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Code · REGISTER · 2008-07-29 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Announcement of meeting

24,054 words·~109 min read·/register/2008/07/29/08-1473

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting ACTION: Announcement of meeting. SUMMARY: This notice announces the 28th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). DATES: August 19, 2008, from 1 p.m. to 4 p.m. [Eastern] ADDRESSES:
Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 1114. Please bring photo ID for entry to a Federal building. FOR FURTHER INFORMATION CONTACT: *http://www.hhs.gov/healthit/ahic/consumer/.* SUPPLEMENTARY INFORMATION: The Workgroup will continue its discussion on how to encourage the widespread adoption of a personal health record that is easy-to-use, portable, longitudinal, affordable, and consumer-centered. The meeting will be available via Web cast.
For additional information, go to: *http://www.hhs.gov/healthit/ahic/consumer/ce_instruct.html* . Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. E8-17297 Filed 7-28-08; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting ACTION:
Announcement of meeting. SUMMARY: This notice announces the 19th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). DATES: August 5, 2008, from 1 p.m. to 4 p.m. [Eastern]. ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 1114. Please use the C Street entrance closest to 3rd Street and bring photo ID for entry to a Federal building.
FOR FURTHER INFORMATION CONTACT: *http://www.hhs.gov/healthit/ahic/quality/.* SUPPLEMENTARY INFORMATION: The Workgroup will continue its discussion on how health information technology can provide the data needed for the development of quality measures that are useful to patients and others in the health care industry, automate the measurement and reporting of a comprehensive current and future set of quality measures, and accelerate the use of clinical decision support that can improve performance on those quality measures.
The meeting will be available via Web cast. For additional information, go to: *http://www.hhs.gov/healthit/ahic/quality/quality_instruct.html* . Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. E8-17298 Filed 7-28-08; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology;
American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting ACTION: Announcement of meeting. SUMMARY: This notice announces the 22nd meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.). DATES: August 21, 2008, from 1 p.m. to 5 p.m. [Eastern Time]. ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 1114.
Please use the C Street entrance closest to 3rd Street and bring photo ID for entry to a Federal building. FOR FURTHER INFORMATION CONACT: *http://www.hhs.gov/healthit/ahic/confidentiality/.* SUPPLEMENTARY INFORMATION: The Workgroup Members will continue discussing and evaluating the confidentiality, privacy, and security protections and requirements for participants in electronic health information exchange environments. The meeting will be available via Web cast. For additional information, go to: *http://www.hhs.gov/healthit/ahic/cps_instruct.html* .
Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc. E8-17313 Filed 7-28-08; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting ACTION: Announcement of meeting.
SUMMARY: This notice announces the 29th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.). DATES: August 20, 2008, from 2 p.m. to 5 p.m. [Eastern Time]. ADDRESSES: Mary C. Switzer Building (330 C Street, SW., Washington, DC 20201), Conference Room 1114. Please use the C Street entrance closest to 3rd Street and bring photo ID for entry to a Federal building.
FOR FURTHER INFORMATION CONTACT: *http://www.hhs.gov/healthit/ahic/population/.* SUPPLEMENTARY INFORMATION: The Workgroup will continue its discussion on how to facilitate the flow of reliable health information among population health and clinical care systems necessary to protect and improve the public's health. The meeting will be available via Web cast. For additional information, go to: *http://www.hhs.gov/healthit/ahic/population/pop_instruct.html* . Judith Sparrow, Director, American Health Information Community, Office of Programs and Coordination, Office of the National Coordinator for Health Information Technology. [FR Doc.
E8-17314 Filed 7-28-08; 8:45 am] BILLING CODE 4150-45-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0389] Food and Drug Administration Amendments Act of 2007; Prohibition Against Food to Which Drugs or Biological Products Have Been Added; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration
(FDA)is requesting comments relevant to the implementation of section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. FDA requests that interested persons submit data, information, and comments that will help provide a context for the agency's decisions on implementation of this provision. To encourage responsive comments, FDA is including a series of questions for interested persons to consider in preparing comments. DATES: Submit written or electronic comments by October 27, 2008. ADDRESSES: Submit written comments, data, and other information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Catherine L. Copp, Center for Food Safety and Applied Nutrition (HFS-4), Food and Drug Administration, 301-436-1589, e-mail: *catherine.copp@ fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA) was enacted. Section 912 of FDAAA establishes section 301(ll) in the Federal Food, Drug, and Cosmetic Act (the act), 21 U.S.C. 331(ll), which adds the following prohibited act to section 301.21 U.S.C. 331: The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless--
(1)such drug or such biological product was marketed in food before any approval of the drug under section 505, before licensure of the biological product under such section 351, and before any substantial clinical investigations involving the drug or the biological product have been instituted;(2) the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food;(3) the use of the drug or the biological product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with--
(A)a regulation issued under section 409 prescribing conditions of safe use in food;(B) a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;(C) the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier's determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;(D) a food contact substance notification that is effective under section 409(h); or(E) such drug or biological product had been marketed for smoking cessation prior to the date of the enactment of the Food and Drug Administration Amendments Act of 2007; or
(4)the drug is a new animal drug whose use is not unsafe under section 512. Section 301(ll) makes it a prohibited act to ship in interstate commerce certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of certain foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Under the act, persons who commit a prohibited act may be enjoined, 21 U.S.C. 332, or prosecuted criminally, 21 U.S.C. 333. In addition, a food which may not, under the provisions of section 301(ll), be introduced or delivered for introduction into interstate commerce, is subject to seizure and forfeiture, 21 U.S.C. 334, and under 21 U.S.C. 381, a food offered for import into the United States that appears to be prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) is subject to refusal of admission. The language of section 301(ll) has a number of parallels to, as well as significant differences from, the language of a similar provision in section 201(ff)(3)(B) (21 U.S.C. 321(ff)(3)(B)), which is part of the act's definition of “dietary supplement.” Although there is legislative history of FDAAA, including a report from the House committee with jurisdiction (H. Rep. No. 225, 110th Cong., 2d Sess. (2007)), section 301(ll) is not addressed in that legislative history. The Secretary of Health and Human Services has delegated to the Commissioner of Food and Drugs the principal responsibility for administering the act. As the administering agency, it is FDA's responsibility generally to implement amendments to the act, including the amendments made by section 912 of FDAAA. Section 301(ll) presents a number of questions of statutory interpretation for FDA to consider. The scope of the agency's discretion to interpret section 301(ll) is defined by the Supreme Court's decision in *Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.* , 467 U.S. 837 (1984). Under *Chevron* , if the language of a statute makes Congressional intent on a particular question clear and unambiguous, the agency charged with administering the statute must give effect to that intent. *Chevron* , 467 U.S. at 842-43. If the statute is silent or ambiguous on the question, however, the agency is permitted to give the statute a reasonable construction, *Chevron* , 467 U.S. at 844-845, and that construction is entitled to deference. *Chevron* , 467 U.S. at 844. II. Questions Presented FDA believes that a fuller understanding of the impact of various interpretations of section 301(ll) would be beneficial as the agency considers how to implement this new provision. Accordingly, FDA is requesting that interested persons submit data, information, and other comments regarding possible approaches to implementation. To guide those submissions and responses, the agency has prepared the following questions. FDA suggests that, in preparing responses to this request for comments, interested persons consider the following: A. Food Section 301(ll) prohibits the introduction or delivery for introduction into interstate commerce of certain “food.” Under section 201(f), “food” means articles used for food or drink for man or other animals, chewing gum, and articles used for components of such articles. Food includes human food, including infant formula, medical foods, and dietary supplements; food contact substances, including food packaging; and animal feed, including pet food and feed ingredients. Consistent with the broad definition of “food” in section 201(f), FDA seeks information about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products. 1. What types or categories of food would likely be subject to the prohibition of section 301(ll)? What types or categories are likely to be unaffected by section 301(ll)? If possible, please provide specific examples of these foods. 2. What is the likely impact of applying section 301(ll) to infant formula? Are there substances used or potentially used in infant formula that would be prohibited from such use by section 301(ll)? 3. What is the likely impact of applying section 301(ll) to dietary supplements? Are there substances used or potentially used in or as dietary supplements that would be prohibited from such use by section 301(ll)? What would be the advantages and disadvantages of applying both section 301(ll) and section 201(ff)(3)(B) to dietary supplements? Would such an approach lead to more effective regulation or less effective regulation of these products, and why? 4. What is the likely impact of applying section 301(ll) to animal feed? Are there substances used or potentially used in animal feed, including pet food and feed ingredients, that would be prohibited from such use by section 301(ll)? 5. What is the likely impact of interpreting “food” in section 301(ll) to include food contact substances, including packaging components that meet the definition of a food additive? Are there substances used or potentially used in food packaging or other food contact substances that would be prohibited from such use by section 301(ll)? B. Previously Marketed Foods Now Barred from Interstate Commerce Section 301(ll) identifies a category of foods that can no longer be introduced or delivered for introduction into interstate commerce although these foods were allowed in interstate commerce before the enactment of FDAAA. Specifically, if a food contains a substance that is an approved drug, that is a licensed biological product, or that has been the subject of substantial clinical investigations that have been made public, and if the substance was added to the food to have an independent biological or therapeutic effect on the person consuming it, rather than to enhance the safety of the food, the food is now barred from interstate commerce if any substantial clinical investigations of the substance were instituted, or the drug was approved or the biologic was licensed, prior to the first marketing of the substance in food. FDA seeks information on foods in this category that were legally marketed prior to the enactment of FDAAA but that are now barred from interstate commerce. 1. How many and what types of foods would be affected? What would be the impact on businesses that produce and sell these foods? 2. What would be the impact on consumers who currently use the products? 3. If possible, please provide specific examples of affected foods. C. Drug Section 301(ll) prohibits the introduction or delivery for introduction into interstate commerce of food to which has been added a “drug approved under section 505.” Implementing section 301(ll)'s restrictions on adding approved drugs to food will require FDA to consider how the identity of a “drug” is to be determined for purposes of section 301(ll). 1. What would be the impact of deeming two substances to be identical if they are chemically identical? 2. Are there approved drugs that cannot be identified by their chemical structure? If so, what would be a scientifically accurate and technically feasible way for FDA to determine the identity of the “drug approved under section 505” or “drug * * * for which substantial clinical investigations have been instituted” and consider whether that drug was marketed in food before the drug's approval by FDA or before the initiation of the substantial clinical investigations? Which drugs or classes of drugs cannot be identified by their chemical structure? D. Biological Product Section 301(ll) prohibits the introduction or delivery for introduction into interstate commerce of food to which has been added a “biological product licensed under section 351 of the Public Health Service Act.” Under section 351(i) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(i)), a “biological product” means “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” • What are the special concerns, if any, related to determining whether a biological product that is added to food has previously been licensed under section 351 of the PHS Act? E. Clinical Investigations Section 301(ll) prohibits the introduction or delivery for introduction into interstate commerce of food to which has been added a “drug” or a “biological product” for which “substantial clinical investigations have been instituted” and for which “the existence of such investigations has been made public,” unless the drug or the biological product was “marketed in food * * * before any substantial clinical investigations involving the drug or the biological product have been instituted.” 1. What is the likely impact of interpreting “clinical investigations” to refer exclusively to studies in humans? 2. What is the likely impact of interpreting the existence of substantial clinical investigations of a substance in humans to prevent the addition of such substance to animal feed, including pet food and feed ingredients? 3. What factors should FDA consider in deciding whether clinical investigations of a substance are “substantial?” 4. What factors should FDA consider in determining whether substantial clinical investigations “involv[ed] the drug or the biological product?” 5. Could this provision operate as a disincentive to conduct clinical studies of substances intended for use in products to be marketed as conventional foods or dietary supplements? If so, is there an approach to implementation that could minimize or eliminate this disincentive? 6. To the extent that this provision discourages clinical investigations of substances added to food and the public disclosure of such investigations, what is the likely impact of this provision on so-called self-determinations of the general recognition of safety
