Bookmark and Share


Federal Register Summary for week of 29 July

    Agriculture

  • National Urban and Community Forestry Advisory Council

    AGENCY: Forest Service, USDA.

    ACTION: Notice of May Call for Nominations 2011.


    SUMMARY: The National Urban and Community Forestry Advisory Council, (NUCFAC) will be filling three positions that will expire at the end of December 2011. Interested applicants may download a copy of the application and position descriptions from the U.S. Forest Service’s Urban and Community Forestry Web site: http://www.fs.fed.us/ucf.

    DATES: Nomination(s) must be “received” (not postmarked) by August 29, 2011.

    ADDRESSES: Nomination applications by courier should be addressed to: Nancy Stremple, Executive Staff to National Urban and Community Forestry Advisory Council, 1400 Independence Avenue, SW., Yates Building (1 Central) MS-1151, Washington, DC 20250-1151. Please submit electronic nomination(s) to: nucfacucfproposals@fs.fed.us. The subject line should read: May NUCFAC Nominations 2011.

    FOR FURTHER INFORMATION CONTACT: Nancy Stremple, Executive Staff to National Urban and Community Forestry Advisory Council, 1400 Independence Avenue, SW., Yates Building (1 Central) MS-1151, Washington, DC 20250-1151, phone 202-205-1054.

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-27/html/2011-18950.htm

  • Commerce

  • National Climate Assessment and Development Advisory Committee (NCADAC)

    AGENCY: Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).

    ACTION: Notice of open meeting.


    SUMMARY: The National Climate Assessment and Development Advisory Committee (NCADAC) was established by the Secretary of Commerce under the authority of the Global Change Research Act of 1990 to synthesize and summarize the science and information pertaining to current and future impacts of climate.

    Time and Date: The meeting will be held August 16 and 17, 2011, from 9 a.m to 6 p.m. and August 18, 2011, from 9 a.m. to 3 p.m. These times and the agenda topics described below are subject to change. Please refer to the web page http://www.globalchange.gov for the most up-to-date meeting agenda.

    Place: The meeting will be held at the EPA Offices at the US EPA Potomac Yard Conference Facility, 1st Floor conference room in the Potomac Yard ONE or SOUTH building. The address is 2777 Crystal Drive, Arlington, VA 22202. Please check the Web site http://www.globalchange.gov for confirmation of the venue and for directions.

    Status: Seating will be available on a first come, first serve basis. Members of the public must RSVP in order to attend all or a portion of the meeting by contacting the NCADAC DFO (Cynthia.Decker@noaa.gov) by August 9, 2011. The meeting will be open to public participation with a 30 minute public comment period on August 17 at 5:30 p.m. (check Web site to confirm time). The NCADAC expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of five (5) minutes. Individuals or groups planning to make a verbal presentation should contact the NCADAC DFO (Cynthia.Decker@noaa.gov) by August 9, 2011 to schedule their presentation. Written comments should be received in the NCADAC DFO's Office by August 9, 2011 to provide sufficient time for NCADAC review. Written comments received by the NCADAC DFO after August 9, 2011 will be distributed to the NCADAC, but may not be reviewed prior to the meeting date.

    FOR FURTHER INFORMATION CONTACT: Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA OAR, R/SAB, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301-734-1156, Fax: 301- 713-1459, E-mail: Cynthia.Decker@noaa.gov; or visit the NCADAC Web site at http://www.globalchange.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-25/html/2011-18653.htm

  • Environmental Protection Agency

  • Nominations to the FIFRA Scientific Advisory Panel; Request for Comments

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice.


    SUMMARY: This notice provides the names, addresses, professional affiliations, and selected biographical data of persons nominated to serve on the Scientific Advisory Panel (SAP) established under section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Panel was created on November 28, 1975, and made a statutory Panel by amendment to FIFRA, dated October 25, 1988. The Agency, at this time, anticipates selecting two new members to serve on the panel as a result of membership terms that will expire next year. Public comments on the nominations are invited, as these comments will be used to assist the Agency in selecting the new chartered Panel members.

    DATES: Comments, identified by docket ID number EPA-HQ-OPP-2011-0550, must be received on or before August 29, 2011.

    ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2011-0550, by one of the following methods:

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

    Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

    Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

    Instructions. Direct your comments to docket ID number EPA-HQ-OPP- 2011-0550. If your comments contain any information that you consider to be CBI or otherwise protected, please contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your comments. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an "anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

    FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address: bailey.joseph@epa.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-29/html/2011-19174.htm

  • Notice of Availability of the External Review Draft of the Microbial Risk Assessment Guideline: Pathogenic Microorganisms With Focus on Food and in Water

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Notice of document availability for public comment.


    SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a 60-day public comment period for the External Review Draft of "Microbial Risk Assessment Guideline: Pathogenic Microorganisms with Focus on Food and in Water.'' EPA developed the Guideline in collaboration with the U.S. Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) and with scientists from other Federal agencies. This draft document is being released solely for the purpose of seeking public comment prior to peer review. The document will undergo independent peer review during an expert peer review meeting, which will be convened, organized, and conducted by an EPA contractor in 2011. The date of the external peer review meeting will be announced in a subsequent Federal Register notice. All comments received by the docket closing date September 26, 2011 will be shared with the external peer review panel for their consideration. Comments received after the close of the comment period may be considered by the two agencies when they finalize the document. This document has not been formally disseminated by EPA or USDA/FSIS. This draft guidance does not represent and should not be construed to represent EPA or USDA/FSIS policy, viewpoint, or determination. Members of the public may obtain the draft guidance from http://www.regulations.gov; or http://www.epa.gov/raf/microbial/index.htm or from Dr. Michael Broder via the contact information below.

    DATES: All comments received by the docket closing date September 26, 2011 will be shared with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA and USDA/FSIS when it finalizes the document.

    ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ- ORD-2011-0532, by one of the following methods:

    http://www.regulations.gov: Follow the on-line instructions for submitting comments.

    E-mail: ORD.Docket@epa.gov.

    Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

    Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20460, Attention Docket ID EPA-HQ-ORD-2011-0532. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID EPA-HQ-ORD-2011- 0532. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected by statute through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an "anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA, without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket is (202) 566-1752.

    FOR FURTHER INFORMATION CONTACT: Dr. Michael W. Broder, Office of the Science Advisor, Mail Code 8105-R, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-3393; fax number: (202) 564-2070, E-mail: broder.michael@epa.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18879.htm

  • Testing of Bisphenol A

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Advance notice of proposed rulemaking (ANPRM).


    SUMMARY: Bisphenol A (BPA) (Chemical Abstracts Service Registry Number (CASRN) 80-05-7), a high production volume (HPV) chemical, is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic. EPA is providing this ANPRM to request comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. EPA is working with the Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time.

    DATES: Comments must be received on or before September 26, 2011.

    ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0812, by one of the following methods:

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

    Hand Delivery: OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2010-0812. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT- 2010-0812. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov Web site is an "anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is (202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

    FOR FURTHER INFORMATION CONTACT: For technical information contact: Mary Dominiak, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-8104; e-mail address: dominiak.mary@epa.gov.

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; e-mail address: TSCA-Hotline@epa.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18842.htm

  • Health and Human Services

  • Clinical Investigator Training Course

    AGENCY: Food and Drug Administration, HHS.

    ACTION: Notice.


    SUMMARY: The Food and Drug Administration (FDA), Office of Critical Path Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research.

    Date and Time: The training course will be held on November 7 and 8, 2011, from 8 a.m. to 5 p.m., and on November 9, 2011, from 8 a.m. to 3:30 p.m.

    Location: The course will be held at the National Labor College, 10000 New Hampshire Ave., Silver Spring, MD 20903-0002.

    Contact Person: Leonard Sacks, Office of Critical Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4174, Silver Spring, MD 20993, 301-796-8502.

    Registration: Register by October 21, 2011. The registration fee is $400 per person. The fee includes course materials and onsite lunch. Early registration is recommended because seating is limited. There will be no onsite registration.

    Register online for the training course at the registration/ information Web site at https://www.trialstransformation.org/fda-clinical-investigator-training-course or by FAX to 919-660-1769. An e-mail will be sent confirming your registration.

    Attendees are responsible for their own accommodations. A block of rooms has been reserved under "FDA Clinical Investigator Course'' at the National Labor College at a reduced conference rate. Reservations can be made at https://www.supportnlc.org/Room_Reservations.html or by calling 301-431-6400. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.

    Registration materials, payment procedures, accommodation information, and a detailed description of the course can be found at https://www.trialstransformation.org/fda-clinical-investigator-training-course.

    If you need special accommodations due to a disability, please contact Leonard Sacks at least 7 days in advance. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-29/html/2011-19149.htm

  • Establishment of the Advisory Committee to the Deputy Director for Intramural Research

    Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. App), the Director, National Institutes of Health (NIH), announces the establishment of the Advisory Committee to the Deputy Director for Intramural Research, National Institutes of Health (ACDDIR).

