Notices. Notice of modified or altered System of Records (SOR)

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BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office For Civil Rights; Privacy Act of 1974; Amended System of Records ACTION: Notice of modified or altered System of Records (SOR). SUMMARY: In accordance with the Privacy Act, we are proposing to modify or alter an existing SOR, “Program Information Management System (PIMS),” System No. 09-90-0052, published at 67 FR 57011, September 6, 2002. First, we propose to add a new authority, the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), to those under which OCR collects information.

The Secretary of HHS has delegated to OCR the authority to enforce the confidentiality provisions of that statute. Second, we propose a new routine use which allows referrals of Age Discrimination Act Complaints to the Federal Mediation and Conciliation Service (FMCS), for purposes of mediation. Third, we give notice of a new routine use permitting disclosure of records to student volunteers, individuals working under a personal services contract, and other individuals performing functions for the Department but technically not having the status of OCR employees, if they need access to the records in order to perform their assigned agency functions.

OCR invites interested parties to submit comments on the proposed additional authority and routine uses. See Effective Dates section for comment period. EFFECTIVE DATES: OCR filed a modified system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)February 15, 2007. To ensure that all parties have adequate time in which to comment, the modified SOR, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless OCR receives comments that require alterations to this notice. ADDRESSES: The public should address comments regarding: FMCS referrals to Richard Lopez, Civil Rights Division, the Patient Safety Act to Linda Sanches, Privacy Division, student volunteers to Sheila D. Marshall, of the Management Operations Division, Office for Civil Rights, Department of Health and Human Services, Room 553E, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. Comments also may be sent via e-mail to *OCRmail@hhs.gov* . Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., Eastern Standard Time. FOR FURTHER INFORMATION CONTACT: For further information regarding FMCS referrals contact Richard Lopez, Civil Rights Division, telephone number

(202)260-1602, the Patient Safety Act contact Linda Sanches, Privacy Division, telephone number

(202)260-7106, student volunteers contact Sheila D. Marshall, of the Management Operations Division, telephone number

(202)619-2742, Office for Civil Rights, Department of Health and Human Services, Room 553E, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. SUPPLEMENTARY INFORMATION: The system of records (i.e., PIMS) described in the OCR's September 6, 2002 Privacy Act notice is used by OCR staff and consists of an electronic repository of information and documents, and supplementary paper document files. PIMS effectively combined and replaced OCR's two previous systems of records, (CIMS and the Complaint File and Log), into a single integrated system with enhanced electronic storage, retrieval and tracking capacities. While the types of information collected and stored in PIMS is the same as the information collected in CIMS and the Complaint File and Log, PIMS allows OCR to manage more effectively the information that it does collect. The Privacy Act permits the OCR to disclose information or records pertaining to an individual without that individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected, 5 U.S.C. 552a

(b)(3). Any such disclosure is known as a “routine use.” This modified notice identifies two new routine uses for the OCR's system of records, as described below. The OCR expects that the routine use disclosures will not result in any unwarranted invasion of personal privacy. The Office for Civil Rights

(OCR)is responsible for enforcing Title VI of the Civil Rights Act of 1964, Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975 and other statutes which prohibit discrimination by programs or entities that receive Federal financial assistance. OCR also has jurisdiction over Federally conducted programs in cases involving disability-based discrimination under Section 504 of the Rehabilitation Act, over state and local public entities in cases involving disability-based discrimination under Title II of the Americans with Disabilities Act and over health plans, health care clearinghouses and certain health care providers with respect to enforcement of medical privacy obligations under the Health Insurance Portability and Accountability Act. We give notice that OCR now enforces the confidentiality provisions of a new authority, the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The PIMS system conforms to applicable law and policy governing the privacy and security of Federal automated information systems. These include, but are not limited to: the Privacy Act of 1974, Computer Security Act of 1987, the Paperwork Reduction Act of 1995, the Clinger-Cohen Act of 1996, and OMB Circular A-130, Appendix, III, “Security of Federal Automated Information Resources.” OCR has prepared a system security plan as required by OMB Circular A-130, Appendix III. This plan conforms fully to guidance issued by the National Institute for Standards and Technology