(GRAS)of substances added to food? F. Marketed Under section 301(ll)(1), a food containing an approved drug or a licensed biological product may be shipped in interstate commerce if the drug or the biological product was “marketed in food” prior to the approval of the drug, the licensing of the biological product, or the initiation of substantial clinical investigations of the drug or biological product. Section 201(ff) contains a similar provision. Section 201(ff) uses the phrase “marketed as a dietary supplement or as a food,” however, while section 301(ll) uses the phrase “marketed in food.” In the context of section 201(ff), FDA has evaluated whether a substance has been “marketed” within the meaning of that provision by considering:
(1)Whether the substance itself has been sold or offered for sale, either as a finished product or as an ingredient;
(2)for substances that are not sold separately but are components present in a marketed product, whether the component itself was marketed to prospective purchasers through, e.g., labeling or advertising for the product that made claims about the component or otherwise highlighted its presence. *See Pharmanex* v. *Shalala* , 2001 WL 741419, at *4 & n.5 (D. Utah March 30, 2001). 1. What would be the likely impact of interpreting the term “marketed” the same way in section 301(ll) as in section 201(ff)? What could be the regulatory significance, if any, of the differing phrases “marketed in food” (section 301(ll)) and “marketed as a dietary supplement or as a food” (section 201(ff))? 2. What could be the significance, if any, of the marketing in food of an approved drug or a licensed biological product outside the United States? 3. What factors should be considered the indicia of being “marketed in food?” What types of evidence should FDA consider in deciding whether a substance has been “marketed in food?” G. Enhance The Safety of The Food Supply Section 301(ll)(3) provides an exception to the prohibition of adding a drug or biological product to a food if use of the drug or biological product is “to enhance the safety of the food * * * and not to have independent biological or therapeutic effects on humans.” 1. What factors should FDA consider in determining whether the use of a substance in food is to “enhance the safety of the food” within the meaning of section 301(ll)? 2. What would be the likely impact of each of the following possible interpretations of what kinds of uses “enhance the safety of the food?” • The addition of a substance to a food enhances the safety of the food only if such addition reduces a risk not inherent in the food itself, such as the risk of microbial or other contamination. • The addition of a substance to a food enhances the safety of the food if such addition reduces either a risk inherent to the food itself, such as inherent toxicity or a risk that derives from the nutritional content of the food (e.g., high saturated fat content), or a risk not inherent in the food itself, such as the risk of microbial or other contamination. H. Independent biological or therapeutic effects on humans As noted, section 301(ll)(3) provides an exception to the prohibition of adding a drug or biological product to a food if use of the drug or biological product is “to enhance the safety of the food * * * and not to have independent biological or therapeutic effects on humans.” 1. What factors should FDA consider in determining whether the use of a substance in food is to have a “biological” effect on humans? 2. What factors should FDA consider in determining whether the use of a substance in food is to have a biological effect on humans that is “independent?” 3. What factors should FDA consider in determining whether the use of a substance in food is to have a “therapeutic” effect on humans? 4. What factors should FDA consider in determining whether the use of a substance in food is to have a therapeutic impact on humans that is “independent?” I. In the Secretary's Discretion Section 301(ll)(2) permits the addition of a drug or biological product to a food “if the Secretary, in the Secretary's discretion, has issued a regulation after notice and comment, approving the use * * * in food.” As noted, the Secretary has delegated his authority under the act to the Commissioner of Food and Drugs. 1. What factors should the Commissioner consider in exercising his discretion under section 301(ll)(2)? 2. What should be the impact, if any, on the exercise of the Commissioner's discretion where use of the drug or biological product in food has been the subject of another statutory or administrative process (e.g., a food contact substance notification that is effective under section 409(h))? III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . Dated: July 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-17356 Filed 7-28-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-P-0300] (formerly 2007P-0326) Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction AGENCY: Food and Drug Administration. HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the **Federal Register** of July 15, 2008 (73 FR 40582). The document announced the determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: In FR Doc. E8-15998, appearing on page 40582 in the **Federal Register** of Tuesday, July 15, 2008, the following correction is made: 1. On page 40582, in the third column, in the headings section of the document, “[Docket No. FDA-2007-P-0326]” is corrected to read “[Docket No. FDA-2007-P-0300] (formerly 2007P-0326)”. Dated: July 22, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-17303 Filed 7-28-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0406] Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards on Frequently Asked Questions—Statement of Investigator (Form FDA 1572); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft information sheet guidance entitled “Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This draft information sheet guidance provides FDA's responses to the most frequently asked questions. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft information sheet guidance by September 29, 2008. ADDRESSES: Submit written comments on this draft information sheet 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.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft information sheet guidance document. FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Office of Science and Health Coordination/Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301-827-3340. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft information sheet guidance for sponsors, clinical investigators, and IRBs entitled “Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” This guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of investigational drugs and biologics in complying with the requirement that each investigator complete and sign a Form FDA 1572 before participating in an investigation. It describes how to complete the Statement of Investigator form (Form FDA 1572). FDA developed this draft information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. In this draft guidance, we provide answers to frequently asked questions concerning the purpose of this form, when this form needs to be completed and signed by the investigator, how to best complete the various blocks within the form, and when the form might need to be updated. In addition, we clarify questions related to the use of Form FDA 1572 by clinical investigators participating in studies conducted outside the United States that may or may not be under an investigational new drug application. This information sheet guidance is part of the Information Sheet Guidance Initiative announced in the **Federal Register** of February 3, 2006 (71 FR 5861), which describes FDA's intention to update the process for developing, issuing, and making available guidances intended for IRBs, clinical investigators, and sponsors. Known as “Information Sheets,” these guidances have provided recommendations to IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in research regulated by the FDA since the early 1980s. The Information Sheet Guidance Initiative is intended to ensure that the Information Sheets are consistent with the FDA's good guidance practices (GGPs). As part of the initiative, which will be ongoing, the agency plans to rescind Information Sheets that are obsolete, revise and reissue Information Sheet Guidances that address current issues, and develop new Information Sheet Guidances as needed. This draft information sheet guidance is being issued consistent with FDA's GGPs regulation (21 CFR 10.115). The draft information sheet guidance, when finalized, will represent the agency's current thinking on completing Form FDA 1572. 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. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information for Form FDA 1572 have been approved under OMB Control No. 0910-0014. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. 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. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at *http://www.regulations.gov* . IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/oc/gcp/draft.html* or *http://www.regulations.gov* . Dated: July 21, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-17305 Filed 7-28-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Blood Products Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on September 10, 2008, from 8 a.m. to 5:45 p.m. and on September 11, 2008, from 8 a.m. to 3 p.m. *Location* : Hilton Hotel, Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. *Contact Person* : Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research
(CBER)(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014519516. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On the morning of September 10, 2008, the Committee will hear an update on the May 29 to 30, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Following this update, the Committee will discuss strategies to enhance bacterial safety of 7 day platelets for transfusion. In the afternoon, the Committee will discuss iron status in blood donors. On September 11, 2008, the Committee will hear updates on the following topics:
(1)April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers;
(2)July 10 to 11, 2008, blood establishment computer software conference;
(3)the development of an automated Biologics License Application submission system; and
(4)Draft Guidance for Industry: Re-qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc). Following these updates, the Committee will discuss options for blood donor screening and re-entry for malaria. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 2, 2008. Oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:30 a.m. and between approximately 4 p.m. and 4:30 p.m. on September 10, 2008, and between approximately 9:15 a.m. and 9:45 a.m. and between approximately 1:30 p.m. and 2 p.m. on September 11, 2008. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 22, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 25, 2008. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald W. Jehn or Pearline K. Muckelvene at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-17359 Filed 7-28-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0038] Risk Communication Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. All attendees should bring some form of government-issued photo identification, such as a driver's license. *Name of Committee* : Risk Communication Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on effective risk communication. *Date and Time* : The meeting will be held on August 14, 2008, from 8 a.m. to 5 p.m. and August 15, 2008, from 8 a.m. to 2 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Lee L. Zwanziger, Office of the Commissioner, Office of Policy, Planning and Preparedness, Office of Planning (HFP-60), Food and Drug Administration, 5600 Fishers Lane (for express delivery: rm 15-22), Rockville, MD 20857, 301-827-2895, FAX: 301-827-3285, Food and Drug Administration, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 8732112560. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On August 14 and 15, 2008, the committee will meet for presentations and discussion of the scientific basis for translating principles of risk communication into practice in situations of emerging and uncertain risk. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is or will be available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 11, 2008. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on August 14 th and 10:30 to 11:30 on August 15 th . Those desiring to make formal oral presentations should notify the contact person and should submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 7, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 8, 2008. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Lee L. Zwanziger at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 17, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-17304 Filed 7-28-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration
(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail *paperwork@hrsa.gov* or call the HRSA Reports Clearance Office on
(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Sickle Cell Disease Treatment Demonstration Program (SCDTDP), Health Resources and Services Administration (HRSA): NEW In 2004 Congress enacted and the President signed into law Public Law 108-357, the American Jobs Creation Act of 2004. Section 712 of Public Law 108-357 authorized a demonstration program for the prevention and treatment of Sickle Cell Disease. The legislation was enacted to
(1)create an optional medical assistance program for individuals with Sickle Cell Diseases for treatment and education, genetic counseling and other services to prevent mortality and decrease morbidity from Sickle Cell Disease, and
(2)create a demonstration program, the SCDTDP, under HRSA. The SCDTDP provides grants to federally-qualified and nonprofit health care providers to establish geographically distributed regional networks that will work with comprehensive Sickle Cell Disease centers and community-based support organizations to provide coordinated, comprehensive, culturally competent, and family-centered care to families with Sickle Cell Disease. In fiscal year 2006, HRSA awarded four, 4-year grants to the Illinois Sickle Cell Association Network, Alabama Network for Sickle Cell Care, Access, Prevention, and Education, Carolina Partnership for Sickle Cell Treatment Continuum of Care, and the Cincinnati Sickle Cell Network. Under the authorizing legislation, a National Coordinating Center
