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Federal Register Summary for week of 1 July

    Agriculture

  • Competitive and Noncompetitive Nonformula Federal Assistance Programs--Administrative Provisions for Biomass Research and Development Initiative; Technical Amendments

    AGENCY: National Institute of Food and Agriculture, USDA.

    ACTION: Final rule; technical amendments.


    SUMMARY: The National Institute of Food and Agriculture (NIFA) published in the Federal Register of June 17, 2011, a document adopting as final an interim rule published June 14, 2010, which contained a set of specific administrative requirements for the Biomass Research and Development Initiative (BRDI). This document contains minor changes to those regulations.

    DATES: Effective on July 1, 2011.

    FOR FURTHER INFORMATION CONTACT: Carmela Bailey, National Program Leader, Plant and Animal Systems, National Institute of Food and Agriculture, U.S. Department of Agriculture, STOP 3356, 1400 Independence Avenue, SW., Washington, DC 20250-2299; Voice: 202-401- 6443; Fax: 202-401-4888; E-mail: cbailey@NIFA.usda.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-01/html/2011-16256.htm

  • Notice of Appointment of Committee Members to the Advisory Committee on Biotechnology and 21st Century Agriculture

    AGENCY: Office of the Under Secretary, Research, Education, and Economics, USDA.

    ACTION: Notice of Appointment of Committee Members to the Advisory Committee on Biotechnology and 21st Century Agriculture.


    SUMMARY: The Office of the Under Secretary, Research, Education, and Economics of the Department of Agriculture, in accordance with the Federal Advisory Committee Act, 5 U.S.C. App. 2, announces the appointment of members to the Advisory Committee on Biotechnology and 21st Century Agriculture ("AC21'').

    FOR FURTHER INFORMATION CONTACT: Michael Schechtman, Telephone: 202- 720-3817, Fax: 202-690-4265, or e-mail AC21@ars.usda.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-30/html/2011-16431.htm

  • Health and Human Services

  • 2011 Scientific Meeting of the National Antimicrobial Resistance Monitoring System; Public Meeting; Request for Comments

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice of public meeting; request for comments.


    The Food and Drug Administration (FDA) is announcing a public meeting entitled: "2011 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.'' The topic to be discussed is animal and retail sampling methods for the National Antimicrobial Resistance Monitoring System (NARMS).

    Date and Time: The public meeting will be held on July 20, 2011, from 8 a.m. to 5 p.m.

    Location: The public meeting will be held at Holiday Inn Select St. Louis Downtown Convention Center Hotel, 811 North 9th Street, St. Louis, MO 63101, 314-421-4000, FAX: 314-421-5974.

    Contact Person: Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9004, FAX: 240-276-9001, e-mail: Aleta.Sindelar@fda.hhs.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-27/html/2011-15982.htm

  • Assessing the Current Research, Policy, and Practice Environment in Public Health Genomics

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

    ACTION: Notice; establishment of docket; request for comments, data and information.


    SUMMARY: The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is announcing the opening of a docket to solicit comments, data, and other information helpful to assess the current research, policy, and practice environment in public health genomics. HHS/CDC is currently leading a process to assess the most important steps for public health genomics in the next five years.

    DATES: Electronic or written comments must be received on or before August 1, 2011.

    ADDRESSES: You may submit written comments to the following address: Office of Public Health Genomics, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-E61, Atlanta, Georgia 30333, Attn: Docket No. CDC-2011-0008.

    You may also submit comments electronically to http://www.regulations.gov, Docket No. CDC-2011-0008. Please follow directions at http://www.regulations.gov to submit comments. All relevant comments received will be posted publicly without change, including any personal or proprietary information provided.

    FOR FURTHER INFORMATION CONTACT: Katherine Kolor, PhD, Office of Public Health Genomics, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-E61, Atlanta, GA 30333, e-mail genetics@cdc.gov, phone 404-498-0001.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-30/html/2011-16422.htm

  • Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19)

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy, and educating the general public.

    DATES: Important dates are as follows:

    1. The application due date is August 1, 2011.
    2. The anticipated start date is September, 2011.
    3. The opening date is the date the Funding Opportunity is published in the Federal Register.
    4. The expiration date is August 2, 2011.

    For Further Information and Additional Requirements Contact:

    Scientific/Programmatic Contact

    Robert Dickey, Office of Food Safety, Gulf Coast Seafood Laboratory, One Iberville Dr., PO. D1-1, rm. 122 (HFS 400), Dauphin Island, AL 36528,. Tele.: 251-690-3368; e-mail: Robert.Dickeyr@fda.hhs.gov.

