Notices. Notice

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

BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0203] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; User Fee Cover Sheet; Form FDA 3397 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 September 28, 2006. 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. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (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. User Fee Cover Sheet; Form FDA 3397—(OMB Control Number 0910-0297)—Extension Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g and 379h), the Prescription Drug User Fee Act of 1992 (PDUFA) (Public Law 102-571), as amended by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115), and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (Public Law 107-188), FDA has the authority to assess and collect user fees for certain drug and biologics license applications and supplements. Under this authority, pharmaceutical companies pay a fee for certain new human drug applications, biologics license applications, or supplements submitted to FDA for review. Because the submission of user fees concurrently with applications and supplements is required, review of an application by FDA cannot begin until the fee is submitted. Form FDA 3397, the user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fee submitted for an application with the actual application by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research

(CDER)and Center for Biologics Evaluation and Research

(CBER)to initiate the administrative screening of new drug applications, biologics license applications, and supplemental applications. Respondents to this collection of information are new drug and biologics manufacturers. Based on FDA's database system for fiscal year

(FY)2005, there are an estimated 243 manufacturers of products subject to PDUFA. However, not all manufacturers will have any submissions, and some may have multiple submissions in a given year. The total number of annual responses is based on the number of submissions received by FDA in FY 2005. CDER estimates 3,085 annual responses that include the following submissions: 101 new drug applications; 3 biologics license applications; 1,915 manufacturing supplements; 921 labeling supplements; and 145 efficacy supplements. CBER estimates 676 annual responses that include the following submissions: 6 biologics license applications, 614 manufacturing supplements, 46 labeling supplements, and 10 efficacy supplements. Based on previous estimates, the rate of submissions is not expected to change significantly in the next few years. The estimated hours per response are based on past FDA experience with the various submissions, and range from 5 to 30 minutes. The hours per response are based on the average of these estimates. In the **Federal Register** of May 25, 2006 (71 FR 30144), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: Table 1.—Estimated Annual Reporting Burden 1 Form No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Respondent Total Hours FDA 3397 243 15.48 3,761 0.30 1,128 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: August 22, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-14266 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0327] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602) 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 proposed collection of information that will permit an applicant to certify that it qualifies as a “small business” within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA). DATES: Submit written or electronic comments on the collection of information by October 30, 2006. 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 Management Programs (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. MDUFMA Small Business Qualification Certification (Form FDA 3602)—(OMB Control Number 0910-0508)—Extension MDUFMA amends the Federal Food, Drug, and Cosmetic Act to provide for user fees for certain medical device applications. FDA published a **Federal Register** notice on August 2, 2006 (71 FR 43784), announcing fees for fiscal year

(FY)2007. To avoid harming small businesses, MDUFMA provides for reduced or waived fees for applicants who qualify as a “small business.” This means there are two levels of fees, a standard fee, and a reduced or waived small business fee. For FY 2006, you can qualify for a small business fee discount under MDUFMA if you reported gross receipts or sales of no more than $100 million on your Federal income tax return for the most recent tax year. If you have any affiliates, partners, or parent firms, you must add their gross receipts or sales to yours and the total must be no more than $100 million. If your gross receipts or sales are no more than $30 million (including all of your affiliates, partners, and parent firms), you will also qualify for a waiver of the fee for your first

(ever)premarket application (PMA, product development protocol (PDP), biologics licensing application (BLA), or Premarket Report). An applicant must pay the full standard fee unless it provides evidence demonstrating to FDA that it meets the “small business” criteria. The evidence required by MDUFMA is a copy of the most recent Federal income tax return of the applicant, and any affiliate, partner, or parent firm. FDA will review these materials and decide whether an applicant is a “small business” within the meaning of MDUFMA. Form FDA 3602 is available in guidance document, “Guidance for Industry and FDA: FY 2006 MDUFMA Small Business Qualification Worksheet and Certification.” This guidance describes the criteria FDA will use to decide whether an entity qualifies as a MDUFMA small business and will help prospective applicants understand what they need to do to meet the small business criteria for FY 2006 and subsequent fiscal years. *Description of Respondents* : Respondents will be businesses or other for-profit organizations. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 FDA Form Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 3602 2,000 1 2,000 1 2,000 Total Hours 2,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The burden is based on the number of applications received in the last 3 years. Dated: August 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-14267 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Allergenic Products 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). At least one portion of the meeting will be closed to the public. *Name of Committee* : Allergenic Products 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 September 13, 2006 from 12 noon to approximately 3:45 p.m. *Location* : National Institutes of Health, Bldg. 29B, Conference Rooms A and B, Bethesda, MD. *Contact Person* : Gail Dapolito or Jane Brown, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512388. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On September 13, 2006, the committee will discuss a proposed strategy for the reclassification of Category IIIA allergenic products. The committee will also receive an update of the research program of the Laboratory of Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic Products, Center for Biologics Evaluation and Research. *Procedure* : On September 13, 2006, from 12 noon to approximately 3:15 pm, the meeting is open to the public. 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 September 6, 2006. Oral presentations from the public will be scheduled between approximately 1:45 pm and 2:45 pm. Time allotted for each presentation may be limited. 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 September 6, 2006. *Closed Committee Deliberations* : On September 13, 2006 from approximately 3:15 pm to 3:45 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss individual research programs in the Office of Vaccines Research and Review. 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 Gail Dapolito 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: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-14295 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an amendment to the notice of meeting of the Cardiovascular and Renal Drugs Advisory Committee. This meeting was originally announced in the **Federal Register** of August 1, 2006 (71 FR 43487). The amendment is being made to reflect changes in the *Agenda* portion of the document. The word “TRASYOL” should read “TRASYLOL”. In the same paragraph, the word “apportioning” should read “aprotinin”. There are no other changes. FOR FURTHER INFORMATION CONTACT: Cathy Groupe, 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, 301-827-7001, FAX: 301-827-6778, e-mail: *Cathy.Groupe@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512533. Please call the information line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of August 1, 2006, FDA announced that the Cardiovascular and Renal Drugs Advisory Committee would meet on September 21, 2006, from 8 a.m. to 5 p.m., and the committee would discuss clinical data for aprotinin injection (trade name, TRASYLOL), an approved product, new drug application

