Request for Comments on Human Subjects Protections in Scientific Studies, 11482-11483 [2011-4658]

Download as PDF emcdonald on DSK2BSOYB1PROD with NOTICES 11482 Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices General description of report: This information collection is mandatory (12 U.S.C. 1844(c)). Confidential treatment is not routinely given to the data in these reports. However, confidential treatment for the reporting information, in whole or in part, can be requested in accordance with the instructions to the form, pursuant to sections (b)(4), (b)(6), and (b)(8) of the Freedom of Information Act [5 U.S.C. 522(b)(4)]. Abstract: The FR Y–11S is an abbreviated reporting form that collects four data items: Net income, total assets, equity capital, and total off-balancesheet data items. The FR Y–11S is filed annually, as of December 31, by top-tier BHCs for each individual nonbank subsidiary (that does not meet the criteria for filing the detailed report) with total assets of at least $50 million, but less than $250 million, or with total assets greater than 1 percent of the total consolidated assets of the top-tier organization. Current actions: On November 3, 2010, the Federal Reserve published a notice in the Federal Register (75 FR 67721) requesting public comment for 60 days on the extension, without revision, of the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Bank Holding Companies. The comment period expired on January 3, 2011. The Federal Reserve did not receive any comment letters. 3. Report title: Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations. Agency form number: FR 2314S. OMB control number: 7100–0073. Frequency: Annually. Reporters: U.S. state member banks, BHCs, and Edge or agreement corporations. Annual reporting hours: 787. Estimated average hours per response: 1.0. Number of respondents: 787. General description of report: This information collection is mandatory (12 U.S.C. 324, 602, 625, and 1844(c)). Confidential treatment is not routinely given to the data in these reports. However, confidential treatment for the reporting information, in whole or in part, can be requested in accordance with the instructions to the form, pursuant to sections (b)(4), (b)(6) and (b)(8) of the Freedom of Information Act [5 U.S.C. 522(b)(4), (b)(6) and (b)(8)]. Abstract: The FR 2314S is an abbreviated reporting form that collects four data items: Net income, total assets, equity capital, and total off-balancesheet data items. The FR 2314S is filed annually, as of December 31, for each individual subsidiary (that does not VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 meet the criteria for filing the detailed report) with assets of at least $50 million but less than $250 million, or with total assets greater than 1 percent of the total consolidated assets of the top-tier organization. Current actions: On November 3, 2010, the Federal Reserve published a notice in the Federal Register (75 FR 67721) requesting public comment for 60 days on the extension, without revision, of the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations. The comment period expired on January 3, 2011. The Federal Reserve did not receive any comment letters. 4. Report title: Financial Reports of Foreign Banking Organizations. Agency form number: FR Y–7NS, FR Y–7Q. OMB control number: 7100–0125. Frequency: Annually and quarterly. Reporters: Foreign banking organizations. Annual reporting hours: FR Y–7NS: 237; FR Y–7Q (quarterly): 340; FR Y–7Q (annual): 111. Estimated average hours per response: FR Y–7NS: 1.0; FR Y–7Q (quarterly): 1.25; FR Y–7Q (annual): 1.0. Number of respondents: FR Y–7NS: 237; FR Y–7Q (quarterly): 68; FR Y–7Q (annual): 111. General description of report: This information collection is mandatory (12 U.S.C. 1844(c), 3106(c), and 3108). Confidential treatment is not routinely given to the data in these reports. However, confidential treatment for information, in whole or in part, on any of the reporting forms can be requested in accordance with the instructions to the form, pursuant to sections (b)(4) and (b)(6) of the Freedom of Information Act [5 U.S.C. 522(b)(4) and (b)(6)]. Abstract: The FR Y–7NS collect financial information for nonfunctionally regulated U.S. nonbank subsidiaries held by FBOs other than through a U.S. BHC, U.S. FHC, or U.S. bank. The FR Y–7NS is filed annually, as of December 31, by top-tier FBOs for each individual nonbank subsidiary (that does not meet the filing criteria for filing the detailed report) with total assets of at least $50 million, but less than $250 million. The FR Y–7Q collects consolidated regulatory capital information from all FBOs either quarterly or annually. FBOs that have effectively elected to become FHCs file the FR Y–7Q quarterly. All other FBOs (those that have not elected to become FHCs) file the FR Y–7Q annually. Current actions: On November 3, 2010, the Federal Reserve published a notice in the Federal Register (75 FR 67721) requesting public comment for PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 60 days on the extension, without revision, of the Financial Reports of Foreign Banking Organizations. The comment period expired on January 3, 2011. The Federal Reserve did not receive any comment letters. Board of Governors of the Federal Reserve System, February 24, 2011. Jennifer J. Johnson, Secretary of the Board. [FR Doc. 2011–4568 Filed 3–1–11; 8:45 am] BILLING CODE 6210–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Comments on Human Subjects Protections in Scientific Studies The Presidential Commission for the Study of Bioethical Issues, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. DATES: To assure consideration, comments must be received by May 2, 2011. 