Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 65177 

available data for similar products or 

other treatments for the disorder or 

similar disorders. 

• What are challenges and strategies/ 

opportunities with interpreting efficacy 

data from individual patients (including 

expanded access) and small groups of 

patients? What opportunities are there 

in leveraging prior and/or collective 

experiences? 

• What strategies can be utilized to 

accumulate and interpret safety data in 

personalized/individualized CGTs? 

• For genetic disorders with clear 

genotype-phenotype associations for 

disease manifestations or severity, what 

opportunities are there for tailoring 

treatments and study design to specific 

genotypes/phenotypes? 

D. Additional Questions To Consider 

• What additional major scientific 

challenges to advance the development 

of individualized CGTs should be 

considered? 

• What existing best practices or 

scientific approaches should be 

leveraged to address any of these 

challenges? Are there specific 

opportunities for collaborations to 

advance the development of 

individualized CGTs? 

• Are there specific areas where 

flexibility in regulatory approaches 

would improve the feasibility of 

developing and commercializing 

individualized CGTs? 

III. References 

The following references are on 

display in 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 are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. President’s Council of Advisors on Science 

and Technology, ‘‘Priorities for 

Personalized Medicine,’’ September 

2008. 

2. FDA, ‘‘Focus Area: Individualized 

Therapeutics and Precision Medicine,’’ 

2022. Available at https://www.fda.gov/ 

science-research/focus-areas-regulatoryscience-report/focus-areaindividualized-therapeutics-andprecision-medicine. 

3. Marks, P. and C. Witten, ‘‘Toward a New 

Framework for the Development of 

Individualized Therapies,’’ Gene 

Therapy, 28:615–617, 2021. 

4. FDA, ‘‘Facilitating End-to-End 

Development of Individualized 

Therapeutics’’ (Public Workshop) (March 

3, 2020). Available at https://

fda.yorkcast.com/webcast/Catalog/ 

Mobile/FolderPresentation/ 

6d6af3ca61754c3c869f7f556bbede9e21/ 

4174764f-a52d-4503-893d0b8bc35e1da7/b9c6ac08f3d040eba

768ef43befb498f1d/. 

5. Fritah, H., R. Rovelli, C.L. Chiang, and C.L. 

Kandalaft, ‘‘The Current Clinical 

Landscape of Personalized Cancer 

Vaccines,’’ Cancer Treatment Reviews, 

106:102383, 2022. 

6. FDA, ‘‘OTP Events, Meetings, and 

Workshop,’’ (2023). Available at https:// 

www.fda.gov/news-events/otp-eventsmeetings-and-workshops. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20452 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3550] 

Considerations for the Conduct of 

Clinical Trials of Medical Products 

During Major Disruptions Due to 

Disasters and Public Health 

Emergencies; Guidance for Industry, 

Investigators, and Institutional Review 

Boards; 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 

‘‘Considerations for the Conduct of 

Clinical Trials of Medical Products 

During Major Disruptions Due to 

Disasters and Public Health 

Emergencies.’’ This guidance 

recommends approaches that sponsors 

of clinical trials of medical products can 

consider when there is a major 

disruption to clinical trial conduct and 

operations due to disasters or public 

health emergencies, which can include 

but are not limited to hurricanes, 

earthquakes, military conflicts, 

infectious disease outbreaks, or 

bioterrorist attacks. The appendix to this 

guidance further explains those 

approaches by providing answers to 

questions that the Agency has received 

about conducting clinical trials during 

major disruptions. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 21, 2023. 