(NDA)020-304, Bayer Pharmaceuticals). On page 43487, in the third column, the *Agenda* portion of the document is amended to read as follows: *Agenda* : The committee will discuss clinical data for aprotinin injection (trade name, TRASYLOL), an approved product, new drug application

(NDA)020-304, Bayer Pharmaceuticals) with the indication for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. This discussion follows a February 8, 2006, FDA Public Health Advisory for the use of aprotinin injection ( *www.fda.gov/cder/drug/advisory/aprotinin.htm* ). The background material for this meeting will be posted 1 business day before the meeting on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* under the heading “Cardiovascular and Renal Drugs Advisory Committee” (Click on the year 2006 and scroll down to the above named committee meeting.) This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-14294 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science; 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* : Clinical Pharmacology Subcommittee of the Advisory Committee for Pharmaceutical Science. *General Function of the Subcommittee* : To provide advice and recommendations to the Committee for Pharmaceutical Science on FDA's regulatory issues. *Date and Time* : The meeting will be held on October 18, 2006, from 8:30 a.m. to 5:30 p.m. and on October 19, 2006, from 8:30 a.m. to 1 p.m. *Location* : Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD. *Contact Person* : Mimi Phan, 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, 301-827-7001, FAX: 301-827-6801, e-mail: *mimi.phan@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in Washington, DC area), code 3014512539. Please call the Information Line for up-to-date information on this meeting. The background material will become available no later than the day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* under the heading “Advisory Committee for Pharmaceutical Science (ACPS).” (Click on the year 2006 and scroll down to ACPS meetings.) *Agenda* : On October 18, 2006, the subcommittee will:

(1)Receive an update on previous Clinical Pharmacology Subcommittee meeting recommendations and an introduction to three new topics of this meeting;

(2)discuss and provide comments on the first new topic: The scope and strength of evidence to support the inclusion of pharmacogenetic information on Cytochrome P2D6 polymorphisms in a revision of the label for tamoxifen to improve the benefit/risk of the drug; and

(3)discuss and provide comments on the second new topic: evaluation of transporter-based drug interactions. On October 19, 2006, the subcommittee will consider the third new topic: The impact of using prior knowledge on drug development and regulatory decisions. Prior knowledge of disease change over time and covariates, placebo variation and drug effects can be used to make better decisions and design more informative clinical trials. Examples will be used to demonstrate these principles. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person on or before October 3, 2006. Oral presentations from the public will be scheduled between approximately 11:15 a.m. and 11:45 a.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentation 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 October 3, 2006. 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 Mimi Phan 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: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-14296 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Cancellation AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The meeting of the Psychopharmacologic Drugs Advisory Committee scheduled for September 7, 2006, is cancelled. This amended meeting was announced in the **Federal Register** of August 17, 2006 (71 FR 47502). FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *cicely.reese@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. Please call the Information Line for up-to-date information on this meeting. Dated: August 23, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-14293 Filed 8-28-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0331] Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.” This draft guidance, when finalized, is intended to assist Institutional Review Boards (IRBs), clinical investigators, and sponsors in the development and conduct of emergency research.The draft guidance also describes the additional specific human subject protection requirements for emergency research. Elsewhere in this issue of the **Federal Register** , FDA is announcing a public hearing on emergency research conducted without informed consent under FDA regulations. DATES: Submit written or electronic comments on the draft guidance by October 30, 2006. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Policy (HF-11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit phone requests to 800-835-4709 or 301-827-1800. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Carolyn Hommel, Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane Rockville, MD 20857, 301-827-3340. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research.” This draft guidance was developed to assist IRBs, clinical investigators, and sponsors in the development and conduct of emergency research, that is, research in emergency settings when an exception from the informed consent requirements is requested under FDA's emergency research regulation. Further, the draft guidance describes the additional specific human subject protection requirements for emergency research, such as community consultation and public disclosure activities, the need for the concurrence of a licensed physician, use of data monitoring committees, use of independent IRBs, and the documentation of efforts to contact a subject's legally authorized representative or family member regarding the subject's participation in the study. In addition to the draft guidance, FDA is holding a public hearing on emergency research conducted without informed consent under FDA regulations. The public hearing is designed to solicit the views of individuals and groups affected by challenges encountered in the conduct of emergency research in the absence of informed consent, including patient advocacy groups, individuals who have participated in clinical trials, IRB members, sponsors, clinical investigators, medical societies, ethicists, and other interested parties. FDA will consider comments and suggestions received at the hearing together with any comments received on the draft guidance to determine whether the current framework is adequate for the ethical conduct of emergency research, or whether modifications would be appropriate. Under the regulations in 21 CFR 50.24, and the conforming amendments contained in 21 CFR parts 56, 312, 314, 601, 812, and 814, an exception may be requested from the requirement to obtain informed consent from each subject, or the subject's legally authorized representative, prior to enrollment in a clinical investigation. The narrow exception applies to emergency research for which, among other things, the following conditions exist:

(1)An investigational new drug application

(IND)or investigational device exemption application

(IDE)is required;

(2)that involves human subjects who have a life-threatening medical condition (for which available treatments are unproven or unsatisfactory);

(3)that involves subjects who because of their medical condition (e.g., unconsciousness) cannot give informed consent; and

