Notices. Notice
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/register/2007/01/08/07-6A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0527] Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170). DATES: Submit written or electronic comments on the collection of information by March 9, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Threshold of Regulation for Substances Used in Food-Contact Articles—21 CFR 170.39 (OMB Control Number 0910-0298)—Extension Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe unless one of the following is applicable:
(1)It conforms to an exemption for investigational use under section 409(j) of the act,
(2)it conforms to the terms of a regulation prescribing its use, or
(3)in the case of a food additive which meets the definition of a food-contact substance in section 409(h)(6) of the act, there is either a regulation authorizing its use in accordance with section 409(a)(3)(A) or an effective notification in accordance with section 409(a)(3)(B). The regulations in § 170.39 (21 CFR 170.39) established a process that provides the manufacturer with an opportunity to demonstrate that the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification. The agency has established two thresholds for the regulation of substances used in food-contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 part per billion (ppb). The second exempts regulated direct food additives for use in food-contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances. In order to determine whether the intended use of a substance in a food-contact article meets the threshold criteria, certain information specified in § 170.39(c) must be submitted to FDA. This information includes the following components:
(1)The chemical composition of the substance for which the request is made,
(2)detailed information on the conditions of use of the substance,
(3)a clear statement of the basis for the request for exemption from regulation as a food additive,
(4)data that will enable FDA to estimate the daily dietary concentration resulting from the proposed use of the substance,
(5)results of a literature search for toxicological data on the substance and its impurities, and
(6)information on the environmental impact that would result from the proposed use. FDA uses this information to determine whether the food-contact article meets the threshold criteria. Respondents to this information collection are individual manufacturers and suppliers of substances used in food-contact articles (i.e., food packaging and food processing equipment) or of the articles themselves. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 170.39 15 1 15 48 720 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In compiling these estimates, FDA consulted its records of the number of regulation exemption requests received in the past 3 years. The annual hours per response reporting estimate is based on information received from representatives of the food packaging and processing industries and agency records. FDA estimates that approximately 15 requests per year will be submitted under the threshold of regulation exemption process of § 170.39. The threshold of regulation process offers one advantage over the premarket notification process for food-contact substances established by section 409(h) of the act (OMB control number 0910-0495) in that the use of a substance exempted by the agency is not limited to only the manufacturer or supplier who submitted the request for an exemption. Other manufacturers or suppliers may use exempted substances in food-contact articles as long as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are those for which the exemption was issued. As a result, the overall burden on both the agency and the regulated industry would be significantly less in that other manufacturers and suppliers would not have to prepare, and FDA would not have to review, similar submissions for identical components of food-contact articles used under identical conditions. Manufacturers and other interested persons can easily access an up-to-date list of exempted substances which is on display at FDA's Division of Dockets Management and on the Internet at *http://www.cfsan.fda.gov* . Having the list of exempted substances publicly available decreases the likelihood that a company would submit a food additive petition or a notification for the same type of food-contact application of a substance for which the agency has previously granted an exemption from the food additive listing regulation requirement. Dated: December 29, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6 