Notices. Notice; request for comments

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

BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0166] International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43, Request for Comments; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability for comments of a draft guidance document for industry (#185) entitled “Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products,”VICH GL43. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document has been developed as a harmonized standard to aid in development of mutually acceptable target animal safety

(TAS)studies for the relevant governmental regulatory bodies. DATES: Submit written or electronic comments on the draft guidance by June 18, 2007, to ensure their adequate consideration in preparation of the final document. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Comments should be identified with the full title of the draft guidance and the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Laura Hungerford, Center for Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6439, e-mail: *laura.hungerford@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries. FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. VICH is a parallel initiative for veterinary medicinal products. VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. The VICH steering committee is composed of member representatives from the European Commission; European Medicines Evaluation Agency; European Federation of Animal Health; Committee on Veterinary Medicinal Products; FDA; the U.S. Department of Agriculture; the Animal Health Institute; the Japanese Veterinary Pharmaceutical Association; the Japanese Association of Veterinary Biologics; and the Japanese Ministry of Agriculture, Forestry, and Fisheries. Four observers are eligible to participate in the VICH steering committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH steering committee meetings. II. Draft Guidance on Target Animal Safety The VICH steering committee held a meeting in December 2006 and agreed that the draft guidance document entitled “Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products,”VICH GL43 should be made available for public comment. This draft VICH guidance document has been developed as a harmonized standard to aid in development of mutually acceptable TAS studies for the relevant governmental regulatory bodies. This draft guidance document is intended to cover TAS studies for any Investigational Veterinary Pharmaceutical Product used in the following species: Bovine, ovine, caprine, feline, canine, porcine, equine, and poultry (chickens and turkeys). Minor species and minor uses may be excluded from this guidance for local registration. The guidance does not provide information for the design of TAS studies in other species including aquatic animals. For other species, TAS studies should be designed following local guidance. FDA and the VICH Expert Working Group will consider comments about the draft guidance document. III. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in section 1-5 of the draft guidance have been approved under OMB Control No. 0910-0032. IV. Significance of Guidance This draft document, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement. The draft VICH guidance (GFI #185) is consistent with the agency's current thinking on this topic. This guidance does not create or confer any rights for or on any person and will not operate to bind FDA or the public. An alternative method may be used as long as it satisfies the requirements of applicable statutes and regulations. IV. Comments This draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit written or electronic comments regarding this draft guidance document to the Division of Dockets Management (see ADDRESSES ). Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Electronic comments may also be submitted electronically on the Web site at *http://www.fda.gov/dockets/ecomments* . Once on this Internet site, select Docket No. 2007D-0166 entitled “Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products,”VICH GL43 and follow the directions. Copies of the draft guidance document entitled “Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products,”VICH GL43 may be obtained on the Web site from the Center for Veterinary Medicine home page at *http://www.fda.gov/cvm* . Dated: May 10, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-9592 Filed 5-17-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: *Proposed Project: OAT Telehealth Outcome Measures:* NEW. In order to help carry out its mission, the Office for the Advancement of Telehealth

(OAT)created a set of performance measures that grantees can use to evaluate the effectiveness of their services programs and monitor their progress through the use of performance reporting data. As required by the Government Performance and Review Act of 1993 (GPRA), all Federal agencies must develop strategic plans describing their overall goal and objectives. The Office for the Advancement of Telehealth

(OAT)has worked with its grantees to develop performance measures to be used to evaluate and monitor the progress of the grantees. Grantee goals are to: Improve access to needed services, reduce rural practitioner isolation, improve health system productivity and efficiency, and improve patient outcomes. In each of these categories, specific indicators were designed to be reported through a performance monitoring Web site. The Program Assessment Response Tool

(PART)is the newest instrument created for use by Federal agencies. The Office of Management and Budget

(OMB)uses the PART to assess Federal programs. The PART is a series of diagnostic questions used to assess and evaluate programs across a set of performance-related criteria including program design and purpose, strategic planning, program management, and results. PART results are used to inform the budget process and improve program management. OAT's Telehealth Network Grant Program has been undergoing a PART assessment this year. Thus, in addition to responding to the GPRA initiative, OAT now has the added responsibility of responding to the PART assessment of its Telehealth Network Grant Program. The proposed performance measures will provide performance data that will address the PART assessment, monitor progress, and evaluate program effectiveness. The estimates of burden are as follows: Form Number of respondents Responses per respondent Total responses Hour burden Total burden hours Performance Measurement Tool 667 2 1,334 7 9,338 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9536 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (44 U.S.C. 3506(c)(2)(A)), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 0915-0184): Extension The operation of the Organ Procurement and Transplantation Network

