Notices. Notice of public meeting; request for comments

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0465] Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1-day workshop involving FDA staff and representatives of the United States Pharmacopeia

(USP)and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous

(IV)drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label. DATES: The public meeting will be held on January 11, 2007, from 8 a.m. to 4 p.m. Submit written or electronic requests to speak by December 28, 2006. Written or electronic comments to the docket will be accepted until April 12, 2007. ADDRESSES: The public meeting will be held at the Lister Hill Center Auditorium (the center), National Institutes of Health

(NIH)campus, 9000 Rockville Pike, bldg. 38A, Bethesda, MD 20815, 301-496-4441. The center can be reached by Metro using the Medical Center Station on the red line. Parking is limited at NIH, so Metro use is recommended. For directions and visitor information, see *http://www.nih.gov/about/visitor/index.htm* . (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** ). Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Submit written or electronic requests to speak at the meeting to the information contact. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at *http://www.fda.gov/cder/meeting/parenteral_labeling.htm* . FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation and Research (HFD-400), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-2380, e-mail: *jean.chung@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Premixed large volume parenterals

(LVPs)and small volume parenterals

(SVPs)in ready to infuse final dosage forms are designed to deliver premixed drugs (e.g., antibiotics, electrolyte solutions, pain management infusions). Premixed LVPs and SVPs improve standardized drug delivery and can reduce the potential for medication errors by reducing the steps required in IV preparation and the additional quality control checks needed by the pharmacy prior to dispensing and administering the product. Premixed LVPs and SVPs:

(1)Provide an end product that is labeled with the ingredients including a product identification code (e.g., bar code),

(2)promote a sterile environment, and

(3)maintain accurate concentration within a closed system. According to the USP, “the designation large-volume intravenous solution applies to a single-dose injection that is intended for intravenous use and is packaged in containers labeled as containing more than 100 mL. The designation small-volume injection applies to an injection that is packaged in containers labeled as containing 100 mL or less.” Although premixed LVPs and SVPs can reduce the potential for mixing errors, the labels and labeling of these products, as well as base solutions of LVPs and SVPs without drug, have been documented as contributing to medication errors in both acute care and ambulatory settings, as well as in home care settings. The types of errors reported involve the inability to distinguish different drug products, as well as different strengths of drug products, because the containers look similar and use similar colors for label text. In addition to these visual similarities, manufacturers may label the same drug product with varying units of measure (e.g., micrograms versus milligrams), which has also contributed to error. There is also a large amount of information that is placed on the container label that can not only crowd the label but can distract from the most important information, that is, the proprietary and established names and product strength.Thus, we would like to explore how current IV labels should be designed to minimize medication errors. II. Scope of the Public Meeting The public meeting is intended to explore how IV labels could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label. This 1-day workshop will assemble drug safety experts, patient advocates, government experts, and pharmaceutical and device manufacturers to discuss outstanding regulatory, technological, and resource issues. Other interested constituencies (e.g., patient advocacy and education groups, pharmaceutical sponsors, general public) will have an opportunity to provide input during the question and comment periods. FDA is interested in obtaining public comment and encourages all interested parties to submit requests to speak at the meeting or to submit written or electronic comments to the docket. (See sections III. and IV. of this document.) The meeting will include an overview of FDA and USP requirements, presentations from the clinical perspective (nurse and pharmacist) and industry perspective, and a series of panel discussions. The following topics will be discussed: Look-alike containers, confusing labels on sterile water containers, container label requirements, and the lack of standardized expression of medication concentration on labels. Questions that will be considered during this public meeting include, but are not limited to, the following: 1. What are the best solutions to differentiate look-alike container labels of premixed LVPs and SVPs containing different medications (among different product lines from the same manufacturer and across different manufacturer product lines)? 2. Would the use of color differentiation on labels prevent medication errors? Can different colors be used on intravenous bags? If not, what are the barriers and possible ways to address them? 3. What information currently required to appear on intravenous container labels can be eliminated or placed elsewhere in order to make room for more important information such as barcodes, larger font size for drug names, new standard ways to express drug concentration, and product warnings? How can industry make the best use of the limited space on labels? What type of standards for layout and type size would need to be applied to correct for the confusion among the products? 4. How does the lack of standardization in the expression of medication concentrations on labels contribute to error? How can we standardize the expression of drug concentrations on IV drug container labels? 5. How do the similar labels for Sterile Water for Injection, Sterile Water for Irrigation, and Sterile Water for Inhalation lead to medication errors (i.e., deaths in some instances have been reported)? How can the label for sterile water be improved to minimize the risk of confusing the different routes of administration? 6. What strategies are there to prevent inadvertent administration of solutions not intended for parenteral IV use? 7. What are the regulatory, technological, and resource

(cost)barriers that would need to be eliminated to correct the challenges identified today, if any? What are the practical resolutions to address these challenges? III. Registration, Requests to Speak, Agenda, and Presentations No registration is required to attend the meeting. Seating will be on a first-come, first-served basis. If you need special accommodations due to a disability, please inform the contact person (see FOR FURTHER INFORMATION CONTACT ). Interested persons may request to speak at the meeting (see FOR FURTHER INFORMATION CONTACT ). Statements from the public will be scheduled between 2:45 p.m. and 3:45 p.m., and the time allotted for each speaker will be limited. Requests to speak at the meeting should include:

(1)The specific topic or issue to be addressed,

(2)a brief summary of remarks, and

(3)the participant's name, address, telephone number, and e-mail. The agenda for the public meeting will be available on FDA's Center for Drug Evaluation and Research

(CDER)Web site at: *http://www.fda.gov/cder/meeting/parenteral_labeling.htm* . After the meeting, the agenda, presentations, and transcript will be placed on file in the Division of Dockets Management under the docket number found in the heading of this document and on CDER's Web site identified in the previous sentence. IV. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the topics discussed in this document (see DATES ). Submit 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. V. Transcripts Copies of the transcript may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 20 working days after the meeting at a cost of 10 cents per page or on compact disc at a cost of $14.25 each. You may also examine the transcript at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-20035 Filed 11-27-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0336] Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration

(FDA)is extending the comment period on the draft guidance entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” FDA announced the availability of this draft guidance in the **Federal Register** of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period. DATES: Submit written or electronic comments on this draft guidance by March 5, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0490, ext. 162. SUPPLEMENTARY INFORMATION: I. Background FDA is extending the comment period on the draft guidance “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” This draft guidance is intended to help eliminate confusion regarding particular marketing practices among ASR manufacturers. With the draft guidance document, FDA seeks to advise ASR manufacturers that it views certain practices as being inconsistent with the marketing of an ASR, as defined in Sec. 864.4020. As the draft guidance document explains, when an ASR is marketed in certain ways, FDA views the product as no longer being an ASR within the meaning of Sec. 860.4020. FDA issued this draft guidance on September 7, 2006. The initial comment period on the draft guidance closes on December 6, 2006, but at the request of in vitro diagnostic device stakeholders, FDA has decided to extend the comment period for an additional 90 days, until March 5, 2007. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions,” you may either send an email request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document, or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1590 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . 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. Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-20030 Filed 11-27-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0310] Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a document entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events,” dated November 2006. The guidance document provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products. The guidance announced in this notice finalizes the draft guidance entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,” dated August 2005, and supplements the recommendations for study subject long-term follow-up in the “Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors” (Retroviral Vector guidance), dated November 2006. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a document entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Subjects for Delayed Adverse Events,” dated November 2006. This guidance provides to sponsors of gene therapy studies recommendations on the following:

(1)Methods to assess the risk of gene-therapy-related delayed adverse events following exposure to investigational gene therapy products,

(2)guidance for determining the likelihood that long-term follow-up observations on study subjects will provide scientifically meaningful information, and

(3)specific advice regarding the duration and design of long-term follow-up observations. In the **Federal Register** of August 23, 2005 (70 FR 49296), FDA announced the availability of the draft guidance entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,” dated August 2005. FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. A summary of changes includes the following:

(1)Clarification on topics not included in the guidance;

(2)revised recommendations for preclinical study design to assess vector biodistribution and persistence; and

(3)revised recommendations for data collection and data reporting in trials involving integrated vectors (e.g., retroviral vectors). The guidance announced in this notice finalizes the draft guidance entitled “Guidance for Industry: Gene Therapy Clinical Trials—Observing Participants for Delayed Adverse Events,” dated August 2005. This guidance also supplements the recommendations in the Retroviral Vector guidance, dated November 2006, for study subject long-term follow-up. The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This 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 in the Investigational New Drug Application

(IND)regulations (21 CFR part 312) have been approved under OMB control number 0910-0014; the Good Laboratory Practice regulations (21 CFR part 58) have been approved under OMB control number 0910-0119. III. Comments Interested persons maysubmit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of 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. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either *http://www.fda.gov/cber/guidelines.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-20129 Filed 11-27-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0347] Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Availability; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. SUMMARY: The Food and Drug Administration

(FDA)is extending the comment period on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” The agency announced the availability of this draft guidance in the **Federal Register** of September 7, 2006 (71 FR 52800). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, the agency has decided to extend the comment period. DATES: Submit written or electronic comments on this draft guidance by March 5, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0490, ext. 162. SUPPLEMENTARY INFORMATION: I. Background FDA is extending the comment period on the “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.” This draft guidance is intended to provide clarification on FDA's approach to regulation of in vitro diagnostic multivariate index assays. The agency issued this draft guidance on September 7, 2006. The initial comment period on the draft guidance closes on December 6, 2006, but at the request of in vitro diagnostic device stakeholders, the agency has decided to extend the comment period for an additional 90 days, until March 5, 2007. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Submit two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1610 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-20032 Filed 11-27-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0468] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)Center for Drug Evaluation and Research

(CDER)is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this notice is to invite pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may submit proposed agendas to the agency by January 29, 2007. ADDRESSES: Submit written proposed agendas regarding the Site Tours Program to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or to Beth Duvall-Miller (see FOR FURTHER INFORMATION CONTACT ). FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-796-0700. SUPPLEMENTARY INFORMATION: I. Background An important part of CDER's commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of the drug review process. To support this primary goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to enhance significantly review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following:

(1)Firsthand exposure to industry's drug development processes and

(2)a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. II. The Site Tours Program In this program, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures. III. Site Selection All travel expenses associated with the site tours will be the responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Firms interested in offering a site tour or learning more about this training opportunity should respond by (see DATES ) by submitting a proposed agenda to the Division of Dockets Management or to Beth Duvall-Miller (see ADDRESSES ). Dated: November 20, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-20041 Filed 11-27-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Infant Mortality (ACIM). *Dates and Times:* November 29, 2006, 9 a.m.-5 p.m.; November 30, 2006, 8:30 a.m.-3 p.m. *Place:* Washington Marriott Hotel, 1221 22nd Street, NW., Washington, DC 20037, (202)-872-1500. *Status:* The meeting is open to the public with attendance limited to space availability. *Purpose:* The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following issues: Department of Health and Human Services' programs that focus on reducing infant mortality and improving the health status of pregnant women and infants, factors affecting the continuum of care with respect to maternal and child health care, and outcomes following childbirth. It also includes strategies to coordinate the variety of Federal, State, local and private programs and efforts that are designed to deal with the health and social problems impacting infant mortality, and the implementation of the Healthy Start program and *Healthy People 2010* infant mortality objectives. *Agenda:* The committee plans to discuss the following topics: The Healthy Start Program and its National Evaluation, Breastfeeding Rates, Maternal and Child Health Bureau's Depression Activities, and Centers for Medicare & Medicaid Services Program update. The meeting allots substantial time for subcommittee and full committee discussions to formulate the ACIM issues agenda. The items on the agenda items are subject to change as the Committee continues to discuss priorities. The Committee provides a 5-minute time limit for each public comment. Submit comments no later than November 17, 2006. *For Further Information Contact:* Anyone requiring information regarding the Committee can contact Peter C. van Dyck, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, Telephone:

(301)443-2170. Individuals who submit public comments or who have questions regarding the meeting and location can contact David S. de la Cruz, Ph.D., M.P.H., HRSA, Maternal and Child Health Bureau, telephone:

(301)443-6332, e-mail: *David.delaCruz@hrsa.hhs.gov* . Dated: November 17, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-20120 Filed 11-27-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request. ACTION: 30-day notice of information collection under review: Notice of Naturalization Oath Ceremony; Form N-445, OMB Control No. 1615-0054. The Department of Homeland Security, U.S. Citizenship and Immigration Service (USCIS) has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on September 12, 2006 at 71 FR 53703, allowing for a 60-day public comment period. No public comments were received on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until December 28, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Management and Budget

(OMB)USCIS Desk Officer. Comments may be submitted to: USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov* , and to the OMB USCIS Desk Officer via facsimile at 202-395-6974 or via email at *kastrich@omb.eop.gov.* When submitting comments by e-mail please make sure to add OMB Control Number 1615-0054 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1)Evaluate whether the 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 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 submission of responses. *Overview of this information collection:*

(1)*Type of Information Collection:* Extension of a currently approved information collection.

(2)*Title of the Form/Collection:* Notice of Naturalization Oath Ceremony.

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form N-445. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract:* Primary: Individual or households. The information furnished on this form refers to events that may have occurred since the applicant's initial interview and prior to the administration of the oath of allegiance. Several months may elapse between these dates and the information that is provided assists the officer in rendering an appropriate decision on the application.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 650,000 responses at 5 minutes (.083) per response.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 53,950 annual burden hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please contact Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services, U.S. Department of Homeland Security, 111 Massachusetts Avenue, NW., Suite 3008, Washington, DC, 20529. Dated: November 21, 2006. Stephen Tarragon, Deputy Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. E6-20047 Filed 11-27-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities; Revision of a Currently Approved Information Collection; Comment Request. AGENCY: U.S. Citizenship and Immigration Services, DHS. ACTION: 30-Day Notice of information collection under review: Petition for Alien Fiance(e); Form I-129F. OMB Control No. 1615-0001. The Department of Homeland Security, U.S. Citizenship and Immigration Service (USCIS) has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on May 26, 2006 at 71 FR 30434, allowing for a 60-day public comment period. USCIS received several comments from the public on this information collection. These comments are addressed in the supporting statement that USCIS will submit to OMB. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until December 28, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), and to the Office of Management and Budget

(OMB)USCIS Desk Officer. Comments may be submitted to: USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, Suite 3008, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov* , and to the OMB USCIS Desk Officer via facsimile at 202-395-6974 or via e-mail at *kastrich@omb.eop.gov* . When submitting comments by e-mail please make sure to add OMB Control Number 1615-0001 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(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

(1)*Type of Information Collection* : Revision of a currently approved information collection.

(2)*Title of the Form/Collection* : Petition for Alien Fiance(e).

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection* : Form I-129F. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract: Individuals or Households* . This information is collected by USCIS to determine whether satisfactory evidence has been submitted by a U.S. citizen to establish that the parties are married, in the case of a citizen seeking to obtain a nonimmigrant visa for his or her spouse.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond* : 200,000 responses at 1 hour and 30 minutes (1.50) per response.