(4)where, to be effective, the intervention must be administered before informed consent from the subjects' legally authorized representative is feasible. Studies involving an exception from the general requirement of informed consent may proceed only after a sponsor has received prior written permission from FDA, and the IRB has found and documented that specific conditions have been met. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the exception from informed consent requirements for emergency research. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 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 part 56 (21 CFR part 56) have been approved under OMB control number 0910-0130, the collections of information in part 312 (21 CFR part 312) have been approved under OMB control number 0910-0014, and the collections of information in part 812 (21 CFR part 812) have been approved under OMB control number 0910-0078. Modifications to these approved information collection requirements are underway or will be made at the time that each information collection is renewed. The agency believes that this is appropriate because this guidance has only a minor impact on these existing collections of information. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: August 21, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-14262 Filed 8-25-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Training in Primary Care Medicine and Dentistry; 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 Committee on Training in Primary Care Medicine and Dentistry. *Date and Time:* September 28, 2006, 8:30 a.m.-5 p.m. and September 29, 2006, 8 a.m.-3 p.m. *Place:* Hilton Hotel, 620 Perry Parkway, Gaithersburg, Maryland 20877. *Status:* The meeting will be open to the public. *Purpose:* The Advisory Committee provides advice and recommendations on a broad range of issues dealing with programs and activities authorized under section 747 of the Public Health Service Act as amended by The Health Professions Education Partnership Act of 1998, Public Law 105-392. At this meeting the Advisory Committee will work on its sixth report which will be submitted to Congress and to the Secretary of the Department of Health and Human Services. The report will focus on the role of Title VII, section 747 grant programs in preparing primary care practitioners to care for underserved high-risk groups and vulnerable populations. *Agenda:* The meeting on Thursday, September 28, will begin with opening comments from the Chair of the Advisory Committee and introductory remarks from senior management of the Health Resources and Services Administration. A plenary session will follow in which there will be a brief review of six papers commissioned for the Advisory Committee's sixth report. The Advisory Committee will develop a definition of “vulnerability” for the report. In both small groups and in the plenary session, the Advisory Committee will determine recommendations for the report. There will be an annual election for chair and two vice chairs. An opportunity will be provided for public comment. On Friday, September 29, the Advisory Committee will discuss in the plenary session how the commissioned papers will be used in the sixth report, determine an initial outline for the report, and discuss how grantee data will be incorporated. Small groups will draft a report abstract, expand the report's outline, and determine commentary to accompany grantee data. Grantee anecdotal information will also be considered for the report. The Advisory Committee will plan next steps in the report preparation process. An opportunity will be provided for public comment. *For Further Information Contact:* Anyone interested in obtaining a roster of members or other relevant information should write or contact Jerilyn K. Glass, M.D., Ph.D., Division of Medicine and Dentistry, Bureau of Health Professions, Health Resources and Services Administration, Room 9A-27, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone

(301)443-6785. The Web address for information on the Advisory Committee is *http://bhpr.hrsa.gov/medicine-dentistry/actpcmd.* Dated: August 21, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-14271 Filed 8-28-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of availability of Draft Policy Documents for Comment AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice of availability and solicitation of comments. SUMMARY: This is a Notice of Availability and request for comments on certain draft policy documents prepared by HRSA's Bureau of Primary Health Care (BPHC). HRSA plans to periodically make some draft policy documents (including draft Program Information Notices (PINs)) available for public comment on the Internet at *http://bphc.hrsa.gov* . Comments will be reviewed and analyzed, and a summary and general response will be published as soon as possible after the deadline for receipt of comments. DATES: We must receive comments on or before the due date specified for each document. ADDRESSES: Addresses to which comments should be sent will be provided on the HRSA Web site along with each draft document. Background: HRSA administers the Consolidated Health Center Program, which supports more than 3,700 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low income and minorities, and deliver preventive and primary care services to patients regardless of their ability to pay. Charges for health care services are set according to income. HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Consolidated Health Center Program. Therefore, HRSA will periodically, as appropriate, solicit comments on some policies and policy documents via the HRSA Web site. This will provide all interested parties with equal access to the proposed document and an opportunity to comment. In some cases, HRSA may solicit comments on new, proposed policies. In other cases, HRSA may seek comments on documents that represent a written statement of an already-existing policy. In these situations, although the policy is being actively applied during the comment period, the written document may be adjusted after the comments are reviewed and analyzed. FOR FURTHER INFORMATION CONTACT: For questions regarding the process described above, please contact Shannon Dunne Faltens, Senior Public Health Analyst, Division of Policy and Development, Bureau of Primary Health Care, at *sdunne-faltens@hrsa.gov.* SUPPLEMENTARY INFORMATION: Note that HRSA will not publish an individual **Federal Register** notice for each document made available for public comment. The applicability of this notice to BPHC policy documents expires 2 years from the date of publication of this notice. Within one year after the publication of this notice, HRSA will publish a second notice to ensure that the public remains aware of this process. **Federal Register** notices will continue to be published inviting public comment on all information collection activities that fall under the purview of the Paperwork Reduction Act of 1995. Dated: August 17, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-14272 Filed 8-28-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [DHS-2006-0045] Data Privacy and Integrity Advisory Committee AGENCY: Office of the Secretary, Department of Homeland Security. ACTION: Notice of Federal Advisory Committee meeting. SUMMARY: This notice announces the date, time, location, and agenda for the next meeting of the Department of Homeland Security Data Privacy and Integrity Advisory Committee. This meeting will be open to the public, with the exception of a one-hour administrative session. DATES: The meeting will be held from 8 a.m. to 11:30 a.m. and 2 p.m. to 5 p.m. on Wednesday, September 20, 2006, in Arlington, Virginia. ADDRESSES: The Department of Homeland Security Data Privacy and Integrity Advisory Committee meeting will be held in the Town Hall at the Transportation Security Administration, 601 South 12th Street, Arlington, Virginia 22202. Persons wishing to make comments or who are unable to attend or speak at the meeting may submit comments at any time. Comments must be identified by DHS-2006-0045 and may be submitted by any one of the following methods: • Federal Rulemaking Portal: *http://www.regulations.gov.* Follow instructions for submitting comments on the Web site. • E-mail: *PrivacyCommittee@dhs.gov.* Include docket number in the subject line of the message. • Fax: 571-227-4171. • Mail: Ms. Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Mail Stop D-3, Arlington, Virginia 22202. *Instructions:* All submissions received must include the Department of Homeland Security and DHS-2006-0045, the docket number for this action. Comments received will also be posted without alteration at *www.regulations.gov,* including any personal information provided. *Docket:* For access to the docket to read background documents or comments received by the DHS Data Privacy and Integrity Committee, go to *http://www.regulations.gov.* Comments received will be posted without alteration at *www.dhs.gov/privacy,* including any personal information provided. FOR FURTHER INFORMATION CONTACT: Hugo Teufel III, Chief Privacy Officer, or Rebecca J. Richards, Executive Director, Data Privacy and Integrity Advisory Committee, Department of Homeland Security, Arlington, Virginia 22202, by telephone