(OPTN)necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. This is a request for an extension of the current recordkeeping and reporting requirements associated with the OPTN. These data will be used by HRSA in monitoring the contracts for the OPTN and the Scientific Registry of Transplant Recipients

(SRTR)and in carrying out other statutory responsibilities. Information is needed to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, to ensure that all qualified entities are accepted for membership in the OPTN, and to ensure patient safety. Estimated Annual Reporting and Recordkeeping Burden Section and Activity Number of respondents Responses per respondents Total responses Hours per response Total burden hours 121.3(b)(2) OPTN membership and application requirements for OPOs, hospitals, and histocompatibility laboratories 40 3 120 15 1, 800 121.3(b)(4) Appeal for OPTN membership 2 1 2 3 6 121.6(c) (Reporting) Submitting criteria for organ acceptance 900 1 900 0.5 450 121.6(c) (Disclosure) Sending criteria to OPOs 900 1 900 0.5 450 121.7(b)(4) Reasons for Refusal 900 38 34,200 0.5 17,100 121.7(e) Transplant to prevent organ wastage 260 1.5 390 0.5 195 121.9(b) Designated Transplant Program Requirements 10 1 10 5.0 50 121.9(d) Appeal for designation 2 1 2 6 12 Total 954 36,524 20,063 Send comments to Susan G. Queen, PhD., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: May 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9538 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The Organ Procurement and Transplantation Network (OMB No. 0915-0286)—Extension The Organ Procurement and Transplantation Network

(OPTN)necessitates certain record keeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. OMB requires review and approval of record keeping and reporting requirements associated with the final rule governing the operation of the OPTN (42 CFR part 121) related to Secretarial review and appeals. There are record keeping and reporting requirements associated with the process for filing appeals in the case where applicants are rejected for membership or designation in the OPTN. To date, no appeals have been filed. The burden requirements for this process are minimal. The estimate of burden for this process consists of preparing a letter requesting reconsideration and compiling supporting documentation. The estimated annual burden is as follows: Section of final rule Number of respondents Responses per respondent Total responses Hours per response Total burden hours 42 CFR 121.3(c)(4) Appeal for OPTN membership 2 1 2 3 6 42 CFR 121.9(d) Appeal for designation 2 1 2 6 12 Total 4 4 18 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9546 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Request for Nominations for Members AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration

(HRSA)is requesting nominations to the National Advisory Council

(NAC)on the National Health Service Corps (NHSC). NAC was established by 42 U.S.C. 254j; Section 337 of the Public Health Service Act, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of NHSC and related programs. DATES: The agency must receive nominations on or before June 18, 2007. ADDRESSES: All nominations are to be submitted to the Tira Patterson, Executive Secretary, NAC on the NHSC, HRSA, Parklawn Building, Room 8A-55, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: Ms. Tira Patterson, Executive Secretary, NAC on the NHSC, HRSA at

(301)594-4140 or e-mail: *tpatterson@hrsa.gov* . SUPPLEMENTARY INFORMATION: Under the authorities that established the NAC and the Federal Advisory Committee Act of October 6, 1972, 5 U.S.C. App., HRSA is requesting nominations for members of the NAC. The NAC on the NHSC is a body of clinicians and health care administrators who possess knowledge of underserved communities and health care implementation and improvement. This cadre of health care experts can serve as a “frontline” source of information to NHSC senior level management. NAC is committed to effectively implementing its mandate to advise the Secretary and, by designation, the Administrator, HRSA. The NAC: • Serves as a forum to identify the priorities for the NHSC and bring forward and anticipate future program issues and concerns through ongoing communication with program staff, professional organizations, communities and program participants; • Functions as a sounding board for proposed policy changes by utilizing the varying levels of expertise represented on the Council to advise on specific program areas; and • Develops and distributes White Papers and briefs that clearly state issues and/or concerns relating to the NHSC with specific recommendations for necessary policy revisions. Interested persons may nominate one or more qualified persons for membership on NAC. Nominations shall state that the nominee is willing to serve as a member of NAC and appears to have no conflicts of interest that would preclude the NAC membership. Potential candidates will be asked to provide detailed information concerning consultancies, research grants, or contracts to permit evaluation of possible sources of conflicts of interest. A curriculum vitae or resume should be submitted with the nomination. The Department of Health and Human Services has special interest in assuring that women, minority groups, and the physically disabled are adequately represented on advisory committees; and therefore, extends particular encouragement to nominations for appropriately qualified female, minority, or disabled candidates. Dated: May 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9545 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration ”Low Income Levels” Used for Various Health Professions and Nursing Programs Included in Titles III, VII and VIII of the Public Health Service Act AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration

(HRSA)is updating income levels used to identify a “low income family” for the purpose of determining eligibility for programs that provide health professions and nursing training for individuals from disadvantaged backgrounds. These various programs are included in Titles III, VII and VIII of the Public Health Service

(PHS)Act. The Department periodically publishes in the **Federal Register** low-income levels used to determine eligibility for grants and cooperative agreements to institutions providing training for

(1)disadvantaged individuals,

(2)individuals from disadvantaged backgrounds, or

(3)individuals from “low-income” families. SUPPLEMENTARY INFORMATION: The various health professions and nursing grant and cooperative agreement programs that use the low income levels to determine whether an individual is from an economically disadvantaged background in making eligibility and funding determinations generally make awards to: Accredited schools of medicine, osteopathic medicine, public health, dentistry, veterinary medicine, optometry, pharmacy, allied health podiatric medicine, nursing, chiropractic, public or private nonprofit schools which offer graduate programs in behavioral health and mental health practice, and other public or private nonprofit health or education entities to assist the disadvantaged to enter and graduate from health professions and nursing schools. Some programs provide for the repayment of health professions or nursing education loans for disadvantaged students. Low-Income Levels The Secretary defines a “low income family” for programs included in Titles III, VII and VIII of the Public Health Service Act as a family having an annual income that does not exceed 200 percent of the Department's poverty guidelines. A “family” is a group of two or more individuals related by birth, marriage, or adoption who live together or an individual who is not living with any relatives. Most HRSA programs use the income of the student's parents to compute low income status. However, a few programs, depending upon the legislative intent of the program, programmatic purpose of the low income level, as well as the age and circumstances of the average participant, will use the student's family income, as long as he or she is not listed as a dependent upon the parents' tax form. Each program will announce the rationale and choice of methodology for determining low income levels in their program guidance. The Department's poverty guidelines are based on poverty thresholds published by the U.S. Bureau of the Census, adjusted annually for changes in the Consumer Price Index. The Secretary annually adjusts the low income levels based on the Department's poverty guidelines and makes them available to persons responsible for administering the applicable programs. The income figures below have been updated to reflect increases in the Consumer Price Index through December 31, 2006. Size of parents' family * Income level ** 1 $20,420 2 27,380 3 34,340 4 41,300 5 48,260 6 55,220 7 62,180 8 69,140 * Includes only dependents listed on Federal income tax forms. Some programs will use the student's family rather than his or her parents' family. ** Adjusted gross income for calendar year 2006. Dated: May 10, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-9548 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting: *Name:* Advisory Commission on Childhood Vaccines (ACCV). *Date And Time:* June 7, 2007, 1 p.m.—5 p.m., EST. *Place:* (Audio Conference Call). The ACCV will meet on Thursday, June 7, from 1 p.m. to 5 p.m., (EST). The public can join the meeting via audio conference call by dialing 1-888-324-8527 on June 7 and providing the following information: *Leader's Name:* Dr. Geoffrey Evans. *Password:* ACCV. *Agenda:* The agenda items for the June meeting will include, but are not limited to: a summary of the “Vaccine Safety Evaluation: Post-Marketing Surveillance” conference; and updates from the Division of Vaccine Injury Compensation (DVIC), Department of Justice, National Vaccine Program Office, Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health), and Center for Biologics and Evaluation Research (Food and Drug Administration). Agenda items are subject to change as priorities dictate. *Public Comments:* Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: LCDR Delia Jones, Principal Staff Liaison, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857 or e-mail: *djones2@hrsa.gov.* Requests should contain the name, address, telephone number, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DVIC will notify each presenter by mail or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the comment period. These persons will be allocated time as it permits. FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding the ACCV should contact LCDR Delia Jones, Principal Staff Liaison, DVIC, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857; telephone

