Request for Comments on Ethical Issues Associated with the Development of Medical Countermeasures for Children, 38631-38632 [2012-15841]

Download as PDF Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices agenda for comments from the public. Alternatively, members of the public may send written comments to: Daniel Kirschner, Designated Federal Officer of the Committee at the address provided above. The meeting is open to the public and the site is fully accessible to people using wheelchairs or other mobility aids. Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to fcc504@fcc.gov or by calling the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). Such requests should include a detailed description of the accommodation needed. In addition, please include your contact information. Please allow at least five days advance notice; last minute requests will be accepted, but may be impossible to fill. Federal Communications Commission. Mark Stone, Deputy Chief, Consumer and Governmental Affairs Bureau. [FR Doc. 2012–15760 Filed 6–27–12; 8:45 am] BILLING CODE 6712–01–P FEDERAL COMMUNICATIONS COMMISSION Radio Broadcasting Services; AM or FM Proposals To Change the Community of License Federal Communications Commission. ACTION: Notice. AGENCY: The following applicants filed AM or FM proposals to change the community of license: AGNUS DEI COMMUNICATIONS, INC., Station NEW, Facility ID 190433, BNPH– 20120529AKN, From MISSION, SD, To MURDO, SD; ALEX MEDIA, INC., Station NEW, Facility ID 190402, BNPH–20120515ABA, From FRANKLIN, LA, To BELLE ROSE, LA; CBS RADIO STATIONS INC., Station WMSF, Facility ID 29567, BPH– 20120529AKO, From WEST PALM BEACH, FL, To MIRAMAR, FL; EDUCATIONAL MEDIA FOUNDATION, Station NEW, Facility ID 190375, BNPH–20120529ALF, From HOTCHKISS, CO, To COLONA, CO; E– STRING WIRELESS, LTD., Station KAGZ, Facility ID 164167, BPH– 20120521BEQ, From LUFKIN, TX, To BURKE, TX; KONA COAST RADIO, LLC, Station NEW, Facility ID 190386, BNPH–20120529AJH, From DUBOIS, ID, To SUGAR CITY, ID; KONA COAST srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:35 Jun 27, 2012 Jkt 226001 RADIO, LLC, Station NEW, Facility ID 190387, BNPH–20120529ALM, From MANILA, UT, To JAMES TOWN, WY; REDWOOD EMPIRE STEREOCASTERS, Station NEW, Facility ID 190436, BNPH–20120524AID, From CLOVERDALE, CA, To GUERNEVILLE, CA; ROY E. HENDERSON, Station KLTR, Facility ID 40775, BPH– 20120529ADI, From BRENHAM, TX, To HEMPSTEAD, TX; ROY E. HENDERSON, Station KTWL, Facility ID 21204, BPH–20120529ADK, From HEMPSTEAD, TX, To TODD MISSION, TX; SOUTHEASTERN OKLAHOMA RADIO, LLC, Station NEW, Facility ID 190388, BNPH–20120529AJN, From PITTSBURG, OK, To HARTSHORNE, OK; THRESHOLD COMMUNICATIONS, Station NEW, Facility ID 189494, BNPH–20110630AHJ, From CLATSKANIE, OR, To NAPAVINE, WA. DATES: The agency must receive comments on or before August 27, 2012. ADDRESSES: Federal Communications Commission, 445 Twelfth Street SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Tung Bui, 202–418–2700. SUPPLEMENTARY INFORMATION: The full text of these applications is available for inspection and copying during normal business hours in the Commission’s Reference Center, 445 12th Street SW., Washington, DC 20554 or electronically via the Media Bureau’s Consolidated Data Base System, https:// svartifoss2.fcc.gov/prod/cdbs/pubacc/ prod/cdbs_pa.htm. A copy of this application may also be purchased from the Commission’s duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room CY–B402, Washington, DC 20554, telephone 1– 800–378–3160 or www.BCPIWEB.com. Federal Communications Commission. James D. Bradshaw, Deputy Chief, Audio Division, Media Bureau. [FR Doc. 2012–15757 Filed 6–27–12; 8:45 am] BILLING CODE 6712–01–P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 38631 bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 23, 2012. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Heartland Bancorp, Inc., Bloomington, Illinois; to acquire Farmer City State Bank, Farmer City, Illinois. Board of Governors of the Federal Reserve System, June 25, 2012. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2012–15861 Filed 6–27–12; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on Ethical Issues Associated with the Development of Medical Countermeasures for Children Department of Health and Human Services, Office of the Secretary, 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 ethical issues associated with the development of medical countermeasures for children, including ethical considerations surrounding clinical research with children, ethical considerations surrounding pediatric medical countermeasure research, and ethical considerations surrounding emergency access to and use of medical countermeasures. SUMMARY: E:\FR\FM\28JNN1.SGM 28JNN1 38632 Federal Register / Vol. 77, No. 125 / Thursday, June 28, 2012 / Notices To ensure consideration, comments must be received by August 27, 2012. Comments received after this date will be considered only as time permits. ADDRESSES: Individuals, groups, and organizations interested in commenting on this topic may submit comments by email to info@bioethics.gov or by mail to the following address: Public Commentary, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue NW., Suite C–100, Washington, DC 20005. FOR FURTHER INFORMATION CONTACT: Hillary Wicai Viers, Communications Director, Presidential Commission for the Study of Bioethical Issues. Telephone: 202–233–3960. Email: hillary.viers@bioethics.gov. Additional information may be obtained at https:// www.bioethics.gov. SUPPLEMENTARY INFORMATION: On November 24, 