Notices. Notice

6,782 words·~31 min read·/register/2006/05/10/06-4354·

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

BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0172] Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Guidance for Industry; Process for Handling Pediatric Referrals to FDA: Additional Safeguards for Children in Clinical Investigations.” This guidance is intended to assist clinical investigators, institutional review boards (IRBs), sponsors, and other interested parties in understanding FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under FDA regulations on additional safeguards for children in clinical investigations. The draft guidance describes the procedures FDA generally intends to follow in handling clinical investigations referred for review under these regulations and in reaching final determinations in accordance with these regulations. DATES: Submit written or electronic comments on the draft guidance by July 10, 2006. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Policy (HF-11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit telephone requests to 800-835-4709 or 301-827-1800. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled “Guidance for Industry; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations.” FDA issued 21 CFR part 50, subpart D, “Additional Safeguards for Children in Clinical Investigations,” (part 50, subpart D) as an interim final rule on April 24, 2001 (66 FR 20598). Under these regulations, an IRB must review clinical investigations involving children as subjects and covered by subpart D and approve only those clinical investigations that satisfy the criteria described in §§ 50.51, 50.52, or 50.53, as well as the conditions of all other applicable sections in subpart D. Under § 50.54, if an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 (21 CFR 56.101) and involving children as subjects meets the requirements of §§ 50.51, 50.52, or 50.53, the clinical investigation may proceed only if the following occurs:

(1)The IRB finds and documents that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(2)the Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either of the following:

(1)The clinical investigation in fact satisfies the conditions of §§ 50.51, 50.52, or 50.53, as applicable, or

(2)the following conditions are met:

(A)The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(B)the clinical investigation will be conducted in accordance with sound ethical principles; and

(C)adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in § 50.55. The draft guidance describes the procedures FDA generally will follow in handling clinical investigations referred for review under § 50.54 and in reaching final determinations under that regulation. The draft guidance is based in part on FDA's experience to date with such referrals. The Department of Health and Human Services

(HHS)has human subject protection regulations that also govern research involving children as subjects and supported or conducted by HHS. (See 45 CFR part 46, subpart D.) The draft guidance also addresses situations in which a clinical investigation is subject to both 21 CFR 50.54 and 45 CFR 46.407. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the process for handling referrals to FDA under 21 CFR 50.54. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth below. With respect to the following collection of information, FDA invites comment 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 on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. The draft guidance is intended to assist clinical investigators, IRBs, sponsors, and other interested parties in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under 21 CFR part 50, subpart D. *Title* : Draft Guidance for Industry; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations. *Burden Estimate* : The information that must be submitted to FDA by sponsors for approval of clinical investigations involving children is contained in the investigational new drug application

(IND)and investigational device exemption

(IDE)regulations (21 CFR parts 312 and 812 (parts 312 and 812), respectively) and is approved under OMB control number 0910-0014 (expires March 31, 2009) for INDs and under OMB control number 0910-0078 (expires August 31, 2006) for IDEs. In addition to the collections of information already required under parts 312 and 812, the draft guidance requests that an IRB submitting a clinical investigation for consideration under § 50.54 include with that submission/referral the documentation of its finding under § 50.54(a) that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. Under § 50.54(a), IRBs must find and document that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children. The requirement to “document” the finding is a recordkeeping requirement. IRB recordkeeping requirements are set forth in FDA regulations on IRBs (part 56) at § 56.115, and are approved under OMB control number 0910-0130 until November 30, 2007. Thus, only the submission to FDA of the IRB's finding would not already be required under § 50.54(a). FDA estimates that each submission would take no more than 15 minutes because, as required by the regulation, the IRB will already have prepared and documented the finding, and the IRB would only have to send the documentation of that finding to FDA. The draft guidance also contains a second collection of information. The introductory paragraph to § 50.54 states that if an IRB does not believe that a clinical investigation within the scope described in §§ 50.1 and 56.101 and involving children as subjects meets the requirements of §§ 50.51, 50.52, or 50.53, the clinical investigation may proceed only if certain conditions set forth in § 50.54 are met. The draft guidance requests that the IRB include, when submitting its finding under § 50.54 that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, an explanation why the IRB does not believe that the clinical investigation meets the requirements of §§ 50.51, 50.52, or 50.53. FDA believes that in most cases this explanation will already be part of the IRB meeting minutes. Because the IRB may need to summarize these minutes in order to send them to FDA, FDA estimates that each explanation would take approximately 1 hour to prepare. According to a 1998 Office of the Inspector General

