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Federal Register Summary for week of 23 July

    Agriculture

  • Solicitation of Letters of Interest to Participate in Biotechnology Quality Management System Program

    AGENCY: Animal and Plant Health Inspection Service, USDA.

    ACTION: Notice.


    SUMMARY: We are advising the public that the Animal and Plant Health Inspection Service (APHIS) is soliciting letters of interest to participate in the APHIS Biotechnology Quality Management System Program. The Biotechnology Quality Management System Program is a voluntary compliance assistance program designed to help regulated entities develop and implement sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered organisms in 7 CFR part 340.

    DATES: Letters of interest may be submitted at any time.

    FOR FURTHER INFORMATION CONTACT: Dr. Edward Jhee, Chief, Compliance Assistance Branch, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737-1236; (301) 734-6356, (edward.m.jhee@aphis.usda.gov).

    http://edocket.access.gpo.gov/2010/2010-17526.htm

  • Energy

  • Notice of Solicitation of Nominations for Appointment as a Member of the Biomass Research and Development Technical Advisory Committee; Correction

    AGENCY: Department of Energy.

    ACTION: Notice of solicitation of members; correction.


    SUMMARY: On July 15, 2010, the Department of Energy published a notice of solicitation of members (75 FR 41166). This document corrects that notice.

    FOR FURTHER INFORMATION CONTACT: Laura McCann, Designated Federal Official for the Committee, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585; (202) 586-7766; e-mail: laura.mccann@ee.doe.gov or Christina Fagerholm at (202) 586-2933; e-mail: christina.fagerholm@ee.doe.gov.

    In the Federal Register of July 15, 2010, in FR Doc. 2010-17285, on page 41167, please make the following correction:

    Under SUPPLEMENTARY INFORMATION, first column, the second to the last paragraph is corrected to read:

    "Nominations are open to all individuals without regard to race, color, religion, sex, national origin, age, mental or physical handicap, marital status, or sexual orientation. Please note, however, that registered lobbyists and individuals already serving on another Federal Advisory Committee are ineligible for nomination.''

    The deadline for Technical Advisory Committee member nominations is July 30, 2010.

    http://edocket.access.gpo.gov/2010/2010-18127.htm

  • Executive Office of the President

  • Executive Order 13547--Stewardship of the Ocean, Our Coasts, and the Great Lakes

    Executive Order 13547 of July 19, 2010

    Stewardship of the Ocean, Our Coasts, and the Great Lakes

    By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

    Section 1. Purpose. The ocean, our coasts, and the Great Lakes provide jobs, food, energy resources, ecological services, recreation, and tourism opportunities, and play critical roles in our Nation's transportation, economy, and trade, as well as the global mobility of our Armed Forces and the maintenance of international peace and security. The Deepwater Horizon oil spill in the Gulf of Mexico and resulting environmental crisis is a stark reminder of how vulnerable our marine environments are, and how much communities and the Nation rely on healthy and resilient ocean and coastal ecosystems. America's stewardship of the ocean, our coasts, and the Great Lakes is intrinsically linked to environmental sustainability, human health and well-being, national prosperity, adaptation to climate and other environmental changes, social justice, international diplomacy, and national and homeland security.

    This order adopts the recommendations of the Interagency Ocean Policy Task Force, except where otherwise provided in this order, and directs executive agencies to implement those recommendations under the guidance of a National Ocean Council. Based on those recommendations, this order establishes a national policy to ensure the protection, maintenance, and restoration of the health of ocean, coastal, and Great Lakes ecosystems and resources, enhance the sustainability of ocean and coastal economies, preserve our maritime heritage, support sustainable uses and access, provide for adaptive management to enhance our understanding of and capacity to respond to climate change and ocean acidification, and coordinate with our national security and foreign policy interests.

    This order also provides for the development of coastal and marine spatial plans that build upon and improve existing Federal, State, tribal, local, and regional decisionmaking and planning processes. These regional plans will enable a more integrated, comprehensive, ecosystem-based, flexible, and proactive approach to planning and managing sustainable multiple uses across sectors and improve the conservation of the ocean, our coasts, and the Great Lakes.