(NCC)was established to
(1)collect, coordinate, monitor, and distribute data, best practices and findings regarding the activities of the demonstration program,
(2)identify a model protocol for eligible entities with respect to the prevention and treatment of Sickle Cell Disease,
(3)identify educational materials regarding the prevention and treatment of Sickle Cell Disease, and
(4)prepare a final report on the efficacy of the demonstration program based on evaluation findings. As part of the evaluation, pre and post utilization and satisfaction data and quality of life assessments will be collected from the demonstration clients during various phases of their participation. These data will be collected through medical record abstractions and self-report using hard copy questionnaires and submitted to the NCC for processing and analysis. The total burden estimate per participant is shown below: Type of respondent Form name Number of respondents Responses per respondent Total responses Hours per response Total burden hours Sickle Cell Disease clients or caregivers Utilization Questionnaire (pre-demonstration) 400 1 400 .75 300 Sickle Cell Disease clients or caregivers Utilization Questionnaire (post demonstration) 400 1 400 .50 200 Sickle Cell Disease clients or caregivers SF-36 Health Survey for adults over 18 years of age 280 2 560 .25 140 Parents of Sickle Cell Disease clients PedsQL for parents 120 2 240 .25 60 Sickle Cell Disease clients age 18 and younger PedsQL for children and adolescents 100 2 200 .25 50 Sickle Cell Disease clients or caregivers The Medical Home Family Index (Health Care Satisfaction) 400 2 800 .25 200 Total 500 2,600 950 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: July 23, 2008. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E8-17354 Filed 7-28-08; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel Member Conflict: Health Risks, Interventions and Outcomes. *Date:* August 5, 2008. *Time:* 11 a.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) *Contact Person:* Michael Micklin, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3136, MSC 7759, Bethesda, MD 20892,
(301)435-1258, *micklinm@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Microcirculation and Renovascular Hypertension. *Date:* August 21, 2008. *Time:* 2 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) *Contact Person:* Olga A. Tjurmina, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4030B, MSC 7814, Bethesda, MD 20892,
(301)451-1375, *ot3d@nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, Cardiac Fibrillation and Defibrillation. *Date:* September 5, 2008. *Time:* 2 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) *Contact Person:* Maqsood A. Wani, PhD, DVM, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2114, MSC 7814, Bethesda, MD 20892, 301-435-2270, *wanimaqs@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel, NIH Rapid Access to Interventional Development Review. *Date:* September 17-18, 2008. *Time:* 8 a.m. to 8 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting) *Contact Person:* James J. Li, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD 20892, 301-435-2417, *lijames@csr.nih.gov* . *Name of Committee:* Oncological Sciences Integrated Review Group, Developmental Therapeutics Study Section. *Date:* September 18-19, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Doubletree Hotel, 1515 Rhode Island Avenue, NW., Washington, DC 20005. *Contact Person:* Sharon K. Gubanich, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6214, MSC 7804,Bethesda, MD 20892,
(301)435-1767, *gubanics@csr.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: July 21, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-17166 Filed 7-28-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; Applications in Response to PAR-07-157. *Date:* August 19, 2008. *Time:* 1 p.m. to 3 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane, Room 3146, Rockville, MD 20852, (Telephone Conference Call). *Contact Person:* Katrina L Foster, PhD, Scientific Review Officer, National Inst on Alcohol Abuse & Alcoholism, National Institutes of Health, 5635 Fishers Lane, Rm. 3042,Rockville, MD 20852, 301-443-4032, *Katrina@mali.ruh.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants, National Institutes of Health, HHS) Dated: July 18, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-17165 Filed 7-28-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute on Alcohol Abuse and Alcoholism, Special Emphasis Panel, Review of Specialized
(P50)and Comprehensive
(P60)Alcohol Research Centers. *Date:* August 26, 2008. *Time:* 1:30 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5365 Fishers Lane, Rockville, MD 20852 (Telephone Conference Call). *Contact Person:* Abraham P. Bautista, PhD, Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse & Alcoholism, National Institutes of Health, 5635 Fishers Lane, Rm. 3039, Rockville, MD 20852, 301-443-9737, *bautista@mail.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants, National Institutes of Health, HHS) Dated: July 18, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-17167 Filed 7-28-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual journals. *Name of Committee:* Literature Selection Technical Review Committee. *Date:* October 23-24, 2008. *Open:* October 23, 2008, 9 a.m. to 11 a.m. *Agenda:* Administrative reports and program discussion. *Place:* National Library of Medicine, Building 38, Board Room, 2 Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Closed:* October 23, 2008, 11 a.m. to 5 p.m. *Agenda:* To review and evaluate journals as potential titles to be indexed by the National Library of Medicine. *Place:* National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Closed:* October 24, 2008, 8:30 a.m. to 2 p.m. *Agenda:* To review and evaluate journals as potential titles to be indexed by the National Library of Medicine. *Place:* National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Contact Person:* Sheldon Kotzin, MLS, Associate Director, Division of Library Operations, National Library of Medicine, 8600 Rockville Pike, Bldg 38/Room 2W06, Bethesda, MD 20894, 301-496-6921, *Sheldon Kotzin@nlm.nih.gov* . Any interested person may file written comments with the Committee by forwarding the statement to the Contact Person listed on this Notice. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government ID. will need to show a photo ID. and sign in at the security desk upon entering the building. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: July 18, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, NIH. [FR Doc. E8-17044 Filed 7-28-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities Under Emergency Review by the Office of Management and Budget The Substance Abuse and Mental Health Services Administration (SAMHSA) has submitted the following request (see below) for emergency OMB review under the Paperwork Reduction Act (44 U.S.C. Chapter 35). OMB approval has been requested by August 8, 2008. A copy of the information collection plans may be obtained by calling the SAMHSA Reports Clearance Officer on
(240)276-1243. *Title:* Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for American Indians and Alaska Natives at Risk for Substance Use and HIV/AID,
(MIA)Rapid HIV Testing Clinical Information Form—NEW. *OMB Number:* 0930-New. *Frequency:* One-time-only *Affected Public:* Tribes, Non-Profit Tribal Organization and Urban Indian Health Centers. The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center Substance Abuse Treatment (CSAT), is requesting an emergency OMB review and approval of the Minority AIDS Initiative for Collaboration for Prevention and Treatment Improvement for American Indians and Alaska Natives at Risk for Substance Use and HIV/AID,
(MIA)Rapid HIV Testing Clinical Information Form. The MAI HIV Rapid Testing Clinical Information Form would allow SAMHSA/CSAT to collect essential clinical information that will be used for quality assurance, quality performance, and product monitoring on approximately 50,000 Rapid HIV Test Kits to be provided to American Indian and Alaska Native (AI/AN) communities at no cost to the recipient provider organizations. This Program is authorized under section 509 of the Public Health Service
(PHs)Act [42 U.S.C. 290bb-2] . The purpose of the MAI is to increase HIV/Screening to American Indians and Alaska Natives at risk for substance use and thus HIV/AIDS in 13 States; build and or strengthen tribes, tribal organizations and urban Indian health centers capacity to provide HIV/AIDS education and prevention services to American Indians and Alaska Natives; reduce the stigma associated with HIV/AIDS screening through outreach and education and increase the number of American Indians and Alaska Natives who know their HIV/AIDS status. The target population for the initiative is tribes, tribal organizations, and urban Indian organizations that reside in Alaska, Arizona, California, Florida, Michigan, Nevada, New Mexico, New York, North Carolina, Oklahoma, Texas, Utah and Washington who are at risk for substance use and HIV/AIDS. The selected states are those with the highest concentration of AI/AN population based on United States Census 2000. It should be noted that 6 of these states (California, Florida, Nevada, North Carolina, and New York) are also designated Block Grant HIV State-aside states (reported 10 HIV cases per 100,000 to CDC). Additionally, the top five AI/AN AIDS Case states are—California, Oklahoma, Washington, Arizona and Alaska, which also are part of the target population. Given the history, SAMHSA could not have anticipated the need for the MAI Rapid HIV Testing Clinical Information Form earlier and is requesting an emergency OMB approval. Due to the six month shelf-life of the Rapid HIV Test Kits it is unlikely that SAMHSA will be able to distribute the kits and collect the essential clinical information prior to the expiration of the existing 20,000 Rapid HIV Test Kits without the emergency OMB approval. Emergency OMB approval will make available the immediate distribution of up to 50,000 no cost Rapid HIV Test kits to American Indian and Alaska Native communities. The MAI Rapid HIV Testing Clinical Information Form would support quality of care, provide minimum but adequate clinical and product monitoring, and provide appropriate safeguards against fraud, waste and abuse of Federal funds. SAMHSA's approach would avoid unnecessary delay in informing any person potentially adversely affected by a test kit recall or public health advisory. The following table is the estimated hour burden: Number of respondents Responses/ respondent Burden hours Total burden hours 50,000 1 .167 8,350 Written comments and recommendations concerning the proposed information collection should be sent within 30 Days of this notice to: John Kraemer, 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. Date: July 24, 2008. Christine Chen, Director, Division of Grants Management. [FR Doc. E8-17336 Filed 7-28-08; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Office of Health Affairs; BioWatch Filter Holder Log AGENCY: Office of Health Affairs, Weapons of Mass Destruction
(WMD)and Biodefense, Chem/Bio Early Detection Division, DHS. ACTION: 30-Day Notice and request for comments; New Information Collection Request 1601-NEW. SUMMARY: The Department of Homeland Security, Office of Health Affairs, WMD and Biodefense, has submitted the following information collection request
(ICR)to the Office of Management and Budget
(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). The Office of Health Affairs, WMD and Biodefense are soliciting comments concerning a new information collection request, Bio Watch Filter Holder Log Form 9500. DHS previously published this information collection request
(ICR)in the **Federal Register** on April 4, 2008 at 73 FR 18542, for a 60-day public comment period. No comments were received by DHS. The purpose of this notice is to allow additional 30-days for public comments. DATES: Comments are encouraged and will be accepted until August 28, 2008. This process is conducted in accordance with 5 CFR 1320.1. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to OMB Desk Officer for the Department of Homeland Security, Office of Health Affairs, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to
(202)395-6974. The Office of Management and Budget is particularly interested in comments which: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions 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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submissions of responses. FOR FURTHER INFORMATION CONTACT: If additional information is required contact: the Department of Homeland Security, Office of Health Affairs, WMD and Biodefense, Chem/Bio Early Detection Division, Washington, DC 20528. Attn: Division Director, Dr. Jeffrey Stiefel, 703-647-8056 or 202-254-6076. SUPPLEMENTARY INFORMATION: The Department of Homeland Security (DHS), Office of Health Affairs, WMD and Biodefense, Chem/Bio Early Detection Division requires the collection of information by BioWatch jurisdictions. The BioWatch Program operates aerosol collector equipment in approximately 30 U.S. jurisdictions to monitor for the presence of organisms that may be related to the deliberate release of a select subset of biological threat agents. Information is collected in writing by a representative of a BioWatch jurisdiction (either an employee, or a contractor) responsible for installing and removing filters from aerosol collection devices and transporting them to local laboratories for sample analysis. A standard filter holder log is completed for each sample and is archived by the BioWatch jurisdiction for a year. The DHS BioWatch Program provides financial support to the participating jurisdictions for the cost of collection and laboratory analysis activities, including the preparation of the filter holder log and other documentation. The Federal Bureau of Investigation