(OIG)report, there are 3,000 to 5,000 IRBs in the United States, and most are associated with hospitals and academic centers (see Department of Health and Human Services, Office of the Inspector General, *Institutional Review Boards: A Time for Reform* , page 3, June 8, 1998). However, based on FDA's experience to date with IRB referrals under § 50.54, only a very small percentage of IRBs (approximately 5 per year) are expected to refer a clinical investigation to FDA under 21 CFR part 50, subpart D. The information collection resulting from the draft guidance that is not already approved by OMB is summarized as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Number of Respondents Number of Responses per Respondent Total Annual Responses Hours per Response Total Hours Submission of finding required under § 50.54(a) 5 1 5 15 min. 1 hour, 15 minutes Explanation why investigation does not meet §§ 50.51, 50.52, or 50.53 5 1 5 1 5 Total 6 hours, 15 minutes 1 There are no capital costs or operating and maintenance costs associated with this collection. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: May 2, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7058 Filed 5-9-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [DHS-2006-0019] Data Privacy and Integrity Advisory Committee AGENCY: Office of the Secretary, Department of Homeland Security. ACTION: Notice of Federal advisory committee meeting. SUMMARY: The notice announces the date, time, location, and agenda for the next meeting of the Department of Homeland Security Data Privacy and Integrity Advisory Committee. This meeting will be open to the public, with the exception of a one-hour administrative session. DATES: The meeting will be held on Wednesday, June 7, 2006, in San Francisco, CA. ADDRESSES: The Department of Homeland Security Data Privacy and Integrity Advisory Committee meeting will be held in the Rita and Ava Room at the Clift Hotel, 495 Geary Street, San Francisco, CA 94102. Persons wishing to make comments or who are unable to attend or speak at the meeting may submit comments at any time. Comments must be identified by DHS-2006-0019 and may be submitted by any *one* of the following methods: • Federal Rulemaking Portal: *http://www.regulations.gov.* Follow instructions for submitting comments on the Web site. • E-mail: *PrivacyCommittee@dhs.gov.* Include docket number in the subject line of the message. • Fax: 571-227-4171. • Mail: Ms. Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Mail Stop D-3, Arlington, VA 22202. *Instructions:* All submissions received must include the Department of Homeland Security and DHS-2006-0019, the docket number for this action. Comments received will also be posted without alteration at *www.regulations.gov* , including any personal information provided. *Docket:* For access to the docket to read background documents or comments received by the DHS Data Privacy and Integrity Committee, go to *http://www.regulations.gov.* Comments received will be posted without alteration at *www.dhs.gov/privacy* , including any personal information provided. FOR FURTHER INFORMATION CONTACT: Maureen Cooney, Acting Chief Privacy Officer and Chief Freedom of Information Act Officer, or Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Arlington, VA 22202, by telephone

