Notices. Notice
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BILLING CODE 6210-01-P FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension AGENCY: Federal Trade Commission (“Commission” or “FTC”). ACTION: Notice. SUMMARY: The FTC is seeking public comments on its proposal to extend through July 31, 2011, the current Paperwork Reduction Act (“PRA”) clearance for information collection requirements contained in the Children’s Online Privacy Protection Act Rule (“COPPA Rule”), which will expire on July 31, 2008.
The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the PRA. DATES: Comments must be submitted on or before July 24, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “FTC COPPA PRA Comment: FTC File No. P084511” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope and should be mailed or delivered to the following address:
Federal Trade Commission, Room H-135 (Annex J), 600 Pennsylvania Ave., N.W., Washington, D.C. 20580. Because paper mail in the Washington area and at the Commission is subject to delay, please consider submitting your comments in electronic form, as prescribed below. If, however, the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled “Confidential.” 1 1 Commission Rule 4.2(d), 16 CFR 4.2(d).
The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission's General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c). Comments filed in electronic form should be submitted by following the instructions on the web-based form at ( *https://secure.commentworks.com/ftc-COPPARule* ).
To ensure that the Commission considers an electronic comment, you must file it on the web-based form at the ( *https://secure.commentworks.com/ftc-COPPARule* ) weblink. If this notice appears at ( *www.regulations.gov* ), you may also file an electronic comment through that website. The Commission will consider all comments that *www.regulations.gov* forwards to it. All comments should additionally be submitted to: Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission.
Comments should be submitted via facsimile to
(202)395-6974 because U.S. Postal Mail is subject to lengthy delays due to heightened security precautions. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments will be considered by the Commission and will be available to the public on the FTC website, to the extent practicable, at *www.ftc.gov* . As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website. More information, including routine uses permitted by the Privacy Act, may be found in the FTC’s privacy policy at ( *http://www.ftc.gov/ftc/privacy.htm* ). FOR FURTHER INFORMATION CONTACT: Requests for additional information regarding this proceeding should be addressed to Mamie Kresses,
(202)326-2070, Federal Trade Commission, Bureau of Consumer Protection, Division of Advertising Practices, 600 Pennsylvania Ave., N.W., Mail Drop NJ-3212, Washington, D.C. 20580. SUPPLEMENTARY INFORMATION: On March 26, 2008, the FTC sought comment on the information collection requirements associated with the COPPA Rule, 16 CFR Part 312 (OMB Control Number 3084-0117). 73 FR 16015. No comments were received. Pursuant to the OMB regulations, 5 CFR Part 1320, that implement the PRA, 44 U.S.C. 3501-3521, the FTC is providing this second opportunity for public comment while seeking OMB approval to extend the existing paperwork clearance for the Rule. All comments should be filed as prescribed in the ADDRESSES section above, and must be received on or before July 24, 2008. **Estimated annual hours burden:** 1,900 hours
(a)*Disclosure Requirements:* 1,800 hours The COPPA Rule contains certain statutorily-required notice requirements, which constitute a “collection of information” under the PRA:
(1)the Rule requires each website and online service directed to children, 2 and any website or online service with actual knowledge that it is collecting personal information from children, to provide notice of how it collects, uses, and discloses such information and, with exceptions, to obtain the prior consent of the child’s parent in order to engage in such collection, use, and disclosure; 2 “Child” is defined under the statute and implementing Rule as an individual under thirteen years of age. 15 U.S.C. 6501(2); 16 CFR 312.2.
(2)the Rule requires the operator to provide the parent with notice of the specific types of personal information being collected from the child, to give the parent the opportunity to forbid the operator at any time from collecting, using, or maintaining such information, and to provide reasonable means for the parent to review the information;
(3)the Rule requires operators to obtain “verifiable parental consent” prior to collecting, using, or disclosing children’s personal information;
(4)the Rule requires website and online service operators to establish procedures that protect the confidentiality, security, and integrity of personal information collected from children; and
(5)the Rule requires operators to provide reasonable means for the parent to review the information. The FTC staff retains its estimate that roughly 30 new web entrants each year will fall within the Rule’s coverage and that, on average, new entrants will spend approximately 60 hours crafting a privacy policy, designing mechanisms to provide the required online privacy notice and, where applicable, the direct notice to parents. 3 Accordingly, staff estimates that complying with the Rule’s disclosure requirements will require approximately 1,800 hours (30 new web entrants x 60 hours per entrant). Consistent with prior estimates, FTC staff estimates that the time spent on compliance would be apportioned five to one between legal (lawyers or similar professionals) and technical (computer programmers) personnel. Staff therefore estimates that lawyers or similar professionals who craft privacy policies will account for 1,500 of the 1,800 hours required. Computer programmers responsible for posting privacy policies and implementing direct notices and parental consent mechanisms will account for the remaining 300 hours. 3 Although staff cannot determine with any degree of certainty the number of new entrants potentially subject to the Rule, it believes its estimate is reasonable. The Commission received no comments challenging staff’s prior PRA analyses in its prior requests for renewed clearance for the Rule or when it most recently sought comment on the Rule itself (70 FR 21107, 21109, April 22, 2005). Accordingly, staff retains those estimates for the instant PRA analysis. For the same reasons, staff retains its prior estimate of 60 hours per new entrant. Website operators that have previously created or adjusted their sites to comply with the Rule will incur no further burden associated with the Rule, unless they opt to change their policies and information collection in ways that will further invoke the Rule’s provisions. Moreover, staff believes that existing COPPA-compliant operators who introduce additional sites beyond those they already have created will incur minimal, if any, incremental PRA burden. This is because such operators already have been through the start-up phase and can carry over the results of that to the new sites they create.
(b)*Reporting Requirements for Safe Harbor Applicants:* 100 hours Operators can comply with the Rule by meeting the terms of industry self-regulatory guidelines that the Commission approves after notice and comment. 4 While the submission of industry self-regulatory guidelines to the agency is voluntary, the Rule includes specific reporting requirements that all safe harbor applicants must provide to receive Commission approval. Staff retains its estimate that it would require, on average, 265 hours per new safe harbor program applicant to prepare and submit its safe harbor proposal in accordance with Section 312.10(c) of the Rule. Industry sources have confirmed that this estimate is reasonable and advised that all of this time would be attributable to the efforts of lawyers. Given that several safe harbor programs are already available to website operators, FTC staff believes that it is unlikely that more than one additional safe harbor applicant will submit a request within the next three years of PRA clearance sought. Thus, annualized burden attributable to this requirement would be approximately 85 hours per year (265 hours ÷ 3 years) or, roughly, 100 hours. Staff believes that most of the records submitted with a safe harbor request would be those that these entities have kept in the ordinary course of business, and that any incremental effort associated with maintaining the results of independent assessments or other records under Section 312.10(d)(3) also would be in the normal course of business. In accordance with the regulations implementing the PRA, the burden estimate excludes effort expended for these activities. 5 CFR 1320.3(b)(2). 4 *See* Section 312.10(c). Approved self-regulatory guidelines can be found on the FTC’s website at ( *http://www.ftc.gov/privacy/privacyinitiatives/childrens_shp.html.* ) Accordingly, FTC staff estimates that total burden per year for disclosure requirements affecting new web entrants and reporting requirements for safe harbor applications would be approximately 2,000 hours, rounded to the nearest thousand. **Labor costs:** Labor costs are derived by applying appropriate hourly cost figures to the burden hours described above. Staff conservatively assumes hourly rates of $150 and $35, respectively, for lawyers or similar professionals and computer programmers. 5 Based on these inputs, staff further estimates that associated annual labor costs for new entrants would be $235,000 [(1,500 hours x $150 per hour for legal) + (300 hours x $35 per hour for computer programmers)] and $15,000 for safe harbor applicants (100 hours per year x $150 per hour), for a total labor cost of $250,000. 5 FTC staff estimates average legal costs at $150 per hour, which is roughly midway between Bureau of Labor Statistics
(BLS)mean hourly wages shown for attorneys (approximately $55) in the most recent whole-year data available online
(2006)and what staff believes may more generally reflect hourly attorney costs ($250) associated with Commission information collection activities. The $35 estimate for computer programmers is also conservatively based on the most recent whole-year data available online from the BLS (2006 National Compensation Survey and 2006 Occupational Employment and Wage Statistics). **Non-labor costs:** Because websites will already be equipped with the computer equipment and software necessary to comply with the Rule’s notice requirements, the sole costs incurred by the websites are the aforementioned estimated labor costs. Similarly, industry members should already have in place the means to retain and store the records that must be kept under the Rule’s safe harbor recordkeeping provisions, because they are likely to have been keeping these records independent of the Rule. David C. Shonka, Acting General Counsel. [FR Doc. E8-14148 Filed 6-23-08: 8:45 am] BILLING CODE 6750-01-S GENERAL SERVICES ADMINISTRATION Privacy Act of 1974; Notice of Updated Systems of Records AGENCY: General Services Administration. ACTION: Notice. SUMMARY: GSA reviewed its Privacy Act systems to ensure that they are relevant, necessary, accurate, up-to-date, covered by the appropriate legal or regulatory authority, and compliant with OMB M-07-16. This notice is an updated Privacy Act system of records notice. DATES: Effective July 24, 2008. FOR FURTHER INFORMATION CONTACT: Call or e-mail the GSA Privacy Act Officer: telephone 202-208-1317; e-mail *gsa.privacyact@gsa.gov* . ADDRESSES: GSA Privacy Act Officer (CIB), General Services Administration, 1800 F Street, NW., Washington, DC 20405. SUPPLEMENTARY INFORMATION: GSA undertook and completed an agency-wide review of its Privacy Act systems of records. As a result of the review, GSA is publishing an updated Privacy Act system of records notice. The revised system notice clarifies the authorities and practices regarding the collection and maintenance of information, but does not change individuals' rights to access or amend their records in the system of records. The updated system notice also includes the new requirement from OMB Memorandum M-07-16 regarding a new routine use that allows agencies to disclose information in connection with a response and remedial efforts in the event of a data breach. Dated: June 12, 2008. Cheryl M. Paige, Director, Office of Information Management. GSA/CIO-1 SYSTEM NAME: Enterprise Level Identity Verification System (ELIVS). SYSTEM LOCATION: ELIVS comprises a Web based application and data is maintained in a secure server facility at GSA Central Office, located at 1800 F Street, NW., Washington, DC 20405. Additionally, some fingerprint data may be located in GSA facilities where staffed fingerprint collection stations (Live Scan system) have been established to handle the contractor Personal Identity Verification
(PIV)process. Contact the System Manager for additional information. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Individuals who require routine access to agency facilities and information technology systems, including: a. Federal employees. b. Contractors. c. Child care workers and other temporary workers with similar access requirements. The system does not apply to occasional visitors or short-term guests, to whom GSA facilities may issue local Facility Access Cards (FAC). CATEGORIES OF RECORDS IN THE SYSTEM: The system contains information needed for issuing and maintaining HSPD-12 credentials and also access privilege information. Records may include: • Employee/contractor/other worker full name • Social Security Number
(SSN)• Date of birth • Facial Image • Fingerprints (within the Live Scan systems) • Organization/office of assignment • Company/agency name • Telephone number • ID card issuance and expiration dates • ID card number • Emergency responder designation • Home address and work location • Contract and supervisor information AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 5 U.S.C. 301, 40 U.S.C. 121, 40 U.S.C. 582, 40 U.S.C. 3101, 44 U.S.C. 3501, 44 U.S.C. 3506, 44 U.S.C. 3602, E.O. 9397, and Homeland Security Presidential Directive 12 (HSPD-12). PURPOSE: The primary purposes of the system are: To act as an authoritative source for GSA identities including employees, contractors, and other workers to verify that all persons requiring routine access to GSA facilities or using GSA information resources have sufficient background investigations and are permitted access, to track and manage HSPD-12 ID cards issued to persons who have routine access to GSA facilities and information systems, and to provide reports of identity data for administrative and staff offices to efficiently track and manage contractors. ROUTINE USES OF THE SYSTEM RECORDS, INCLUDING CATEGORIES OF USERS AND THEIR PURPOSE FOR USING THE SYSTEM: System information may be accessed and used by: a. GSA Personnel when needed for official business, including the Security Office, HSPD-12 Points of Contacts, and designated analysts and managers for official business; PIV card requesting officials and Human Resource Officers to track, verify, and update identity information of GSA personnel; and Regional Credential Officers
(RCOs)to issue and track PIV ID cards; b. To verify suitability of an employee or contractor before granting access to specific resources; c. To disclose information to agency staff and administrative offices who may restructure the data for management purposes; d. An authoritative source of identities for Active Directory and Lotus Notes and other GSA systems; e. In any legal proceeding, where pertinent, to which GSA is a party before a court or administrative body; f. To authorized officials engaged in investigating or settling a grievance, complaint, or appeal filed by an individual who is the subject of the record. g. To a Federal, state, local, foreign, or tribal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision; h. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), or the Government Accountability Office
(GAO)when the information is required for program evaluation purposes; i. To a Member of Congress or staff on behalf of and at the request of the individual who is the subject of the record; j. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant; k. To the National Archives and Records Administration
(NARA)for records management purposes; l. To appropriate agencies, entities, and persons when
(1)the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
(2)the Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and
(3)the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING RECORDS IN THE SYSTEM: STORAGE: Computer records are stored on a secure server and accessed over the web using encryption software. Paper records, when created, are kept in file folders and cabinets in secure rooms. The Live Scan systems are kept in secure locations with limited access to authorized personnel only. RETRIEVABILITY: Records are retrievable by a combination of first name and last name. Group records are retrieved by organizational code. SAFEGUARDS: Computer records are protected by a password system. Paper records are stored in locked metal containers or in secured rooms when not in use. Information is released to authorized officials based on their need to know. RETENTION AND DISPOSAL: Records are disposed of as specified in the handbook, GSA Records Maintenance and Disposition System (CIO P 1820.1). SYSTEM MANAGER AND ADDRESS: Program Manager, HSPD-12 Program Management Office, General Services Administration, 1800 F Street, NW., Room 2208 Washington, DC 20405. NOTIFICATION PROCEDURE: An individual can determine if this system contains a record pertaining to him/her by sending a request in writing, signed, to the System Manager at the above address. When requesting notification of or access to records covered by this notice, an individual should provide his/her full name, date of birth, region/office, and work location. An individual requesting notification of records in person must provide identity documents sufficient to satisfy the custodian of the records that the requester is entitled to access, such as a government-issued photo ID. CONTESTING RECORD PROCEDURES: Rules for contesting the content of a record and appealing a decision are contained in 41 CFR 105-64. RECORD SOURCES CATEGORIES: The sources for information in the system are the individuals about whom the records are maintained, the supervisors of those individuals, existing GSA systems, sponsoring agency, former sponsoring agency, other Federal agencies, contract employer, former employer, and the U.S. Office of Personnel Management (OPM). [FR Doc. E8-14199 Filed 6-23-08; 8:45 am] BILLING CODE 6820-34-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Agency for Healthcare Research and Quality, HHS. ACTION: Notice. SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality
(AHRQ)to request that the Office of Management and Budget
(OMB)approve the proposed information collection project: “Assessing the Impact of the Patient Safety Improvement Corps
(PSIC)Training Program.” In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the **Federal Register** on April 16th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by July 24, 2008. ADDRESSES: Written comments should be submitted to: AHRQTs OMB Desk Officer by fax at
(202)395-6974 (attention: AHRQ's desk officer) or by e-mail at *OIRA_submission@omb.eop.gov* ( *attention:* AHRQ's desk officer). Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer. FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports Clearance Officer,
(301)427-1477, or by e-mail at *doris.letkowitz(2iahrg.hhs.gov* . SUPPLEMENTARY INFORMATION: Proposed Project Assessing the Impact of the Patient Safety Improvement Corps
(PSIC)Training Program AHRQ proposes to assess the impact of the PSIC training program. This three-week program was designed and implemented by AHRQ and the Veteran's Administration's
(VA)National Center for Patient Safety
(NCPS)to improve patient safety by training participants in various patient safety concepts, tools, information, and techniques. The PSIC program represents a new approach to training for AHRQ by focusing on disseminating patient safety information and building skill sets to ultimately foster a national network of individuals who support, promote, and speak a common language of patient safety. Participants have included representatives from State health departments, hospitals and health systems, Quality Improvement Organizations, and a very small number of other types of organizations. AHRQ will use an independent contractor to conduct the assessment of the PSIC training program. The goal of the assessment is to determine the extent to which the PSIC concepts, tools, information, and techniques have been used on the job by training participants and successfully disseminated within and beyond the participating organizations, local areas, regions, and states. AHRQ is assessing the PSIC program pursuant to its authority under 42 U.S.C. 299(b) and 42 U.S.C. 299a(a) to evaluate its strategies for improving health care quality. The assessment involves two Web-based questionnaires to examine post-training activities and patient safety outcomes of the training from multiple perspectives. One questionnaire is directed to training participants while the other is directed to leaders of the organizations from which the training participants were selected. Questionnaires will focus on the following topics:
(1)Post-PSIC activities (including how PSIC material has been utilized in their home organizations, types of patient safety activities conducted post-PSIC, and number of people trained in some or all aspects of PSIC since their attendance);
(2)barriers to and facilitators of the use of PSIC in the workplace; and
(3)perceived outcomes of PSIC participation (e.g., improved patient safety; improved patient safety processes, standards, or policies; improved investigative and analytical processes and selection and implementation of patient safety interventions; improved patient safety culture; improved communications). Method of Collection All training participants and organizational leaders from participating organizations will be invited to respond to their corresponding Web-based questionnaire. Invitations will be sent via e-mail, using contact information previously collected by AHRQ and NCPS. Standard non response follow-up techniques, such as two reminder e-mails that include the link to the questionnaire, will be used. Individuals and organizations will be assured of the privacy of their responses. Estimated Annual Respondent Burden Exhibit 1 shows the estimated annualized burden hours for the respondent's time to participate in the study. The training participant questionnaire is estimated to require 30 minutes to complete and the organizational leader questionnaire is estimated to require 15 minutes to complete, resulting in a total burden of 169 hours. Exhibit 1.—Estimated Annualized Burden Hours Form name Number of respondents Number of responses per respondent Hours per response Total burden hours Training participant questionnaire 300 1 30/60 150 Organizational leader questionnaire 75 1 15/60 19 Total 375 NA NA 169 Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to participate in the study. The total cost burden is estimated to be $5,552.80. Exhibit 2.—Estimated Annualized Cost Burden Form name Number of respondents Total burden hours Average hourly wage rate * Total cost burden Training participant questionnaire 300 150 $32.18 $4,827.00 Organizational leader questionnaire 75 19 $38.20 725.80 Total 375 169 NA 5,552.80 * Based upon the mean of the average wages for health professionals for the training participant questionnaire and for executives, administrators, and managers for the organizational leader questionnaire presented in the National Compensation Survey: Occupational Wages in the United States, June 2005, U.S. Department of Labor, Bureau of Labor Statistics. Estimated Annual Costs to the Federal Government The total cost to the government for this activity is estimated to be $127,442 to conduct the two one-time questionnaires and to analyze and present its results. This amount includes costs for developing the data collection tools ($50,976); collecting the data ($25,488); analyzing the data and reporting the findings ($44,605); and administrative support activities ($6,373). Request for Comments In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following:
(a)Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research, quality improvement and information dissemination functions, including whether the information will have practical utility;
(b)the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Dated: June 16, 2006. Carolyn Clancy, Director. [FR Doc. E8-14052 Filed 6-23-08; 8:45 am] BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention; Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Postpartum Hemorrhage Among Women With an Undiagnosed Bleeding Disorder, Potential Extramural Project 2008-R-28 *Correction:* This notice was published in the **Federal Register** on April 18, 2008, Volume 73, Number 76, page 21138. The aforementioned meeting has been rescheduled to the following: *Time and Date:* 1 p.m.-3 p.m., July 8, 2008 (Closed). *For More Information Contact:* Linda Shelton, Program Specialist, Coordinating Center for Health and Information Service, Office of the Director, CDC, 1600 Clifton Road, NE., Mailstop E21, Atlanta, GA 30333. Telephone
(404)498-1194. 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. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E8-14136 Filed 6-23-08; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [OMB No.: 0970-0278] Submission for OMB Review; Comment Request *Title:* Reunification Procedures for Unaccompanied Alien Children. *Description:* Description: Following the passage of the 2002 Homeland Security Act (Pub. L. 107-2 96), the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is charged with the care and placement of unaccompanied alien children in Federal custody, and implementing a policy for the release of these children, when appropriate, upon the request of suitable sponsors while awaiting immigration proceedings. In order for ORR to make determinations regarding the release of these children, the potential sponsors must meet certain conditions pursuant to section 462 of the Homeland Security Act and the *Flores* v. *Reno Settlement Agreement No. CV85 4544-RJK* (C.D. Cal. 1997). The proposed information collection requests information to be utilized by ORR for determining the suitability of a sponsor/respondent for the release of a minor from ORR custody. The proposed instruments are the Sponsors Agreement to Conditions of Release, Verification of Release, Family Reunification Packet, and the Authorization for Release of Information. *Respondents:* Sponsors requesting release of unaccompanied alien children to their custody. *Respondents:* Annual Burden Estimates Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Agreement 4,288 2 .0835 716 Verification of Release 4,288 1 .167 716 Family Reunification 4,288 18 .0416 3,122 Authorization 4,288 15 0.0222 1,428 Estimated Total Annual Burden Hours: *Additional Information:* Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L'Enfant Promenade, SW., Washington, DC 20447, *Attn:* ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: *infocollection@acf.hhs.gov* . *OMB Comment:* OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the **Federal Register** . Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974, Attn: Desk Officer for the Administration for Children and Families. Dated: June 16, 2008. Robert Sargis, Reports Clearance, Officer. [FR Doc. E8-14046 Filed 6-23-08; 8:45 am] BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0345] Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback” 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 relating to FDA's regulation of current good manufacturing practice and related regulations for blood and blood components; and requirements for donor testing, donor notification, and “lookback.” DATES: Submit written or electronic comments on the collection of information by August 25, 2008. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.regulations.gov* . 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. Current Good Manufacturing Practice and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback” (OMB Control Number 0910-0116)—Extension All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacture into injectable products, have a license, issued upon a demonstration that the product is safe, pure and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic (FD&C) Act also applies to biological products. Blood and blood components for transfusion or for further manufacture into injectable products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the act, blood and plasma establishments must comply with the substantive provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351(a)), drugs are deemed “adulterated” if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice
(CGMP)and related regulations. The CGMP regulations (part 606) (21 CFR part 606)) and related regulations implement FDA's statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donors for evidence of infection due to communicable disease agents and in notifying donors is to prevent the transmission of communicable disease. For example, the “lookback” requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to users of blood and blood components and appropriate notification of recipients of transfusion who are at increased risk for transmitting human immunodeficiency virus
(HIV)or hepatitis C virus
(HCV)infection. The information collection requirements in the CGMP, donor testing, donor notification, and “lookback” regulations provide FDA with the necessary information to perform its duty to ensure the safety, purity, and potency of blood and blood components. These requirements establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventive and remedial purposes. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action. Under the reporting requirements, § 606.170(b), in brief, requires that facilities notify FDA's Center for Biologics Evaluation and Research (CBER), as soon as possible after confirming a complication of blood collection or transfusion to be fatal. The collecting facility is to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a written report of the investigation within 7 days after the fatality. In fiscal years 2006 and 2007, FDA received, on average, 100 of these reports. Section 610.40(c)(1)(ii) (21 CFR 610.40(c)(1)(ii)), in brief, requires that each donation dedicated to a single identified recipient be labeled as required under § 606.121 and with a label entitled “INTENDED RECIPIENT INFORMATION LABEL” containing the name and identifying information of the recipient. Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an establishment to obtain written approval from FDA to ship human blood or blood components for further manufacturing use prior to completion of testing for evidence of infection due to certain communicable disease agents. Section 610.40(h)(2)(ii)(A) (21 CFR 610.40(h)(2)(ii)(A)), in brief, requires an establishment to obtain written approval from FDA to use or ship human blood or blood components found to be reactive by a screening test for evidence of certain communicable disease agent(s) or collected from a donor with a record of a reactive screening test. Furthermore, § 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) (21 CFR 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D)), in brief, requires an establishment to label certain reactive human blood and blood components with the appropriate screening test results, and, if they are intended for further manufacturing use into injectable products, include a statement on the label indicating the exempted use specifically approved by FDA. Finally, § 610.40(h)(2)(vi) (21 CFR 610.40(h)(2)(vi)) requires each donation of human blood or blood components, excluding Source Plasma, that tests reactive by a screening test for syphilis and is determined to be a biological false positive to be labeled with both test results. Section 610.42(a) (21 CFR 610.42(a)) requires a warning statement “indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified communicable disease agent(s)” in the labeling for medical devices containing human blood or a blood component found to be reactive by a screening test for evidence of infection due to a communicable disease agent(s) or syphilis. In brief, §§ 610.46 and 610.47 (21 CFR 610.46 and 610.47) require blood collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV prospective “lookback” when:
(1)A donor tests reactive for evidence of HIV or HCV infection or
(2)the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (“prospective lookback”) (see §§ 610.46(a)(1) and 610.47(a)(1)). The requirement for “an appropriate system” requires the collecting establishment to design standard operating procedures
(SOPs)to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection. Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must, among other things, notify consignees to quarantine all identified previously collected in-date blood and blood components (§§ 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (§§ 610.46(a)(3) and 610.47(a)(3)). Consignees also must establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (§§ 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for, among other things, notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application
