Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 80255 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per response 2 Total hours 

Pretest 

Pretest Screener Completes .................................................................. 400 1 400 0.03 (2 minutes) ......... 12 

Pretest Questionnaire Completes .......................................................... 80 1 80 0.30 (18 minutes) ....... 24 

Main Study 

Main Study Screener Completes ........................................................... 3,200 1 3,200 0.03 (2 minutes) ......... 96 

Main Study Questionnaire Completes ................................................... 640 1 640 0.30 (18 minutes) ....... 192 

Total ................................................................................................ .......................... .......................... ........................ ..................................... 324 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format. 

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 

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, 

http://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-02- 

2020-2757/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] 

BILLING CODE 4164–01–P 

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. 


lotter on DSK11XQN23PROD with NOTICES1
80256 Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 

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, 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices 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 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 

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. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

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 


lotter on DSK11XQN23PROD with NOTICES1