    Grants Management Contact

    Gladys Melendez-Bohler, Office of Acquisition and Grant Services (OAGS), Food and Drug Administration, 5630 Fishers Lane, rm. 1078, Rockville, MD 20857, Tele.: 301-827-7175; e-mail: Gladys-Melendez-Bohler@fda.hhs.gov.

    For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at http://www.fda.gov/Food/NewsEvents/default.htm.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-01/html/2011-16627.htm

  • Meeting of the Secretary's Advisory Committee on Human Research Protections

    AGENCY: Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health.

    ACTION: Notice.


    SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-fifth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

    DATES: The meeting will be held on Tuesday, July 19, 2011 from 8:30 a.m. until 5 p.m. and Wednesday, July 20, 2011 from 8:30 a.m. until 5 p.m.

    ADDRESSES: U.S. Department of Health and Human Services, 200 Independence Avenue, SW., Hubert H. Humphrey Building, Room 800, Washington, DC 20201.

    FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP), or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-8141; fax: 240-453-6909; e-mail address: Julia.Gorey@hhs.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-27/html/2011-16051.htm

  • New Proposed Collection; Comment Request; Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study

    SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23609-23611, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study and federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment.

    Proposed Collection:

    Title: Biospecimen and Physical Measures Formative Research Methodology Studies for the National Children's Study (NCS).

    Type of Information Collection Request: Generic Clearance.

    Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

    (a) Purpose.--It is the purpose of this section to authorize the National Institute of Child Health and Human Development* to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development.

    (b) In General.--The Director of the National Institute of Child Health and Human Development* shall establish a consortium of representatives from appropriate Federal agencies (including the Centers for Disease Control and Prevention, the Environmental Protection Agency) to--

    1. plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and
    2. investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes.

    (c) Requirement.--The study under subsection (b) shall--

    1. incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences on children's well-being;
    2. gather data on environmental influences and outcomes on diverse populations of children, which may include the consideration of prenatal exposures; and
    3. consider health disparities among children, which may include the consideration of prenatal exposures.

    To fulfill the requirements of the Children's Health Act, the results of formative research tests will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of biospecimen and physical measurement collection procedures, accompanying questionnaires, storage and information management processes, and assay procedures, thereby informing data collection methodologies for the National Children's Study (NCS) Vanguard and Main Studies. With this submission, the NCS seeks to obtain OMB's generic clearance to conduct formative research featuring biospecimen and physical measurement collections.

    The results from these formative research projects will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of NCS Vanguard and Main Study biospecimen collection procedures and physical measurements in a manner that minimizes public information collection burden compared to burden anticipated if these projects were incorporated directly into either the NCS Vanguard or Main Study.

    Frequency of Response: Annual [As needed on an on-going and concurrent basis].

    Affected Public: Members of the public, researchers, practitioners, and other health professionals.

    Type of Respondents: Women of child-bearing age, infants, children, fathers, health care facilities and professionals, public health professional organizations and practitioners, and hospital administrators.

    These include both persons enrolled in the NCS Vanguard Study and their peers who are not participating in the NCS Vanguard Study.

    Annual reporting burden: See Table 1. The annualized cost to respondents is estimated at: $600,000 (based on $10 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

    Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, National Institute of Child Health and Human Development, 31 Center Drive Room 2A18, Bethesda, Maryland, 20892, or call non-toll free number (301) 496-1877 or e-mail your request, including your address to glavins@mail.nih.gov.

    Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-29/html/2011-16299.htm

  • New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study

    SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23603-23605, and allowed 60 days for public comment. One written comment was received. The comment questioned the cost and utility of the study specifically and of federally funded biomedical research in general. The purpose of this notice is to allow an additional 30 days for public comment.

    Proposed Collection

    Title: Environmental Science Formative Research Methodology Studies for the National Children's Study (NCS).

    Type of Information Collection Request: Generic Clearance.

    Need and Use of Information Collection: The Children's Health Act of 2000 (Pub. L. 106-310) states:

    (a) PURPOSE.--It is the purpose of this section to authorize the National Institute of Child Health and Human Development* to conduct a national longitudinal study of environmental influences (including physical, chemical, biological, and psychosocial) on children's health and development.

    (b) IN GENERAL.--The Director of the National Institute of Child Health and Human Development* shall establish a consortium of representatives from appropriate Federal agencies (including the Centers for Disease Control and Prevention, the Environmental Protection Agency) to--

    1. plan, develop, and implement a prospective cohort study, from birth to adulthood, to evaluate the effects of both chronic and intermittent exposures on child health and human development; and
    2. investigate basic mechanisms of developmental disorders and environmental factors, both risk and protective, that influence health and developmental processes.