(571)227-3813, by facsimile

(571)227-4171, or by e-mail *PrivacyCommittee@dhs.gov.* SUPPLEMENTARY INFORMATION: The Data Privacy and Integrity Advisory Committee (“Privacy Advisory Committee”) will be meeting on Wednesday, June 7, 2006, in the Rita and Ava Rooms at the Clift Hotel, 495 Geary Street, San Francisco, CA 94102. The meeting will begin at 8:30 a.m. and is anticipated to end at 5 p.m. Although most of the meeting is open to the public, there will be a closed session between 12 p.m. and 1 p.m., in order to permit the Privacy Advisory Committee members to discuss administrative and planning items. At the meeting, the Acting Chief Privacy Officer and Chief Freedom of Information Act Officer will provide an update on the activities of the Privacy Office. The subcommittees on Emerging Applications and Technology, Data Sharing and Usage, Framework, and Screening will update the Committee on the work currently being conducted. In the morning and afternoon sessions, invited speakers will discuss expectations of privacy in public spaces and identity management. An agenda will be posted on the Privacy Committee Web site at *http://www.dhs.gov/privacy* prior to the meeting. The Committee is researching effective means to receive public comments during their public meetings. As an experiment, for the June 7, 2006 meeting, comments will be accepted for a “Public Comment Panel” starting at or about 4 p.m. This panel will be made up of no more than four individuals; each will be allotted 15 minutes to speak. In order to be considered for the Public Comment Panel, individuals must provide a written request to Rebecca J. Richards via e-mail at *PrivacyCommittee@dhs.gov* no later than Friday, May 26, 2006 with the following information:

(1)A brief biographical description, including name and affiliation;

(2)A list of the topic(s) that the potential panelist would like to address, and a one-paragraph summary of the potential panelist's unique perspective or knowledge of each such topic; and

(3)Contact information, including a daytime telephone number, and e-mail address. The Executive Director, in consultation with the Chair, Vice Chair, and subcommittee Chairs of the Committee will choose the panelists based upon the written submissions. The Executive Director will notify the panelists chosen for the Public Comment Panel both via e-mail and through the Committee's Web site. Public attendance is encouraged. Any member of the public who wishes to attend the public session is requested to provide his or her name no later than 12:00 p.m. EST, Friday, June 2, 2006, to Rebecca J. Richards via e-mail at *PrivacyCommittee@dhs.gov,* or via telephone at

(571)227-3813. This will assist with the preparation of meeting materials and seating arrangements. Everyone who plans to attend is respectfully requested to be present and seated by 8:15 a.m. for the morning session and by 12:45 p.m. for the afternoon session. Persons with disabilities who require special assistance should indicate this in their admittance request and are encouraged to identify anticipated special needs as early as possible. Although every effort will be made to accommodate all members of the public, seating is limited and will be allocated on a first-come, first-served basis. Basis for Closure A portion of this Committee meeting will be closed for administrative and planning purposes that are referenced above. The closed portion is excluded from the Open Meetings requirement, pursuant to the authority contained in 41 CFR 102-3.160(b). Dated: May 4, 2006. Maureen Cooney, Acting Chief Privacy Officer. [FR Doc. E6-7147 Filed 5-9-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [OR-936-1430-ET; HAG-06-0096; WAOR-11331] Notice of Proposed Withdrawal Extension and Opportunity for Public Meeting; Washington AGENCY: Bureau of Land Management, Interior. ACTION: Notice. SUMMARY: The Secretary of the Interior proposes to extend on behalf of the Bureau of Land Management, the duration of Public Land Order