(301)443-6593 or e-mail: *djones2@hrsa.gov.* Dated: May 11, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9533 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration C.W. Bill Young Cell Transplantation Program: National Cord Blood Inventory Related Cord Blood Donor Demonstration Project AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Request for information. SUMMARY: Public Law 109-129 requires the Secretary of Health and Human Services to establish a 3-year demonstration project for qualified cord blood banks to collect and store at no charge to families, umbilical cord blood units for families where a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. Umbilical cord blood units collected through the demonstration project do not count toward the current National Cord Blood Inventory

(NCBI)goal of 150,000 cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program. Qualified umbilical cord blood banks participating in the demonstration project must provide assurances that the cord blood units will be available for directed transplantation until such time as the cord blood unit is needed. Within 90 days of the termination of the demonstration project, the Secretary will submit to Congress a report on the outcomes of the project including recommendations with respect to the continuation of such a project. HRSA's Healthcare Systems Bureau (HSB), Division of Transplantation

(DoT)is in the process of information-gathering to assist in implementation of the related cord blood demonstration project. The purpose of this solicitation is to receive public input on the following:

(1)The key questions that should be studied through this project;

(2)the mechanism for funding this project; and,

(3)umbilical cord blood bank liability. HRSA has identified the following key study questions to be considered in the design of this demonstration project:

(1)What is the value and feasibility of implementing a long-term program modeled after this demonstration project;

(2)how often and for what clinical indications are cord blood units banked through this project used for transplantation;

(3)what is the breakdown of cord blood units collected, stored, and transplanted by race, ethnicity, and disease;

(4)do those cord blood units, especially those released for transplant, represent rare Human Leukocyte Antigen

(HLA)types such that the recipient would otherwise have been unable to find a matched unrelated donor;

(5)how do transplant outcomes using these cord blood units compare to unrelated allogeneic umbilical cord blood transplants and unrelated allogeneic transplants using blood stem cells from adult donors; and,

(6)what are the general physical characteristics of these units (e.g., total nucleated count, CD34+ content) and how does their quality compare to that of the general public inventory. HRSA proposes to invite the first cohort of umbilical cord blood banks receiving NCBI contracts to submit competitive proposals for participation in this demonstration project with an emphasis on:

(1)Establishment of nationwide collections; and,

(2)encouraging banks to subcontract with other experienced, high-quality cord blood banks to assist in their education, collection, processing, and storing efforts. HRSA has approximately $200,000 available for this demonstration project this fiscal year and anticipates selecting 2 or 3 banks to participate in this demonstration project to be funded through modification of their existing NCBI contracts with HRSA. HRSA recognizes the need for this service is likely greater than what can be satisfied in a limited demonstration project. Because of the great diversity in HLA types among African-Americans, HRSA recognizes that patients from this population are significantly less likely to find a suitably matched unrelated blood stem cell donor than patients from other racial or ethnic groups. Therefore, HRSA invites comments on the desirability of limiting participation to African-American families in which a first-degree relative has been diagnosed with a condition that may benefit from blood stem cell transplantation. HRSA understands that there may be special considerations associated with liability for those umbilical cord blood banks participating in this project. HRSA invites comment on how umbilical cord blood banks participating in this project may best address these concerns. Interested parties are invited to submit written comments on the key study questions, the funding approach, and umbilical cord blood bank liability for this demonstration project to the address below. DATES: Written comments must be received at HRSA by June 18, 2007. Comments will be made publicly available by submitting a written request to the address below. ADDRESSES: Please send all written comments to: James F. Burdick, M.D.; Attn: Related Cord Blood Demo Project; HHS/HRSA/HSB/DoT; 5600 Fishers Lane, Room 12C-06; Rockville, Maryland 20857; telephone

(301)443-7577; fax

(301)594-6095; or e-mail: *jburdick@hrsa.gov.* Please include in the subject line of electronic correspondence “Related Cord Blood Demo Project.” FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, DoT, HSB, HRSA, 5600 Fishers Lane, Room 12C-06, Rockville, Maryland 20857; telephone

