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Code · REGISTER · 2007-03-13 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

14,839 words·~67 min read·/register/2007/03/13/07-1193·

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

BILLING CODE 6750-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Thrombosis and Hemostasis Centers Research and Prevention Network, Request for Applications
(RFA)DD07-004 and RFA DD07-005 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned SEP: *Time and Date:* 12 p.m.-4 p.m., May 3, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of scientific merit of grant applications received in response to RFAs DD07-004 and DD07-005, “Thrombosis and Hemostasis Centers Research and Prevention Network.” *For Further Information Contact:* Christine Morrison, Ph.D., Scientific Review Administrator, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop D72, Atlanta, GA 30333, Telephone 404.639.3098. 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 CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-4533 Filed 3-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Arthritis Program Programmatic Review In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the aforementioned meeting. *Time and Date:* 8 a.m.-5 p.m., April 24, 2007 (Closed). *Place:* Renaissance Hotel, 590 W. Peachtree Street NW., Atlanta, GA 30308, telephone 404-881-6000. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)
(4)and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of the NCCDPHP Arthritis Program. *For Further Information Contact:* Lee Ann B. Ramsey, Designated Federal Official, Division of Adult and Community Health, CDC, 4770 Buford Hwy. NE., Mailstop K51, Atlanta, GA 30341, Telephone 770-488-6036. 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 CDC and the Agency for Toxic Substances and Disease Registry. Dated: March 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-4537 Filed 3-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Notice of Annual Meeting The National Center for Environmental Health
(NCEH)of the Centers for Disease Control and Prevention
(CDC)Vessel Sanitation Program
(VSP)announces the following meeting: *Name:* Vessel Sanitation Program: Current Program Status and Experience to Date with Program Operations. *Time and Date:* 9 a.m. to 4 p.m., April 17, 2007. *Location:* Auditorium, Port Everglades Administration Building, 1850 Eller Drive, Ft. Lauderdale, Florida 33316. *Status:* Open to the public, limited by the space available. The meeting room accommodates approximately 100 people. *Meeting Objectives:* CDC staff, cruise ship industry representatives, private sanitation consultants, and other interested parties will meet to discuss the current status of the Vessel Sanitation Program and experience to date. *Topics to be discussed include but are not limited to the following:* • 2006 Program Review, • Updates to the Vessel Sanitation Program Operations Manual 2005, • Updates to the Vessel Sanitation Program Construction Guidelines 2005, and • Updates on cruise ship outbreaks and Norovirus. The official record of this meeting will remain open for a period of 15 days following the meeting (through May 1, 2007) so that additional materials or comments may be submitted and made part of the record of the meeting. Advanced registration is encouraged. Please provide the following information: Name, title, company name, mailing address, telephone number, facsimile number, and e-mail address to Lisa Beaumier at 770-488-7138, FAX 770-488-4127, or *lbeaumier@cdc.gov.* If you need additional information, please contact Lisa Beaumier (see contact information above). Dated: March 5, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-4530 Filed 3-12-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0079] Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft final guidance document entitled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables” (the draft final fresh-cut guidance). This document complements FDA's Current Good Manufacturing Practice
(CGMP)requirements for foods by providing specific guidance on the processing of fresh-cut produce. The draft final fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form. FDA also 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 (the PRA). DATES: Submit written or electronic comments on the guidance at any time. Fax written comments on the collection of information by April 12, 2007. 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. Submit written requests for single copies of the draft final guidance entitled: “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh-Cut Fruits and Vegetables” to the Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods (HFS-306), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1400 or FAX: 301-436-2651. Include a self-addressed adhesive label to assist that office in processing your request. Submit written comments on the draft final guidance, identified with Docket No. 2006D-0079, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. A copy of the draft final guidance is available for public examination in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain the draft final guidance at *http://www.cfsan.fda.gov/~dms/guidance.html* . FOR FURTHER INFORMATION CONTACT: *With regard to the information collection* : Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. *With regard to the draft final guidance document* : Amy Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025 or FAX: 301-436-2651, e-mail: *amy.green@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Fresh-cut fruits and vegetables are minimally processed fruits and vegetables that have been altered in form by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment. The methods by which produce is grown, harvested, and processed may contribute to its contamination with pathogens and, consequently, the role of the produce in transmitting foodborne illness. Factors such as the high degree of handling and mixing of the product, the release of cellular fluids during cutting or chopping, the high moisture content of the product, the absence of a step lethal to pathogens, and the potential for temperature abuse in the processing, storage, transport, and retail display all enhance the potential for pathogens to survive and grow in fresh-cut produce. With this notice, FDA is announcing the availability of the draft final fresh-cut guidance. The draft final fresh-cut guidance is intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form. The draft final guidance was revised based on public comments. This draft final guidance represents FDA's current thinking on the microbiological hazards presented by most fresh-cut fruits and vegetables and the recommended control measures for such hazards in the processing of such produce. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT ). II. Paperwork Reduction Act of 1995 This draft final guidance contains information collection provisions that are subject to review by the OMB under the PRA (44 U.S.C 3501-3520). Under the PRA, Federal agencies must obtain approval from 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 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, in the **Federal Register** of March 6, 2006 (71 FR 11209), FDA gave interested persons 60 days to comment on the information collection provisions in the draft guidance. FDA received a number of comments on the draft guidance but received no comments regarding the information collection provisions. After publishing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FDA will not finalize this guidance unless and until OMB approves the collection of information. If the collection is approved, FDA will publish a notice in the **Federal Register** announcing that the guidance is final and providing an OMB control number. Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables *Description* : The Federal Food, Drug, and Cosmetic Act (the act) prohibits the distribution of adulterated food in interstate commerce (21 U.S.C. 331 and 342). In response to the increased consumption of fresh-cut fruits and vegetables and the potential for foodborne illness associated with these products, FDA recognizes the need for guidance specific to the processing of fresh-cut fruits and vegetables. Accordingly, FDA encourages fresh-cut produce processors to adopt the general recommendations in the guidance and to tailor practices to their individual operations. FDA's draft final fresh-cut guidance represents the agency's recommendations to industry based on the current state of science. Following the recommendations set forth in the fresh-cut guidance is the choice of each individual fresh-cut operation, plant, or processor. FDA estimates the burden of this guidance on industry by assuming that those in the fresh-cut industry who do not currently follow the recommendations put forth in the guidance will find it of value to do so. Therefore, the estimates of the burden associated with the issuance of this guidance represent the upper bound estimate of burden, the burden if every fresh-cut plant, processor, or operation that does not follow the recommendations of the guidance should choose to do so. A. Industry Profile Estimates of the paperwork burden to the fresh-cut industry that may result from the publication of FDA's draft final fresh-cut guidance are based on information from FDA's relationship with a fresh-cut processor who has developed and maintained these programs and information from a fresh-cut produce industry trade association. Because of the small number of fresh-cut processors, the agency is able to extrapolate data from industry programs to calculate the total estimated upper bound burdens that may result from the issuance of this draft final fresh-cut guidance (see table 1 of this document). The burden to industry of developing and maintaining the activities recommended in FDA's draft final fresh-cut guidance will vary considerably among fresh-cut processors, depending on the type and number of products involved, the sophistication of the equipment or instruments (e.g., those that automatically monitor and record food safety controls), and the type of controls monitored under any individual preventive control program, such as critical control points
