Request for Comments on Synthetic Biology, 52752-52753 [2010-21359]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with NOTICES 52752 Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices suggestions from the public on the activities of the Trans-Atlantic Taskforce on Antimicrobial Resistance (TATFAR). DATES: A public meeting will be held in Bethesda, MD, on Friday, October 1, 2010 from 1:30 to approximately 4:30 p.m. Persons wishing to participate, including those who wish to make an oral presentation, must register in advance and provide a copy of their presentation by noon Friday, September 24, 2010. Deadline for Registration for all Attendees: All Other Attendees must register by noon, Friday, September 24, 2010. Deadline for Requests for Special Accommodation: Requests for special accommodation should be submitted by noon, Friday, September 17, 2010. ADDRESSES: Meeting Location: The public meeting will be held on the Campus of the National Institutes of Health, 9000 Rockville Pike, Building 31, Wing C, Room 6, Bethesda, MD 20892. Submission of Written Comments: Written comments can be e-mailed to OGHA.OS@HHS.gov or sent via regular mail to Elana Clarke, Office of Global Health Affairs, Switzer Building Room 2319, 330 C Street, SW., Washington, DC 20201. Registration and Special Accommodations: Individuals wishing to participate or who need special accommodations or both must register by contacting Elana Clarke at Elana.Clarke@hhs.gov. See Registration To Attend and/or Participate in the Public Hearing for instructions on how to submit electronic notices of participation. FOR FURTHER INFORMATION CONTACT: Elana Clarke at Elana.Clarke@hhs.gov or 202 260–0443. Registration To Attend and/or Participate in the Public Meeting: To ensure there is sufficient room we ask that you pre-register. If you wish to make an oral presentation during the open public comment period of the hearing, state your intention to present on your registration submission. To register, please send an electronic mail message to Elana.Clarke@hhs.gov by the deadline listed under DATES. Your email should include your name and email address. Please submit a written statement at the time of registration, identifying each focus area you wish to address and the approximate time requested to make your presentation. Organizations should provide this information as well as the names and e-mail addresses of all participants. Registered individuals will VerDate Mar<15>2010 15:33 Aug 26, 2010 Jkt 220001 be notified of the approximate time scheduled for their presentation prior to the meeting. Depending on the number of presentations, HHS may need to limit the time allotted for presentations. SUPPLEMENTARY INFORMATION: and any documentation may be submitted as Adobe PDF, MSWord or Text (.txt) files. Written comments submitted by regular mail should clearly identify ‘‘TATFAR Comments’’ as the subject. 1. Background On November 3, 2009, the United States and the European Union (EU) agreed to establish a task force to focus ‘‘on urgent antimicrobial resistance issues focused on appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, prevention of both healthcare- and community-associated drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs, which could be better addressed by intensified cooperation.’’ (2009 EU–U.S. Summit Declaration). The TATFAR is made up of government representatives from the U.S. Department of Health and Human Services for the United States and from the European Commission, European Union agencies, and representatives of three EU member states for the EU. Information about the TATFAR is available at: https://ecdc.europa.eu/en/ activities/diseaseprogrammes/TATFAR/ Pages/index.aspx. 3. Building and Security Guidelines 2. Public Comment and Meeting The public meeting process provides an opportunity for the public to become aware of the activities of the TATFAR to date. In addition, OGHA invites written comments and/or oral presentations of interested persons on the three focus areas of the TATFAR as defined in the 2009 EU/US Summit Declaration: • Appropriate therapeutic use of antimicrobial drugs in the medical and veterinary communities, • Prevention of both healthcare- and community-associated drug-resistant infections, and • Strategies for improving the pipeline of new antimicrobial drugs. Comments should identify specific antimicrobial resistance-related activities in these three areas where intensified cooperation between the United States and the European Union could have the most impact, keeping in mind that the work of the TATFAR will be carried out using currently available resources. In particular, input is sought on activities that can be undertaken in the near-term, with a reasonable possibility of completion over the next 12–15 months. Written comments submitted by email should use the following subject line ‘‘TATFAR Comments.’’ Comments PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 The meeting is being held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, please take account of the need to clear security. All visitors must enter through the NIH Gateway Center and must present government-issued photo identification. All persons entering the building must pass through a metal detector. All items brought to HHS are subject to inspection. For more information on NIH security requirements for visitors, please go to: https://www.nih.gov/about/ visitorsecurity.htm. Signed: August 23, 2010. Nils Daulaire, Director, Office of Global Health Affairs. [FR Doc. 2010–21351 Filed 8–26–10; 8:45 am] BILLING CODE 4150–38–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on Synthetic Biology Department of Health and Human Services, Office of Public Health and Science, The Presidential Commission for the Study of Bioethical Issues. ACTION: Notice. AGENCY: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the emerging science of synthetic biology, including its potential applications and risks, as well as appropriate ethical boundaries to assure that America reaps the benefits of this new technology. DATES: To assure consideration, comments must be received by October 1, 2010. ADDRESSES: Individuals, groups, and organizations interested in commenting on this topic may submit comments by e-mail to info@bioethics.gov or by mail to the following address: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave., NW., Suite C–100, Washington, DC 20005. FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of Communications, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., SUMMARY: E:\FR\FM\27AUN1.SGM 27AUN1 WReier-Aviles on