Notices. Notice
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/register/2007/06/14/07-2934A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0219] Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions 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 reporting requirements for the animal drug user fees, fee waivers and reductions. DATES: Submit written or electronic comments on the collection of information by August 13, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: 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. Animal Drug User Fees and Fee Waivers and Reductions (OMB Control Number 0910-0540)—Extension Enacted on November 18, 2003, the Animal Drug User Fee Act (ADUFA) (Public Law 108-130), amended the Federal Food, Drug, and Cosmetic Act and requires FDA to assess and collect user fees for certain applications, products, establishments, and sponsors. It also requires the agency to grant a waiver from, or a reduction of those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled “Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed--application fees, product fees, establishment fees, or sponsor fees. Respondents to this collection of information are new animal drug sponsors. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 740(d)(1)(A) Significant barrier to innovation 5 1 time for each application 5 2 10 740(d)(1)(B) Fees exceed cost 1 1 time for each application 1 2 2 740(d)(1)(C) Free choice feeds 5 1 time for each application 5 2 10 740(d)(1)(D) Minor use or minor species 10 1 time for each application 10 2 20 740(d)(1)(E) Small business 2 1 time for each application 2 2 4 Request for reconsideration of a decision 5 1 time for each application 5 2 10 Request for review—(user fee appeal officer) 2 1 time for each application 2 2 4 Total 60 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on FDA's database system, there are an estimated 250 sponsors of products subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the number of submission types received by FDA in fiscal year 2003. FDA's Center for Veterinary Medicine estimates 30 waiver requests that include the following: 5 significant barriers to innovation, 1 fee exceed cost, 5 free choice feeds, 10 minor use or minor species, 2 small business waiver requests, 5 requests for reconsideration of a decision, and 2 requests for user fee appeal officer. The estimated hours per response are based on past FDA experience with the various waiver requests in FDA's Center for Drug Evaluation and Research. The hours per response are based on the average of these estimates. Dated: June 7, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11425 Filed 6-13-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0221] Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of a new drug application
(NDA)for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. Otsuka has voluntarily requested that approval of this application be withdrawn because the product is no longer marketed, thereby waiving its opportunity for a hearing. DATES: Effective June 14, 2007. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In a letter dated March 5, 2003, Otsuka requested that FDA withdraw approval of NDA 20-695 for RAXAR (grepafloxacin HC1) Tablets, stating that the product was no longer being marketed. In FDA's acknowledgment letter of June 20, 2003, the agency informed Otsuka that RAXAR (grepafloxacin HCl) Tablets, indicated for the treatment of a variety of infections, had been removed from the market because of safety concerns; in its follow-up letter of January 12, 2007, the agency also informed Otsuka that it had determined that the RAXAR NDA should be withdrawn under § 314.150(d) (21 CFR 314.150(d)) because of its effect on cardiac repolarization, manifested as QTc interval prolongation on the electrocardiogram, which could put patients at risk of Torsade de Pointes. In its letter of March 20, 2007, Otsuka concurred in the agency's determination to initiate withdrawal of the RAXAR NDA and waived its opportunity for a hearing, provided under 21 CFR 314.150(a) and (b). Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)), § 314.150(d), and under authority delegated to the Director, Center for Drug Evaluation and Research (21 CFR 5.105(a)), approval of the NDA 20-695, and all amendments and supplements thereto, is withdrawn, effective (see DATES ). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the act (21 U.S.C. 331(d)). Dated: May 31, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7-11427 Filed 6-13-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Oncologic Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on July 24, 2007, from 8 a.m. to 5 p.m. *Location* : Advisors and Consultants Staff Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 20857. *Contact Person* : Johanna Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-6761, FAX: 301-827-6776, e-mail: *Johanna.Clifford@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The committee will discuss the following new drug applications (NDAs):