(PLO)No. 6631 for an additional 20 year period. PLO No. 6631 withdrew 24.65 acres of public land in Okanogon County, Washington, from settlement, sale, location or entry under the general land laws, including the United States mining laws, to protect the natural and recreational values, and the investment in Federal funds at the Split Rock Recreation Area. This notice also gives an opportunity to comment on the proposed action and to request a public meeting. DATES: Comments and requests for a public meeting must be received by August 8, 2006. ADDRESSES: Comments and meeting requests should be sent to the Oregon/Washington State Director, BLM, P.O. Box 2965, Portland, Oregon 97208-2965. FOR FURTHER INFORMATION CONTACT: William Schurger, Wenatchee Field Office, 509-665-2116, or, Charles R. Roy, BLM Oregon/Washington State Office, 503-808-6189. SUPPLEMENTARY INFORMATION: The withdrawal created by PLO No. 6631 (51 FR 43003) will expire on November 27, 2006, unless extended. The Bureau of Land Management has filed an application to extend Public Land Order No. 6631 which withdrew the following described public land from settlement, sale, location and entry under the general land laws, including the United States mining laws, subject to valid existing rights, to protect the Split Rock Recreation Site: Willamette Meridian Split Rock Recreation Site T. 39 N., R.26 E., Sec. 18, lot 7. The area described contains 24.65 acres in Okanogan County. The BLM petition/application has been approved by the Assistant Secretary of the Interior. Therefore, it constitutes a withdrawal proposal of the Secretary of the Interior (43 CFR 2310.1-3(e)). The use of a right-of-way, interagency agreement, or cooperative agreement would not adequately constrain non-discretionary uses and would not provide adequate protection of the Federal investment in the improvements located on the land. There are no suitable alternative sites with equal or greater benefit to the government. No additional water rights will be needed to fulfill the purpose of the requested withdrawal. The preliminary mineral potential evaluation found the above described lands to be non-mineral in character. The purpose of the proposed withdrawal extension is to protect the natural, and recreation values, and the investment of Federal funds at the Split Rock Recreation Area. For a period of 90 days from the date of publication of this notice, all persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal extension may present their views in writing to the State Director at the address indicated above. Individual respondents may request confidentiality. If you wish to withhold your name or address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comments. Such requests will be honored to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public inspection in their entirety. Notice is hereby given that an opportunity for a public meeting is afforded in connection with the proposed withdrawal extension. All interested parties who desire a public meeting for the purpose of being heard on the proposed withdrawal must submit a written request to the State Director at the address indicated above within 90 days from the publication of this notice. Upon determination by the authorized officer that a public meeting will be held, a notice of the time and place will be published in the **Federal Register** at least 30 days before the scheduled date of the meeting. The withdrawal extension application will be processed in accordance with the regulations set forth in 43 CFR 2310.4. (Authority: 43 CFR 2310.3-1) Dated: May 2, 2006. Michael L. Barnes, Acting Chief, Branch of Lands and Mineral Resources. [FR Doc. E6-7116 Filed 5-9-06; 8:45 am] BILLING CODE 4310-33-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [MT-926-06-1910-BJ-5REW] Montana: Filing of Plat of Survey AGENCY: Bureau of Land Management, Montana State Office, Interior. ACTION: Notice of filing of plat of survey. SUMMARY: The Bureau of Land Management

(BLM)will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, thirty

(30)days from the date of publication in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Steve Toth, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669, telephone

(406)896-5121 or

(406)896-5009. SUPPLEMENTARY INFORMATION: This survey was executed at the request of the Northern Cheyenne Agency, through the Rocky Mountain Regional Director, Bureau of Indian Affairs and was necessary to determine Trust and Tribal lands. The lands we surveyed are: Principal Meridian, Montana T. 3 S., R. 44 E. The plat, in 2 sheets, representing the dependent resurvey of a portion of the subdivisional lines, the adjusted original meanders of the former left bank of the Tongue River through sections 10 and 15, portions of the subdivision of sections 10 and 15, and the subdivision of sections 10 and 15, and the survey of portions of the meanders of the present left bank of the Tongue River through sections 10 and 15, Township 3 South, Range 44 East, Principal Meridian, Montana, was accepted April 24, 2006. We will place a copy of the plat, in 2 sheets, and related field notes we described in the open files. They will be available to the public as a matter of information. If BLM receives a protest against this survey, as shown on this plat, in 2 sheets, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file this plat, in 2 sheets, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals. Dated: May 2, 2006. Thomas M. Deiling, Chief Cadastral Surveyor, Division of Resources. [FR Doc. E6-7102 Filed 5-9-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [MT-926-06-1420-BJ-TRST] Montana: Filing of Plat of Survey AGENCY: Bureau of Land Management, Montana State Office, Interior. ACTION: Notice of Filing of Plat of Survey. SUMMARY: The Bureau of Land Management

