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Code · REGISTER · 2006-11-14 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

11,461 words·~52 min read·/register/2006/11/14/06-9192

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

BILLING CODE 4150-04-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-06AW] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Supplement to the National Birth Defects Prevention Study: Qualitative Assessment of the Attitudes Mothers Have Toward Collecting Biological Specimens on their Infants and Young Children to Study Risk Factors for Birth Defects and Preterm Delivery—New—National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Center on Birth Defects and Developmental Disabilities (NCBDDD), Centers for Disease Control and Prevention (CDC), has been conducting the National Birth Defects Prevention Study (OMB number 0920-0010, Exp. 5/31/2009) since 1997. The NBDPS is a case-control study of major birth defects that includes cases identified from existing birth defect surveillance registries in nine states, including metropolitan Atlanta. Control infants are randomly selected from birth certificates or birth hospital records. Mothers of case and control infants are interviewed using a computer-assisted telephone interview. Parents are asked to collect cheek cells from themselves and their infants for DNA testing. Information gathered from both the interviews and the DNA specimens will be used to study independent genetic and environmental factors as well as gene-environment interactions for a broad range of carefully classified birth defects. This proposed supplement to the National Birth Defects Prevention Study will use qualitative research to provide data on the barriers to participation in the collection of biological specimens by mothers on themselves, their infants, and young children. It is costly to implement the collection of biological specimens into an interview/questionnaire-based study. However, an ever-increasing number of studies include the examination of environmental and genetic interactions to help medical and public health professionals' better target appropriate interventions. A critical component for studies of gene variants is the collection of biological specimens. Participation and non-participation in the collection of biological specimens is not fully understood. We will conduct multiple well-designed focus groups to assess the attitudes of both mothers who participated and mothers who did not participate in the collection of biological specimens to increase the effectiveness of these studies. This information will be useful to many groups at the CDC who are currently collecting biological specimens from infants and their families but with less than optimal response rates and those who are working to implement studies that include the use of biological specimens. Scientists from the National Birth Defects Prevention Study (NBDPS) in NCBDDD, the Pregnancy Risk Assessment Monitoring System (PRAMS) in NCCDPHP, and the Office of Genomics and Disease Prevention
(OGDP)have received Collaborative Initiative intramural funding to conduct focus groups aimed at gaining insight into the barriers and motivations women have for participating in the collection of biological specimens. Among the three collaborating Centers within the Coordinating Center for Health Promotion, NCBDDD's National Birth Defects Prevention Study provides a unique opportunity for exploring the barriers and motivations toward collection of genetic material. This focus group project will recruit mothers who participated in the maternal interview for the National Birth Defects Prevention Study (NBDPS). There are no costs to the respondents other than their time. The total estimated annualized burden hours are 214. Estimated Annualized Burden Hours Type of respondent Number of respondents Frequency of response Avg. burden/response (in hours) Annual burden (in hours) Focus group Participants 72 1 2.5 180 Dated: November 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-19144 Filed 11-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0217] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Vital Statistics Training Application, OMB No. 0920-0217—Extension—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description In the United States, legal authority for the registration of vital events, *i.e.* , births, deaths, marriages, divorces, fetal deaths, and induced terminations of pregnancy, resides individually with the States (as well as cities in the case of New York City and Washington, DC) and Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. These governmental entities are the full legal proprietors of vital records and the information contained therein. As a result of this State authority, the collection of registration-based vital statistics at the national level, referred to as the U.S. National Vital Statistics System (NVSS), depends on a cooperative relationship between the States and the Federal Government. This data collection, authorized by 42 U.S.C. 242k, has been carried out by NCHS since it was created in 1960. NCHS assists in achieving the comparability needed for combining data from all States into national statistics, by conducting a training program for State and local vital statistics staff to assist in developing expertise in all aspects of vital registration and vital statistics. The training offered under this program includes courses for registration staff, statisticians, and coding specialists, all designed to bring about a high degree of uniformity and quality in the data provided by the States. This training program is authorized by 42 U.S.C. 242b, section 304(a). In order to offer the types of training that would be most useful to vital registration staff members, NCHS requests information from State and local vital registration officials about their projected needs for training. NCHS also asks individual candidates for training to submit an application form containing name, address, occupation, work experience, education, and previous training. These data enable NCHS to determine those individuals whose needs can best be met through the available training resources. NCHS is requesting 3 years of OMB clearance for this project. There is no cost to respondents in providing these data. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours State, local, and Territory Registration Officials 57 1 20/60 19 Training applicants 100 1 15/60 25 Total 44 Dated: November 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-19145 Filed 11-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-06-05CH] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project An assessment of the determinants of HIV risk factors for African-American and Hispanic women in the southeastern United States—New—The National Center for HIV/AIDS, STD and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC is requesting OMB approval to administer a questionnaire and rapid oral test for HIV in heterosexual African American and Hispanic women at three sites in the southeastern United States. This proposed data collection will occur over 3 years. This study is designed to assess risk factors for HIV infection in these women and addresses goals of CDC's “HIV Prevention Strategic Plan Through 2005”. CDC plans to meet specific goals by
(1)decreasing the number of women at high risk of acquiring or transmitting HIV infection;
(2)increasing the proportion of HIV-infected women who know they are infected;
(3)increasing the number of HIV-infected women who are linked to appropriate prevention, care, and treatment services; and
