Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability, 80255-80257 [2024-22562]
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80255
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response 2
Total hours
Pretest
Pretest Screener Completes ..................................................................
Pretest Questionnaire Completes ..........................................................
400
80
1
1
400
80
0.03 (2 minutes) .........
0.30 (18 minutes) .......
12
24
Main Study
Main Study Screener Completes ...........................................................
Main Study Questionnaire Completes ...................................................
3,200
640
1
1
3,200
640
0.03 (2 minutes) .........
0.30 (18 minutes) .......
96
192
Total ................................................................................................
..........................
..........................
........................
.....................................
324
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
2 Burden
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References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
1. Wojdynski, B.W. and G.J. Golan, ‘‘Native
Advertising and the Future of Mass
Communication,’’ American Behavioral
Scientist, vol. 60, pp. 1403–1407, 2016,
https://doi.org/10.1177/
0002764216660134.
2. King, J., ‘‘Native Advertising: What It Is
and How It Benefits Advertisers and
Publishers,’’ EMARKETER, October 11,
2023. Available at: https://
www.emarketer.com/insights/native-adspending. Accessed on June 12, 2024.
3. Campbell, C. and L.J. Marks, ‘‘Good Native
Advertising Isn’t a Secret,’’ Business
Horizons, vol. 58, pp. 599–606, 2015,
https://doi.org/10.1016/
j.bushor.2015.06.003.
4. Campbell, C. and P.E. Grimm, ‘‘The
Challenges Native Advertising Poses:
Exploring Potential Federal Trade
Commission Responses and Identifying
Research Needs,’’ Journal of Public
Policy & Marketing, vol. 38, pp. 110–123,
2019, https://doi.org/10.1177/
0743915618818576.
5. Campbell, M.C. and A. Kirmani,
‘‘Consumers’ Use of Persuasion
Knowledge: The Effects of Accessibility
and Cognitive Capacity on Perceptions of
an Influence Agent,’’ Journal of
Consumer Research, vol. 27, pp. 69–83,
2000, https://doi.org/10.1086/314309.
6. Wei, M.-L., E. Fischer, and K.J. Main, ‘‘An
VerDate Sep<11>2014
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Examination of the Effects of Activating
Persuasion Knowledge on Consumer
Response to Brands Engaging in Covert
Marketing,’’ Journal of Public Policy &
Marketing, vol. 27, pp. 34–44, 2008,
https://doi.org/10.1509/jppm.27.1.34.
7. Pierre, L., ‘‘The Effect of Covert
Advertising Recognition on Consumer
Attitudes: A Systematic Review,’’
Journal of Marketing Communications,
pp. 1–22, 2023, https://doi.org/10.1080/
13527266.2023.2184851.
8. Hastak, M. and M.B. Mazis, ‘‘Deception by
Implication: A Typology of Truthful but
Misleading Advertising and Labeling
Claims,’’ Journal of Public Policy &
Marketing, vol. 30, pp. 157–167, 2011,
https://www.jstor.org/stable/23209271.
9. Cain, R.M., ‘‘Embedded Advertising on
Television: Disclosure, Deception, and
Free Speech Rights,’’ Journal of Public
Policy & Marketing, vol. 30, pp. 226–238,
2011, https://doi.org/10.1509/
jppm.30.2.226.
10. Lee, S.S., H. Chen, and Y.-H. Lee, ‘‘How
Endorser-Product Congruity and SelfExpressiveness Affect Instagram MicroCelebrities’ Native Advertising
Effectiveness,’’ Journal of Product &
Brand Management, vol. 31, pp. 149–
162, 2022, https://www.emerald.com/
insight/content/doi/10.1108/JPBM-022020-2757/full/html.
*11. Untitled Letter to Aclaris Therapeutics,
Inc. (June 14, 2019). Available at: https://
www.fda.gov/media/128151/
download?attachment.
*12. Untitled Letter to Biohaven
Pharmaceuticals (March 8, 2021).
Available at: https://www.fda.gov/media/
146528/download?attachment.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22575 Filed 10–1–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–1105]
Electronic Systems, Electronic
Records, and Electronic Signatures in
Clinical Investigations: Questions and
Answers; 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 final
guidance for industry entitled
‘‘Electronic Systems, Electronic
Records, and Electronic Signatures in
Clinical Investigations: Questions and
Answers.’’ The guidance provides
information for sponsors, clinical
investigators, institutional review
boards (IRBs), contract research
organizations (CROs), and other
interested parties on the use of
electronic systems, electronic records,
and electronic signatures in clinical
investigations of foods, medical
products, tobacco products, and new
animal drugs. The guidance provides
recommendations regarding the
requirements in our regulations,
pursuant to which FDA considers
electronic systems, electronic records,
and electronic signatures to be
trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on
paper. This guidance finalizes the draft
guidance of the same title issued on
March 16, 2023, and supersedes the
guidance for industry entitled
‘‘Computerized Systems Used in
Clinical Investigations’’ issued in May
2007.
SUMMARY:
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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
The announcement of the
guidance is published in the Federal
Register on October 2, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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’’).