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: Hillary Wicai Viers, Communications Director, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., Suite C–100, Washington, DC 20005. Telephone: 202–233–3963. E-mail: 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 (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 assure ethically responsible conduct of scientific research, healthcare delivery, SUMMARY: E:\FR\FM\02MRN1.SGM 02MRN1 emcdonald on DSK2BSOYB1PROD with NOTICES Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices and technological innovation. In 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. The Commission has begun a review of the current rules and standards for protecting human subjects in scientific studies supported by the Federal Government. The President requested this study on November 24, 2010, following revelations that the U.S. Public Health Service supported research on sexually transmitted diseases in Guatemala from 1946 to 1948 involving the intentional infection of vulnerable populations. President Obama asked the Commission Chair ‘‘to convene a panel to conduct * * * a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and wellbeing of participants in scientific studies supported by the Federal Government.’’ The President charged the Commission to seek the insights and perspective of international experts and consult with counterparts in the global community. The Commission will provide the President with a report of its findings and recommendations later this year. To implement this mission, the Commission wishes to develop a thorough understanding of the current U.S. and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. 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 existing standards for protecting human subjects, both domestically and internationally; how the current system of global research works in practice; and the ethical and social justice issues that emerge from the current research system. Comments concerning the benefits of medical research; differences across global norms and standards; standards for ancillary care and posttrial access to treatment; trial design; duties to participants; challenges, if any, faced by U.S.-funded researchers working internationally, or international researchers collaborating on U.S.funded research; and other specific information are all especially welcome. VerDate Mar<15>2010 16:34 Mar 01, 2011 Jkt 223001 11483 reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the ABRWH to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2011. Purpose: The ABRWH is charged with Dated: February 17, 2011. (a) Providing advice to the Secretary, Valerie H. Bonham, HHS, on the development of guidelines Executive Director, The Presidential under Executive Order 13179; (b) Commission for the Study of Bioethical Issues. providing advice to the Secretary, HHS, [FR Doc. 2011–4658 Filed 3–1–11; 8:45 am] on the scientific validity and quality of BILLING CODE 4154–06–P dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advising the DEPARTMENT OF HEALTH AND Secretary on whether there is a class of HUMAN SERVICES employees at any Department of Energy facility who were exposed to radiation Centers for Disease Control and but for whom it is not feasible to Prevention estimate their radiation dose, and on whether there is a reasonable likelihood Subcommittee on Procedures Review, that such radiation doses may have Advisory Board on Radiation and endangered the health of members of Worker Health (ABRWH), National this class. The Subcommittee on Institute for Occupational Safety and Procedures Review was established to Health (NIOSH) aid the ABRWH in carrying out its duty In accordance with section 10(a)(2) of to advise the Secretary, HHS, on dose the Federal Advisory Committee Act reconstructions. The Subcommittee on (Pub. L. 92–463), the Centers for Disease Procedures Review is responsible for Control and Prevention (CDC) overseeing, tracking, and participating announces the following meeting for the in the reviews of all procedures used in the dose reconstruction process by the aforementioned subcommittee: Time and Date: 9 a.m.–5 p.m., March NIOSH Division of Compensation 22, 2011. Analysis and Support (DCAS) and its Place: Cincinnati Airport Marriott, dose reconstruction contractor. 2395 Progress Drive, Hebron, KY 41018. Matters to be Discussed: The agenda Telephone (859) 334–4611, Fax (859) for the Subcommittee meeting includes discussion of the following ORAU and 334–4619. Status: Open to the public, but OCAS procedures: ORAUT–RPRT–0044 without a public comment period. To (‘‘Analysis of Bioassay Data with a access by conference call dial the Significant Fraction of Less-Than following information: (866) 659–0537, Results’’), OCAS TIB–0013 (‘‘Special Participant Pass Code 9933701. External Dose Reconstruction Background: The ABRWH was Considerations for Mallinckrodt established under the Energy Employees Workers’’), OTIB–014 (‘‘Rocky Flats Occupational Illness Compensation Internal Dosimetry Co-Worker Program Act of 2000 to advise the Extension’’), OTIB–019 (‘‘Analysis of President on a variety of policy and Coworker Bioassay Data for Internal technical functions required to Dose Assignment’’), OTIB–0029 implement and effectively manage the (‘‘Internal Dosimetry Coworker Data for compensation program. Key functions of Y–12’’), OTIB–0047 (‘‘External Radiation Monitoring at the Y–12 Facility During the ABRWH include providing advice the 1948–1949 Period’’), OTIB–0049 on the development of probability of (‘‘Estimating Doses for Plutonium causation guidelines that have been Strongly Retained in the Lung’’), OTIB– promulgated by the Department of 0052 (‘‘Parameters to Consider When Health and Human Services (HHS) as a Processing Claims for Construction final rule; advice on methods of dose Trade Workers’’), OTIB–0054 (‘‘Fission reconstruction which have also been and Activation Product Assignment for promulgated by HHS as a final rule; Internal Dose-Related Gross Beta and advice on the scientific validity and Gross Gamma Analyses’’), and OTIB– quality of dose estimation and The Commission is under a very tight deadline and would appreciate comments within 60 days. 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. PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11482-11483]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Comments on Human Subjects Protections in Scientific 
Studies

