Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88637 

ANNUALIZED BURDEN HOUR TABLE

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden hours 

per response 

Total burden 

hours 

Participants in customer interviews ................................................................. 500 1 1 500 

Participants in focus groups ............................................................................ 450 1 90/60 675 

Participants of feedback surveys ..................................................................... 2,000,000 1 3/60 100,000 

Participants in user testing (rapid) ................................................................... 400 1 15/60 100 

Participants in user testing (deep dive) ........................................................... 200 1 30/60 100 

Total .......................................................................................................... 2,001,550 ........................ ........................ 101,375 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2023–28283 Filed 12–21–23; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice and Request for Comments on 

the Implications of Access and Benefit 

Sharing (ABS) Commitments/Regimes 

and Other Proposed Commitments 

Being Considered Under a WHO 

Convention, Agreement or Other 

International Instrument on Pandemic 

Prevention, Preparedness and 

Response 

AGENCY: Office for Global Affairs, Office 

of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: This Request for Comment 

seeks information from stakeholders, 

broadly defined, on concepts currently 

under consideration by parties 

negotiating a World Health Organization 

(WHO) Pandemic Preparedness 

Agreement. It seeks information on how 

stakeholders’ efforts to facilitate 

response efforts, including the rapid 

creation and equitable deployment of 

safe and effective vaccines, diagnostic 

tests, and treatments, can be advanced 

or hindered by concepts and 

commitments under consideration by 

the negotiating parties as reflected in 

current negotiating text. 

DATES: To be assured consideration, 

written comments must be received by 

5 p.m. Eastern time on January 22, 2024. 

Written comments should be emailed to 

OGA.RSVP@hhs.gov with the subject 

line ‘‘Written Comment Re: Implications 

of Access and Benefit Sharing (ABS) 

Commitments/Regimes and Other 

Proposed Commitments in the WHO 

Pandemic Agreement’’ by January 22, 

2024. Comments received after that date 

will be considered to the extent 

practicable. 

The Department’s policy is to make 

all comments received from members of 

the public available for public viewing 

on the Federal eRulemaking Portal at 

www.regulations.gov. In this instance, 

business confidential submissions will 

also be accepted. Note that relevant 

comments submitted to regulations.gov 

will be posted without editing and will 

be available to the public; therefore, 

business-confidential information 

should be clearly identified as such and 

an accompanying redacted version 

should be submitted for posting on 

regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Susan Kim, Office for Global Affairs, 

Office of the Secretary, HHS, Room 

(639H) Hubert H. Humphrey Building, 

200 Independence Avenue SW, 

Washington, DC 20201, (202) 235–3537. 

SUPPLEMENTARY INFORMATION: 

Background: In December 2021, 

WHO’s Member States decided at a 

Special Session of the World Health 

Assembly to establish an 

intergovernmental negotiating body 

(INB), representing all regions of the 

world, to draft and negotiate a WHO 

convention, agreement, or other 

international instrument on pandemic 

prevention, preparedness, and response. 

More information about the INB process 

can be found here: https://inb.who.int/ 

home/inb-process. The INB currently 

intends to submit its outcome to the 

Seventy-seventh World Health 

Assembly in May 2024. 

The United States has expressed 

support for the development of an 

international instrument to protect the 

world from pandemic health threats 

now and in the future, and in a more 

rapid and equitable manner. 

The United States is seeking the 

following key outcomes in the 

negotiations: 

• Enhance the capacity of countries 

around the world to prevent, prepare 

for, and respond to pandemic 

emergencies and provide clear, credible, 

consistent information to their citizens. 

• Ensure that all countries share data 

and laboratory samples from emerging 

outbreaks quickly, safely, and 

transparently to facilitate response 

efforts and inform public health 

decision making regarding effective 

disease control measures, including the 

rapid creation of safe and effective 

vaccines, diagnostic tests, and 

treatments. 

• Support more equitable and timely 

access to, and delivery of, vaccines, 

diagnostic tests, treatments, and other 

mitigation measures to quickly contain 

outbreaks, reduce illness and death, and 

minimize impacts on the economic and 

national security of people around the 

world. 

Purpose: The U.S. Department of 

Health and Human Services (HHS) and 

the Department of State are charged 

with co-leading the U.S. delegation to 

the Intergovernmental Negotiating Body 

(INB) to draft and negotiate a WHO 

convention, agreement or other 

international instrument on pandemic 

prevention, preparedness, and response. 