(FBI)has instructed the BioWatch Program to maintain a written record for each collected filter sample to support law enforcement activities, including criminal prosecution in the case of a deliberate release of a biological agent. Collection of written records establishing chain of custody for samples containing biological agents and toxins for the purpose of evidence in a criminal proceeding is consistent with the “Best Evidence Rule”, Section 1002, of the federal Rules of Evidence. The FBI instruction to the BioWatch program is consistent with Section 7 of the FBI Quality Assurance Guidelines for Laboratories Performing Microbial Forensic Work, produced by the members of the Scientific Working Group on Microbial Genetics and Forensics (SWGMGF). Such record keeping supports mandatory reporting requirements directed by The APHIS Interim Final Rule 7 CFR Part 331, Possession, Use, and Transfer of Biological Agents and Toxins; and the CDC Interim Final Rule 42 CFR Part 73 Possession, Use, and Transfer of Select Agents and Toxins, *inter alia.* Analysis *Agency:* Department of Homeland Security, Office of Health Affairs, WMD and Biodefense, Chem/Bio Early Detection Division. *Title:* BioWatch Filter Holder Log. *DHS Form:* 9500 (5/07). *OMB Number:* 1601-NEW. *Frequency:* Once daily. *Affected Public:* State, Local, and Tribal Governments. *Number of Respondents:* 522. *Estimated Time per Respondent:* 1 minute. *Total Burden Hours:* 3,182 annual burden hours. *Total Burden Cost (capital/startup):* $0.00. *Total Burden Cost (operating/maintaining):* $144,770. Dated: July 17, 2008. Richard Mangogna, Chief Information Officer. [FR Doc. E8-17338 Filed 7-28-08; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R4-ES-2008-N0183; 40120-1113-0000-C4] Endangered and Threatened Wildlife and Plants; 5-Year Status Review of 20 Southeastern Species AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice. SUMMARY: The U.S. Fish and Wildlife Service (Service) is initiating 5-year status reviews of the slender chub ( *Erimystax cahni* ), blackside dace ( *Phoxinus cumberlandensis* ), vermillion darter ( *Etheostoma chermocki* ), pygmy madtom (Noturus stanauli), palezone shiner ( *Notropis albizonatus* ), fanshell ( *Cyprogenai stegaria* ), inflated heelsplitter ( *Potamilus inflatus* ), pink mucket ( *Lampsilis abrupta* ), spruce-fir moss spider ( *Microhexura montivaga* ), cave crayfish ( *Cambarus aculabrum* ), Pyne's ground plum ( *Astragalus bibulatus* ), small-anthered bittercress ( *Cardamine micranthera* ), leafy prairie clover ( *Dalea foliosa* ), smooth coneflower ( *Echinacea laevigata* ), spreading avens ( *Geum radiatum* ), Roan Mountain bluet ( *Hedyotis purpurea var. montana* ), rough-leaved loosestrife ( *Lysimachia asperulaefolia* ), Michaux's sumac ( *Rhus michauxii* ), Alabama canebrake pitcher plant ( *Sarracenia rubra* ssp. *alabamensis* ), and Blue Ridge goldenrod ( *Solidago spithamaea* ), under section 4(c)(2) of the Endangered Species Act of 1973, as amended (Act). The purpose of reviews conducted under this section of the Act is to ensure that the classification of species as threatened or endangered on the List of Endangered and Threatened Wildlife and Plants (50 CFR 17.11 and 17.12) is accurate. A 5-year review is an assessment of the best scientific and commercial data available at the time of the review. DATES: To allow us adequate time to conduct this review, information submitted for our consideration must be received on or before September 29, 2008. However, we will continue to accept new information about any listed species at any time. ADDRESSES: Information submitted on the slender chub, pygmy madtom, Pyne's groundplum, and leafy prairie clover should be sent to Geoff Call, Tennessee Field Office, U.S. Fish and Wildlife Service, 446 Neal Street, Cookeville, TN 38501, fax 931-528-7075. Information on the palezone shiner, blackside dace, and fanshell should be sent to Mike Floyd, Kentucky Field Office, U.S. Fish and Wildlife Service, 330 W. Broadway, Rm. 265, Frankfort, KY 40601, fax 502-695-1024. Information on the smooth coneflower, Michaux's sumac, and rough-leaved loosestrife should be sent to Dale Suiter, Raleigh Field Office, U.S. Fish and Wildlife Service, P.O. Box 33726, Raleigh, NC 27636, fax 919-856-4556. Information on the pink mucket, spruce fir moss spider, spreading avens, Blue Ridge goldenrod, Roan Mountain bluet, and small-anthered bittercress should be sent to Field Supervisor, Asheville Field Office, U.S. Fish and Wildlife Service, 160 Zillicoa St., Asheville, NC 28801, fax 828-258-5330. Information on the vermillion darter, inflated heelsplitter, and Alabama canebrake pitcher plant should be sent to Cary Norquist, Mississippi Field Office, U.S. Fish and Wildlife Service, 6578 Dogwood View Pkwy., Jackson, MS 39213, fax 601-965-4340. Information on the cave crayfish should be sent to David Kampwerth, Arkansas Field Office, 110 South Amity Road, Suite 300, Conway, AR 72032, fax 501-513-4480. Information received in response to this notice of review will be available for public inspection by appointment, during regular business hours, at the same addresses. FOR FURTHER INFORMATION CONTACT: Geoff Call at Cookeville, Tennessee address above for the slender chub, pygmy madtom, Pyne's groundplum and leafy prairie clover (telephone, 931/528-6481 ext. 213, e-mail *geoff_call@fws.gov* ); Mike Floyd at the Frankfort, Kentucky, address above for the palezone shiner, blackside dace, and fanshell (telephone, 502/695-0468 ext. 102, e-mail *mike_floyd@fws.gov* ); Dale Suiter at the Raleigh, North Carolina address above for the smooth coneflower, Michaux's sumac, and rough-leaved loosestrife (telephone, 919/856-4520 ext. 18, e-mail *dale_suiter@fws.gov* ); Bob Butler at Asheville, North Carolina address above for the pink mucket (telephone, 828/258-3939 ext. 235, e-mail *robert_butler@fws.gov* ); John Fridell at the Asheville, North Carolina for the spruce fir moss spider (telephone, 828/258-3939 ext. 225, e-mail *john_fridell@fws.gov* ); Carolyn Wells at Asheville, North Carolina for the spreading avens, Blue Ridge goldenrod, Roan Mountain bluet, and small-anthered bittercress (telephone, 828/258-3939 ext. 231, *carolyn_wells@fws.gov* ); Cary Norquist at Jackson, Mississippi address above for the vermillion darter, inflated heelsplitter, and Alabama canebrake pitcher plant (telephone, 601/321-1128, e-mail *cary_norquist@fws.gov* ); and David Kampwerth at Conway, Arkansas for the cave crayfish (telephone, 501-501-4477, e-mail *david_kampwerth@fws.gov* ). SUPPLEMENTARY INFORMATION: Under the Act (16 U.S.C. 1531 *et seq.* ), the Service maintains a list of endangered and threatened wildlife and plant species at 50 CFR 17.11 (for wildlife) and 17.12 (for plants) (collectively referred to as the List). Section 4(c)(2)(A) of the Act requires that we conduct a review of listed species at least once every 5 years. Then, on the basis of such reviews, under section 4(c)(2)(B), we determine whether or not any species should be removed from the List (delisted), or reclassified from endangered to threatened or from threatened to endangered. Delisting a species must be supported by the best scientific and commercial data available and only considered if such data substantiate that the species is neither endangered nor threatened for one or more of the following reasons:
(1)The species is considered extinct;
(2)the species is considered to be recovered; and/or
(3)the original data available when the species was listed, or the interpretation of such data, were in error. Any change in Federal classification would require a separate rulemaking process. Amendments to the List through final rules are published in the **Federal Register** . The regulations at 50 CFR 424.21 require that we publish a notice in the **Federal Register** announcing those species currently under active review. This notice announces our active review of the following species that are currently listed as endangered: vermillion darter, pygmy madtom, palezone shiner, fanshell, pink mucket, spruce-fir moss spider, cave crayfish, Pyne's groundplum, small-anthered bittercress, leafy prairie clover, smooth coneflower, spreading avens, Roan Mountain bluet, rough-leaved loosestrife, Michaux's sumac, and Alabama canebrake pitcher plant. The other four species in this notice are currently listed as threatened. The List is also available on our Internet site at *http://endangered.fws.gov/wildlife.html#Species.* What information is considered in the review? A 5-year review considers the best scientific and commercial data that have become available since the current listing determination or most recent status review of each species, such as: A. Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics; B. Habitat conditions, including but not limited to amount, distribution, and suitability; C. Conservation measures that have been implemented to benefit the species; D. Threat status and trends (see five factors under heading “How do we determine whether a species is endangered or threatened?”); and E. Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods. Definitions Related to This Notice We provide the following definitions to assist individuals submitting information regarding the species being reviewed: A. *Species* includes any species or subspecies of fish, wildlife, or plant, and any distinct population segment of any species of vertebrate which interbreeds when mature. B. *Endangered* means any species that is in danger of extinction throughout all or a significant portion of its range. C. *Threatened* means any species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. How do we determine whether a species is endangered or threatened? Section 4(a)(1) of the Act establishes that we determine whether a species is endangered or threatened based on one or more of the following five factors: A. The present or threatened destruction, modification, or curtailment of its habitat or range; B. Overutilization for commercial, recreational, scientific, or educational purposes; C. Disease or predation; D. The inadequacy of existing regulatory mechanisms; or E. Other natural or manmade factors affecting its continued existence. What could happen as a result of this review? If we find that there is new information concerning any of these 20 species indicating that a change in classification may be warranted, we may propose a new rule that could do one of the following:
(a)Reclassify the species from endangered to threatened (downlist);
(b)reclassify the species from threatened to endangered (uplist); or
(c)delist the species. If we determine that a change in classification is not warranted, then the species will remain on the List under their current status. Public Solicitation of New Information We request any new information concerning the status of any of these 20 species. See “What information is considered in the review?” heading for specific criteria. Information submitted should be supported by documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources. Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home addresses, etc., but if you wish us to withhold this information, you must state this prominently at the beginning of your comments. In addition, you must present a rationale for withholding this information. This rationale must demonstrate that disclosure would constitute a clearly unwarranted invasion of privacy. Unsupported assertions will not meet this burden. In the absence of exceptional, documental circumstances, this information will be released. We will always make submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. Authority This document is published under the authority of the Endangered Species Act (16 U.S.C. 1531 *et seq.* ). Dated: June 30, 2008. Cynthia K. Dohner, Acting Regional Director. [FR Doc. E8-17368 Filed 7-28-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WY-050-08-1310-DB] Notice of Intent To Prepare an Environmental Impact Statement for the Beaver Creek Coal Bed Natural Gas Development Project, Wyoming AGENCY: Bureau of Land Management, Interior. ACTION: Notice of intent. SUMMARY: The Bureau of Land Management
(BLM)Lander Field Office intends to prepare an Environmental Impact Statement
(EIS)for a proposed coal bed natural gas
(CBNG)development approximately 9 miles southeast of Riverton, Wyoming. The proposed development project is known as the Beaver Creek Coal Bed Natural Gas Development Project (Project), located in Fremont County, Wyoming. DATES: The BLM will announce public scoping meetings hosted in Lander and Riverton, Wyoming to identify relevant issues through local media, newsletters, individual mailings, and the BLM Web site at *www.blm.gov/wy/st/en/info/NEPA/lfodocs/beavercreek_cbng.html* at least 15 days prior to each meeting. We will provide additional opportunities for public participation upon publication of the Draft EIS, including a minimum 45-day public comment period. ADDRESSES: You may submit your issues and comments related to the Beaver Creek Coal Bed Natural Gas Development Project EIS by any of the following methods: • *Web Site: www.blm.gov/wy/st/en/info/NEPA/lfodocs/beavercreek_cbng.html* . • *E-mail: Curtis_Bryan@blm.gov* . • *Fax:* 307-332-8444. • *Mail:* Lander Field Office, 1335 Main Street, Lander, WY 82520. Documents pertinent to this proposal may be examined at the Lander Field Office. FOR FURTHER INFORMATION CONTACT: For further information, contact Curtis Bryan, Telephone
(307)332-8400; E-mail: *Curtis_Bryan@blm.gov* . SUPPLEMENTARY INFORMATION: This document provides notice that the BLM Lander Field Office, Lander, Wyoming, intends to prepare an EIS on the potential impacts of a proposed natural gas field development, ancillary facilities, pipelines, and roads. The Beaver Creek Project area is located 9 miles southeast of the town of Riverton in Fremont County, Wyoming. The proposed Project is within the Beaver Creek Unit in Township 33 North, Range 96 West, in all or portions of Sections 1-4, 9-16, 21-23, and 28-29; Township 34, Range 96 West, in all or portions of Sections 20-28 and 33-36 (6th Principal Meridian). The Beaver Creek Project area encompasses approximately 16,515 acres. Approximately 82 percent of the Project area is public lands and Federal mineral estate administered by the BLM, with some interspersed State and private lands and other mineral estate. The Proponent, Devon Energy Production Co. LP (Devon) has submitted a proposal to drill up to 228 natural gas wells, of which 208 would produce CBNG and about 20 would produce conventional natural gas. The estimated drilling and completion period would occur over the course of 5 to 10 years and the life of the project is anticipated to be between 20 and 40 years. Devon proposes to drill the CBNG wells at a density of one well every 40 acres. The proposed CBNG wells are expected to be drilled vertically and would be completed in the Mesa Verde formation, while the proposed conventional gas wells would likely be completed in the Madison and Phosphoria formations. Because the target formations are located in different geologic formations, conventional gas wells may overlap with the CBNG well density. Facilities associated with the proposed project include access roads, pipelines, overhead power lines, central production facilities, four water disposal (re-injection) wells, two evaporation ponds, and equipment storage areas. The Beaver Creek Unit has experienced extensive gas development over the last 50 years, and the Proponent would utilize existing roads and facilities to the extent practical. During the short-term, while well pads are in construction, pad size is expected to be about 2.5 acres for each the CBNG wells and about 3 acres for conventional wells. This would result in an estimated total short-term well pad disturbance of about 565 acres. Following reclamation, an estimated 390 acres of surface from well pads would be left without vegetation and disturbance. Approximately 24 miles of new access roads would be constructed with most new roads developed as laterals off existing roads. Total disturbance associated with the construction of access roads is estimated to be approximately 117 acres. These roads would be open for the life of the project. In the short-term, construction and installation of approximately 66 miles of new pipelines and overhead powerlines would disturb approximately 550 acres, most of which would be reclaimed for the long-term. Produced water from the wells would be disposed of into four proposed water disposal (re-injection) wells and two proposed evaporation ponds. The injection wells would serve as the primary method of produced water disposal. No surface discharge of produced water is proposed. During the drilling phase of the proposed project, Devon estimates that the total short-term surface disturbance would be approximately 1,280 acres. After reclamation and for the life of the proposed project, Devon estimates that the long-term surface disturbance would be about 550 acres. Major issues identified at this time include: Potential impacts to air quality; disposal of produced waste water; and the potential effects of development and production on surface resources including vegetation, cultural resources, and wildlife habitat. In addition to the proposed action and the no action alternatives, other alternatives may be developed. These may include: An alternative that considers less than 228 wells; an alternative that considers re-injection of some or all produced water; and an alternative that would eliminate the need for overhead power lines by requiring the proponent to bury all power lines. Martin G. Griffith, Acting State Director. [FR Doc. E8-17327 Filed 7-28-08; 8:45 am] BILLING CODE 4310-22-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [ID-300-1020-PH; DDG080004] Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting AGENCY: Bureau of Land Management, Interior. ACTION: Notice of public meetings. SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management