(1)NDA 022-042, EVISTA (raloxifene hydrochloride) Tablets, Eli Lilly and Co., proposed indications for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of breast cancer; and
(2)NDA 021-801, proposed trade name ORPLATNA (satraplatin capsules), GPC Biotech Inc., proposed indication for the treatment of patients with androgen independent (hormone refractory) prostate cancer
(HRPC)that has failed prior chemotherapy. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before July 10, 2007. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 2, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 3, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Johanna Clifford at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 6, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-11496 Filed 6-13-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Recruitment of Sites for Assignment of Corps Personnel AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: General notice. SUMMARY: The Health Resources and Services Administration
(HRSA)announces that the listing of entities, and their Health Professional Shortage Area
(HPSA)scores, that will receive priority for the assignment of National Health Service Corps
(NHSC)personnel (Corps Personnel, Corps members) for the period July 1, 2007 through June 30, 2008 is posted on the NHSC Web site at *http://nhsc.bhpr.hrsa.gov/resources/fedreg-hpol/* . This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option. Eligible HPSAs and Entities To be eligible to receive assignment of Corps personnel, entities must:
(1)Have a current HPSA designation by the Shortage Designation Branch in the Office of Workforce Evaluation and Quality Assurance, Bureau of Health Professions, Health Resources and Services Administration;
(2)enter into an agreement with the State agency that administers Medicaid, accept payment under Medicare and the State Children's Health Insurance Program, see all patients regardless of their ability to pay, and use and post a discounted fee plan; and
(3)be determined by the Secretary to have
(a)a need and demand for health manpower in the area;
(b)appropriately and efficiently used Corps members assigned to the entity in the past;
(c)general community support for the assignment of Corps members;
(d)made unsuccessful efforts to recruit; and
(e)a reasonable prospect for sound fiscal management by the entity with respect to Corps members assigned there. Priority in approving applications for assignment of Corps members goes to sites that
(1)provide primary, mental, and/or oral health services to a HPSA of greatest shortage;
(2)are part of a system of care that provides a continuum of services, including comprehensive primary health care and appropriate referrals or arrangements for secondary and tertiary care;
(3)have a documented record of sound fiscal management; and
(4)will experience a negative impact on its capacity to provide primary health services if a Corps member is not assigned to the entity. Entities that receive assignment of Corps personnel must assure that
(1)the position will permit the full scope of practice and that the clinician meets the credentialing requirements of the State and site; and
(2)the Corps member assigned to the entity is engaged in full-time clinical practice at the approved service location for a minimum of 40 hours per week with at least 32 hours per week in the ambulatory care setting. Obstetricians/gynecologists, certified nurse midwives (CNMs), and family practitioners who practice obstetrics on a regular basis, are required to engage in a minimum of 21 hours per week of outpatient clinical practice. The remaining hours, making up the minimum 40-hour per week total, include delivery and other clinical hospital-based duties. For all Corps personnel, time spent on-call does not count toward the 40 hours per week. In addition, sites receiving assignment of Corps personnel are expected to
(1)report to the NHSC all absences in excess of the authorized number of days (up to 35 work days or 280 hours per contract year);
(2)report to the NHSC any change in the status of an NHSC clinician at the site;
(3)provide the time and leave records, schedules, and any related personnel documents for NHSC assignees (including documentation, if applicable, of the reason(s) for the termination of an NHSC clinician's employment at the site prior to his or her obligated service end date); and
(4)submit a Uniform Data System
(UDS)report. The UDS system allows the site to assess the age, sex, race/ethnicity of, and provider encounter records for, its user population. The UDS reports are site specific. Providers fulfilling NHSC commitments are assigned to a specific site or, in some cases, more than one site. The scope of activity to be reported in UDS includes all activity at the site(s) to which the Corps member is assigned. Evaluation and Selection Process In approving applications for the assignment of Corps members, the Secretary shall give priority to any such application that is made regarding the provision of primary health services to a HPSA with the greatest shortage. For the program year July 1, 2007-June 30, 2008, HPSAs of greatest shortage for determination of priority for assignment of Corps personnel will be defined as follows:
(1)Primary care HPSAs with scores of 14 and above are authorized for the assignment of Corps members who are primary care physicians, family nurse practitioners (NPs), physician assistants (PAs), or CNMs participating in the Scholarship Program;
(2)mental health HPSAs with scores of 19 and above are authorized for the assignment of Corps members who are psychiatrists participating in the Scholarship Program;
(3)dental HPSAs with scores of 18 and above are authorized for the assignment of Corps members who are dentists participating in the Scholarship Program; and
(5)HPSAs (appropriate to each discipline) with scores of 17 and above are authorized for priority assignment of Corps members who are participating in the Loan Repayment Program. HPSAs with scores below 17 will be eligible to receive assignment of Corps personnel participating in the Loan Repayment Program only after assignments are made of those Corps members matching to those HPSAs receiving priority for placement of Corps members through the Loan Repayment Program (i.e., HPSAs scoring 17 or above). Placements made through the Loan Repayment Program in HPSAs with scores 16 or below will be made by decreasing HPSA score, and only to the extent that funding remains available. All sites on the list are eligible sites for individuals wishing to serve in an underserved area but who are not contractually obligated under the Scholarship or Loan Repayment Program. A listing of HPSAs and their scores is posted at *http://hpsafind.hrsa.gov/.* Sites qualifying for automatic primary care and dental HPSA designations have been scored and may be authorized to receive assignment of Corps members if they meet the criteria outlined above and their HPSA scores are above the stated cutoffs. If there are any sites on the list with an unscored HPSA designation they are authorized for the assignment of Corps personnel participating in the Loan Repayment Program only, after assignments are made of those Corps members matching to scored HPSAs and only to the extent that funding remains available. When these HPSAs receive scores, these sites will then be authorized to receive assignment of Corps members if they meet the criteria outlined above and their newly assigned scores are above the stated cutoffs. The number of new NHSC placements through the Scholarship and Loan Repayment Programs allowed at any one site are limited to the following:
(1)Primary Health Care
(a)Loan Repayment Program—no more than 2 allopathic
(MD)or osteopathic
(DO)physicians; and no more than a combined total of 2 NPs, PAs, or CNMs.
(b)Scholarship Program—no more than 2 physicians (MD or DO); and no more than a combined total of 2 NPs, PAs, or CNMs.
(2)Dental
(a)Loan Repayment Program—no more than 2 dentists and 2 dental hygienists.
(b)Scholarship Program—no more than 1 dentist.
(3)Mental Health
(a)Loan Repayment Program—no more than 2 psychiatrists (MD or DO); and no more than a combined total of 2 clinical or counseling psychologists; licensed clinical social workers, licensed professional counselors, marriage and family therapists, or psychiatric nurse specialists.
(b)Scholarship Program—no more than 1 psychiatrist. Application Requests, Dates and Address The list of HPSAs and entities that are eligible to receive priority for the placement of Corps personnel may be updated periodically. Entities that no longer meet eligibility criteria, including HPSA score, will be removed from the priority listing. Entities interested in being added to the high priority list must submit an NHSC Recruitment and Retention Assistance Application to: National Health Service Corps, 5600 Fishers Lane, Room 8A-08, Rockville, MD 20857, fax 301-594-2721. These applications must be submitted on or before the deadline date of March 28, 2008. Applications submitted after this deadline date will be considered for placement on the priority placement list in the following program year. Any changes to this deadline will be posted on the NHSC Web site at *http://nhsc.bhpr.hrsa.gov.* Entities interested in receiving application materials may do so by calling the HRSA call center at 1-800-221-9393. They may also get information and download application materials from: *http://nhsc.bhpr.hrsa.gov/applications/rraa.cfm.