(571)227-3813, by facsimile

(571)227-4171, or by e-mail *PrivacyCommittee@dhs.gov.* SUPPLEMENTARY INFORMATION: The Data Privacy and Integrity Advisory Committee (“Privacy Advisory Committee”) will be meeting on Wednesday, September 20, 2006, in the Town Hall at the Transportation Security Administration, 601 South 12th Street, Arlington, Virginia 22202. The meeting will be held from 8 a.m. to 11:30 a.m. and 2 p.m. to 5 p.m. At the meeting, the Chief Privacy Officer will provide an update on the activities of the Privacy Office. The subcommittees will update the Committee on the work currently being conducted. In the morning and afternoon sessions, invited speakers will discuss screening, redress, and data integrity. A tentative agenda has been posted on the Privacy Advisory Committee Web site at *www.dhs.gov/privacy.* Public comments will be accepted during the meeting between 4:30 p.m. and 5 p.m. All those who wish to testify during this time may register in advance or sign-up on the day of the meeting. In order to allow as many people as possible to testify, witnesses should limit their remarks to three minutes. For those wishing to make written comments, please follow the procedure noted above. Public attendance is encouraged. Any member of the public who wishes to attend the public session is requested to provide his or her name and affiliation no later than 2 p.m. EST, Tuesday, September 19, 2006, to Rebecca J. Richards via e-mail at *PrivacyCommittee@dhs.gov,* or via telephone at

(571)227-3813. This will assist with the preparation of name badges, meeting materials and seating arrangements. Everyone who plans to attend is respectfully requested to be present and seated by 7:45 a.m. for the morning session and by 1:45 p.m. for the afternoon session. All attendees are required to enter the Transportation Security Administration building through the Visitors' Center located to the left of the main entrance. Identification is required for all visitors to enter the building. Name badges will be issued to identify meeting attendees. Persons with disabilities who require special assistance should indicate this in their admittance request and are encouraged to identify anticipated special needs as early as possible. Although every effort will be made to accommodate all members of the public, seating is limited and will be allocated on a first-come, first-served basis. Hugo Teufel III, Chief Privacy Officer. [FR Doc. E6-14321 Filed 8-28-06; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5041-N-31] Notice of Proposed Information Collection: Comment Request; Submission Requirements for the Section 202 Supportive Housing for the Elderly and the Section 811 Supportive Housing for Persons With Disabilities Capital Advance Programs AGENCY: Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below will be 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. DATES: *Comments Due Date:* October 30, 2006. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Lillian Deitzer, Reports Management Officer, Department of Housing and Urban Development, 451 7th Street, SW., L'Enfant Plaza Building, Room 8003, Washington, DC 20410 or *Lillian_Deitzer@hud.gov.* FOR FURTHER INFORMATION CONTACT: Willie Spearmon, Director, Office of Housing Assistance and Grants Administration, U.S. Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410, telephone

(202)708-3000 (this is not a toll free number) for copies of the proposed forms and other available information. SUPPLEMENTARY INFORMATION: The Department is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended). This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to:

(1)Evaluate whether the proposed collection 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 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:* Submission Requirements for the Section 202 Supportive Housing for the Elderly and the Section 811 Supportive Housing for Persons with Disabilities Capital Advance Programs. *OMB Control Number, if applicable:* 2502-0470. *Description of the need for the information and proposed use:* This submission, for which the Department is requesting clearance, is to permit the continued processing of all Sections 202 and 811 capital advance projects that have not yet been finally closed. The submission includes processing of the application for firm commitment to final closing of the capital advance. The information collection is needed to assist HUD in determining the Owner's eligibility and capacity to finalize the development of a housing project under the Section 202 and Section 811 Capital Advance Programs. A thorough evaluation of an Owner's capabilities is critical to protect the Government's financial interest, and to mitigate any possibility of fraud, waste and mismanagement of public funds. *Agency form numbers, if applicable:* HUD-: 2453.1-CA, 2554, 90163-CA, 90164-CA, 90165-CA, 90166A-CA, 90166-CA, 90167-CA, 90169-CA, 90169.1-CA, 90170-CA, 90171-CA, 90172A-CA, 90172B-CA, 90173-A-CA, 90173-B-CA, 90173-C-CA, 90174-CA, 90175-CA, 90175.1-CA, 90176-CA, 90177-CA, 90178-CA, 90179-CA, 91732A-CA, 92434-CA, 92435-CA, 92466.1-CA, 92452, 92452-A, 92452-CA, 92476-A-CA, 92004-F, 92433-CA, 92443-CA, 92450-CA, 92466-CA, 92476-A, 93432-CA, 93566-CA, and 93566.1-CA. *Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response:* The estimated number of burden hours needed to prepare the information collection is 8,413. The number of respondents is 260 generating approximately 2,500 annual responses; the frequency of response is monthly, annually, and on occasion; and the estimated time needed to prepare the response varies from 30 minutes to 6 hours. *Status of the proposed information collection:* Revision of a currently approved collection. Authority: The Paperwork Reduction Act of 1995, 44 U.S.C., Chapter 35, as amended. Dated: August 24, 2006. Frank L. Davis, General Deputy Assistant Secretary for Housing-Deputy Federal Housing Commissioner. [FR Doc. E6-14350 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket Nos. FR-4723-FA-09, FR-4800-FA-19, FR-4900-FA-17, and FR-4950-FA-14] Announcement of Funding Awards for the Housing Opportunities for Persons with AIDS (HOPWA) Program, Fiscal Years 2002, 2003, 2004, and 2005 AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice of funding awards. SUMMARY: In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of past funding decisions made by the Department in a competition for funding under the 2002, 2003, 2004 and 2005 Notices of Funding Availability (NOFAs) for the Housing Opportunities for Persons with AIDS (HOPWA) program. This announcement contains the names of the awardees and the amounts of the awards made available by HUD in 2002, 2003, 2004 and 2005. **Federal Register** notices on these actions were not published at the time; however, the public was advised of these grant selections since they were posted on HUD's Web site. The postings contained listings of the selected applicants including descriptions of the projects. FOR FURTHER INFORMATION CONTACT: David Vos, Director, Office of HIV/AIDS Housing, Office of Community Planning and Development, 451 Seventh Street, SW., Room 7212, Washington, DC 20410-7000; telephone

