Notices. Notice

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BILLING CODE 6712-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated.

The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 4, 2006. **A. Federal Reserve Bank of Atlanta** (Andre Anderson, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. John L. Harvey* , Flora, Mississippi; to retain voting shares of Madison Financial Corporation and thereby indirectly retain voting shares of Madison County Bank, both of Madison, Mississippi.

Board of Governors of the Federal Reserve System, July 17, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-11517 Filed 7-19-06; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Notice of Proposals to Engage in Permissible Nonbanking Activities or to Acquire Companies that are Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR part 225) to engage *de novo* , or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies.

Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *http://www.ffiec.gov/nic/* .

Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 14, 2006. **A. Federal Reserve Bank of Cleveland** (Cindy West, Manager) 1455 East Sixth Street, Cleveland, Ohio 44101-2566: *1. National City Corporation* , Cleveland, Ohio; to acquire Harbor Florida Bancshares, Inc., Fort Pierce, Florida, and thereby indirectly acquire Harbor Federal Savings Bank, Fort Pierce, Florida, and engage in operating a savings association, pursuant to section 225.28(b)(4)(ii), and Appraisal Analysis, Inc., Fort Pierce, Florida, and engage in providing real estate appraisal services, pursuant to section 225.28(b)(2)(i) of Regulation Y.

Board of Governors of the Federal Reserve System, July 17, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-11518 Filed 7-19-06; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-0234] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project National Ambulatory Medical Care Survey (NAMCS) 2007-2008 (OMB No. 0920-0234)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Ambulatory Medical Care Survey (NAMCS) was conducted annually from 1973 to 1981, again in 1985, and resumed as an annual survey in 1989. The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States. Ambulatory services are rendered in a wide variety of settings, including physicians' offices and hospital outpatient and emergency departments. The NAMCS target population consists of all office visits made by ambulatory patients to non-Federal office-based physicians (excluding those in the specialties of anesthesiology, radiology, and pathology) who are engaged in direct patient care. For the first time in 2006, physicians and mid-level providers (i.e., nurse practitioners, physician assistants, and nurse midwives) practicing in community health centers

(CHCs)were added to the NAMCS sample, and these data will continue to be collected in 2007-2008. To complement NAMCS data, NCHS initiated the National Hospital Ambulatory Medical Care Survey (NHAMCS, OMB No. 0920-0278) to provide data concerning patient visits to hospital outpatient and emergency departments. The NAMCS provides a range of baseline data on the characteristics of the users and providers of ambulatory medical care. Data collected include the patients' demographic characteristics, reason(s) for visit, physicians' diagnosis(es), diagnostic services, medications, and visit disposition. In addition, a Cervical Cancer Screening Supplement

(CCSS)will continue to be a key focus in 2007-2008. The CCSS collects information on cervical cancer screening practices performed by selected physician specialties. It will allow the CDC/National Center for Chronic Disease Prevention and Health Promotion to evaluate cervical cancer screening methods and the use of human papillomavirus tests. Users of NAMCS data include, but are not limited to, congressional offices, Federal agencies, state and local governments, schools of public health, colleges and universities, private industry, nonprofit foundations, professional associations, clinicians, researchers, administrators, and health planners. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 8,645. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses/respondent Avg. burden per response (in hrs) Office-based physicians (eligible): Physician Induction Interview 2,662 1 35/60 Patient Record form 2,263 30 5/60 Pulling and re-filing Patient Record form 399 30 1/60 CCSS 712 1 15/60 Office-based physicians (ineligible): Patient Induction Interview 888 1 5/60 Community Health Center Directors: Community Health Center Induction Interview 104 1 20/60 CHC Providers: Physician Induction Interview 312 1 35/60 Patient Record Form 265 30 5/60 Pulling and re-filing Patient Record form 47 30 1/60 CCSS 312 1 15/60 Dated: July 11, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-11521 Filed 7-19-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Psychopharmacologic Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on September 7 and 8, 2006, from 8 a.m. to 5 p.m. *Location* : Hilton Hotel,The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD 20877. *Contact Person* : Cicely Reese, 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: 301-827-6776, 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. 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 “Psychopharmacologic Drugs Advisory Committee (PDAC).” (Click on the year 2006 and scroll down to PDAC meetings.) *Agenda* : On September 7, 2006, the committee will discuss new drug application