(301)443-7577; fax

(301)594-6095; or e-mail: *jburdick@hrsa.gov.* SUPPLEMENTARY INFORMATION: Background On December 20, 2005, the Stem Cell Therapeutic and Research Act of 2005 was enacted as Public Law 109-129. The Act authorizes the establishment of the National Cord Blood Inventory and the C.W. Bill Young Cell Transplantation Program successor to the National Bone Marrow Donor Registry. The National Cord Blood Inventory is to be comprised of 150,000 high quality, genetically diverse cord blood units to be made available through the C.W. Bill Young Cell Transplantation Program for patients in need of a blood stem cell transplant. The Act also authorizes establishment of a 3-year related cord blood donor demonstration project to begin in FY 2007. Program Authority The C.W. Bill Young Cell Transplantation Program is authorized by Public Law 109-129, which amends Part I of the Public Health Service Act. Dated: May 10, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-9550 Filed 5-17-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. SUMMARY: The Federal Emergency Management Agency

(FEMA)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. 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 FEMA will use. *Title* : Community Rating System

(CRS)Program—Application Worksheets and Commentary. *OMB Number:* 1660-0022. *Abstract* : CRS Application Cover Page, Recertification Worksheet and Modification/Cycle Cover Page are used by a community to apply or renew CRS program participation and specify what activities will be performed by the community. CRS Activity Worksheets are used by the community to provide details in the selected activities based on the CRS Coordinator's Manual. *Affected Public:* State, Local or Tribal Government. *Number of Respondents:* 150 for application and 950 for maintenance. *Estimated Time per Respondent* : 31 hours for application and 4 hours for maintenance. *Estimated Total Annual Time Burden:* 8,450 hours. *Annual Frequency of Response:* 1. *Comments* : 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/FEMA, and sent via electronic mail to *oira_submission@omb.eop.gov* or faxed to

(202)395-6974. Comments must be submitted on or before June 18, 2007. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection should be made to Chief, Records Management, FEMA, 500 C Street, SW., Room 609, Washington, DC 20472, facsimile number

(202)646-3347, or e-mail address *FEMA-Information-Collections@dhs.gov* . Dated: May 14, 2007. John A. Sharetts-Sullivan, Chief, Records Management and Privacy Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E7-9567 Filed 5-17-07; 8:45 am] BILLING CODE 9110-11-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5125-N-20] Federal Property Suitable as Facilities To Assist the Homeless AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. SUMMARY: This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless. EFFECTIVE DATE: May 18, 2007. FOR FURTHER INFORMATION CONTACT: Kathy Ezzell, Department of Housing and Urban Development, Room 7262, 451 Seventh Street SW., Washington, DC 20410; telephone

(202)708-1234; TTY number for the hearing- and speech-impaired

(202)708-2565, (these telephone numbers are not toll-free), or call the toll-free Title V information line at 1-800-927-7588. SUPPLEMENTARY INFORMATION: In accordance with the December 12, 1988 court order in *National Coalition for the Homeless* v. *Veterans Administration* , No. 88-2503-OG (D.D.C.), HUD publishes a Notice, on a weekly basis, identifying unutilized, underutilized, excess and surplus Federal buildings and real property that HUD has reviewed for suitability for use to assist the homeless. Today's Notice is for the purpose of announcing that no additional properties have been determined suitable or unsuitable this week. Dated: May 10, 2007. Mark R. Johnston, Deputy Assistant Secretary for Special Needs. [FR Doc. E7-9340 Filed 5-17-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5130-N-03] Privacy Act of 1974; New System of Records, Line of Credit Control System (LOCCS, A-67), HUD/CFO-03 AGENCY: Office of the Chief Information Officer, HUD. ACTION: Establish a New Privacy Act System of Records. SUMMARY: HUD proposes to establish a new record system to add to its inventory of systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The proposed new system of records identified as HUD/CFO-03, entitled Line of Credit Control System (LOCCS, A-67) will be used to monitor and manage payments and collections from persons doing business with HUD. DATES: *Effective Date:* This action will be effective without further notice on June 18, 2007 unless comments are received that would result in a contrary determination. *Comments Due Date:* June 18, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this new system of records to the Rules Docket Clerk, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10276, Washington, DC 20410-0500. Communications should refer to the above docket number and title. Facsimile

(Fax)comments are not acceptable. A copy of each communication submitted will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. FOR FURTHER INFORMATION CONTACT: Jeanette Smith, Departmental Privacy Act Officer, telephone number