(CCPs)monitored under a hazard analysis and critical control point (HACCP) program. Currently, the fresh-cut trade association estimates that there are 250 fresh-cut plants in operation in the United States. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year. Many of the existing firms in the fresh-cut industry already make use of CGMP-related, recall, HACCP, and other activities. FDA estimates that the burden of this draft final fresh-cut guidance will fall on both existing and new firms entering the industry who may follow the recommendations in the guidance. B. SOPs and SSOPs Two general recommendations in this draft final guidance are for operators to develop and implement both a written standard operating procedures
(SOPs)plan and a written sanitary standard operation procedures (SSOPs) plan. SOPs describe in writing the performance of the day-to-day operations of a processing plant. Examples of activities that would fall under SOPs would be developing written specifications for agricultural inputs, ingredients, and packaging materials; production steps for the processing and packaging operations; instructions for packaging and storage activities; and procedures for equipment maintenance, calibration, and replacement and facility maintenance and upkeep; and maintaining SOP records on product processing and distribution activities. SSOPs provide written instructions or procedures for sanitary practices developed for each specific sanitation activity in and around the facility. Sanitation activities include procedures for cleaning equipment, food-contact surfaces and plant facilities; chemical use and storage; cleaning equipment maintenance, use, and storage; pest control; and maintaining SSOP records for the activities. From communication with the fresh-cut industry, we know that existing fresh-cut processors already have developed SOPs and SSOPs. We therefore consider the development of SOPs and SSOPs to be “usual and customary” for manufacturers and processors in the fresh-cut industry (see 5 CFR 1320.3(b)(2)). Thus, we do not calculate this burden for existing firms or new firms entering this industry. FDA recommends that facilities not only develop but also maintain SOPs and SSOPs. Implementation and maintenance of SOPs and SSOPs include maintaining daily records for each of the firm's operational days for the following activities: Inspection of incoming ingredients, such as the fresh produce and packaging material; facility and production sanitation inspections; equipment maintenance, sanitation, and visual safety inspections; equipment calibration, e.g., checking pH meters; facility and premises pest control audits; temperature controls during processing and in storage areas; and audits of ingredients, food contact surfaces, and equipment for microbiological contamination. Of the 250 fresh-cut processors, the fresh-cut trade association estimates that well over half have SOP and SSOP maintenance programs in place. Therefore, for purposes of estimating the annual recordkeeping burden for SOP and SSOP maintenance programs, the agency assumed that 40 percent of the existing processors, or 100 firms, and the 10 new firms do not have SOP and SSOP maintenance programs in place. FDA estimates the recordkeeping burden for SOP and SSOP maintenance programs by assuming that these 110 firms will choose to implement such a maintenance strategy as a result of the recommendations in this draft final fresh-cut guidance document, when finalized. A typical fresh-cut processing plant operates about 255 days per year. For an 8-hour shift, assuming the ingredients are received twice during that time, under the recommendations in the draft final guidance, there would be about 13 records kept (2 for inspecting incoming ingredients; 2 for inspecting the facility and production areas once every 4 hours; 3 records for equipment (maintenance, sanitation, and visual inspections for defects); one for calibrating equipment; 2 temperature recording audits (1 time for each of the 2 processing runs); and 3 microbiological audits (ingredients, food contact surfaces, and equipment)). Therefore, the annual frequency of recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x 13) per year per firm; 110 firms will be performing these activities to generate a total 364,650 records (3,315 x 110) annually, assuming all firms choose to follow the recommendations on keeping records. The total time to record observations for SOP and SSOP maintenance is estimated to take 4 minutes or 0.067 hours per record, and the number of records maintained is 364,650. Therefore, the total annual burden in hours for 110 processors to maintain their SOP and SSOP records is approximately 24,432 hours. The maintenance burden for these 110 firms, along with the annual maintenance burden of audits or testing, is estimated in row 1 of table 1 of this document. Again, these figures assume that all firms choose to follow the recommendations on recording observations. C. Recall and Traceback We recommend that fresh-cut processors establish and maintain written traceback procedures to respond to food safety hazard problems when they arise and establish and maintain a written contingency plan for use in initiating and effecting a recall. In order to facilitate tracebacks and recalls, we recommend that processors establish a program that documents and tracks fresh-cut products back to the source of their raw ingredients, and keep records of product identity and specifications, the product in inventory, and where, when, to whom, and how much of the product is shipped. Traceback programs are used for those times when a food safety problem has been identified or a product has been implicated in a foodborne illness outbreak. The burden to develop a traceback program is a one-time activity estimated to take approximately 20 hours. Firms in the industry may choose to begin a traceback program after this guidance is made available. The total annual estimated burden for this activity for the 250 existing fresh cut firms and the 10 new businesses expected to enter the industry annually is 5,200 hours. The burden estimate of developing a traceback program is shown in row 2 of table 1 of this document. Traceback program adjustments or revisions may, or may not, be needed annually. Firms may test their traceback programs yearly to see if adjustments are needed to maintain traceback capabilities. Evaluating and updating traceback programs is estimated to take 40 hours to complete. The annual burden of maintaining a traceback program is estimated for the 250 existing firms in the industry plus the 10 firms new to the industry that may decide to implement this type of program. Assuming that each firm completes this exercise once a year, the total maintenance burden of traceback programs is 10,400 hours yearly. This burden estimate is shown in row 3 of table 1 of this document. This draft final fresh-cut guidance refers to previously approved collections of information found in FDA regulations. The recommendations in this document regarding establishing and maintaining a recall plan, as provided in 21 CFR 7.59, have been approved under OMB control number 0910-0249. Therefore, FDA is not calculating a new paperwork burden for recall plans. D. Preventative Control Program When properly designed and maintained by the establishment's personnel, a preventive control program is a valuable program for managing the safety of food products. A common preventive control program used by the fresh-cut industry is a HACCP system. A HACCP system allows managers to assess the inherent risks and identify hazards attributable to a product or a process, and then determine the necessary steps to control the hazards. Monitoring and verification steps, which include recordkeeping, are included in the HACCP system to ensure that potential risks are controlled. We use HACCP as an example of a preventive control program that a firm may choose based on the recommendations in the draft final guidance to estimate the burden of developing, implementing, and reviewing a preventive control program. FDA estimated the paperwork burden of developing and implementing a HACCP plan based on a plan with two CCPs. The number of CCPs may vary depending on how the processor chooses to identify the CCPs for a particular operation. Of the estimated 250 fresh-cut processors, the fresh-cut industry estimates that approximately 50 percent of the firms already have HACCP plans in place. Therefore, assuming that the remaining fresh-cut processors voluntarily decide to develop a HACCP plan, 125 existing firms plus the 10 new firms, will develop a HACCP plan. Developing a HACCP plan is a one-time activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time. The HACCP team identifies the CCPs and measures needed to control them, and then identifies the approach needed to verify the effectiveness of the controls. During this plan development period, the firm chooses the records to be kept and information and observations to be recorded. This is a one-time process during the first year. Therefore, the total time for 135 processors to develop their individual HACCP plans is approximately 13,500 hours. This one-time burden is shown in row 4 of table 