(4)strengthening the capacity nationwide to monitor the HIV epidemic. In addition, project data will provide important epidemiologic information useful for the development and targeting of future HIV prevention activities. To identify recruitment venues, 250 African American and 125 Hispanic women (n = 375) will be recruited to take part in an anonymous one-time 3-minute intercept interview. (Data on the table below are shown annualized over the 3 year period for this project.) About 2025 women, recruited directly from the selected venues (e.g. health clinics, beauty salons, laundromats, etc.) and by word of mouth using a respondent-driven sampling
(RDS)approach, will be asked to complete a 10-minute eligibility screening interview. We estimate that 80% of screened women will be eligible for our study. Among the estimated 1620 eligible women about 270 women are anticipated to decline participation in the study. To get a better understanding of the reasons for declining participation, those 270 women will be asked to complete a 10-minute questionnaire. The remaining 1350 eligible participants (850 African American and 500 Hispanic) that are at risk for HIV infection will be enrolled. They will respond to a one-time, 45-minute computerized questionnaire capturing information on demographic, psychological, behavioral, sociocultural, and environmental/contextual dimensions relevant for understanding risk for contracting HIV infection. They will also receive rapid oral HIV testing and counseling. The HIV counseling and testing will take an additional 45 minutes to complete. Each woman will receive 10-minute RDS training on how they can tell other women in their social networks about the study. A sub-sample of 40 African American and 20 Hispanic women (n = 60) will also take part in separate qualitative interviews. The one-hour qualitative interview will be scheduled for a different day that is convenient for the women. The total response burden for the three-year period is estimated to be 2711.25 hours (904 annualized burden hours). There is no cost to the respondents other than their time. Estimated Annualized Burden Hours Activity with women volunteers Number of respondents Number of responses per respondent Average burden per response (hours) Hours Venue intercept interview 125 1 3/60 6.25 Eligibility screening interview 675 1 10/60 112.5 Refusal questionnaire 90 1 10/60 15 ACASI survey interview 450 1 45/60 337.5 HIV Testing & Counseling 450 1 45/60 337.5 RDS Training 450 1 10/60 75 Qualitative interview 20 1 1 20 Total 903.75 Dated: November 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-19146 Filed 11-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0604] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project School Associated Violent Death Surveillance System—Extension—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Violence Prevention (DVP), National Center for Injury Prevention and Control (NCIPC) proposes to maintain a system for the surveillance of school-associated homicides and suicides. The system will rely on existing public records and interviews with law enforcement officials and school officials. The purpose of the system is to
(1)estimate the rate of school-associated violent death in the United States and
(2)identify common features of school-associated violent deaths. The system will contribute to the understanding of fatal violence associated with schools, guide further research in the area, and help direct ongoing and future prevention programs. Violence is the leading cause of death among young people, and increasingly recognized as an important public health and social issue. In 1998, over 3,500 school aged children (5 to 18 years old) in the United States died violent deaths due to suicide, homicide, and unintentional firearm injuries. The vast majority of these fatal injuries were not school associated. However, whenever a homicide or suicide occurs in or around school, it becomes a matter of particularly intense public interest and concern. NCIPC conducted the first scientific study of school-associated violent deaths during the 1992-99 academic years to establish the true extent of this highly visible problem. Despite the important role of schools as a setting for violence research and prevention interventions, relatively little scientific or systematic work has been done to describe the nature and level of fatal violence associated with schools. Until NCIPC conducted the first nationwide investigation of violent deaths associated with schools, public health and education officials had to rely on limited local studies and estimated numbers to describe the extent of school-associated violent death. The system will draw cases from the entire United States in attempting to capture all cases of school-associated violent deaths that have occurred. Investigators will review public records and published press reports concerning each school-associated violent death. For each identified case, investigators will also interview an investigating law enforcement official (defined as a police officer, police chief, or district attorney), and a school official (defined as a school principal, school superintendent, school counselor, school teacher, or school support staff) who are knowledgeable about the case in question. Researchers will request information on both the victim and alleged offender(s)—including demographic data, their academic and criminal records, and their relationship to one another. They will also collect data on the time and location of the death; the circumstances, motive, and method of the fatal injury; and the security and violence prevention activities in the school and community where the death occurred, before and after the fatal injury event. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 70. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden/response (in hours) School Officials 35 1 1 Police Officials 35 1 1 Dated: November 7, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-19147 Filed 11-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee for Injury Prevention and Control: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Advisory Committee for Injury Prevention and Control, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 28, 2008. For information, contact Amy Harris, Executive Secretary, Advisory Committee for Injury Prevention and Control, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop K61, Atlanta, Georgia 30333, telephone 770/488-1484 or fax 770/488-4222. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: November 6, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-19151 Filed 11-13-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0329] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 14, 2006 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medicated Feed Mill Licensing Application—21 CFR Part 515 (OMB Control No. 0910-0337)—Extension The Animal Drug Availability Act
(ADAA)of October 9, 1996, amended section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) to replace the system for the approval of specific medicated feed with a general licensing system for feed mills. Before passage of the ADAA, medicated feed manufacturers were required to obtain approval of Medicated Feed Applications