    Sec. 2. Policy. (a) To achieve an America whose stewardship ensures that the ocean, our coasts, and the Great Lakes are healthy and resilient, safe and productive, and understood and treasured so as to promote the well-being, prosperity, and security of present and future generations, it is the policy of the United States to:

    (i) protect, maintain, and restore the health and biological diversity of ocean, coastal, and Great Lakes ecosystems and resources;

    (ii) improve the resiliency of ocean, coastal, and Great Lakes ecosystems, communities, and economies;

    (iii) bolster the conservation and sustainable uses of land in ways that will improve the health of ocean, coastal, and Great Lakes ecosystems;

    (iv) use the best available science and knowledge to inform decisions affecting the ocean, our coasts, and the Great Lakes, and enhance humanity's capacity to understand, respond, and adapt to a changing global environment;

    (v) support sustainable, safe, secure, and productive access to, and uses of the ocean, our coasts, and the Great Lakes;

    (vi) respect and preserve our Nation's maritime heritage, including our social, cultural, recreational, and historical values;

    (vii) exercise rights and jurisdiction and perform duties in accordance with applicable international law, including respect for and preservation of navigational rights and freedoms, which are essential for the global economy and international peace and security;

    (viii) increase scientific understanding of ocean, coastal, and Great Lakes ecosystems as part of the global interconnected systems of air, land, ice, and water, including their relationships to humans and their activities;

    (ix) improve our understanding and awareness of changing environmental conditions, trends, and their causes, and of human activities taking place in ocean, coastal, and Great Lakes waters; and

    (x) foster a public understanding of the value of the ocean, our coasts, and the Great Lakes to build a foundation for improved stewardship.

    (b) The United States shall promote this policy by:

    (i) ensuring a comprehensive and collaborative framework for the stewardship of the ocean, our coasts, and the Great Lakes that facilitates cohesive actions across the Federal Government, as well as participation of State, tribal, and local authorities, regional governance structures, nongovernmental organizations, the public, and the private sector;

    (ii) cooperating and exercising leadership at the international level;

    (iii) pursuing the United States' accession to the Law of the Sea Convention; and

    (iv) supporting ocean stewardship in a fiscally responsible manner.

    Sec. 3. Definitions. As used in this order:

    (a) "Final Recommendations'' means the Final Recommendations of the Interagency Ocean Policy Task Force that shall be made publicly available and for which a notice of public availability shall be published in the Federal Register.

    (b) The term "coastal and marine spatial planning'' means a comprehensive, adaptive, integrated, ecosystem-based, and transparent spatial planning process, based on sound science, for analyzing current and anticipated uses of ocean, coastal, and Great Lakes areas. Coastal and marine spatial planning identifies areas most suitable for various types or classes of activities in order to reduce conflicts among uses, reduce environmental impacts, facilitate compatible uses, and preserve critical ecosystem services to meet economic, environmental, security, and social objectives. In practical terms, coastal and marine spatial planning provides a public policy process for society to better determine how the ocean, our coasts, and Great Lakes are sustainably used and protected--now and for future generations.

    (c) The term "coastal and marine spatial plans'' means the plans that are certified by the National Ocean Council as developed in accordance with the definition, goals, principles, and process described in the Final Recommendations.

    Sec. 4. Establishment of National Ocean Council. (a) There is hereby established the National Ocean Council (Council).

    (b) The Council shall consist of the following:

    (i) the Chair of the Council on Environmental Quality and the Director of the Office of Science and Technology Policy, who shall be the Co-Chairs of the Council;

    (ii) the Secretaries of State, Defense, the Interior, Agriculture, Health and Human Services, Commerce, Labor, Transportation, Energy, and Homeland Security, the Attorney General, the Administrator of the Environmental Protection Agency, the Director of the Office of Management and Budget, the Under Secretary of Commerce for Oceans and Atmosphere (Administrator of the National Oceanic and Atmospheric Administration), the Administrator of the National Aeronautics and Space Administration, the Director of National Intelligence, the Director of the National Science Foundation, and the Chairman of the Joint Chiefs of Staff;

    (iii) the National Security Advisor and the Assistants to the President for Homeland Security and Counterterrorism, Domestic Policy, Energy and Climate Change, and Economic Policy;

    (iv) an employee of the Federal Government designated by the Vice President; and

    (v) such other officers or employees of the Federal Government as the Co- Chairs of the Council may from time to time designate.