(BLM)will file the plats of survey of the lands described below in the BLM Montana State Office, Billings, Montana, thirty

(30)days from the date of publication in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Randy Thomas, Cadastral Surveyor, Branch of Cadastral Survey, Bureau of Land Management, 5001 Southgate Drive, Billings, Montana 59101-4669, telephone

(406)896-5134 or

(406)896-5009. SUPPLEMENTARY INFORMATION: This survey was executed at the request of the Rocky Mountain Regional Director, Bureau of Indian Affairs, and was necessary to determine Trust and Tribal land. The lands we surveyed are: Principal Meridian, Montana T. 27 N., R. 53 E. The plat, in two sheets, representing the dependent resurvey of portions of the east, west, and north boundaries, a portion of the subdivisional lines, the adjusted original meanders of the former left bank of the Missouri River, downstream, through sections 1, 2, and 6, and a portion of the subdivision of sections 1, 2, and 6, the subdivision of sections 1 and 2, and the survey of the meanders of the present left bank of the Missouri River, downstream, through sections 1, 2, and 6, and certain division of accretion lines, in Township 27 North, Range 53 East, Principal Meridian, Montana, was accepted April 26, 2006. We will place a copy of the plats, in two sheets, and related field notes we described in the open files. They will be available to the public as a matter of information. If BLM receives a protest against these surveys, as shown on these plats, in two sheets, prior to the date of the official filing, we will stay the filing pending our consideration of the protest. We will not officially file these plats, in two sheets, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals. Dated: May 3, 2006. Thomas M. Deiling, Chief Cadastral Surveyor, Division of Resources. [FR Doc. E6-7104 Filed 5-9-06; 8:45 am] BILLING CODE 4310-$$-P DEPARTMENT OF THE INTERIOR Minerals Management Service Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Minerals Management Service (MMS), Interior. ACTION: Notice of extension of an information collection (1010-0154). SUMMARY: To comply with the Paperwork Reduction Act of 1995 (PRA), we are inviting comments on a collection of information that we will submit to the Office of Management and Budget

(OMB)for review and approval. The information collection request

(ICR)concerns the paperwork requirements under the Endangered Species Act Biological Opinions, issued by the Fish and Wildlife Service

(FWS)and National Oceanic and Atmospheric Administration Fisheries (NOAA Fisheries) and is titled: “Notices to Lessees and Operators (NTLs)—Implementation of Seismic Survey Mitigation Measures and Protected Species Observer Program, NTL—Vessel Strike Avoidance and Injured/Dead Protected Species Reporting; and NTL—Marine Trash and Debris Awareness and Elimination.” DATES: Submit written comments by July 10, 2006. ADDRESSES: You may submit comments by any of the following methods listed below. Please use the Information Collection Number 1010-0154 as an identifier in your message. • Public Connect on-line commenting system, *https://ocsconnect.mms.gov* . Follow the instructions on the Web site for submitting comments. • E-mail MMS at *rules.comments@mms.gov* . Identify with Information Collection Number 1010-0154 in the subject line. • Fax: 703-787-1093. Identify with Information Collection Number 1010-0154. • Mail or hand-carry comments to the Department of the Interior; Minerals Management Service; Attention: Rules Process Team (RPT); 381 Elden Street, MS-4024; Herndon, Virginia 20170-4817. Please reference “Information Collection 1010-0154” in your comments. FOR FURTHER INFORMATION CONTACT: Cheryl Blundon, Rules Processing Team at

(703)787-1600. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the NTLs that require the subject collection of information. SUPPLEMENTARY INFORMATION: *Title:* Notices to Lessees and Operators (NTLs)—Implementation of Seismic Survey Mitigation Measures and Protected Species Observer Program, NTL—Vessel Strike Avoidance and Injured/Dead Protected Species Reporting; and NTL—Marine Trash and Debris Awareness and Elimination. *OMB Control Number:* 1010-0154. *Abstract:* The Outer Continental Shelf