1 of this document. After the HACCP plan is developed, the frequency for recordkeeping for implementing or maintaining daily records is estimated to be 510 records per year. (This is based on a firm choosing to maintain daily records for 2 CCPs for one 8-hour shift per day for each of the estimated 255 operational days per year.) The total time to record observations for the CCPs was estimated to take 4 minutes or 0.067 hours per record. Therefore, the total annual records kept by the 135 firms choosing to implement the HACCP plan is 68,850, and the “Total Hours” required are 4,613. This annual burden is shown in row 5 of table 1 of this document. After the HACCP plan has been developed and implemented, we recommend that the plan is reviewed regularly to ensure that it is working properly. Fresh-cut processors are estimated to review their HACCP plans four times per year (once per quarter). Assuming that it takes each of the 135 firms 4 hours per review each quarter, the total burden of this activity, for firms that choose to review their plans annually, is 2,160 hours per year. This annual burden is shown in row 6 of table 1 of this document. FDA estimates the burden of the collection of information described in the previous paragraphs as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 Activity No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours SOP and SSOP: Maintenance 110 3,315 364,650 0.067 24,432 Traceback Development 2 260 1 260 20 5,200 Traceback Maintenance 260 1 260 40 10,400 Preventive control program comparable to a HACCP system: System development 2 135 1 135 100 13,500 Preventive control program comparable to a HACCP system: System implementation 135 510 68,850 0.067 4,613 Preventive control program comparable to a HACCP system: Implementation review 135 4 540 4 2,160 One-time burden hours 18,700 Annual burden hours 41,605 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 First year activity. Summing the “Total Hours” column, the estimated one-time recordkeeping burden for firms that choose to follow the recommendations is 18,700 hours; the annual burden for firms, existing and new, is estimated to be 41,605 hours. III. Comments Interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES ) regarding this guidance document at any time. 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 final guidance and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft final guidance document at *http://www.cfsan.fda.gov/~dms/guidance.html* . Dated: March 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4446 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0073] Agency Information Collection Activities; Proposed Collection; Comment Request; Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements establishing restrictions on the import, capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. DATES: Submit written or electronic comments on the collection of information by May 14, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Control of Communicable Diseases; African Rodents and Other Animals That May Carry the Monkeypox Virus—21 CFR 1240.63 (OMB Control Number 0910-0519)—Extension Under 21 CFR 1240.63(a)(2)(ii), an individual must submit a written request to seek permission to capture, offer to capture, transport, offer to transport, sell, barter, or exchange, offer to sell, barter, or exchange, distribute, offer to distribute, and/or release into the environment any of the following animals: • Prairie dogs ( *Cynomys* sp.), • African Tree squirrels ( *Heliosciurus* sp.), • Rope squirrels ( *Funisciurus* sp.), • African Dormice ( *Graphiurus* sp.), • Gambian giant pouched rats ( *Cricetomys* sp.), • Brush-tailed porcupines ( *Atherurus* sp.), • Striped mice ( *Hybomys* sp.), or • Any other animal so prohibited by order of the Commissioner of Food and Drugs (the Commissioner) because of that animal's potential to transmit the monkeypox virus. The request cannot seek written permission to sell, barter, or exchange, or offer to sell, barter, or exchange, as a pet, the animals listed previously or any animal covered by an order by the Commissioner. The request must state the reasons why an exemption is needed, describe the animals involved, and explain why an exemption will not result in the spread of monkeypox within the United States. Our estimates are based on our current experience with the interim final rule. To estimate the number of respondents, we examined the number of requests we have received in fiscal year 2006. There were 122 requests, submitted by 65 individuals, in that time, and this figure represents a minor increase over the previous estimate of 120 annual responses. (See 69 FR 7752 (February 19, 2004).) As we cannot determine whether the latest data indicates a trend towards more requests or is an anomaly, we have elected to increase our estimate to 122 requests. We also have revised the estimated number of respondents to 65 (compared to 120 in our previous estimate) and, as a result, adjusted the annual frequency per response to 1.88 (which represents 122 responses/65 respondents; the actual result is 1.8769, which we have rounded up to 1.88). Furthermore, consistent with our earlier Paperwork Reduction Act submission, we will estimate that each respondent will need 4 hours to complete its request for an exemption. Therefore, the total reporting burden under 21 CFR 1240.63(a)(2)(ii)(A) and
(B)will be 488 hours (122 responses x 4 hours per response = 488 hours). FDA estimates the burden of this collection of information as follows: **Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total No. of Responses Hours per Response Total Hours 1240.63(a)(2)(ii)(A) and
(B)65 1.88 122 4 488 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: March 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4450 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0130] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Trans Fatty Acids in Nutrition Labeling AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Food Labeling; Trans Fatty Acids in Nutrition Labeling” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 12, 2006 (71 FR 60157), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0515. The approval expires on January 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: March 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4454 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0257] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a collection of information entitled “Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle” has been approved by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of October 11, 2006 (71 FR 59653), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0597. The approval expires on January 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: March 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4455 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0069] Animal Drug User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration
(FDA)is announcing a public meeting on the Animal Drug User Fee Act of 2003 (ADUFA) to seek public comments relative to the program's overall performance and reauthorization as directed by Congress. *Date and Time* : The public meeting will be held on April 24, 2007, beginning at 9 a.m. *Location* : The public meeting will be held at the Food and Drug Administration, 7519 Standish Pl., third floor, rm. A, Rockville, MD 20855. There is parking near the building. Photo identification is required to clear building security. *Contact* : Aleta Sindelar, Office of the Director (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9004, FAX 240-276-9020, e-mail: *aleta.sindelar@fda.hhs.gov* . *Registration and Requests for Oral Presentations* : Registration is not required to attend the meeting. Requests to make an oral presentation at the meeting must be submitted by April 17, 2007, to the contact person. Your request to make a presentation should include the following information: Name, title, firm name, address, telephone, fax number, and e-mail address. We will try to accommodate all persons who wish to make a presentation. The time allotted for presentations may depend on the number of persons who wish to speak. If you require special accommodations due to a disability, please contact Aleta Sindelar at least 7 days in advance of the meeting. *Comments* : Interested persons may submit to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, written or electronic comments. Electronic comments may be submitted to the docket at the following site: *http://www.fda.gov/dockets/ecomments* . Submit a single copy of electronic comments or two paper copies of 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. The docket will remain open for written or electronic comments through May 24, 2007. SUPPLEMENTARY INFORMATION: I. Background ADUFA amended the Federal Food, Drug, and Cosmetic Act (the act) and authorized FDA to collect fees for certain animal drug applications, establishments, products and sponsors in support of the review of animal drugs. These additional resources support FDA's responsibilities under the act to provide greater public health protection by ensuring that animal drug products that are approved to be safe and effective are readily available for both companion animals and animals intended for food consumption. The FDA animal drug user fee program was authorized in 2003 and implemented in 2004. A significant part of the preparations for the program included determining the fee levels for fiscal year
(FY)2004. ADUFA provides for four fees:
(1)A sponsor fee,
(2)an establishment fee,
(3)a product fee, and
