15094 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Proposed Rules 

3While FBOTs initially had operated pursuant to 

no-action relief, in 2011, following the Dodd-Frank 

Wall Street and Consumer Protection Act of 2010, 

the Commission began registering FBOTs. See 

Registration of Foreign Boards of Trade, Final Rule, 

76 FR 80674 (Dec. 23, 2011), https://www.federal

register.gov/documents/2011/12/23/2011-31637/ 

registration-of-foreign-boards-of-trade. 

4See 17 CFR 48.4. 

5The Commission generally defines an IB as an 

individual or organization that solicits or accepts 

orders to buy or sell futures contracts, commodity 

options, retail off-exchange forex or commodity 

contracts, or swaps, but does not accept money or 

other assets from customers to support these orders. 

See CEA section 1a(31); 17 CFR 1.3(mm). The 

Commission registers IBs under CEA section 4d(g) 

and Regulation 3.4(a). See 7 U.S.C. 6d(g) and 17 

CFR 3.4(a). 

6U.S. customers could also use a firm exempted 

by the Commission pursuant to Regulation 30.10. 

The CFTC’s part 30 regulations govern the offer and 

sale of foreign futures and options contracts to U.S. 

customers. Regulation 30.4 requires that in order to 

accept any money, securities or property (or extend 

credit in lieu thereof) to margin, guarantee or secure 

transactions conducted by U.S. persons on an 

FBOT, a person must be registered as an FCM. See 

17 CFR 30.4(a). The Commission may grant and has 

granted exemptions to this requirement to register 

as an FCM based on petitions filed pursuant to 17 

CFR 30.10. A Regulation 30.10 exemptive order 

permits firms subject to regulation by a foreign 

regulator to conduct business from locations 

outside of the U.S. for U.S. persons on FBOTs 

without registering as FCMs, based upon the firm’s 

substituted compliance with a foreign regulatory 

structure found comparable to that administered by 

the Commission under the CEA. 

7Commissioner Pham Announces New Members 

and Leadership of the CFTC’s Global Markets 

Advisory Committee and Subcommittees (June 30, 

2023), https://www.cftc.gov/PressRoom/ 

PressReleases/8740-23. 

8Opening Statement of Commissioner Caroline D. 

Pham before the Global Markets Advisory 

Committee (Feb. 13, 2023), https://www.cftc.gov/ 

PressRoom/SpeechesTestimony/ 

phamstatement021323. Most recently, the GMAC 

made eight recommendations to the CFTC that 

promote access to markets and competition while 

safeguarding financial stability. CFTC Global 

Markets Advisory Committee Advances Key 

Recommendations (Feb. 8, 2024), https://

www.cftc.gov/PressRoom/PressReleases/8860-24. 

access for U.S. market participants to nonU.S. markets in realization of the global 

economy and international business.3 The 

main substantive amendment in today’s 

Proposed FBOT Amendments is to 

Regulation 48.4, which currently permits 

futures commission merchants (FCMs), 

commodity pool operators (CPOs), and 

commodity trading advisors (CTAs) to enter 

orders on behalf of customers or commodity 

pools via direct access on a registered FBOT.4

As explained in the Proposal, the 

Commission is proposing to permit 

introducing brokers (IBs) 5 to submit 

customer orders via direct access to FBOTs 

by adding IBs to the list of permissible 

intermediaries in Regulation 48.4. Doing so 

would permit IBs to act as executing brokers 

for U.S. customers that in turn use another 

intermediary, like an FCM,6 for clearing and 

carrying the customer accounts, similar to the 

way IBs currently perform this service on 

CFTC-registered designated contract markets 

(DCMs). Among other benefits, U.S. market 

participants interested in trading foreign 

futures could have more choices in brokers 

and broker arrangements. The Proposed 

FBOT Amendments will also ensure that 

customer protections are in place, similar to 

the current FBOT requirements for FCMs, 

CPOs, and CTAs. 

As sponsor of the CFTC’s Global Markets 

Advisory Committee (GMAC),7 I have 

devoted a significant part of my 

Commissionership to supporting solutions 

that will enhance the resiliency and 

efficiency of global markets.8 The Proposal is 

policy that mitigates market fragmentation 

and the associated impact on liquidity, and 

promotes the overall competitiveness of our 

derivatives markets. I am pleased to support 

the Proposed FBOT Amendments, and I look 

forward to the public comments. 

[FR Doc. 2024–04117 Filed 2–29–24; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 50 

[Docket No. FDA–2022–D–2997] 

Key Information and Facilitating 

Understanding in Informed Consent; 

Draft Guidance for Sponsors, 

Investigators, and Institutional Review 

Boards; Availability 

AGENCY: The Office for Human Research 

Protections, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, and the Food and Drug 

Administration, HHS. 

ACTION: Notification of availability. 