(MFAs)in order to manufacture certain types of medicated feeds. An individual approved MFA was required for each and every applicable medicated feed. The ADAA streamlined the paperwork process for gaining approval to manufacture medicated feeds by replacing the MFA system with a facility license for each medicated feed manufacturing facility. Implementing regulations are at part 515 (21 CFR part 515). In the **Federal Register** of August 25, 2006 (71 FR 50433), FDA solicited comments on the information collection provisions of this proposed collection. In response to that request, FDA received no comments. *Description of Respondents* : Medicated feed manufacturers. FDA estimates the burden for this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 515.10(b) 7 1 7 0.25 1.75 515.11(b) 100 1 100 0.25 25 515.23 25 1 25 0.25 6.25 515.30(c) 0.15 1 0.15 24 3.6 Total 36.6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 2.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours 510.305 1,070 1 1,070 0.03 32.10 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting burden on industry is 36.6 hours as shown in table 1 of this document. Industry estimates it takes about 1/4 hour to submit the application. We estimate 132 original and supplemental applications, and voluntary revocations for a total of 33 hours (132 submissions x 1/4 hour). An additional 3.6 hours is added for the rare notice of opportunity for a hearing to not approve or revoke an application. Finally, we estimate 36 hours for maintaining and retrieving labels as required by 21 CFR 510.305. We estimated .03 hours for each of approximately 1,070 licensees. Thus, the total burden for recordkeeping requirements is 32.10 hours (1,070 x 0.03). Dated: November 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-19152 Filed 11-13-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0441] Draft Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of draft guidance for industry (#136) entitled “Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods.” This draft guidance provides our recommendations for protocols for conducting the transfer study of a single-laboratory validated Type C medicated feed assay method to laboratories that have no experience with the test method. DATES: Submit written or electronic comments on this draft guidance by January 29, 2007, to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Rebecca L. Owen, Center for Veterinary Medicine (HFV-141), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9842, e-mail: *rebecca.owen@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Section 512(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) establishes the requirements for a new animal drug approval. FDA regulations specify the information you (the sponsor) must submit as part of your new animal drug application
(NADA)and the proper format for the NADA submission (§ 514.1 (21 CFR 514.1)). As part of your NADA submission, you must describe analytical procedures capable of determining the active component(s) of the new animal drug within a reasonable degree of accuracy and of assuring the identity of such components (21 CFR 514.1(b)(5)(vii)). This includes a description of practicable methods of analysis (assay methods) that have adequate sensitivity to determine the amount of the new animal drug in the final dosage form (21 CFR 514.1(b)(5)(vii)(a)). In the case of a Type A medicated article, the Type C medicated feed is a final dosage form used to treat the animal. Thus as part of the NADA review process, FDA looks at assay methods for determining the amount of a new animal drug in Type C medicated feed. This draft guidance provides our (the Office of New Animal Drug Evaluation or ONADE) recommendations for protocols for conducting the transfer study of a single-laboratory validated Type C medicated feed assay method to laboratories that have no experience with the test method. Many testing laboratories, including state feed laboratories and contract laboratories, use Type C medicated feed assay methods to determine whether the drug in a medicated feed is within the assay limits. The term “assay limits” refers to the amount of the drug detected when a Type B/C feed is assayed. The limit is a range that is codified at 21 CFR 558.4(d). When feed assay values fall within this range, it indicates that the feed has been prepared with the correct amount of Type A medicated article. Because many different laboratories use medicated feed assays, it is important that the assay methods are reproducible. Sponsors should conduct method transfer studies to evaluate reproducibility. A method transfer study is part of the evaluation process for a Type C medicated feed assay method and demonstrates the transferability of the feed assay method among different laboratories by comparing the results each laboratory obtains when using the method to analyze a specific set of feed samples. Sponsors may expand the method transfer study to include other medicated feed products, such as Top Dress Type C, Free-Choice Type C, and Type B medicated feeds. II. 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 in § 514.1 have been approved under OMB control nos. 0910-0032 and 0910-0154. III. Significance of Guidance This draft level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance, when finalized, will represent the agency's current thinking on the 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 alternate method may be used as long as it satisfies the requirements of applicable statutes and regulations. IV. Comments This draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this draft guidance 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. V. Electronic Access Electronic comments may be submitted on the Internet at *http://www.fda.gov/dockets/ecomments* . Copies of the draft guidance document entitled “Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods” may be obtained from the CVM Home Page ( *http://www.fda.gov/cvm* ) and from the Division of Dockets Management Web site ( *http://www.fda.gov/ohrms/dockets/default.htm* ). Dated: November 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-19204 Filed 11-13-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0419] Draft Voluntary National Retail Food Regulatory Program Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft document entitled “Voluntary National Retail Food Regulatory Program Standards” (the Program Standards). The Program Standards are intended to help state, local, and tribal regulators design and manage a retail food regulatory program that is focused on the reduction of foodborne illness risk factors. DATES: Submit written or electronic comments concerning the draft Program Standards document and its recommendations for collection of information by January 16, 2007. ADDRESSES: Submit written requests for single copies of the draft Program Standards document to Glenda R. Lewis, Center for Food Safety and Applied Nutrition (HFS-626), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2150. Send one self-addressed adhesive label to assist that office in processing your request. Submit written comments concerning the draft Program Standards document and its recommendations for collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft Program Standards document and its recommendations for collection of information to *http://www.fda.gov/dockets/ecomments* . All comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft manuals and received comments. FOR FURTHER INFORMATION CONTACT: Glenda R. Lewis, Center for Food Safety and Applied Nutrition (HFS-626), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-2150. SUPPLEMENTARY INFORMATION: I. Background While the responsibility for regulating retail and foodservice establishments lies primarily with state, local, and tribal jurisdictions, FDA provides assistance to these jurisdictions through multiple means including, but not limited to, training and technical assistance. Authority for providing such assistance is derived from section 311 of the Public Health Service Act (42 U.S.C. 243). In addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and sanitary, and section 903(b)(4) of the act directs FDA to cooperate with food retailers, among others, in carrying out this part of its mission. The Centers for Disease Control and Prevention has identified the major contributing factors associated with foodborne illness outbreaks. Five