(4)an application fee. ADUFA also provides for specific waivers and exemptions from fees. FDA prepared guidance for the industry regarding the fees, billings and submission of fees, as well as waivers and exemptions ( *http://www.fda.gov/cvm/adufa.htm* ). The total amounts authorized for collection were: $5 million for FY 2004; $8 million in FY 2005; and $10 million in each FY 2006 through 2008, subject to annual inflation and workload adjustments after 2004. ADUFA provided for four types of fees to be assessed each fiscal year, with each fee type expected to raise 25 percent of the annual amount collected. Thus, in FY 2004, we expected to receive $1.25 million from sponsor fees, establishment fees, product fees, and application fees, for a total of $5 million dollars. The user fees are used to achieve shorter, more predictable review times by increasing the review staff at FDA and building better management systems. As a result, we anticipate substantial savings to the industry in regulatory review and developmental expenses. FDA's animal drug premarket review program is making continual and substantial improvements in the animal drug review process as a result of user fees. This helps ensure an adequate supply of safe and effective therapeutic and production animal drugs. II. Agenda In the language authorizing ADUFA, Congress directed the Secretary of Health and Human Services (the Secretary) to consult with the Committee on Energy and Commerce of the House of Representatives; the Committee on Health, Education, Labor and Pensions of the Senate; appropriate scientific and academic experts; veterinary professionals; representatives of consumer advocacy groups; and the regulated industry in developing recommendations to Congress for the reauthorization of ADUFA and for the goals and plans for meeting the goals associated with the process for review of animal drug applications. As directed by Congress, FDA is holding a public meeting to gather information on what we should consider to include in the reauthorization of ADUFA ( *http://www.fda.gov/cvm/adufa.htm* ) and hear stakeholder views on this subject. We are offering the following two general questions for consideration, and we are interested in responses to these questions and any other pertinent information stakeholders would like to share. 1. What is your assessment of the overall performance of the ADUFA program thus far? 2. What suggestions or changes would you make relative to the reauthorization of ADUFA? We have published a number of reports that may help inform the public about the ADUFA program. Key documents such as, ADUFA-related guidance, legislation, performance reports, and financial reports, can be found at *http://www.fda.gov/cvm/adufa.htm* . III. Meeting Format In general, the meeting format will include presentations by FDA followed by the open public comment period. Registered speakers for the open public comments will be grouped and invited to speak in the order of their affiliation and time of registration (scientific and academic experts/veterinary professionals, representatives of consumer advocacy groups, and the regulated industry). FDA presentations are planned from 9 a.m. until 10:30 a.m. The open public comment portion of the meeting for registered speakers is planned to begin at 10:30 a.m. An opportunity for public comments from meeting attendees will commence following the registered presentations, if time permits. The docket will remain open for written or electronic comments through May 24, 2007. IV. Transcripts Meeting transcripts will be made available on the CVM Website ( *http://www.fda.gov/cvm/adufa.htm* ) approximately 30 working days after the meeting. The transcript will also be available for public examination at the Division of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday. Dated: March 6, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4452 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0064] Electronic Case Report Form Submission; Notice of Pilot Project AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Center for Drug Evaluation and Research
(CDER)and the Center for Biologics Evaluation and Research
(CBER)in the Food and Drug Administration
(FDA)are seeking sponsors interested in participating in a pilot project to test the submission of case report form
(CRF)data provided electronically in extensible markup language
(XML)based on the Operational Data Model
(ODM)developed by the Clinical Data Interchange Standards Consortium (CDISC). This pilot will test the ability of a new data format to support all review activity, which our current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. We anticipate that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies employing electronic data capture
(EDC)in ODM format in marketing applications provided in electronic format. DATES: Submit written or electronic requests to participate in the pilot project by September 10, 2007. General comments on the pilot project are welcome at any time. ADDRESSES: Submit written requests to participate and comments regarding this pilot project 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: Armando Oliva, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6310, Silver Spring, MD 20993-0002, 301-796-0514. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the opportunity to participate in a pilot project being conducted by CDER and CBER involving the testing of the ODM standard developed by the CDISC, with the goal of replacing the existing portable document format (PDF)-based CRFs derived from clinical trials that use EDC and, therefore, lack paper CRFs. CDISC is an open, multidisciplinary, nonprofit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission, and archiving of clinical trial data and metadata for medical and biopharmaceutical product development ( *http://www.cdisc.org* ). Under existing Federal regulations (21 CFR 314.50), applicants must provide CRFs with a marketing application. Since November 1997, under 21 CFR part 11, we have accepted CRFs in electronic format instead of paper. FDA has issued several guidances that provide recommendations concerning electronic submissions. In the **Federal Register** of October 19, 2005 (70 FR 60842), FDA announced the availability of a guidance entitled “Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” ( *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/cber/gdlns/esubapp.htm* ). In section III.E.3. of that guidance, FDA recommends that applicants submit an individual subject's complete CRF as a single, PDF file. The guidance recommends that if a paper CRF was used in the clinical trial, the submitted CRF should be a scanned image of the paper CRF, including all original entries with modifications, addenda, corrections, comments, annotations, and any extemporaneous additions (i.e., audit trail). The guidance further recommends that if EDC was used in the clinical trial, the applicant should submit a PDF-generated form or other PDF representation of the information (e.g., subject profile). Based on our experience, PDF-based CRFs from clinical trials that employ EDC are not ideal to support all review activity. Although the PDF-based CRFs for trials that use EDC can provide a record of the observations collected during the trial (i.e., the data) and additional information about what was collected (metadata), they typically do not provide an audit trail. CDER and CBER are interested in adopting a new, standard format that can replace the PDF-based CRF and that can reliably provide all three components of the CRF in an electronic format: Data, metadata, and audit trail. The ODM is an XML-based standard that facilitates the electronic exchange of clinical trial data, metadata, and audit trail. We are working with CDISC to develop the capabilities within CDER and CBER to review CRFs using ODM. CDISC employed the current production version (Version 1.2) of the ODM on the CDISC Web site, and we performed some initial testing of limited CRF data in ODM. To help in this development, we are launching this pilot project and seeking sponsors willing to provide CRFs in ODM format to test our capabilities to review these files. However, data supplied during the pilot project will not replace any regulatory requirements for submitting CRFs. The purpose of this pilot project is to obtain additional experience with ODM-based CRFs. We anticipate that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies that employ EDC in ODM format in marketing applications submitted in electronic format. II. Pilot Project Description This pilot project is part of an effort to improve the quality of CRFs provided to CDER and CBER in electronic format and to improve the centers' capability to review these files. Eventually, CDER and CBER expect to recommend new technical specifications for the submission of CRFs that are derived from clinical trials that employ EDC and, therefore, lack paper CRFs. A. Initial Approach Because only a limited number of sponsors are needed (i.e., approximately five), CDER and CBER will use their discretion in choosing participants, based on participants' previous experience submitting CRFs in accordance with existing guidance. Participants should be willing to provide the same CRFs in two formats: PDF, in accordance with existing guidance, and ODM. If PDF-based CRFs have already been submitted as part of an existing new drug application or biologics license application on file with the agency, then participants need only provide the ODM-based CRFs with the same information. Having the same information available in both PDF and ODM provides the best opportunity to compare the two formats. B. How to Participate Written requests to participate in the pilot project should be submitted to the Division of Dockets Management (see ADDRESSES ). Requests are to be identified with the docket number found in brackets in the heading of this document. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this pilot project. 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: March 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-4451 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003D-0044] Guidance for Industry and Food and Drug Administration Staff; Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the guidance entitled “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.” This guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests” 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 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: Kristen Meier, Center for Devices and Radiological Health (HFZ-550), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3060. SUPPLEMENTARY INFORMATION: I. Background On February 11, 1998, the Center for Devices and Radiological Health