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– 

2023–D–3550 for ‘‘Considerations for 

the Conduct of Clinical Trials of 

Medical Products During Major 

Disruptions Due to Disasters and Public 

Health Emergencies.’’ 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 


ddrumheller on DSK120RN23PROD with NOTICES1
65178 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 

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 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: Dat 

Doan, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 3334, Silver Spring, 

MD 20993, 301 796–2500, CDEROMP@

fda.hhs.gov; Anne Taylor, 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, 10903 

New Hampshire Ave., Bldg. 66, Silver 

Spring, MD 20993–0002, 301–796–6359. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a final guidance for industry, 

investigators, and institutional review 

boards entitled ‘‘Considerations for the 

Conduct of Clinical Trials of Medical 

Products During Major Disruptions Due 

to Disasters and Public Health 

Emergencies.’’ Disasters and public 

health emergencies (PHEs) have the 

potential to cause major disruptions in 

the conduct of clinical trials for medical 

products. Such events can include, but 

are not limited to, weather events, 

military conflicts, infectious disease 

outbreaks, and bioterrorist attacks. The 

purpose of the guidance is to provide 

general considerations to assist 

sponsors, investigators, and institutional 

review boards in assuring the safety of 

trial participants, maintaining 

compliance with good clinical practice, 

and minimizing risks to trial integrity 

during disasters and PHEs that may lead 

to major disruption of clinical trial 

conduct and operations. The appendix 

to the guidance further explains these 

general considerations in a questionand-answer format. 

FDA recognizes that disasters and 

PHEs can cause major disruptions to the 

conduct of clinical trials of medical 

products. For example, disasters or 

PHEs can lead to population 

quarantines, trial site closures, travel 

limitations, interruptions to the supply 

chain for the investigational product, or 

other considerations related to the type 

of disaster or emergency. These 

challenges can create difficulties for 

complying with protocol-specified 

procedures, including administering or 

using the investigational product or 

adhering to protocol-specific visits and 

laboratory/diagnostic testing. This final 

guidance provides recommendations on 

how to manage major disruptions to 

clinical trials during disasters and PHEs 

to help ensure the protection of 

participants and the ability of clinical 

trials to generate evidence to support 

regulatory decision-making during these 

times. 

The final guidance provides 

recommendations for helping to address 

those challenges, including, among 

other things, recommendations related 

to the safety of trial participants, 

whether to continue or suspend a trial, 

protocol amendments and deviations, 

study monitoring, alternative delivery of 

the investigational product, remote 

safety and endpoint assessment, 

informed consent, and reporting of 

adverse events. Some of the 

recommendations in this final guidance 

provide less burdensome approaches 

that can be utilized, when appropriate, 

in the conduct of clinical trials during 

major disruptions due to a disaster or 

PHE and that are consistent with public 

health. For example, the guidance 

provides recommendations regarding a 

change to virtual, rather than in-person, 

clinical trial visits when necessary. 

In March 2020, FDA first published 

the guidance for industry entitled 

‘‘Conduct of Clinical Trials of Medical 

Products During the COVID–19 Public 

Health Emergency’’ (COVID–19 Conduct 

guidance) to support public health 

efforts following a declaration, under 

section 319 of the Public Health Service 

(PHS) Act (42 U.S.C. 247d), by the 

Secretary of Health and Human Services 

of a public health emergency related to 

Coronavirus Disease 2019 (the disease 

caused by SARS–CoV–2). The COVID– 

19 Conduct guidance focused on 

addressing the COVID–19 PHE. 

In the Federal Register of March 13, 

2023 (88 FR 15417), FDA listed the 

COVID–19-related guidance documents 

that would no longer be effective after 

the PHE declared under the PHS Act 

expired on May 11, 2023. The March 13, 

2023, notice also listed COVID–19- 

related guidance documents that FDA 

was revising to continue in effect for 

180 days after the expiration of the PHE 

declaration to provide a period for 

stakeholder transition and then would 

no longer be in effect, and documents 

that FDA was revising to continue in 

effect for 180 days after the expiration 

of the PHE declaration, during which 

time FDA planned to further revise the 

guidances with any appropriate changes 

based on comments received and the 

Agency’s experience with 

implementation. The COVID–19 

Conduct guidance was included in the 

latter category and was revised to 

remain in effect for 180 days postexpiration of the PHE declaration. FDA 

believes that most of the 

recommendations set forth in the 

COVID–19 Conduct guidance are 

applicable outside the context of the 

COVID–19 PHE to major disruptions to 

clinical trial conduct in the setting of 

disasters and PHEs more broadly. 