Filed 1-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0526] International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance entitled “E15 Terminology in Pharmacogenomics.” The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The draft guidance is intended facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes. DATES: Submit written or electronic comments on the draft guidance by April 9, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed labels to assist the office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding the guidance* : Felix Frueh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 4512, Silver Spring, MD 20993-0002, 301-796-1530; or Raj K. Puri, Center for Biologics Evaluation and Research (HFM-735), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-0471. *Regarding the ICH* : Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission, the European Federation of Pharmaceutical Industries Associations, the Japanese Ministry of Health, Labour, and Welfare, the Japanese Pharmaceutical Manufacturers Association, the Centers for Drug Evaluation and Research and Biologics Evaluation and Research, FDA, and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In October 2006, the ICH Steering Committee agreed that a draft guidance entitled “E15 Terminology in Pharmacogenomics” should be made available for public comment. The draft guidance is the product of the E15 Pharmacogenomics Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the E15 Pharmacogenomics Expert Working Group. The draft guidance represents an international effort to harmonize pharmacogenomics definitions and sample coding. Inconsistent definitions make it difficult to achieve agreement on parameters for implementation of pharmacogenomics in global pharmaceutical development, and might lead to inconsistent assessments by regulators. The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. Timely harmonisation of terminology and definitions will create a common foundation for future guidance on pharmacogenomics. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/publications.htm* . Dated: December 29, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5 Filed 1-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on
(240)276-1243. *Proposed Project:* GPRA Client Outcomes for the Substance Abuse and Mental Health Services Administration (SAMHSA)—(OMB No. 0930-0208)—Revision. The mission of the Substance Abuse and Mental Health Services Administration (SAMHSA) is to improve the effectiveness and efficiency of substance abuse and mental health treatment and prevention services across the United States. All of SAMHSA's activities are designed to ultimately reduce the gap in the availability of substance abuse and mental health services and to improve their effectiveness and efficiency. Data are collected from all SAMHSA discretionary services grants and contracts where client/participant outcomes are to be assessed at three points (for the Center for Substance Abuse Treatment (CSAT): Intake, discharge, and post-intake and for the Center for Substance Abuse Prevention (CSAP): pre-intervention, post-intervention, and follow-up). SAMHSA-funded projects are required to submit these data as a contingency of their award. The analysis of the data also will help determine whether the goal of reducing health and social costs of drug use to the public is being achieved. The primary purpose of this data collection activity is to meet the reporting requirements of the Government Performance and Results Act
(GPRA)by allowing SAMHSA to quantify the effects and accomplishments of SAMHSA programs. The burden for the Center for Mental Health Services
(CMHS)will be transferred from this data collection to its own separate Office of Management and Budget
(OMB)clearance. The 60-day **Federal Register** Notice for National Outcome Measures
(NOMS)for Consumers Receiving Mental Health Services was published on Friday, June 9, 2006 (71 FR 33476). The burden for the CSAP gradually reduces due to the fact that this clearance request only pertains to a continuation of data collection for those grantees initially funded prior to FY2006. The new grantees (FY2006 and beyond) are approved under the NOMS for CSAP (OMB No. 0930-0230). CSAT has no revisions to the instrument and the data collection time will remain the same but there is an increase in the number of respondents due to identifying the seven Screening, Brief Intervention, and Referral to Treatment program grantees that provide data uploads. The estimated annual response burden for this effort is provided in the table