(BLM)Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below. DATES: The RAC will next meet in Dubois and Idaho Falls, Idaho on September 10-11, 2008 for a two day field tour. The group will meet at the new Dubois Fire Station, Clark Ave, Dubois, Idaho starting at 10 a.m. The second day the group will be meeting at the Idaho Falls BLM Office, 1405 Hollipark Drive, Idaho Falls, Idaho at 8 a.m. followed by a tour to the desert. Meeting topics include noxious weeds, power line corridors, Snake River Activity Operations Plan, Upper Snake RMP and fire. Other topics will be scheduled as appropriate. All meetings are open to the public. SUPPLEMENTARY INFORMATION: The 15-member Council advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in the BLM Idaho Falls District (IFD), which covers eastern Idaho. All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM as provided below. FOR FURTHER INFORMATION CONTACT: Joanna Wilson, RAC Coordinator, Idaho Falls District, 1405 Hollipark Dr., Idaho Falls, ID 83401. Telephone
(208)524-7550. E-mail: *Joanna_Wilson@blm.gov* . Dated: July 23, 2008. Joanna Wilson, RAC Coordinator, Public Affairs Specialist. [FR Doc. E8-17330 Filed 7-28-08; 8:45 am] BILLING CODE 4310-GG-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [CO-922-08-1310-FI; COC70365] Notice of Proposed Reinstatement of Terminated Oil and Gas Lease AGENCY: Bureau of Land Management, Interior. ACTION: Notice of proposed reinstatement of terminated oil and gas lease. SUMMARY: Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management
(BLM)received a petition for reinstatement of oil and gas lease COC70365 from Hunt Petroleum (AEC), Inc., for lands in Rio Blanco County, Colorado. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law. FOR FURTHER INFORMATION CONTACT: Bureau of Land Management, Milada Krasilinec, Land Law Examiner, Branch of Fluid Minerals Adjudication, at 303.239.3767. SUPPLEMENTARY INFORMATION: The lessee has agreed to the amended lease terms for rentals and royalties at rates of $10.00 per acre or fraction thereof, per year and 16 2/3 percent, respectively. The lessee has paid the required $500 administrative fee and $163 to reimburse the Department for the cost of this **Federal Register** notice. The lessee has met all the requirements for reinstatement of the lease as set out in Section 31(d) and
(e)of the Mineral Lands Leasing Act of 1920 (30 U.S.C. 188), and the Bureau of Land Management is proposing to reinstate lease COC70365 effective July 1, 2008, under the original terms and conditions of the lease and the increased rental and royalty rates cited above. Dated: July 23, 2008. Milada Krasilinec, Land Law Examiner. [FR Doc. E8-17317 Filed 7-28-08; 8:45 am] BILLING CODE 4310-JB-P INTERNATIONAL TRADE COMMISSION [Investigation Nos. 332-350 and 332-351] Monitoring of U.S. Imports of Tomatoes; Monitoring of U.S. Imports of Peppers AGENCY: United States International Trade Commission ACTION: Notice of opportunity to submit information for 2008 monitoring reports. SUMMARY: Pursuant to statute (see below), the Commission monitors U.S. imports of fresh or chilled tomatoes and fresh or chilled peppers, other than chili peppers, for the purpose of expediting an investigation under certain U.S. safeguard laws, should an appropriate petition be filed. As part of that monitoring, the Commission has instituted investigations under section 332 of the Tariff Act of 1930 (19 U.S.C. 1332) for the purpose of compiling data on trade and the domestic industry. The Commission is in the process of preparing its reports for the period ending June 30, 2008, and is seeking input from interested members of the public. The Commission expects to make its reports available to the public in electronic form on the Commission's Web site in November 2008. DATES: September 11, 2008: Deadline for filing written submissions and other information. November 21, 2008: Anticipated posting of Commission report. ADDRESSES: All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street, SW., Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street, SW., Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket
(EDIS)at *http://www.usitc.gov/secretary/edis.htm.* FOR FURTHER INFORMATION CONTACT: Brendan Lynch (202-205-3313, *brendan.lynch@usitc.gov* ) or Jonathan Coleman (202-205-3465, *jonathan.coleman@usitc.gov* ), Agriculture and Fisheries Division, Office of Industries, for general information, or William Gearhart (202-205-3091, *william.gearhart@usitc.gov* ), Office of the General Counsel, for information on legal aspects. The media should contact Margaret O'Laughlin (202-205-1819 or *margaret.olaughlin@usitc.gov* ), Office of External Relations. Hearing-impaired individuals may obtain information on this matter by contacting the Commission's TDD terminal at 202-205-1810. General information concerning the Commission may also be obtained by accessing its Internet server ( *http://www.usitc.gov* ). Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. *Background:* Section 316 of the North American Free-Trade Agreement Implementation Act (NAFTA Implementation Act) (19 U.S.C. 3881) requires that the Commission monitor U.S. imports of fresh or chilled tomatoes (HTS heading 0702.00) and fresh or chilled peppers, other than chili peppers (HTS subheading 0709.60.00), until January 1, 2009, for purposes of expediting an investigation concerning provisional relief under section 202 of the Trade Act of 1974 or section 302 of the NAFTA Implementation Act. Section 316 does not require that the Commission publish reports on this monitoring activity or otherwise make the information available to the public. However, the Commission maintains current data files on tomatoes and peppers in order to conduct an expedited investigation should a request be received. Following enactment of section 316, the Commission instituted investigation No. 332-350, *Monitoring of U.S. Imports of Tomatoes* (59 FR 1763), and investigation No. 332-351, Monitoring of U.S. *Imports of Peppers* (59 FR 1762). The Commission will continue to make its reports available to the public in electronic form (with the exception of any confidential business information (CBI)), and will maintain electronic copies of its reports on its Web site until one year after the monitoring requirement expires on January 1, 2009. The most recent Commission monitoring reports in this series were published in November 2007 and are available on the Commission's Web site. *Written Submissions:* The Commission does not plan to hold a public hearing in connection with preparation of these reports. However, interested persons are invited to submit written statements containing data and other information concerning the matters to be addressed. All submissions should be addressed to the Secretary, and should be received no later than the close of business on September 11, 2008. All written submissions must conform with the provisions of section 201.8 of the Commission's *Rules of Practice and Procedure* (19 CFR 201.8). Section 201.8 requires that a signed original (or a copy so designated) and fourteen
(14)copies of each document be filed. In the event that confidential treatment of a document is requested, at least four
(4)additional copies must be filed, in which the confidential information must be deleted (see the following paragraph for further information regarding confidential business information). The Commission's rules authorize the filing of submissions with the Secretary by facsimile or electronic means only to the extent permitted by section 201.8 of the rules (see Handbook for Electronic Filing Procedures, *http://www.usitc.gov/secretary/fed_reg_notices/rules/documents/handbook_on_electronic_filing.pdf* ). Persons with questions regarding electronic filing should contact the Secretary (202-205-2000). Any submissions that contain confidential business information must also conform with the requirements of section 201.6 of the *Commission's Rules of Practice and Procedure* (19 CFR 201.6). Section 201.6 of the rules requires that the cover of the document and the individual pages be clearly marked as to whether they are the “confidential” or “non-confidential” version, and that the confidential business information be clearly identified by means of brackets. All written submissions, except for confidential business information, will be made available for inspection by interested parties. The Commission will not publish such confidential business information in the monitoring reports it posts on its Web site in a manner that would reveal the operations of the firm supplying the information. However, the Commission may include such information in any report it sends to the President under section 202 of the Trade Act of 1974 or section 302 of the NAFTA Implementation Act, if it is required to conduct an investigation involving these products under either of these statutory authorities. By order of the Commission. Issued: July 23, 2008. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-17311 Filed 7-28-08; 8:45 am] BILLING CODE 7020-02-P INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-1010 (Review)] Lawn and Garden Steel Fence Posts from China AGENCY: United States International Trade Commission. ACTION: Termination of five-year review. SUMMARY: The subject five-year review was initiated in May 2008 to determine whether revocation of the antidumping duty order on lawn and garden steel fence posts from China would be likely to lead to continuation or recurrence of material injury. On July 18, 2008, the Department of Commerce published notice that it was revoking the order effective June 12, 2008, “{b}ecause the domestic interested parties did not participate in the sunset review * * *” (73 FR 41316). Accordingly, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), the subject review is terminated. DATES: *Effective Date:* June 12, 2008. FOR FURTHER INFORMATION CONTACT: Mary Messer (202-205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server ( *http://www.usitc.gov* ). Authority: This review is being terminated under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.69 of the Commission's rules (19 CFR 207.69). By order of the Commission. Issued: July 23, 2008. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-17312 Filed 7-28-08; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—American Society of Mechanical Engineers Notice is hereby given that, on July 2, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), American Society of Mechanical Engineers (“ASME”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing additions or changes to its standards development activities. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, since March 6, 2008, ASME has established one new standards-writing committee, disbanded two standards-writing committees, published five new standards, and initiated three new standards activities within the general nature and scope of ASME's standards development activities, as specified in its original notification. More detail regarding these changes can be found at *http://www.asme.org* . On September 15, 2004, ASME filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on October 13, 2004 (69 FR 60895). The last notification was filed with the Department on March 6, 2008. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on April 7, 2008 (73 FR 18812). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-17043 Filed 7-28-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Cooperative Research Group on Clean Diesel V Notice is hereby given that, on June 24, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), Southwest Research Institute—Cooperative Research Group on Clean Diesel V (“Clean Diesel V”) has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Caterpillar, Inc., Mossville, IL; Toyota Motor Corp., Shizuoka, JAPAN and its subsidiary, Hino Motors, Ltd., Tokyo, JAPAN; EASF Catalysts LLC, Iselin, NJ; Chrysler, LLC, Auburn Hills, MI; and Shell Global Solutions (US), Inc., Houston, TX, have been added as parties to this venture. No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Clean Diesel V intends to file additional written notifications disclosing all changes in membership. On January 10, 2008, Clean Diesel V filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on February 25, 2008 (73 FR 10064). The last notification was filed with the Department on April 23, 2008. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on June 5, 2008 (73 FR 32051). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-17042 Filed 7-28-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—LiMo Foundation Notice is hereby given that, on June 12, 2008, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), LiMo Foundation (“LiMo”) filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing changes in its membership. The notifications were filed for the purpose of extending the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Specifically, Verizon Communications Inc., Basking Ridge, NJ; Texas Instruments, Dallas, TX; and Red Bend Software, Inc., Hod Hasharon, ISRAEL, have been added as parties to this venture. No other changes have been made in either the membership or planned activity of this group research project. Membership in this group research project remains open, and LiMo intends to file additional written notifications disclosing all changes in membership. On March 1, 2007, LiMo filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the **Federal Register** pursuant to Section 6(b) of the Act on April 9, 2007 (72 FR 17583). The last notification was filed with the Department on March 27, 2008. A notice was published in the **Federal Register** pursuant to Section 6(b) of the Act on May 9, 2008 (73 FR 26414). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-17041 Filed 7-28-08; 8:45 am] BILLING CODE 4410-11-M DEPARTMENT OF JUSTICE Antitrust Division Notice Pursuant to the National Cooperative Research and Production Act of 1993—Recreational Off-Highway Vehicle Organization Notice is hereby given that, on June 23, 2008, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301 *et seq.* (“the Act”), the Recreational Off-Highway Vehicle Organization