    (c) The Co-Chairs shall invite the participation of the Chairman of the Federal Energy Regulatory Commission, to the extent consistent with the Commission's statutory authorities and legal obligations, and may invite the participation of such other independent agencies as the Council deems appropriate.

    (d) The Co-Chairs of the Council, in consultation with the National Security Advisor and the Assistant to the President for Homeland Security and Counterterrorism, shall regularly convene and preside at meetings of the Council, determine its agenda, direct its work, and, as appropriate to address particular subject matters, establish and direct committees of the Council that shall consist exclusively of members of the Council.

    (e) A member of the Council may designate, to perform committee functions of the member, any person who is within such member's department, agency, or office and who is (i) an officer of the United States appointed by the President, (ii) a member of the Senior Executive Service or the Senior Intelligence Service, (iii) a general officer or flag officer, or (iv) an employee of the Vice President.

    (f) Consistent with applicable law and subject to the availability of appropriations, the Office of Science and Technology Policy and the Council on Environmental Quality shall provide the Council with funding, including through the National Science and Technology Council or the Office of Environmental Quality. The Council on Environmental Quality shall, to the extent permitted by law and subject to the availability of appropriations, provide administrative support necessary to implement this order.

    (g) The day-to-day operations of the Council shall be administered by a Director and a Deputy Director, who shall supervise a full-time staff to assist the Co- Chairs in their implementation of this order.

    Sec. 5. Functions of the Council. (a) The Council shall have the structure and function and operate as defined in the Final Recommendations. The Council is authorized, after the Council's first year of operation, to make modifications to its structure, function, and operations to improve its effectiveness and efficiency in furthering the policy set forth in section 2 of this order.

    (b) To implement the policy set forth in section 2 of this order, the Council shall provide appropriate direction to ensure that executive departments', agencies', or offices' decisions and actions affecting the ocean, our coasts, and the Great Lakes will be guided by the stewardship principles and national priority objectives set forth in the Final Recommendations, to the extent consistent with applicable law. The Council shall base its decisions on the consensus of its members. With respect to those matters in which consensus cannot be reached, the National Security Advisor shall coordinate with the Co- Chairs and, as appropriate, the Assistants to the President for Energy and Climate Change, and Economic Policy, and the employee of the United States designated by the Vice President, subject to the limitations set forth in section 9 of this order, to present the disputed issue or issues for decision by the President.

    Sec. 6. Agency Responsibilities. (a) All executive departments, agencies, and offices that are members of the Council and any other executive department, agency, or office whose actions affect the ocean, our coasts, and the Great Lakes shall, to the fullest extent consistent with applicable law:

    (i) take such action as necessary to implement the policy set forth in section 2 of this order and the stewardship principles and national priority objectives as set forth in the Final Recommendations and subsequent guidance from the Council; and

    (ii) participate in the process for coastal and marine spatial planning and comply with Council certified coastal and marine spatial plans, as described in the Final Recommendations and subsequent guidance from the Council.

    (b) Each executive department, agency, and office that is required to take actions under this order shall prepare and make publicly available an annual report including a concise description of actions taken by the agency in the previous calendar year to implement the order, a description of written comments by persons or organizations regarding the agency's compliance with this order, and the agency's response to such comments.

    (c) Each executive department, agency, and office that is required to take actions under this order shall coordinate and contribute resources, as appropriate, to assist in establishing a common information management system as defined in the Final Recommendations and shall be held accountable for managing its own information assets by keeping them current, easily accessible, and consistent with Federal standards.