below: Estimates of Annualized Hour Burden 1 Center/form/respondent type Number of respondents Responses per respondent Total responses Hours per response Total hour burden Added burden proportion 2 Total annual burden hours CSAP GPRA Participant Outcome Measures for Discretionary Programs Participants: FY2007 7,000 3 21,000 .33 6,930 .72 4,990 FY2008 3,000 3 9,000 .33 2,970 .72 2,138 CSAP Subtotal 10,000 3 30,000 .33 9,900 .72 7,128 CSAP Annualized Subtotal 5,000 15,000 3,564 CSAT GPRA Client Outcome Measures for Discretionary Programs Clients Adults 28,000 3 84,000 .33 27,720 .33 9,148 Adolescents 3,900 4 15,600 .33 5,148 .33 1,699 Screening, Brief Intervention and Referral to Treatment (SBIRT): 3 Screening Only 150,618 1 150,618 .10 15,062 0 0 Brief Intervention 27,679 3 83,037 .16 13,286 0 0 Brief Tx & Referral to Tx 9,200 3 27,600 .33 9,108 .33 3,006 SBIRT Client Subtotal 187,497 261,255 37,456 3,006 Client Subtotal 219,397 360,855 13,853 Data Extract by Grants: 4 Adult Records 400 grants 70 × 3 210 .16 34 34 Adolescent Records 73 grants 53 × 4 212 .16 34 34 Screening, Brief Intervention and Referral to Tx (SBIRT) Records: Screening Only 7 grants 21,517 × 1 21,517 .05 1,076 1,076 Brief Intervention 7 grants 3,954 × 3 11,862 .08 949 949 Brief Tx & Referral to Tx 7 grants 1,314 × 3 3,942 .16 631 631 Data Extract Subtotal 480 37,743 2,724 Upload 5 5 grants 171,639 1 hr. per 6,000 records 29 29 Upload Subtotal 5 grants 171,639 29 CSAT Subtotal 219,896 570,237 16,606 TOTAL 224,896 585,237 20,170 NOTES: 1. This table represents the maximum additional burden if adult respondents provide three sets of responses/data and if CSAT adolescent respondents provide four sets of responses/data. 2. Added burden proportion is an adjustment reflecting customary and usual business practices programs engage in (e.g., they already collect the data items). 3. Screening, Brief Intervention, Treatment and Referral (SBIRT) grant program: • 150,618 Screening Only
(SO)respondents complete section A of the GPRA instrument, all of these items are asked during a customary and usual intake process resulting in zero burden; and • 27,679 Brief Intervention
(BI)respondents complete sections A & B of the GPRA instrument, all of these items are asked during a customary and usual intake process resulting in zero burden; and • 9,200 Brief Treatment
(BT)& Referral to Treatment
(RT)respondents complete all sections of the GPRA instrument. 4. Data Extract by Grants: Grant burden for capturing customary and usual data. 5. Upload: 5 of the 7 SBIRT grants upload data; the other 2 grants conduct direct data entry. 6. Estimate based on $5.15 for program staff and $15 for IT staff. Written comments and recommendations concerning the proposed information collection should be sent by February 5, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: December 22, 2006. Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E6-22576 Filed 1-5-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Coast Guard DEPARTMENT OF TRANSPORTATION [USCG-2006-24685] Long Range Aids to Navigation (LORAN) Program; Office of Navigation and Spectrum Management AGENCY: Coast Guard, DHS, Office of the Secretary, DOT. ACTION: Notice; request for public comments. SUMMARY: The Department of Transportation in coordination with the Department of Homeland Security is considering the need to continue to operate or invest in the North American LORAN-C Radionavigation System beyond fiscal year 2007. Future investment decisions might include: Decommissioning the LORAN-C system, maintaining the LORAN-C system as currently configured, or developing a fully deployed Enhanced LORAN (eLORAN) system. Contributing factors to these decisions are
(1)whether the Global Positioning System
(GPS)and other available back-up systems are adequate for the public's navigation and timing needs, thus making the LORAN-C system redundant, and
(2)whether the eLORAN investments made to date provide enhancements that now merit consideration as a complementary capability to GPS, and not merely as a GPS back-up. The Department of Transportation and the Department of Homeland Security seek public input on the various decisions currently under consideration. For more information on LORAN, you may visit *http://www.navcen.uscg.gov.* DATES: Comments and related material must reach the Docket Management Facility on or before February 7, 2007. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2006-24685 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)*Web Site: http://dms.dot.gov.*
(2)*Mail:* Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001.
(3)*Fax:* 202-493-2251.