(ROVO)has filed written notifications simultaneously with the Attorney General and the Federal Trade Commission disclosing
(1)the name and principal place of business of the standards development organization and
(2)the nature and scope of its standards development activities. The notifications were filed for the purpose of invoking the Act's provisions limiting the recovery of antitrust plaintiffs to actual damages under specified circumstances. Pursuant to section 6(b) of the Act, the name and principal place of business of the standards development organization is: Recreational Off-Highway Vehicle Organization, Irvine, CA. The nature and scope of ROVO's standards development activities are: The development of a proposed voluntary standard (ANSI/ROVO-1-200_) addressing the design, configuration and performance aspects of Recreational Off-Highway Vehicles (ROVs). Patricia A. Brink, Deputy Director of Operations, Antitrust Division. [FR Doc. E8-17040 Filed 7-28-08; 8:45 am] BILLING CODE 4410-11-M NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES Delegation of Authority AGENCY: National Endowment for the Arts. ACTION: Notice. SUMMARY: Notice is hereby given of the order of succession in the absence of the Chairman of the National Endowment for the Arts. DATES: Upon publication. FOR FURTHER INFORMATION CONTACT: Craig McCord, Director of Human Resources, National Endowment for the Arts, 1100 Pennsylvania Avenue, NW., Room 627, Washington, DC 20506,
(202)682-5473. In the absence of the Chairman, those listed below are designated to exercise the duties of the Chairman: Senior Deputy Chairman, or if the incumbent is unavailable, Deputy Chairman for Management and Budget, or if the incumbent is unavailable, Deputy Chairman for Grants and Awards, or if the incumbent is unavailable, Deputy Chairman for States, Regions, and Local Arts Agencies, or if the incumbent is unavailable, Director of the Office of Government Affairs, or if the incumbent is unavailable, Chief Information Officer, or if the incumbent is unavailable, Director of the Office of Research and Analysis. This delegation will remain in effect until revoked or otherwise superseded. Kathleen Edwards, Director of Administrative Services, National Endowment for the Arts. [FR Doc. E8-17240 Filed 7-28-08; 8:45 am] BILLING CODE 7537-01-P NUCLEAR REGULATORY COMMISSION Application for a License To Export High-Enriched Uranium Pursuant to 10 CFR 110.70 (b)(2) “Public Notice of Receipt of an Application,” please take notice that the Nuclear Regulatory Commission
(NRC)has received the following request for an export license. Copies of the request can be accessed through the Public Electronic Reading Room
(PERR)link *http://www.nrc.gov/reading-rm/adams.html* at the NRC Homepage. A request for a hearing or petition for leave to intervene may be filed within 30 days after publication of this notice in the **Federal Register** . Any request for hearing or petition for leave to intervene shall be served by the requestor or petitioner upon the applicant, the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555; the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555; and the Executive Secretary, U.S. Department of State, Washington, DC 20520. A request for a hearing or petition for leave to intervene may be filed with the NRC electronically in accordance with NRC's E-Filing rule promulgated in August 2007, 72 Fed. Reg 49139 (Aug. 28, 2007). Information about filing electronically is available on timely electronic filing, at least five days prior to the filing deadline, the petitioner/requestor should contact the Office of the Secretary by e-mail at *HEARINGDOCKET@NRC.GOV* , or by calling
(301)415-1677, to request a digital ID certificate and allow for the creation of an electronic docket. In addition to a request for hearing or petition for leave to intervene, written comments, in accordance with 10 CFR 110.81, should be submitted within thirty
(30)days after publication of this notice in the **Federal Register** to Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Rulemaking and Adjudications. The information concerning this license application follows. NRC Export License Application Name of applicant date of application date received Application No. Docket No. Description of Material Material type Total quantity End use Recipient country DOE/NNSA—Y-12 National Security Complex—July 11, 2008, July 14, 2008, XSNM3545, 11005747 High-Enriched Uranium (93.35%) Up to 17.5 kilograms uranium (16.33 kilograms U-235) To fabricate targets for irradiation in the National Research Universal
(NRU)Reactor to produce medical isotopes Canada. Dated this 23rd day of July 2008 at Rockville, Maryland. For the Nuclear Regulatory Commission. Scott W. Moore, Deputy Director, Office of International Programs. [FR Doc. E8-17315 Filed 7-28-08; 8:45 am] BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION Biweekly Notice; Applications and Amendments to Facility Operating Licenses Involving No Significant Hazards Considerations I. Background Pursuant to section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC staff) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from July 3, 2008 to July 16, 2008. The last biweekly notice was published on July 15, 2008 (73 FR 40629). Notice of Consideration of Issuance of Amendments to Facility Operating Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not
(1)involve a significant increase in the probability or consequences of an accident previously evaluated; or
(2)create the possibility of a new or different kind of accident from any accident previously evaluated; or
(3)involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below. The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination. Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the **Federal Register** a notice of issuance. Should the Commission make a final No Significant Hazards Consideration Determination, any hearing will take place after issuance. The Commission expects that the need to take this action will occur very infrequently. Written comments may be submitted by mail to the Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001, and should cite the publication date and page number of this **Federal Register** notice. Written comments may also be delivered to Room 6D22, Two White Flint North, 11545 Rockville Pike, Rockville, Maryland, from 7:30 a.m. to 4:15 p.m. Federal workdays. Copies of written comments received may be examined at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1F21, 11555 Rockville Pike (first floor), Rockville, Maryland. The filing of requests for a hearing and petitions for leave to intervene is discussed below. Within 60 days after the date of publication of this notice, person(s) may file a request for a hearing with respect to issuance of the amendment to the subject facility operating license and any person whose interest may be affected by this proceeding and who wishes to participate as a party in the proceeding must file a written request via electronic submission through the NRC E-Filing system for a hearing and a petition for leave to intervene. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/doc-collections/cfr/* . If a request for a hearing or petition for leave to intervene is filed within 60 days, the Commission or a presiding officer designated by the Commission or by the Chief Administrative Judge of the Atomic Safety and Licensing Board Panel, will rule on the request and/or petition; and the Secretary or the Chief Administrative Judge of the Atomic Safety and Licensing Board will issue a notice of a hearing or an appropriate order. As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements:
(1)The name, address, and telephone number of the requestor or petitioner;
(2)the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding;
(3)the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and
(4)the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the petitioner/requestor seeks to have litigated at the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner/requestor intends to rely in proving the contention at the hearing. The petitioner/requestor must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner/requestor intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner/requestor to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party. Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing. If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment. A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated in August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the Internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below. To comply with the procedural requirements of E-Filing, at least five
(5)days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at *hearingdocket@nrc.gov* , or by calling
(301)415-1677, to request
(1)a digital ID certificate, which allows the participant (or its counsel or representative) to digitally sign documents and access the E-Submittal server for any proceeding in which it is participating; and/or
(2)creation of an electronic docket for the proceeding (even in instances in which the petitioner/requestor (or its counsel or representative) already holds an NRC-issued digital ID certificate). Each petitioner/requestor will need to download the Workplace Forms Viewer TM to access the Electronic Information Exchange (EIE), a component of the E-Filing system. The Workplace Forms Viewer TM is free and is available at *http://www.nrc.gov/site-help/e-submittals/install-viewer.html* . Information about applying for a digital ID certificate is available on NRC's public Web site at *http://www.nrc.gov/site-help/e-submittals/apply-certificates.html* . Once a petitioner/requestor has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format
(PDF)in accordance with NRC guidance available on the NRC public Web site at *http://www.nrc.gov/site-help/e-submittals.html* . A filing is considered complete at the time the filer submits its documents through EIE. To be timely, an electronic filing must be submitted to the EIE system no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of a transmission, the E-Filing system time-stamps the document and sends the submitter an e-mail notice confirming receipt of the document. The EIE system also distributes an e-mail notice that provides access to the document to the NRC Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system. A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at *http://www.nrc.gov/site-help/e-submittals.html* or by calling the NRC technical help line, which is available between 8:30 a.m. and 4:15 p.m., Eastern Time, Monday through Friday. The help line number is
(800)397-4209 or locally,
(301)415-4737. Participants who believe that they have a good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by:
(1)First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or
(2)courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board that the petition and/or request should be granted and/or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date. Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at *http://ehd.nrc.gov/EHD_Proceeding/home.asp* , unless excluded pursuant to an order of the Commission, an Atomic Safety and Licensing Board, or a Presiding Officer. Participants are requested not to include personal privacy information, such as social security numbers, home addresses, or home phone numbers in their filings. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission. For further details with respect to this amendment action, see the application for amendment which is available for public inspection at the Commission's PDR, located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/adams.html* . If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the PDR Reference staff at 1
(800)397-4209,
(301)415-4737 or by e-mail to *pdr@nrc.gov.* Dominion Nuclear Connecticut, Inc., Docket Nos. 50-336 and 50-423, Millstone Power Station, Unit Nos. 2 and 3, New London County, Connecticut *Date of amendment request:* March 25, 2008. *Description of amendment request:* The proposed amendment would revise the reactor coolant system
(RCS)specific activity to utilize a new indicator, Dose Equivalent Xenon-133 and only take into account the noble gas activity in the primary coolant, instead of the current indicator, average disintegration energy (E Bar). Specifically, the current Technical Specification 3.4.8, “Specific Activity,” limit on RCS gross specific activity would be replaced with a new limit on RCS noble gas specific activity. This change was proposed by the industry's Technical Specification Task Force
(TSTF)and is designated TSTF-490, “Deletion of E Bar Definition and Revision to RCS Specific Activity Tech. Spec. [Technical Specification].” The Nuclear Regulatory Commission
(NRC)staff issued a notice of opportunity for comment in the **Federal Register** on November 20, 2006 (71 FR 67170), on possible amendments concerning TSTF-490, including a model safety evaluation and model no significant hazards
(NSHC)determination, using the consolidated line item improvement process. The NRC staff subsequently issued a notice of availability of the models for referencing in license amendment applications in the **Federal Register** on March 15, 2007 (72 FR 12217). Dominion Nuclear Connecticut, Inc., affirmed the applicability of the following NSHC determination in its application dated March 25, 2008. *Basis for proposed no significant hazards consideration determination:* As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below, with NRC staff annotations: *Criterion 1* —The Proposed Change Does Not Involve a Significant Increase in the Probability or Consequences of an Accident Previously Evaluated. Reactor coolant specific activity is not an initiator for any accident previously evaluated. The Completion Time when primary coolant gross activity is not within limit is not an initiator for any accident previously evaluated. The current variable limit on primary coolant iodine concentration is not an initiator to any accident previously evaluated. As a result, the proposed change does not significantly increase the probability of an accident. The proposed change will limit primary coolant noble gases to concentrations consistent with the accident analyses. The proposed change to the Completion Time has no impact on the consequences of any design basis accident since the consequences of an accident during the extended Completion Time are the same as the consequences of an accident during the Completion Time. As a result, the consequences of any accident previously evaluated are not significantly increased. *Criterion 2* —The Proposed Change Does Not Create the Possibility of a New or Different Kind of Accident from any Accident Previously Evaluated. The proposed change in specific activity limits does not alter any physical part of the plant nor does it affect any plant operating parameter [besides the allowable specific activity in the RCS.] [The change which impacts the allowable specific activity in the RCS is consistent with the accident analyses.] [Therefore] [t]he change does not create the potential for a new or different kind of accident from any previously calculated. *Criterion 3* —The Proposed Change Does Not Involve a Significant Reduction in [a] Margin of Safety. The proposed change revises the limits on noble gas radioactivity in the primary coolant. [The proposed change will have no impact on the radiological consequences of a design basis accident because it will limit the RCS noble gas specific activity to be consistent with the accident analysis.] The proposed change is consistent with the assumptions in the safety analyses [and will ensure the monitored values protect the initial assumptions in the safety analyses.] [Therefore the change does no involve a reduction in a margin of safety.] Based upon the reasoning presented above and the previous discussion of the amendment request, the requested change does not involve a significant hazards consideration. The NRC staff has reviewed the licensee's analysis, with consideration of the NRC staff annotations, and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration. *Attorney for licensee:* Lillian M. Cuoco, Esquire, Senior Nuclear Counsel, Dominion Resources Services, Inc., Building 475, 5th Floor, Rope Ferry Road, Waterford, CT 06385. *NRC Branch Chief:* Harold K. Chernoff. Florida Power and Light Company, Docket Nos. 50-250 and 50-251, Turkey Point Plant, Units 3 and 4, Miami-Dade County, Florida *Date of amendment request:* September 5, 2007. *Description of amendment request:* The proposed amendment would remove notes associated with License Amendment No. 221 regarding the inoperability of the Unit 4 Rod Position Indication