    The ACDDIR will provide advice and recommendations to the Deputy Director for Intramural Research, NIH, or other appropriate delegated officials on matters related to the Office of Intramural Research and include (1) the Office of Intramural Training and Education; (2) the Office of Animal Care and Use; (3) the Office of Human Subjects Research; (4) the Office of NIH History; (5) the Office of Technology Transfer; and (6) any other program located in the Office of Intramural Research. Advice provided may include specific accomplishments, overall strengths and weaknesses of a particular program, as well as recommendations for future directions, the overall design, content, development and/or delivery of training programs to specific groups, as well as recommendations concerning program and policy development and resource allocation.

    Duration of this committee is two years from the date the Charter is filed.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-29/html/2011-19226.htm

  • Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

    AGENCIES: The Office of the Secretary, HHS, and the Food and Drug Administration, HHS.

    ACTION: Advance notice of proposed rulemaking.


    SUMMARY: The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

    The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.

    DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 26, 2011.

    ADDRESSES: You may submit comments, identified by docket ID number HHS- OPHS-2011-0005, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Enter the above docket ID number in the "Enter Keyword or ID'' field and click on "Search.'' On the next Web page, click on "Submit a Comment'' action and follow the instructions.

    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

    Comments received, including any personal information, will be posted without change to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240-453-6900 or 1-866-447-4777; facsimile: 301-402-2071; e-mail: jerry.menikoff@hhs.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm

  • National Biodefense Science Board; Call for Nominees

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

    ACTION: Notice.


    SUMMARY: The Office of the Secretary is accepting resumes or curricula vitae from qualified individuals who wish to be considered for membership on the National Biodefense Science Board. Seven members have membership expiration dates of December 31, 2011; therefore seven new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry; academia, practicing healthcare professional, and organizations representing other appropriate stakeholders. Submit a resume or curriculum vitae nbsb@hhs.gov" by August 19, 2011.

    FOR FURTHER INFORMATION CONTACT: CAPT Leigh A. Sawyer, D.V.M., M.P.H., Executive Director, National Biodefense Science Board, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, 330 C Street, SW., Switzer Building Room, 5127, Washington, DC 20447; 202-205-3815; fax: 202-205-8508; e-mail address: leigh.sawyer@hhs.gov.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-25/html/2011-18756.htm

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

    AGENCY: National Institutes of Health, PHS, Department of Health and Human Services.

    ACTION: Proposed Minor Action under the NIH Guidelines.


    SUMMARY: The Office of Biotechnology Activities (OBA) is updating Appendix B of the NIH Guidelines by specifying the risk group (RG) classification for several common attenuated strains of bacteria and viruses that are frequently used in recombinant DNA research. OBA is also adding the risk group for several viruses not previously listed in Appendix B. The NIH Guidelines provide guidance to investigators and local Institutional Biosafety Committees (IBCs) for setting containment for recombinant DNA research. Section II-A, Risk Assessment, instructs investigators and IBCs to make an initial risk assessment based on the RG of the agent (see Appendix B, Classification of Human Etiologic Agents on the Basis of Hazard). The RG of the agent often establishes the minimum containment level required for experiments subject to the NIH Guidelines.

    The classification of agents into various RG categories is based largely on their ability to cause human disease and the availability of treatments for that disease. For the most part, the organisms listed in Appendix B are wild-type, non-attenuated strains and a distinction is not made between the RG classification for the wild-type organism and a corresponding attenuated strain. A few attenuated strains of organisms are classified in Appendix B at a lower RG than that of the parental organism. However, there are a number of additional, well-established attenuated strains employed in research subject to the NIH Guidelines that are not specifically listed and thus by default are included in the same RG as the wild-type organism. Therefore, the biosafety level (BL) specified for research subject to the NIH Guidelines may be identical for experimentation with either the attenuated or the wild- type strain. OBA has therefore conducted an evaluation of certain attenuated strains, focusing on those for which a risk assessment had been undertaken and containment recommendations determined in the Centers for Disease Control and Prevention (CDC)/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL) (5th edition). Specifying the risk groups for these attenuated strains in Appendix B of the NIH Guidelines will lead to more uniform containment recommendations that are commensurate with the biosafety risk. In addition, OBA has identified several RG3 viruses that are not currently specified in Appendix B or are currently specified as a member of a family of viruses otherwise classified as RG2. Therefore, Appendix B is being updated to address these viruses as well.

