84 FR 26928 - Notice and Request for Comments on the Implications of Access and Benefit-Sharing (ABS) Regimes on Global Health and Biomedical Research

In order to inform U.S. Government policy and international engagement, the U.S. Department of State (DOS) invites submission of comments from the public, academia, relevant industries, and other interested stakeholders on the implications of Access and Benefit- Sharing (ABS) regimes on global health and biomedical research. In particular, DOS invites comments related to the effects of Nagoya Protocol and other ABS implementation on public health systems. The Department will hold at least two public meetings to discuss these issues, on June 25 and September 20, 2019. Any future Meetings will be announced at https://www.state.gov/bureaus-offices/under-secretary-for- economic-growth-energy-and-the-environment/bureau-of-oceans-and- international-environmental-and-scientific-affairs/office-of- international-health-and-biodefense/.

[Federal Register Volume 84, Number 111 (Monday, June 10, 2019)]
[Notices]
[Pages 26928-26929]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2019-12150]


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DEPARTMENT OF STATE

[Public Notice: 10789]


Notice and Request for Comments on the Implications of Access and 
Benefit-Sharing (ABS) Regimes on Global Health and Biomedical Research

AGENCY: Department of State.

SUMMARY: In order to inform U.S. Government policy and international 
engagement, the U.S. Department of State (DOS) invites submission of 
comments from the public, academia, relevant industries, and other 
interested stakeholders on the implications of Access and Benefit-
Sharing (ABS) regimes on global health and biomedical research. In 
particular, DOS invites comments related to the effects of Nagoya 
Protocol and other ABS implementation on public health systems. The 
Department will hold at least two public meetings to discuss these 
issues, on June 25 and September 20, 2019. Any future Meetings will be 
announced at https://www.state.gov/bureaus-offices/under-secretary-for-economic-growth-energy-and-the-environment/bureau-of-oceans-and-international-environmental-and-scientific-affairs/office-of-international-health-and-biodefense/.

DATES: Written comments are welcome before each of the two planned 
public meetings referenced above and will be reviewed periodically 
beginning July 10, 2019.

ADDRESSES: One submission per meeting is welcome, with no more than 10 
pages of single-spaced text including relevant examples with no more 
than one page per example. Submissions should be made via the internet 
at www.regulations.gov docket number DOS-2019-0016. For alternatives to 
online submissions, please contact Dr. Jennifer Seedorff at (202) 647-
3017 or [email protected]. 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 submitted by email. The public is 
strongly encouraged to file submissions electronically rather than by 
facsimile or mail.

FOR FURTHER INFORMATION CONTACT: Questions regarding the submission of 
comments should be directed to Dr. Jennifer Seedorff (202) 647-3017, 
[email protected].

SUPPLEMENTARY INFORMATION: Representatives from the Department of State 
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. In particular, we seek comments on and specific examples 
of the impacts of other countries' implementation of the Nagoya 
Protocol or other ABS measures on such issues as: International 
research collaborations, international pathogen sample sharing, 
infectious disease research, including influenza, Zika and other 
diseases, pandemic and epidemic preparedness and response, medical 
countermeasure product development efforts, investor interest in 
vaccine development, and other aspects. We would also welcome views on 
what the World Health Organization (WHO), other UN bodies, and non-
governmental organizations can do to effectively protect public health 
equities in the context of the Nagoya Protocol and

[[Page 26929]]

other national level ABS implementation. We also welcome examples of:
    (1) Monetary or non-monetary benefits to the global public health 
system that are facilitated by international sharing of pathogens, 
biospecimens, pathogen genetic sequence data, and/or relevant metadata.
    (2) Influenza-specific issues and/or examples related to the items 
described above or other items that could affect global influenza 
pandemic preparedness and response or efforts to combat seasonal 
influenza.
    (3) Non-ABS challenges and barriers with sharing pathogens 
internationally or that otherwise have significant implications for 
global pandemic or epidemic preparedness and response efforts that 
might merit additional attention or analysis.
    Background: Biological threats to the U.S. homeland--whether as the 
result of deliberate attack, accident, or a natural outbreak--are 
growing and require actions to address them at their source. Naturally 
emerging outbreaks of viruses such as Ebola and Severe Acute 
Respiratory Syndrome (SARS), as well as the deliberate 2001 anthrax 
attacks in the United States, demonstrated the impact of biological 
threats on national security by taking lives, generating economic 
losses, and contributing to a loss of confidence in government 
institutions. To effectively prepare for or respond to epidemic and 
pandemic infectious disease threats, the United States government and 
other public health actors need rapid, systematic, and consistent 
access to both information and samples from outbreaks, including 
pathogens, related clinical material, pathogen genetic sequence data, 
epidemiological data, and relevant metadata. The Global Influenza 
Surveillance and Response System and Pandemic Influenza Preparedness 
Framework facilitate the sharing of samples of influenza viruses and 
access to vaccines and other benefits. WHO is engaging with Member 
States, stakeholders, and other UN bodies to better understand the 
impacts of Nagoya Protocol and other ABS measures on public health, 
including the sharing of influenza and non-influenza pathogens.
    Several meetings are planned in association with this request for 
written submissions.
    Time and Date: Two initial meetings are planned on Tuesday, June 25 
and Friday, September 20, 2019. Each meeting will begin at 1:30 p.m. 
EDT and last for up to two hours. If the Department decides to hold 
additional public meetings, the time and place will be announced on the 
Department website: https://www.state.gov/bureaus-offices/under-secretary-for-economic-growth-energy-and-the-environment/bureau-of-oceans-and-international-environmental-and-scientific-affairs/office-of-international-health-and-biodefense/.
    Place: The two initial meetings will be held at the U.S. State 
Department's Harry S. Truman Building, 2201 C Street NW, Washington, DC 
20520. Please use the 21st Street entrance, and plan to arrive at least 
twenty minutes prior to the start of the meeting to allow for ID 
verification and escorting requirements.
    Status: The meetings will be open to the public. Persons planning 
on attending must provide their full name and organization to Dr. 
Jennifer Seedorff at [email protected] and copy [email protected] 
at least three days prior to each meeting. Persons who need special 
accommodations should also contact Dr. Seedorff at [email protected] 
or (202) 647-3017 and copy [email protected] at least seven days 
before each meeting. Requests made after that time will be considered, 
but might not be possible to accommodate. Personal data is requested 
pursuant to Public Law 99-399 (Omnibus Diplomatic Security and 
Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT 
Act); and E.O. 13356. The purpose of the collection is to validate the 
identity of individuals who enter 1033 Department facilities. The data 
will be entered into the Visitor Access Control System (VACS-D) 
database. Please see the Security Records System of Records Notice 
(State-36) at http://www.state.gov/documents/organization/242611.pdf 
for additional information.

    Dated June 4, 2019.
Jerrold L. Mallory,
Deputy Assistant Secretary for Science Space and Health (Acting), 
Bureau of Oceans and International Environmental and Scientific 
Affairs, Department of State.
[FR Doc. 2019-12150 Filed 6-7-19; 8:45 am]
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