(202)708-1934 (this is not a toll-free number). Hearing- and speech-impaired persons may access this number via TTY by calling the Federal Relay Service toll-free at

(800)877-8339. For general information on this and other HUD programs, call Community Connections at

(800)998-9999 or visit the HUD Web site at *http://www.hud.gov.* SUPPLEMENTARY INFORMATION: The HOPWA program competition was designed to award grants for the renewal of continuing permanent supportive housing activities and for new projects, referred to as Special Projects of National Significance, that provide housing assistance and supportive services to persons and their families living with HIV/AIDS. Funds were made available for a three-year operating period starting the year following the respective competition. New project grants were made under two categories of assistance:

(1)Special Projects of National Significance which, due to their innovative nature or their potential for replication, are likely to serve as effective models in addressing the needs of low-income persons living with HIV/AIDS and their families; and

(2)projects which are part of Long-Term Comprehensive Strategies (Long-Term) for providing housing and related services for low-income persons living with HIV/AIDS and their families in areas that do not receive HOPWA formula allocations. For the Fiscal Year 2002 competition, a total of $28,755,493 was provided to 28 grant recipients nationwide. For the Fiscal Year 2003 competition, a total of $25,935,009 was provided to 25 grant recipients nationwide. For the Fiscal Year 2004 competition, a total of $20,175,475 was provided to 22 grant recipients nationwide. For the Fiscal Year 2005 competition, a total of $37,501,089 was provided to 35 grant recipients nationwide. Project information for all years was made available on the Department's Web site. Notices on these grant selections were inadvertently not published at the time in the **Federal Register** . The HOPWA assistance made available in this announcement was authorized by the AIDS Housing Opportunity Act (42 U.S.C. 12901), as amended by the Housing and Community Development Act of 1992 (Pub. L. 102-550, approved October 28, 1992) and was appropriated by the HUD Appropriations Act for 2001. The grants competitions were included within the SuperNOFA (Notice of Funding Availability) announcements for HUD's Discretionary Programs published in the **Federal Register** on March 26, 2002 (67 FR 14457) for the Fiscal Year 2002 competition; April 25, 2003 (68 FR 21741) for the Fiscal Year 2003 competition; May 14, 2004 (69 FR 27633) for the Fiscal Year 2004 competition; and March 21, 2005 (70 FR 14110) for the Fiscal Year 2005 competition. Applications were reviewed and rated on the basis of selection criteria contained in each corresponding NOFA. This notice fulfills a required grants management action. Dated: August 3, 2006. Pamela H. Patenaude, Assistant Secretary for Community Planning and Development. Fiscal Year 2002 Funding Awards for the HOPWA Program Recipient State Amount Alaska Housing Finance Corporation AK $740,800.00 AIDS Alabama, Inc AL 480,580.00 Tenderloin AIDS Resource Center CA 1,302,645.00 Alameda Co. Housing and Community Development Corporation CA 1,370,000.00 Maui AIDS Foundation HI 1,324,743.00 Gregory House Programs HI 50,000.00 Travelers and Immigrants Aid/Chicago Connections IL 1,151,382.00 AIDS Foundation of Chicago IL 1,293,331.00 Pioneer Civic Services IL 440,166.00 Kansas Department of Health and Environment KS 1,370,000.00 Kentucky Housing Corporation KY 50,000.00 Desire Community Housing Corp LA 1,279,890.00 Action, Inc MA 1,292,869.00 Baltimore City Dept. of Housing & Community Development MD 1,370,000.00 Maryland Dept. of Health & Mental Hygiene, AIDS Foundation MD 1,139,977.00 AIDS Project ME 895,913.00 Clare Housing MN 1,150,583.00 Interfaith Residence dba Doorways MO 1,322,930.00 New Hampshire, Division of Behavioral Health, Office of Homeless and Housing Services NH 908,000.00 New Jersey Department of Health and Human Services NJ 925,653.00 United Bronx Parents, Inc NY 1,227,143.00 Bailey House Inc NY 1,286,000.00 Greyston Health Services, Inc NY 1,141,814.00 Oregon Housing and Community Services OR 706,965.00 Tarrant Co TX 813,346.00 Vermont Housing and Conservation Board VT 1,073,048.00 Downtown Emergency Service Center WA 1,307,305.00 Spokane Co. Community Services Dept WA 1,340,410.00 Total 28,755,493.00 Fiscal Year 2003 Funding Awards for the HOPWA Program Recipient State Amount Alaska Housing Finance Corporation AK $731,120.00 Cochise County AZ 677,377.00 San Jose City CA 1,323,800.00 San Francisco Redevelopment Agency CA 1,286,000.00 The Salvation Army Alegria Program CA 1,010,991.00 I.M. Sulzbacher Center for the Homeless FL 1,186,841.00 City of Savannah, Georgia