(OCS)Lands Act, as amended (43 U.S.C. 1331 *et seq.* and 43 U.S.C. 1801 *et seq.* ), authorizes the Secretary of the Interior to prescribe rules and regulations to administer leasing of the OCS. Such rules and regulations will apply to all operations conducted under a lease. Operations on the OCS must preserve, protect, and develop oil and natural gas resources in a manner that is consistent with the need to make such resources available to meet the Nation's energy needs as rapidly as possible; to balance orderly energy resource development with protection of human, marine, and coastal environments; to ensure the public a fair and equitable return on the resources of the OCS; and to preserve and maintain free enterprise competition. The Department of the Interior, MMS, as a Federal agency, has a continuing affirmative duty to comply with the Endangered Species Act (ESA). This includes a substantive duty to carry out any agency action in a manner that is not likely to jeopardize protected species as well as a procedural duty to consult with the FWS and NOAA Fisheries before engaging in a discretionary action that may affect a protected species. MMS follows these procedural requirements by conducting formal consultations with FWS and NOAA Fisheries prior to lease sales. Consultations on OCS lease sales 181, 184, and the 5-year multisale (2002-2007) program in the Central and Western Planning Areas of the Gulf of Mexico resulted in no-jeopardy biological opinions from the FWS and NOAA Fisheries. In their biological opinions, NOAA Fisheries determined that some activities associated with the proposed action (lease sale and related exploration, development, and production activities) may adversely affect

(harm)marine wildlife, marine mammals including sperm whales, and sea turtles in the action area and that certain reasonable and prudent measures are necessary to minimize the potential for incidental take of these animals. To be exempt from the prohibitions of Section 9 of the ESA (Endangered Species Act) (which prohibits taking listed species), MMS must implement and enforce nondiscretionary terms and conditions. The ESA also requires monitoring and reporting. Monitoring programs resulting from ESA interagency consultations are designed to:

(1)Detect adverse effects resulting from a proposed action,

(2)Assess the actual level of incidental take in comparison with the level of anticipated incidental take documented in the biological opinion,