Consistent with what we said in the 

Federal Register of March 13, 2023, 

FDA is therefore issuing this revised 

final guidance, which supersedes the 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 65179 

COVID–19 Conduct guidance. FDA’s 

revisions include broadening the 

guidance’s scope to apply during 

disasters and PHEs, removing several 

outdated questions, clarifying 

recommendations regarding use of riskbased approaches for monitoring 

clinical investigations, clarifying 

recommendations concerning charging 

for investigational products, and making 

other editorial changes to improve 

clarity and consistency. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with our good guidance 

practices regulation (21 CFR 

10.115(g)(3)) without initially seeking 

prior comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (see 21 CFR 10.115(g)(2) 

and section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because 

disasters and PHEs may occur without 

notice and, as we have learned from 

experience during the COVID–19 PHE, 

may rapidly cause major disruptions to 

clinical trial conduct. It is thus 

important to public health to provide 

guidance on approaches to assure the 

safety of trial participants and minimize 

risks to trial integrity during such major 

disruptions. Moreover, portions of the 

guidance reflect a less burdensome 

approach that is consistent with public 

health and that can be used during a 

disaster or PHE when appropriate. 

Interested parties had an opportunity to 

comment on the recommendations in 

the COVID–19 Conduct guidance, and 

FDA considered those comments when 

revising the guidance to apply those 

recommendations to disasters and 

public health emergencies more 

broadly. Although this guidance 

document is being implemented 

immediately, it remains subject to 

comment in accordance with FDA’s 

good guidance practices regulation 

(§ 10.115(g)(3)(D)). 

The guidance represents the current 

thinking of FDA on ‘‘Considerations for 

the Conduct of Clinical Trials of 

Medical Products During Major 

Disruptions Due to Disasters and Public 

Health Emergencies.’’ 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 

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 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 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 0910–0630; 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 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/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20474 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Engineered T 

Cell Therapies for the Treatment of 

HPV-Positive Cancer(s) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

Patents and Patent Applications listed 

in the SUPPLEMENTARY INFORMATION

section of this Notice to Scarlet TCR, 

Inc. (‘‘Scarlet’’), presently headquartered 

in Kingston, New Jersey. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before October 6, 2023 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive Patent License should be 

directed to: Andrew Burke, Ph.D., 

Senior Technology Transfer Manager, 

NCI Technology Transfer Center, 

Telephone: (240) 276–5484; Email: 

andy.burke@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

1. United States Provisional Patent 

Application No. 62/004,335 filed May 

29, 2014, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–US– 

01]; 

2. PCT Patent Application No. PCT/ 

US2015/033129 filed May 29, 2015, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–PCT–02]; 

3. Australian Patent No. 2015266818 

issued January 16, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–AU–03]; 

4. Brazilian Patent Application No. 

BR112016027805–4 effective filing date 

of May 29, 2015, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–BR– 

04]; 

5. Canadian Patent Application No. 

2,950,192 effective filing date of May 29, 

2015, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0– 

CA–05]; 

6. Chinese Patent No. 

ZL201580031789.X issued May 4, 2021, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–CN–06]; 

7. European Patent No. 3149031 

issued December 18, 2019, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–EP–07]; 

a. Validated in: AL, AT, BE, BG, CH, 

CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, 

HR, HU, IE, IS, IT, LT, LU, LV, MK, MT, 

NL, NO, PL, PT, RO, SE, SI, SK, SM and 

TR. 

8. Israeli Patent No. 248797 issued 

September 1, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–IL–08]; 


ddrumheller on DSK120RN23PROD with NOTICES1