(6)*An estimate of the total public burden (in hours) associated with the collection* : 300,000 hours. If you have additional comments, suggestions, or need a copy of the information collection instrument, please contact Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services, U.S. Department of Homeland Security, 111 Massachusetts Avenue, NW., Suite 3008, Washington, DC 20529. Dated: November 22, 2006. Richard A. Sloan, Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. E6-20151 Filed 11-27-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5041-N-48] Notice of Proposed Information Collection: Comment Request; Application for Mortgage Insurance for Cooperative and Condominium Housing AGENCY: Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below will be submitted to the Office of Management and Budget

(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: *Comments Due Date:* January 29, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian Dietzer, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., Room 4178, Washington, DC 20410 or *Lillian_Deitzer@hud.gov.* FOR FURTHER INFORMATION CONTACT: Joseph Malloy, Deputy Director, Office of Multifamily Development, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410, telephone

(202)708-1142 (this is not a toll free number) for copies of the proposed forms and other available information. SUPPLEMENTARY INFORMATION: The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to:

(1)Evaluate whether the proposed collection 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;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This Notice also lists the following information: *Title of Proposal:* Application for Mortgage Insurance for Cooperative and Condominium Housing. *OMB Control Number, if applicable:* 2502-0141. *Description of the need for the information and proposed use:* HUD uses the information collected to analyze specific project information including financial data, cost data, drawings, and specifications to determine whether a cooperative or condominium project is eligible for FHA mortgage insurance. HUD technical specialists in appraisal, cost, architecture, and mortgage credit determine if the project is eligible for mortgage insurance and analyze information provided. If the information were not collected and analyzed, the Department would have to rely solely on a sponsor's undocumented request, and the Department could expect to sustain substantial losses to the FHA Insurance Fund. *Agency form numbers, if applicable:* HUD-93201. *Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response:* The estimated total number of hours needed to prepare the information collection is 90 hours; the number of respondents is 15; the frequency of response is on occasion; and the number of hours per response is 4 hours for reporting and 2 hours for recordkeeping. *Status of the proposed information collection:* This is a reinstatement of collection 2502-0141. Authority: The Paperwork Reduction Act of 1995, 44 U.S.C., Chapter 35, as amended. Dated: November 20, 2006. Frank L. Davis, General Deputy Assistant Secretary for Housing-Deputy Federal Housing Commissioner. [FR Doc. E6-20040 Filed 11-27-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Performance Review Board Appointments AGENCY: Department of the Interior. ACTION: Notice of Performance Review Board Appointments. SUMMARY: This notice provides the name of individuals who have been appointed to serve as members of the Department of the Interior Performance Review Board. DATES: These appointments are effective upon publication in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Marilia Matos, Director, Office of Human Resources, Office of the Secretary, Department of the Interior, 1849 C Street, NW., Washington, DC 20240, Telephone Number:

(202)208-6761. Dated: October 30, 2006. Marilia Matos, Director, Office of Human Resources. 2006 Performance Review Board The following individuals have been appointed to serve on the Department of the Interior 2006 Performance Review Board: Ethel Abeita Director, Office of Trust Records. David Achterberg Director, Safety, Security and Law Enforcement. Kevin Adams Assistant Director, Law Enforcement. Martha Aikens Program Manager. David Allen Regional Director, Portland. William Alley Senior Science Advisor. Joseph Alston Park Manager. David Applegate Senior Science Advisor for Earthquakes and Geologic Hazards. Carl Artman Associate Solicitor. Maryanne Bach Director, Research & Development. Charles Bacon Research Geologist. Anne Badgley Executive Director—Regional Ecosystems Office. Karen Baker Associate Director for Administrative Policy & Services. Mark Bathrick Associate Director, Aviation Management. Theresa Bayani Program Director for Compliance and Asset Management. Keith Beartusk Regional Director. Mark Beighley Director, Office of Wildland Fire Coordination. Richard Beck Director, Office of Planning and Performance Management. William Benjamin Regional Director—Great Plains. Julio Betancourt Research Hydrologist. Henri Bisson Deputy Director. John Bennett Director Trust Program Management Center. Robert A. Bennett State Director. Edith Blackwell Deputy Associate Solicitor—Indian Affairs. Stephen Blanchard Senior Science Advisor for Surface Water. L. Michael Bogert Counselor to the Secretary. David Boore Research Geophysicist. Douglas Bourgeois Director, National Business Center. Charles Breece Principal Deputy Director, Office of Hearings & Appeals. Robert Brown Associate Director for Administration and Budget. John Buffington Regional Director, Western Region. Melvin Burch Regional Fiduciary Trust Administrator. Brenda Burman Deputy Commissioner. Kenneth Burnham Statistician. Carla Burzyk Chief, Office of Budget and Performance. James Byrnes Attorney-Advisor. Chad Calvert Deputy Assistant Secretary—Land and Minerals Management. Richard Cardinale Senior Advisor to the Assistant Secretary. William Carswell Regional Hydrologist. Thomas Casadevall Regional Director, Central Region. Niles Cesar Regional Director. Dolores Chacon-Alleva President, DOI University. Ralph Cheng Research Hydrologist. Bernard Chouet Research Geophysicist. Debbie Clark Deputy Assistant Secretary—Management. Horace Clark Regional Solicitor. Colleen Coggins Interior Enterprise Architect. David Cohen Deputy Assistant Secretary for Insular Affairs. Robert Comer Regional Solicitor. Anthony Conte Regional Solicitor. Elizabeth Cordova-Harrison Director, Management Services Office. Robert Craff Regional Fiduciary Trust Administrator. Walter Cruickshank Deputy Director. Elena Daly Assistant Director, National Landscape Conservation Systems. Elmer Danenberger Chief, Offshore Engineering and Operations Division. James Davis Research Hydrologist. Daniel Deerinwater Regional Director. Ivan DeLoatch Federal Geographic Data Committee Staff Director. Frank DeLuise Director, Natural Resources Damage Assessment and Restoration Program. Lucy Querques-Denett Associate Director for Minerals Revenue Management. James Devine Senior Advisor for Science Application. Clare Doherty Deputy Director, Budget. Douglas Domenech Deputy Chief of Staff. Robert Doyle Deputy Director. Matthew C. Eames Director, Congressional and Legislative Affairs. Sharon Eller Director, Office of Civil Rights. Donna Erwin Principal Deputy Special Trustee. Max Ethridge Regional Geographer. Michael Ferguson Assistant Director, Business and Fiscal Resources. Olivia Ferriter Director, Conservation, Partnership and Management Policy. Lawrence Finfer Deputy Director, Office of Policy Analysis. Daniel Fletcher Director, Office of Financial Management and Deputy Chief Financial Officer. Vicki Forrest Regional Fiduciary Trust Administrator. Arthur Frankel Research Geophysicist. Art Gary Associate Solicitor—General Law. Jerold Gidner Deputy Bureau Director, Tribal Services. Rick Gold Regional Director. Martin Goldhaber Research Chemist. John Goll Regional Director, Alaska OCS Region. Maria E. Gonzales Senior Advisor for Collaborative Action and Dispute Resolution. Roseanne Gonzales-Schreiner Director, Program and Policy Services. Rowan Gould Regional Director—Anchorage. Clayton Gregory Regional Director. Stephen Guptill Research Physical Scientist. Samuel Hamilton Regional Director—Atlanta. Jeanette Hanna Regional Director. Susan Haseltine Associate Director for Biology. Abraham Haspel Assistant Deputy Secretary. Bruce R. Harris Deputy Chief Administrative Judge, IBLA. James Harris Associate Solicitor—Minerals Resources. William Hartwig Chief, National Wildlife Refuge System. Nina Hatfield Deputy Assistant Secretary, Business Management and Wildland Fire. Pamela Haze Co-Director, Office of Budget. Lisa Hemmer Administrative Judge, IBLA. Paul Henne Assistant Director, Budget Management and Operations. Edward Hildreth Research Geologist. Catherine Hill Regional Hydrologist. David Hill Research Geophysicist. Robert Hirsch Associate Director for Water. Paul Hoffman Deputy Assistant Secretary for Performance, Accountability and Human Resources. Amy Holley Senior Advisor to the Assistant Secretary. Wandafa Hollingsworth Chief, Division of Budget and Program Review. Brian Holly Chief Appraiser. H. Barry Holt Chief Administrative Judge. Patricia Hooks Regional Director, Southeast Region. David Hughes Administrative Judge, IBLA. James Hughes Deputy Director, Programs and Policy. Fay Iudicello Director, Office of Executive Secretariat and Regulatory Affairs. Richard Iverson Research Hydrologist. James Jackson Administrative Judge. Julia Jacobsen Deputy Assistant Secretary—Land and Minerals Management. Jim James Regional Fiduciary Trust Administrator. Christopher Jarvi Associate Director, Partnerships Interpretation & Education, Volunteers & Outdoor Recreation. Jonathan Jarvis Regional Director, Pacific West Region. Lawrence Jensen Regional Solicitor. Bruce A. Johnson Attorney-Examiner. Douglas Johnson Research Statistician. Lynn Johnson Regional Solicitor. Robert Johnson Regional Director. Blair Jones Research Hydrologist. Kenneth Jones Chief Scientist for Geography. Marshall Jones Deputy Director. Daniel Jorjani Counselor to the Deputy Secretary. Christina Kalavritinos Administrative Judge, IBLA. Donna Kalvels Director, Center for Competitive Sourcing. Edward Keable Associate Solicitor, Administration. Christopher Kearney Deputy Assistant Secretary for Policy and International Affairs. M. Franklin Keel Regional Director. John Kelmelis Senior Science Advisor. Suzette Kimball Regional Director, Eastern Region. Jerry Mitch King Regional Director—Denver. Stephen Kirby Research Geophysicist. Allen Klein Regional Director. Leonard Konikow Research Hydrologist. Ernestine Kreisher Director, Office of Communications. Michael Kruse Chief Justice. Robert LaBelle Deputy Associate Director. Matthew Larsen Chief Scientist for Hydrology. Joseph Lawler Regional Director, National Capital Region. Phillip Leahy Associate Director for Geology. David Lehman Senior