(FMCS)for purposes of mediation. The following amended notice is written in the present, rather than future tense, in order to avoid the unnecessary expenditure of public funds to modify the amended notice after the system has become effective. Dated: February 13, 2007. Winston Wilkinson, Director, Office for Civil Rights. 09-90-0052 System Name: “Program Information Management System (PIMS), HHS/OS/OCR.” Security Classification: None. System Location: The automated portion of the system is maintained at OCR Headquarters. Paper files are maintained in headquarters and regional offices as noted in Appendix I. Categories of Individuals Covered by the System: Covered individuals include persons who file complaints alleging discrimination or violation of their rights or other violations under the statutes identified below (Authority for Maintenance) and covered entities (e.g., service providers) that are individuals and not organization or institutions, investigated by OCR as a result of complaints filed or through reviews conducted by OCR. Covered individuals also include persons who submit correspondence to OCR related to other compliance activities, (e.g., outreach and public education) and other correspondence unrelated to a complaint or review and requiring responses by OCR. In addition, OCR employees who use the system to record the status of their work are covered. Categories of Records in the System: The system encompasses a variety of records having to do with complaints, reviews, and correspondence. The complaint files and log include complaint allegations, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the investigation, as well as status information for all complaints. This component of PIMS is exempt from the notification, access, correction and amendment provisions of the Privacy Act (see below: Systems Exempted From Certain Provisions of the Act). Equivalent types of information are maintained for reviews and correspondence activities—namely information gathered, findings, results, correspondence and status. Authority for Maintenance of the System: Title VI of the 1964 Civil Rights Act; Sections 533, 542, 794, 855, 1947 and 1908 of the Public Health Service Act; Sections 504 and 508 of the Rehabilitation Act of 1973: Title II of the Americans with Disabilities Act of 1990; the Age Discrimination Act of 1975; the Equal Employment Opportunity Provisions of the Public Telecommunications Financing Act of 1978; Title VI and Title XVI of the Public Health Service Act (the “community services obligation” of facilities funded under the Act); Title IX of the 1972 Education Amendments; Section 407 of the Drug Abuse Office and Treatment Act; Section 321 of the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970; Section 508 of the Social Security Act, the Family Violence Prevention and Services Act; Low-Income Home Energy Assistance Act of 1981; Section 1808 of the Small Business Job Protection Act of 1996; the Health Insurance Portability and Accountability Act of 1996; and the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). Purpose(s) of the System: PIMS is used by OCR staff and consists of an electronic repository of information and documents, and supplementary paper document files. PIMS effectively combines and replaces OCR's two previous systems of records, the “Case Information Management System (CIMS), HHS/OS/OCR, 09-90-0050,” and the “Complaint File and Log, HHS/OS/OCR 09-00-0051,” into a single integrated system with enhanced electronic storage, retrieval and tracking capacities. While the types of information collected and stored in PIMS is the same as the information collected in CIMS and the Complaint File and Log, PIMS allows OCR to manage more effectively the information that it does collect. The system is designed to allow OCR to integrate all of OCR's various business processes, including all its compliance activities, to allow for real time access and results reporting and other varied information management needs. PIMS provides:

(1)A single, central, electronic, repository of all significant OCR documents and information, including investigative files, correspondence, administrative records, policy and procedure manuals and other documents and information developed or maintained by OCR;

(2)easy, robust capability to search all the information in OCR's repository;

(3)better quality control at the front end with simplified data entry and stronger data validation;