    (d) To the extent permitted by law, executive departments, agencies, and offices shall provide the Council such information, support, and assistance as the Council, through the Co-Chairs, may request.

    Sec. 7. Governance Coordinating Committee. The Council shall establish a Governance Coordinating Committee that shall consist of 18 officials from State, tribal, and local governments in accordance with the Final Recommendations. The Committee may establish subcommittees chaired by representatives of the Governance Coordinating Committee. These subcommittees may include additional representatives from State, tribal, and local governments, as appropriate to provide for greater collaboration and diversity of views.

    Sec. 8. Regional Advisory Committees. The lead Federal department, agency, or office for each regional planning body established for the development of regional coastal and marine spatial plans, in consultation with their nonfederal co-lead agencies and membership of their regional planning body, shall establish such advisory committees under the Federal Advisory Committee Act, 5 U.S.C. App., as they deem necessary to provide information and to advise the regional planning body on the development of regional coastal and marine spatial plans to promote the policy established in section 2 of this order.

    Sec. 9. General Provisions. (a) Nothing in this order, the establishment of the Council, and the Final Recommendations shall be construed to impair or otherwise affect:

    (i) authority granted by law to an executive department or agency or the head thereof; or

    (ii) functions assigned by the President to the National Security Council or Homeland Security Council (including subordinate bodies) relating to matters affecting foreign affairs, national security, homeland security, or intelligence.

    (b) Nothing in this order shall be construed to impair or otherwise affect the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

    (c) In carrying out the provisions of this order and implementing the Final Recommendations, all actions of the Council and the executive departments, agencies, and offices that constitute it shall be consistent with applicable international law, including customary international law, such as that reflected in the Law of the Sea Convention.

    (d) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

    Sec. 10. Revocation. Executive Order 13366 of December 17, 2004, is hereby revoked.

    (Presidential Sig.)

    THE WHITE HOUSE,

    July 19, 2010.

    http://edocket.access.gpo.gov/2010/2010-18169.htm

  • Health and Human Services

  • Office of Biotechnology Activities; Recombinant DNA Research: Proposed Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)

    AGENCY: National Institutes of Health (NIH), PHS, DHHS.

    ACTION: Notice of proposed action under the NIH Guidelines.


    SUMMARY: Under the NIH Guidelines, experiments involving the generation of transgenic rodents by recombinant DNA technology must be registered with the Institutional Biosafety Committee (IBC). Specifically, Section III-E-3 of the NIH Guidelines addresses the generation of transgenic rodents that may be housed under biosafety level (BL) 1 conditions and allows the work to proceed simultaneously with registration of the experiment with the IBC. The IBC must then review and approve the experiment. The NIH Guidelines address two pathways for "generation of a transgenic rodent'': altering the animal's genome using recombinant DNA technology or breeding one or more transgenic rodents to create a new transgenic rodent (i.e., breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent).

    The NIH Office of Biotechnology Activities (OBA) received a request that the breeding of well-characterized transgenic rodents that can be maintained under BL1 conditions be exempt from the NIH Guidelines. The rationale is that these experiments pose little if any biosafety risk and therefore the requirement for registration with the IBC may impose an administrative burden without enhancing the safe conduct of this research. In response to this request, OBA brought a proposal to amend the NIH Guidelines to the Recombinant DNA Advisory Committee (RAC) for consideration. The initial proposal was discussed at the March 11, 2010 RAC meeting and a revised proposal was discussed at the June 16, 2010 RAC meeting (Webcasts of these discussions are available at http://oba.od.nih.gov/rdnarac/racmeetings.html). The RAC endorsed a proposal that would exempt from the NIH Guidelines the breeding of almost all transgenic rodents that can be housed at BL1, with the exception of rodents that contain a gene encoding more than fifty percent of an exogenous eukaryotic virus and transgenic rodents in which the transgene is under the control of a gammaretroviral promoter. This notice seeks public comment on this proposal.

