Technical Service Provider Assistance
AGENCY: Natural Resources Conservation Service, USDA.
ACTION: Final rule.
SUMMARY: The Natural Resources Conservation Service (NRCS) is issuing a final rule for technical service provider assistance as authorized under section 1242 of the Food Security Act of 1985 (Food Security Act), as amended by the Farm Security and Rural Investment Act of 2002, P.L. 107-171 (2002 Farm Bill). This final rule responds to comments received on the Interim Final Rule and two amendments, makes adjustments to the implementation of Technical Service Provider (TSP) assistance in response to these comments, and sets forth the final process for providing conservation technical assistance through technical service providers. The Secretary of Agriculture has delegated responsibility for administering technical services provided by technical service providers to NRCS.
DATES: Effective November 29, 2004.
FOR FURTHER INFORMATION CONTACT: Angel Figueroa, Technical Service Provider Coordinator, NRCS, P.O. Box 2890, Washington, DC 20013-2890, telephone: (202) 720-2520; fax: (202) 720-0428; submit e-mail to: firstname.lastname@example.org, Attention: Technical Service Provider Assistance.
Notice of Appointees to the Agricultural Air Quality Task Force
AGENCY: Natural Resources Conservation Service, USDA.
ACTION: Notice of appointees.
SUMMARY: The Secretary of Agriculture has renewed the Agricultural Air Quality Task Force (AAQTF), and has appointed qualified individuals to serve as members.
DATES: The effective date of the appointment is September 17, 2004.
FOR FURTHER INFORMATION CONTACT: Elvis Graves, Acting Designated Federal Official; telephone: (336) 370-3331, extension 421; fax: (202) 720-2646, e-mail: email@example.com.
Notice of Proposed Changes to the Natural Resources Conservation Service National Handbook of Conservation Practices
AGENCY: Natural Resources Conservation Service (NRCS), USDA.
ACTION: Notice of availability of proposed changes in the NRCS National Handbook of Conservation Practices for public review and comment.
SUMMARY: Notice is hereby given of the intention of NRCS to issue a series of new or revised conservation practice standards in its National Handbook of Conservation Practices. These standards include: Closure of Waste Impoundments (Code 360), Cross Wind Trap Strips (Code 589C), Irrigation Water Management (Code 449), Land Reclamation, Landslide Treatment (Code 453), Mine Shaft and Adit Closing (Code 457), Pond Sealing or Lining, Compacted Clay Treatment (Code 521D), and Water Well (Code 642). NRCS State Conservationists who choose to adopt these practices for use within their States will incorporate them into Section IV of their respective electronic Field Office Technical Guides (eFOTG). These practices may be used in conservation systems that treat highly erodible land, or on land determined to be wetland.
DATES: Comments will be received for a 30-day period commencing with this date of publication. This series of new or revised conservation practice standards will be adopted after the close of the 30-day period.
FOR FURTHER INFORMATION CONTACT: Copies of these standards can be downloaded or printed from the following Web site: ftp://ftp-fc.sc.egov.usda.gov/NHQ/practice-standards/federal-register/.
Single copies of these standards are available from NRCS in Washington, DC. Submit individual inquiries in writing to Daniel Meyer, National Agricultural Engineer, Natural Resources Conservation Service, Post Office Box 2890, Room 6139-S, Washington, DC 20013-2890.
SUPPLEMENTARY INFORMATION: Section 343 of the Federal Agriculture Improvement and Reform Act of 1996 requires NRCS to make available, for public review and comment, proposed revisions to conservation practice standards used to carry out the highly erodible land and wetland provisions of the law. For the next 30 days, NRCS will receive comments relative to the proposed changes. Following that period, a determination will be made by NRCS regarding disposition of those comments, and a final determination of changes will be made.
Notice of Request for Extension of Approval of an Information Collection
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Extension of approval of an information collection; comment request.
SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the possession, use, and transfer of biological agents and toxins that have the potential to pose a severe threat to human and animal health, to animal health, to plant health, or to animal products and plant products.