    In addition to considering the risk assessment articulated in the BMBL, OBA also consulted with members of the NIH Recombinant DNA Advisory Committee (RAC) as well as other subject matter experts from NIH, CDC, and academia. Of note, the RAC discussed the appropriate containment for two attenuated strains of Yersinia pestis (lcr(-) and pgm(-) mutants) at its June 16, 2010, meeting when the committee considered which antibiotic markers could be used in these strains without requiring RAC review under Section III-A- 1-a. (A webcast of that discussion is available at http://oba.od.nih.gov/rdna_rac/rac_past_meetings_2010.html.) The RAC recommendations regarding containment for work with these attenuated strains of Yersinia pestis are being implemented by amending Appendix B to indicate that these specific strains are RG2 organisms rather than RG3 organisms.

    This update does not include all attenuated strains identified in the BMBL. OBA has tried to select attenuated strains commonly used in recombinant DNA research. OBA has also not modified the RG for viruses for which the NIH Guidelines already provides specific containment recommendations. For example, human immunodeficiency virus (HIV) is currently classified as a RG3 virus in Appendix B of the NIH Guidelines. However, Section II-A-3 makes specific recommendations regarding when BL2 is acceptable for research with HIV and OBA's guidance titled Biosafety Considerations for Research with Lentiviral Vectors (see http://oba.od.nih.gov/rdna_rac/rac_guidance_lentivirus.html) provides additional containment recommendations for lentiviral vectors derived from HIV.

    Revision of Appendix B is considered a Minor Action under Section IV-C-3 of the NIH Guidelines and therefore can be implemented by OBA after consultation with the RAC Chair and one or more RAC members as needed. This consultation is complete. However, in the interest of soliciting broad public input, OBA is submitting this action for public comment and will finalize the changes after reviewing any comments.

    DATES: The public is encouraged to submit written comments on this minor action. 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. The NIH will consider all comments submitted by September 9, 2011. All written comments received in response to this notice will be available for public inspection at the NIH OBA office, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20817-7985, 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 changes, please contact OBA by e- mail at oba@od.nih.gov, telephone (301-496-9838), or mail to the Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, Maryland 20892-7985.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-25/html/2011-18726.htm

  • Interior

  • Agency Information Collection Activities: Comment Request for the North American Amphibian Monitoring Program (NAAMP)

    AGENCY: U.S. Geological Survey (USGS), Interior.

    ACTION: Notice of an extension of a currently approved information collection (1028-0078).


    SUMMARY: We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection request (ICR) for the North American Amphibian Monitoring Program (NAAMP). As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR. This ICR is scheduled to expire on July 31, 2011.

    DATES: To ensure that we are able to consider your comments on this IC we must receive them on or before August 29, 2011.

    ADDRESSES: Please submit written comments on this ICR to the OMB Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior via e-mail to oira_docket@omb.eop.gov or fax at 202-395-5806; and reference Information Collection 1028-0078 in the subject line. Please also submit a copy of your comments to the USGS, Information Collection Officer, U.S. Geological Survey, Mail Stop 807, 12201 Sunrise Valley Drive, Reston, VA 20192. Please reference Information Collection 1028-0078 in the subject line.

    FOR FURTHER INFORMATION CONTACT: Linda Weir at 301-497-5932 or by mail at U.S. Geological Survey, Patuxent Wildlife Research Center, 12100 Beech Forest Road, Laurel, Maryland 20708-4038. To see a copy of the entire ICR submitted to OMB, go to http://www.reginfo.gov (Information Collection Review, Currently under Review).

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-29/html/2011-19245.htm

  • National Science Foundation

  • Agency Information Collection Activities: Proposed Collection; Comment Request

    AGENCY: National Science Foundation.

    ACTION: Submission for OMB review; comment request.


    SUMMARY: Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501 et seq.), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public and other Federal agencies to comment on this proposed continuing information collection. The full submission may be found at: http://www.reginfo.gov/public/do/PRAMain. This is the second notice for public comment; the first was published in the Federal Register at 76 FR 28244 and no comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice.

    DATES: Comments regarding these information collections are best assured of having their full effect if received by OMB within 30 days of publication in the Federal Register.

    ADDRESSES: Written comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of NSF, including whether the information will have practical utility; (b) the accuracy of NSF's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; or (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725-17th Street, NW. Room 10235, Washington, DC 20503, and to Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230 or send e-mail to splimpto@nsf.gov. Copies of the submission may be obtained by calling (703) 292-7556.

    FOR FURTHER INFORMATION CONTACT: Suzanne H. Plimpton, NSF Reports Clearance Officer at (703) 292-7556 or send e-mail to splimpto@nsf.gov.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    http://www.gpo.gov/fdsys/pkg/FR-2011-07-27/html/2011-18964.htm