    DATES: The public is encouraged to submit written comments on these proposed changes. Comments may be submitted to the OBA in paper or electronic form at the OBA mailing, fax, and e-mail addresses shown below under the heading FOR FURTHER INFORMATION CONTACT. All comments received by September 1, 2010 will be considered. All written comments received in response to this notice will be available for public inspection in the NIH OBA office, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, MD 20892-7985, (Phone: 301-496-9838) weekdays between the hours of 8:30 a.m. and 5 p.m.

    FOR FURTHER INFORMATION CONTACT: If you have questions, or require additional information about these proposed changes, please contact OBA by e-mail at oba@od.nih.gov, or telephone at 301-496-9838. Comments can be submitted to the same email address or by fax to 301-496-9839 or mail to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, Maryland 20892-7985.

    Background: Section III-E of the NIH Guidelines addresses experiments for which IBC notification is required at the time the research is initiated. Experiments covered in this section of the NIH Guidelines are considered to be of low biosafety risk and therefore although IBC review and approval is still required, such approval need not be obtained prior to initiating research. This is in contrast to all other covered experiments described in the NIH Guidelines for which IBC review and approval is required prior to initiation of the experiment.

    Under the NIH Guidelines, certain experiments can be exempted from the NIH Guidelines if they do not present a significant risk to public health or the environment (Section III-F-6). These exemptions are delineated in Appendix C of the NIH Guidelines. OBA was recently approached regarding the Section III-E-3 requirement to register the breeding of transgenic rodents and whether such experiments met the criteria for exemption under Section III-F-6. OBA sought the advice of the RAC on this issue.

    Currently, the purchase or transfer of transgenic rodents that require BL1 containment are exempt from the NIH Guidelines. This proposal would extend that exemption to almost all experiments that involve the generation of transgenic rodents by breeding, as long as the transgenic rodents are appropriate to be maintained under BL1 conditions. The rationale is that three decades of experience working with and breeding transgenic rodents has demonstrated that the overwhelming majority of experiments involving breeding of transgenic rodents that can be housed under BL1 conditions result in a rodent that can be appropriately housed under BL1 conditions. These breeding experiments do not pose an appreciable risk to human health or to the environment. In addition, while the registration with the IBC is not a significant burden, the total number of registrations required constitutes a significant collective administrative burden on the IBC and researchers that does not appear to be commensurate with the very low biosafety risk.

    There are still some breeding experiments for which IBC registration would be required in order to ensure that a risk assessment is conducted and that the resulting rodent is disposed of appropriately. The proposed exemption would retain the requirement to register with the IBC when the genome of one of the parental transgenic rodents contains more than 50 percent of the genome of an exogenous, eukaryotic virus from a single family or if the transgenic rodent's transgene is under the control of a gammaretroviral long terminal repeat (LTR). The restriction regarding exogenous eukaryotic viruses is designed to prevent inadvertent reconstitution of an exogenous virus in the resultant transgenic mouse. The restriction regarding transgenes under control of a gammaretroviral long terminal repeat addresses the small risk of recombination with endogenous retroviruses which could potentially result in mobilization of the transgene via a replication- competent mouse retrovirus. As the risk of recombination and possible transmission to humans is more likely with gammaretroviral LTRs (e.g., MLV, XMRV, FeLV), the requirement for registration is limited to rodents containing a transgene under control of these LTRs.

    Specifically, the following changes are proposed to Appendix C of the NIH Guidelines:

    Appendix C-VII. Generation of BL1 Transgenic Rodents via Breeding

    The breeding of two different transgenic rodents or the breeding of a transgenic rodent with a non-transgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment will be exempt from the NIH Guidelines if:

    Both parental rodents can be housed under BL1 containment, and neither parental transgenic rodent contains the following genetic modifications:

    (a) More than one-half of the genome of an exogenous virus from a single Family of viruses; or

    (b) A transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and

    It is anticipated that the transgenic rodent that results from this breeding:

    (a) Will contain no more than one-half of an exogenous viral genome from a single Family of viruses.

    The current Appendix C-VII and Appendices C-VII-A through C-VII-E would be renumbered to Appendix C-VIII and Appendices C-VIII-A though C-VIII-E, respectively.