of these contributing factors directly relate to retail and foodservice establishments and are called “foodborne illness risk factors” by FDA. In an effort to assist state, local, and tribal regulators and the retail and food service entities they regulate, FDA developed draft Program Standards. The Program Standards were developed to address the need for national uniformity among retail food regulatory programs, to promote uniform application of the FDA Food Code, and to reduce the occurrence of foodborne illness risk factors. The Program Standards were developed with extensive input from state, tribal, and local regulatory authorities. They capture the best management practices currently in use by those authorities and are intended to help those authorities design and manage a retail food regulatory program that is focused on the reduction of foodborne illness risk factors. The incorporation of a risk-based methodology into regulatory inspection programs is an important element in reaching the goals established by the President's Council on Food Safety in the document entitled “Food Safety Strategic Plan” released in January 2001 (available at *http://www.foodsafety.gov/~fsg/cstrpl-4.html* ) as well as FDA's food safety program goals. II. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. *Title* : Voluntary National Retail Food Regulatory Program Standards In the **Federal Register** of May 9, 2001 (66 FR 23715), a 60-day notice was published soliciting comments on FDA's collection of information from local, state and tribal authorities concerning their use of or planned use of FDA's Program Standards. No comments were received in response to that notice. The agency has decided to reissue this 60-day notice for further comment because the Program Standards have been revised since the previous notice. The January 2005 revision of the Program Standards is available in draft for comment on FDA's Web site at *http://www.cfsan.fda.gov/~dms/ret3toc.html* . The Program Standards define nine essential elements of an effective regulatory program for retail food establishments, establish basic quality control criteria for each element, and provide a means of recognition for those state, local, and tribal regulatory programs that meet the Program Standards. The program elements addressed by the Program Standards are as follows:
(1)Regulatory foundation,
(2)trained regulatory staff,
(3)inspection program based on HACCP principles,
(4)uniform inspection program,
(5)foodborne illness and food security preparedness and response,
(6)compliance and enforcement,
(7)industry and community relations,
(8)program support and resources, and
(9)program assessment. Each standard includes a list of records needed to document compliance with the standard (referred to in the Program Standards document as “quality records”) and has one or more corresponding appendices that contain forms and worksheets to facilitate the collection of information needed to assess a retail program under that standard. The respondents are State, local and tribal government agencies. Regulatory agencies may use existing, available records or may choose to develop and use alternate forms and worksheets that capture the same information. In the course of their normal activities, state, local, and tribal regulatory agencies already collect and keep on file many of the records needed as quality records to document compliance with the end of each Program Standard by jurisdictions that enroll. Although the detail and format in which this information is collected and recorded may vary by jurisdiction, records that are kept as a usual and customary part of normal agency activities include inspection records, written quality assurance procedures and records of quality assurance checks, staff training certificates and other training records, a log or database of food-related illness or injury complaints, records of investigations resulting from such complaints, an inventory of inspection equipment, records of outside audits, and records of outreach efforts (e.g., meeting agendas and minutes, documentation of food safety education activities). No new recordkeeping burden is associated with these existing records, which are already a part of usual and customary program recordkeeping activities by state, local, and tribal regulatory agencies, and which can serve as quality records under the Program Standards. State, local, and tribal regulatory agencies that enroll in the Program Standards and seek listing in the FDA National Registry are required to report to FDA on the completion of the following three management tasks outlined in the Program Standards:
(1)Conducting a program self assessment;
(2)conducting a baseline survey of the regulated industry; and
(3)obtaining an independent outside audit (verification audit). All three tasks must be completed within a 3-year time span. The results are reported to FDA on Form FDA 3519, “FDA National Registry Report,” and Form FDA 3520, “Permission to Publish in National Registry.” These forms are located in Appendix I of the Program Standards. If a regulatory agency follows all the recordkeeping recommendations in the individual standards and their appendices, it will have all the information needed to complete the forms. The time required to complete the forms is minimal. Recordkeeping FDA's recordkeeping burden estimate includes time required for a state, local, or tribal agency to review the instructions in the Program Standards, compile information from existing sources, and create any records recommended in the Program Standards that are not already kept in the normal course of the agency's usual and customary activities. Worksheets (Appendices) are provided to assist in this compilation. In estimating the time needed for the program self-assessment (Program Standards 1-8, shown in chart 1 of this document), FDA considered responses from four state and three local jurisdictions that participated in an FDA Program Standards Pilot study. Chart 2 of this document shows the estimated recordkeeping burden for the completion of the baseline data collection and chart 3 of this document shows the estimated recordkeeping burden for the verification audit. The overall program improvement cycle is a 3-year period for completion of all three management tasks. **CHART 1.—YEAR ONE—SELF ASSESSMENT** Standard Recordkeeping Activity Hours per Recordkeeper (Year One) No. 1 Regulatory Foundation Self Assessment: (Appendix A 1 ) Completion of worksheet recording results of evaluations and comparison on worksheets 16 No. 2 Trained Regulatory Staff Self Assessment: (Appendix B 1 ) Completion of summary worksheet of each employee training records 2 19 No. 3 HACCP Principles Self Assessment: (Appendix C 1 ) Completion of worksheet documentation 4 No. 4 Uniform Inspection Program Self Assessment: (Appendix D 1 ) Completion of worksheet documentation of jurisdiction's quality assurance procedures 2 19 No. 5 Foodborne Illness and Food Security Preparedness and Response Self Assessment: (Appendix E 1 ) Completion of worksheet documentation 5 No. 6 Compliance Enforcement Self Assessment: (Appendix F 1 ) Selection and review of 20 to 70 establishment files @ 25 minutes per file. Estimate is based on a mean number of 45. Completion of worksheet 19 No. 7 Industry and Community Relations Self Assessment: (Appendix G 1 ) Completion of worksheet 2 No. 8 Program Support and Resources Self Assessment: (Appendix H 1 ) Selection and review of establishment files 8 Subtotal 92 1 Or comparable documentation. 2 Estimates will vary depending on the number of regulated food establishments and the number of inspectors employed by the jurisdiction. CHART 2.