DATES: We will consider all comments that we receive on or before February 1, 2005.
FOR FURTHER INFORMATION CONTACT: For information regarding the select agent registration process associated with the possession, use, or transfer of biological agents and toxins in 7 CFR part 331, contact Ms. Gwendolyn Burnett, Regulatory Permit Specialist, Biological and Technical Services, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 734-7211.
For information regarding the select agent registration process associated with the possession, use, or transfer of biological agents and toxins in 9 CFR part 121, contact Dr. Monica Brown-Reid, Select Agent Program Manager, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 734-3399.
For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
Notice of Request for Approval of an Information Collection
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: New information collection; comment request.
SUMMARY: In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to initiate a new information collection associated with health certificates for the export of live crustaceans, finfish, mollusks, and related products.
DATES: We will consider all comments that we receive on or before February 1, 2005.
FOR FURTHER INFORMATION CONTACT: For information on health certificates for the export of live crustaceans, finfish, mollusks, and related products, contact Ms. Jill B. Rolland, Fishery Biologist, Certification and Control Team, National Center for Animal Health Programs, VS, APHIS, 4700 River Road Unit 46, Riverdale, MD 20737; (301) 734-6479. For copies of more detailed information on the information collection, contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
Partnerships in the Provision of Environmental Information
AGENCY: National Oceanic and Atmospheric Administration, Department of Commerce.
ACTION: Notice of availability.
SUMMARY: The National Oceanic and Atmospheric Administration (NOAA) has adopted a policy regarding the provision of information products and services to the public, which implements relevant provisons of the Paperwork Reduction Act of 1995 (44 U.S.C. part 35) and Office of Management and Budget Circular No. A-130, "Management of Federal Information Resources.'' This policy will strengthen the existing partnership between government, academia and the private sector, which provides the nation with high quality environmental information.
ADDRESSES: The policy is available electronically at http://www.nws.noaa.gov/partnershippolicy. Requests for hard copies should be sent to Room 11404, 1325 East-West Highway, Silver Spring, MD 20910-3283.
FOR FURTHER INFORMATION CONTACT: Peter Weiss 301-713-0258. firstname.lastname@example.org.
National Advisory Committee on Institutional Quality and Integrity, (National Advisory Committee); Notice of Meeting Changes
AGENCY: National Advisory Committee on Institutional Quality and Integrity, Department of Education.
SUMMARY: This notice advises interested parties of changes concerning the December 2004 meeting of the National Advisory Committee and amends information provided in the original meeting notice published in the October 14, 2004 Federal Register (69 FR 60991).
FOR FURTHER INFORMATION CONTACT: Ms. Bonnie LeBold, the Executive Director of the National Advisory Committee on Institutional Quality and Integrity, U.S. Department of Education, room 7007, MS 7592, 1990 K St., NW., Washington, DC 20006, telephone: (202) 219-7009, fax: (202) 219-7008, e-mail: Bonnie.LeBold@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service at 1-800-877-8339 between 8 a.m. and 8 p.m. Eastern time, Monday through Friday.
Clean Air Act Advisory Committee (CAAAC) Notice of Meeting
Summary: The Environmental Protection Agency (EPA) established the Clean Air Act Advisory Committee (CAAAC) on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical scientific, and enforcement policy issues.
Open Meeting Notice: Pursuant to 5 U.S.C. App. 2 section 10 (a) (2), notice is hereby given that the Clean Air Act Advisory Committee will hold its next open meeting on Thursday, December 16, 2004, from approximately 8:30 a.m. to 3:30 p.m. at the Renaissance Mayflower Hotel, 1127 Connecticut Avenue, NW., Washington, DC. Seating will be available on a first come, first served basis. Subcommittee meetings will be held on, December 15, 2004, from approximately 8:30 a.m to 3:30 p.m. at the Renaissance Mayflower, the same location as the full Committee. The Mobile Source Technical Review Panel will not meet at this time. The agenda for the meeting will be posted on the CAAAC Web site: http://www.epa.gov/oar/caaac/.