GA 299,278.00 Gregory House Programs HI 1,080,000.00 Idaho Housing And Finance Assn ID 1,314,000.00 Interfaith Residence, dba Doorways IL 342,238.00 AIDS Foundation of Chicago IL 1,280,742.00 Commonwealth of Kentucky KY 496,608.00 Community Healthlink, Inc MA 1,286,000.00 Cambridge Cares about AIDS, Inc MA 1,335,524.00 Health Care for the Homeless, Inc MD 1,083,657.00 Frannie Peabody Center ME 1,327,675.00 City of Detroit Health Department MI 1,370,000.00 Nebraska Dept. Health and Human Services NE 1,357,192.00 State of New Hampshire NH 607,545.00 The Fortune Society, Inc NY 1,132,788.00 Our House of Portland OR 1,306,963.00 Asociacion de Puertorriquenos en Marcha, Inc PA 1,286,000.00 Virgin Islands Community AIDS Resource and Education VI 1,158,225.00 Burlington Housing Authority VT 368,445.00 AIDS Resource Center of Wisconsin WI 1,286,000.00 Total 25,935,009.00 Fiscal Year 2004 Funding Awards for the HOPWA Program Recipient State Amount AIDS Alabama, Inc AL $616,405.00 Pima County, Arizona, Community Development and Neighborhood Conservation Department AZ 945,443.00 Housing Services Affiliate of the Bernal Heights Neighborhood Ctr CA 537,270.00 Del Norte Neighbor Development Corporation CO 489,036.00 Delaware HIV Consortium DE 734,000.00 City of Key West, Community Development Office FL 1,422,000.00 City of Savannah, Community Planning and Development Division GA 710,696.00 Cornerstone Services, Inc IL 773,628.00 Lexington-Fayette Urban County Government, Division of Community Development KY 1,426,690.00 UNITY for the Homeless, Inc LA 540,139.00 Justice Resource Institute MA 1,137,716.00 Salvation Army MN 368,731.00 State of Montana, Department of Public Health and Human Services MT, ND & SD 1,450,800.00 Harbor Homes, Inc NH 525,457.00 Santa Fe Community Housing Trust NM 1,215,680.00 Church Avenue Merchants Block Association, Inc (CAMBA) NY 822,154.00 State of Oregon Department of Human Services OR 1,455,000.00 Rhode Island Housing and Mortgage Finance Corp (Sunrise Project) RI 1,265,606.00 Rhode Island Housing and Mortgage Finance Corp. (New Transitions Project) RI 766,355.00 AIDS Resource Center of Wisconsin WI 1,364,000.00 State of West Virginia Office of Economic Opportunity WV 1,001,581.00 State of Wyoming Department of Health WY 607,088.00 Total 20,175,475.00 Fiscal Year 2005 Funding Awards for the HOPWA Program Recipient State Amount AIDS Alabama AL $502,679.00 Health Services Center, Inc AL 572,331.00 Alaska Housing Finance Corporation AK 757,675.00 County of Alameda CA 1,425,362.00 The Salvation Army, a California Corporation CA 281,326.00 Stanislaus Community Assistance Project CA 1,244,488.00 East Oakland Community Project CA 1,287,500.00 Colorado Health Network DBA Colorado AIDS Project CO 730,643.00 Connections Community Support Programs, Inc DE 1,339,000.00 Gulf Coast Jewish Services, Inc FL 1,339,000.00 Maui AIDS Foundation HI 1,381,120.00 AIDS Foundation of Chicago IL 1,132,016.00 Cornerstone Services, Inc IL 1,192,264.00 Heartland Human Care Services, Inc IL 1,020,510.00 Heartland Human Care Services, Inc IL 1,339,000.00 Pioneer Civic Services IL 406,443.00 Kentucky Housing Corporation KY 1,027,915.00 Odyssey House Louisiana, Inc LA 1,388,000.00 Frannie Peabody Center ME 990,976.00 City of Baltimore Heath Department MD 1,300,974.00 AIDS Interfaith Residential Services, Inc MD 1,018,355.00 State of Montana, Department of Public Health and Human Services MT 1,429,307.00 State of New Hampshire NH 824,120.00 City of Nashua, NH, Division of Public Health & Community Services NH 1,360,232.00 Bailey House, Inc NY 991,478.00 United Bronx Parents, Inc NY 1,338,999.00 Greyston Health Services NY 1,239,639.00 Regional HIV/AIDS Consortium NC 1,190,276.00 Calcutta House, Inc PA 741,268.00 Tarrant County TX 916,010.00 Alamo Area Resource Center TX 1,209,281.00 City of Dallas TX 773,839.00 State of Vermont VT 1,227,657.00 Spokane County WA 1,151,406.00 State of West Virginia, Office of Economic Opportunities WV 1,430,000.00 Total 37,501,089.00 [FR Doc. E6-14250 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-4800-FA-17] Announcement of Funding Awards for the Self-Help Homeownership Opportunity Program; Fiscal Year 2003 AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice of funding awards. SUMMARY: In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department in a competition for funding under the Notice of Funding Availability

(NOFA)for the Self-Help Homeownership Opportunity Program (SHOP). This announcement contains the names of the awardees and the amounts of the awards made available by HUD. FOR FURTHER INFORMATION CONTACT: Clifford Taffet, Deputy Director, Office of Affordable Housing Programs, Office of Community Planning and Development, 451 Seventh Street, SW., Room 7162, Washington, DC 20410-7000; telephone