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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–1105 for ‘‘Electronic Systems,
Electronic Records, and Electronic
Signatures in Clinical Investigations:
Questions and Answers.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
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• 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 this 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 or to 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.
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.
PO 00000
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FOR FURTHER INFORMATION CONTACT:
Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332,
Silver Spring, MD 20993–0002, 301–
796–6439, Elizabeth.Kunkoski@
fda.hhs.gov; 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; 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–
796–6539, Soma.Kalb@fda.hhs.gov;
Yuguang Wang, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., Rm.
4A–012, College Park, MD 20740, 240–
402–1757, Yuguang.Wang@fda.hhs.gov;
Justin Sherren, Center for Tobacco
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Silver Spring, MD
20993–0002, 240–402–7970, CTPBIMO@fda.hhs.gov; Eric Nelson, Center
for Veterinary Medicine (HFV–230),
Food and Drug Administration, 7519
Standish Pl., MPN #4, Rm. 106,
Rockville, MD 20855, 240–402–5642,
Eric.Nelson@fda.hhs.gov; or Paul
Kluetz, Oncology Center of Excellence,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm.
2223, Silver Spring, MD 20993, 301–
796–9567, paul.kluetz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Electronic Systems, Electronic
Records, and Electronic Signatures in
Clinical Investigations: Questions and
Answers.’’ The guidance provides
information for sponsors, clinical
investigators, IRBs, CROs, and other
interested parties on the use of
electronic systems, electronic records,
and electronic signatures in clinical
investigations of foods, medical
products, tobacco products, and new
animal drugs. The goals of the guidance
are to: (1) update recommendations for
applying and implementing data
integrity and data security controls,
including the use of audit trails and the
protection of records in the current
environment of electronic systems used
in clinical investigations; (2) expand
upon recommendations on the riskbased approach to validation of
electronic systems described in the
guidance for industry ‘‘Part 11,
Electronic Records; Electronic
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Signatures—Scope and Application’’
(August 2003); (3) provide
recommendations on using information
technology service providers to provide
services during a clinical investigation;
(4) provide recommendations regarding
the collection of data through digital
health technologies; (5) facilitate the use
of electronic signatures; and (6)
facilitate the use of electronic systems,
electronic records, and electronic
signatures to improve the quality and
efficiency of clinical investigations.
This guidance finalizes the draft
guidance of the same title issued on
March 16, 2023 (88 FR 16268). FDA
considered comments received on the
draft guidance as the guidance was
finalized. Changes from the draft to the
final guidance include: (1) clarifying the
applicability of part 11 (21 CFR part 11)
to real-world data sources submitted to
FDA; (2) clarifying the applicability of
part 11 to clinical investigations
conducted outside of the United States;
(3) describing electronic systems
deployed by regulated entities in
clinical investigations and using a riskbased approach for validation; (4)
clarifying the focus of FDA inspections
of regulated entities; (5) providing
recommendations for agreements
between information technology service
providers and regulated entities; (6)
providing recommendations regarding
data collection from digital health
technologies used in clinical
investigations; and (7) clarifying
recommendations for the use of
electronic signatures in clinical
investigations, including information on
submission of letters of non-repudiation
to certify that an electronic signature is
the legally binding equivalent of a
traditional handwritten signature. In
addition, editorial changes were made
to improve clarity.
This 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 ‘‘Electronic
Systems, Electronic Records, and
Electronic Signatures in Clinical
Investigations: Questions and Answers.’’
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
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Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in part 11 have been
approved under OMB control number
0910–0303; the collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130; the collections of
information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; 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 parts 314 and
601 have been approved under OMB
control numbers 0910–0001 and 0910–
0338, respectively; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; and the collections
of information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm, https://www.fda.gov/
medical-devices/device-advicecomprehensive-regulatory-assistance/
guidance-documents-medical-devicesand-radiation-emitting-products,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22562 Filed 10–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4310]
Center for Drug Evaluation and
Research Quantitative Medicine Center
of Excellence; Program Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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80257
publishing this notice to announce the
establishment of the Center for Drug
Evaluation and Research (CDER)
Quantitative Medicine Center of
Excellence (QM CoE). Quantitative
medicine (QM) is used to inform
premarket product review, post-market
product assessment, policy
development, and policy
implementation within several CDER
offices. The QM CoE will act as a
coordinating body that drives
innovation and facilitates integration of
QM methodologies and principles
across CDER. To realize this purpose,
the QM CoE will introduce new
activities and coordinate existing
activities in key areas, including
multidisciplinary education and
exchange, development and
implementation of applied science
policy, knowledge management, and
community engagement.
DATES: The formation of the QM CoE
was announced on March 25, 2024. For
more details, please visit https://
www.fda.gov/about-fda/center-drugevaluation-and-research-cder/cderquantitative-medicine-centerexcellence-qm-coe.
FOR FURTHER INFORMATION CONTACT:
Daphne Guinn, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–837–7122, Daphne.Guinn@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
QM involves the development and
application of exposure-based,
biological, and quantitative modeling
and simulation approaches derived from
nonclinical, clinical, and real-world
sources to inform: (1) drug
development, (2) regulatory decisionmaking, and (3) patient care. The
technical scope includes pharmacostatistical modeling, mechanistic
modeling, biomarker-endpoint
development, artificial intelligence and
machine learning, and clinical trial
simulations and in silico predictions.