(3)Detect when the level of anticipated take is exceeded, and

(4)Determine the effectiveness of reasonable and prudent alternatives and their implementing terms and conditions. To provide supplementary guidance and procedures, MMS issues NTLs on a regional or national basis. Regulation 30 CFR 250.103 allows MMS to issue NTLs to clarify, supplement, or provide more detail about certain requirements. To implement the nondiscretionary terms and conditions of these biological opinions, the MMS issued three NTLs: • NTL 2004-G01—Implementation of Seismic Survey Mitigation Measures and Protected Species Observer Program, • NTL 2003-G11—Marine Trash and Debris Awareness and Elimination, and • NTL 2003-G10—Vessel Strike Avoidance and Injured/Dead Protected Species Reporting. The MMS will use the information collected to report annually to NOAA Fisheries the effectiveness of mitigation, any adverse effects of the proposed action, and any incidental take, in accordance with 50 CFR 402.14(i)(3). The MMS engineers, geologists, geophysicists, environmental scientists, and other Federal agencies (FWS, NOAA Fisheries, etc.) will also analyze the information and data collected under these NTLs to better evaluate the potential impacts to listed species and to plan operations in a manner that will further reduce and/or avoid adverse impacts to protected species in the OCS. We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR part 2) and under regulations at 30 CFR parts 250, 251, and 252. No items of a sensitive nature are collected. Responses are mandatory or required to obtain or retain a benefit. *Frequency:* On occasion and on the 1st and 15th of each month for the marine mammal observation reports. *Estimated Number and Description of Respondents:* Approximately 130 Federal OCS lessees and operators. *Estimated Reporting and Recordkeeping “Hour” Burden:* The currently approved annual reporting burden for this collection is 22,305 hours. The following chart details the individual components and respective hour burden estimates of this ICR. In calculating the burdens, we assumed that respondents perform certain requirements in the normal course of their activities. We consider these to be usual and customary and took that into account in estimating the burden. NTL Reporting and recordkeeping requirement Hour burden Implementation of Seismic Survey Mitigation Measures and Protected Species Observer Program Submit marine mammal observation reports/forms (including observer, survey, sighting, shut-down, borehole, and passive acoustic monitoring reports) 1 hour/report. Actual visual observation on duty 8 hours/day 3 observers/vessel = 24. Submit to MMS observer training requirement materials and information 1/2 hour. Observer training. 8 hours. Training certification and recordkeeping 1/2 hour. Submit to MMS information on passive acoustic monitoring system before its use (voluntary program) 1 hour. Vessel Strike Avoidance and Injured/Dead Protected Species Rpting Submit injured/dead protected species report 1/2 hour/report. Marine Trash and Debris Awareness and Elimination Write to obtain training video (optional) 1/2 hour/request. Submit annual report to MMS on training process and certification 1/2 hour/record. Training recordkeeping 1/2 hour/record. Post placards on vessels and structures. (Exempt from information collection burden because MMS is providing exact language for the trash and debris warning, similar to the “Surgeon General's Warning” exemption.) *Estimated Reporting and Recordkeeping “Non-Hour Cost” Burden:* We have identified no “non-hour cost” burdens for this collection. *Public Disclosure Statement:* The PRA (44 U.S.C. 3501, *et seq.* ) provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. *Comments:* Before submitting an ICR to OMB, PRA section 3506(c)(2)(A) requires each agency “* * * to provide notice * * * and otherwise consult with members of the public and affected agencies concerning each proposed collection of information * * *.” Agencies must specifically solicit comments to:

(a)Evaluate whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful;

(b)evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)enhance the quality, usefulness, and clarity of the information to be collected; and

(d)minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology. Agencies must also estimate the “non-hour cost” burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased:

(i)Before October 1, 1995;

(ii)to comply with requirements not associated with the information collection;

(iii)for reasons other than to provide information or keep records for the Government; or

(iv)as part of customary and usual business or private practices. We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB. *Public Comment Procedures:* MMS's practice is to make comments, including names and addresses of respondents, available for public review. If you wish your name and/or address to be withheld, you must state this prominently at the beginning of your comment. MMS will honor this request to the extent allowable by law; however, anonymous comments will not be considered. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public inspection in their entirety. *MMS Information Collection Clearance Officer:* Arlene Bajusz

(202)208-7744. Dated: May 3, 2006. William S. Hauser, Acting Chief, Office of Offshore Regulatory Programs. [FR Doc. E6-7068 Filed 5-9-06; 8:45 am] BILLING CODE 4310-MR-P DEPARTMENT OF THE INTERIOR National Park Service Cape Cod National Seashore, Massachusetts; Draft Environmental Impact Statement for the Hunting Program AGENCY: National Park Service, Interior. ACTION: Notice of Availability of the Draft Environmental Impact Statement for the Hunting Program at Cape Cod National Seashore. SUMMARY: The National Park Service

(NPS)announces the availability of the Draft Environmental Impact Statement for the Hunting Program at Cape Cod National Seashore (DEIS). The draft document describes and analyzes the environmental impacts of a preferred alternative, another action alternative, and a no action alternative. DATES: The DEIS will be available for public review and comment for 60 days from the date of publication of the Environmental Protection Agency's Notice of Availability in the **Federal Register** . Comments will be accepted until the close of the 60-day review period. Public information meetings are scheduled for 7 p.m., Thursday, June 8, 2006, at the Salt Pond Visitor Center in Eastham, Massachusetts, and for 9 a.m., Saturday, June 10, 2006, at the Province Lands Visitor Center in Provincetown, Massachusetts. ADDRESSES: The DEIS may be viewed online at *http://www.nps.gov/caco* through the “In Depth” link on the homepage under “Management”. The DEIS will be available in hard copy at outer cape libraries and Marconi headquarters for onsite review. Comments may be submitted by mail to the address below, or by e-mail to *CACO_Hunt_EIS@nps.gov* (please note the underscore between words). FOR FURTHER INFORMATION CONTACT: Superintendent, Cape Cod National Seashore, 99 Marconi Site Road, Wellfleet, Massachusetts 02667. Telephone:

(508)349-3785. Fax:

(508)349-9052. SUPPLEMENTARY INFORMATION: Pursuant to section 102(2)(C) of the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2), the NPS has prepared a DEIS that considers three alternatives for managing the hunting program at Cape Cod National Seashore. The draft document describes and analyzes the environmental impacts of a preferred alternative, another action alternative, and a no action alternative. Comments may be submitted by mail to: Cape Cod National Seashore, 99 Marconi Site Road, Wellfleet, Massachusetts 02667; or by e-mail to *CACO_Hunt_EIA@nps.gov* (please note the underscore between words). It is our practice to make comments, including the names and home addresses of respondents, available for public review during normal business hours. Individual respondents may request that we withhold their home addresses from the record, which we will honor to the extent allowable by law. There also may be circumstances in which we would withhold the respondent's identity. If you wish us to withhold your address you must state this prominently at the beginning of your comment. We will make all submissions from organizations or businesses identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety. *Alternative A (No Action):* The National Park Service would continue the hunting program as it was prior to a court decision to enjoin the pheasant hunting and stocking program. Hunting would continue in accordance with the seasons and regulations established by the Massachusetts Division of Fisheries and Wildlife (MDFW), and in accordance with the existing rules established by Cape Cod National Seashore pertaining to the time of year hunting is allowed, the species that can be hunted, and no-hunting zones. Under this alternative, the pheasant hunting and stocking program would be re-established. *Alternative B (Preferred Alternative):* The hunting program described in Alternative A would be modified as described below. These modifications were derived from the input received during public scoping, and would retain hunting as part of Cape Cod's cultural heritage while addressing concerns raised by non-hunting visitors. *Element 1:* An adaptive management approach would be used to phase out the pheasant stocking and hunting program over a 15-year period. The number of pheasants stocked each year would be determined in coordination with MDFW, and would be based on hunting pressure and the response of native quail populations to cultural landscape restoration activities. If at the end of 15 years, native upland game bird hunting opportunities have not increased to a level roughly commensurate to the stocked pheasant hunt, the park will work with MDFW to create opportunities for a stocked quail hunt. *Element 2:* This element would simplify the scope of hunting areas, and would designate hunting-permitted areas versus the current policy which allows hunting in all areas except where specifically prohibited. The hunting-permitted areas would be delineated based on the existing 500-foot no-hunting buffers around paved roads and buildings, expanding the no-hunting buffers around bicycle paths from 150 feet to 500 feet, and eliminating the small patches and thin slivers of area that cannot practicably be hunted. *Element 3:* This element would increase traditional hunting opportunities for native upland bird species. Specifically, the park's rules would be revised to allow the State's spring eastern turkey hunt to occur within the park. Additionally, this element would include developing and implementing cultural landscape restoration activities that are expected to improve habitat quality for upland game birds, particularly northern bobwhite quail. *Element 4:* Improved information regarding hunting-permitted areas, hunting regulations, and safety measures would be developed. Outreach strategies would be developed to improve hunter and visitor understanding of the hunting program. *Alternative C:* This alternative would consider eliminating hunting at Cape Cod National Seashore. A sub-element of Alternative C would eliminate only the pheasant program while retaining the other aspects of the hunting program. George E. Price, Jr., Superintendent, Cape Cod National Seashore. [FR Doc. 06-4354 Filed 5-9-06; 8:45 am]

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