(202)708-2684 (this is not a toll-free number). Hearing- and speech-impaired persons may access this number via TTY by calling the Federal Relay Service toll-free at 1-800-877-8339. For general information on this and other HUD programs, call Community Connections at 1-800-998-9999 or visit the HUD Web site at *http://www.hud.gov.* SUPPLEMENTARY INFORMATION: The Fiscal Year 2002 Self-Help Homeownership Opportunity Program competition is designed to facilitate and encourage innovative homeownership opportunities through self-help housing where the homebuyer contributes a significant amount of sweat-equity toward the construction of the new dwelling. Applicants must be a national or regional nonprofit organization or consortium. The competition was announced in the SuperNOFA published March 26, 2002 (67 FR 14157). The NOFA allowed for approximately $22,000,000 for SHOP. Applications were rated and selected for funding on the basis of selection criteria contained in that Notice. For the Fiscal Year 2002 competition, a total of $22,000,000 was awarded to five projects nationwide. In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), the Department is publishing the grantees and amounts of the awards in Appendix A to this document. Dated: August 3, 2006. Nelson R. Bregon, General Deputy Assistant Secretary for Community Planning and Development. Fiscal Year 2002 Funding Awards for Self-Help Homeownership Opportunity Programs Recipient State Amount Habitat for Humanity International GA $10,809,000.00 Housing Assistance Council DC 6,861,000.00 PPEP Microbusiness and Housing Development Corporation AZ 2,356,000.00 Community Frameworks WA 1,623,000.00 ACORN Housing Corporation IL 351,000.00 Total 22,000,000.00 [FR Doc. E6-14348 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5086-N-01] Robert L. Woodson, Jr., Award: Changes to the Award Program AGENCY: Office of General Counsel, HUD. ACTION: Notice. SUMMARY: In 2004, HUD established the Robert L. Woodson, Jr., Award (Woodson Award) as an annual award program of America's Affordable Communities Initiative. The award program was established to recognize state and local governments for excellence in providing affordable housing through regulatory reduction. Through this notice, HUD announces its intention to alter the award process in order to provide more flexibility in the nomination and selection of award recipients. HUD intends to eliminate time restrictions for submitting applications that nominate jurisdictions for exhibiting outstanding leadership in reducing regulatory burden. This notice would eliminate the current time restrictions for submitting applications for the Woodson Award. This notice would allow applications to be submitted at any time during the calendar year, and allow HUD to announce Woodson Award winners at any time during the year. This added flexibility should help encourage creativity in reducing regulatory barriers to affordable housing. FOR FURTHER INFORMATION CONTACT: Camille E. Acevedo, Associate General Counsel for Legislation and Regulations, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 10282, Washington, DC 20410-0500, telephone

(202)708-1793 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at

(800)877-8339. SUPPLEMENTARY INFORMATION: In 2003, HUD established America's Affordable Communities Initiative

(AACI)as a departmentwide effort designed to help communities across America identify and overcome regulatory barriers that impede the availability of affordable housing, as well as help HUD identify its own regulations that present barriers to the development of affordable housing. The Robert L. Woodson, Jr., Award, named in memory and in honor of HUD's late Chief of Staff, is designed to recognize state and local governments that aggressively work toward and have had success in the reduction of regulatory barriers to affordable housing. The award program currently provides for nominations of jurisdictions to be submitted on an annual basis in March, with nominations reviewed and jurisdictions selected for awards generally by June of each year. In the first 2 years of the award program, one state agency and 17 communities from across the country received the Woodson Award. As HUD reaches out to communities throughout the year, through AACI or other HUD initiatives, it strives to encourage efforts and activities to bring affordable housing within reach of all Americans. HUD has decided that it would be better to honor communities for being successful in regulatory reform at various times of the year, rather than only annually. HUD believes that a more frequent focus on states and communities that have successfully increased the supply of affordable housing through regulatory reform will better promote awareness of the effectiveness of this policy priority in creating affordable housing opportunities. The change may also help maintain an active national discussion of this important subject. In addition, the more immediate dissemination of the successful steps taken by the honorees to expand affordable housing may also be of immediate assistance to other communities exploring similar ideas. This notice announces that, commencing with Fiscal Year 2007 (which begins October 1, 2006), state and local governments can be nominated for and receive a Woodson Award at any point during the year. In addition to the benefits that HUD sees through this change in the award program, HUD also believes that it will reduce the burden on those who desire to nominate state and local governments by eliminating the time constraints imposed by a set application date. This change will enable jurisdictions to apply for an award when they are best prepared to do so. Additional information about the Robert L. Woodson, Jr., Award program, and the recipients honored to date, and America's Affordable Communities Initiative can be found at *http:// www.hud.gov/affordablecommunities.* Dated: August 21, 2006. A. Bryant Applegate, Senior Counsel and Director of America's Affordable Communities Initiative. [FR Doc. E6-14249 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-4950-FA-33] Announcement of Funding Awards for the Housing Opportunities for People Who Are Homeless and Addicted to Alcohol Program; Fiscal Year 2005 AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice of funding awards. SUMMARY: In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department in a competition for funding under the Notice of Funding Availability

(NOFA)for the Housing Opportunities for People who are Homeless and Addicted to Alcohol Program. This announcement contains the names of the awardees and the amounts of the awards made available by HUD. FOR FURTHER INFORMATION CONTACT: Robyn Raysor, Deputy Director, Office of Special Needs Assistance Programs, Office of Community Planning and Development, 451 Seventh Street, SW., Room 7262, Washington, DC 20410-7000; telephone

(202)708-4300 (this is not a toll-free number). Hearing- and speech-impaired persons may access this number via TTY by calling the Federal Relay Service toll-free at

(800)877-8339. For general information on this and other HUD programs, call Community Connections at

(800)998-9999 or visit the HUD Web site at *http://www.hud.gov.* SUPPLEMENTARY INFORMATION: The Fiscal Year 2005 Housing Opportunities for People who are Homeless and Addicted to Alcohol Program was designed to provide supportive housing assistance to chronically homeless persons who have been living on the streets for at least three-hundred sixty-five