(4)tools to help staff work on and manage their casework, and

(5)supplementary paper document files. The system has the capacity to generate reports concerning the status of all current and closed complaints, reviews and correspondence, and allows OCR to track outreach, training and other activities and to locate and retrieve information in order to manage more efficiently its work and report results. In addition, PIMS allows for the tracking of work assignments to employees to facilitate workload balancing, timely response to complaints and completion of reviews, and outreach and public education initiatives focused on organizations and individuals. Routine Uses of Records Maintained in the System, Including Categories or Users and the Purposes of Such Uses: The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The routine uses in this system meet the compatibility requirement of the Privacy Act. We are establishing the following routine use disclosures of information maintained in the system: I. The first routine use for this system, permitting disclosure to a congressional office, allows subject individuals to obtain assistance from their representatives in Congress, should they so desire. Such disclosure would be made only pursuant to the request of the individual. II. The second routine use allows disclosure to the Department of Justice or a court in the event of litigation. III. The third routine use allows referral to the appropriate agency, in the event that a System of Records maintained by this agency to carry out its functions indicates a violation or potential violation of law. IV. The fourth routine use allows disclosure of records to contractors for the purpose of processing or refining records in the system. V. The fifth routine use allows records to be disclosed to student volunteers, individuals working under a personal services contract, and other individuals performing functions for the Department but technically not having the status of agency employees, if they need access to the records in order to perform their assigned agency functions. VI. The sixth routine use allows referrals of Age Discrimination Act Complaints to the Federal Mediation and Conciliation Service

(FMCS)for purposes of mediation. Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: Automated records are maintained on magnetic disc and tape back-up. Paper records are kept in file folders. Retrievability: Records are indexed by transaction number, but may be retrieved by name, street address, and other complainant or covered entity characteristic (such as type of entity, city, state and type of service provided) by OCR staff engaged in compliance activities. Safeguards: The PIMS system conforms to applicable law and policy governing the privacy and security of Federal automated information systems. These include but are not limited to: the Privacy Act of 1974, Computer Security Act of 1987, the Paperwork Reduction Act of 1995, the Clinger-Cohen Act of 1996, and OMB Circular A-130, Appendix, III, “Security of Federal Automated Information Resources.” OCR has prepared a system security plan as required by OMB Circular A-130, Appendix III. This plan conforms fully to guidance issued by the National Institute for Standards and Technology