    (c) REQUIREMENT.--The study under subsection (b) shall--

    1. incorporate behavioral, emotional, educational, and contextual consequences to enable a complete assessment of the physical, chemical, biological, and psychosocial environmental influences on children's well-being;
    2. gather data on environmental influences and outcomes on diverse populations of children, which may include the consideration of prenatal exposures; and
    3. consider health disparities among children, which may include the consideration of prenatal exposures.

    To fulfill the requirements of the Children's Health Act, the results of formative research will be used to maximize the efficiency (measured by scientific robustness, participant and infrastructure burden, and cost) of environmental sample collection procedures and technology, storage procedures, accompanying questionnaires, and assays, and thereby inform data collection methodologies for the National Children's Study (NCS) Vanguard and Main Studies. With this submission, the NCS seeks to obtain OMB's generic clearance to collect environmental samples from homes and child care settings, and conduct accompanying short surveys related to the physical and chemical environment.

    The results from these formative research projects will inform the feasibility (scientific robustness), acceptability (burden to participants and study logistics) and cost of NCS Vanguard and Main Study environmental sample and information collection in a manner that minimizes public information collection burden compared to burden anticipated if these projects were incorporated directly into either the NCS Vanguard or Main Study.

    Frequency of Response: Annual [As needed on an on-going and concurrent basis].

    Affected Public: Members of the public, researchers, practitioners, and other health professionals.

    Type of Respondents: Women of child-bearing age, fathers, public health and environmental science professional organizations and practitioners, and schools and child care organizations. These include both persons enrolled in the NCS Vanguard Study and their peers who are not participating in the NCS Vanguard Study.

    Annual reporting burden: See Table 1. The annualized cost to respondents is estimated at: $780,000 (based on $10 per hour). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

    Request for comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, National Institute of Child Health and Human Development, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call non-toll free number (301) 496-1877 or E-mail your request, including your address to glavins@mail.nih.gov.

    DATES: Comments due date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-29/html/2011-16300.htm

  • Interior

  • Wind Turbine Guidelines Advisory Committee; Announcement of Public Meeting and Webcast

    AGENCY: Fish and Wildlife Service, Interior.

    ACTION: Notice of public meeting and webcast.


    SUMMARY: We, the U.S. Fish and Wildlife Service (Service), will host a Wind Turbine Guidelines Advisory Committee (Committee) meeting in- person and via webcast. The meeting and webcast are open to the public. The meeting agenda will include a presentation and discussion of the Service's Draft Land-Based Wind Energy Guidelines.

    DATES: The meeting and webcast will take place over 2 days: On July 20, from 8:30 a.m. to 5 p.m., and on July 21, from 8:30 a.m. to 12 p.m. Eastern Time. If you are a member of the public wishing to attend in person or participate via webcast, you must register online no later than July 13, 2011 (see "Meeting Participation Information'' under SUPPLEMENTARY INFORMATION).

    ADDRESSES: Meeting Location: Holiday Inn Ballston, 4610 N Fairfax Drive, Arlington, VA 22203. (See "Meeting Location Information'' under SUPPLEMENTARY INFORMATION). Instructions for webcast participants will be given upon registration.

    FOR FURTHER INFORMATION CONTACT: Rachel London, Division of Habitat and Resource Conservation, U.S. Fish and Wildlife Service, U.S. Department of the Interior, (703) 358-2161.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-01/html/2011-16527.htm

  • Marine Mammal Commission

  • Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information

    AGENCY: Marine Mammal Commission.

    ACTION: Proposed guidelines; request for comments.


    SUMMARY: The Marine Mammal Commission proposes to adopt guidelines to ensure and maximize the quality, objectivity, utility, and integrity of information disseminated by the agency in accordance with the directive issued by the Office of Management and Budget (67 FR 8452-8460), pursuant to section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001.

    DATES: Comments on these proposed guidelines must be received by July 27, 2011.

    ADDRESSES: Comments may be submitted by the following methods:

    E-mail: to mmc@mmc.gov. The subject line should read: Information quality guidelines.

    Fax: (301) 504-0099, Attn: Michael L. Gosliner.

    Mail: Marine Mammal Commission; Attn.: Michael L. Gosliner, General Counsel, 4340 East-West Highway, Room 700, Bethesda, MD 20814.

    FOR FURTHER INFORMATION CONTACT: Michael L. Gosliner, General Counsel, Marine Mammal Commission, 4340 East-West Highway, Room 700, Bethesda, MD 20814; telephone: (301) 504-0087; fax: (301) 504-0099.

    http://www.gpo.gov/fdsys/pkg/FR-2011-06-27/html/2011-15953.htm

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