(365)days over the last five

(5)years and have a long term addiction to alcohol, otherwise known as serial inebriates. Clients served by these funds will have been living on the streets at the time of initial contact and will have no history of living in transitional or permanent housing over the last five years. The competition was announced in the SuperNOFA published March 21, 2005 (70 FR 14135). The NOFA allowed for approximately $10,000,000 to award approximately ten two-year grants that averaged approximately $1,000,000 per award. Applications were rated and selected for funding on the basis of selection criteria contained in that Notice. For the Fiscal Year 2005 competition, a total of $10,000,000 was awarded to 12 program providers nationwide. Public Law 108-7, approved February 20, 2003 (111 Stat. 494) authorizes this two-year demonstration program. The Supportive Housing Program is authorized by Title IV, Subtitle C, of the Stewart B. McKinney-Vento Homeless Assistance Act (McKinney-Vento Act), 42 U.S.C. 11381. In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), the Department is publishing the names of grantees and amounts of awards in Appendix A to this document. Dated: August 3, 2006. Nelson R. Bregon, General Deputy Assistant Secretary for Community Planning and Development. Appendix A—Fiscal Year 2005 Funding Awards for the Housing Opportunities for People Who Are Homeless and Addicted to Alcohol Program Recipient State Amount South East Tennessee Human Resource Agency TN $993,436.00 Community Mental Health Council, Inc IL 248,595.00 Contra Costa Health Services CA 990,307.00 Colorado Coalition for the Homeless CO 990,495.00 Emergency Services and Homeless Coalition of Jacksonville FL 894,150.00 Common Ground Community, Inc NY 803,628.00 Project Renewal, Inc NY 633,416.00 San Francisco Department of Public Health CA 982,033.00 ECH Lifebuilders CA 992,339.00 Santa Cruz County Health Services Agency CA 701,840.00 City of Santa Monica CA 712,489.00 Pathways to Housing DC DC 991,933.00 Total 9,934,661.00 [FR Doc. E6-14344 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket Nos. FR-4900-FA-15 and FR-4951-FA-03] Announcement of Funding Awards for the Self-Help Homeownership Opportunity Program; Fiscal Years 2004 and 2005 AGENCY: Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice of funding awards. SUMMARY: In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department in a competition for funding under the Notice of Funding Availability

(202)708-2684 (this is not a toll-free number). Hearing- and speech-impaired persons may access this number via TTY by calling the Federal Relay Service toll-free at 1-800-877-8339. For general information on this and other HUD programs, call Community Connections at 1-800-998-9999 or visit the HUD Web site at *http://www.hud.gov* . SUPPLEMENTARY INFORMATION: The Fiscal Years 2004 and 2005 Self-Help Homeownership Opportunity Program competitions were designed to facilitate and encourage innovative homeownership opportunities through self-help housing where the homebuyer would contribute a significant amount of sweat-equity toward the construction of the new dwelling. Applicants were required to be a national or regional nonprofit organization or consortium. The competitions were announced in the SuperNOFAs published May 14, 2004 (69 FR 27359) for the Fiscal Year 2004 competition and September 8, 2005 (70 FR 53490) for the Fiscal Year 2005 competition. The NOFA allowed for approximately $26,840,700 for SHOP for the Fiscal Year 2004 competition and approximately $24,800,000 for SHOP for the Fiscal Year 2005 competition. Applications were rated and selected for funding on the basis of selection criteria contained in that Notice. For the Fiscal Year 2004 competition, a total of $26,840,700 was awarded to three projects nationwide. For the Fiscal Year 2005 competition, a total of $24,800,000 was awarded to four projects nationwide. In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989 (103 Stat. 1987, 42 U.S.C. 3545), the Department is publishing the grantees and amounts of the awards in Appendix A to this document. Dated: August 3, 2006. Nelson R. Bregon, General Deputy Assistant Secretary for Community Planning and Development. Appendix A Fiscal Year 2004 Funding Awards for Self-Help Homeownership Opportunity Programs Recipient State Amount Habitat for Humanity International GA $14,000,000 Housing Assistance Council DC 10,000,000 PPEP Microbusiness and Housing Development Corporation AZ 2,840,700 Total 26,840,700 Fiscal Year 2005 Funding Awards for Self-Help Homeownership Opportunity Programs Recipient State Amount ACORN Housing Corporation IL $527,000 Community Frameworks WA 4,500,000 Housing Assistance Council DC 9,000,000 Habitat for Humanity International GA 10,773,000 Total 24,800,000 [FR Doc. E6-14345 Filed 8-28-06; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Geological Survey Request for Public Comments on Information Collection To Be Submitted to the Office of Management and Budget for Review Under the Paperwork Reduction Act A request extending the collection of information listed below will be submitted to the Office of Management and Budget for approval under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35). Copies of the proposed collection of information and related forms may be obtained by contacting the USGS Clearance Officer at the phone number listed below. Comments and suggestions on the requirement should be made within 60 days directly to the USGS Clearance Officer, U.S. Geological Survey, 807 National Center, Reston, VA 20192. As required by OMB regulations at CFR 1320.8(d)(1), the U.S. Geological Survey solicits specific public comments regarding the proposed information collection as to: 1. Whether the collection of information is necessary for the proper performance of the functions of the USGS, including whether the information will have practical utility; 2. The accuracy of the USGS estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; 3. The utility, quality, and clarity of the information to be collected; and, 4. How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated electronic, mechanical, or other forms of information technology. *Title:* Industrial Minerals Surveys. *Current OMB approval number:* 1028-0062. *Abstract:* Respondents supply the U.S. Geological Survey with domestic production and consumption data on nonfuel mineral commodities. This information will be published as monthly, quarterly, semiannual, and annual reports for use by Government agencies, industry, and the general public. *Bureau form number:* Various (38 forms). *Frequency:* Monthly, Quarterly Semiannual, and Annual. *Description of respondents:* Producers and Consumers of Industrial Materials. *Annual Responses:* 16,758. *Annual burden hours:* 12,100. *Bureau clearance officer:* Alfred Travnicek, 703-648-7231. W. David Menzie, Acting Chief Scientist, Minerals Information Team. [FR Doc. 06-7209 Filed 8-28-06; 8:45 am]

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