* Additional Information Entities wishing to provide additional data and information in support of their inclusion on the proposed list of HPSAs and entities that would receive priority in assignment of Corps members, must do so in writing no later than July 16, 2007. This information should be submitted to: Susan Salter, Chief, Site Identification and Application Branch, Division of National Health Service Corps, 5600 Fishers Lane, Room 8A-08, Rockville, MD 20857. This information will be considered in preparing the final list of HPSAs and entities that are receiving priority for the assignment of Corps personnel. *Paperwork Reduction Act:* The Recruitment & Retention Assistance Application has been approved by the Office of Management and Budget under the Paperwork Reduction Act. The OMB clearance number is 0915-0230. The program is not subject to the provisions of Executive Order 12372, Intergovernmental Review of Federal Programs (as implemented through 45 CFR part 100). Dated: June 7, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-11423 Filed 6-13-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY National Protection and Programs Directorate (NPPD), Telecommunications Services Priority
(TSP)System; Agency Information Collection Activities: Request for Continuation of an Already Existing Collection for OMB Review, Comment Request AGENCY: DHS, NPPD, Telecommunications Services Priority
(TSP)System. ACTION: Notice; 30-day notice and request for comments. SUMMARY: The Department of Homeland Security (DHS), has submitted the following information collection to the Office of Management and Budget
(OMB)for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). The information collection was previously published in the **Federal Register** on April 11, 2007 at 72 FR 18263—18264 allowing for a 60-day public comment period. No comments were received on this existing information collection. The purpose of this notice is to allow an additional 30 days for public comments. The submission describes the nature of the information collection, the categories of respondents, the estimated burden ( *i.e.* , the time, effort and resources used by respondents to respond) and cost, and includes the actual data collection instruments DHS will use. DATES: Comments are encouraged and will be accepted until July 16, 2007. ADDRESSES: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management Budget, Attention: Nathan Lesser, Desk Officer, Department of Homeland Security/NPPD and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to
(202)395-6974. FOR FURTHER INFORMATION CONTACT: A copy of this ICR, with applicable supporting documentation, may be obtained by calling Nathan Lesser, Desk Officer, Department of Homeland Security Washington, DC 20528; and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to
(202)395-6974 (this is not a toll free number). SUPPLEMENTARY INFORMATION: *Title:* Telecommunications Services Priority
(TSP)System (Standard Forms 314, 315, 317, 318, 319). *OMB Number:* 1670-0005. *Affected Public:* Individuals or households; businesses or other for profit; not-for-profit institutions; State, local or tribal government; foreign government. *Number of Respondents:* 37. *Estimated Time per Respondent:* SF314 (TSP Revalidations for Service Users): .05 Minutes. SF315 (TSP Request for Service Users): 1.25 Hours. SF317 (TSP Action Appeal for Service Users): 3.0 Hours. SF318 (TSP Service Confirmation for Service Vendors): .05 Hours. SF319 (TSP Service Reconciliation for Service Vendors): 8.0 Hours. *Estimated Total Annual Burden Hours:* 2,762. *Frequency of Response:* On Occasion. The Telecommunications Service Priority
(TSP)System provides telecommunications service vendors a means of identifying the services that should be restored or provisioned first in the event of an emergency or crisis; and the legal protection giving a preference to certain users over others. This critical aspect of the TSP program benefits government at all levels as well as the general public. The collection includes mechanisms to collect information to request a priority, to obtain a sponsor for requesting a priority, and for other administrative requirements of the program, is required from any person or organization having an NS/EP service for which they wish priority restoration from the vendor providing the service. Information is also required to allow immediate installation of a new service to support NS/EP requirements. Information is required from vendors to allow the OMNCS to track and identify the telecommunications services that are being provided priority treatment. This is a previously approved collection. Charlie Church, Chief Information Officer, National Protection and Programs Directorate, Department of Homeland Security. [FR Doc. E7-11495 Filed 6-13-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-47] Notice of Submission of Proposed Information Collection to OMB; Historically Black Colleges and Universities
(HBCU)AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget
(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Grants to assist nonprofit Historically Black Colleges and Universities
(HBCU)of higher education expand their role and effectiveness in addressing community development needs, such as neighborhood revitalization, housing, and economic development, in their localities. DATES: *Comments Due Date:* July 16, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2528-0235) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L._Deitzer@HUD.gov* or telephone