—YEAR TWO—BASELINE DATA COLLECTION Standard Recordkeeping Activity Hours Per Recordkeeper (Year Two) No. 9 Program Assessment Baseline Data Collection (Appendices I and J). Selection and inspection of randomly selected statistical sample of 9 to 87 establishments from each of 9 facility types 1 333 1 Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type. Estimates will vary depending on the number of regulated food establishments within a jurisdiction and the number of inspectors employed by the jurisdiction. **CHART 3.—YEAR THREE—VERIFICATION AUDIT** Standard Recordkeeping Activity Hours per Recordkeeper (Year Three) 9 Verification Audit (Appendices I and J) 1 46 1 We estimate that no more than 50 percent of time spent to complete self assessment of all nine Standards is spent completing verification audit worksheets. Time will be considerably less if less than nine standards require verification audits. FDA estimated the annual hours per recordkeeper (i.e., per enrolled jurisdiction) in table 1 of this document by adding the recordkeeping estimates for the management tasks of self assessment, baseline data collection, and verification audit (charts 1, 2, and 3 of this document) that enrolled jurisdictions must perform during a 3-year cycle, then dividing the total by three to obtain an annual average. The estimates in tables 1 and 2 of this document are based on the estimated participation of 500 regulatory jurisdictions in the Program Standards. There are approximately 3,000 jurisdictions in the United States and its territories that have retail food regulatory programs. Enrollment in the Program Standards is voluntary, and therefore FDA does not expect all jurisdictions to participate in the near future. In its 2002 operational plan, the FDA National Retail Food Team established a goal of enrolling 15 percent of eligible agencies, or 450 programs, in the Program Standards by the year 2010. For purposes of this burden estimate, it is reasonable to take into account the possibility that this goal could be exceeded by approximately 10 percent, for a total of approximately 500 participating agencies. Thus, FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 FDA Worksheets 2 No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours Appendices A through J 500 1 500 157 78,500 Total Burden Hours 78,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Or comparable documentation. Reporting Based on the number and nature of the items that need to be completed, FDA estimates a total of 12 minutes annually for each enrolled jurisdiction to complete both FDA Form 3519, “FDA National Registry Report,” and Form 3520, “Permission to Publish in National Registry.” Form 3519 requires the name and address of the jurisdiction; completion dates for the self assessment, baseline survey (original and update), and verification audit; names of the person(s) who completed the self-assessment, verification audit, baseline survey, baseline survey update, and action plan; signature of the program manager; and date the form was completed. Form 3520 requires the name of the jurisdiction, completion date of the self assessment, date of the verification audit report, name of the auditor, signature and title of the official completing the form, and date the form was completed. As explained previously in this document, FDA estimates that 500 regulatory jurisdictions will enroll in the Program Standards. The reporting burden in table 2 of this document includes only the time necessary to fill out and send the forms, as compiling the underlying information (including self-assessment reports, baseline surveys, outside audits, and supporting documentation) is accounted for under the recordkeeping estimates in table 1 of this document. Thus, FDA estimates the burden for this collection of information as follows: **Table 2.—Estimated Annual Reporting Burden** 1 FDA Forms No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3519 500 1 500 6 min 50 hours 3520 500 1 500 6 min 50 hours Total Burden Hours 100 hours 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft Program Standards document and its recommendations for collection of information. 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 draft Program Standards document 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 draft Program Standards document at *http://www.cfsan.fda.gov/~dms/ret3toc.html* . Dated: October 31, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-19195 Filed 11-13-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [DHS-2006-0070] Data Privacy and Integrity Advisory Committee AGENCY: Office of the Secretary, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee Meeting. SUMMARY: This notice announces the date, time, location, and agenda for the next meeting of the Department of Homeland Security Data Privacy and Integrity Advisory Committee. This meeting will be open to the public, with the exception of a one-hour administrative session. DATES: The meeting will be held from 8 a.m. to 11:15 a.m. and 12:15 p.m. to 2:30 p.m. on Wednesday, December 6, 2006, in Miami Beach, Florida. ADDRESSES: The Department of Homeland Security Data Privacy and Integrity Advisory Committee meeting will be held in the Key Biscayne A room of the Eden Roc Hotel, 4525 Collins Avenue, Miami Beach, Florida 33140. Persons wishing to make comments or who are unable to attend or speak at the meeting may submit comments at any time. All submissions received must include the docket number: DHS-2006-0070 and may be submitted by any one of the following methods: • *Federal Rulemaking Portal: http://www.regulations.gov.* Follow instructions for submitting comments on the Web site. • *E-mail: PrivacyCommittee@dhs.gov.* Include docket number in the subject line of the message. • *Fax:*
(571)227-4171. • *Mail:* Ms. Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Mail Stop D-3, Arlington, Virginia 22202. *Instructions:* All submissions received must include the docket number: DHS-2006-0070. Comments received will also be posted without alteration at *www.regulations.gov* , including any personal information provided. *Docket:* For access to the docket to read background documents or comments received by the DHS Data Privacy and Integrity Committee, go to *www.regulations.gov.* Comments received will be posted without alteration at *http://www.dhs.gov/privacy* , including any personal information provided. FOR FURTHER INFORMATION CONTACT: Hugo Teufel III, Chief Privacy Officer, or Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Arlington, Virginia 22202, by telephone
(571)227-3813, by fax
(571)227-4171, or by e-mail *PrivacyCommittee@dhs.gov.* SUPPLEMENTARY INFORMATION: The Data Privacy and Integrity Advisory Committee (“Privacy Advisory Committee”) will be meeting on Wednesday, December 6, 2006, in the Key Biscayne A room of the Eden Roc Hotel, 4525 Collins Avenue, Miami Beach, Florida 33140. The meeting will be held from 8 a.m. to 11:15 a.m. and 12:15 p.m. to 2:30 p.m. During the meeting, the DHS Chief Privacy Officer will provide an update on the activities of the DHS Privacy Office. The Subcommittees will update the Committee on the work currently being conducted. In the morning and afternoon sessions, invited speakers will discuss data integrity and credentialing programs. A tentative agenda has been posted on the Privacy Advisory Committee Web site at *http://www.dhs.gov/privacy.* Public comments will be accepted during the meeting between 2 p.m. and 2:30 p.m. All those who wish to make public comments during this time may register in advance or sign-up on the day of the meeting. In order to allow as many people as possible to testify, witnesses should limit their remarks to three minutes. For those wishing to make written comments, please follow the procedure noted above. Public attendance is encouraged. Any member of the public who wishes to attend the public session is requested to provide his or her name and affiliation no later than 2 p.m. EST, Friday, December 1, 2006, to Rebecca J. Richards via e-mail at *PrivacyCommittee@dhs.gov* , or via telephone at