    For clarity the following will be added to Section III-E-3.

    Section III-E-3-a. Experiments involving the breeding of certain BL1 transgenic rodents are exempt under Section III-F, Exempt Experiments (See Appendix C-VII, Generation of BL1 Transgenic Rodents via Breeding).

    http://edocket.access.gpo.gov/2010/2010-17668.htm

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List

    AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION: Advance notice of proposed rulemaking and request for comments.


    SUMMARY: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a) (the Bioterrorism Act) requires the biennial review and republication of the HHS list of select agents and toxins. Accordingly, we are soliciting public comment on the current HHS list of select agents and toxins, including whether any biological agent or toxin should be added to or removed from the list. We are also seeking comments as to whether we should "tier'' the HHS select agent list based on the relative bioterrorism risk of each agent or toxin and possibly further "stratify'' the security requirements for agents in the highest tier based on type of use or other factors.

    DATES: We will consider all comments received on or before August 20, 2010.

    ADDRESSES: Comments in response to this notice should be marked "Comments on the changes to the list of select agents and toxins'' and mailed to: Centers for Disease Control and Prevention, Division of Select Agents and Toxins, 1600 Clifton Road, MS A-46, Atlanta, GA 30333. Comments may be e-mailed to: SAPcomments@cdc.gov.

    FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Rd., MS A-46, Atlanta, GA 30333. Telephone: (404) 718- 2000.

    http://edocket.access.gpo.gov/2010/2010-17728.htm

  • Request for Information on Development of an Inventory of Comparative Effectiveness Research

    AGENCY: Office of the Assistant Secretary for Planning and Evaluation.

    ACTION: Request for Information.


    SUMMARY: The Office of the Assistant Secretary for Planning Evaluation (ASPE) is developing a national inventory of comparative effectiveness research (CER) and CER-related information. This initiative is driven by the American Recovery and Reinvestment Act of 2009 (ARRA) which provided $1.1 billion for research and development in the area of CER. ARRA allocated $400 million to the Office of the Secretary (OS) in the U.S. Department of Health and Human Services (HHS), $400 million to the National Institutes of Health (NIH), and $300 million to the Agency for Healthcare Research and Quality. ARRA also established the Federal Coordinating Council for CER, which, after significant public input, developed a strategic framework and recommended high-level priorities for OS funds. While the FCC's Report to Congress drew on an initial CER inventory focused on federal investments, the process of cataloguing CER activities and infrastructure will be critical to tracking ongoing and future investments in CER. An important component of this effort is creating an inventory of CER to ensure that patients, clinicians, and other decision makers can identify and locate relevant CER in a timely manner.

    ASPE seeks input on approaches to developing a CER Inventory that capture ongoing and existing CER in the United States. This inventory will be accessible to the public, including patients, clinicians, and policymakers, through a web-based system. Comments should focus on appropriate resources and approaches for developing the CER Inventory, rather than the methodology of CER or suggestions for particular CER studies that should be included in the CER Inventory. Requested information includes suggestions regarding sources of CER and ways to encourage participation in the inventory; comments related to categorizing content; and approaches to ensure the CER Inventory is useful and sustainable over time.

    DATES: Submit comments by 11:59 p.m. Eastern Time on August 9, 2010.

    ADDRESSES: Written or electronic comments should be submitted to HHS as directed below.

    Comments should be identified by referring to the "CER Inventory'', and may be submitted to the Department of HHS by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Written comments (one original and two copies) may be mailed to: Department of Health and Human Services, Attention: CER Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence Avenue, SW., Washington, DC 20201.

    Hand or courier delivery: Comments may be delivered to Room 447-D, Department of Health and Human Services, Attention: CER Inventory, Hubert H. Humphrey Building, Room 447-D, 200 Independence Avenue, SW., and Washington, DC 20201. Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CER Inventory drop box located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain proof of filing by stamping in and retaining an extra copy of the comments being filed.