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

ACTION: Notice.

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

SUMMARY: The Presidential Commission for the Study of Bioethical Issues 
is requesting public comment on the Federal and international standards 
for protecting the health and well-being of participants in scientific 
studies supported by the Federal Government.

DATES: To assure consideration, comments must be received by May 2, 
2011.

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: Hillary Wicai Viers, Communications 
Director, The Presidential Commission for the Study of Bioethical 
Issues, 1425 New York Avenue, NW., Suite C-100, Washington, DC 20005. 
Telephone: 202-233-3963. E-mail: 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 (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 assure ethically responsible conduct of 
scientific research, healthcare delivery,

[[Page 11483]]

and technological innovation. In 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.
    The Commission has begun a review of the current rules and 
standards for protecting human subjects in scientific studies supported 
by the Federal Government. The President requested this study on 
November 24, 2010, following revelations that the U.S. Public Health 
Service supported research on sexually transmitted diseases in 
Guatemala from 1946 to 1948 involving the intentional infection of 
vulnerable populations. President Obama asked the Commission Chair ``to 
convene a panel to conduct * * * a thorough review of human subjects 
protection to determine if Federal regulations and international 
standards adequately guard the health and well-being of participants in 
scientific studies supported by the Federal Government.''
    The President charged the Commission to seek the insights and 
perspective of international experts and consult with counterparts in 
the global community. The Commission will provide the President with a 
report of its findings and recommendations later this year.
    To implement this mission, the Commission wishes to develop a 
thorough understanding of the current U.S. and international standards 
for protecting the health and well-being of participants in scientific 
studies supported by the Federal Government. 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 existing standards for 
protecting human subjects, both domestically and internationally; how 
the current system of global research works in practice; and the 
ethical and social justice issues that emerge from the current research 
system. Comments concerning the benefits of medical research; 
differences across global norms and standards; standards for ancillary 
care and post-trial access to treatment; trial design; duties to 
participants; challenges, if any, faced by U.S.-funded researchers 
working internationally, or international researchers collaborating on 
U.S.-funded research; and other specific information are all especially 
welcome. The Commission is under a very tight deadline and would 
appreciate comments within 60 days.
    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: February 17, 2011.
Valerie H. Bonham,
Executive Director, The Presidential Commission for the Study of 
Bioethical Issues.
[FR Doc. 2011-4658 Filed 3-1-11; 8:45 am]
BILLING CODE 4154-06-P

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