DSKGBLS3C1PROD with NOTICES Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices Suite C–100, Washington, DC 20005. Telephone: 202/233–3960. E-mail: info@ bioethics.gov. Additional information may be obtained by viewing the Web site: https://www.bioethics.gov. SUPPLEMENTARY INFORMATION: On November 24, 2009, the President established the Presidential Commission for the Study of Bioethical Issues to advise him on bioethical issues generated by novel and emerging research in biomedicine and related areas of science and technology. The Commission is charged to identify and promote policies and practices that assure ethically responsible conduct of scientific research, healthcare delivery, and technological innovation. In undertaking these duties, the Commission will identify and examine specific bioethical, legal, and social issues related to potential scientific and technological advances; examine diverse perspectives and possibilities for dynamic international collaboration on these issues, and recommend legal, regulatory, or policy actions as appropriate. As its first order of business, the Commission has begun an inquiry into the emerging science of synthetic biology. The President asked the Commission to address this topic on May 20, 2010, following the announcement that the J. Craig Venter Institute had successfully engineered a synthetic cell—the insertion into a bacterium of a complete, functional genome synthesized entirely from a digitized sequence that replaced the native genome of the host over a series of replications. Daniel G. Gibson et al., Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome, Science Express (May 20, 2010). The President charged the Commission to consider any potential medical, environmental, security, and other benefits, as well as any related risks. Additionally, the President asked the Commission to develop ‘‘recommendations about any actions the Federal government should take to ensure that America reaps the benefits of this developing field of science while identifying appropriate ethical boundaries and minimizing identified risks.’’ The Commission will report back its finding and recommendations later this year. To begin its work, the Commission convened a public meeting in Washington, DC on July 8–9, 2010. At that meeting, representatives with expertise in science, ethics, and public policy, as well as advocates with diverse perspectives on this new field provided information and insight to help guide VerDate Mar<15>2010 15:33 Aug 26, 2010 Jkt 220001 the Commission in its thinking. Leading scientists in the field created context for the discussion by explaining the state of the science and discussing possible applications. Among the anticipated benefits discussed were employing bacterial cells as microscopic factories in the production of pharmaceuticals and biofuels. Additionally, with regard to potential risks, the Commission heard discussion about possible biosafety, biosecurity and environmental concerns, including risks that may arise as synthetic biology relies on organisms that can evolve and selfreplicate, and existing practices to protect against these risks. The Commission also heard discussion about ethical boundaries and the views of faith communities. As the approaches to, and applications of, synthetic biology proliferate, the Commission wishes to develop a multifaceted understanding of its scientific and technological implications, and learn more about the views of the public on the existing or potential ethical and social ramifications. To this end, the Commission is inviting interested parties to provide input and advice through written comments. Among other issues, the Commission is interested in receiving comments on the potential benefits that the emerging field of synthetic biology is likely to yield, now or in the future, the risks that may arise, the ethical boundaries that should be considered, and policies and strategies to assure that the public will benefit from these new tools and products. Please address comments by e-mail to info@bioethics.gov, or by mail to the following address: Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave., NW., Suite C–100, Washington, DC 20005. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted. 52753 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB) Title: TANF Emergency Fund Subsidized Employment Report, Form OFA–200. OMB No.: New Collection. Description: On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (Recovery Act) which establishes the Emergency Contingency Fund for State TANF Programs (Emergency Fund) as section 403(c) of the Social Security Act (the Act). This legislation provides up to $5 billion to help States, territories, and tribes in fiscal year (FY) 2009 and FY 2010 that have an increase in assistance caseloads or in certain types of expenditures. The Recovery Act also made other changes to TANF— extending supplemental grants through FY 2010, expanding flexibility in the use of TANF funds carried over from one fiscal year to the next, and adding a hold-harmless provision to the caseload reduction credit for States and territories serving more TANF families. The Emergency Fund is intended to build upon and renew the principles of work and responsibility that underlie successful welfare reform initiatives. The Emergency Fund provides resources to States, territories, and tribes (referred to collectively here as ‘‘jurisdictions’’) to support work and families during this difficult economic period. Many jurisdictions are implementing subsidized employment programs as a result of the availability of this new funding, and there is substantial interest in understanding how this funding has been used. There is also significant public interest in the number of individuals that are being placed in subsidized employment as a result of the Recovery Act. As a result, we are proposing a voluntary data collection for jurisdictions regarding information Dated: August 17, 2010. on the number of individuals in Valerie H. Bonham, subsidized employment funded in Executive Director, The Presidential whole or in part by the TANF Commission for the Study of Bioethical Issues. Emergency Fund or that were included [FR Doc. 2010–21359 Filed 8–26–10; 8:45 am] in the calculation of a TANF Emergency BILLING CODE 4154–06–P Fund award. We initially requested emergency clearance to collect this data and posted a Federal Register notice on June 8 stating our intent to collect this information and invited comments. As a result of our June 8 notice we received PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\27AUN1.SGM 27AUN1