(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD's Web site at *http://www5.hud.gov:63001/po/i/icbts/collectionsearch.cfm.* SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:
(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;
(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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Historically Black Colleges and Universities (HBCU). *OMB Approval Number:* 2528-0235. *Form Numbers:* SF-424, SF-424 Supplement, HUD-424CB, SFLLL, HUD-27300, HUD-2880, HUD-2990, HUD-2991, HUD-2993, HUD-2944A, HUD-40076, HUD-96010, HUD-96011. *Description of the Need for the Information and Its Proposed Use:* Grants to assist nonprofit Historically Black Colleges and Universities
(HBCU)of higher education expand their role and effectiveness in addressing community development needs, such as neighborhood revitalization, housing, and economic development, in their localities. *Frequency of Submission:* Semi-annually, Other Final Report. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 105 2.85 119 35,940 *Total Estimated Burden Hours:* 35,940. *Status:* Extension of a currently collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: June 8, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E7-11429 Filed 6-13-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-46] Notice of Submission of Proposed Information Collection to OMB; Section 108 Loan Guarantee Program Application AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget
(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. A provision of the CDBG program provides communities financing for economic development, housing rehab, public facilities, and physical development projects. The information collection is necessary in order to render judgments on the eligibility of the activities proposed to be financed with Section 108 loan guarantee assistance and to ensure that the loan guarantee does not pose a financial risk to the Federal Government. DATES: *Comments Due Date:* July 16, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2506-0161) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L._Deitzer@HUD.gov* or telephone
(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD's Web site at *http://www5.hud.gov:63001/po/i/icbts/collectionsearch.cfm.* SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:
(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;
(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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Section 108 Loan Guarantee Program Application. *OMB Approval Number:* 2506-0161. *Form Numbers:* None. *Description of the Need for the Information and Its Proposed Use:* A provision of the CDBG program provides communities financing for economic development, housing rehab, public facilities, and physical development projects. The information collection is necessary in order to render judgments on the eligibility of the activities proposed to be financed with Section 108 loan guarantee assistance and to ensure that the loan guarantee does not pose a financial risk to the Federal Government. *Frequency of Submission:* On occasion. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 50 1 125 6,250 *Total Estimated Burden Hours:* 6,250. *Status:* Extension of a currently collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: June 8, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E7-11430 Filed 6-13-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Draft Recovery Plan for the Northern Spotted Owl (Strix occidentalis caurina) AGENCY: U.S. Fish and Wildlife Service, Interior. ACTION: Extension of comment period. SUMMARY: We, the U.S. Fish and Wildlife Service, announce a 60-day extension of the comment period for the Draft Recovery Plan for the Northern Spotted Owl ( *Strix occidentalis caurina* ) (northern spotted owl). DATES: Comments on the draft recovery plan must now be received on or before August 24, 2007. ADDRESSES: Comments on the plan can be sent electronically to *NSOplan@fws.gov* , or mailed to NSO Recovery Plan, U.S. Fish and Wildlife Service, Ecological Services, 911 NE 11th Avenue, Portland, Oregon 97232. Copies of the draft recovery plan will be available by request from the same Portland address (telephone: 503-231-2194). An electronic copy of the draft recovery plan is also available at *http://www.fws.gov/pacific/ecoservices/endangered/recovery/plans.html* . FOR FURTHER INFORMATION CONTACT: Paul Phifer, Northern Spotted Owl Recovery Plan Project Manager, at the Portland address identified above (telephone 503-724-1886, fax 503-231-2050). SUPPLEMENTARY INFORMATION: Background Restoring endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program. The Endangered Species Act (16 U.S.C. 1531 *et seq.* )