Within CDER, QM approaches have
been used to inform premarket product
review, post-market product assessment,
policy development, and policy
implementation.
While CDER has been at the forefront
of advancing QM over the decades, the
efforts in outreach and education,
scientific and regulatory initiatives, and
operations have largely been
decentralized. Recognizing the
opportunity for synergy, CDER has
begun a coordinated QM effort that
maximally leverages its subject matter
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]]>Agencies
[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80255-80257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22562]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-1105]
Electronic Systems, Electronic Records, and Electronic Signatures
in Clinical Investigations: Questions and Answers; 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 final guidance for industry entitled ``Electronic
Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers.'' The guidance provides
information for sponsors, clinical investigators, institutional review
boards (IRBs), contract research organizations (CROs), and other
interested parties on the use of electronic systems, electronic
records, and electronic signatures in clinical investigations of foods,
medical products, tobacco products, and new animal drugs. The guidance
provides recommendations regarding the requirements in our regulations,
pursuant to which FDA considers electronic systems, electronic records,
and electronic signatures to be trustworthy, reliable, and generally
equivalent to paper records and handwritten signatures executed on
paper. This guidance finalizes the draft guidance of the same title
issued on March 16, 2023, and supersedes the guidance for industry
entitled ``Computerized Systems Used in Clinical Investigations''
issued in May 2007.
[[Page 80256]]
DATES: The announcement of the guidance is published in the Federal
Register on October 2, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2017-D-1105 for ``Electronic Systems, Electronic Records, and
Electronic Signatures in Clinical Investigations: Questions and
Answers.'' 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 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 this 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 or to 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. 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: Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002, 301-
796-6439, [email protected]; 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; 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, 301-796-6539,
[email protected]; Yuguang Wang, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., Rm. 4A-012,
College Park, MD 20740, 240-402-1757, [email protected]; Justin
Sherren, Center for Tobacco Products, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 75, Silver Spring, MD 20993-0002, 240-
402-7970, [email protected]; Eric Nelson, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
MPN #4, Rm. 106, Rockville, MD 20855, 240-402-5642,
[email protected]; or Paul Kluetz, Oncology Center of Excellence,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm.
2223, Silver Spring, MD 20993, 301-796-9567, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Electronic Systems, Electronic Records, and Electronic
Signatures in Clinical Investigations: Questions and Answers.'' The
guidance provides information for sponsors, clinical investigators,
IRBs, CROs, and other interested parties on the use of electronic
systems, electronic records, and electronic signatures in clinical
investigations of foods, medical products, tobacco products, and new
animal drugs. The goals of the guidance are to: (1) update
recommendations for applying and implementing data integrity and data
security controls, including the use of audit trails and the protection
of records in the current environment of electronic systems used in
clinical investigations; (2) expand upon recommendations on the risk-
based approach to validation of electronic systems described in the
guidance for industry ``Part 11, Electronic Records; Electronic
[[Page 80257]]
Signatures--Scope and Application'' (August 2003); (3) provide
recommendations on using information technology service providers to
provide services during a clinical investigation; (4) provide
recommendations regarding the collection of data through digital health
technologies; (5) facilitate the use of electronic signatures; and (6)
facilitate the use of electronic systems, electronic records, and
electronic signatures to improve the quality and efficiency of clinical
investigations.
This guidance finalizes the draft guidance of the same title issued
on March 16, 2023 (88 FR 16268). FDA considered comments received on
the draft guidance as the guidance was finalized. Changes from the
draft to the final guidance include: (1) clarifying the applicability
of part 11 (21 CFR part 11) to real-world data sources submitted to
FDA; (2) clarifying the applicability of part 11 to clinical
investigations conducted outside of the United States; (3) describing
electronic systems deployed by regulated entities in clinical
investigations and using a risk-based approach for validation; (4)
clarifying the focus of FDA inspections of regulated entities; (5)
providing recommendations for agreements between information technology
service providers and regulated entities; (6) providing recommendations
regarding data collection from digital health technologies used in
clinical investigations; and (7) clarifying recommendations for the use
of electronic signatures in clinical investigations, including
information on submission of letters of non-repudiation to certify that
an electronic signature is the legally binding equivalent of a
traditional handwritten signature. In addition, editorial changes were
made to improve clarity.
This 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 ``Electronic Systems, Electronic Records,
and Electronic Signatures in Clinical Investigations: Questions and
Answers.'' 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 part 11 have been approved under OMB control number 0910-0303; the
collections of information in 21 CFR parts 50 and 56 have been approved
under OMB control number 0910-0130; the collections of information in
21 CFR part 211 have been approved under OMB control number 0910-0139;
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 parts 314 and 601 have been approved under OMB control numbers
0910-0001 and 0910-0338, respectively; the collections of information
in 21 CFR part 511 have been approved under OMB control number 0910-
0117; and the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22562 Filed 10-1-24; 8:45 am]
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