This Request for Comments procedure 

is designed to seek input from 

stakeholders and subject matter experts 

to help inform the U.S. government 

negotiating position, including new 

approaches, proposals, or concerns with 

the current version of the negotiating 

text. 

The most recent Negotiating Text of 

the WHO Pandemic Agreement 

(Negotiating Text) can be found here: 

https://apps.who.int/gb/inb/pdf_files/ 

inb7/A_INB7_3-en.pdf. 

Representatives from HHS, State and 

the Department of Commerce will 

review written submissions and share 

them, as appropriate, with staff from 

other Federal Agencies to inform U.S. 

Government policy and our 

international engagements on these 

issues. U.S. officials may contact 

individuals making submissions for 

further information or explanation. 

Respondent information. Please note 

the following information is not 

required but will assist us in 

contextualizing responses. If possible, in 

your submission, please include 

institution or organization name and 

type; for foreign-based entities, please 


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88638 Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 

1The content or phrasing of questions in this 

Request for Comment should not be taken to 

indicate that the U.S. is favoring or preparing to 

accept commitments and/or not engage in further 

negotiation over them. Rather, we are seeking to 

learn more about stakeholder positions on these 

pivotal questions to further refine the U.S. 

delegation’s negotiating stance. 

specify country/ies in which the 

institution or organization is 

headquartered; if your institution or 

organization is a potential provider of 

pandemic-related products or services, 

please specify the types of products or 

services with which you are commonly 

associated or seeking to develop. All 

personal identifying information (for 

example, name and address) voluntarily 

submitted by the commenter may be 

publicly accessible. 

Specific topics and questions: 

Stakeholders are invited to provide 

comments on any and all issues raised 

by the negotiating text, including 

potential vehicles and means for 

implementation of commitments to 

which the U.S. may subscribe. To the 

extent commenters choose to comment 

on specific provisions of the negotiating 

text, it is helpful to reference any 

articles or sub-articles being addressed. 

In addition, stakeholders are invited 

to respond to any or all of the following 

questions.1 Unless otherwise indicated, 

quotations are from the relevant article 

of the Proposal for negotiating text. 

Article 9, Research and Development 

• What approaches or incentives 

might be provided to governments, 

research institutions, or the private 

sector to encourage participation of 

relevant stakeholders to, as proposed in 

the Negotiating Text, ‘‘accelerate 

innovative research and development, 

including community-led and crosssector collaboration, for addressing 

emerging and re-emerging pathogens 

with pandemic potential’’? 

• What voluntary steps could 

Research & Development (R&D) 

stakeholders take that would build 

capacities and promote more inclusive 

research collaborations and 

participation from basic science through 

advanced development and clinical 

research, addressing the global calls for 

equity and inclusion? 

• What national policies might be 

developed that (as proposed in the 

Negotiating Text), ‘‘support the 

transparent, public sharing of clinical 

trial protocols and results conducted 

either within their territories or through 

partnerships with other Parties, such as 

through open access publications’’? 

• What are respective pros and cons 

of, the following proposed language in 

the Negotiating Text: ‘‘in accordance 

with national laws and considering the 

extent of public funding provided, 

publish[ing] the terms of governmentfunded research and development 

agreements for pandemic-related 

products, including information on: (a) 

research inputs, processes and outputs, 

including scientific publications and 

data repositories, with data shared and 

stored securely in alignment with 

findability, accessibility, 

interoperability and reusability 

principles; (b) the pricing of endproducts, or pricing policies for endproducts; (c) licensing to enable the 

development, manufacturing and 

distribution of pandemic-related 

products, especially in developing 

countries; and (d) terms regarding 

affordable, equitable and timely access 

to pandemic-related products during a 

pandemic’’? In your view, are there 

alternative recommended actions or 

commitments that could be considered? 

• What is the appropriate role for 

WHO in facilitating the R&D process in 

areas focusing on infectious diseases? 

• Are there provisions that could 

reasonably be included in governmentfunded research or advanced 

development agreements, or policies 

related to licensing of governmentowned and/or government-funded 

technology that would promote global 

access to pandemic-related products, 

without disincentivizing innovation or 

partnering with the U.S. government 

around research and development? 

Article 10, Sustainable Production 

• What approaches or incentives 

might be used to encourage 

manufacturers and others ‘‘to grant, 

subject to any existing licensing 

restrictions, on mutually agreed terms, 

non-exclusive, royalty-free licenses to 

any manufacturers, particularly from 

developing countries, to use their 

intellectual property and other 

protected substances, products, 

technology, know-how, information and 

knowledge used in the process of 

pandemic-related product development 

and production, in particular for prepandemic and pandemic diagnostics, 

vaccines and therapeutics for use in 

agreed developing countries’’? 