Inspection of Committee Documents: The Committee agenda and any documents prepared for the meeting will be publicly available at the meeting. Thereafter, these documents, together with CAAAC meeting minutes, will be available by contacting the Office of Air and Radiation Docket and requesting information under docket item A-94-34 (CAAAC). The Docket office can be reached by telephoning 202-260-7548; FAX 202-260-4400.
For Further Information Contact: Concerning the CAAAC , please contact Pat Childers, Office of Air and Radiation, U.S. EPA (202) 564-1082, FAX (202) 564-1352 or by mail at U.S. EPA, Office of Air and Radiation (Mail code 6102 A), 1200 Pennsylvania Avenue, NW., Washington, DC 20004. For information on the Subcommittee meetings, please contact the following individuals: (1) Permits/NSR/Toxics IntegrationB Debbie Stackhouse, 919-541-5354; and (2) Linking Transportation, Land Use and Air Quality Concerns B Robert Larson, 734- 214-4277; and (3) Economic Incentives and Regulatory Innovations B Carey Fitzmaurice, 202-564-1667. Additional Information on these meetings, CAAAC and its Subcommittees can be found on the CAAAC Web site: http://www.epa.gov/oar/caaac/.
National Drinking Water Advisory Council's Water Security Working Group Meeting Announcement
AGENCY: Environmental Protection Agency.
SUMMARY: The Environmental Protection Agency (EPA) announces the third public meeting of the Water Security Working Group (WSWG) of the National Drinking Water Advisory Council (NDWAC), which was established under the Safe Drinking Water Act. The purpose of this meeting is to provide an opportunity for the WSWG members to continue deliberations on the features of active and effective security programs for drinking water and wastewater utilities (water sector), to continue deliberations on incentives to encourage broad adoption of active and effective security programs throughout the water sector, and to begin deliberations on mechanisms to measure the extent of implementation of water security programs. Final WSWG findings and recommendations will be provided to the NDWAC for their consideration. The WSWG anticipates providing findings and recommendations to the NDWAC in Spring 2005. Two additional meetings of the WSWG are planned and will be announced in the near future.
DATES: The WSWG meeting is December 15-17, 2004. On December 15, 2004, the meeting is scheduled from 12:30 p.m. to 6 p.m., eastern time (e.t.). On December 16, 2004, the meeting is scheduled from 8 a.m. to 5:30 p.m., e.t. On December 17, 2004, the meeting is schedule from 8 a.m. to 12 p.m., e.t.
ADDRESSES: The meeting will take place at the Radisson Barcelo Hotel, Washington, 2121 P Street, NW., Washington, DC 20037. The telephone number for this hotel is (202) 293-3100.
FOR FURTHER INFORMATION CONTACT: Interested participants from the public should contact Marc Santora, Designated Federal Officer, U.S. Environmental Protection Agency, Office of Ground Water and Drinking Water, Water Security Division (Mail Code 4601-M), 1200 Pennsylvania Avenue, NW., Washington, DC, 20460. Please contact Marc Santora at email@example.com or call 202-564-1597 to receive additional details.
Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
SUMMARY: The Food and Drug Administration (FDA) Pacific Region, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA Clinical trial statutory and regulatory requirements. Topics for discussion include: Pre-IND (investigational new drug application) meetings and FDA meeting process, medical device, drug and biological product aspects of clinical research, investigator initiated research, informed consent requirements, adverse event reporting, how FDA conducts bioresearch inspections, ethics in subject enrollment, FDA regulation of Institutional Review Boards, FDA and confidence in the conduct of clinical research, and what happens after the FDA inspection. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA.
Date and Time: The public workshop is scheduled for Wednesday, January 12, 2005, from 8:15 a.m. to 4:15 p.m. and Thursday, January 13, 2005, from 8:15 a.m. to 4 p.m.