(IND)or an investigational device exemption (IDE), is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (§§ 610.46(b)(3) and 610.47(b)(3)). Section 630.6(a) (21 CFR 630.6(a)) requires an establishment to make reasonable attempts to notify any donor who has been deferred as required by § 610.41 (21 CFR 610.41), or who has been determined not to be eligible as a donor. Section 630.6(d)(1) requires an establishment to provide certain information to the referring physician of an autologous donor who is deferred based on the results of tests as described in § 610.41. Under the recordkeeping requirements, § 606.100(b), in brief, requires that written SOPs be maintained for all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components used for transfusion and further manufacturing purposes. Section 606.100(c) requires the review of all records pertinent to the lot or unit of blood prior to release or distribution. Any unexplained discrepancy or the failure of a lot or unit of final product to meet any of its specifications must be thoroughly investigated, and the investigation, including conclusions and followup, must be recorded. In brief, § 606.110(a) provides that the use of plateletpheresis and leukaphesis procedures to obtain a product for a specific recipient may be at variance with the additional standards for that specific product if, among other things, the physician certifies in writing that the donor's health permits plateletpheresis or leukapheresis. Section 606.110(b) requires establishments to request prior approval from CBER for plasmapheresis of donors who do not meet donor requirements. The information collection requirements for § 606.110(b) are approved under OMB control number 0910-0338 and, therefore, are not reflected in tables 1 and 2 of this document. Section 606.151(e) requires that SOPs for compatibility testing include procedures to expedite transfusion in life-threatening emergencies; records of all such incidents must be maintained, including complete documentation justifying the emergency action, which must be signed by a physician. So that each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components can be clearly traced, § 606.160 requires that legible and indelible contemporaneous records of each such step be made and maintained for no less than 10 years. Section 606.160(b)(1)(viii)) requires records of the quarantine, notification, testing and disposition performed under the HIV and HCV “lookback” provisions. Furthermore, § 606.160(b)(1)(ix) requires a blood collection establishment to maintain records of notification of donors deferred or determined not to be eligible for donation, including appropriate followup. Section 606.160(b)(1)(xi) requires an establishment to maintain records of notification of the referring physician of a deferred autologous donor, including appropriate followup. Section 606.165, in brief, requires that distribution and receipt records be maintained to facilitate recalls, if necessary. Section 606.170(a) requires records to be maintained of any reports of complaints of adverse reactions arising as a result of blood collection or transfusion. Each such report must be thoroughly investigated, and a written report, including conclusions and followup, must be prepared and maintained. When an investigation concludes that the product caused the transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility. Section 610.40(g)(1) (21 CFR 610.40(g)(1)) requires an establishment to appropriately document a medical emergency for the release of human blood or blood components prior to completion of required testing. In addition to the CGMP regulations in part 606, there are regulations in part 640 (21 CFR part 640) that require additional standards for certain blood and blood components as follows: Sections 640.3(a)(1), (a)(2), and (f); 640.4(a)(1) and (a)(2); 640.25(b)(4) and (c)(1); 640.27(b); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b). The information collection requirements and estimated burdens for these regulations are included in the part 606 burden estimates, as described in tables 1 and 2 of this document. Respondents to this collection of information are licensed and unlicensed blood establishments that collect blood and blood components, including Source Plasma and Source Leukocytes, inspected by FDA, and other transfusion services inspected by Centers for Medicare and Medicaid Services (CMS). Based on information received from CBER's database systems, there are approximately 81 licensed Source Plasma establishments with multiple locations and approximately 2,000 registered blood collection establishments, for an estimated total of 2,081 establishments. Of these establishments, approximately 696 perform plateletpheresis and leukopheresis. These establishments annually collect approximately 28 million units of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and are required to follow FDA “lookback” procedures. In addition, there are another 4,980 establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 (formerly referred to as facilities approved for Medicare reimbursement) that transfuse blood and blood components. The following reporting and recordkeeping estimates are based on information provided by industry, CMS, and FDA experience. Based on information received from industry, we estimate that there are approximately 13 million donations of Source Plasma from approximately 2 million donors and approximately 15 million donations of Whole Blood, including approximately 300,000 (2 percent of 15 million) autologous donations, from approximately 8 million donors. Assuming each autologous donor makes an average of 2 donations, FDA estimates that there are approximately 150,000 autologous donors. FDA estimates that approximately 5 percent (12,000) of the 240,000 donations that are donated specifically for the use of an identified recipient would be tested under the dedicated donors' testing provisions in § 610.40(c)(1)(ii). Under § 610.40(g)(2) and (h)(2)(ii)(A), the only product currently shipped prior to completion of testing for evidence of certain communicable disease agents is a licensed product, Source Leukocytes, used in the manufacture of interferon, which requires rapid preparation from blood. Shipments of Source Leukocytes are pre-approved under a biologics license application and each shipment does not have to be reported to the agency. Based on information from CBER's database system, FDA receives less than 1 application per year from manufacturers of Source Leukocytes. However, for calculation purposes, we are estimating 1 application annually. Under § 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D), FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood components per month (12 per year) that would require 2 labels; one as reactive for the appropriate screening test under § 610.40(h)(2)(ii)(C), and the other stating the exempted use specifically approved by FDA under § 610.40(h)(2)(ii)(D). According to CBER's database system, there are approximately 40 licensed manufacturers that ship known reactive human blood or blood components. Based on information we received from industry, we estimate that approximately 18,000 donations:
(1)Annually test reactive by a screening test for syphilis,
(2)are determined to be biological false positives by additional testing, and
(3)are labeled accordingly (§ 610.40(h)(2)(vi)). Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device, e.g., a positive control for an in vitro diagnostic testing kit. It is usual and customary business practice for manufacturers to include on the container label a warning statement that identifies the communicable disease agent. In addition, on the rare occasion when a human blood or blood component with a reactive screening test is the only component available for a medical device that does not require a reactive component, then a warning statement must be affixed to the medical device. To account for this rare occasion under § 610.42(a), we estimate that the warning statement would be necessary no more than once a year. FDA estimates that approximately 3,500 repeat donors will test reactive on a screening test for HIV. We also estimate that an average of three components was made from each donation. Under §§ 610.46(a)(1)(ii)(B) and 610.46(a)(3), this estimate results in 10,500 (3,500 x 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 10,500 (3,500 x 3) notifications to consignees of subsequent test results. We estimate an average of 10 minutes per notification of consignees. Moreover, we estimate that § 610.46(b)(3) will require 4,980 consignees to notify transfusion recipients, their legal representatives, or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors x 3) notifications. Under § 610.46(b)(3), we also estimate 1 hour to accommodate the time to gather test results and records for each recipient and to accommodate multiple attempts to contact the recipient. Furthermore, we estimate that approximately 7,800 repeat donors per year would test reactive for antibody to HCV. Under §§ 610.47(a)(1)(ii)(B) and 610.47(a)(3), collecting establishments would notify the consignee 2 times for each of the 23,400 (7,800 x 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 46,800 notifications as an annual ongoing burden. Under § 610.47(b)(3), we estimate that approximately 4,980 consignees would notify approximately 2,050 recipients or their physicians of record annually. Finally, we estimate 1.0 hours to complete notification. Industry estimates that approximately 13 percent of 10 million potential donors (1.3 million donors) who come to donate annually are determined not to be eligible for donation prior to collection because of failure to satisfy eligibility criteria. It is the usual and customary business practice of approximately 2,000 blood collecting establishments to notify onsite and to explain why the donor is determined not to be suitable for donating. Based on such available information, we estimate that two-thirds (1,333) of the 2,000 blood collecting establishments provided onsite additional information and counseling to a donor determined not to be eligible for donation as usual and customary business practice. Consequently, we estimate that only one-third, or 667, approximately, blood collecting establishments would need to provide, under § 630.6(a), additional information and onsite counseling to the estimated 430,000 (one-third of approximately 1.3 million) ineligible donors. It is estimated that another 4.5 percent of 10 million potential donors (450,000 donors) are deferred annually based on test results. We estimate that currently approximately 95 percent of the establishments that collect 99 percent of the blood and blood components notify donors who have reactive test results for HIV, Hepatitis B Virus (HBV), HCV, Human T-Lymphotropic Virus (HTLV), and syphilis as usual and customary business practice. Consequently, 5 percent of the 2,081 establishments
(104)collecting 1 percent (4,500) of the deferred donors (450,000) would notify donors under § 630.6(a). As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process required under § 630.6(d)(1). However, we estimate that approximately 5 percent of the 2,000 blood collection establishments
(100)may not notify the referring physicians of the estimated 2 percent of 150,000 autologous donors with the initial reactive test results (3,000) as their usual and customary business practice. The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers, which collect 99 percent of the blood supply, have developed SOPs as part of their customary and usual business practice. Establishments may minimize burdens associated with CGMP and related regulations by using model standards developed by industries' accreditation organizations. These accreditation organizations represent almost all registered blood establishments. Under § 606.160(b)(1)(ix), we estimate the total annual records based on the approximately 1.3 million donors determined not to be eligible to donate and each of the estimated 1.75 million (1.3 million + 450,000) donors deferred based on reactive test results for evidence of infection because of communicable disease agents. Under § 606.160(b)(1)(xi), only the 2,000 registered blood establishments collect autologous donations and, therefore, are required to notify referring physicians. We estimate that 4.5 percent of the 150,000 autologous donors (6,750) will be deferred under § 610.41, which in turn will lead to the notification of their referring physicians. FDA has concluded that the use of untested or incompletely tested but appropriately documented human blood or blood components in rare medical emergencies should not be prohibited. We estimate the recordkeeping under § 610.40(g)(1) to be minimal with one or fewer occurrences per year. The reporting of test results to the consignee in § 610.40(g) does not create a new burden for respondents because it is the usual and customary business practice or procedure to finish the testing and provide the results to the manufacturer responsible for labeling the blood products. The hours per response and hours per record are based on estimates received from industry or FDA experience with similar recordkeeping or reporting requirements. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 606.170(a) 353 5 1.20 424 0.5 212 606.170(b) 2 100 1 100 20 2,000 610.40(c)(1)(ii) 2,081 5.77 12,000 0.08 960 610.40(g)(2) 1 1 1 1 1 610.40(h)(2)(ii)(A) 1 1 1 1 1 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) 40 12 480 0.2 96 610.40(h)(2)(vi) 2,081 8.65 18,000 0.08 1,440 610.42(a) 1 1 1 1 1 610.46(a)(1)(ii)(B) 2,000 5.25 10,500 0.17 1,785 610.46(a)(3) 2,000 5.25 10,500 0.17 1,785 610.47(b)(3) 4,980 0.41 2,050 1.0 2,050 610.47(a)(1)(ii)(B) 2,000 11.70 23,400 0.17 3,978 610.47(a)(3) 2,000 11.70 23,400 0.17 3,978 610.47(b)(3) 4,980 0.41 2,050 1.0 2,050 630.6(a) 3 667 644.68 430,000 0.08 34,400 630.6(a) 4 104 43.27 4,500 1.5 6,750 630.6(d)(1) 100 30 3,000 1 3,000 Total 64,487 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b). 3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 4 Notification of donors deferred based on reactive test results for evidence of infection due to communicable disease agents. 5 Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,980 + 2,081). **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 606.100(b) 2 353 5 1 353 24 8,472 606.100(c) 353 5 10 3,530 1 3,530 606.110(a) 3 35 6 1 35 0.5 18 606.151(e) 353 5 12 4,236 0.083 352 606.160 4 353 5 793.20 280,000 0.75 210,000 606.160(b)(1)(viii) HIV consignee notification 2,000 10.50 21,000 .17 3,570 4,980 4.21 21,000 .17 3,570 HCV consignee notification 2,000 23.40 46,800 .17 7,956 4,980 9.4 46,800 .17 7,956 HIV recipient notification 4,980 0.35 1,755 .17 298 HCV recipient notification 4,980 0.41 2,050 .17 349 606.160(b)(1)(ix) 2,081 840.94 1,750,000 0.05 875,000 606.160(b)(1)(xi) 2,000 3.375 6,750 0.05 338 606.165 353 5 793.20 280,000 0.083 23,240 606.170(a) 353 5 12 4,236 1.00 4,236 610.40(g)(1) 2,081 1 2,081 0.50 1,041 Total 1,149,926 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The recordkeeping requirements in §§ 640.3(a)(1), 640.4(a)(1), and 640.66, which address the maintenance of SOPs, are included in the estimate for § 606.100(b). 3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for § 606.110(a). 4 The recordkeeping requirements in §§ 640.3(a)(2) and (f); 640.4(a)(2); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.61; 640.63(b)(3), (e)(1), and (e)(3); 640.65(b)(2); 640.71(b)(1); 640.72; and 640.76(a) and (b), which address the maintenance of various records are included in the estimate for § 606.160. 5 Five percent of establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 that transfuse blood and components and FDA-registered blood establishments (0.05 x 4,980 + 2,081). 6 Five percent of plateletpheresis and leukopheresis establishments (0.05 x 696). Dated: June 17, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14248 Filed 6-23-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0169] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 24, 2008. 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, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number 0910-0188. Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Infant Formula Recall Regulations—(OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(e)) provides that if the manufacturer of an infant formula has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer has left its control and may not provide the nutrients required in section 412(i) of the act or is otherwise adulterated or misbranded, the manufacturer must promptly notify the Secretary of Health and Human Services (the Secretary). If the Secretary determines that the infant formula presents a risk to human health, the manufacturer must immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. Section 412(f)(2) of the act states that the Secretary shall by regulation prescribe the scope and extent of recalls of infant formula necessary and appropriate for the degree of risk to human health presented by the formula subject to recall. FDA's infant formula recall regulations in part 107 (21 CFR part 107) implement these statutory provisions. Section 107.230 requires each recalling firm to conduct an infant formula recall with the following elements:
(1)Evaluate the hazard to human health,
(2)devise a written recall strategy,
(3)promptly notify each affected direct account (customer) about the recall, and
(4)furnish the appropriate FDA district office with copies of these documents. If the recalled formula presents a risk to human health, the recalling firm must also request that each establishment that sells the recalled formula post (at point of purchase) a notice of the recall and provide FDA with a copy of the notice. Section 107.240 requires the recalling firm to conduct an infant formula recall with the following elements:
(1)Notify the appropriate FDA district office of the recall by telephone within 24 hours,
(2)submit a written report to that office within 14 days, and
(3)submit a written status report at least every 14 days until the recall is terminated. Before terminating a recall, the recalling firm is required to submit a recommendation for termination of the recall to the appropriate FDA district office and wait for written FDA concurrence (§ 107.250). Where the recall strategy or implementation is determined to be deficient, FDA may require the firm to change the extent of the recall, carry out additional effectiveness checks, and issue additional notifications (§ 107.260). In addition, to facilitate location of the product being recalled, the recalling firm is required to maintain distribution records for at least 1 year after the expiration of the shelf life of the infant formula (§ 107.280). The reporting and recordkeeping requirements described previously are designed to enable FDA to monitor the effectiveness of infant formula recalls in order to protect babies from infant formula that may be unsafe because of contamination or nutritional inadequacy or otherwise adulterated or misbranded. FDA uses the information collected under these regulations to help ensure that such products are quickly and efficiently removed from the market. In the **Federal Register** of March 26, 2008 (73 FR 16018), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 107.230 2 1 2 4,500 9,000 107.240 2 1 2 1,482 2,964 107.250 2 1 2 120 240 107.260 1 1 1 650 650 Total 12,854 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and customary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. The reporting burden estimate is based on agency records, which show that there are five manufacturers of infant formula and that there have been, on average, two infant formula recalls per year for the past 3 years. Dated: June 17, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8-14258 Filed 6-23-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; *telephone:* 301-496-7057; *fax:* 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Novel Fluorinated Dmt-Tic Analogues for Use as PET Radiotracers *Description of Technology:* Researchers at the NIH have developed fluorine-18 ( 18 F) labeled analogues specific for the delta-opioid receptors. These radioligands include analogues of the Dmt-Tic pharmacophore, containing a delta-opioid receptor antagonist that may be useful for imaging opioid receptors expressed in lung malignant tumors or other peripheral tumors that express delta-opioid receptors. This methodology might be readily applicable to Dmt-Tic pharmacophoric ligands that exhibit dual antagonism for delta-/mu-opioid receptors. Studies by the inventors have shown that injected radioligand failed to cross the blood-brain barrier