(NDA)21-999, paliperidone extended-release

(ER)tablets, Janssen, L.P./Johnson & Johnson Pharmaceutical Research and Development, L.L.C., proposed indication for treatment of schizophrenia. On September 8, 2006, the committee will discuss NDA 21-992, desvenlafaxine succinate (DVS 233), ER tablets, Wyeth Pharmaceuticals, proposed indication for treatment of major depressive disorder. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 23, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on both days. 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 August 23, 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 Cicely Reese 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: July 13, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-11537 Filed 7-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Advisory Committee for Reproductive Health Drugs; 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* : Advisory Committee for Reproductive Health Drugs. *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 August 29, 2006, from 8 a.m. to 5:30 p.m. *Location* : Hilton Hotel, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Teresa Watkins, 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: 301-827-6776, e-mail: *Teresa.Watkins@fda.hhs.gov* or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512537. Please call the Information Line for up-to-date information on this meeting. When available, background materials for this meeting will be posted 1 business day prior to the meeting on the FDA Website at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* . Click on the year 2006 and scroll down to the Advisory Committee for Reproductive Health Drugs.) *Agenda* : The committee will discuss new drug application

(NDA)21-945, proposed trade name Gestiva, 17 alpha-hydroxyprogesterone caproate injection, 250 mg/mL, Adeza Biomedical, for the proposed indication prevention of preterm delivery in women with a history of a prior preterm delivery. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 15, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 August 15, 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 Teresa Watkins 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: July 13, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-11538 Filed 7-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0246] Draft Manufactured Food Regulatory Program Standards; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft document entitled “Manufactured Food Regulatory Program Standards” (draft program standards). The draft program standards, which establish a uniform foundation for the design and management of State programs responsible for regulation of plants that manufacture, process, pack, or hold foods in the United States, are being distributed for comment purposes only. This document is neither final nor is it intended for implementation at this time. DATES: Written comments on the draft program standards may be submitted by September 18, 2006. General comments on the draft program standards are welcome at any time. Submit written comments on the information collection provisions by September 18, 2006. ADDRESSES: Submit written comments on the information collection provisions 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* . Identify comments with the docket number found in brackets in the heading of this document. Submit written requests for single copies of the draft program standards to the Division of Federal-State Relations (HFC-150), Office of Regional Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist the office in processing your request, or fax your request to 716-551-3845. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft program standards. FOR FURTHER INFORMATION CONTACT: Beverly Kent, Division of Federal-State Relations, Food and Drug Administration, 300 Pearl St., suite 100, Buffalo, NY 14202, 716-541-0331. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled “Manufactured Food Regulatory Program Standards.” The standards were developed after the Department of Health and Human Services, Office of Inspector General