2009, the President established the Presidential Commission for the Study of Bioethical Issues (the Commission) 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 ensure ethically responsible conduct of scientific research and healthcare delivery. Undertaking these duties, the Commission seeks to identify and examine specific bioethical, legal, and social issues related to potential scientific and technological advances; examine diverse perspectives and possibilities for international collaboration on these issues; and recommend legal, regulatory, or policy actions as appropriate. On January 6, 2012, HHS Secretary Kathleen Sebelius asked the Commission to ‘‘conduct a thorough review of the ethical considerations of conducting clinical trials of medical countermeasures in children,’’ including the ethical considerations of conducting a pre- and post-event pediatric study of Anthrax Vaccine Adsorbed (AVA) as a component of post-exposure prophylaxis, in order to address ‘‘how best to obtain clinical data on medical countermeasures in children.’’ Accordingly, the Commission is examining ethical issues surrounding the development of medical treatments to keep children safe in the event of a public health emergency. While significant progress has been made in the development of medical countermeasures for adults, the development of similar products for children has lagged, in part because of challenges in conducting safety and srobinson on DSK4SPTVN1PROD with NOTICES DATES: VerDate Mar<15>2010 16:35 Jun 27, 2012 Jkt 226001 immunogenicity studies. In the 2011 report, ‘‘Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis,’’ the National Biodefense Science Board recommended that the Department of Health and Human Services move forward with testing AVA before a public health emergency but only after the ethical considerations are adequately addressed and reviewed. The Commission is requesting public comment on the ethical issues associated with the development of medical countermeasures for children, including ethical considerations surrounding clinical research with children, ethical considerations surrounding pediatric medical countermeasure research, and ethical considerations surrounding emergency access to and use of medical countermeasures. To this end, the Commission is inviting interested parties to provide input and advice through written comments. The Commission is particularly interested in policies, practices, research, and perspectives on ethical issues associated with pre- and postevent studies testing the safety, dose, and/or immunogenicity of medical countermeasures for and with children. Among other issues, specifically: • How to conceptualize and consider risk and societal value when reviewing pediatric clinical research in general and for medical countermeasures in particular; • the types of information, data, or facts needed to ensure evidence-based decision-making for conducting pediatric medical countermeasure research; • possible criteria, if any, that might classify proposed studies testing medical countermeasures for pediatric use as minimal risk; • ethical issues related to access to and allocation of medical countermeasures previously studied within pediatric populations in a public health emergency; • scientific and public health strategies that could minimize the risk or ethical concerns associated with pediatric medical countermeasure research; • strategies for communicating risk to prospective participants and their families; and • the role communities play in the design and support of pediatric research and pediatric medical countermeasure research. Please address comments by email to info@bioethics.gov, or by mail to the following address: Public Commentary, PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue 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: June 15, 2012. Lisa M. Lee, Executive Director, Presidential Commission for the Study of Bioethical Issues. [FR Doc. 2012–15841 Filed 6–27–12; 8:45 am] BILLING CODE 4154–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Mona Thiruchelvam, Ph.D., University of Medicine and Dentistry of New Jersey: Based on the report of an investigation conducted by the University of Medicine and Dentistry of New Jersey (UMDNJ) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Mona Thiruchelvam, former Assistant Professor, Department of Environment and Occupational Health Science Institute (EOHSI), UMDNJ, engaged in research misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grants P30 ES05022, P30 ES01247, and R01 ES10791 and the intramural program at the National Institute on Drug Abuse (NIDA), NIH. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating cell count data that she claimed to have obtained through stereological methods in order to falsely report the effects of combined exposure of the pesticides paraquat and maneb on dopaminergic neuronal death and a neuroprotective role for estrogen in a murine model of Parkinson’s disease. The Respondent provided to the institution corrupted data files as the data for stereological cell counts of nigrostriatal neurons in brains of several mice and rats by copying a single data file from a previous experiment and renaming the copies to fit the description of 13 new experiments composed of 293 data files when SUMMARY: E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 77, Number 125 (Thursday, June 28, 2012)]
[Notices]
[Pages 38631-38632]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Ethical Issues Associated with the 
Development of Medical Countermeasures for Children

