs; and
for IRBs to evaluate protocol deviations.
DATES: Submit either electronic or
written comments on the draft guidance
by February 28, 2025 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:
• 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–
2023–D–5016 for ‘‘Protocol Deviations
for Clinical Investigations of Drugs,
Biological Products, and Devices.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
E:\FR\FM\30DEN1.SGM
30DEN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
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.govinfo.gov/content/pkg/FR-201509-18/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, 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 draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002; or
the Office of Policy, Guidance and
Policy Development, Center for Devices
VerDate Sep<11>2014
23:58 Dec 27, 2024
Jkt 265001
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Dat
Doan, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3334, Silver Spring,
MD 20993, 240–402–8926; or James
Myers, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911; or
Soma Kalb, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G318, Silver Spring,
MD 20993–0002, 301–796–6359.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Protocol Deviations for Clinical
Investigations of Drugs, Biological
Products, and Devices.’’ Protocols
document the study design, objectives,
population, planned procedures,
investigational product management,
method(s) of data capture, monitoring
and oversight plans, and statistical
analysis plans either directly or by
reference to associated investigational
plans. In the conduct of a clinical
investigation, some deviations from the
specifics outlined in the protocol may
occur.
This guidance provides
recommendations to assist sponsors,
clinical investigators, and IRBs in
defining, identifying, and reporting
protocol deviations. FDA regulations do
not include a definition of the term
protocol deviation or provide a system
for classifying the various types of
deviations that may occur during the
conduct of a clinical investigation. A
system that applies consistent
classification, reporting, and
documentation standards is important
to assure the most interpretable and
useful information emerges from the
reporting of protocol deviations. To
address these considerations, this
guidance includes (1) definitions for
protocol deviations and important
protocol deviations, (2)
recommendations on the types of
protocol deviations that sponsors
should report to FDA in clinical study
reports, (3) recommendations on the
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106511
types of protocol deviations that
investigators should report to sponsors
and to IRBs, and (4) recommendations
for IRBs in their evaluation of protocol
deviations.
This 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 ‘‘Protocol Deviations for Clinical
Investigations of Drugs, Biological
Products, and Devices.’’ 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. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 56 have been
approved under OMB control number
0910–0130; the collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 320 have
been approved under OMB control
number 0910–0291; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078; and the collections
of information in 21 CFR part 814 have
been approved under OMB control
number 0910–0231.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
medical-devices/device-advicecomprehensive-regulatory-assistance/
guidance-documents-medical-devicesand-radiation-emitting-products, or
https://www.regulations.gov.
E:\FR\FM\30DEN1.SGM
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106512
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
Dated: December 17, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
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.
[FR Doc. 2024–31261 Filed 12–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
De Novo Classification Process
(Evaluation of Automatic Class III
Designation)—21 CFR Part 860, Subpart
D
Food and Drug Administration
[Docket No. FDA–2024–N–2149]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; De Novo
Classification Process (Evaluation of
Automatic Class III Designation)
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: Submit written comments
(including recommendations) on the
collection of information by January 29,
2025.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0844. 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
OMB Control Number 0910–0844—
Revision
This information collection supports
FDA regulations and information
collection discussed in associated
guidance. Sections 201(h), 513(a) and
(f), 701(a), and 704 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 321(h), 360c(a) and (f), 371(a),
and 374) establish a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513(f)(2) of the FD&C Act
provides for a ‘‘De Novo’’ classification
process, most recently amended by
section 3101 of the 21st Century Cures
Act (Pub. L. 114–255). The final rule
‘‘Medical Device De Novo Classification
Process’’ (86 FR 54826), established part
860, subpart D (21 CFR part 860, subpart
D) (§§ 860.200 through 860.260) to
implement provisions in section
513(f)(2) of the FD&C Act. These
regulations govern format and content
elements for De Novo device
classification requests, as well as
withdrawal of the requests, and explain
FDA procedures for acceptance, review,
and granting or denying a request.
FDA’s guidance for industry and FDA
staff, ‘‘De Novo Classification Process
(Evaluation of Automatic Class III
Designation)’’, provides guidance on the
process for the submission and review
of a De Novo classification request
under section 513(f)(2) of the FD&C Act,
also known as the De Novo
classification process. This process
provides a pathway to class I or class II
classification for medical devices for
which general controls or general and
special controls provide a reasonable
assurance of safety and effectiveness,
but for which there is no legally
marketed predicate device.