    Written submissions should be brief (no more than three pages per submission), and should be in the form of a letter. Please do not submit duplicate comments. Please do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. Consequently, comments should not include any sensitive health information from medical records or other individually identifiable health information, or any non-public, corporate or trade association information, such as trade secrets or other proprietary information. Comments may be submitted anonymously.

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. All comments will be made available publicly on the internet at http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

    FOR FURTHER INFORMATION CONTACT: Pierre Yong, Office of the Assistant Secretary for Planning and Evaluation, Department of Health and Human Services, (202) 690-8384, Pierre.Yong@hhs.gov.

    http://edocket.access.gpo.gov/2010/2010-17244.htm

  • Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors

    AGENCY: Department of Health and Human Services.

    ACTION: Proposed rule; extension of comment period; request for comments.


    SUMMARY: The Department of Health and Human Services (HHS or the Department), including the HHS Public Health Service (PHS), is extending the comment period for a proposed rule that would amend the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors, and is clarifying certain elements of the proposed rule for which we are seeking additional comment. The proposed rule was published in the Federal Register on May 21, 2010 (75 FR 28688). The comment period is extended by 30 days and thus will end on August 19, 2010.

    DATES: Comments must be received on or before August 19, 2010 in order to ensure we will be able to consider the comments when preparing the final rule.

    ADDRESSES: Individuals, organizations and institutions interested in submitting comments identified by RIN 0925-AA53 and Docket Number [NIH- 2010-0001] may do so by any of the following methods:

    Electronic Submissions

    You may submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    To ensure timely processing of comments, NIH is no longer accepting comments submitted to the agency by e-mail.

    Written Submissions

    You may submit written comments in the following ways:

    Fax: 301-402-0169.

    Mail: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669.

    Hand Delivery/Courier (for paper, disk, or CD-ROM submissions). Attention: Jerry Moore, 6011 Executive Boulevard, Suite 601, Rockville, MD 20852-7669.

    Instructions: All submissions received must include the agency name and Regulatory Information Number (RIN) [0925-AA53] and docket number [NIH-2010-0001] for this rulemaking action. All comments may be posted without change, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received concerning this rulemaking action, go to the eRulemaking.gov Portal: http://www.regulations.gov and follow the instructions provided for conducting a search, using the docket number [NIH-2010-0001].

    FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, Office of Management Assessment, National Institutes of Health, 6011 Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20852-7669, telephone 301-496-4607, fax 301-402-0169, e-mail jm40z@nih.gov, concerning questions about the rulemaking process and Dr. Sally Rockey, NIH Deputy Director for Extramural Research, concerning substantive questions about the proposed rule, e-mail FCOI-NPRM@mail.nih.gov.

    http://edocket.access.gpo.gov/2010/2010-17739.htm

  • Interior

  • 60-Day Notice of Intention To Request Clearance of Collection of Information; Opportunity for Public Comment

    AGENCY: National Park Service, Department of the Interior.

    ACTION: Notice and request for comments.


    SUMMARY: Under the provisions of the Paperwork Reduction Act of 1995 and 5 CFR Part 1320, Reporting and Record Keeping Requirements, the National Park Service (NPS) invites public comments on an extension of a currently approved information collection Office of Management and Budget (OMB) 1024-0236.

    DATES: Public comments on this Information Collection Request (ICR) will be accepted on or before September 20, 2010.

    ADDRESSES: Send comments to: Dr. John G. Dennis, Natural Resources (Room 1160), NPS, 1201 Eye Street, NW., Washington, DC 20005; Phone: 202-513-7174; fax: 202-371-2131; e-mail WASONRSSresearchcoll@nps.gov. All responses to this notice will be summarized and included in the request for the Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

    FOR FURTHER INFORMATION CONTACT: Bill Commins, Natural Resources (Room 1125), 1201 Eye St., NW., Washington, DC 20005. Phone 202-513-7166; Fax: 202-371-2131; E-mail: bill_commins@nps.gov. You may obtain additional information about the application and manual reporting forms and existing guidance and explanatory material from the NPS Research Permit and Reporting System Web site at: https://science.nature.nps.gov/research.

    http://edocket.access.gpo.gov/2010/2010-17823.htm