SUMMARY: The Office for Human 

Research Protections, Office of the 

Assistant Secretary for Health (OHRP), 

and the Food and Drug Administration 

(FDA) are announcing the availability of 

a draft guidance entitled ‘‘Key 

Information and Facilitating 

Understanding in Informed Consent.’’ 

This draft guidance provides 

recommendations related to two 

provisions of the revised Federal Policy 

for the Protection of Human Subjects 

(the revised Common Rule) by the U.S. 

Department of Health and Human 

Services (HHS) and identical provisions 

in FDA’s proposed rule ‘‘Protection of 

Human Subjects and Institutional 

Review Boards.’’ FDA’s proposed rule, if 

finalized, would harmonize certain 

sections of FDA’s regulations on human 

subject protections and institutional 

review boards (IRBs), to the extent 

practicable and consistent with other 

statutory provisions, with the revised 

Common Rule, in accordance with the 

21st Century Cures Act (Cures Act). The 

guidance addresses the provisions of the 

revised Common Rule that require 

informed consent to begin with key 

information about the research and to 

present information in a way that 

facilitates understanding and identical 

provisions in FDA’s proposed rule. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 30, 2024 to ensure that FDA 

and OHRP consider your comment on 

this draft guidance before the agencies 

begin 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– 

2022–D–2997 for ‘‘Key Information and 

Facilitating Understanding in Informed 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Proposed Rules 15095 

1Boudewyns, V., A.C. O’Donoghue, B. Kelly, et 

al. (2015), ‘‘Influence of Patient Medication 

Information Format on Comprehension and 

Application of Medication Information: A 

Randomized, Controlled Experiment,’’ Patient 

Education and Counseling, vol. 98(12), pp. 1592– 

1599, https://doi.org/10.1016/j.pec.2015.07.003. 

2The Office of the Federal Register has published 

this document under the category ‘‘Rules and 

Regulations’’ pursuant to its interpretation of 1 CFR 

5.9(b). We note that the categorization as such for 

purposes of publication in the Federal Register 

does not affect the content or intent of the 

document. See 1 CFR 5.1(c). 

Consent.’’ 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.’’ We 

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, 

800–835–4709 or 240–402–8010; the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002, CDRH-Guidance@

fda.hhs.gov; the Office of Clinical 

Policy, 10903 New Hampshire Ave., 

Bldg. 32, Rm. 5103, Silver Spring, MD 

20993, 301–796–8340, or the Division of 

Policy and Assurances, Office for 

Human Research Protections, 1101 

Wootton Pkwy., Suite 200, Rockville, 

MD 20852, 240–453–6900 or 866–447– 

4777; ohrp@hhs.gov. 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: 

Alyson Karesh, Center for Drug 

Evaluation and Research (CDER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6356, 

Silver Spring, MD 20993–0002, 301– 

796–3826; 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. 3516, 

Silver Spring, MD 20993, 301–796– 

5490; the Office of Clinical Policy, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5103, 

Silver Spring, MD 20993, 301–796– 

8340; or the Division of Policy and 

Assurances, Office for Human Research 

Protections, 1101 Wootton Pkwy., Suite 

200, Rockville, MD 20852, 240–453– 

6900 or 866–447–4777. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA and OHRP are announcing the 

availability of a draft guidance entitled 

‘‘Key Information and Facilitating 

Understanding in Informed Consent.’’ 

This draft guidance provides 

recommendations related to two 

provisions of the revised Common Rule 

and identical provisions in FDA’s 

proposed rule ‘‘Protection of Human 

Subjects and Institutional Review 

Boards’’ (87 FR 58733, September 28, 

2022). The FDA’s proposed rule, if 

finalized, would harmonize certain 

sections of FDA’s regulations on human 

subject protection and IRBs, to the 

extent practicable and consistent with 

other statutory provisions, with the 

revised Common Rule (codified by the 

Department of Health and Human 

Services at 45 CFR part 46, subpart A), 

in accordance with the Cures Act (Pub. 

L. 114–255, section 3023). The guidance 

addresses the provisions of the revised 

Common Rule that require informed 

consent to begin with key information 

about the research and to present 

information in a way that facilitates 

understanding and identical provisions 

in FDA’s proposed rule. 

In this draft guidance, FDA and OHRP 

provide recommendations for 

developing a key information section for 

clinical trials or studies, including 

strategies to make consent information 

as a whole more understandable for 

prospective research participants. We 

also provide a sample approach to the 

key information section that is based, in 

part, on research regarding patient 

understanding of information found in 

labeling for prescription drugs. By using 

simple phrases and plain language 

principles, as well as formatting and 

organizational tools, researchers found 

that presenting information in a discrete 

bubble format with topics organized or 

grouped together can facilitate 

consumer understanding.1 In the 

appendix of the draft guidance, we 

provide an example of a key information 

section using the bubble format. We 

encourage interested parties, with input 

from IRBs, to develop innovative ways 

to provide key information that will 

help prospective subjects better 

understand the reasons why one might 

or might not want to participate in 

research. 