Advisor to the Secretary. John Lemon Director, National Conservation Training Center. Ronnie Levine Assistant Director, Information Resources Management. Suzanne Lewis Superintendent. Steven Linscheid Chief Administrative Judge. Melinda Loftin Designated Agency Ethics Official. Renne Lohoefener Assistant Director—Endangered Species. Thomas Lonnie Assistant Director, Minerals, Realty and Resource Protection. Douglas Lords Deputy Special Trustee—Field Operations. D. Jeffrey Lords Director, Trust Review and Audit. Thomas Loveland Research Physical Scientist. Samuel Luoma Research Hydrologist. Jane Lyder Legislative Counsel. Kathryn Lynn Administrative Judge. Julie MacDonald Deputy Assistant Secretary—Fish and Wildlife and Parks. Pamela Malam Associate Director for Human Capital. Stephen Martin Deputy Director, Internal Management. Sue Masica Associate Director, Park Planning, Facilities and Lands. Marilia Matos Director, Office of Human Resources. R. Bryan McDaniel Administrative Judge, IBLA. John McDonald Regional Director. Robert McKenna Chief Information Officer. Edward Meagher Deputy Chief Information Officer. David Mech Research Wildlife Biologist. Thomas Melius Assistant Director—External Affairs. Robert Middleton Director, Indian Energy Resource Development. Alan Mikuni Regional Geographer. Mary Jane Miller Budget Officer. Timothy Miller Senior Science Advisor—Water Quality. Paul Milly Research Hydrologist. Robert More Director, Office of Hearings and Appeals. Ralph Morgenweck Fish and Wildlife Advisor. Marvin Moriarty Regional Director. Lawrence Morrin Regional Director. Michael Nedd State Director. James Nichols Research Wildlife Biologist. Darrell Nordstrom Research Hydrologist. William Normark Research Geologist. Michael Olsen Counselor to the Assistant Secretary. Brian O'Neill Park Manager. Kameran Onley Assistant Deputy Secretary. Frederick Ore Deputy Director, Operations. Ronald Oremland Research Hydrologist. Glenda Owens Deputy Director. Emma Pawlicki Associate Solicitor. Larry Parkinson Deputy Assistant Secretary, Law Enforcement and Security. Mamie Parker Assistant Director, Fisheries Habitat Conservation. Edward Parisian Deputy Director, OIEP. Drue Pearce Senior Advisor to the Secretary. Jason Peltier Deputy Assistant Secretary—Water and Science. Zell Peterman Research Geologist. Lynn Peterson Regional Solicitor. Tim Petty Deputy Assistant Secretary—Water and Science. Neil Plummer Research Hydrologist. Stanley Ponce Senior Liaison for Interagency Programs. Michael Pool State Director. Britt Price Administrative Judge, IBLA. Robert Quinn Director, Washington Operations. Ernest Quintana Regional Director, Midwest Region. William Ragsdale Director, Bureau of Indian Affairs. Thomas Rever Director, Facilities, Environmental, Safety and Cultural Resources Management. Thomas Reynolds Regional Fiduciary Trust Administrator. Sterling Rideout Assistant Director—Program Support. James Roberts Administrative Judge, IBLA. Kirk Rodgers Regional Director. Michael Roluti Senior Advisor, Power Liaison. Hedy Rossmeissl Senior Advisor, Info Policy and Services. Barry Roth Deputy Associate Solicitor. Lawrence Ruffin Chief Information Security Officer. Catherine Rugen Regional Fiduciary Trust Administrator. Linda S. C. Rundell State Director. David Russ Regional Geologist. Barbara Ryan Associate Director for Geography. Michael Ryan Regional Director, Great Plains. Robert Rye Research Geologist. Carol Sampson Associate Director for Financial Policy and Operations. Charles Sandberg Regional Director. Daud Santosa Chief Technical Officer. Christine Schabacker Director, Office of Policy Analysis. Carl Schreck Research Fishery Biologist. Paul Schmidt Assistant Director, Migratory Birds and State Program. James Scott Research Wildlife Biologist. Mary G. Scott Park Manager (Superintendent). William Sexton Regional Hydrologist. William Shapiro Research Hydrologist. David Shearer Project Director—FBMS. Denise Sheehan Assistant Director, Budget, Planning and Human Resources. Edward Shepard State Director, Oregon. Daniel Shillito Regional Solicitor. Karen Siderelis Associate Director for Geographic Information. Selma Sierra State Director. Shayla Simmons Senior Counsel for CADR. Jerry Simpson Assistant Director, Human Capital. Gary Smith Director, External and Intergovernmental Affairs. Gregory Smith Program Director for RIK. Michael Smith Deputy Director, Field Operations. Paul Smyth Deputy Associate Solicitor, Land & Water. Michael Snyder Regional Director. Debra Sonderman Director, Acquisition and Property Management. Laurence Soderblom Research Geophysicist. Michael Soukup Associate Director, Natural Resources. Stanley Speaks Regional Director. Kenneth Stansell Assistant Director, International Affairs. Ross Stein Research Geophysicist. Katherine Stevenson Heritage Education Advisor. E. Melodee Stith Associate Director, Acquisition and Financial Asst. James Tate Science Advisor to the Secretary. Willie Taylor Director, Office of Environmental Policy and Compliance. Karen Taylor-Goodrich Associate Director, Visitors & Resource Protection. Wayne Thatcher Research Geophysicist. Kim Thorsen Director, Office of Law Enforcement and Security. Robyn Thorson Regional Director. Whitney H. Tipton Chief Information Officer & Director, Office of IRM. Larry Todd Deputy Commissioner, Policy, Administration & Budget. Michael Tollefson Superintendent. John Trezise Co-Director, Office of Budget. George Triebsch Associate Director for Policy. Deborah Tschudy Deputy Associate Director for Minerals Revenue Management. Randall Updike Regional Geologist. Janine Velasco Assistant Director, Human Capital. David Verhey Deputy Assistant Secretary—Fish and Wildlife and Parks. Terrance Virden Regional Director—Midwest. Brent Wahlquist Regional Director. Barbara Wainman Director, Office of Communication and Outreach. A. Wesley Ward Regional Geologist. Jess Weaver Regional Hydrologist. Sandra Weisman Chief Financial Advisor. Ronald Wenker State Director. Kathleen Wheeler Deputy Chief Human Capital Officer. Arthur White Research Physical Scientist. Byron Williams Senior Science Advisor—Coop Research. Margaret Williams Deputy Special Trustee—Trust Accountability. Richard Williams Research Geologist. Thomas Winter Research Hydrologist. Sarah Wisely State Director. Robert Wolf Director, Program and Budget. William Woody Director, Law Enforcement, Security and Protection. Theodore Woronka Assistant Director for Finance and Administration. Elaine Zielinski State Director. [FR Doc. E6-20117 Filed 11-27-06; 8:45 am] BILLING CODE 4310-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Intent To Prepare an Environmental Impact Statement/Environmental Impact Report for the Habitat Conservation Plan for the Occidental of Elk Hills, Inc., Elk Hills Oil and Gas Field, Kern County, CA AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent. SUMMARY: Pursuant to the National Environmental Policy Act (NEPA), we, the Fish and Wildlife Service (Service), are issuing this notice to advise the public that we intend to gather information necessary to prepare, in coordination with the California Department of Fish and Game