(RPI)system for control rod F-8 in Shutdown Bank B and Amendment No. 230 from associated notes regarding the inoperability of the Unit 3 RPI system for control rod M-6 in Control Bank C. *Basis for proposed no significant hazards consideration determination:* As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below: 1. Will operation of the facility in accordance with this proposed change involve a significant increase in the probability or consequences of an accident previously evaluated? No. The proposed amendments do not involve a significant increase in the probability or consequences of an accident previously evaluated because the proposed amendments are purely administrative in nature. The proposed amendments do not make substantive changes to the Technical Specifications and do not affect any assumptions contained in plant safety analyses, the physical design and/or operation of the plant; and they do not affect the Technical Specifications that preserve safety analysis assumption. Therefore, the proposed changes do not affect the probability or consequences of accidents previously analyzed. 2. Does the proposed change create the probability of a new or different accident from any accident previously evaluated? No. The proposed administrative changes to the Technical Specifications do not create the possibility of a new or different kind of accident from any previously evaluated, since the proposed amendments will not change the physical plant or the modes of plant operation defined in the facility operating licenses. No new failure mode is introduced due to the proposed administrative changes, since the proposed changes do not involve the addition or modification of equipment, nor do they alter the design or operation of affected plant systems, structures, or components. Therefore, operation of the facility in accordance with the proposed amendments would not create the possibility of a new or different kind of accident from any previously evaluated. 3. Does the proposed change involve a significant reduction in a margin of safety? No. The operating limits and functional capabilities of the affected systems, structures, and components are unchanged by the proposed amendment. The changed Technical Specifications remove notes which are no longer in effect and do not reduce any of the margins of safety. Therefore, operation of the facility in accordance with the proposed amendments would not involve a significant reduction in the margin of safety. Based upon the reasoning presented above it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration. *Attorney for licensee:* M.S. Ross, Attorney, Florida Power & Light, P.O. Box 14000, Juno Beach, Florida 33408-0420. *NRC Branch Chief:* Thomas H. Boyce. Pacific Gas and Electric Company, Docket Nos. 50-275 and 50-323, Diablo Canyon Nuclear Power Plant, Unit Nos. 1 and 2, San Luis Obispo County, California *Date of amendment requests:* April 3, 2008. *Description of amendment requests:* The proposed amendments would revise Technical Specification
(TS)3.7.5, “Auxiliary Feedwater System,” to remove Surveillance Requirement 3.7.5.6, and revise TS 3.7.6, “Condensate Storage Tank
(CST)and Fire Water Storage Tank (FWST),” to remove the FWST level requirements, revise the CST level requirements, and revise TS 3.7.6 to be consistent with the NUREG-1431 Standard Technical Specifications. *Basis for proposed no significant hazards consideration determination:* As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below: 1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated? Response: No. The proposed changes would revise TS 3.7.5, “Auxiliary Feedwater System,” to remove SR 3.7.5.6, and revise TS 3.7.6, “Condensate Storage Tank
(CST)and Fire Water Storage Tank (FWST),” to remove the FWST level requirements, revise the CST level requirements, and revise TS 3.7.6 to be consistent with the NUREG-1431 Standard Technical Specifications. The proposed changes reflect a design change to the CST that enables the CST to provide the entire required source of usable volume of safety grade water to the AFW System pumps to remove decay and sensible heat from the Reactor Coolant System (RCS). The CST and AFW System pumps are not accident initiators, and are credited to mitigate accidents and events. The changes have no impact on the method by which the CST or AFW system performs its functions or the required AFW system pump flowrate to be provided. With the changes, a sufficient quantity of water will continue to be supplied by the CST to the AFW pumps to remove heat from the RCS in the event of a loss of normal feedwater to the SGs, and thus the FWST volume is no longer required to be contained in the TS. With the change, the overall quantity of water required by TS 3.7.6 to be available for the AFW pumps is reduced. This reduction in available AFW supply is acceptable based on revised plant-specific CST minimum storage volume calculations, which incorporate the design of the replacement Westinghouse Model Delta 54 Steam Generators, and the design change in Unit 2 to a T <sup>cold</sup> upper head design. Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated. 2. Does the proposed change create the possibility of a new or different accident from any accident previously evaluated? Response: No. The CST and AFW pumps are not accident initiators, and are credited to mitigate accidents and events. The changes have no impact on the method by which the CST or AFW system performs its functions or the required AFW system pump flowrate to be provided. The increase in the available CST volume enables the CST for each unit to provide the required volume for the limiting natural circulation cooldown event without reliance on the FWST. The FWST will no longer need to be manually transferred to the AFW System pump suction when CST inventory is depleted following a natural circulation cooldown event. Therefore, the proposed change does not create the possibility of a new or different accident from any accident previously evaluated. 3. Does the proposed change involve a significant reduction in a margin of safety? Response: No. The accident analyses credit CST inventory to meet RCS design pressure, containment design pressure, 10 CFR 100 dose limits, and 10 CFR 50.36 peak cladding temperature limits. The increase in the TS 3.7.6 available CST volume enables the CST for each unit to provide the required volume for the limiting natural circulation cooldown event without reliance on the FWST. The CST volume for the natural circulation cooldown event is greater than that required to mitigate accidents. Thus the CST will provide the entire required source of usable volume of safety grade water to the AFW System pumps to remove decay and sensible heat from the RCS. Therefore, the proposed change does not involve a significant reduction in a margin of safety. The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment requests involve no significant hazards consideration. *Attorney for licensee:* Jennifer Post, Esq., Pacific Gas and Electric Company, P.O. Box 7442, San Francisco, California 94120. *NRC Acting Branch Chief:* Balwant K. Singal. PSEG Nuclear LLC, Docket No. 50-354, Hope Creek Generating Station, Salem County, New Jersey *Date of amendment request:* April 25, 2008. *Description of amendment request:* The proposed amendment would revise the Technical Specifications
(TSs)to remove the current restriction on operation of the hydrogen water chemistry
(HWC)system at low power levels. Currently, the TSs state that the HWC system shall not be placed in service until reactor power reaches 20% of rated thermal power. The original restriction on HWC operation was intended to prevent increases in main steamline
(MSL)radiation background levels before the MSL radiation monitors (MSLRM) setpoints were adjusted because it was assumed that the MSL radiation would increase significantly with HWC operation. The licensee's application stated that the present HWC injection rate does not cause an appreciable increase in MSL radiation, therefore, the reason for prohibiting HWC operation below 20% of rated thermal power no longer exists. *Basis for proposed no significant hazards consideration determination:* As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below: 1. Does the change involve a significant increase in the probability or consequences of an accident previously evaluated? Response: No. Hope Creek Generating Station
(HCGS)proposes to amend Technical Specification
(TS)3/4.3.2 to remove a limitation on operation of the Hydrogen Water Chemistry
(HWC)System below 20% of rated thermal power. The original HWC system injected hydrogen into the condensate system at levels that caused significant increases in the main steamline radiation background. As a consequence, it was necessary to also increase the Main Steamline Radiation Monitor (MSLRM) setpoints to prevent undesirable MSLRM alarms and reactor water sample line isolations. However, the MSLRM is credited with mitigating the consequences of a Control Rod Drop Accident
(CRDA)that is of concern only below 10% power. An increase in setpoint would reduce the sensitivity of the MSLRM to fuel failures resulting from a CRDA. Therefore, increasing the MSLRM setpoints is permitted only above 20% of rated thermal power where a control rod drop was analyzed not to create fuel failures. As a result of a revised system application, the HWC injection rate is now much lower than that applied originally, and main steamline radiation does not increase significantly when HWC is placed in service. Consequently there is no impact on the MSLRM setpoints at low power (below 20%). HWC injection itself is not associated with any accident or operational occurrence analyzed in the Updated Final Safety Analysis Report (UFSAR). The purpose of HWC is to reduce Intergranular Stress Corrosion Cracking (IGSCC) in the reactor coolant system. IGSCC can lead to a loss of coolant accident. Lowering the power level at which HWC injection is initiated will increase the time that hydrogen is injected and improve IGSCC prevention. Low power operation is recommended, by EPRI [Electric Power Research Institute], to increase the time that HWC is in service. EPRI has evaluated HWC operation on plant safety systems and concluded that there are no adverse effects associated with HWC injection at low power. The implementation of low power HWC operation will follow the guidelines in BWRVIP-156 [Boiling Water Reactor Vessel and Internals Project 156 (BWRVIP-156), “Generic Guidelines for Improvement in HWC System Availability,” EPRI Report No. 1011706] to ensure reliable operation of the HWC system. The [CRDA] is the only accident applicable to the MSLRM isolation actuation function. This accident can result in fuel failures if it occurs below 10% of rated thermal power but is not of concern above 10% power. The MSLRM trips the two Mechanical Vacuum Pumps
(MVP)and isolates reactor water sample lines on high main steamline radiation. The MSLRM is credited with fuel failure detection and MVP trips in the CRDA Analysis. The MVPs are secured prior to reaching 5% of rated thermal power. The proposed change does not alter the present TS requirement prohibiting MSLRM setpoint increases below 20% of rated thermal power and thereby does not change the plant response assumed in the CRDA Analysis. In conclusion, the proposed change will not significantly increase the probability or consequences of an accident previously evaluated. 2. Does the change create the possibility of a new or different kind of accident from any accident previously evaluated[?] Response: No. The HWC injects hydrogen into the secondary condensate pump suction lines and injects oxygen into the Offgas system. The existing TS prohibits HWC operation at power levels below 20% of rated thermal power. The proposed change would permit HWC at any power level. Operating procedures would begin the HWC injection at approximately 5% power when sufficient condensate flow is available to transport the hydrogen in the reactor coolant system. Injection of hydrogen into the reactor coolant system has proven to be beneficial to the reactor vessel and recirculation system piping components. The implementation of low power HWC operation will follow the guidelines in BWRVIP-156 [ ] to ensure reliable operation of the HWC system. The TS requirements for the MSLRM Isolation Actuation functions will remain unchanged. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated. 3. Does the change involve a significant reduction in a margin of safety? Response: No. The safety margin applicable to this change is the MSLRM setpoint to main steamline radiation assumed in the CRDA Analysis. The MSLRM trip of the MVPs is credited in the CRDA Analysis. The MSLRM setpoint requirements are not changed by this proposed license amendment; both the existing and proposed footnotes associated with the MSLRM Isolation Actuation TS permit increasing the MSLRM setpoints only if the plant is operated above 20% of thermal power. This is outside the power range at which the CRDA is of concern. There is no other safety margin associated with operation of HWC. Therefore, there is no reduction in the margin of safety. The NRC staff has reviewed the licensee's analysis and, based on this review, with changes in the areas noted above, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration. *Attorney for licensee:* Jeffrie J. Keenan, Esquire, Nuclear Business Unit—N21, P.O. Box 236, Hancocks Bridge, NJ 08038. *NRC Branch Chief:* Harold K. Chernoff. Virginia Electric and Power Company, Docket Nos. 50-280 and 50-281, Surry Power Station, Unit Nos. 1 and 2, Surry County, Virginia *Date of amendment request:* June 9, 2008. *Description of amendment request:* The proposed changes would revise action statements in Technical Specification