(CDRH)convened a joint meeting of the Microbiology, Hematology/Pathology, Clinical Chemistry/Toxicology and Immunology Devices Panels. The purpose of this meeting was to obtain recommendations on “appropriate data collection, analysis, and resolution of discrepant results, using sound scientific and statistical analysis to support indications for use of the in vitro diagnostic devices when the new device is compared to another device, a recognized reference method or ‘gold standard’, or other procedures not commonly used, and/or clinical criteria for diagnosis.” Using the input from that meeting, a draft guidance document was developed discussing some statistically valid approaches to reporting results from evaluation studies for new diagnostic devices. The draft guidance was released for public comment on March 12, 2003. Following publication of the draft guidance, 11 comments were submitted to FDA. Overall, comments were favorable and requested that additional information be included in the final guidance. We reviewed the comments and took their suggestions into consideration in writing this guidance, including consideration of the comments requesting greater attention to the use of standard terminology. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on reporting results from studies evaluating diagnostic tests. 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests,” 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 1620 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* . IV. 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 21 CFR part 807 have been approved under OMB Control No. 0910-0120; and the collections of information in 21 CFR part 814 have been approved under OMB Control No. 0910-0231. V. 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: March 2, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-4453 Filed 3-12-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2007-27372] Towing Safety Advisory Committee AGENCY: Coast Guard, DHS. ACTION: Notice of meetings. SUMMARY: The Towing Vessel Inspection Working Group of the Towing Safety Advisory Committee
(TSAC)will meet to discuss matters relating to these specific issues of towing safety. The meetings will be open to the public. DATES: The Towing Vessel Inspection Working Group will meet on Tuesday, March 27, 2007 from 9 a.m. to 5 p.m. and on Wednesday, March 28, 2007 from 9 a.m. to 3 p.m. The meetings may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before March 14, 2007. Requests to have a copy of your material distributed to each member of the Working Group should reach the Coast Guard on or before March 14, 2007. ADDRESSES: The Working Group will meet at the Westin Arlington Gateway, 801 North Glebe Road, Arlington, VA 22203. Send written material and requests to make oral presentations to Mr. Gerald Miante, Commandant (CG-3PSO-1), U.S. Coast Guard Headquarters, 2100 Second Street SW., Washington, DC 20593-0001. This notice and related documents are available on the Internet at *http://dms.dot.gov* under the docket number USCG-2007-27372. FOR FURTHER INFORMATION CONTACT: Mr. Gerald Miante, Assistant Executive Director of TSAC, telephone 202-372-1401, fax 202-372-1926, or e-mail *Gerald.P.Miante@uscg.mil.* SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2 (Pub. L. 92-463, 86 Stat. 770, as amended). Agenda of Working Group Meetings The agenda for the Towing Vessel Inspection Working Group tentatively includes the following items:
(1)Review draft sections of potential regulations currently under development;
(2)Develop recommendations concerning the draft sections for TSAC's consideration. Procedural The meetings are open to the public. Please note that the meetings may close early if all business is finished. At the Chair's discretion, members of the public may make oral presentations during the meeting. If you would like to make an oral presentation at the meeting, please notify the Assistant Executive Director (as provided above in FOR FURTHER INFORMATION CONTACT ) no later than March 14, 2007. Written material for distribution at the meeting should reach the Coast Guard no later than March 14, 2007. Information on Services for Individuals With Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Miante at the number listed in FOR FURTHER INFORMATION CONTACT as soon as possible. Dated: February 28, 2007. J.G. Lantz, Director of Standards, Assistant Commandant for Prevention. [FR Doc. E7-4469 Filed 3-12-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF THE INTERIOR Office of the Secretary Establishment of Wind Turbine Guidelines Advisory Committee AGENCY: Office of the Secretary, Interior. ACTION: Notice of Establishment and Call for Nominations. SUMMARY: The Secretary of the Interior, after consultation with the General Services Administration, has established the Wind Turbine Guidelines Advisory Committee. The Committee will provide advice and recommendations to the Secretary of the Interior (Secretary) on developing effective measures to avoid or minimize impacts to wildlife and their habitats related to land-based wind energy facilities. DATES: Requests to participate on this Committee must be postmarked by April 12, 2007. ADDRESSES: Send resumes and explanations of interest to Susan L. Goodwin, Office of Collaborative Action and Dispute Resolution, U.S. Department of the Interior, 1801 Pennsylvania Avenue, Suite 500, Washington DC 20006, e-mail address *susan_goodwin@ios.doi.gov* , fax number 202/327-5390. FOR FURTHER INFORMATION CONTACT: Susan L. Goodwin, 202/327-5346. SUPPLEMENTARY INFORMATION: We are publishing this notice in accordance with the requirements of the Federal Advisory Committee Act (5 U.S.C. App.) (FACA). The Secretary of the Interior certifies that he has determined that the formation of the Committee is necessary and is in the public interest. The Committee will conduct its operations in accordance with the provisions of the FACA. It will report to the Secretary of the Interior through the Director, U.S. Fish and Wildlife Service and will function solely as an advisory body. The Committee will provide recommendations and advice to the Department and the Service on developing effective measures to protect wildlife resources and enhance potential benefits to wildlife that may be identified. The Secretary will appoint members who can effectively represent the varied interests associated with wind energy development and its potential impacts to wildlife species and their habitats. Members will represent stakeholders, Federal and State agencies, and tribes. Members will be senior representatives of their respective constituent groups with knowledge of: wind energy facility location, design, operation, and transmission requirements; wildlife species potentially affected and potential positive and negative impacts; wildlife survey techniques; applicable laws and regulations; and current research on wind/wildlife interactions. The Secretary may appoint Committee members based on nominations submitted by interested parties, including but not limited to the U.S. Fish and Wildlife Service and other Federal agencies, States, tribes, wind energy development organizations, nongovernmental conservation organizations, and local regulatory/licensing commissions. The Committee will also include independent experts in wind energy/wildlife interactions, appointed as special Government employees, to provide technical advice. The Secretary may also appoint alternate members to serve in the event that a member cannot attend a meeting. Parties interested in participating on this Committee should send their resumes and explanations of interest to Susan L. Goodwin, Office of Collaborative Action and Dispute Resolution, at the contact address listed in ADDRESSES , by the date specified in DATES . The Committee is expected to meet approximately four times per year. All Committee members serve without compensation. Travel costs will be provided for Committee members who are special Government employees. The Service will provide necessary support services to the Committee. Committee meetings will be open to the public. Notice of committee meetings will be published in the **Federal Register** at least 15 days before the date of the meeting. The public will have an opportunity to provide input at these meetings. The Committee is expected to exist for 2 years. Its continuation is subject to biennial renewal. In accordance with FACA, we will file a copy of the Committee's charter with the Committee Management Secretariat, General Services Administration; Committee on Environment and Public Works, United States Senate; Committee on Resources, United States House of Representatives; and the Library of Congress. The Certification for establishment is published below. Certification I hereby certify that the Wind Turbine Guidelines Advisory Committee is necessary and is in the public interest in connection with the performance of duties imposed on the Department of the Interior by Public Laws 16 U.S.C. 703-712, Migratory Bird Treaty Act; 16 U.S.C. 668-668d, Bald and Golden Eagle Protection Act; 16 U.S.C. 1531-1544, Endangered Species Act; and 42 U.S.C. 4371 *et seq.