In addition to regulatory requirements
set forth in part 860, subpart D, the
guidance document entitled
‘‘Acceptance Review for De Novo
Classification Requests’’ communicates
our thinking on criteria set out in
§ 860.230, in assessing whether a De
Novo request should be accepted for
substantive review. The guidance
document includes an ‘‘Acceptance
Checklist’’ to assist respondents in this
regard.
The guidance document ‘‘Electronic
Submission Template for Medical
Device De Novo Requests,’’ provides the
standards for the submission of De Novo
requests by electronic format, a
timetable for establishment of these
standards, and criteria for waivers of
and exemptions from the requirements
to meet a statutory requirement. This
guidance is also intended to represent
one of several steps in meeting FDA’s
commitment to the development of
electronic submission templates to serve
as guided submission preparation tools
for industry to improve submission
consistency and enhance efficiency in
the review process.
The collections of information
described by this notice are necessary to
satisfy the previously mentioned
statutory requirements for
administration of this voluntary
submission program. FDA uses the
information to evaluate whether a
medical device may be reclassified from
class III into class I or II and, if
applicable, to determine the general
and/or special controls necessary to
sufficiently regulate the medical device.
Respondents to this information
collection are private sector or other forprofit businesses.
In the Federal Register of May 29,
2024 (89 FR 46402), 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:
ddrumheller on DSK120RN23PROD with NOTICES1
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
21 CFR part 860, subpart D;
information collection activity
§§ 860.210, 860.220, 860.230; De
Novo requests—format, content,
and acceptance elements.
§ 860.230; FDA acceptance of request (GFI Acceptance Checklist;
Appendix A) 1.
VerDate Sep<11>2014
23:58 Dec 27, 2024
Number of
responses per
respondent
Number of
respondents
Jkt 265001
Total annual
responses
Average burden per response
Total hours
79
1
79
182 ...................................................
14,378
79
1
79
...........................................................
........................
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Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106510-106512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31261]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5016]
Protocol Deviations for Clinical Investigations of Drugs,
Biological Products, and Devices; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Protocol
Deviations for Clinical Investigations of Drugs, Biological Products,
and Devices.'' This draft guidance provides recommendations to assist
sponsors, clinical investigators, and institutional review boards
(IRBs) in defining, identifying, and reporting protocol deviations. The
guidance provides definitions for protocol deviations and important
protocol deviations. In addition, the guidance provides a recommended
classification system for sponsors to report protocol deviations to FDA
in clinical study reports for drugs, biological products, and devices;
for investigators to report protocol deviations to sponsors and to
IRBs; and for IRBs to evaluate protocol deviations.
DATES: Submit either electronic or written comments on the draft
guidance by February 28, 2025 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:
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-2023-D-5016 for ``Protocol Deviations for Clinical Investigations
of Drugs, Biological Products, and Devices.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at
[[Page 106511]]
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
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 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.govinfo.gov/content/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, 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 draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
the Office of Policy, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926; or James
Myers, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002, 240-402-7911; or Soma Kalb, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G318, Silver Spring, MD 20993-0002, 301-
796-6359.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Protocol Deviations for Clinical Investigations of Drugs,
Biological Products, and Devices.'' Protocols document the study
design, objectives, population, planned procedures, investigational
product management, method(s) of data capture, monitoring and oversight
plans, and statistical analysis plans either directly or by reference
to associated investigational plans. In the conduct of a clinical
investigation, some deviations from the specifics outlined in the
protocol may occur.
This guidance provides recommendations to assist sponsors, clinical
investigators, and IRBs in defining, identifying, and reporting
protocol deviations. FDA regulations do not include a definition of the
term protocol deviation or provide a system for classifying the various
types of deviations that may occur during the conduct of a clinical
investigation. A system that applies consistent classification,
reporting, and documentation standards is important to assure the most
interpretable and useful information emerges from the reporting of
protocol deviations. To address these considerations, this guidance
includes (1) definitions for protocol deviations and important protocol
deviations, (2) recommendations on the types of protocol deviations
that sponsors should report to FDA in clinical study reports, (3)
recommendations on the types of protocol deviations that investigators
should report to sponsors and to IRBs, and (4) recommendations for IRBs
in their evaluation of protocol deviations.
This 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 ``Protocol
Deviations for Clinical Investigations of Drugs, Biological Products,
and Devices.'' 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 56 have been approved under OMB control number 0910-
0130; the collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014; the collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001; the collections of information in 21 CFR part 320
have been approved under OMB control number 0910-0291; the collections
of information in 21 CFR part 601 have been approved under OMB control
number 0910-0338; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.
[[Page 106512]]
Dated: December 17, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31261 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P