(TS)3.12 for insertion limit and shutdown margin requirements, revise the applicability for the operability of the rod position indication and bank demand position indication systems, revise/add action statements for rod position indication, and add action statements for group step demand counters. These revisions enhance completeness of the Surry TS and are consistent with NUREG-1431, Revision 3.0, “Standard Technical Specifications, Westinghouse Plants.” *Basis for proposed no significant hazards consideration determination:* As required by 10 CFR 50.91(a), the licensee has provided its analysis of the issue of no significant hazards consideration, which is presented below: 1. Does the change involve a significant increase in the probability or consequences of an accident previously evaluated? Response: No. The proposed change is being made to enhance the completeness of the Surry TS and to achieve consistency with NUREG-1431 with respect to requirements and action statements for insertion limits, SDM, rod position indication, and group step demand counters. The proposed change does not add or modify any plant systems, structures or components (SSCs). Thus, the proposed change does not affect initiators of analyzed events or assumed mitigation of accident or transient events. Therefore, this change does not involve a significant increase in the probability or consequences of an accident previously evaluated. 2. Does the change create the possibility of a new or different kind of accident from any accident previously evaluated? Response: No. The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Although the proposed change revises the applicability of the operability requirements for the Rod Position Indication and Bank Demand Position Indication Systems, it does not involve a change in methods governing plant startup, operation, or shutdown. The proposed change does not adversely affect accident initiators or precursors, nor does it alter the design assumptions, conditions, or configuration of the facility. The proposed change does not alter or prevent the ability of SSCs to perform their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. Thus, this change does not create the possibility of a new or different kind of accident from any accident previously evaluated. 3. Does this change involve a significant reduction in a margin of safety? Response: No. The proposed change does not result in plant operation in a configuration outside the analyses or design basis, nor does it alter the condition or performance of equipment or systems used in accident mitigation or assumed in any accident analysis. Therefore, the proposed TS change does not involve a significant reduction in a margin of safety. The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration. *Attorney for licensee:* Lillian M. Cuoco, Esq., Senior Counsel, Dominion Resources Services, Inc., 120 Tredegar Street, RS-2, Richmond, VA 23219. *NRC Branch Chief:* Melanie C. Wong. Previously Published Notices of Consideration of Issuance of Amendments to Facility Operating Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing The following notices were previously published as separate individual notices. The notice content was the same as above. They were published as individual notices either because time did not allow the Commission to wait for this biweekly notice or because the action involved exigent circumstances. They are repeated here because the biweekly notice lists all amendments issued or proposed to be issued involving no significant hazards consideration. For details, see the individual notice in the **Federal Register** on the day and page cited. This notice does not extend the notice period of the original notice. FPL Energy Duane Arnold, LLC, Docket No. 50-331, Duane Arnold Energy Center, Linn County, Iowa *Date of amendment request:* February 19, 2008. *Brief description of amendment request:* The proposed amendment revises the technical specification Actions for the Emergency Diesel Generators
(EDG)to remove the conditional surveillance requirement to test the alternate EDG whenever one EDG is taken out of service for pre-planned preventive maintenance and testing. *Date of publication of individual notice in* Federal Register: June 13, 2008 (73 FR 33853). *Expiration date of individual notice:* August 12, 2008. Notice of Issuance of Amendments to Facility Operating Licenses During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment. Notice of Consideration of Issuance of Amendment to Facility Operating License, Proposed No Significant Hazards Consideration Determination, and Opportunity for A Hearing in connection with these actions was published in the **Federal Register** as indicated. Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated. For further details with respect to the action see
(1)the applications for amendment,
(2)the amendment, and
(3)the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management Systems (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site, *http://www.nrc.gov/reading-rm/adams.html* . If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the PDR Reference staff at 1
(800)397-4209,
(301)415-4737 or by e-mail to *pdr@nrc.gov* . AmerGen Energy Company, LLC, Docket No. 50-461, Clinton Power Station, Unit No. 1, DeWitt County, Illinois *Date of application for amendment:* January 26, 2006, as supplemented by letters dated June 6, October 11, 2007, and April 10, 2008. *Brief description of amendment:* The proposed changes would revise TS 3.3.1.1, “Reactor Protection System
(PRS)Instrumentation,” Table 3.3.1.1-1, “Reactor Protection System Instrumentation,” Function 8, “Scram Discharge Volume [SDV] Water Level—High,” item b, “Float Switch,” by replacing SR 3.3.1.1.9 with SR 3.3.1.1.12. This change will effectively revise the surveillance frequency for the SDV level float switch from every 92 days to every 24 months. *Date of issuance:* June 30, 2008. *Effective date:* As of the date of issuance and shall be implemented within 60 days. *Amendment No.:* 179. *Facility Operating License No. NPF-62:* The amendment revised the Technical Specifications and License. *Date of initial notice in* Federal Register: May 22, 2007 (72 FR 28719). The June 6, October 11, 2007, and April 10, 2008 supplements contained clarifying information and did not change the NRC staff's initial proposed finding of no significant hazards consideration. The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 30, 2008. No significant hazards consideration comments received: No. Dominion Energy Kewaunee, Inc., Docket No. 50-305, Kewaunee Power Station, Kewaunee County, Wisconsin *Date of application for amendment:* July 2, 2007. *Brief description of amendment:* The proposed amendment would delete operating license
(OL)condition 2.C (5), “Fuel Burnup,” which restricts maximum rod average burnup to 60 giga-watt days per metric ton uranium (GWD/MTU). Deletion of the OL condition will provide the opportunity to increase maximum rod average burnup to as high as 62 GWD/MTU and allow fuel management flexibility. *Date of issuance:* July 2, 2008. *Effective date:* As of the date of issuance and shall be implemented within 60 days. *Amendment No.:* 198. *Facility Operating License No. DPR-43:* Amendment revised the Technical Specifications. *Date of initial notice in* Federal Register: August 28, 2007 (72 FR 49571). The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 2, 2008. No significant hazards consideration comments received: No. Energy Northwest, Docket No. 50-397, Columbia Generating Station, Benton County, Washington *Date of application for amendment:* July 30, 2007. *Brief description of amendment:* The amendment revises the Technical Specification
(TS)requirements related to control room envelope habitability in accordance with TS Task Force
(TSTF)traveler TSTF-448-A, “Control Room Habitability,” Revision 3. *Date of issuance:* June 30, 2008. *Effective date:* As of its date of issuance and shall be implemented within 150 days from the date of issuance. *Amendment No.:* 207. *Facility Operating License No. NPF-21:* The amendment revised the Facility Operating License and Technical Specifications. *Date of initial notice in* Federal Register: August 28, 2007 (72 FR 49573). The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 30, 2008. No significant hazards consideration comments received: No. Entergy Operations, Inc., Docket No. 50-313, Arkansas Nuclear One, Unit No. 1, Pope County, Arkansas *Date of amendment request:* March 13, 2008. *Brief description of amendment:* The amendment revises Surveillance Requirement
(SR)3.6.5.8 to require verification that the reactor building spray nozzles are unobstructed following maintenance that could result in nozzle blockage, in lieu of the current SR of performing the test every 10 years. *Date of issuance:* July 9, 2008. *Effective date:* As of the date of issuance and shall be implemented within 90 days from the date of issuance. *Amendment No.:* 233. *Renewed Facility Operating License No. DPR-51:* Amendment revised the Technical Specifications/license. *Date of initial notice in* Federal Register: May 6, 2008 (73 FR 25038). The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated July 9, 2008. No significant hazards consideration comments received: No. Southern Nuclear Operating Company, Inc., Docket Nos. 50-424 and 50-425, Vogtle Electric Generating Plant, Units 1 and 2, Burke County, Georgia *Date of application for amendments:* January 9, 2008, as supplemented on February 6, 2008, March 5, 2008 and May 22, 2008. *Brief description of amendments:* The amendments revised Technical Specifications
(TSs)3.3.2, “Engineered Safety Feature Actuation System (ESFAS) Instrumentation,” Table 3.3.2-1, “Engineered Safety Feature Actuation System Instrumentation,” Function 7.b, and TS 3.5.4, “Refueling Water Storage Tank (RWST),” Surveillance Requirement
(SR)3.5.4.2. The proposed change to TS 3.3.2 lowered the nominal trip setpoint and corresponding allowable value of the refueling water storage tank
(RWST)Level-Low Low at which the semi-automatic switchover from the RWST to the containment emergency sump occurs. *Date of issuance:* July 7, 2008. *Effective date:* As of the date of issuance and shall be implemented within 30 days from the date of issuance. *Amendment Nos.:* Unit 1—151; Unit 2—132. *Facility Operating License Nos. NPF-68 and NPF-81:* Amendments revised the licenses and the technical specifications. *Date of initial notice in* Federal Register: January 29, 2008 (73 FR 5230). The supplements dated February 6, 2008, March 5, 2008 and May 22, 2008, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 7, 2008. No significant hazards consideration comments received: No. Virginia Electric and Power Company, et al., Docket Nos. 50-280 and 50-281, Surry Power Station, Units 1 and 2, Surry County, Virginia *Date of application for amendments:* July 13, 2007, as supplemented on August 20, 2007. *Brief description of amendments:* These amendments revised the Technical Specifications
(TSs)requirements related to main control room and emergency switchgear room envelope habitability. These changes are consistent with the Nuclear Regulatory Commission (NRC)-approved Revision 3 of Technical Specification Task Force
(TSTF)Standard Technical Specifications
(STS)Change Traveler TSTF-448, “Control Room Habitability.” *Date of issuance:* July 7, 2008. *Effective date:* As of the date of issuance and shall be implemented within 90 days. *Amendment Nos.:* 260, 260. *Renewed Facility Operating License Nos. DPR-32 and DPR-37:* Amendments changed the licenses and the technical specifications. *Date of initial notice in* Federal Register: August 14, 2007 (72 FR 45463). The supplement dated August 20, 2007, provided additional information that clarified the application, did not expand the scope of the application as originally noticed, and did not change the staff's original proposed no significant hazards consideration determination. The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated July 7, 2008. No significant hazards consideration comments received: No. Dated at Rockville, Maryland, this 17th day of July 2008. For the Nuclear Regulatory Commission. Joseph G. Giitter, Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. E8-17102 Filed 7-28-08; 8:45 am] BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION Sunshine Federal Register Notice DATES: Weeks of July 28, August 4, 11, 18, 25, September 1, 2008. Place: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. Status: Public and Closed. Week of July 28, 2008 Wednesday, July 30, 2008. 1:30 p.m. Discussion of Management Issues (Closed—Ex. 2). Week of August 4, 2008—Tentative There are no meetings scheduled for the week of August 4, 2008. Week of August 11, 2008—Tentative Tuesday, August 12, 2008. 1:30 p.m. Meeting with FEMA and State and Local Representatives on Offsite Emergency Preparedness Issues (Public Meeting) (Contact: Lisa Gibney, 301-415-8376). This meeting will be webcast live at the Web address— *http://www.nrc.gov* . Thursday, August 14, 2008. 1:30 p.m. Meeting with Organization of Agreement States
(OAS)and Conference of Radiation Control Program Directors (CRCPD) (Public Meeting) (Contact: Andrea Jones, 301-415-2309). This meeting will be webcast live at the Web address— *http://www.nrc.gov* . Week of August 18, 2008—Tentative There are no meetings scheduled for the week of August 18, 2008. Week of August 25, 2008—Tentative There are no meetings scheduled for the week of August 25, 2008. Week of September 1, 2008—Tentative There are no meetings scheduled for the week of September 1, 2008. The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—(301) 415-1292. Contact person for more information: Michelle Schroll,
(301)415-1662. The NRC Commission Meeting Schedule can be found on the Internet at: *http://www.nrc.gov/about-nrc/policy-making/schedule.html* . The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g. braille, large print), please notify the NRC's Disability Program Coordinator, Rohn Brown, at 301-492-2279, TDD: 301-415-2100, or by e-mail at *REB3@nrc.gov* . Determinations on requests for reasonable accommodation will be made on a case-by-case basis. This notice is distributed by mail to several hundred subscribers; if you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969). In addition, distribution of this meeting notice over the Internet system is available. If you are interested in receiving this Commission meeting schedule electronically, please send an electronic message to *dkw@nrc.gov* . Dated: July 24, 2008. Rochelle C. Bavol, Office of the Secretary. [FR Doc. 08-1473 Filed 7-25-08; 11:12 am]
Connectionstraces to 26
Traces to 26 documents
15 references not yet in our index
  • Pub. L. 92-463
  • Pub. L. 110-85
  • 467 U.S. 837
  • 44 USC 3501-3520
  • Pub. L. 108-357
  • Pub. L. 104-13
  • 5 CFR 1320.1
  • 7 CFR 331
  • 42 CFR 73
  • 50 CFR 17.11
  • 50 CFR 424.21
  • 43 CFR 3108.2-3(a)
  • 19 USC 3881
  • 10 CFR 2
  • 10 CFR 100
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Notices
Announcement of meeting
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U.S.C.§ 333
U.S.C.§ 334
U.S.C.§ 381
U.S.C.§ 321
U.S.C.§ 262
C.F.R.§ 10.115
U.S.C.§ 290bb–2
SCOTUS467 U.S. 837
Pub. L.Pub. L. 92-463
Pub. L.Pub. L. 110-85
Cites 41 · showing 12Cited by 0 across 0 sources
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