(4)*Delivery:* Room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329. FOR FURTHER INFORMATION CONTACT: If you have questions on this notice, call Mr. Greg Wheeler, Department of Transportation, Office of Navigation and Spectrum Policy, 202-366-4894, e-mail *Greg.Wheeler@dot.gov* or LT Michael Herring, Project Officer, Office of Navigation Systems, Coast Guard, telephone 202-372-1561, e-mail *Michael.L.Herring@uscg.mil.* If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-493-0402. You may obtain a copy of this notice by calling the U.S. Coast Guard Infoline at 1-800-368-5647 or read it on the Internet on the Coast Guard Navigation Center Web site at *http://www.navcen.uscg.gov* or at *http://dms.dot.gov.* SUPPLEMENTARY INFORMATION: Request for Comments All comments received will be posted, without change, to *http://dms.dot.gov* and will include any personal information you have provided. Please see DOT's “Privacy Act” paragraph below. *Submitting comments:* If you submit a comment, please include your name and address, identify the docket number for this notice (USCG-2006-24685) and give the reason for each comment. You may submit your comments by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments received during the comment period. *Viewing comments and documents:* To view comments, go to *http://dms.dot.gov* at any time, click on “Simple Search,” enter the last five digits of the docket number for this notice, and click on “Search.” You may also visit the Docket Management Facility in room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. *Privacy Act:* Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://dms.dot.gov.* Background and Purpose The North American LORAN-C system is a low frequency hyperbolic radionavigation system. It is approved for use in the U.S. Coastal Confluence Zone
(CCZ)and as a supplemental air navigation aid. More information about LORAN-C is available at: *http://www.navcen.uscg.gov/loran/default.htm.* While the current LORAN-C system is based on technology developed in the 1960's, a portion of the stations have been updated to allow for an enhanced signal (Enhanced LORAN) once the entire system is upgraded. More information about Enhanced LORAN (eLORAN) is available at: *http://www.navcen.uscg.gov/loran/9th-pulse-modulation-ldc.html.* Although eLORAN would improve both the accuracy and reliability of LORAN transmissions, and provide a precise timing service, further capital investment would be required before such a system would be fully operational. The Department of Transportation and the Department of Homeland Security are evaluating:
(1)Decommissioning the LORAN system,
(2)maintaining the system as currently configured, and
(3)whether further investment in modernizing and improving LORAN is in the public interest. Next Steps for this Project At this time, the Department of Transportation and the Department of Homeland Security seek public input on the various decisions currently under consideration, namely
(1)the extent to which the current LORAN-C in its current form is used for positioning, navigation and timing, and
(2)the extent to which eLORAN would be applied to these same practices as either a complementary service or as a backup to GPS. After considering all comments, the Department of Transportation and the Department of Homeland Security will inform the public of the agreed course of action with respect to future investment in LORAN. Dated: December 22, 2006. Robert Zitz, Deputy Under Secretary for Preparedness, Department of Homeland Security. Jeffrey N. Shane, Under Secretary for Policy, Department of Transportation. [FR Doc. E6-22421 Filed 1-5-07; 8:45 am] BILLING CODE 4910-15-P INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, AND UNITED STATES SECTION Notice of Availability of a Draft Environmental Assessment and Finding of No Significant Impact for Improvements to the Lateral A/Retamal Dike Levee System, in the Lower Rio Grande Flood Control Project, located in Hidalgo County, TX AGENCY: United States Section, International Boundary and Water Commission, United States and Mexico. ACTION: Notice of Availability of Draft Environmental Assessment
(EA)and Draft Finding of No Significant Impact (FONSI). SUMMARY: Pursuant to Section 102(2)(c) of the National Environmental Policy Act
(NEPA)of 1969, the Council on Environmental Quality Final Regulations (40 CFR Parts 1500 through 1508), and the United States Section, International Boundary and Water Commission's (USIBWC) Operational Procedures for Implementing Section 102 of NEPA, published in the **Federal Register** September 2, 1981, (46 FR 44083); the USIBWC hereby gives notice that the Draft Environmental Assessment and FONSI for Improvements to the Lateral A/Retamal Dike Levee System, in the Lower Rio Grande Flood Control Project, located in Hidalgo County, Texas, are available. FOR FURTHER INFORMATION CONTACT: Daniel Borunda, Environmental Protection Specialist, Environmental Management Division, United States Section, International Boundary and Water Commission; 4171 N. Mesa, C-100; El Paso, Texas 79902. Telephone:
(915)832-4767; e-mail: *daniel.borunda@ibwc.state.gov.* DATES: Comments on the Draft EA and Draft FONSI will be accepted through February 5, 2007. SUPPLEMENTARY INFORMATION: Background The USIBWC is authorized to construct, operate, and maintain any project or works projected by the United States of America on the Lower Rio Grande Flood Control Project (LRGFCP), as authorized by the Act of the 74th Congress, Sess. I Ch. 561 (H.R. 6453), approved August 19, 1935 (49 Stat. 660), and codified at 22 U.S.C. Section 277, 277a, 277b, 277c, and Acts amendatory thereof and supplementary thereto. The LRGFCP was constructed to protect urban, suburban, and highly developed irrigated farmland along the Rio Grande delta in the United States and Mexico. The USIBWC, in cooperation with the U.S. Fish and Wildlife Service (USFWS), prepared this Draft Environmental Assessment (Draft EA) for the proposed action of raising the Lateral A/Retamal Dike Levee System located in Hidalgo County, Texas to improve flood control. This levee system is part of the LRGFCP that extends approximately 180 miles from the Town of Peñitas in south Texas to the Gulf of Mexico. The Lateral A/Retamal Dike Levee System extends approximately 14 miles, from the Carlson Settling Basin to Retamal Diversion Dam. Proposed Action The Proposed Action would increase the flood containment capacity of the Lateral A/Retamal Dike System to meet the 3-foot freeboard design criterion for flood protection. Throughout the approximately 11.5-mile Lateral A segment, height increases between 1.5 and 4 feet are typically needed to reach the design freeboard value. For the 3.5-mile Retamal Dike segment, typical increases in levee height range from 0 to 2 feet. The increase in levee height will result in an expansion to the levee footprint by lateral extension of the structure. Structural improvements, such as a slurry cutoff barrier or a riverside impermeable liner, may be required for some levee segments where seepage is a potential problem. Alternatives to the Proposed Action A No Action Alternative was evaluated for the Lateral A/Retamal Dike System. This alternative will retain the existing configuration of the system, as designed over 30 years ago, and the current level of protection currently associated with this system. Under severe storm events, current containment capacity may be insufficient to fully control Rio Grande flooding, with risks to personal safety and potential property damage. Summary of Findings Pursuant to NEPA guidance (40 Code of Federal Regulations 1500-1508), The President's Council on Environmental Quality issued regulations for NEPA implementation which included provisions for both the content and procedural aspects of the required Environmental Assessment. The USIBWC completed an EA of the potential environmental consequences of raising the Lateral A/Retamal Dike System to meet current requirements for flood control. The EA, which supports this Finding of No Significant Impact, evaluated the Proposed Action and No Action Alternative. Levee System Evaluation No Action Alternative The No Action Alternative was evaluated as the single alternative action to the Proposed Action. The No Action Alternative will retain the current configuration of the Lateral A/Retamal Dike System, with no impacts to biological and cultural resources, land use, community resources, or environmental health issues. In terms of flood protection, however, current containment capacity under the No Action Alternative may be insufficient to fully control Rio Grande flooding under severe storm events, with associated risks to personal safety and property. Proposed Action Biological Resources Improvements to the Lateral A/Retamal Dike Levee would require vegetation removal. The approximate removal is 151 acres of herbaceous vegetation, 3 acres of Mesquite-Acacia woodland, and 8 acres of Texas Ebony-Anacua forest. Given its small extent, woodland removal would have a minimum impact on wildlife habitat. No significant effects are anticipated for any of the 25 threatened and endangered species with potential habitat near the right-of-way (ROW). None of 17 wetlands located within the ROW are located within the construction corridor and would be impacted by the potential levee expansion. Indirect impacts to wetlands near the corridor will be avoided, as required, by modification of the levee expansion alignment. Cultural Resources Improvements to the Lateral A/Retamal Levee system may adversely affect known archaeological resources, by mechanical excavation or by burial under the expanded levee footprint. Resources potentially affected include nine areas with a high probability to contain historic or prehistoric archaeological materials, and two known archaeological sites. Historic-age resources would also be affected, primarily structures associated with irrigation canals along the levee. These resources are the