(571)227-3813. This will assist with the preparation of name badges, meeting materials and seating arrangements. Everyone who plans to attend is respectfully requested to be present and seated by 7:45 a.m. for the morning session and by 12 p.m. for the afternoon session. Persons with disabilities who require special assistance should indicate this in their admittance request and are encouraged to identify anticipated special needs as early as possible. Although every effort will be made to accommodate all members of the public, seating is limited and will be allocated on a first-come, first-served basis. Hugo Teufel III, Chief Privacy Officer. [FR Doc. E6-19173 Filed 11-13-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Withdrawal of Notice of Availability of a Technical Agency Draft Recovery Plan for the Puerto Rican Parrot AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice, withdrawal. SUMMARY: We, the Fish and Wildlife Service, withdraw the notice of availability of the revised technical agency draft recovery plan for the Puerto Rican Parrot ( *Amazona vittata vittata* ). The Puerto Rican parrot, largely green with a red forehead and blue flight feathers, is one of nine extant Amazona parrots occurring in the West Indies. The notice (71 FR 58426, October 3, 2006) was released in error, however, we anticipate announcing the current revision of the recovery plan in fiscal year 2007, which incorporates new information, describes actions considered necessary for the conservation of this species, establishes criteria (important milestones) for recognizing the recovery levels for downlisting from endangered to threatened, and estimates the time and cost for implementing the recovery measures needed. ADDRESSES: Copies of the original recovery plan are available by request from the Boquerón Field Office, U.S. Fish and Wildlife Service, P.O. Box 491, Boquerón, Puerto Rico 00622 (telephone 787/851-7297) or by visiting our Web site at *http://endangered.fws.gov/recovery/index.html* . FOR FURTHER INFORMATION CONTACT: Field Supervisor at the above address. SUPPLEMENTARY INFORMATION: Background The Puerto Rican parrot is presently considered one of the 10 most endangered birds in the world. Since 1973, the number of wild parrots has never surpassed 47 birds, and currently stands at a minimum of 28 individuals mostly confined within the Caribbean National Forest boundaries in the Luquillo Mountains. The Puerto Rican parrot is a fruit-eating cavity nester seldom seen far from forests. The decline of the parrot and its restricted distribution are due to many factors, mostly the widespread habitat loss ( *e.g.* , deforestation.) The extant parrot population may have retreated to the Luquillo Mountains because preferred lowland habitat was destroyed. Due to its nesting requirements, it depends on mature forests with large cavity-forming trees. Many stands of cavity-forming trees are old enough to meet nesting requirements in the Caribbean National Forest. Parrots concentrate their use of habitat within the largest remaining area of essentially unmodified forest. However, some observations suggest that the parrots are using private areas bordering the southern and northern parts of the Caribbean National Forest. Despite the present low numbers and limited distribution, many of the historical threats, such as nest competition and predation of eggs and chicks by pearly-eyed thrashers ( *Margarops fuscatus* ), predation of fledglings and adults by red-tailed hawks ( *Buteo jamaicensis* ), predation by rats ( *Rattus rattus* and *R. norvegicus* ), parasitism by warble flies ( *Philornis pici* ), and the impact of hurricanes and competition for cavities with European and Africanized honeybees ( *Apis mellifera* ), have been controlled through management strategies. Restoring an endangered or threatened animal or plant to the point where it is again a secure, self-sustaining member of its ecosystem is a primary goal of the endangered species program. To help guide the recovery effort, we are preparing recovery plans for most listed species. Recovery plans describe actions considered necessary for conservation of the species, establish criteria for downlisting or delisting, and estimate time and cost for implementing recovery measures. The Act requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species. Section 4(f) of the Act requires us to provide a public notice and an opportunity for public review and comment during recovery plan development. When we announce the availability of the current revision of the recovery plan in fiscal year 2007, we will provide opportunity for public review and comment. Authority The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f). Dated: October 12, 2006. Cynthia K. Dohner, Acting Regional Director. [FR Doc. E6-19162 Filed 11-13-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Notice of Intent to Prepare an Environmental Impact Statement for the Ginn Company Battle Mountain Habitat Conservation Plan AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of intent. SUMMARY: Under the National Environmental Policy Act (NEPA), the U.S. Fish and Wildlife Service (Service) advises the public that we intend to gather information necessary to prepare, in coordination with the Ginn Company (Applicant), an Environmental Impact Statement
(EIS)for the Battle Mountain Habitat Conservation Plan
(HCP)in accordance with section 10(a)(1)(B) of the Endangered Species Act. The Service provides this notice to—(1) Describe the proposed actions and possible alternatives;
(2)advise other Federal and State agencies, affected Tribes, and the public of our intent to prepare an EIS;
(3)announce the initiation of a public scoping period; and
(4)obtain suggestions and information on the scope of issues and alternatives to be included in the EIS. DATES: Written comments should be received on or before December 14, 2006. ADDRESSES: Information, written comments, or questions related to the preparation of the EIS and the NEPA process should be submitted to Al Pfister, Western Colorado Field Office, 764 Horizon Drive, Building B, Grand Junction, Colorado 81506-3964 or via fax to
(970)245-6933. Comments may be submitted by e-mail to the following address: *GinnHCP_scoping@fws.gov* . FOR FURTHER INFORMATION CONTACT: Al Pfister, Western Colorado Project Leader, at the above address, or telephone 970-243-2778, extension 29. SUPPLEMENTARY INFORMATION: Background Section 9 of the Endangered Species Act
(Act)(16 U.S.C. 1538) and Federal regulations prohibit the “take” of a fish or wildlife species listed as threatened or endangered. Under the Act, the following activities are defined as take: to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture or collect listed animal species, or to attempt to engage in such conduct (16 U.S.C. 1532). However, under section 10(a)(1)(B) of the Act, we may issue permits to authorize “incidental take” of listed species. “Incidental take” is defined by the regulations that implement the Act as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing permits for threatened species and endangered species are at 50 CFR 17.32 and 50 CFR 17.22, respectively. The EIS would analyze the Service's potential issuance of an Incidental Take Permit
(ITP)to the Applicant for its proposed Battle Mountain development. Should a permit be issued, the permit may include assurances under the Service's “No Surprises” regulations. The Applicant's proposed development project for private land on Battle Mountain includes a resort and an accompanying private ski area between the towns of Minturn and Red Cliff in Eagle County, Colorado. The project area encompasses approximately 1,943 hectares