(BBB)of rats; therefore, these compounds could serve as radiotracers for assessing and locating certain carcinomas that contain high levels of delta-opioid receptors, such as lung, breast and/or colon cancers. Since there is an increasing demand of radioligands for in vivo imaging of peripheral opioid receptors, this technology has the potential of enhancing current practices of PET imaging in oncology. Available for licensing are compositions and methods of locating delta- and/or mu-opioid receptors located in peripheral cancers, such as in lung, breast, and/or colorectal cancer, using opiate radioligands. *Applications:* Non-invasive tool for screening lung, breast, and/or colorectal cancers. Diagnostic tool for use in PET imaging. *Market:* For 2007, it was projected that close to 1.5 million Americans would develop cancer. PET imaging is steadily becoming a technique of choice in oncology so many of these patients will likely undergo scans several times during their treatment to assess the stage of their disease. This is supported by rising sales of FDG, which are expected to reach $933 million by 2012. *Development Status:* Early stage. *Inventors:* Lawrence H. Lazarus (NIEHS) *et al.* *Relevant Publication:* KA Roth and JD Barchas. Small cell carcinoma cell lines contain opioid peptides and receptors. Cancer 1986 Feb 15;57(4):769-773. *Patent Status:* U.S. Provisional Application No. 60/970,143 filed 05 Sep 2007 (HHS Reference No. E-317-2007/0-US-01). *Licensing Status:* Available for licensing. *Licensing Contact:* Charlene A. Sydnor, PhD.; 301-435-4689; *sydnorc@mail.nih.gov* . *Collaborative Research Opportunity:* The NIEHS Laboratory of Pharmacology, Medicinal Chemistry Group, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Elizabeth Denholm, PhD., Director, NIEHS Office of Technology Transfer, at 919-541-0981 or *denholme@mail.nih.gov* for more information. Novel Isoform of KCNH2 for the Treatment of Schizophrenia *Description of Technology:* Researchers at the NIH report the discovery and characterization of a novel isoform of the voltage-gated potassium channel KCNH2. This novel isoform is shown to control neurological firing and has implication as a genetic risk factor for schizophrenia. It is highly expressed in the hippocampus of schizophrenic patients and also in normal individuals who carry risk-associated alleles of KCNH2. This novel isoform may be a suitable target for drug development as is it minimally expressed in the heart with the potential to exert less adverse cardiovascular side-effects, which is often a consequence of currently available antipsychotic drugs. Available for licensing and commercial development are nucleic acids, polypeptides and antibodies specific for this novel isoform, as well as methods of screening for therapeutic agents and predicting susceptibility to schizophrenia. *Applications:* Potential new psychotherapeutic agent with less cardiac side-effects. Potential drug screening assay for identifying new psychotherapeutic drugs. Potential diagnostic tool for determining susceptibility of schizophrenia. *Market:* Schizophrenia is among the most severe of the mental illnesses and has a lifetime prevalence of approximately 1% worldwide. More than 2,000,000 Americans have schizophrenia and it accounts for 2.5% of U.S. health care costs and 75% of expenditures for long-term mental health. *Development Status:* Early stage. *Inventors:* Daniel R. Weinberger *et al.* (NIMH). *Patent Status:* U.S. Provisional Application No. 60/920,220 filed 26 Mar 2007 (HHS Reference No. E-245-2006/0-US-01). PCT Application No. PCT/US2008/057913 filed 21 Mar 2008 (HHS Reference No. E-245-2006/0-PCT-02). *Licensing Status:* Available for licensing. *Licensing Contact:* Charlene A. Sydnor, PhD.; 301-435-4689; *sydnorc@mail.nih.gov* . *Collaborative Research Opportunity:* The NIMH Clinical Brain Disorders Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize potassium channel isoform associated with schizophrenia. Please contact Suzanne Winfield at 301-402-4324/ *winfiels@mail.nih.gov* for more information. Dated: June 13, 2008. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E8-14257 Filed 6-23-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Clinical Research Grants in Diabetes, Endocrine and Metabolic Diseases. *Date:* July 1-2, 2008. *Time:* 8 a.m. to 8 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Stuart B. Moss, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 20892, 301-435-1044, *mossstua@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Neurogenetics. *Date:* July 8, 2008 *Time:* 11 a.m. to 1 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Joseph G. Rudolph, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7844, Bethesda, MD 20892, 301-435-2212, *josephru@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Small Business: Orthopaedics and Skeletal Biology. *Date:* July 11, 2008. *Time:* 8:30 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Doubletree Hotel, 1515 Rhode Island Avenue, NW., Washington, DC 20005. *Contact Person:* John P. Holden, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301-496-8551, *holdenjo@csr.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Member Conflicts: Neuropharmacology. *Date:* July 14-15, 2008. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Christine L. Melchior, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5176, MSC 7844, Bethesda, MD 20892,
(301)435-1713, *melchioc@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Neurodevices and Bioengineering. *Date:* July 16, 2008. *Time:* 11 a.m. to 1 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). *Contact Person:* Joseph G. Rudolph, PhD, Scientific Review Administrator, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5186, MSC 7844, Bethesda, MD 20892, 301-435-2212, *josephru@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel; AIDS Fellowship Review. *Date:* July 29-August 1, 2008. *Time:* 8 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting). *Contact Person:* Hilary D. Sigmon, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892,
(301)594-6377, *sigmonh@csr.nih.gov* . *Name of Committee:* Center for Scientific Review Special Emphasis Panel; Member Conflicts in Developmental Disabilities and Childhood-Origin Psychopathology. *Date:* August 5-6, 2008. *Time:* 9 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). *Contact Person:* Maribeth Champoux, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3146, MSC 7759, Bethesda, MD 20892, 301-594-3163, *champoum@csr.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: June 16, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-14043 Filed 6-23-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute on Aging Special Emphasis Panel; Degenerative and Dementing Disease of Aging. *Date:* July 9, 2008. *Time:* 1 p.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Room 2C212, Bethesda, MD 20814, (Telephone Conference Call). *Contact Person:* Bita Nakhai, PhD, Scientific Review Administrator, Scientific Review Office, National Institute on Aging, Gateway Bldg., 2c212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, *nakhaib@nia.nih.gov* . This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* National Institute on Aging Special Emphasis Panel; Biochemical Risk Markers. *Date:* July 25, 2008. *Time:* 1 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institute on Aging, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* William Cruce, PhD, Health Scientist Administrator, Scientific Review Office, National Institute on Aging, National Institutes of Health, Room 2c212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7704, *crucew@nia.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: June 16, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-14044 Filed 6-23-08; 8:45 am] BILLING CODE 4140-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Interagency Autism Coordinating Committee. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting. *Name of Committee:* Interagency Autism Coordinating Committee (IACC). *Date:* July 15, 2008. *Time:* 9 a.m. to 4 p.m. *Agenda:* Review strategic planning workgroup comments on draft plan; discuss and approve draft strategic plan for autism spectrum disorder
(ASD)research, summary of advances in ASD research, and process for implementation of strategic plan, report from Services Subcommittee; scientific presentation. *Place:* Natcher Conference Center, National Institutes of Health, Rooms E1 and E2, 45 Center Drive, Bethesda, MD. *Contact Person:* Tanya Pryor, Interagency Autism Coordinating Committee, National Institute of Mental Health, NIH, 6001 Executive Boulevard, Room 6187, MSC 9669, Bethesda, MD 20892-9669,
(301)443-7153, *pryort@mail.nih.gov.* Any member of the public interested in presenting oral comments to the Committee should notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations should submit a letter of intent, a brief description of the organization represented, and a written copy of their oral presentation in advance of the meeting. Only one representative of an organization will be allowed to present oral comments and presentations will be limited to a maximum of five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the Committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. All visitors should be prepared to have their personal belongings inspected and to go through metal detection inspection. You are strongly encouraged to take public transportation to the NIH campus as there are very few visitor parking spaces available. If you must drive, short-term metered parking may be available near the Natcher Conference Center in Lot B. Natcher is a 5-minute walk from the Medical Center Station on the Red Line of the Metro. A registration link and information about the about the IACC meeting will be available on the IACC Web site: *http://www.nimh.nih.gov/research-funding/scientific-meetings/recurring-meetings/iacc/events/index.shtml.* (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: June 18, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8-14265 Filed 6-23-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-MB-2008-N00164] [91100-3740-GRNT 7C] Proposed Information Collection; OMB Control Number 1018-0100; North American Wetlands Conservation Act (NAWCA) Grant Programs AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) will ask the Office of Management and Budget
(OMB)to approve the information collection
(IC)described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on September 30, 2008. We 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. DATES: You must submit comments on or before August 25, 2008. ADDRESSES: Send your comments on the IC to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail); *hope_grey@fws.gov* (e-mail); or
(703)358-2269 (fax). FOR FURTHER INFORMATION CONTACT: To request additional information about this ICR, contact Hope Grey by mail, fax, or e-mail (see ADDRESSES) or by telephone at
(703)358-2482. SUPPLEMENTARY INFORMATION: **I. Abstract** The North American Waterfowl Management Plan (NAWMP) is a tripartite agreement among Canada, Mexico, and the United States to enhance, restore, and protect habitat to benefit waterfowl and other wetlands-associated wildlife. Because the NAWMP did not include a mechanism to provide for broadly based and sustained financial support for wetland conservation activities, Congress passed the North American Wetlands Conservation Act in 1989. The NAWCA promotes, through partnerships between the private and public sectors, long-term conservation of North American wetland ecosystems and the waterfowl and other migratory birds, fish, and wildlife that depend upon such habitat. In addition to providing for a continuing and stable funding base, NAWCA establishes an administrative body, the North American Wetlands Conservation Council. It is made up of a State representative from each of the four flyways, three representatives from nonprofit wetlands conservation organizations, the Secretary of the Board of the National Fish and Wildlife Foundation, and the Director of the Fish and Wildlife Service. The Council recommends funding of select wetlands conservation project proposals to the Migratory Bird Conservation Commission. There is a Standard and a Small Grants Program. Both are competitive grants programs and require that grant requests be matched by partner contributions at no less than a 1-to-1 ratio. Funds from U.S. Federal sources may contribute to a project, but are not eligible as match. The Standard Grants Program supports projects in Canada, the United States, and Mexico that involve long-term protection, restoration, and/or enhancement of wetlands and associated uplands habitats. In Mexico, partners may also conduct projects involving technical training, environmental education and outreach, organizational infrastructure development, and sustainable-use studies. The Small Grants Program operates only in the United States. It supports the same type of projects and adheres to the same selection criteria and administrative guidelines as the U.S. Standard Grants Program. However, project activities are usually smaller in scope and involve fewer project dollars. Grant requests may not exceed $75,000, and funding priority is given to grantees or partners new to the NAWCA Grants Program. We publish notices of funding availability on the Grants.gov website (http://www.grants.gov) as well as in the Catalog of Federal Domestic Assistance. To compete for grant funds, partnerships submit applications that describe in substantial detail project locations, project resources, future benefits, and other characteristics that meet the standards established by the Council and the requirements of NAWCA. Materials that describe the program and assist applicants in formulating project proposals for Council consideration are available on our website at http://www.fws.gov/birdhabitat/Grants/NAWCA. Persons who do not have access to the Internet may obtain instructional materials by mail. We have not made any major changes in the scope and general nature of the instructions since the OMB first approved the information collection in 1999. **II. Data** *OMB Control Number:* 1018-0100. *Title:* North American Wetlands Conservation Act (NAWCA) Grant Programs. *Service Form Number(s):* None. *Type of Request:* Extension of currently approved collection. *Affected Public:* Households and individuals; businesses and other for-profit organizations; educational organizations; not-for-profit institutions; and Federal, State, local and/or tribal governments. *Respondent's Obligation:* Required to obtain or retain a benefit. *Frequency of Collection:* On occasion. The Small Grants Program has one project proposal period per year and the Standard Grants Program has two per year. Annual reports are due 90 days after the anniversary date of the grant agreement. Final reports are due 90 days after the end of the project period. The project period is 2 years. Activity Number of annual respondents Number of annual responses Completion time per response Annual burden hours Small Grants - Application 70 70 60 hours 4,200 Small Grants - Reports 150 150 30 hours 4,500 Standard Grants - Application 85 85 325 hours 27,625 Standard Grants - Reports 200 200 40 hours 8,000 Totals 505 505 44,325 **III. Request for Comments** We invite comments concerning this IC on:
(1)whether or not the collection of information is necessary, including whether or not the information will have practical utility;
(2)the accuracy of our estimate of the burden for this collection of information;
(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. Comments that you submit in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: May 29, 2008 Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. [FR Doc. E8-14223 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-MB-2008-N0155] [91100-3740-GRNT-7C] Proposed Information Collection; OMB Control Number 1018-0113; Neotropical Migratory Bird Conservation Act (NMBCA) Grant Programs AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) will ask the Office of Management and Budget
(OMB)to approve the information collection
(IC)described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on December 31, 2008. We 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. DATES: You must submit comments on or before August 25, 2008. ADDRESSES: Send your comments on the IC to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail); *hope_grey@fws.gov* (e-mail); or
(703)358-2269 (fax). FOR FURTHER INFORMATION CONTACT: To request additional information about this ICR, contact Hope Grey by mail, fax, or e-mail (see ADDRESSES) or by telephone at
(703)358-2482. SUPPLEMENTARY INFORMATION: **I. Abstract** The NMBCA establishes a matching grants program to fund projects that promote the conservation of neotropical migratory birds in the United States, Canada, Latin America, and the Caribbean. The purposes of NMBCA are to:
(1)Perpetuate healthy populations of neotropical migratory birds;
(2)Assist in the conservation of these birds by supporting conservation initiatives in the United States, Canada, Latin America, and the Caribbean; and
(3)Provide financial resources and foster international cooperation for those initiatives. Principal conservation actions supported by NMBCA are:
(1)Protection and management of neotropical migratory bird populations.