levee, canals, weir gates, standpipes, bridges, and residential structures. Several of the historic-age resources identified are located landside of the levee, across irrigation canals, and will not be adversely affected or minimally affected. Water Resources Improvements to the levee system would increase flood containment capacity to control the design flood event with a negligible increase in water surface elevation. Levee footprint expansion would not affect water bodies. Land Use The expansion would take place almost completely within the ROW. Removal of approximately 3 acres of woodlands from natural resources management areas would be required. Levee expansion would affect less than 1 acre of active agricultural areas. Two irrigation canals along the levee would be temporarily affected by construction activities. There is a minimum potential for impacts on urban areas since no residential developments are located near the levee. Community Resources In terms of socioeconomic resources, the influx of federal funds into Hidalgo County from the levee improvement would have a positive local economic impact limited to the construction period; the impact would represent less than 1 percent of the annual county employment, income and sales values. No adverse impacts to disproportionately high minority and low-income populations were identified for construction activities. Moderate utilization of public roads is required during construction; a temporary increase in access road use would be required for equipment mobilization to staging areas. Environmental Health Issues Estimated air emissions of five criteria pollutants during construction represent less than 0.7 percent of the Hidalgo County annual emissions inventory. There would be a moderate increase in ambient noise levels due to excavation and fill activities. No long-term and regular exposure is expected above noise threshold values. A database search identified no waste storage or disposal sites within the expanded levee footprint and its vicinity. Best Management Practices and Mitigation Engineering design measures will be used, including optimization of the levee expansion alignment to avoid impacts on wooded vegetation, wetlands, and other natural resources. Riverside expansion will be used for a majority of the Lateral A/Retamal Dike Levee System. During construction, best management practices will include development of a storm water pollution prevention plan to minimize impacts of receiving waters, and use of sediment barriers and soil wetting to minimize erosion. To protect vegetation, the construction corridor may be re-vegetated with herbaceous or woody vegetation, as agreed with the natural resources management organization where the corridor is located. Final surveys prior to the start of the project would determine the types and amounts of vegetation to be removed, and separation between construction corridor and boundaries of wetlands. To protect wildlife, construction activities will be scheduled to occur, to the extent possible, outside the bird migratory season. If buried cultural materials are encountered during construction, work would cease and notification given to the State Historic Preservation Officer. Mitigation actions recommended by the Texas Historical Commission
(THC)for potential impacts to historical or archaeological resources will be specified in a Memorandum of Agreement between THC and the USIBWC. Availability Single hard copies of the Draft Environmental Assessment and Finding of No Significant Impact may be obtained by request at the above address. Electronic copies may also be obtained from the USIBWC Home Page at *http://www.ibwc.state.gov.* Dated: December 29, 2006. Allen Thomas, Attorney Advisor. [FR Doc. E7-46 Filed 1-5-07; 8:45 am] BILLING CODE 7010-01-P JUDICIAL CONFERENCE OF THE UNITED STATES Hearing of the Judicial Conference Advisory Committee on Rules of Bankruptcy Procedure AGENCY: Judicial Conference of the United States, Advisory Committee on Rules of Bankruptcy Procedure. ACTION: Notice of cancellation of open hearing. SUMMARY: The public hearing on proposed amendments to the Federal Rules of Bankruptcy Procedure, scheduled for January 22, in Washington, DC, has been canceled. [Original notice of hearing appeared in the **Federal Register** of October 2, 2006.] FOR FURTHER INFORMATION CONTACT: John K. Rabiej, Chief, Rules Committee Support Office, Administrative Office of the United States Courts, Washington, DC 20544, telephone
(202)502-1820. Dated: December 22, 2006. John K. Rabiej, Chief, Rules Committee Support Office. [FR Doc. 07-6 Filed 1-5-07; 8:45 am]
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Traces to 6 documents
4 references not yet in our index
- 21 CFR 170
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- 49 Stat. 660
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Cite21 CFR 170
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Stat.49 Stat. 660
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