(ESA)requires the development of recovery plans for listed species unless such a plan would not promote the conservation of a particular species. Recovery plans help guide the recovery effort by describing actions considered necessary for the conservation of the species, establishing criteria for downlisting or delisting listed species, and estimating time and cost for implementing the measures needed for recovery. Section 4(f) of the ESA requires that public notice, and an opportunity for public review and comment, be provided during recovery plan development. We will consider all information presented during the public comment period. Substantive comments on the recovery needs of the species or other aspects of recovery plan development may result in changes to the recovery plan. Substantive comments regarding recovery plan implementation may not necessarily result in changes to the recovery plan, but will be forwarded to appropriate Federal agencies or other entities so that they can take these comments into account during the course of implementing recovery actions. Individual responses to comments will not be provided. The northern spotted owl inhabits structurally complex forests from southwest British Columbia through the Cascade Mountains and coastal ranges in Washington, Oregon, and California, as far south as Marin County. When the northern spotted owl was listed under the ESA as a threatened species on June 26, 1990, the major threats were identified as widespread loss and adverse modification of suitable habitat across the owl's entire range and the inadequacy of existing regulatory mechanisms to conserve the owl. Currently, populations of northern spotted owls are declining, especially in the northern parts of the species' range. Scientific research and monitoring have reported that northern spotted owls generally rely on older forested habitats because such habitats contain the structures and characteristics required for nesting, roosting, and foraging. Recent landscape-level studies in several southern portions of the northern spotted owl's range suggest a mosaic of forest conditions may result in good northern spotted owl habitat, though other studies have not reported that finding. The most important threat currently facing the northern spotted owl is believed to be competition with the barred owl ( *Strix varia* ). Actions associated with addressing the barred owl threat were given the highest recovery priority, meaning the action “must be taken to prevent extinction or prevent the species from declining irreversibly in the foreseeable future.” Other important threats to the northern spotted owl continue to be loss of habitat quality and quantity as a result of past activities and disturbances, and ongoing and projected loss of habitat as a result of fire, logging and conversion of habitat to other uses. The draft recovery plan provides two options for recovery, and we are seeking public comment on the effectiveness of both options to achieve recovery. Both options are based on the same underlying science, and contain essentially the same recovery goal, objectives, criteria, and actions. The options differ in that option 1 identifies ( *i.e.* , maps) the specific conservation area boundaries in which most of the recovery actions and criteria will be targeted. Option 2 does not designate specific conservation area boundaries, rather it provides a “rule set” that will help guide the Federal land management agencies when undertaking conservation actions for the northern spotted owl. Both options rely on Federal lands to provide the primary contribution for northern spotted owl recovery. The intent of providing two options for public comment in a draft recovery plan is to promote open public discussion about how to successfully recover this species. Public Comments Solicited We are soliciting written comments on the draft recovery plan described. All comments received by the date specified above will be considered in the finalization of this plan. 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. Comments and materials received will be available for public inspection, by appointment, during normal business hours at the above address. We would specifically appreciate comments on the following topics found in both options: • The methods used to determine desired habitat percentages listed in Recovery Criterion 4. If recommendations are offered, respondents are asked to explain the scientific foundation supporting their comments; • The biological need, design and feasibility of attempting to provide connectivity between the Olympic Peninsula and central Washington northern spotted owl populations; • The biological value in identifying conservation areas in southwest Washington and northwest Oregon; • The practicality of Appendix E, which provides examples of how a salvage logging action (Recovery Action 22) may be implemented; • The identified boundaries of the Managed Owl Conservation Areas (option 1 only) and the Conservation Support Areas; • Methods for managing the threat posed by barred owls; and • Ways to create incentives for private land owners and managers to support recovery of the northern spotted owl. Authority The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f). Dated: May 25, 2007. David J. Wesley, Acting Regional Director, Region 1, U.S. Fish and Wildlife Service. [FR Doc. E7-11492 Filed 6-13-07; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO-250-1231-EB-24 1A] Submission to Office of Management and Budget—Information Collection, OMB Control Number 1004-0119 AGENCY: Bureau of Land Management, Interior. ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management