* , National Environmental Policy Act. The Committee will assist the Department of the Interior by providing advice and recommendations on developing effective measures to avoid or minimize impacts to wildlife and their habitats. Dated: February 28, 2007. Dirk Kempthorne, Secretary of the Interior. [FR Doc. E7-4545 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Proposed Low-Effect Quino Checkerspot Butterfly Habitat Conservation Plan for the San Diego Gas and Electric Company, San Diego, Riverside, and Orange Counties, CA AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), have received an application from the San Diego Gas and Electric Company (Applicant) for a 40-year incidental take permit for one covered species pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act). The application addresses the potential for “take” of the federally endangered Quino checkerspot butterfly ( *Euphydryas editha quino* ) associated with the operation and maintenance of the existing gas and electric system, and construction of new facilities. A conservation program to mitigate for the project activities would be implemented by the Applicant as described in the Quino Checkerspot Butterfly Habitat Conservation Plan for the San Diego Gas and Electric Company, San Diego, Riverside and Orange Counties, California (Plan), which would be implemented by the Applicant. We are requesting comments on the permit application and on the preliminary determination that the proposed Plan qualifies as a “low-effect” Habitat Conservation Plan, eligible for a categorical exclusion under the National Environmental Policy Act
(NEPA)of 1969, as amended. The basis for this determination is discussed in the Environmental Action Statement and the associated Low Effect Screening Form (Screening Form), which is also available for public review. DATES: Written comments should be received on or before April 12, 2007. ADDRESSES: Comments should be addressed to the Field Supervisor, Fish and Wildlife Service, Carlsbad Fish and Wildlife Office, 6010 Hidden Valley Road, Carlsbad, CA 92011. Written comments may be sent by facsimile to
(760)431-5901. FOR FURTHER INFORMATION CONTACT: Mr. Chris Otahal, Fish and Wildlife Biologist, Carlsbad Fish and Wildlife Office (see ADDRESSES ); telephone
(760)431-9440. SUPPLEMENTARY INFORMATION: Availability of Documents Individuals wishing copies of the application, proposed Plan, and Screening Form should immediately contact the Service by telephone at
(760)431-9440 or by letter to the Carlsbad Fish and Wildlife Office. Copies of the proposed Plan and Screening Form also are available for public inspection during regular business hours at the Carlsbad Fish and Wildlife Office (see ADDRESSES ). Background Section 9 of the Act (16 U.S.C. 1531 *et. seq.* ) and its implementing Federal regulations prohibit the take of animal species listed as endangered or threatened. Take is defined under the Act as 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. 1538). However, under section 10(a) of the Act, the Service may issue permits to authorize incidental take of listed species. “Incidental take” is defined by the Act as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity. Regulations governing incidental take permits for threatened and endangered species, respectively, are found in the Code of Federal Regulations at 50 CFR 17.22 and 50 CFR 17.32. The Applicant is seeking a permit for take of the Quino checkerspot butterfly during the life of the permit. This species is referred to as the “QCB” in the proposed Plan. The Applicant proposes to grade existing gas and electrical transmission line access roads, many of which have not been graded in a number of years and now support QCB habitat, and conduct other activities such as construction of new facilities, equipment repair and replacement, insulator washing, tree trimming, maintenance of fire control areas, pole in-setting, and pole brushing. With the exception of road grading and construction of new facilities, operation and maintenance activities are expected to result in temporary impacts to QCB habitat. The Applicant proposes habitat restoration and enhancement in areas temporarily impacted, where appropriate, as specified in the Plan. Additionally, the Applicant's operation and maintenance activities typically result in minor impacts to the landscape ( *i.e.* , impacts are usually measured in square-feet) and are spread over a broad area, which will reduce the level of significance of potential impacts to QCB habitat. Impacts of maintenance and operation activities will also spread over a 40-year period, thus providing an opportunity for habitat re-establishment and, in some areas, minimizing potential take from repetitive impacts within the same location. Up to 33 acres of QCB habitat may be lost through implementation of the Plan over 40 years. The Applicant estimates 15 of the 33 acres of potential impacts to QCB habitat will result from road grading, and that other activities ( *e.g.* , new construction, pole brushing, and pole in-setting) will account for the remaining 18 acres of potential impact. These impacts would occur in unoccupied QCB habitat; occupied QCB habitat; and QCB critical habitat as outlined in the Plan. The Applicant proposes to mitigate the effects to QCB by fully implementing the Plan. The Plan emphasizes protection of habitat through impact avoidance and use of operational protocols, designed to avoid or minimize impact to QCB. The Applicant will supplement these operational protocols, or avoidance and minimization measures, with habitat restoration and enhancement measures, and other mitigation. The Applicant proposes to implement general and QCB-specific operational protocols, designed to avoid or minimize take of QCB. To mitigate temporary impacts, QCB habitat will be enhanced or restored, where appropriate. To mitigate for permanent impacts, the Applicant will implement one of the following mitigation measures:
(1)Pay into a QCB habitat fund; the money will be used to benefit QCB through the acquisition, restoration, or enhancement of QCB habitat;
(2)Enhance an unallocated portion of the Applicant's existing mitigation parcel for the benefit of QCB;
(3)Purchase credits from a to-be-established Quino checkerspot butterfly bank, should one be approved by the Service in the future; or
(4)Acquire a mitigation parcel that supports or could support QCB. Specific details regarding these mitigation measures may be found in the Plan. The Proposed Action consists of the issuance of an incidental take permit and implementation of the proposed Plan, which includes measures to mitigate impacts of the proposed activities on QCB. Two alternatives to the proposed action are considered in the Plan. Under the No Action Alternative, no permit would be issued and the Applicant would avoid take of QCB; however, avoidance of impacts will not be possible for some of the Applicant's projects, which would preclude some critical projects from being completed or require the Applicant to seek individual take authorizations. Under this alternative, conservation measures would likely be developed on a case-by-case basis at the time that a project required take authorization. Under the Project-by-Project Alternative, take of QCB would be addressed either through section 7 or 10 of the Act on a project-by-project basis, but with a common set of minimization and mitigation measures developed in advance. The proposed Plan provides more comprehensive conservation of QCB than either of the two alternatives. In addition, the proposed Plan would be more efficient and would provide the Applicant with long-term predictability concerning the nature of its operations for which incidental takings are permitted, avoiding potential facility-compromising delays. The Service has made a preliminary determination that approval of the proposed Plan qualifies as a categorical exclusion under NEPA, as provided by the Department of the Interior Manual (516 DM 2, Appendix 1 and 516 DM 6, Appendix 1) and as a “low-effect” plan as defined by the Habitat Conservation Planning Handbook (November 1996). Determination of Low-effect Habitat Conservation Plans is based on the following three criteria:
(1)Implementation of the proposed Plan would result in minor or negligible effects on federally listed, proposed, and candidate species and their habitats;
(2)Implementation of the proposed Plan would result in minor or negligible effects on other environmental values or resources; and