AGENCY: Department of Health and Human Services, Office of the 
Secretary, 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 ethical issues associated with the 
development of medical countermeasures for children, including ethical 
considerations surrounding clinical research with children, ethical 
considerations surrounding pediatric medical countermeasure research, 
and ethical considerations surrounding emergency access to and use of 
medical countermeasures.

[[Page 38632]]


DATES: To ensure consideration, comments must be received by August 27, 
2012. Comments received after this date will be considered only as time 
permits.

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

FOR FURTHER INFORMATION CONTACT: Hillary Wicai Viers, Communications 
Director, Presidential Commission for the Study of Bioethical Issues. 
Telephone: 202-233-3960. Email: hillary.viers@bioethics.gov. Additional 
information may be obtained at https://www.bioethics.gov.

SUPPLEMENTARY INFORMATION: On November 24, 2009, the President 
established the Presidential Commission for the Study of Bioethical 
Issues (the Commission) 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 ensure ethically responsible conduct of 
scientific research and healthcare delivery. Undertaking these duties, 
the Commission seeks to identify and examine specific bioethical, 
legal, and social issues related to potential scientific and 
technological advances; examine diverse perspectives and possibilities 
for international collaboration on these issues; and recommend legal, 
regulatory, or policy actions as appropriate.
    On January 6, 2012, HHS Secretary Kathleen Sebelius asked the 
Commission to ``conduct a thorough review of the ethical considerations 
of conducting clinical trials of medical countermeasures in children,'' 
including the ethical considerations of conducting a pre- and post-
event pediatric study of Anthrax Vaccine Adsorbed (AVA) as a component 
of post-exposure prophylaxis, in order to address ``how best to obtain 
clinical data on medical countermeasures in children.'' Accordingly, 
the Commission is examining ethical issues surrounding the development 
of medical treatments to keep children safe in the event of a public 
health emergency. While significant progress has been made in the 
development of medical countermeasures for adults, the development of 
similar products for children has lagged, in part because of challenges 
in conducting safety and immunogenicity studies. In the 2011 report, 
``Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the 
Pediatric Population as a Component of Post-Exposure Prophylaxis,'' the 
National Biodefense Science Board recommended that the Department of 
Health and Human Services move forward with testing AVA before a public 
health emergency but only after the ethical considerations are 
adequately addressed and reviewed.
    The Commission is requesting public comment on the ethical issues 
associated with the development of medical countermeasures for 
children, including ethical considerations surrounding clinical 
research with children, ethical considerations surrounding pediatric 
medical countermeasure research, and ethical considerations surrounding 
emergency access to and use of medical countermeasures. To this end, 
the Commission is inviting interested parties to provide input and 
advice through written comments.
    The Commission is particularly interested in policies, practices, 
research, and perspectives on ethical issues associated with pre- and 
post-event studies testing the safety, dose, and/or immunogenicity of 
medical countermeasures for and with children. Among other issues, 
specifically:
     How to conceptualize and consider risk and societal value 
when reviewing pediatric clinical research in general and for medical 
countermeasures in particular;
     the types of information, data, or facts needed to ensure 
evidence-based decision-making for conducting pediatric medical 
countermeasure research;
     possible criteria, if any, that might classify proposed 
studies testing medical countermeasures for pediatric use as minimal 
risk;
     ethical issues related to access to and allocation of 
medical countermeasures previously studied within pediatric populations 
in a public health emergency;
     scientific and public health strategies that could 
minimize the risk or ethical concerns associated with pediatric medical 
countermeasure research;
     strategies for communicating risk to prospective 
participants and their families; and
     the role communities play in the design and support of 
pediatric research and pediatric medical countermeasure research.
    Please address comments by email to info@bioethics.gov, or by mail 
to the following address: Public Commentary, Presidential Commission 
for the Study of Bioethical Issues, 1425 New York Avenue 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: June 15, 2012.
Lisa M. Lee,
Executive Director, Presidential Commission for the Study of Bioethical 
Issues.
[FR Doc. 2012-15841 Filed 6-27-12; 8:45 am]
BILLING CODE 4154-06-P
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