(2)Maintenance, management, protection, and restoration of neotropical migratory bird habitat.
(3)Research and monitoring.
(4)Law enforcement.
(5)Community outreach and education. We publish notices of funding availability on the Grants.gov website (http://www.grants.gov) as well as in the Catalog of Federal Domestic Assistance (http://cfda.gov). To compete for grant funds, partnerships submit applications that describe in substantial detail project locations, project resources, future benefits, and other characteristics that meet the standards established by the Fish and Wildlife Service and the requirements of NMBCA. Materials that describe the program and assist applicants in formulating project proposals for consideration are available on our website at http://www.fws.gov/birdhabitat. Persons who do not have access to the Internet may obtain instructional materials by mail. We have not made any major changes in the scope and general nature of the instructions since the OMB first approved the information collection in 2002. **II. Data** *OMB Control Number:* 1018-0113. *Title:* Neotropical Migratory Bird Conservation Act (NMBCA) Grant Programs. *Service Form Number(s):* None. *Type of Request:* Extension of currently approved collection. *Affected Public:*
(1)an individual, corporation, partnership, trust, association, or other private entity;
(2)an officer, employee, agent, department, or instrumentality of any State, municipality, or political subdivision of a State, or of any foreign government:
(3)a State, municipality, or political subdivision of a State;
(4)any other entity subject to the jurisdiction of the United States or of any foreign country; and
(5)an international organization. *Respondent's Obligation:* Required to obtain or retain a benefit. *Frequency of Collection:* On occasion. This grants program has one project proposal submission per year. Annual reports are due 90 days after the anniversary date of the grant agreement. Final reports are due 90 days after the end of the project period. The project period is up to 2 years. Activity Number of annual respondents Number of annual responses Completion time per response Annual burden hours Grant Applications 160 160 70 hours 11,200 Reports 60 60 30 hours 1,800 Totals 220 220 13,000 **III. Request for Comments** We invite comments concerning this IC on:
(1)whether or not the collection of information is necessary, including whether or not the information will have practical utility;
(2)the accuracy of our estimate of the burden for this collection of information;
(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. Comments that you submit in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: June 11, 2008 Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. [FR Doc. E8-14225 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R5-FHC-2008-N00165] [51320-1334-0000 L4] Proposed Information Collection; OMB Control Number 1018-0127; Horseshoe Crab Tagging Program AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. SUMMARY: We (Fish and Wildlife Service) will ask the Office of Management and Budget
(OMB)to approve the information collection
(IC)described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on December 31, 2008. We 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. DATES: You must submit comments on or before August 25, 2008. ADDRESSES: Send your comments on the IC to Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service, MS 222-ARLSQ, 4401 North Fairfax Drive, Arlington, VA 22203 (mail); *hope_grey@fws.gov* (e-mail); or
(703)358-2269 (fax). FOR FURTHER INFORMATION CONTACT: To request additional information about this ICR, contact Hope Grey by mail, fax, or e-mail (see ADDRESSES) or by telephone at
(703)358-2482. SUPPLEMENTARY INFORMATION: **I. Abstract** Horseshoe crabs are among the world's oldest creatures. People have used this evolutionary survivor for centuries. Horseshoe crabs play an important role in the ecology of the coastal ecosystem, and, over time, have provided opportunities for commercial, recreational, medical, scientific, and educational uses. In 1998, the Atlantic States Marine Fisheries Commission (ASMFC), a management organization with representatives from each State on the Atlantic Coast, developed a horseshoe crab management plan. The ASMFC plan and its subsequent addenda established mandatory State-by-State harvest quotas, and created the 1,500 square mile Carl N. Shuster, Jr. Horseshoe Crab Sanctuary off the mouth of Delaware Bay. Fishermen use active management and innovative techniques to conserve bait that have successfully reduced commercial horseshoe crab landings in recent years. Conch and eel fishermen have been using bait bags in their traps so they can use a portion of one crab per trap, compared to using a whole crab in each trap. The bait bags have reduced the demand for bait by 50 to 75 percent. Although restrictive measures have been taken in recent years, populations are not showing immediate increases. Because horseshoe crabs do not breed until they reach 9 years or older, it may take some time before the population measurably increases. A Horseshoe Crab Cooperative Tagging Program was established to monitor this species. Cooperating Federal and State agencies, universities, and biomedical companies tag and release horseshoe crabs. Agencies that tag and release the crabs complete the Horseshoe Crab Tagging Release Form (FWS Form 3-2311) and provide the Service with:
(1)Organization name.
(2)Contact person name.
(3)Tag number.
(4)Sex of crab.
(5)Prosomal width.
(6)Capture site, latitude, longitude, waterbody, State, and date. Through public participants who recover tagged crabs, we collect the following information using FWS Form 3-2310 (Horseshoe Crab Recapture Report):
(1)Tag number.
(2)Whether or not tag was removed.
(3)Whether or not the tag was circular or square.
(4)Condition of crab.
(5)Date captured/found.
(6)Crab fate.
(7)Finder type.
(8)Capture method.
(9)Capture location.
(10)Reporter information.
(11)Comments. If the public participant who reports the tagged crab requests information, we send data pertaining to the tagging program, and tag and release information on the horseshoe crab he/she found or captured. The information that we collect is stored at the Maryland Fishery Resources Office, Fish and Wildlife Service, and used to evaluate migratory patterns, survival, and abundance of horseshoe crabs. **II. Data** *OMB Control Number:* 1018-0127. *Title:* Horseshoe Crab Tagging Program. *Service Form Number(s):* FWS Forms 3-2310 and 3-2311. *Type of Request:* Extension of currently approved collection. *Affected Public:* Tagging agencies include Federal and State agencies, universities, and biomedical companies. Members of the general public provide recapture information. *Respondent's Obligation:* Voluntary. *Frequency of Collection:* On occasion. When horseshoe crabs are tagged and when horseshoe crabs are found or captured. Activity Number of annual respondents Number of annual responses Completion time per response Annual burden hours FWS Form 3-2310 500 1,500 10 minutes 250 FWS Form 3-2311 10 10 73 hours* 730 Totals 510 1,510 980 *Average time required per response is dependent on the number of tags applied by an agency in 1 year. Agencies tag between 25 and 9,000 horseshoe crabs annually, taking between 2 to 5 minutes per crab to tag. Each agency determines the number of tags it will apply. **III. Request for Comments** We invite comments concerning this IC on:
(1)whether or not the collection of information is necessary, including whether or not the information will have practical utility;
(2)the accuracy of our estimate of the burden for this collection of information;
(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. Comments that you submit in response to this notice are a matter of public record. We will include and/or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Dated: May 29, 2008 Hope Grey, Information Collection Clearance Officer, Fish and Wildlife Service. [FR Doc. E8-14228 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-S DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R6-R-2008-N0143; 60138-1265-6CCP-S3] Pathfinder National Wildlife Refuge, Alcova, WY; Correction AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability: Draft comprehensive conservation plan and environmental assessment; request for comment; correction. SUMMARY: We, the U.S. Fish and Wildlife Service, recently published a notice in error requesting comments on a draft Comprehensive Conservation Plan
(CCP)and associated Environmental Assessment
(EA)that are not yet available for comment. We will republish a notice and request for comment when these documents become available. FOR FURTHER INFORMATION CONTACT: Toni Griffin, *Toni_Griffin@fws.gov* or
(303)236-4378, or John Esperance, *John_Esperance@fws.gov* or
(303)236-4369. SUPPLEMENTARY INFORMATION: On June 16, 2008, we published a **Federal Register** notice (73 FR 34034) in error. The notice announced the availability for public review and comment of a draft CCP and EA, which would describe how we intend to manage Pathfinder National Wildlife Refuge for the next 15 years. Because the draft CCP and EA are not yet available for comment, we announce now that we will republish a notice and request for comment when the draft CCP and EA become available. We will accept comments at that time. Dated: June 17, 2008. Sara Prigan, Federal Register Liaison. [FR Doc. E8-14270 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-IA-2008-N0146; 96300-1671-0000-P5] 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 and marine mammals. DATES: Written data, comments or requests must be received by July 24, 2008. 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 212, 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:* National Institute of Allergy and Infectious Diseases, Laboratory of Molecular Microbiology, Bethesda, MD, PRT-182606. The applicant requests a permit to acquire from Coriell Institute, Camden, NJ, in interstate commerce skin fibroblast cell cultures from a male Bornean orangutan ( *Pongo pygmaeus* ) and a male Sumatran orangutan ( *Pongo abelii* ) for the purpose of scientific research. This notification covers the one-time acquisition only. *Applicant:* Duke Lemur Center, Duke University, Durham, NC, PRT-182626. The applicant requests a permit to import biological samples from the following species: Mouse lemur ( *Microcebus rufus* ), Gray mouse lemur ( *Microcebus murinus* ), Berthe's mouse lemur ( *Microcebus berthae* ), Verreaux's sifaka ( *Prophitecus verreauxi* ), Diademed sifaka ( *Propithecus diadema* ), Red-fronted brown lemur ( *Eulemur rufus* ), White-fronted brown lemur ( *Eulemur albifrons* ), and Indri ( *Indri indri* ) for the purpose of enhancement of the species through scientific research. This notification covers activities conducted by the applicant for a five-year period. Endangered Marine Mammals The public is invited to comment on the following application for a permit to conduct certain activities with endangered marine mammals. The application was submitted to satisfy requirements 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.* ), and the regulations governing endangered species (50 CFR Part 17) and marine mammals (50 CFR Part 18). Written data, comments, or requests for copies of the complete applications or requests for a public hearing on these applications should be submitted to the Director (address above). Anyone requesting a hearing should give specific reasons why a hearing would be appropriate. The holding of such a hearing is at the discretion of the Director. *Applicant:* Michael A.Wharton, Wharton Media, Aptos, CA, PRT-183345. The applicant requests a permit to photograph Southern sea otters ( *Enhydra lutris nereis* ), both under and above water, for commercial and educational purposes. This notification covers activities to be conducted by the applicant over a one-year period. Concurrent with the publication of this notice in the **Federal Register** , the Division of Management Authority is forwarding copies of the above applications to the Marine Mammal Commission and the Committee of Scientific Advisors for their review. Dated: May 30, 2008. Lisa J. Lierheimer, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E8-14200 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R9-IA-2008-N0151; 96300-1671-0000-P5] 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 and/or marine mammals. DATES: Written data, comments or requests must be received by July 24, 2008. 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 212, 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:* Wildlife Conservation Society, Bronx, NY, PRT-184427. The applicant requests a permit to export one male and one female captive-born Snow leopard ( *Uncia uncia* ) to the ZooParc Beauval, France for the purpose of enhancement of the species through captive breeding and conservation education. *Applicant:* Gerald R. Bloom, Richland, WA, PRT-184076. 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. *Applicant:* John K. Miller, Boerne TX, PRT-180827. 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. Marine Mammals The public is invited to comment on the following application for a permit to conduct certain activities with marine mammals. The application was submitted to satisfy requirements of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 *et seq.* ), and the regulations governing marine mammals (50 CFR part 18). Written data, comments, or requests for copies of the complete applications or requests for a public hearing on these applications should be submitted to the Director (address above). Anyone requesting a hearing should give specific reasons why a hearing would be appropriate. The holding of such a hearing is at the discretion of the Director. *Applicant:* Bruce R. Schoeneweis, Alton, IL, PRT-182542. The applicant requests a permit to import a polar bear ( *Ursus maritimus* ) sport hunted from the Gulf of Boothia polar bear population in Canada prior to February 18, 1997, for personal, noncommercial use. Dated: June 6, 2008. Lisa J. Lierheimer, Senior Permit Biologist, Branch of Permits, Division of Management Authority. [FR Doc. E8-14201 Filed 6-23-08; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [CA-110] Meeting of the Central California Resource Advisory Council Off-Highway Vehicle Subcommittee ACTION: Notice of Public Meeting. SUMMARY: In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management