(3)Impacts of the proposed Plan, considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not result, over time, in cumulative effects to environmental values or resources that would be considered significant. Based upon this preliminary determination, we do not intend to prepare further NEPA documentation. We will consider public comments in making the final determination on whether to prepare such additional documentation. Public Review Written comments from interested parties are welcome to ensure that the issues of public concern related to the proposed action are identified. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the office listed in the ADDRESSES section of this notice. All comments and materials received, including names and addresses, will become part of the administrative record and may be released 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. This notice is provided pursuant to section 10(c) of the Act. We will evaluate the permit application, the proposed Plan, and comments submitted thereon to determine whether the application meets the requirements of section 10(a) of the Act. If the requirements are met, we will issue a permit to the Applicant for the incidental take of the Quino checkerspot butterfly associated with the operation and maintenance of the existing gas and electric system and construction of new facilities within San Diego, Riverside and Orange Counties, California. Dated: March 7, 2007. Jim A. Bartel, Field Supervisor, Carlsbad Fish and Wildlife Office, Carlsbad, California. [FR Doc. E7-4531 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Receipt of Applications for Permit AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of applications for permit. SUMMARY: The public is invited to comment on the following applications to conduct certain activities with endangered species. DATES: Written data, comments or requests must be received by April 12, 2007. ADDRESSES: Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents within 30 days of the date of publication of this notice to: U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203; fax 703/358-2281. FOR FURTHER INFORMATION CONTACT: Division of Management Authority, telephone 703/358-2104. SUPPLEMENTARY INFORMATION: Endangered Species The public is invited to comment on the following applications for a permit to conduct certain activities with endangered species. This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ). Written data, comments, or requests for copies of these complete applications should be submitted to the Director (address above). *Applicant:* New York State Museum, Albany, NY, PRT-146078. The applicant requests a permit to import from the Smithsonian Tropical Research Institute, Panama, salvaged skeletons and skulls from animals found dead on Barro Colorado Island, Panama of the following species: howler monkey ( *Alouatta palliata* ), Baird's tapir ( *Tapirus bairdii* ), and ocelot ( *Leopardus pardalis* ) for the purpose of scientific research. *Applicant:* Dr. Mary K. Gonder, University of Maryland, Dept. of Biology, College Park, MD, PRT-146529. The applicant requests a permit to import DNA samples taken from the blood of captive-held chimpanzees ( *Pan troglodytes* ) at the Limbe Wildlife Centre, Limbe, Cameroon, for the purpose of scientific research. *Applicant:* Tom W. Veurink, Alto, MI, PRT-145874. The applicant requests a permit to import the sport-hunted trophy of one cheetah ( *Acinonyx jubatus* ) taken in Namibia for the purpose of enhancement of the survival of the species. *Applicant:* Gary F. Bogner, N. Muskeyon, MI, PRT-120003. The applicant requests a permit to import the sport-hunted trophy of one male bontebok ( *Damaliscus pygargus pygargus* ) culled from a captive herd maintained under the management program of the Republic of South Africa, for the purpose of enhancement of the survival of the species. Dated: February 16, 2007. Monica Farris, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E7-4519 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Endangered and Threatened Wildlife and Plants; Final Conservation Strategy for the Grizzly Bear in the Greater Yellowstone Area AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: We, the Fish and Wildlife Service (Service), announce the availability of the Final Conservation Strategy for the Grizzly Bear in the Greater Yellowstone Area (Final Conservation Strategy). This document will guide management decisions for the Yellowstone grizzly bear population upon delisting. ADDRESSES: You may obtain a copy of the Final Conservation Strategy by any of the following means: 1. World Wide Web: *http://mountain-prairie.fws.gov/species/mammals/grizzly/yellowstone.htm.* 2. U.S. mail or in-person pickup: By appointment, during normal business hours at U.S. Fish and Wildlife Service, University Hall, Room 309, University of Montana, Missoula, MT 59812. Call
(406)243-4903 to make arrangements. FOR FURTHER INFORMATION CONTACT: Dr. Christopher Servheen, Grizzly Bear Recovery Coordinator (see ADDRESSES above),
(406)243-4903. SUPPLEMENTARY INFORMATION: Background Restoring an endangered or threatened animal or plant to the point where it is no longer in need of the protections under the Endangered Species Act is a primary goal of our endangered species program. Recovery plans help guide the recovery effort by describing actions considered necessary for the conservation of the species, establishing criteria for downlisting and delisting listed species, and estimating time and cost for implementing the measures needed for recovery measures. Under the provisions of the Endangered Species Act of 1973, as amended
(Act)(16 U.S.C. 1531 et seq., we approved the first Grizzly Bear Recovery Plan on January 29, 1982 (U.S. Fish and Wildlife Service 1982). In 1993, we approved a revision to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993), which included additional tasks and new information that increased the focus and effectiveness of recovery efforts. Since the 1993 revision, we have approved three additional supplements to the Recovery Plan (U.S. Fish and Wildlife Service 1997, 1998, 2007). The Recovery Plan stated that a conservation strategy should be developed for each ecosystem before delisting. The purpose of the Final Conservation Strategy (U.S. Fish and Wildlife Service 2007) is to serve as the regulatory mechanism guiding our management as we delist and establish the monitoring approach that will be taken for the Yellowstone grizzly bear population. The Final Conservation Strategy satisfies the requirements for post-delisting monitoring required by section 4(g) of the Act for species delisted due to recovery. Considering all of the comments received, we finalized the Final Conservation Strategy for the Grizzly Bear in the Greater Yellowstone Area. References Cited For a complete list of all references cited herein, contact the Grizzly Bear Recovery Coordinator (see ADDRESSES above). Authority The authority for this Notice is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f). Dated: January 10, 2007. James J. Slack, Deputy Regional Director, Denver, Colorado. [FR Doc. E7-4566 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Supplements to the Grizzly Bear Recovery Plan AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: We, the Fish and Wildlife Service (Service), announce the availability of two supplements to the Grizzly Bear ( *Ursus arctos horribilis* ) Recovery Plan. The supplements, appended to the Grizzly Bear Recovery Plan, present revised methods to estimate population size and sustainable mortality limits for the Yellowstone grizzly bear population, and establish habitat-based recovery criteria for the Yellowstone grizzly bear population. ADDRESSES: You may obtain a copy of the recovery plan, including these supplements, by any of the following means: 1. World Wide Web: *http://endangered.fws.gov/recovery/index.html#plans* or *http://mountain-prairie.fws.gov/species/mammals/grizzly/yellowstone.htm;* or 2. U.S. mail or in-person pickup: By appointment, during normal business hours, at: U.S. Fish and Wildlife Service, University Hall, Room 309, University of Montana, Missoula, MT 59812. Call
(406)243-4903 to make arrangements. FOR FURTHER INFORMATION CONTACT: Dr. Christopher Servheen, Grizzly Bear Recovery Coordinator (see ADDRESSES above),
(406)243-4903. SUPPLEMENTARY INFORMATION: Background Restoring an endangered or threatened animal or plant to the point where it is again a secure member of its ecosystem is a primary goal of our endangered species program. Recovery plans help guide recovery efforts by describing actions we consider necessary for the conservation of the species, establishing criteria for downlisting and delisting listed species, and estimating time and cost for implementing the measures needed for recovery measures. Under the provisions of the Endangered Species Act of 1973, as amended
(Act)(16 U.S.C. 1531 *et seq.* ), we approved the first Grizzly Bear Recovery Plan on January 29, 1982 (U.S. Fish and Wildlife Service 1982). In 1993, we approved a revision to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993), which included additional tasks and new information that increased the focus and effectiveness of recovery efforts. Supplements to the Recovery Plan were approved in 1997 and 1998 (U.S. Fish and Wildlife Service 1997, 1998). In 1994, The Fund for Animals, Inc., and 42 other organizations and individuals filed suit over the adequacy of the 1993 Recovery Plan. In 1995, the U.S. District Court for the District of Columbia issued an order remanding for further study and clarification four issues relevant to the Yellowstone grizzly bear population including the methods we use to measure the status of bear populations ( *Fund for Animals* v. *Babbitt,* 903 F. Supp. 96 (D. D.C. 1995)). Following appeals by both parties, we entered into a subsequent settlement agreeing to establish habitat-based recovery criteria prior to any delisting action ( *Fund for Animals* v. *Babbitt,* 967 F. Supp. 6 (D. D.C. 1997)). Regarding the methods used to measure the status of bear populations, beginning in 2000, the Interagency Grizzly Bear Study Team, which the U.S. Geological Survey leads in cooperation with various University specialists, began a comprehensive evaluation of the demographic data and the methodology used to estimate population size and establish the sustainable level of mortality for grizzly bears in the Greater Yellowstone Area. The Grizzly Bear Recovery Plan Task Y11 also recommended further consideration of population objectives, stating that the team should work to “determine population conditions at which the species is viable and self sustaining” and “reevaluate and refine population