(NIST)in NIST Special Publication 800-18, “Guide for Developing Security Plans for Information Technology Systems.” The plan includes conduct of a risk assessment that addresses the confidentiality and integrity of the data. Only authorized users have access to the information in the system. Categories of users include: OCR investigators, regional and headquarters managers, team leaders, OCR budget and Government Performance and Results Act planning staff, program and policy staff, and data analysts. Specific access is structured around need and is determined by the person's role in the organization. Access is managed through the use of electronic access control lists, which regulate the ability to read, change and delete information in the system. Each OCR user has read access to designated information in the system, with the ability to modify only their own submissions or those of others within their region or group. Data identified as confidential is so designated and only specified individuals are granted access. The system maintains an audit trail of all actions against the data base. All electronic data is stored on servers maintained in locked facilities with computerized access control allowing access to only those support personnel with a demonstrated need for access. A database is kept of all individuals granted security card access to the room, and all visitors are escorted while in the room. The server facility has appropriate environmental security controls, including measures to mitigate damage to automated information system resources caused by fire, electricity, water and inadequate climate controls. Access control to servers, individual computers and databases includes a required user log-on with a password, inactivity lockout to systems based on a specified period of time, legal notices and security warnings at log-on, and remote access security that allows user access for remote users (e.g., while on government travel) under the same terms and conditions as for users within the office. System administrators have appropriate security clearance. Printed materials are filed in secure cabinets in secure Federal buildings with access based on need as described above for the automated component of the PIMS system. Retention And Disposal: Documents related to complaints and reviews are retained at OCR for two years from the date the complaint is closed and then are archived at the National Archives and Records Administration for 15 years. Correspondence is retained for one year following the end of the fiscal year in which processed. System Manager and Address: PIMS Project Manager, Resource Management Division, Office for Civil Rights, 200 Independence Ave. SW., Room 509F, Washington, DC 20201. Notification Procedure: Contact System Manager (above). Include name and address of complainant, and name of the recipient against which the allegation was filed. The Department is exempting all investigative records from this provision (see below: Records Exempted). Record Access Procedure: Same as notification procedures. Requesters should also reasonably specify the record contents being sought. Requests should be made to the system manager (above). The Department is exempting all investigative records from this provision (see below: Records Exempted). Contesting Record Procedure: Contact the official(s) at the address specified under System Manager, and reasonably identify the record and specify the information to be contested and corrective action sought with supporting justification. (These procedures are in accordance with Department Regulations (45 CFR 5b.7) **Federal Register** , October 8, 1975, page 47411.) The Department is exempting all investigative records from this provision (see below: Records Exempted). Record Source Categories: Information is provided by complainants and covered entities. System Records Exempted From Certain Provisions Of The Act: OCR investigative records maintained in PIMS, either as paper records or electronic documents are records compiled for law enforcement purposes are exempt under subsection (k)(2) from the notification, access, correction and amendment provisions of the Privacy Act. Appendix Number 1—System Locations: This system is located at HHS offices in the following cities. Headquarters, PIMS Project Manager, Resource Management Division, Office for Civil Rights, 200 Independence Ave., SW., Room 509F, Washington, DC 20201. Region I, Regional Manager, OCR/HHS, J.F. Kennedy Federal Building—Room 1875 Boston, Massachusetts 02203. Region II, Regional Manager, OCR/HHS, 26 Federal Plaza—Suite 3312, New York, NY 10278. Region III, Regional Manager, OCR/HHS, 150 S. Independence Mall West, Suite 372, Public Ledger Building, Philadelphia, PA 19106. Region IV, Regional Manager, OCR/HHS, Atlanta Federal Center, Suite 3B70, 61 Forsyth Street, SW., Atlanta, GA 30303. Region V, Regional Manager, OCR/HHS, 233 N. Michigan Ave, Suite 240, Chicago, IL 60601. Region VI, Regional Manager, OCR/HHS, 1301 Young Street, Suite 1169, Dallas, TX 75202. Region VII, Regional Manager, OCR/HHS, 601 E. 12th Street—Room 248, Kansas City, MO 64106. Region VIII, Regional Manager, OCR/HHS, Federal Office Building, 1961 Stout Street—Room 1185, Denver, CO 80294. Region IX, Regional Manager, OCR/HHS, 50 United Nations Plaza—Room 322, San Francisco, CA 94102. Region X, Regional Manager, OCR/HHS, 2201 Sixth Avenue—Suite 900, Seattle, WA 98121. [FR Doc. E7-3283 Filed 2-26-07; 8:45 am] BILLING CODE 4153-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-05CZ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan Karr, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

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

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

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

(DDI)was launched in 10 locations around the U.S. to identify a portion of the estimated 5 million people with undiagnosed Type 2 diabetes, targeting specific areas in each of 10 locales in which residents are likely to be at higher risk for Type 2 diabetes. Implementation of the DDI involved distributing a paper-and-pencil risk test. Individuals whose score indicated that they were at an increased risk for diabetes were advised to see their regular doctor (or to schedule an appointment at one of several clinics that had agreed to participate in the DDI), to receive a finger-stick or other tests to confirm whether or not they have diabetes. Whether or not the DDI should be expanded to other communities depends on the health benefits and costs of the program. The CDC is planning to conduct a study to provide this critical information. The planned study will assess the resources used, the cost per case detected, and the perceived benefit of the DDI to participants. Data for the economic assessment will be obtained by conducting three separate surveys:

(1)A local implementation team survey will be administered to the 10 DDI local implementation leaders to obtain information on resources used by the members of DDI local implementation teams and community based organizations to implement the non-medical service delivery activities for the DDI program;