Location: The public workshop will be held at the Holiday Inn Fisherman's Wharf, 1300 Columbus Ave., San Francisco, CA 94133, 415-771-9000, FAX: 415-771-7006.
Contact: Marcia Madrigal, Small Business Representative, FDA, 1301 Clay St., suite 1180-N, Oakland, CA 94612-5217, FAX: 510-637-3977, e-mail: firstname.lastname@example.org.
Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $485 (member) or $560 (nonmember), $460 (government employee nonmember) (includes a 1 year membership). The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to http://www.socra.org/FDA_Conference.htm. (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.)
The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-345-7369 or via e-mail: email@example.com. Attendees are responsible for their own accommodations. To make reservations at the Holiday Inn Fisherman's Wharf, at the reduced conference rate, contact the Holiday Inn (see Location) before December 21, 2004.
The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration.
If you need special accommodations due to a disability, please contact Marcia Madrigal at least 7 days in advance of the workshop.
National Institutes of Health
Submission for OMB Review; Comment Request; Longitudinal Investigation of Fertility and the Environment
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register, under the title "Determinants of Male and Female Fecundity and Fertility,'' on January 9, 2004, page 1589 and allowed 60-days for public comment. Two public comments were received from the American Society for Reproductive Medicine and the American Chemistry Council Phthalate Esters Panel regarding specific aspects of the proposed methodology. Overall, comments from the former group pertained predominantly to clinical issues while the latter group's comments provided their rationale for the omission of phthalates from the protocol. These comments were useful in modifying the proposed study and instruments. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General Requirements) Reporting and Recordkeeping
Requirements: Final Rule requires that the agency inform the potentialpersons 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. This information is required to be stated in the 30-day Federal Register notice.
Proposed Collection: Title: Longitudinal Investigation of Fertility and the Environment (LIFE Study). Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of the LIFE Study is to assess the impact of environmental factors, broadly defined to include lifestyle factors, on human reproduction and development. The LIFE Study is consistent with the mission of the
National Institute of Child Health and Human Development that includes conducting basic, clinical and epidemiologic research focusing on factors and processes associated with human reproduction and development, thereby, ensuring the birth of healthy infants capable of reaching full adult potential unimpaired by physical or mental disabilities.
This study will assess the relation between select environmental factors and human reproduction and development. This research proposes to recruit and retain 800 couples interested in becoming pregnant and willing to participate in a longitudinal study. Couples will be selected from geographic regions that were chosen from peer reviewed competitive proposals. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Infertility will be recognized for couples unable to conceive within 12 months of trying. The study's primary environmental exposures include: organochlorine pesticides; polychlorinated biphenyls; polybrominated diphenyl ethers; metals; perfluorinated compounds; cotinine; and phytoestrogens. A growing body of literature suggests these compounds may exert adverse effects on human reproduction and development; however, definitive data are lacking especially for sensitive endpoints. Couples will participate in a 25-minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to globally assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed.
The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures such as use of cigarettes and alcohol, consistent with the manner in which human beings are exposed. Frequency of
Response: Following the baseline interview (25 minutes), couples will each complete a 2-minute daily diary on select lifestyle factors. Women will perform daily fertility testing (7 minutes) approximately 11 days per cycle and pregnancy testing (4 minutes) at day of expected menses using a dipstick test in urine. Approximately 60% of women will become pregnant after 2 to 3 months, at which point they will switch to the less intensive portion of the protocol. Men will provide two semen samples, a month apart, requiring approximately 20 minutes for each collection, and women will collect two saliva samples, a month apart, requiring approximately 6 minutes each. Participating couples will be given a choice to submit their information by mail or to send it electronically to the Data Coordinating Center. This option will be available throughout data collection in the event couples change their minds about how they would like to submit information. Study participants will collect semen and saliva samples and forward them in
prepaid delivery packages to the study's laboratories. Research nurses will collect blood and urine samples and return them to the study's laboratories. Affected Public: Individuals from participating communities. Type of Respondents: Men aged 18+ years and women aged 18-40 years. Estimated Number of Respondents: Approximately 1,000 couples enrolling (minimum of 800 completing the study). Estimated Number of Response Sets Per Respondent: 7 per woman and 4 per man over approximately two years. Average Burden Hours Per Response: (1) 0.17 hours for completing the screening instrument; (2) 0.42 hours for baseline interviews with men and women; (3) 2.5 hours for daily journal while attempting pregnancy for men and women; (4) 0.38 and 0.7 hours for biospecimen collection for women and men, respectively; (5) 2.6 hours for fertility monitors; (6) 0.27 hours for pregnancy testing for women; and (7) 0.29 hours for pregnancy journals for women. Estimated Total Annual Burden Hours Requested: 3,280 to 9,900 hours for female participants and 2,100 to 5,480 hours for male participants depending upon the length of time required for pregnancy. There is no cost to respondents. There are no Capital Costs, Operating Costs, and/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) Evaluate 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) evaluate 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) enhance the quality, utility, and clarity of the information to be collected; and
(4) 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.
Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Germaine M. Buck Louis, Epidemiology Branch, Division of Epidemiology, Statistics and Prevention Research, NICHD, 6100 Executive Boulevard, Room 7B03, Rockville, MD 20852, (301) 496-6155. You may also e-mail your request to firstname.lastname@example.org.
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.
Public Health Service
National Toxicology Program; National Institute of Environmental Health Sciences (NIEHS); National Institutes of Health (NIH) Notice of Additional Data and Analyses for the Assessment of the Current Validation Status of In Vitro Testing Methods for Identifying Potential Ocular Irritants
The National Toxicology Program (NTP) Interagency Center for theEvaluation of Toxicological Methods (NICEATM) recently published a notice in the Federal Register (Vol. 69, No. 212, pages 64081-2, November 3, 2004) announcing the availability of and requesting comments on Background Review Documents (BRDs) for four in vitro assays proposed for identifying potential ocular corrosives and severe irritants. Notice is hereby given of the availability of additional data and analyses for the Hen's Egg Test-Chorion Allantoic Membrane (HET-CAM) assay. Copies of the additional analyses and any other updates on information relevant to this meeting can be obtained on the ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov or by contacting NICEATM [NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC, 27709, (phone) (919) 541-3398, (fax) (919) 541-0947, (e-mail) email@example.com.
Interested parties are invited to check the ICCVAM/NICEATM Web site periodically for additional information and/or analyses for this meeting.
North American Wetlands Conservation Council Meeting Announcement
AGENCY: Fish and Wildlife Service, Interior.
ACTION: Notice of meeting.
SUMMARY: The North American Wetlands Conservation Council (Council) will meet to select North American Wetlands Conservation Act (NAWCA) grant proposals for recommendation to the Migratory Bird Conservation Commission (Commission). The meeting is open to the public.
DATES: December 7, 2004, 1-4 p.m.
ADDRESSES: The meeting will be held at the Hotel Playa Mazatlan, Mazatlan, Mexico. The Council Coordinator is located at the U.S. Fish and Wildlife Service, 4401 N. Fairfax Drive, Mail Stop: MBSP 4501-4075, Arlington, Virginia 22203.
FOR FURTHER INFORMATION CONTACT: David A. Smith, Council Coordinator, (703) 358-1784 or firstname.lastname@example.org.
SUPPLEMENTARY INFORMATION: In accordance with NAWCA (Pub. L. 101-233, 103 Stat. 1968, December 13, 1989, as amended), the State-private-Federal Council meets to consider wetland acquisition, restoration, enhancement, and management projects for recommendation to, and final funding approval by, the Commission. Proposal due dates, application instructions, and eligibility requirements are available through the NAWCA Web site at http://birdhabitat.fws.gov. Proposals require a minimum of 50 percent non-Federal matching funds. Mexican and U.S. Standard grant proposals will be considered at the Council meeting. The tentative date for the Commission meeting is March 2, 2005.