(ha)(4,800 acres (ac)). The residential development will include approximately 480 single and multiple family homes and 250 condo-style units. The ski area will include trails for all ability levels, creating approximately 445 ha (1,100 ac) of skiing, and will include skier services and amenities. The project is divided into three character areas for purposes of a conceptual plan. The Holy Cross Character Area consists of approximately 512 ha (1,265 ac). It will principally contain single-family homes on 0.4- and 0.8-ha (1- and 2-ac) lots and will interface with the ski area development to create ski in/out lodging. Approximately 62 dwelling units are proposed in this area. Approximately 438 ha (1,081 ac) of land in this character area will be designated recreation open space, which allows for year-round activities, including hiking, biking, and skiing. The Rock Creek Character Area consists of approximately 522 ha (1,290 ac) and is proposed to contain primarily single-family homes (up to 306 units) on varying lot sizes that also will interface with ski area development. This area will contain the Bolts Lake Gondola terminal for the top of the mountain, which will be utilized for services and passenger transport. This building will be associated with some skier services and amenities. Approximately 327 ha (807 ac) of this character area will be designated recreation open space, which allows for year-round activities, including hiking, biking, and skiing. The Willow Creek Character Area consists of approximately 457 ha (1,130 ac) and is proposed to contain primarily multiple-family units (up to 265), with approximately 84 single-family homes on 0.2-ha (0.5-ac) lots. This area will contain the resort core buildings that also will interface with ski area development. The Bolts Lake gondola will terminate at the icon building in Willow Creek, which contains the majority of skier services and amenities, including restaurants and the beginner ski area with teaching terrain. Approximately 392 ha (968 ac) of this character area will be designated recreation open space, which allows for year-round activities, including hiking, biking, and skiing. The following four species are proposed to be addressed in the HCP: Canada lynx ( *Lynx canadensis* ), bald eagle ( *Haliaetus leucocephalus* ), boreal toad ( *Bufo boreas boreas* ) (not a listed species), and slender moonwort ( *Botrychium lineare* ). Each of these species may be directly or indirectly affected by the Applicant's proposed development. The proposed HCP and ITP would cover incidental take associated with the construction, operation, and maintenance of the Battle Mountain residential resort and ski area, including—(1) Vegetation clearing in areas of suitable Canada lynx habitat;
(2)construction and increased human activity within the project area; and
(3)increased vehicle traffic on both I-70 and Highway 24, as well as within the project area. The draft HCP, prepared by the Applicant in support of the ITP application, will describe the impacts of take on proposed covered species, and will propose a conservation strategy to minimize and mitigate those impacts to the maximum extent practicable. The Applicant will develop habitat conservation measures for these species, with assistance from the Service. The Applicant is currently considering the following conservation measures as part of the HCP—(1) Creation of suitable winter forage habitat for lynx;
(2)designing and implementing a traffic management plan to address increased vehicular traffic;
(3)creating a fund for habitat protection and enhancement opportunities in the Eagle River Basin; and
(4)financial support of Canada lynx reintroduction programs by the Colorado Division of Wildlife. The Applicant and the Service will assess the implementation of these conservation measures for the duration of the HCP and term of the ITP. Implementation of the HCP would include monitoring compliance and regular reporting to the Service. Environmental Impact Statement The Service and the Applicant will select an environmental consulting firm to prepare the draft EIS to be prepared in accordance with NEPA. Although consultants will prepare the EIS, we will supervise the scope and content of the document for NEPA purposes. The EIS will consider the proposed action and a reasonable range of alternatives. A detailed description of the proposed action and alternatives will be included in the EIS. It is anticipated that several alternatives will be developed, which may vary by level of conservation, impacts caused by the proposed activities, permit area, or a combination of these factors. These alternatives will address alternative actions that can achieve some or all of the proposed action's purposes and needs. Additionally, we will evaluate a No-Action alternative. Under the No-Action alternative, we would not issue a section 10(a)(1)(B) permit. The EIS also will evaluate potentially significant impacts on biological resources, land use, and socioeconomic and other environmental issues that could occur directly or indirectly with implementation of the proposed action and alternatives. For all potential impacts, the EIS will identify mitigation measures, where feasible, to reduce these impacts to a level below significance. We will conduct an environmental review of the EIS in accordance with the requirements of NEPA (42 U.S.C. 4321 *et seq.* ), its implementing regulations (40 CFR parts 1500-1508), other applicable regulations, and our procedures for compliance with those regulations. We are furnishing this notice in accordance with 40 CFR 1501.7 of the NEPA implementing regulations, to obtain suggestions and information from other agencies and the public on the scope of issues and alternatives to be addressed in the EIS. The primary purpose of the scoping process is to identify important issues raised by the public that are related to the proposed action. We invite written comments from interested parties to help us identify the full range of issues related to the proposed action. You may submit written comments by mail or facsimile transmission (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. The Service requests that comments be specific. In particular, we request information regarding—direct, indirect, and cumulative impacts that implementation of the proposed HCP or other alternatives could have on endangered and threatened and other covered species, and their communities and habitats; other possible alternatives that meet the purpose and need of the proposed HCP; potential adaptive management and/or monitoring provisions; funding issues; existing environmental conditions in the plan area; other plans or projects that might be relevant to this proposed project; permit duration; maximum acreage that should be covered; specific species that should or should not be covered; specific landforms that should or should not be covered; and minimization and mitigation efforts. The Service estimates that the draft EIS will be available for public review in the spring of 2007. Dated: October 4, 2006. James J. Slack, Deputy Regional Director, Region 6. [FR Doc. E6-19142 Filed 11-13-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-964-1410-HY-P; F-21963, F-21966, F-21967, F-22006, F-22862, F-21945, F-21937] Alaska Native Claims Selection AGENCY: Bureau of Land Management, Interior. ACTION: Notice of decision approving lands for conveyance. SUMMARY: As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving the surface and subsurface estates in certain lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Bering Straits Native Corporation. The lands are in the vicinity of Wales and White Mountain, Alaska. Notice of the decision will also be published four times in the Nome Nugget. DATES: The time limits for filing an appeal are: 1. Any party claiming a property interest which is adversely affected by the decision shall have until December 14, 2006 to file an appeal. 2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal. Parties who do not file an appeal in accordance with the requirements of 43 CFR Part 4, Subpart E, shall be deemed to have waived their rights. ADDRESSES: A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, #13, Anchorage, Alaska 99513-7599. FOR FURTHER INFORMATION, CONTACT: The Bureau of Land Management by phone at 907-271-5960, or by e-mail at *ak.blm.conveyance@ak.blm.gov.* Persons who use a telecommunication device