Agencies

[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52752-52753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Synthetic Biology

AGENCY: Department of Health and Human Services, Office of Public 
Health and Science, The Presidential Commission for the Study of 
Bioethical Issues.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Presidential Commission for the Study of Bioethical Issues 
is requesting public comment on the emerging science of synthetic 
biology, including its potential applications and risks, as well as 
appropriate ethical boundaries to assure that America reaps the 
benefits of this new technology.

DATES: To assure consideration, comments must be received by October 1, 
2010.

ADDRESSES: Individuals, groups, and organizations interested in 
commenting on this topic may submit comments by e-mail to 
info@bioethics.gov or by mail to the following address: Public 
Commentary, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Ave., NW., Suite C-100, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: Ms. Diane M. Gianelli, Director of 
Communications, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Avenue, NW.,

[[Page 52753]]

Suite C-100, Washington, DC 20005. Telephone: 202/233-3960. E-mail: 
info@bioethics.gov. Additional information may be obtained by viewing 
the Web site: https://www.bioethics.gov.

SUPPLEMENTARY INFORMATION: On November 24, 2009, the President 
established the Presidential Commission for the Study of Bioethical 
Issues to advise him on bioethical issues generated by novel and 
emerging research in biomedicine and related areas of science and 
technology. The Commission is charged to identify and promote policies 
and practices that assure ethically responsible conduct of scientific 
research, healthcare delivery, and technological innovation. In 
undertaking these duties, the Commission will identify and examine 
specific bioethical, legal, and social issues related to potential 
scientific and technological advances; examine diverse perspectives and 
possibilities for dynamic international collaboration on these issues, 
and recommend legal, regulatory, or policy actions as appropriate.
    As its first order of business, the Commission has begun an inquiry 
into the emerging science of synthetic biology. The President asked the 
Commission to address this topic on May 20, 2010, following the 
announcement that the J. Craig Venter Institute had successfully 
engineered a synthetic cell--the insertion into a bacterium of a 
complete, functional genome synthesized entirely from a digitized 
sequence that replaced the native genome of the host over a series of 
replications. Daniel G. Gibson et al., Creation of a Bacterial Cell 
Controlled by a Chemically Synthesized Genome, Science Express (May 20, 
2010). The President charged the Commission to consider any potential 
medical, environmental, security, and other benefits, as well as any 
related risks. Additionally, the President asked the Commission to 
develop ``recommendations about any actions the Federal government 
should take to ensure that America reaps the benefits of this 
developing field of science while identifying appropriate ethical 
boundaries and minimizing identified risks.'' The Commission will 
report back its finding and recommendations later this year.
    To begin its work, the Commission convened a public meeting in 
Washington, DC on July 8-9, 2010. At that meeting, representatives with 
expertise in science, ethics, and public policy, as well as advocates 
with diverse perspectives on this new field provided information and 
insight to help guide the Commission in its thinking. Leading 
scientists in the field created context for the discussion by 
explaining the state of the science and discussing possible 
applications. Among the anticipated benefits discussed were employing 
bacterial cells as microscopic factories in the production of 
pharmaceuticals and biofuels.
    Additionally, with regard to potential risks, the Commission heard 
discussion about possible biosafety, biosecurity and environmental 
concerns, including risks that may arise as synthetic biology relies on 
organisms that can evolve and self-replicate, and existing practices to 
protect against these risks. The Commission also heard discussion about 
ethical boundaries and the views of faith communities.
    As the approaches to, and applications of, synthetic biology 
proliferate, the Commission wishes to develop a multifaceted 
understanding of its scientific and technological implications, and 
learn more about the views of the public on the existing or potential 
ethical and social ramifications. To this end, the Commission is 
inviting interested parties to provide input and advice through written 
comments. Among other issues, the Commission is interested in receiving 
comments on the potential benefits that the emerging field of synthetic 
biology is likely to yield, now or in the future, the risks that may 
arise, the ethical boundaries that should be considered, and policies 
and strategies to assure that the public will benefit from these new 
tools and products.
    Please address comments by e-mail to info@bioethics.gov, or by mail 
to the following address: Public Commentary, The Presidential 
Commission for the Study of Bioethical Issues, 1425 New York Ave., NW., 
Suite C-100, Washington, DC 20005. Comments will be publicly available, 
including any personally identifiable or confidential business 
information that they contain. Trade secrets should not be submitted.

    Dated: August 17, 2010.
Valerie H. Bonham,
Executive Director, The Presidential Commission for the Study of 
Bioethical Issues.
[FR Doc. 2010-21359 Filed 8-26-10; 8:45 am]
BILLING CODE 4154-06-P
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