criteria as new information becomes available” for the Yellowstone population of grizzly bears (U.S. Fish and Wildlife Service 1993, p. 44). After evaluating current methods, scientific literature, and alternative methods, the Interagency Grizzly Bear Study Team recommended the most valid technique based on the best available science (Interagency Grizzly Bear Study Team 2005, 2007) and drafted the Reassessing Methods to Estimate Population Size and Sustainable Mortality Limits for the Yellowstone Grizzly Bear document (Reassessing Methods document). As per section 4(f) of the Act (16 U.S.C. 1533(f)), we released a draft version of the Reassessing Methods document for public comment on November 22, 2005 (70 FR 70632). Considering all comments received, the Study Team produced a Supplement to the Reassessing Methods document (Interagency Grizzly Bear Study Team 2006) and finalized this document. We have attached relevant portions of these reports to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993) in a supplement. Regarding the settlement agreeing to establish habitat-based recovery criteria prior to any delisting action, on June 17, 1997, we held a public workshop in Bozeman, Montana, to develop and refine habitat-based recovery criteria for the Yellowstone grizzly bear population. A **Federal Register** notice notified the public of this workshop and provided interested parties an opportunity to participate and submit comments (62 FR 19777, April 23, 1997). Grizzly Bear Recovery Plan Task Y423 also recommended further consideration of this issue, stating that we should work to “establish a threshold of minimal habitat values to be maintained within each Cumulative Effects Analysis Unit in order to ensure that sufficient habitat is available to support a viable population” (U.S. Fish and Wildlife Service 1993, p. 55). After considering 1,167 written comments, we developed biologically-based habitat criteria with the goal of maintaining or improving habitat conditions at 1998 levels. As per section 4(f) of the Act (16 U.S.C. 1533(f)), we published these draft criteria in the **Federal Register** for review and comment on July 16, 1999 (64 FR 38464). Considering all comments we received, we finalized the Habitat-Based Recovery Criteria. We have attached the established Habitat-Based Recovery Criteria to the Grizzly Bear Recovery Plan (U.S. Fish and Wildlife Service 1993) in a supplement. References Cited To obtain a complete list of all references cited herein, contact the Grizzly Bear Recovery Coordinator (see ADDRESSES above). Authority The authority for this Notice is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f). Dated: January 10, 2007. James J. Slack, Deputy Regional Director, Denver, Colorado. [FR Doc. E7-4568 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Issuance of Permits AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of issuance of permits for endangered species and marine mammals. SUMMARY: The following permits were issued. ADDRESSES: Documents and other information submitted with these applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents to: U.S. Fish and Wildlife Service, Division of Management Authority, 4401 North Fairfax Drive, Room 700, Arlington, Virginia 22203; fax 703/358-2281. FOR FURTHER INFORMATION CONTACT: Division of Management Authority, telephone 703/358-2104. SUPPLEMENTARY INFORMATION: Notice is hereby given that on the dates below, as authorized by the provisions of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ), and the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 *et seq.* ), the Fish and Wildlife Service issued the requested permits subject to certain conditions set forth therein. For each permit for an endangered species, the Service found that
(1)The application was filed in good faith,
(2)the granted permit would not operate to the disadvantage of the endangered species, and
(3)the granted permit would be consistent with the purposes and policy set forth in Section 2 of the Endangered Species Act of 1973, as amended. Endangered Species Permit number Applicant Receipt of application Federal Register notice Permit issuance date 138823 Kathlyn C. Story 71 FR 76685, December 21, 2006 January 30, 2007. 139893 Dr. Michael L. Fetterolf 71 FR 76684, December 21, 2006 January 30, 2007. 140189 James M. Shook 71 FR 76684, December 21, 2006 January 30, 2007. 140644 Carroll E. Moran 71 FR 76682, December 21, 2006 January 30, 2007. Marine Mammals Permit number Applicant Receipt of application Federal Register notice Permit issuance date MA101713 The Marine Mammal Center 71 FR 44679; August 3, 2005 January 29, 2007. Dated: February 16, 2007. Monica Farris, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E7-4547 Filed 3-12-07; 8:45 am] BILLING CODE 4310-55-P INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-596] In the Matter of Certain GPS Chips, Associated Software and Systems, and Products Containing Same; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION: Institution of investigation pursuant to 19 U.S.C. 1337. SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 8, 2007, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of SiRF Technology, Inc. of San Jose, California. A supplemental letter was filed on February 22, 2007. The complaint, as supplemented, alleges violations of section 337 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain GPS chips, associated software and systems, and products containing same by reason of infringement of U.S. Patent Nos. 6,304,216; 7,043,363; 7,091,904; and 7,132,980. The complaint, as supplemented, further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainant requests that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and a permanent cease and desist order. ADDRESSES: The complaint and supplement, except for any confidential information contained therein, are available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server at *http://www.usitc.gov.* The public record for this investigation may be viewed on the Commission's electronic docket
(EDIS)at *http://edis.usitc.gov.* FOR FURTHER INFORMATION CONTACT: Kevin Baer, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone
(202)205-2221. *Authority:* The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2006). *Scope of Investigation:* Having considered the complaint, the U.S. International Trade Commission, on March 7, 2007, *ordered that* —
(1)Pursuant to subsection
(b)of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain GPS chips, associated software or systems, or products containing same by reason of infringement of one or more of claims 1, 3, 5-19, 21-36, 38-59, 61-78, and 80-87 of U.S. Patent No. 6,304,216; claims 1-2, 4-8, 10-12, 16, and 18-20 of U.S. Patent No. 7,043,363; claims 1, 3, 5-8, 10-12, 14, 16-18, and 20-21 of U.S. Patent No. 7,091,904; and claims 1, 5-7, 10-11, 13-14, 16-17, 24, 29-32, and 34 of U.S. Patent No. 7,132,980; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2)For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a)The complainant is—SiRF Technology, Inc., 217 Devcon Drive, San Jose, CA 95112.
(b)The respondent is the following entity alleged to be in violation of section 337, and is the party upon which the complaint is to be served: Global Locate, Inc., 3190 South Bascom Ave., San Jose, CA 92618.
(c)The Commission investigative attorney, party to this investigation, is Kevin Baer, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Room 401-L, Washington, DC 20436; and
(3)For the investigation so instituted, the Honorable Robert L. Barton, Jr. is designated as the presiding administrative law judge. Responses to the complaint and the notice of investigation must be submitted by the named respondent in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown. Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of a limited exclusion order or cease and desist order or both directed against the respondent. By order of the Commission. Issued: March 8, 2007. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E7-4555 Filed 3-12-07; 8:45 am] BILLING CODE 7020-02-P INTERNATIONAL TRADE COMMISSION [USITC SE-07-003] Government in the Sunshine Act Meeting Notice Agency Holding the Meeting: United States International Trade Commission. Time and Date: March 15, 2007 at 11 a.m. Place: Room 101, 500 E Street SW., Washington, DC 20436, Telephone:
(202)205-2000. Status: Open to the public. Matters to be Considered 1. Agenda for future meetings: None. 2. Minutes. 3. Ratification List. 4. Inv. No. 731-TA-706 (Second Review) (Canned Pineapple Fruit from Thailand)—briefing and vote. (The Commission is currently scheduled to transmit its determination and Commissioners' opinions to the Secretary of Commerce on or before March 29, 2007.) 5. Outstanding action jackets: none. In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting. By order of the Commission. Issued: March 8, 2007. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. 07-1193 Filed 3-9-07; 12:37 pm]
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  • Pub. L. 92-463
  • 44 USC 3501-3520
  • 5 CFR 1320.3
  • 5 CFR 1320.3(b)(2)
  • 5 CFR 1320.3(c)
  • 21 CFR 1240.63
  • 21 CFR 1240.63(a)(2)(ii)
  • 21 CFR 1240.63(a)(2)(ii)(A)
  • 21 CFR 11
  • 21 CFR 807
  • 21 CFR 814
  • 16 USC 703-712
  • 16 USC 668-668d
  • 16 USC 1531-1544
  • 50 CFR 17.22
  • 50 CFR 17.32
  • 903 F. Supp. 96
  • 967 F. Supp. 6
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Notices
Notice
U.S.C.§ 3502
U.S.C.§ 3506
U.S.C.§ 3507
U.S.C.§ 331
C.F.R.§ 7.59
C.F.R.§ 314.50
C.F.R.§ 10.115
Stat.Public Law 92–463
U.S.C.§ 4371
F. Supp.903 F. Supp. 96
F. Supp.967 F. Supp. 6
Pub. L.Pub. L. 92-463
Cites 35 · showing 12Cited by 0 across 0 sources
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