(2)a health clinic leadership survey will be sent to the clinic directors in each of the 43 clinics that participated in the DDI across the 10 locations to obtain information on the cost of delivering the medical services required in diabetes screening and diagnosis; and

(3)a patient survey will be administered to a sample of 600 patients at the 43 participating clinics to obtain information regarding patient out-of-pocket medical and non-medical direct health care costs and the perceived economic benefits of diabetes screening. The results of the study will also provide information needed for conducting a more complete cost-effectiveness analysis of screening for undiagnosed diabetes. The local implementation team survey will be mailed to the local DDI implementation team leader in each of the 10 regions to collect information regarding the staff time and other resources used to implement the DDI program (including the staff time and resources used by community-based organizations that participated in the DDI implementation). These planning and implementation activities include participating in meetings and conference calls, recruiting clinics and community-based organizations to participate in the DDI, distributing risk tests, organizing health fairs and other community events, and designing media campaigns to promote the DDI. The health clinic leadership survey will be mailed to the clinic director at each of the 43 clinics across the 10 locations that participated in the DDI implementation. The survey will collect information regarding the costs associated with the clinic's participation in the DDI. These will include the medical costs of providing care to patients who visited the clinic as a result of the DDI, staff time associated with DDI planning and implementation, and any staff time that was devoted to performing finger stick tests at locations other than the health clinic ( *e.g.* , health fairs, shopping malls, work sites, housing complexes). Of the 43 clinics to be surveyed, we expect that 30 (70%) will complete the survey. A computer-assisted in-person patient survey will be administered to a sample of 600 clinic patients at the 43 clinics that participated in the DDI. The survey will collect background information, out-of-pocket medical and non-medical direct health care costs ( *e.g.* , co-payments, transportation costs, value of patients' time associated with the clinic visit), and preferred features of a diabetes screening program. There are no costs to respondents other than their time. Estimated Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response (in hours) Total burden (in hours) Implementation team members 10 1 2 20 Clinic staff 30 1 1 30 Patients at DDI clinics 600 1 20/60 200 Total 250 Dated: February 22, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-3333 Filed 2-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AJ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention

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

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Racial and Ethnic Approaches to Community Health across the U.S. (REACH US) Management Information System (MIS)—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Racial and Ethnic Approaches to Community Health (REACH) currently funds forty local coalitions to establish community based programs and culturally appropriate interventions to eliminate racial and ethnic health disparities. Communities served by REACH include: African American, American Indian, Hispanic American, Asian American, and Pacific Islander. These communities select among infant mortality, deficits in breast and cervical cancer screening and management, cardiovascular diseases, diabetes, HIV/AIDS, and deficits in childhood and adult immunizations to focus their interventions. Guided by logic models, each community articulates goals, objectives, and related activities; tracks whether goals and objectives are met, ongoing, or revised; and evaluates all program activities. This information will then be entered into the REACH Management Information System (REACH MIS). REACH MIS is a customized internet-based support system that allows REACH grantees to perform remote data entry and retrieval of data. The contract for our current Information Network (REACH IN), OMB control number 0920-0603, (Expires 02/28/2010) is expected to end and since we will not be renewing the contract CDC is developing its own system. This support system is designed to create on-demand graphs and reports of grantees' activities and accomplishments, monitor progress toward the achievement of goals and objectives, and share and synthesize information across grantees' activities. Both quantitative and qualitative analyses can be performed. The REACH Management Information System will collect in electronic format:

(a)Data needed to measure progress toward, or achievement of, newly developed performance indicators,

(b)information on REACH grantees that is currently being reported in hard-copy documents. An Internet-based management information system will allow CDC to monitor, and report on, grantee activities more efficiently. Data reported to CDC through the REACH management information system will be used by CDC to identify training and technical assistance needs, monitor compliance with cooperative agreement requirements, evaluate the progress made in achieving center-specific goals, and obtain information needed to respond to Congressional and other inquiries regarding program activities and effectiveness. The annualized estimated burden is based on 40 respondents. It is estimated that they each will use the system four times a year to enter data, each data entry taking about 45 minutes. There are no costs to respondents other than their time. Estimated Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response (in hours) Total burden (in hours) Grantees 40 4 45/60 120 Dated: February 22, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-3334 Filed 2-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Program Peer Review Subcommittee