(BLM)has submitted a request for an extension of an approved information collection to the Office of Management and Budget
(OMB)for approval. DATES: The OMB is required to respond to this request within 60 days but may respond after 30 days. Submit your comments to OMB at the address below by July 16, 2007 to receive maximum consideration. ADDRESSES: Send comments to the OMB, Interior Department Desk Officer (1004-0119), at OMB-OIRA via e-mail *OIRA_DOCKET@omb.eop.gov* or via facsimile at
(202)395-6566. Also please send a copy of your comments to BLM via Internet and include your name, address, and ATTN: 1004-0119 in your Internet message to *comments_washington@blm.gov* or via mail to: U.S. Department of the Interior, Bureau of Land Management, Mail Stop 401LS, 1849 C Street, NW., ATTN: Bureau Information Collection Clearance Officer (WO-630), Washington, DC 20240. FOR FURTHER INFORMATION CONTACT: You may contact Shirlean Beshir to obtain copies and explanatory material on this information collection at
(202)452-5033. Persons who use a telecommunication device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)on 1-800-877-8330, 24 hours a day, seven days a week, to contact Ms. Beshir. SUPPLEMENTARY INFORMATION: On June 21, 2006, the BLM published a notice in the **Federal Register** (71 FR 35696) requesting comments on the information collection. The comment period closed on August 21, 2006. The BLM did not receive any comments. We are soliciting comments on the following:
(a)Whether the collection of information is necessary for the proper functioning of the agency, including whether the information will have practical utility;
(b)The accuracy of our estimates of the information collection burden, including the validity of the methodology and assumptions we use;
(c)Ways to enhance the quality, utility, and clarity of the information collected; and
(d)Ways to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Title:* Permits for Recreation on Public Lands (43 CFR part 2930). *OMB Control Number:* 1004-0119. *Abstract:* The BLM manages the recreation use program on public lands according to the regulations at (43 CFR part 2930). These regulations implement the following statutes:
(1)The Land and Water Conservation Fund Act, as amended (16 U.S.C. 460 *l* -6a, (b), (g));
(2)The Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701(a)(8)), (43 U.S.C. 302(b)), and (43 U.S.C. 303);
(3)The Sentencing Reform Act (18 U.S.C. 3571); and
(4)36 CFR part 71. The BLM uses this information to approve and collect fees for recreation use on public lands. *Burden Estimate per Form:* We estimate the completion time for this form and non-form information that is submitted on occasion to the BLM by individuals and the private sector as follows: Burden hours information collected Number of actions per year Burden hours per action Total annual burden hours
(a)Special Recreation Application and Permit (Form 2930-1) and non-form information in 43 CFR subpart 2932 1,450 8 11,600
(b)43 CFR subpart 2933; Non-form information to reserve a fee-use campground site, to collect recreation use fees, and obtain a recreation use permit 364,395 1 364,395 Totals 365,845 375,995 *Annual Responses:* 365,845. *Application Fee per Response:* 0. *Annual Burden Hours:* 375,995. Dated: June 8, 2007. Ted R. Hudson, Bureau of Land Management, Acting Division Chief Regulatory Affairs. [FR Doc. 07-2934 Filed 6-13-07; 8:45 am]
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U.S. Code
- Definitions§ 3502
- Federal agency responsibilities§ 3506
- New drugs§ 355
- Prohibited acts§ 331
- Congressional findings and declaration of purposes and policy§ 1531
- Determination of endangered species and threatened species§ 1533
- Natchez Trace Parkway§ 460
- Congressional declaration of policy§ 1701
- Repealed. Pub. L. 94–579, title VII, § 702, Oct. 21, 1976, 90 Stat. 2787§ 302
- Sentence of fine§ 3571
register
10 references not yet in our index
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- Pub. L. 108-130
- 21 CFR 5.105(a)
- 45 CFR 100
- Pub. L. 104-13
- 44 USC 35
- 43 CFR 2930
- 43 USC 303
- 36 CFR 71
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cites case law
Notices
Notice
Cite44 USC 3501-3520
Cite5 CFR 1320.3(c)
Pub. L.Pub. L. 108-130
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