(DFG)and Occidental of Elk Hills, Inc. (OEHI), a joint Environmental Impact Statement/Environmental Impact Report (EIS/EIR) on the Habitat Conservation Plan for the Elk Hills Oil and Gas field (Plan). OEHI intends to apply for a 50-year Endangered Species Act

(ESA)Section 10 incidental take permit from the Service. The permit is needed to authorize the incidental take of threatened and endangered species that could occur as a result of future operations of the Elk Hills Oil and Gas Field. The Service provides this notice to

(1)describe the proposed action and possible alternatives;

(2)advise other Federal and State agencies, affected Tribes, and the public of our intent to prepare an EIS/EIR;

(3)announce the initiation of a public scoping period; and

(4)obtain suggestions and information on the scope of issues to be included in the EIS/EIR. DATES: Written comments should be received on or before December 28, 2006. ADDRESSES: Written comments should be submitted to Lori Rinek, Chief, Conservation Planning and Recovery Division, Fish and Wildlife Service, Sacramento Fish and Wildlife Office, 2800 Cottage Way, W-2605, Sacramento, California 95825. Comments may also be sent by facsimile to 916-414-6713. FOR FURTHER INFORMATION CONTACT: Joseph Terry, Fish and Wildlife Biologist, or Lori Rinek, Chief, Conservation Planning and Recovery Division, Sacramento Fish and Wildlife Office, at 916-414-6600 [see ADDRESSES ]. SUPPLEMENTARY INFORMATION: Reasonable Accommodation Persons needing reasonable accommodations in order to attend and participate in the public meeting should contact Lori Rinek at 916-414-6600 as soon as possible. In order to allow sufficient time to process requests, please call no later than one week before the public meeting. Information regarding this proposed action is available in alternative formats upon request. Background Section 9 of the ESA and Federal regulations prohibit the “take” of wildlife species listed as endangered or threatened (16 U.S.C. 1538). The ESA defines the term “take” as: to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed species, or to attempt to engage in such conduct (16 U.S.C. 1532). Harm includes significant habitat modification or degradation that actually kills or injures listed wildlife by significantly impairing essential behavioral patterns, including breeding, feeding, and sheltering [50 CFR 17.3(c)]. Pursuant to section 10(a)(1)(B) of the ESA, the Service may issue an “incidental take permit” to take listed species if such taking is incidental to, and not the purpose of, otherwise lawful activities. Regulations governing permits for threatened species and endangered species, respectively, area at 50 CFR 17.32 and 50 CFR 17.22. Although take of listed plant species is not prohibited under the ESA, and therefore cannot be authorized under an incidental take permit, plant species may be included on a permit in recognition of the conservation benefits provided to them under a habitat conservation plan. All species included on an incidental take permit would receive assurances under the FWS' “No Surprises” regulation [50 CFR 17.22(b)(5) and 17.32(b)(5)]. Species proposed for coverage in the HCP are species that are currently listed as federally threatened or endangered or have the potential to become listed during the life of this HCP and have some likelihood to occur within the project area. Should unlisted covered wildlife species become listed under the ESA during the term of the permit, take authorization for those species would become effective upon listing. The specific federally listed endangered species proposed for coverage in this HCP are: the giant kangaroo rat ( *Dipodomys ingens* ), San Joaquin kit fox ( *Vulpes macrotis mutica* ), Tipon kangaroo rat ( *Dipodomys nitratoides nitratoides* ), Buena Vista shrew ( *Sorex ornatus relictus* ), blunt-nosed leopard lizard ( *Gambelia sila* ), Kern mallow ( *Eremalche kernensis* ), and San Joaquin woolly-threads ( *Lembertia congdonii* ). The specific unlisted species proposed for coverage in the HCP are: the San Joaquin antelope squirrel ( *Ammospermophilus nelsoni* ), short-nosed kangaroo rat ( *Dipodomys nitratoides brevinasus* , San Joaquin LeConte's thrasher ( *Toxostoma lecontei macmillanoura* ), western burrowing owl ( *Athene cunicularia hypugea* ), Tejon poppy ( *Eschscholzia lemmonii* ssp. *kernensis* ), oil nestraw ( *Stylocline citroleum* , and heartscale ( *Atriplex cordulata* ). Species may be added or deleted during the course of the development of the Plan based on further analysis, new information, ageny consultation, and public comment. The Federal government established the Elk Hills Oil and Gas Field in 1912 for national defense purposes as part of the Naval Petroleum Reserves (NPR). It was then referred to as “NPR-1” and operated by the U.S. Department of Energy (DOE). Given the potential effects of operating NPR-1 on listed species, DOE engaged in several formal consultations with the Service under section 7 of the ESA, resulting in the issuance by the Service of several Biological Opinions (the most recent opinion was completed in 1995). Congress directed DOE to sell NPR-1 in the National Defense Authorization Act for Fiscal year 1996 and authorized DOE to transfer the Incidental Take Statement contained in the 1995 Biological Opinion to the purchase of NPR-1. OEHI (the purchaser) is approaching the limit to take authorized in the 1995 Biological Opinion and therefore has applied for authorization for additional incidental take through this HCP. The Plan area is located in the Elk Hills, 26 miles southwest of Bakersfield, California, and includes oil and gas reserves on the 47,729-acre Elk Hills Oil and Gas Field and a contiguous 2-mile-wide HCP Permit Area around the perimeter of the oil and gas field. The HCP would result in the permanent disturbance of up to 4,000 acres and the temporary disturbance of up to 3,000 acres of presently undisturbed land in the Elk Hills. The proposed duration of the HCP and the incidental take permit would be 50 years. The HCP would establish a 7,801-acre conservation area and habitat management program located on the northern and southern edges of the Elk Hills. Implementation activities that may be covered under the Plan include all activities associated with ongoing and new oil and gas production operations, including but not limited to:

(1)Construction, operation, and maintenance of production facilities;

(2)surface excavations;

(3)activities required by the California Division of Oil, Gas and Geothermal Resources;

(4)construction and operation of related facilities;

(5)installation, maintenance, and repair of perimeter and interior fencing;

(6)transmission lines;

(7)emergency response and environmental remediation;

(8)livestock grazing;

(9)regulatory agency requirements;

(10)recreational and educational activities;

(11)scientific research;

(12)implementation of conservation program;

(13)maintenance of off-site facilities; and

(14)construction of off-site facilities. The effects of the covered activities on the covered species are proposed to be minimized and mitigated through implementation of a detailed conservation program that will be fully described in the HCP. Components of the proposed conservation program may include: avoidance and minimization measures, monitoring, adaptive management, and mitigation measures consisting of preservation, restoration, and enhancement of habitat. Environmental Impact Statement/Report The EIS/EIR will consider the proposed action, the issuance of an ESA incidental take permit, no action (no permit), and a reasonable range of alternatives. A detailed description of the proposed action and alternatives will be included in the EIS/EIR. The alternatives to be considered for analysis in the EIS/EIR may include: modified lists of covered species, land coverage areas, and intensity of future development. The EIS/EIR will also identify potentially significant impacts on biological resources, land use, air quality, water quality, water resources, economics, and other environmental resource issues that could occur directly or indirectly with implementation of the proposed action and alternatives. Different strategies for minimizing and mitigating the impacts of incidental take may also be considered. Environmental review of the EIS/EIR will be conducted in accordance with the requirements of NEPA (42 U.S.C. 4321 *et seq.* ), it s implementing regulations (40 CFR parts 1500-1508), other applicable regulations, and Service procedures for compliance with those regulations. This notice is being furnished in accordance with 40 CFR 1501.7 and 1508.22 to obtain suggestions and information from other agencies and the public on the scope of issues and alternatives to be addressed in the EIS/EIR. The primary purpose of the scoping process is to identify important issues raised by the public related to the proposed action. Written comments from interested parties are invited to ensure that the full range of issues related to the permit application is identified. Comments will only be accepted in written form. You may submit written comments by mail, facsimile transmission, or in person (see ADDRESSES ). All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public. Our practice is to make comments, including names, home addresses, home phone numbers, and e-mail addresses of respondents, available for public review. Individual respondents may request that we withhold their names and/or homes addresses, etc., but if you wish us to consider withholding 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, documentable circumstances, this information will be released. We will always make submissions from organization or businesses, and from individuals identifying themselves as representatives of or officials of organizations or businesses, available for public inspection in their entirety. Dated: November 17, 2006. Ken McDermond, Deputy Manager, California/Nevada Operations Office, Sacramento, California. [FR Doc. 06-9410 Filed 11-27-06; 8:45 am]

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