(BLM)Central California Resource Advisory Council Off-Highway Vehicle
(OHV)Subcommittee will meet as indicated below. DATES: The meeting will be held Saturday, July 12, 2008, at Pea Soup Andersen's Restaurant, Santa Nella, California, from 10 a.m. to noon. Members of the public are welcome to attend the meeting. The subcommittee will conduct organizational business and discuss OHV issues for the subcommittee to address. FOR FURTHER INFORMATION CONTACT: BLM Folsom Field Office Manager Bill Haigh or BLM Central California Public Affairs Officer David Christy, both at
(916)985-4474. SUPPLEMENTARY INFORMATION: The twelve-member Central California RAC advises the Secretary of the Interior, through the BLM, on a variety of public land issues associated with public land management in the Central California. The RAC approved formation of an OHV Subcommittee in April 2007. The meeting is open to the public. Individuals who plan to attend and need special assistance such as sign language interpretation or other reasonable accommodations should contact the BLM as indicated above. Dated: June 17, 2008. David Christy, Public Affairs Officer. [FR Doc. E8-14235 Filed 6-23-08; 8:45 am] BILLING CODE 4310-HC-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-963-1430-ET; F-025943] Public Land Order No. 7710; Extension of Public Land Order No. 3708, as Modified by Public Land Order No. 6709; Alaska AGENCY: Bureau of Land Management, Interior. ACTION: Public Land Order. SUMMARY: This order extends the withdrawal created by Public Land Order No. 3708, as modified by Public Land Order No. 6709, and partially revoked by Public Land Order No. 7682, for an additional 20-year period. The extension is necessary to continue protection of the National Oceanic and Atmospheric Administration's Gilmore Satellite Tracking Station, also known as the Fairbanks Command and Data Acquisition Station, located near Fairbanks, Alaska. DATES: *Effective Date:* February 15, 2009. FOR FURTHER INFORMATION CONTACT: Terrie D. Evarts, Bureau of Land Management, Alaska State Office, 222 W. 7th Avenue, No. 13, Anchorage, Alaska 99513-7504, 907-271-5630. SUPPLEMENTARY INFORMATION: Public Land Order No. 7682 partially revoked 63 acres and the acreage in this extension order reflects that revocation. The withdrawal extended by this order will expire on February 14, 2029, unless, as a result of a review conducted prior to the expiration date pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f) (2000), the Secretary determines that the withdrawal shall be further extended. Order By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 (2000), it is ordered as follows: Public Land Order No. 3708 (30 FR 8753 (1965)), as modified by Public Land Order No. 6709 (54 FR 6919 (1989)), and partially revoked by Public Land Order No. 7682 (72 FR 71940 (2007)), which withdrew approximately 8,437 acres of public lands from all forms of appropriation under the public land laws, including the mining laws, but not from leasing under the mineral leasing laws, is hereby extended for an additional 20-year period until February 14, 2029. Dated: June 4, 2008. C. Stephen Allred, Assistant Secretary—Land and Minerals Management. [FR Doc. E8-14216 Filed 6-23-08; 8:45 am] BILLING CODE 4310-JA-P DEPARTMENT OF THE INTERIOR National Park Service Notice of Intent To Prepare an Environmental Assessment and Scoping AGENCY: National Park Service, Department of the Interior. ACTION: Notice of Intent to Prepare an Environmental Assessment and scoping for transferring jurisdiction of a portion of Fort Dupont Park to the District of Columbia for recreational development and uses and possible amendment of the 2004 Final Management Plan for Fort Circle Parks. SUMMARY: In accordance with § 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4321 *et. seq.* ), the National Park Service
(NPS)will prepare an Environmental Assessment
(EA)for transferring jurisdiction of a portion of NPS property within Fort Dupont Park, part of the Fort Circle Parks, to the District of Columbia (the District) for development of recreational facilities which may result in amending the NPS' 2004 Final Management Plan for Fort Circle Parks. This also serves as an announcement of a public scoping comment period to run until July 24, 2008. Comments submitted to the Park or through Planning, Environment and Public Comment
(PEPC)during the public scoping period and at public meetings for this EA will be considered as part of the planning process for the current proposed action. Comments submitted at the public meeting held May 12, 2008, will be considered as part of the planning process for the current proposed action and do not need to be resubmitted. There is the possibility that the NPS might proceed to prepare an Environmental Impact Statement
(EIS)in which case written comments submitted now on the scope of the alternatives and impacts will continue to be considered. DATES: NPS is soliciting public input for the subject Proposed Action until July 24, 2008. ADDRESSES: Comments may be submitted through the Planning, Environment and Public Comment
(PEPC)Web site at * http:// parkplanning.nps.gov/NACE * or by mail to: Superintendent, National Capital Parks-East, RE: Fort Dupont Park Land Transfer Proposal, 1900 Anacostia Drive, SE., Washington, DC 20020. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. FOR FURTHER INFORMATION CONTACT: Gayle Hazelwood, Superintendent, National Capital Parks-East, RE: Fort Dupont Park Land Transfer Proposal, at 1900 Anacostia Drive, SE., Washington, DC 20020, by telephone at
(202)690-5127, or by e-mail at *gayle_hazelwood@nps.gov* . SUPPLEMENTARY INFORMATION: The 376-acre Fort Dupont Park is one of the Civil War Defenses of Washington and is one of the Fort Circle Parks managed by the NPS. In 2004, the NPS completed the Final Management Plan for Fort Circle Parks and an action to transfer these lands to the District will likely result in amendment of that plan. The transfer is to facilitate the development of new recreational facilities and programs on the subject property by the District, including a proposal to create a baseball academy and another to expand an existing indoor ice skating arena. The District's proposal would involve the help of private-sector partners. The current Proposed Action is to transfer approximately 14 acres of NPS property situated on the north side of Fort Dupont Park along Ely Place in Southeast Washington, DC, to the District. This land is not in an area associated with the Civil War Defense of Washington, and does not contain earthworks or other historic or archeological resources. Once transferred, this property will no longer be part of the Park and no longer be managed or administered by the NPS. This transfer is part of an effort by the District to expand public facilities and recreational opportunities for area youth the NPS supports. The new recreational facilities and programs would be developed and operated by the District and its partners. Information and comments gathered during scoping and public meetings will be used to identify the range of issues and potential impacts of this proposed action. It may also be used for other planning and decision-making. Dated: April 23, 2008. Joseph M. Lawler, Regional Director, National Capital Region. [FR Doc. E8-14213 Filed 6-23-08; 8:45 am] BILLING CODE 4312-JK-P DEPARTMENT OF THE INTERIOR National Park Service Notice of Inventory Completion: Slater Museum of Natural History, University of Puget Sound, Tacoma, WA AGENCY: National Park Service, Interior. ACTION: Notice. Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains in the possession of the Slater Museum of Natural History, University of Puget Sound, Tacoma, WA. The human remains were removed from Yachats, Lincoln County, OR. This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice. A detailed assessment of the human remains was made by Slater Museum of Natural History, University of Puget Sound professional staff and a consultant in consultation with representatives of the Confederated Tribes of Coos, Lower Umpqua and Siuslaw Indians of Oregon; Confederated Tribes of the Siletz Reservation, Oregon; and Coquille Tribe of Oregon. At an unknown date, human remains representing a minimum of one individual were removed from the vicinity of Yachats, Lincoln County, OR, by Dr. L. E. Hibbard. Dr. Hibbard gave the human remains to Stanley G. Jewett. Mr. Jewett donated the human remains to the Slater Museum in 1955. No known individual was identified. No associated funerary objects are present. The individual is most likely of Native American ancestry as indicated by morphological features. Writing on the skull indicates that the human remains were removed from the vicinity of “Yahats,” which is reasonably believed to be a misspelling of Yachats. The geographical location where the human remains were recovered is consistent with the historically documented territory of the tribes now represented by the Confederated Tribes of the Siletz Reservation, Oregon. Members of the Confederated Tribes of Coos, Lower Umpqua and Siuslaw Indians of Oregon and Coquille Tribe of Oregon were moved to the Yachats area where they lived from 1859-1875. Absent additional information about the burial period, officials of the Slater Museum of Natural History reasonably believe that the human remains are most likely affiliated with the Alsea Tribe who had villages in the vicinity of Yachats, which had inhabited the area prior to the arrival of the Confederated Tribes of Coos, Lower Umpqua and Siuslaw Indians of Oregon and Coquille Tribe of Oregon, and continued to inhabit the area afterwards. The Alsea Tribe from the Yachats area are now members of the Confederated Tribes of the Siletz Reservation, Oregon. Furthermore, based on information provided during consultation with tribal representatives, there is a reasonable belief that the human remains share a common ancestry with members of tribes now represented by the Confederated Tribes of the Siletz Reservation, Oregon. Officials of the Slater Museum of Natural History have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of one individual of Native American ancestry. Officials of the Slater Museum of Natural History also have determined that, pursuant to 25 U.S.C. 3001 (2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Confederated Tribes of the Siletz Reservation, Oregon. Representatives of any other Indian tribe that believes itself to be culturally affiliated with the human remains should contact Peter Wimberger, Slater Museum of Natural History, University of Puget Sound, 1500 N. Warner, Tacoma, WA 98416, telephone
(253)879-2784, before July 24, 2008. Repatriation of the human remains to the Confederated Tribes of the Siletz Reservation, Oregon may proceed after that date if no additional claimants come forward. The Slater Museum of Natural History is responsible for notifying the Confederated Tribes of Coos, Lower Umpqua and Siuslaw Indians of Oregon; Confederated Tribes of the Siletz Reservation, Oregon; and Coquille Tribe of Oregon that this notice has been published. Dated: May 30, 2008. Sherry Hutt, Manager, National NAGPRA Program. [FR Doc. E8-14230 Filed 6-23-08; 8:45 am] BILLING CODE 4312-50-S DEPARTMENT OF THE INTERIOR National Park Service Notice of Inventory Completion: University of Hawai`i at Hilo, Department of Anthropology, Hilo, HI AGENCY: National Park Service, Interior. ACTION: Notice. Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains in the possession and control of the University of Hawai`i at Hilo, Department of Anthropology, Hilo, HI. The human remains were removed from Hawai`i Island, HI. This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice. A detailed assessment of the human remains was made by University of Hawai`i at Hilo professional staff in consultation with representatives of the Hawai`i Island Burial council, Hui Malama I Na Kupuna O Hawai`i Nei, and Office of Hawaiian Affairs. In the late 1970s or early 1980s, human remains representing a minimum of one individual were removed from an unknown shoreline location near the old Kona Airport in the North Kona District, Hawai`i Island, HI. An unknown student delivered the human remains to faculty in the anthropology department at that time. No known individual was identified. No associated funerary objects are present. The human remains are heavily weathered and come from an area where shoreline erosion of Native Hawaiian human remains is well documented. Property ownership in the area includes both State land and private land and it is unclear where the human remains originated. Based on the lack of definitive information of removal and location, the University of Hawai`i at Hilo has proceeded as the responsible entity. Officials of the University of Hawai`i at Hilo have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of one individual of Native Hawaiian ancestry. Officials of the University of Hawai`i at Hilo also have determined that, pursuant to 25 U.S.C. 3001 (2), there is a relationship of shared group identity that can be reasonably traced between the Native Hawaiian human remains and Hui Malama I Na Kupuna O Hawai`i Nei and Office of Hawaiian Affairs. Representatives of any other Native Hawaiian Organization or Indian tribe that believes itself to be culturally affiliated with the human remains should contact Peter R. Mills, Department of Anthropology, Social Sciences Division, University of Hawai`i at Hilo, 200 West Kawili Street, Hilo, HI 96720-4091, telephone
(808)974-7465, before July 24, 2008. Repatriation of the human remains jointly to the Hui Malama I Na Kupuna O Hawai`i Nei and Office of Hawaiian Affairs may proceed after that date if no additional claimants come forward. The University of Hawai`i at Hilo is responsible for notifying the Hawai`i Island Burial council, Hui Malama I Na Kupuna O Hawai`i Nei, and Office of Hawaiian Affairs that this notice has been published. Dated: May 30, 2008 Sherry Hutt, Manager, National NAGPRA Program. [FR Doc. E8-14227 Filed 6-23-08; 8:45 am] BILLING CODE 4312-50-S INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-567] In the Matter of Certain Foam Footwear; Notice of Commission Determination to Review-In-Part a Final Initial Determination Finding No Violation of Section 337 AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has determined to review-in-part the presiding administrative law judge's (“ALJ”) final determination