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 our current thinking on ‘‘Key 

Information and Facilitating 

Understanding in Informed Consent.’’ It 

does not establish any rights for any 

person and is not binding on FDA, 

OHRP, or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations.2


ddrumheller on DSK120RN23PROD with PROPOSALS1
15096 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Proposed Rules 

II. Paperwork Reduction Act of 1995

This draft guidance refers to proposed

collections of information described in 

FDA’s September 28, 2022, proposed 

rule on ‘‘Protection of Human Subjects 

and Institutional Review Boards’’ (87 FR 

58733), which this draft guidance is 

intended to interpret, and with 

previously approved collections of 

information described in the revised 

Federal Policy for the Protection of 

Human Subjects (the revised Common 

Rule). The proposed collections of 

information in the proposed rule 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). As 

required by the PRA, FDA has 

published an analysis of the information 

collection provisions of the proposed 

rule (87 FR 58733 at 58744) and they 

have been approved under OMB control 

number 0910–0130. The collections of 

information in 45 CFR 46 and the final 

rule entitled, ‘‘Federal Policy for the 

Protection of Human Subjects’’ 

(Common Rule) have been approved 

under OMB control number 0990–0260. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm, 

https://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm, 

https://www.fda.gov/about-fda/officeclinical-policy-and-programs/officeclinical-policy, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, http://

www.hhs.gov/ohrp/newsroom/rfc/ 

index.html, or https://

www.regulations.gov. 

Dated: February 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04377 Filed 2–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2023–0626; FRL–11614– 

03–R9] 

Air Plan Disapproval; California; Los 

Angeles-South Coast Air Basin; 1997 

8-Hour Ozone; Extension of Comment

Period

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: The Environmental Protection 

Agency (EPA) is extending the comment 

period for a proposed rule published 

February 2, 2024. The current comment 

period for the proposed rule was set to 

end on March 4, 2024. In response to 

requests from several commenters, the 

EPA is extending the comment period 

for the proposed action to April 3, 2024. 

DATES: The comment period for the 

proposed rule published on February 2, 

2024, at 89 FR 7320 is extended. 

Comments must be received on or 

before April 3, 2024. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R09– 

OAR–2023–0626 at https://

www.regulations.gov. For comments 

submitted at Regulations.gov, follow the 

online instructions for submitting 

comments. Once submitted, comments 

cannot be edited or removed from 

Regulations.gov. The EPA may publish 

any comment received to its public 

docket. Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. The EPA will generally not 

consider comments or comment 

contents located outside of the primary 

submission (i.e., on the web, cloud, or 

other file sharing system). For 

additional submission methods, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

For the full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

https://www.epa.gov/dockets/ 

commenting-epa-dockets. If you need 

assistance in a language other than 

English or if you are a person with a 

disability who needs a reasonable 

accommodation at no cost to you, please 

contact the person identified in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Ginger Vagenas, EPA Region IX, 75 

Hawthorne St., San Francisco, CA 

94105. By phone: (415) 972–3964 or by 

email at vagenas.ginger@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

February 2, 2024, the EPA published a 

proposal to disapprove a state 

implementation plan revision submitted 

by the State of California to meet Clean 

Air Act (CAA) requirements for the 1997 

8-hour ozone national ambient air

quality standards (NAAQS) in the Los

Angeles-South Coast Air Basin,

California ozone nonattainment area.

This submission, titled ‘‘Final

Contingency Measure Plan—Planning

for Attainment of the 1997 80 ppb 8-

hour Ozone Standard in the South Coast

Air Basin,’’ addresses the CAA

requirements for the submission of

contingency measures that will be

implemented if emissions reductions

from anticipated technologies associated

with the area’s 1997 ozone NAAQS

attainment demonstration are not

achieved. For more detailed information

about this matter, please refer to the

February 2, 2024 Federal Register

document.

The notice of proposed rulemaking 

initially provided for comments to be 

submitted to the EPA on or before 

March 4, 2024 (a 30-day public 

comment period). The EPA received 

several comments requesting an 

extension of the comment period. To 

ensure the public has sufficient time to 

evaluate the proposal and develop 

comments, the EPA is extending the 

comment period until April 3, 2024. 

Dated: February 23, 2024. 

Matthew Lakin, 

Acting Director, Air and Radiation Division, 

Region IX. 

[FR Doc. 2024–04287 Filed 2–29–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2023–0617; FRL–11781– 

01–R3] 

Air Plan Approval; Delaware; 

Amendments to Delaware’s 

Requirements for Public Notice of 

Certain Permits 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 


ddrumheller on DSK120RN23PROD with PROPOSALS1