(OIG)audited FDA's oversight of food firm inspections conducted by States through contracts. In June 2000, the OIG released its findings. The OIG recommended that FDA take steps to promote “equivalence among Federal and State food safety standards, inspection programs, and enforcement practices.” The report is on the Internet at *http://www.oig.hhs.gov/oei/reports/oei-01-98-00400.pdf* . (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the **Federal Register** .) In response to the OIG's findings, FDA established a committee to draft a set of quality standards for manufactured food regulatory programs. The committee was comprised of officials from FDA and from State agencies responsible for the regulation and inspection of food plants. These draft program standards establish a uniform foundation for the design and management of a State program that is an operational unit(s) responsible for the regulatory oversight of food plants that manufacture, process, pack, or hold foods in the United States. The elements of the draft program standards describe best practices of a high-quality regulatory program. Achieving conformance with these program standards will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation. All self-assessment worksheets and supporting documents will be retained by the State agency. II. Significance of Program Standards These draft program standards represents the agency's current thinking on how to build a uniform foundation for managing a State program that is an operational unit(s) responsible for the regulatory oversight of food plants that manufacture, process, pack, or hold foods in the United States. The elements of the draft program standards describe best practices of a high-quality regulatory program. III. Electronic Access Persons with access to the Internet may obtain the draft program standards at either *http://www.fda.gov/ora/fed_state/default.htm* or *http://www.fda.gov.ohrms/dockets/default.htm* . IV. Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (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 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection of 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 the following 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. *Title* : Manufactured Food Regulatory Program Standards *Description* : The elements of the draft program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The ten standards describe the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the State program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. The State program is not required to use the forms and worksheets contained herein; however, alternate forms should be equivalent to the forms and worksheets in the draft program standards. These draft program standards do not address the performance appraisal processes that a State agency may use to evaluate individual employee performance. When finalized, FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations. The implementation of the program standards will be negotiated as an option for payment under the State contract. States that are awarded this option will receive up to $5,000 to perform the self assessment and to maintain an operational plan for self improvement. FDA recognizes that full use and implementation of the program standards by those States will take several years. Such States will, however, be expected to implement improvement plans to demonstrate that their programs are moving toward full implementation. Those self assessments and improvement plans will be audited as a part of the program oversight of the FDA state contracts. The goal is to enhance food safety by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The development and implementation of these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in plants that manufacture, process, pack, or hold foods. Consequently, the safety and security of the food supply in the United States will improve. **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 40 0.5 20 40 800 1 Because State agencies already keep records of the usual and customary activities required by their inspection programs, the burden from compiling these records is not included in the burden chart. **Table 2.—Estimated 5-Year Self Assessment Burden** No. of Respondents 5-Year Frequency per Response Total 5-Year Responses Hours per Response 1 Total Hours 1 40 1 40 100/40 4,000/1,600 1 The initial self assessment is estimated at 100 hours per respondent. Subsequent updates of the self assessments will be conducted every 5 years and should be completed in 40 hours or less. **Table 3.—Estimated Annual “Improvement Plan” Burden** No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 40 1 40 5 200 V. Comments The draft program standards are being distributed for comment purposes only and are not intended for implementation at this time. 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. A copy of the draft program standards and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m. Monday through Friday. Dated: July 14, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-11539 Filed 7-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Service Administration Advisory Committee on Interdisciplinary, Community-Based Linkages; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). *Dates and Times:* (Face-to-face meeting). July 24, 2006, 8:30 a.m. to 5 p.m. July 25, 2006, 8:30 a.m. to 3 p.m. *Place:* Doubletree Hotel, 1750 Rockville Pike, Rockville, MD 20852, Telephone: 301-468-1100. *Status:* The meeting will be open to the public. *Purpose:* The Committee will be focusing on interdisciplinary training and education, specifically examining evidence-based models/research as regards interdisciplinary training. In addition, the Committee will be looking at the potential impact of interdisciplinary training programs on health service delivery networks including how such training programs address the needs of various underserved populations. Included in the meeting will be discussions of community-based training initiatives. The meeting will allow the Committee to formulate appropriate recommendations for the Secretary and Congress regarding interdisciplinary training, and community-based training. *Agenda:* The agenda includes an overview of the Committee's general business activities. The Committee will hear presentations from experts on interdisciplinary training and community-based training, and will discuss best practices to formulate recommendations for the Secretary and the Congress. Agenda items are subject to change as priorities indicate. *Supplementary Information:* This meeting notice is delayed due to the resolution of fiscal year 2006 budget issues and the status of Committee membership. *For Further Information Contact:* Anyone requesting information regarding the Committee should contact Lou Coccodrilli, Federal Official for the ACICBL, and Acting Director of the Division of State, Community & Public Health, Bureau of Health Professions, Health Resources and Services Administration, 5600 Fishers Lane, Maryland 20857; Telephone

(301)443-7774. Dated: July 17, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. 06-6382 Filed 7-17-06; 3:39 pm]

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