(ID)finding no violation of section 337 in the above-captioned investigation with respect to U.S. Patent No. 6,993,858 (“the `858 patent) and U.S. Patent No. D517,789 (“the `789 patent”). FOR FURTHER INFORMATION CONTACT: Clint Gerdine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone
(202)708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be 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., Washington, DC 20436, telephone
(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* . Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on
(202)205-1810. SUPPLEMENTARY INFORMATION: The Commission instituted this investigation on May 11, 2006, based on a complaint, as amended, filed by Crocs, Inc. (“Crocs”) of Niwot, Colorado. 71 FR 27514 (2006). The amended complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain foam footwear, by reason of infringement of claims 1-2 of U.S. Patent No. 6,993,858; U.S. Patent No. D517,789; and the Crocs trade dress (the image and overall appearance of Crocs-brand footwear). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complaint requests that the Commission issue a permanent general exclusion order and permanent cease and desist orders. The complaint identifies 11 respondents that include:
(1)Collective Licensing International, LLC (“Collective”) of Englewood, Colorado;
(2)Double Diamond Distribution Ltd. (“Double Diamond”) of Saskatoon, Saskatchewan;
(3)Effervescent Inc. (“Effervescent”) of Fitchburg, Massachusetts;
(4)Gen-X Sports, Inc. (“Gen-X Sports”) of Toronto, Ontario;
(5)Holey Shoes Holding Ltd. (“Holey Shoes”) of Vancouver, British Columbia;
(6)Australia Unlimited, Inc. of Seattle, Washington;
(7)Cheng's Enterprises Inc. of Carlstadt, New Jersey;
(8)D. Myers & Sons, Inc. of Baltimore, Maryland;
(9)Inter-Pacific Trading Corp. of Los Angeles, California;
(10)Pali Hawaii of Honolulu, Hawaii; and
(11)Shaka Shoes of Kaliua-Kona, Hawaii. The Commission terminated the investigation as to the trade dress allegation on September 11, 2006. A twelfth respondent, Old Dominion Footwear, Inc. of Madison Heights, Virginia, was added to the investigation on October 10, 2006. All but five respondents have been terminated from the investigation on the basis of a consent order, settlement agreement, or undisputed Commission determination of non-infringement. The five remaining respondents are:
(1)Collective;
(2)Double Diamond;
(3)Effervescent;
(4)Gen-X Sports; and
(5)Holey Shoes. On April 11, 2008, the ALJ issued his final ID finding no violation of section 337 by the remaining respondents. On April 24, 2008, the Commission issued a notice extending the deadline for determining whether to review the final ID by 15 days to June 11, 2008. On June 11, 2008, the Commission issued a notice extending the deadline for determining whether to review the final ID by 7 days to June 18, 2008. Upon considering the parties' filings, the Commission has determined to review-in-part the final ID. Specifically, with respect to the `789 patent, the Commission has determined to review the ALJ's findings concerning non-infringement by the respondents' products and lack of satisfaction of the technical prong of the domestic industry requirement by Crocs' footwear. The Commission has also determined to review the ALJ's finding of invalidity with respect to the `858 patent. The Commission does not request any further written submissions at this time. The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in sections 210.42-45 of the Commission's Rules of Practice and Procedure, 19 CFR 210.42-45. By order of the Commission. Issued: June 18, 2008. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E8-14179 Filed 6-23-08; 8:45 am] BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on June 11, 2008, a proposed Consent Decree in *United States et al.* v. *Centex Homes, a Nevada General Partnership,* Civil Action No. 1:08CV605 was lodged with the United States District Court for the Eastern District of Virginia. In this action the United States sought civil penalties and injunctive relief for alleged violations of the Clean Water Act (“CWA”), 33 U.S.C. 1311 *et seq.* , as well as violations of state and federal National Pollutant Discharge Elimination System (“NPDES”) permits governing the discharge of storm water from Centex's construction sites. The proposed consent decree would require Centex to pay a civil penalty of $1,485,000 and implement a company-wide compliance program that goes beyond current regulatory requirements. The Department of Justice will receive for a period of thirty
(30)days from the date of this publication comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to *pubcomment-ees.enrd@usdoj.gov* or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to *United States* v. *Centex Homes,* D.J. Ref. No. 90-5-1-1-08059. The consent decree and associated appendices may be examined at the Office of the United States Attorney, Eastern District of Virginia, 2100 Jamieson Avenue, Alexandria, Virginia 22314. During the public comment period, the consent decree also may be examined on the following Department of Justice Web site: *http://www.usdoj.gov/enrd/Consent_Decrees.html* . A copy of the consent decree and the associated appendices may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing or e-mailing a request to Tonia Fleetwood ( *tonia.fleetwood@usdoj.gov* ), fax no.
(202)514-0097, phone confirmation number
(202)514-1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $ 39.25 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. To obtain a copy of the proposed consent decree exclusive of exhibits, please enclose a check in the amount of $19.50 (25 cents per page reproduction cost) payable to the U.S. Treasury. All requests for documents should refer to *United States* v. *Centex Homes,* Civil Action Number 1:08CV605, and D.J. Ref. No. 90-5-1-1-08059. Karen Dworkin, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8-14095 Filed 6-23-08; 8:45 am] BILLING CODE 4410-15-P DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on June 11, 2008, a proposed Consent Decree in *United States* *et al.* v. *KB Home* , Civil Action No. 1:08CV603 was lodged with the United States District Court for the Eastern District of Virginia. In this action the United States sought civil penalties and injunctive relief for alleged violations of the Clean Water Act (“CWA”), 33 U.S.C. 1311 *et seq.* , as well as violations of state and federal National Pollutant Discharge Elimination System (“NPDES”) permits governing the discharge of storm water from KB Home's construction sites. The proposed consent decree would require KB Home to pay a civil penalty of $1,185,000 and implement a company-wide compliance program that goes beyond current regulatory requirements. The Department of Justice will receive for a period of thirty
(30)days from the date of this publication comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to *pubcomment-ees.enrd@usdoj.gov* or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to *United States* v. *KB Home* , D.J. Ref. No. 90-5-1-1-08057. The consent decree and associated appendices may be examined at the Office of the United States Attorney, Eastern District of Virginia, 2100 Jamieson Avenue, Alexandria, Virginia 22314. During the public comment period, the consent decree also may be examined on the following Department of Justice Web site: * http://www.usdoj.gov/enrd/Consent_Decrees.html* . A copy of the consent decree and the associated appendices may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing or e-mailing a request to Tonia Fleetwood ( *tonia.fleetwood@usdoj.gov* ), fax no.
(202)514-0097, phone confirmation number
(202)514-1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $34.75 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. To obtain a copy of the proposed consent decree exclusive of exhibits, please enclose a check in the amount of $17.75 (25 cents per page reproduction cost) payable to the U.S. Treasury. All requests for documents should refer to *United States* v. *KB Home* , Civil Action Number 1:08CV603, and D.J. Ref. No. 90-5-1-1-08057. Karen Dworkin, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8-14099 Filed 6-23-08; 8:45 am] BILLING CODE 4410-15-P DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on June 11, 2008, a proposed Consent Decree in *United States* *et al.* v. *M.D.C. Holdings, Inc.,* *et al.* , Civil Action No. 1:08CV604 was lodged with the United States District Court for the Eastern District of Virginia. In this action the United States sought civil penalties and injunctive relief for alleged violations of the Clean Water Act (“CWA”), 33 U.S.C. 1311 *et seq.* , as well as violations of state and federal National Pollutant Discharge Elimination System (“NPDES”) permits governing the discharge of storm water from construction sites owned and operated by M.D.C. Holdings and certain affiliated entities. The proposed consent decree would require M.D.C. Holdings and certain affiliated entities to pay a civil penalty of $795,000 and implement a company-wide compliance program that goes beyond current regulatory requirements. The Department of Justice will receive for a period of thirty
(30)days from the date of this publication comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to *pubcomment-ees.enrd@usdoj.gov* or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to *United States* v. *M.D.C. Holdings, Inc.,* D.J. Ref. No. 90-5-1-1-08285. The consent decree and associated appendices may be examined at the Office of the United States Attorney, Eastern District of Virginia, 2100 Jamieson Avenue, Alexandria, Virginia 22314. During the public comment period, the consent decree also may be examined on the following Department of Justice Web site: *http://www.usdoj.gov/enrd/Consent_Decrees.html* . A copy of the consent decree and the associated appendices may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing or e-mailing a request to Tonia Fleetwood ( *tonia.fleetwood@usdoj.gov* ), fax no.
(202)514-0097, phone confirmation number
(202)514-1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $39.75 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. To obtain a copy of the proposed consent decree exclusive of exhibits, please enclose a check in the amount of $18.75 (25 cents per page reproduction cost) payable to the U.S. Treasury. All requests for documents should refer to *United States* v. *M.D.C. Holdings, Inc.,* Civil Action Number 1:08CV604, and D.J. Ref. No. 90-5-1-1-08285. Karen Dworkin, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8-14098 Filed 6-23-08; 8:45 am] BILLING CODE 4410-15-P DEPARTMENT OF JUSTICE Notice of Lodging of Consent Decree Under the Clean Water Act Notice is hereby given that on June 11, 2008, a proposed Consent Decree in *United States* *et al.* v. *Pulte Homes, Inc.,* Civil Action No. 1:08CV602 was lodged with the United States District Court for the Eastern District of Virginia. In this action the United States sought civil penalties and injunctive relief for alleged violations of the Clean Water Act (“CWA”), 33 U.S.C. 1311 *et seq.* , as well as violations of state and federal National Pollutant Discharge Elimination System (“NPDES”) permits governing the discharge of storm water from Pulte's construction sites. The proposed consent decree would require Pulte Homes to pay a civil penalty of $877,000, perform a supplemental environmental project at a minimum cost of $608,000, and implement a company-wide compliance program that goes beyond current regulatory requirements. The Department of Justice will receive for a period of thirty
(30)days from the date of this publication comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to *pubcomment-ees.enrd@usdoj.gov* or mailed to P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to *United States* v. *Pulte Homes,* D.J. Ref. No. 90-5-1-1-08332. The consent decree and associated appendices may be examined at the Office of the United States Attorney, Eastern District of Virginia, 2100 Jamieson Avenue, Alexandria, Virginia 22314. During the public comment period, the consent decree also may be examined on the following Department of Justice Web site: *http://www.usdoj.gov/enrd/Consent_Decrees.html* . A copy of the consent decree and the associated appendices may also be obtained by mail from the Consent Decree Library, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611 or by faxing or e-mailing a request to Tonia Fleetwood ( *tonia.fleetwood@usdoj.gov* ), fax no.
(202)514-0097, phone confirmation number
(202)514-1547. In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $35.50 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address. To obtain a copy of the proposed consent decree exclusive of exhibits, please enclose a check in the amount of $22.00 (25 cents per page reproduction cost) payable to the U.S. Treasury. All requests for documents should refer to *United States* v. *Pulte Homes* , civil action number 1:08CV602, and D.J. Ref. No. 90-5-1-1-08332. Karen Dworkin, Assistant Chief, Environmental Enforcement Section, Environment and Natural Resources Division. [FR Doc. E8-14097 Filed 6-23-08; 8:45 am] BILLING CODE 4410-15-P DEPARTMENT OF JUSTICE Office of Justice Programs [OMB Number 1121-0064] Agency Information Collection Activities: Proposed Collection; Comment Request ACTION: 60-day notice of information collection under review: Extension of a currently approved collection: Annual Parole Survey, Annual Probation Survey, and Annual Probation Survey (Short Form). The Department of Justice (DOJ), Office of Justice Programs (OJP), Bureau of Justice Statistics
(BJS)will be submitting the following information collection request to the Office of Management and Budget
(OMB)for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until August 25, 2008. This process is in accordance with 5 CFR 1320.10. If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Lauren E. Glaze, Statistician
(202)305-9628, Bureau of Justice Statistics, 810 Seventh St., NW., Washington, DC 20531. Request written comments and suggestions from the public and affected agencies concerning the proposed collection of information. Your comments should address one or more of the following four points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. permitting electronic submission of responses. Overview of This Information Collection:
(1)*Type of information collection:* Extension of currently approved collection.
(2)*The title of the Form/Collection:* Annual Parole Survey, Annual Probation Survey, and Annual Probation Survey (Short Form).