(202)402-8062 or Gail B. Dise, Assistant Chief Financial Officer for Systems, telephone number

(202)402-3749. (These are not toll free numbers.) SUPPLEMENTARY INFORMATION: Title 5 U.S.C. 552a(e)(4) and

(11)provide that the public be afforded a 30-day period in which to comment on the new record system. The new system report, as required by 5 U.S.C. 552a(r) of the Privacy Act was submitted to the Committee on Homeland Security and Governmental Affairs of the United States Senate, the Committee on Government Reform and Oversight of the House of Representatives, and the Office of Management and Budget

(OMB)pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, Federal Agency Responsibilities for Maintaining Records About Individuals, dated June 25, 1993 (58 FR 36075, July 2, 1993). Authority: 5 U.S.C. 552a. Dated: May 7, 2007. Lisa Schlosser, Chief Information Officer. HUD/CFO-3 Name: Line of Credit Control Systems (LOCCS, A-67). System location: HUD Headquarters and field offices. Categories of individuals covered by the system: Grantees, subsidy, and project recipients; commercial vendors; builders, developers, contractors, and appraisers. Categories of records in the system: Vendors' name, address, social security number, bank account, bank routing number, income, financial data, funds control records, receivable records; and contract records; payment vouchers records; deposit and receipt records; disbursement and cancelled check records, subsidiary ledger records. Authority for maintenance of the system: Sec. 113 of the Budget and Accounting Act of 1950 31 U.S.C. 66a. (Pub. L. 81-784). Purpose (s): The purpose of the system of records is to monitor and manage payments and collections from persons doing business with HUD. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, other routine uses are as follows:

(a)To the U.S. Treasury—for disbursements and adjustments thereof;

(b)To the Internal Revenue Service—for reporting payments for goods and services and for reporting of discharge indebtedness; and

(c)To the Department of the Treasury to conduct computer matching programs for the purpose of matching LOCCS vendor information with Treasury vendor numbers to validate Tax Identification Numbers

(TIN)for individuals and companies. Disclosure to consumer reporting agencies: Disclosures pursuant to 5 U.S.C. 552a(b)(12). Pursuant to 5 U.S.C. 552a(b)(12), disclosures may be made from the record system to consumer reporting agencies as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f) or the Federal Claims Collection Act of 1966, 31 U.S.C. 3701(a)(3)). The disclosure is limited to information necessary to establish the identity of the vendor, including name, address and taxpayer identification number; the amount, status, and history of the claim, and the agency or program under which the claim arose for the sole purpose of allowing the consumer reporting agency to prepare a credit report. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Electronic files on stored primarily on Storage Area Network

(SAN)and back up files are stored on tapes. Retrievability: By name; schedule number; control number; receipt number; voucher number; contract number, and Grant Agreement number. Safeguards employed include: Background screening, limited authorizations and access, with access limited to authorized personnel and technical restraints employed with regard to accessing the records; access to automated systems by authorized users by passwords. Retention and disposal: Are in accordance with GSA schedules of retention and disposal. System Manager(s)and address: Assistant Chief Financial Office for Systems, Office of the Chief Financial Officer, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410. Notification procedure: For information assistance, or inquiry about existence of records, contact the Privacy Act Officer at the appropriate 451 Seventh Street, SW., Room 4176, Washington, DC 20410, in accordance with the procedures in 24 CFR part 16. Record access procedures: The Department's rules for providing access to records to the individual concerned appears in 24 CFR part 16. If additional information or assistance is required, contact the Privacy Act Officer at HUD, 451 Seventh Street, SW., Room 4176, Washington, DC 20410. Contesting record procedures: The procedures for requesting amendment or correction of records appear in 24 CFR part 16. If additional information is needed, contact

(i)in relation to contesting contents of records, the Privacy Act Officer at HUD, 451 Seventh Street, SW., Room 4178, Washington, DC 20410; and

(ii)in relation to appeals of initial denials, HUD, Departmental Privacy Appeals Officer, Office of General Counsel, 451 Seventh Street, SW., Washington, DC 20410. Record source categories: Subject individuals; other individuals; financial institutions, private corporations or firms doing business with HUD; federal and non-federal governmental agencies; HUD personnel. Exemptions from certain provisions of the Act: None. [FR Doc. 07-2456 Filed 5-17-07; 8:45 am]

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