• How helpful or harmful would the 

following proposed obligations for 

governments be for public health, 

business, and innovation interests 

generally: 

Æ ‘‘(a) encourage research and 

development institutes and 

manufacturers, in particular those 

receiving significant public financing, to 

waive or manage, for a limited duration, 

royalties on the use of their technology 

for the production of pandemic-related 

products; 

Æ (b) promote the publication, by 

private rights holders, of the terms of 

licensing agreements or technology 

transfer agreements for pandemicrelated products; and 

Æ (c) promote the voluntary licensing 

and transfer of technology and related 

know-how for pandemic-related 

products by private rights holders with 

established regional or global 

technology transfer hubs or other 

multilateral mechanisms or networks.’’ 

• How can we work to promote a 

globally sustainable medical 

countermeasures (MCM) manufacturing 

system, including leveraging regional 

approaches to production and 

maintaining readiness of facilities 

between pandemic emergencies? 

Article 11, Transfer of Technology and 

Know-How 

• What measures could be taken, or 

incentives provided, to ‘‘strengthen 

existing, and develop innovative, 

multilateral mechanisms [under WHO], 

including through the pooling of 

knowledge, intellectual property and 

data, that promote the transfer of 

technology and know-how for the 

production of pandemic-related 

products, on mutually agreed terms as 

appropriate, to manufacturers, 

particularly in developing countries’’? 

• What measures could be taken, or 

incentives provided, to ‘‘make available 

non-exclusive licensing of governmentowned technologies, on mutually agreed 

terms as appropriate, for the 

development and manufacturing of 

pandemic-related products, and publish 

the terms of these licenses’’? 

• In your view, is there a lack of 

transparency concerning information 

regarding pandemic-related products, 

their technological specifications, and 

manufacturing details? If so, could the 

establishment of a new mechanism at 

the WHO effectively address this lack of 

transparency? 

• What net impacts, positive or 

negative, would you envision arising 

from commitments presently outlined in 

Article 11.3, including: 

Æ ‘‘(a) commit to agree upon, within 

the framework of relevant institutions, 

time-bound waivers of intellectual 

property rights to accelerate or scale up 

the manufacturing of pandemic-related 

products to the extent necessary to 

increase the availability and adequacy 

of affordable pandemic-related 

products; 

Æ (b) encourage all holders of patents 

related to the production of pandemicrelated products to waive or manage, as 

appropriate, for a limited duration, the 


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Federal Register / Vol. 88, No. 245 / Friday, December 22, 2023 / Notices 88639 

payment of royalties by developing 

country manufacturers on the use, 

during the pandemic, of their 

technology for the production of 

pandemic-related products, and shall 

require, as appropriate, those that have 

received public financing for the 

development of pandemic-related 

products to do so; and 

Æ (c) encourage manufacturers within 

its jurisdiction to share undisclosed 

information, in accordance with 

paragraph 2 of Article 39 of the TradeRelated Aspects of Intellectual Property 

Rights (TRIPS) Agreement, with 

qualified third-party manufacturers 

when the withholding of such 

information prevents or hinders urgent 

manufacture by qualified third parties of 

a pharmaceutical product that is 

necessary to respond to the pandemic’’? 

Article 12, Access and Benefit Sharing 

• A key negotiating objective of the 

United States has been to ensure that all 

countries share pathogen samples and 

associated data, including genetic 

sequence data, from emerging outbreaks 

quickly and transparently to facilitate 

response efforts, including the rapid 

creation of safe and effective vaccines, 

diagnostic tests, and treatments. 

Æ What sample and data access 

impediments have you encountered in 

the past or what impediments would 

you envision based on the proposed 

Pathogen Access and Benefit Sharing 

(PABS) System in the Negotiating Text 

that might thwart or delay research 

efforts? 

D Does implementation of Nagoya 

Protocol requirements impede the rapid 

development or deployment of vaccines, 

diagnostic test, and treatments? Explain. 

Æ How important is a commitment by 

negotiating parties to provide parties 

with the access to pathogen samples and 

data that are needed to contribute to 

rapid creation of safe and effective 

vaccines, diagnostic tests, and 

treatments? 

Æ Are alternative strategies for 

‘‘access’’ to samples and data available 

and how do they compare in terms of 

effectiveness and efficiency? 

Æ How might such commitments 

impact researchers and institutions? 