(TTD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8330, 24 hours a day, seven days a week, to contact the Bureau of Land Management. Dina L. Torres, Land Law Examiner, Branch of Adjudication II. [FR Doc. E6-19149 Filed 11-13-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-964-1410-KC-P; F-14844-A] Alaska Native Claims Selection AGENCY: Bureau of Land Management, Interior. ACTION: Notice of decision approving lands for conveyance. SUMMARY: As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving the surface and subsurface estates in certain lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Ahtna, Incorporated, successor in interest to Cantwell Yedatene-Na Corporation. The lands are in the vicinity of Cantwell, Alaska, and are located in: U.S. Survey No. 3229, Alaska Containing 5.00 acres. Notice of the decision will also be published four times in the Fairbanks Daily News-Miner. DATES: The time limits for filing an appeal are: 1. Any party claiming a property interest which is adversely affected by the decision shall have until December 14, 2006 to file an appeal. 2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal. Parties who do not file an appeal in accordance with the requirements of 43 CFR part 4, subpart E, shall be deemed to have waived their rights. ADDRESSES: A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, #13, Anchorage, Alaska 99513-7599. FOR FURTHER INFORMATION CONTACT: The Bureau of Land Management by phone at 907-271-5960, or by e-mail at *ak.blm.conveyance@ak.blm.gov.* Persons who use a telecommunication device
(TTD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8330, 24 hours a day, seven days a week, to contact the Bureau of Land Management. Jennifer L. Noe, Land Law Examiner, Branch of Adjudication II. [FR Doc. E6-19150 Filed 11-13-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Minerals Management Service 5-Year Outer Continental Shelf
(OCS)Oil and Gas Leasing Programs for 2002-2007 and 2007-2012; OCS Lease Sale 201 and Proposed Lease Sale 205, Central Gulf of Mexico; Draft Environmental Impact Statement
(EIS)for 5-Year Leasing Program for 2007-2012 AGENCY: Minerals Management Service, Interior. ACTION: Revision of 5-Year Leasing Program and Request for Comment. SUMMARY: On October 24, 2006, the Department of Interior/MMS and the State of Louisiana announced the settlement of the case of *Blanco,* *et al.* , v. *Burton* , *et al.* The District Court approved the settlement and dismissed the case on October 24, 2006. As a result of the settlement agreement, the MMS proposes to expand Lease Sale 205, scheduled in the Proposed 5-Year Program for 2007-2012 and accompanying Draft EIS, from the currently proposed program area (Map 1) to include all available acreage in the Central Gulf of Mexico Planning Area as proposed in the new program for subsequent Central Gulf sales (Map 2). The MMS is providing a 45-day comment period to specifically address this proposed change. The earlier comment periods on the Proposed 5-Year Program and Draft EIS, remain as announced on August 25, 2006. The comment period on the Program closes on November 24, 2006, and on the Draft EIS on November 22, 2006. DATES: MMS is accepting comments regarding this newly proposed change for the Proposed 5-Year OCS Program for 2007-2012 and accompanying Draft EIS until December 29, 2006. Note that the comment periods for the earlier proposed 5-Year OCS Program for 2007-2012 and the Draft EIS remain the same as previously announced. This new 45-day comment period is for comments associated with the change identified here as a result of the settlement with Louisiana. ADDRESSES: If you wish to comment, you may submit your comments by one of two methods. You may comment electronically using MMS's Public Connect online commenting system. This is the preferred method for commenting. This system can be accessed at *http://www.mms.gov/5-year/2007-2012main.htm* . From the Public Connect “Welcome” screen, search for “Proposed 5-Year OCS Oil and Gas Program Revisions and Draft EIS” or select it from the “Projects Open for Comment” menu. You may also mail comments. Please label your comments and the packaging in which they are submitted according to the subject matter. For those pertaining to program preparation, label as “Comments on Revisions to Proposed 5-Year Program for 2007-2012” and mail to: Ms. Renee Orr, 5-Year Program Manager, Minerals Management Service (MS-4010), Room 3120, 381 Elden Street, Herndon, Virginia 20170-4817. For those pertaining to EIS preparation, label as “Comments on 2007-2012 Oil and Gas Program Revisions for Draft Environmental Impact Statement” and mail to: Mr. James F. Bennett, Chief, Branch of Environmental Assessment, 381 Elden Street, Mail Stop 4042, Herndon, Virginia 20170-4817. If you submit any privileged or proprietary information to be treated as confidential, please mark the envelope, “Contains Confidential Information.” Before including your address, phone number, e-mail address, or other personal identifying information in your comment, be advised that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so. However, we will not consider anonymous comments. Except for proprietary information, we will make all 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. FOR FURTHER INFORMATION CONTACT: Ms. Renee Orr, Minerals Management Service, Chief, Leasing Division, at
(703)787-1215; or Mr. James Bennett, Chief, Environmental Assessment Branch, at
(703)787-1660. SUPPLEMENTARY INFORMATION: On July 20, 2006, the State of Louisiana filed a lawsuit in U.S. District Court for the Eastern District of Louisiana under the Administrative Procedures Act alleging that MMS violated the terms of the National Environmental Policy Act, the Coastal Zone Management Act, and the OCS Lands Act. The court denied the State of Louisiana's request to enjoin holding Lease Sale 200 as scheduled on August 16, 2006, and opening the bids or awarding any leases, and set the case for trial on November 13, 2006. Lease Sale 200 was held as scheduled. The MMS and the State have entered into a Settlement Agreement. Under this settlement, MMS has agreed to prepare an EIS before conducting the next sale in the Gulf of Mexico. As a result, MMS is canceling Lease Sale 201, scheduled for March 2007 in the current 5-year program for 2002-2007. We also propose to enlarge Lease Sale 205 from that in the proposed 5-year program for 2007-2012, released for comment on August 25, 2006, to include all of the available acreage comprising the Central Gulf of Mexico Planning Area, as proposed in the new program for subsequent Central Gulf sales (Map 2). In effect, this change simply postpones for several months the estimated effects of Sale 201. The environmental impacts of this change are not significant beyond the change in timing of the offering. Dated: November 6, 2006. R.M. “Johnnie” Burton, Director, Minerals Management Service. BILLING CODE 4310-MR-P EN14NO06.009 EN14NO06.010 [FR Doc. 06-9192 Filed 11-13-06; 8:45 am]
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