(3)*The agency form number, if any, and the applicable component of the Department sponsoring the collection: Forms:* CJ-7 Annual Parole Survey; CJ-8 Annual Probation Survey; and CJ-8A Annual Probation Survey (Short Form). Corrections Statistics Program, Bureau of Justice Statistics, Office of Justice Programs, United States Department of Justice. *(4) Affected public who will be asked to respond, as well as a brief abstract:* *Primary:* State Departments of Corrections or State probation and Parole authority. *Others:* The Federal Bureau of Prisons, city and county courts and probation offices for which a central reporting authority does not exist. For the CJ-7 form, 54 central reporters (two State jurisdictions in California and one each from the remaining States, the District of Columbia, the Federal Bureau of Prisons, and one local authority) responsible for keeping records on parolees will be asked to provide information for the following categories:
(a)As of January 1, 2008 and December 31, 2008, the number of adult parolees under their jurisdiction;
(b)The number of adults entering parole during 2008 through discretionary release from prison, mandatory release from prison, a term of supervised release, or reinstatement of parole;
(c)The number of adults released from parole during 2008 through completion, incarceration, treatment, absconder status, transfer to another parole jurisdiction, or death;
(d)Whether the number of adult parolees reported as of December 31, 2008 represents individuals or cases;
(e)Whether adult parolees supervised out of State have been included in the total number of parolees on December 31, 2008, and the number of adult parolees supervised out of State;
(f)As of December 31, 2008, the number of adult parolees under their jurisdiction with a sentence of more than one year, or a year or less;
(g)As of December 31, 2008, the number of male and female adult parolees under their jurisdiction;
(h)As of December 31, 2008, the number of white (not of Hispanic origin), black or African American (not of Hispanic origin), Hispanic or Latino, American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Islander, two or more races, or the number of adult parolees for which no information was available;
(i)As of December 31, 2008, the number of adult parolees who had as their most serious offense a violent, property, drug, public-order, or other offense;
(j)As of December 31, 2008, the number of adult parolees under their jurisdiction who were active, only have financial conditions remaining, inactive, absconders, or supervised out of state;
(k)As of December 31, 2008, the number of adult parolees under their jurisdiction who were supervised following a discretionary release, a mandatory release, a term of supervised release, a special conditional release, or other type of release from prison;
(l)Whether the parole authority supervised any adult parolees who were also on probation supervision, held in local jails, prisons, community-based correctional facilities, or an ICE holding facility, and the number of adult parolees held in each on December 31, 2008;
(m)Whether the parole authority uses GPS monitoring systems to track the location of adult parolees, and the number of adult parolees tracked with GPS on December 31, 2008;
(n)Whether the parole authority collects data on the number of adult paroleess in a treatment program, and the number of adult parolees in treatment programs by type of program;
(o)Whether the parole authority collects data on the number of serious assaults or deaths of parole officers while in the line of duty, and the number of serious assaults or deaths of officers during 2008; For the CJ-8 form, 344 reporters (one from each State, the District of Columbia, and the Federal Bureau of Prisons; and 292 from local authorities) responsible for keeping records on probations will be asked to provide information for the following categories:
(a)As of January 1, 2008 and December 31, 2008, the number of adult probationers under their jurisdiction;
(b)The number of adults entering probation during 2008 with and without a sentence to incarceration;
(c)The number of adults discharged from probation during 2008 through completion, incarceration, treatment, absconder status, a detainer or warrant, transfer to another parole jurisdiction, and death;
(d)Whether the number of adult probationers reported as of December 31, 2008 represents individuals or cases;
(e)As of December 31, 2008, the number of male and female adult probationers under their jurisdiction;
(f)As of December 31, 2008, the number of white (not of Hispanic origin), black or African American (not of Hispanic origin), Hispanic or Latino, American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Islander, two or more races, or the number of adult probationers for which no information was available;
(g)As of December 31, 2008, the number of adult probationers under their jurisdiction who were sentenced for a felony, misdemeanor, or other offense type;
(h)As of December 31, 2008, the number of adult probationers who had as their most serious offense domestic violence, other violent offense, property offense, drug law violation, driving while intoxicated or under the influence of alcohol or drugs, or other traffic offense;
(i)Whether adult probationers supervised out of State have been included in the total number of probationers on December 31, 2008, and the number of adult probationers supervised out of State;
(j)Whether the probation authority collects data on the number of adult probationers who had previously served a sentence to prison for the same offense for which they are on probation;
(k)Whether the probation authority supervised adult probationers who were also on parole supervision, any probationers held in local jails, prisons, community-based correctional facilities, or an ICE holding facility, and the number of adult probationers held in each on December 31, 2005;
(l)As of December 31, 2008, the number of adult probationers under their jurisdiction who had entered probation with a direct sentence to probation, a split sentence to probation, a suspended sentence to incarceration, or a suspended imposition of sentence;
(m)As of December 31, 2008, the number of adult probationers under their jurisdiction who were active, in a residential or other treatment program, only had financial conditions remaining, inactive, absconders, those on warrant status, or supervised out of state;
(n)Whether the probation authority collects data on the number of adult probationers required to pay fines/restitution, and the number of adult probationers required to pay fines/restitution by type;
(o)Whether the probation authority collects data on the number of adult probationers in a treatment program, and the number of adult probationers in treatment programs by type of program;
(p)Whether the probation authority collects data on the number of serious assaults or deaths of probation officers while in the line of duty, and the number of serious assaults or deaths of officers during 2008; For the CJ-8A form, 120 reporters (from local authorities) responsible for keeping records on probationers will be asked to provide information for the following categories:
(a)As of January 1, 2008 and December 31, 2008, the number of adult probationers under their jurisdiction;
(b)The number of adults entering probation and discharged from probation during 2008;
(c)Whether the number of adult probationers reported as of December 31, 2008 represents individuals or cases;
(d)As of December 31, 2008, the number of male and female adult probationers under their jurisdiction;
(e)As of December 31, 2008, the number of adult probationers under their jurisdiction who were sentenced for a felony, misdemeanor, or other offense type. The Bureau of Justice Statistics uses this information in published reports and for the U.S. Congress, Executive Office of the President, practitioners, researchers, students, the media, and others interested in criminal justice statistics.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 518 respondents each taking an average of 1.27 hours to respond.
(6)*An estimate of the total public burden (in hours) associated with the collection:* 657 annual burden hours. If additional information is required, contact: Lynn Bryant, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530. Dated: June 18, 2008. Lynn Bryant, Department Clearance Officer, PRA, United States Department of Justice. [FR Doc. E8-14272 Filed 6-23-08; 8:45 am] BILLING CODE 4410-18-P FEDERAL MINE SAFETY AND HEALTH REVIEW COMMISSION Sunshine Act Meeting June 17, 2008. Time And Date: 10 a.m., Wednesday, July 9, 2008. Place: The Richard V. Backley Hearing Room, 9th Floor, 601 New Jersey Avenue, NW., Washington, DC. Status: Open. Matters to be Considered: The Commission will hear oral argument in the matter Secretary of Labor v. *Spartan Mining Company* , Docket Nos. WEVA 2004-117-RM, *et al.* (Issues include whether the Administrative Law Judge properly found violations and assessed penalties for the following standards: 30 CFR 75.606 (requiring protecting cables); 30 CFR 75.511 (requiring locking and tagging out before electrical work); 30 CFR 75.1725(a) (requiring unsafe equipment to be removed from service); and 30 CFR 75.313(a)(3) (requiring withdrawal from a working section in mine fan outage)). Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d). Contact Person for More Info: Jean Ellen
(202)434-9950/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free. Sandra G. Farrow, Acting Chief Docket Clerk, Federal Mine Safety & Health Review Commission. [FR Doc. E8-14207 Filed 6-23-08; 8:45 am] BILLING CODE 6735-01-P NUCLEAR REGULATORY COMMISSION [Docket Nos. 52-014-COL, 52-015-COL; ASLBP No. 08-864-02-COL-BD01] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the **Federal Register** , 37 FR 28,710 (1972), and the Commission's regulations, *see* 10 CFR 2.104, 2.300, 2.303, 2.309, 2.311, 2.318, and 2.321, notice is hereby given that an Atomic Safety and Licensing Board (Board) is being established to preside over the following proceeding: Tennessee Valley Authority (Bellefonte Nuclear Power Plant Units 3 and 4) This proceeding concerns a Petition to Intervene and Request for Hearing submitted by the Bellefonte Efficiency and Sustainability Team, the Blue Ridge Environmental Defense League, and the Southern Alliance for Clean Energy, which was submitted in response to a February 8, 2008 Notice of Hearing and Opportunity To Petition for Leave To Intervene on a Combined License for Bellefonte Units 3 and 4 (73 FR 7,611), and an April 11, 2008 Notice of Extension of Time for Petition for Leave To Intervene on a Combined License Application for Bellefonte Units 3 and 4 (73 FR 19,904). The Petition to Intervene and Request for Hearing challenges the application filed by Tennessee Valley Authority pursuant to Subpart C of 10 CFR Part 52 for a combined license for Bellefonte Units 3 and 4, which would be located at the Bellefonte Nuclear Power Plant in Jackson County, Alabama. The Board is comprised of the following administrative judges: G. Paul Bollwerk, III, Chair, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; Dr. Anthony J. Baratta, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; Dr. William W. Sager, Atomic Safety and Licensing Board Panel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. All correspondence, documents, and other materials shall be filed in accordance with the NRC E-Filing rule, which the NRC promulgated in August 2007 (72 FR 49,139). Issued at Rockville, Maryland, this 18th day of June 2008. E. Roy Hawkens, Chief Administrative Judge, Atomic Safety and Licensing Board Panel. [FR Doc. E8-14204 Filed 6-23-08; 8:45 am] BILLING CODE 7590-01-P NUCLEAR REGULATORY COMMISSION Sunshine Federal Register Notice Agency Holding the Meetings: Nuclear Regulatory Commission. Date: Weeks of June 23, 30, July 7, 14, 21, 28, 2008. Place: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. Status: Public and Closed. Week of June 23, 2008 Wednesday, June 25, 2008 1 p.m. Periodic Briefing on New Reactor Issues (Public Meeting) (Contact: Donna Williams, 301 415-1322). This meeting will be Webcast live at the Web address * http://www.nrc.gov.* Week of June 30, 2008—Tentative Tuesday, July 1, 2008 9 a.m. Hearing: Diablo Canyon, 10 CFR Part 2, Subpart K Proceeding, Oral Arguments (Public Meeting) (Contact: John Cordes, 301 415-1600). This meeting will be Webcast live at the Web address *http://www.nrc.gov.* Week of July 7, 2008—Tentative There are no meetings scheduled for the week of July 7, 2008. Week of July 14, 2008—Tentative Thursday, July 17, 2008 1 p.m. Briefing on Fire Protection Issues (Public Meeting) (Contact: Alex Klein, 301 415-2822). This meeting will be Webcast live at the Web address *http://www.nrc.gov.* Week of July 21, 2008—Tentative Wednesday, July 23, 2008 1:30 p.m. Discussion of Security Issues (Closed—Ex. 1 & 3). Thursday, July 24, 2008 1:30 p.m. Discussion of Security Issues (Closed—Ex. 1 & 3). Week of July 28, 2008—Tentative There are no meetings scheduled for the week of July 28, 2008. * The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—(301) 415-1292. Contact person for more information: Michelle Schroll,
(301)415-1662. The NRC Commission Meeting Schedule can be found on the Internet at: *http://www.nrc.gov/about-nrc/policy-making/schedule.html.* The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g. braille, large print), please notify the NRC's Disability Program Coordinator, Rohn Brown, at 301-492-2279, TDD: 301-415-2100, or by e-mail at *REB3@nrc.gov.* Determinations on requests for reasonable accommodation will be made on a case-by-case basis. This notice is distributed by mail to several hundred subscribers; if you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301-415-1969). In addition, distribution of this meeting notice over the Internet system is available. If you are interested in receiving this Commission meeting schedule electronically, please send an electronic message to *dkw@nrc.gov.* Dated: June 19, 2008. R. Michelle Schroll, Office of the Secretary. [FR Doc. 08-1384 Filed 6-20-08; 10:30 am]
Connectionstraces to 39
Traces to 39 documents
CFR
- Requirements as to form, and filing of documents other than correspondence.§ 4.2
- The public record.§ 4.9
- Definitions.§ 312.2
- Test requirements.§ 610.40
- Restrictions on use for further manufacture of medical devices.§ 610.42
- Human immunodeficiency virus (HIV) “lookback” requirements.§ 610.46
- Donor deferral.§ 610.41
- Protection of trailing cables.§ 75.606
- Low-, medium-, or high-voltage distribution circuits and equipment; repair.§ 75.511
- Machinery and equipment; operation and maintenance.§ 75.1725
- Main mine fan stoppage with persons underground.§ 75.313
- Program accessibility: Existing facilities.§ 2706.150
- Notice of hearing.§ 2.104
U.S. Code
- Definitions§ 6501
- Departmental regulations§ 301
- Administrative§ 121
- Management of buildings by Administrator of General Services§ 582
- Public buildings under control of Administrator of General Services§ 3101
- Purposes§ 3501
- Federal agency responsibilities§ 3506
- Office of Electronic Government§ 3602
- Mission and duties§ 299
- General authorities§ 299a
- Definitions§ 3502
- Regulation of biological products§ 262
- Regulations to control communicable diseases§ 264
- Definitions; generally§ 321
- Adulterated drugs and devices§ 351
- Public information collection activities; submission to Director; approval and delegation§ 3507
- Infant formulas§ 350a
- Domestic and foreign protection of federally owned inventions§ 207
- Congressional findings and declaration of purposes and policy§ 1531
- Congressional findings and declaration of policy§ 1361
- Withdrawals of lands§ 1714
- Congressional declaration of purpose§ 4321
- Inventory for human remains and associated funerary objects§ 3003
- Definitions§ 3001
- Unfair practices in import trade§ 1337
- Effluent limitations§ 1311
18 references not yet in our index
- 16 CFR 312
- 5 CFR 1320
- 44 USC 3501-3521
- 5 CFR 1320.3(b)(2)
- 41 CFR 105
- Pub. L. 107-2
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- 21 CFR 606
- 21 CFR 630.6(a)
- 21 CFR 640
- 21 CFR 107
- 50 CFR 17
- 50 CFR 18
- 19 CFR 210.42-45
- 5 CFR 1320.10
- 10 CFR 52
- 10 CFR 2
Citation graph
cites case law
Notices
Notice
Cite16 CFR 312
Cite5 CFR 1320
Cite44 USC 3501-3521
Cites 57 · showing 12Cited by 0 across 0 sources