• The Article 12 negotiating text 

proposes that sanctioned use of the 

WHO PABS System would be 

recognized as a specialized international 

access and benefit-sharing instrument 

within the meaning of paragraph 4 of 

Article 4 of the Nagoya Protocol; such 

recognition would provide for the 

exemption of the pathogens covered 

under the PABS System from additional 

access and benefit sharing requirements. 

Æ How valuable would such an 

‘‘exemption’’ be to U.S. stakeholders? 

What pathogens would benefit from 

exemption status? 

Æ What additional incentives might 

be needed to encourage participation in 

an ABS system exempt from Nagoya 

Protocol requirements? 

• The Article 12 negotiating text 

envisions parties agreeing to set aside 

certain percentages of pandemic-related 

products (proposed in the current 

negotiating text as a minimum of 20%) 

and facilitating their exportability. 

Æ What, from your perspective, are 

the pros and cons of such a 

requirement? 

Æ Would such a requirement advance 

or hinder rapid research and 

development efforts? 

• The Article 12 negotiating text 

further envisions required monetary 

contributions from recipients of shared 

samples or data, including researchers 

and manufacturers, for privileges of 

access. What in your view is the 

monetary value of access that would be 

provided in terms of an annual or 

percentage-based contribution from 

your organization? How would 

requiring monetary contributions from 

academic, government, or other nonprofit research institutions impact, 

positive or negative, research? 

• The Article 12 negotiating text 

specifies other benefits that should be 

considered for provision to developing 

countries, including ‘‘(i) encouraging 

manufacturers from developed countries 

to collaborate with manufacturers from 

developing countries . . . to transfer 

technology and know-how and 

strengthen capacities for the timely 

scale-up of production of pandemicrelated products; (ii) tiered-pricing or 

other cost-related arrangements, such as 

no loss/no profit loss arrangements, for 

purchase of pandemic-related products 

. . .; and (iii) encouraging of 

laboratories . . . to actively seek the 

participation of scientists from 

developing countries in scientific 

projects associated with research on 

WHO PABS Materials.’’ 

Æ How helpful would these 

additional measures be in advancing the 

rapid creation and/or production scaleup of safe and effective vaccines, 

diagnostic tests, and treatments? What 

are the risks or potential negative 

impacts could come from including 

such provisions? 

Æ What incentives might be provided 

to stakeholders to encourage/assure 

participation in such voluntary 

measures? 

• What provisions might companies, 

academic research institutions, and 

other industry stakeholders look for 

when assessing voluntary participation 

in such a proposed Access and Benefit 

Sharing system? What samples/data are 

needed the most and how could such a 

system improve access to needed 

resources? What provisions are missing 

that would incentivize broad 

participation in the system that Member 

States should consider? 

Article 13, Global Supply Chain and 

Logistics (SCL) Network 

• The WHO SCL Network proposed 

in Article 13 envisions performing a 

range of functions ordinarily left to 

individual governments, institutions, or 

organizations. 

Æ What functions of Access to 

COVID–19 Tools-Accelerator (ACT–A) 

should or should not be 

institutionalized? 

Æ Should the U.S. consider incentives 

to encourage U.S. stakeholders’ 

participation in such an effort and what 

would compelling incentives be? 

Susan Kim, 

Principal Deputy Assistant Secretary, Office 

for Global Affairs. 

[FR Doc. 2023–28341 Filed 12–20–23; 4:15 pm] 

BILLING CODE 4150–38–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

[245A2100DD/AAKC001030/ 

A0A501010.999900] 

Indian Gaming; Approval of TribalState Class III Gaming Compact 

Amendment Between Minnesota 

Chippewa Tribe, Minnesota—Leech 

Lake Band and the State of Minnesota 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Notice. 

SUMMARY: This notice publishes the 

approval of the Addendum to the 

Tribal-State Compact for Control of 

Class III Blackjack between the 

Minnesota Chippewa Tribe, 

Minnesota—Leech Lake Band and the 

State of Minnesota. 

DATES: The Amendment takes effect on 

December 22, 2023. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Paula L. Hart, Director, Office of Indian 

Gaming, Office of the Assistant 

Secretary—Indian Affairs, Washington, 

DC 20240, IndianGaming@bia.gov; (202) 

219–4066. 

SUPPLEMENTARY INFORMATION: Under 

section 11 of the Indian Gaming 

Regulatory Act (IGRA), Public Law 100– 

497, 25 U.S.C. 2701 et seq., the 

Secretary of the Interior shall publish in 


ddrumheller on DSK120RN23PROD with NOTICES1