(PPRS)of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR): Teleconference. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), CDC, NCEH/ATSDR announces the teleconference meeting of the aforementioned subcommittee: *Time and Date:* 8:30 a.m.-10:30 a.m. Eastern Daylight Saving Time, March 19, 2007. *Place:* The teleconference will originate at NCEH/ATSDR in Atlanta, Georgia. To participate, dial 877/315-6535 and enter conference code 383520. *Purpose:* Under the charge of the BSC, NCEH/ATSDR, the PPRS will provide the BSC, NCEH/ATSDR with advice and recommendations on NCEH/ATSDR program peer review. They will serve the function of organizing, facilitating, and providing a long-term perspective to the conduct of NCEH/ATSDR program peer review. *Matters To Be Discussed:* Review and approve previous meeting minutes; report on site-specific activities peer review; a discussion of preparedness and emergency response peer review: breadth and approach of the review, and areas of expertise required for the review; nominations for a PPRS panel member, a chairperson, peer reviewers, and partners and customers. Agenda items are subject to change as priorities dictate. SUPPLEMENTARY INFORMATION: This meeting is scheduled to begin at 9 a.m. Eastern Daylight Saving Time. To participate, please dial 877/315-6535 and enter conference code 383520. Public comment period is scheduled for 10 a.m.-10:15 a.m. FOR MORE INFORMATION CONTACT: Sandra Malcom, Committee Management Specialist, Office of Science, NCEH/ATSDR, M/S E-28, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone 404/498-0622. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and ATSDR. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-3372 Filed 2-26-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Grant to the National Eligibility Workers Association: Professionals Associated Through Human Services (NEW:PATHS); Office of Family Assistance AGENCY: Office of Family Assistance, ACF, HHS. ACTION: Notice to Award a Grant Award. *C.F.D.A Number:* 93.086. SUMMARY: Notice is hereby given that an award is being made to the National Eligibility Workers Association: Professionals Associated Through Human Services of Cavalier, North Dakota, in the amount of $100,000 to develop a best practices handbook for front line social workers. NEW:PATHS is the only national organization dedicated to improving the personal and professional well-being of eligibility professionals and they are uniquely qualified to develop a handbook of best practices. Its members implement Temporary Assistance to Needy Families regulations, network with other eligibility professionals at local, regional, and national conferences and possess exceptional insights concerning Federal programs. NEW:PATHS has the capability of consulting with a national audience and its members are in direct contact with employment agencies to move participants from welfare to work and increase the percentage of families and children living in safe environments. After the appropriate reviews, it has been determined that this unsolicited proposal qualifies for funding. The period of this funding will extend from October 1, 2006 through March 31, 2008. *Contact:* Paul Maiers, Office of Family Assistance, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone: 202-401-5438, E-mail: *paul.maiers@acf.hhs.gov* . Dated: February 17, 2007. Sidonie Squier, Director, Office of Family Assistance. [FR Doc. E7-3415 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Deputy Director/Commissioner, Office of Child Support Enforcement, the following authority vested in me by the Secretary of Health and Human Services in memoranda dated August 20, 1991, Delegations of Authority for Social Security Act Programs and September 16, 1997, Delegations of Authority for the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (Pub. L. 104-193).

(a)Authorities Delegated 1. Authority to administer the provisions of the Child Support and Establishment of Paternity Program under Title IV-D of the Social Security Act, and as amended now and hereafter. 2. Authority under section 409(a)(8) of the Social Security Act to make determinations regarding State compliance or performance and technical noncompliance and to impose penalties and the authority under section 410(a) of the Social Security Act to issue notices to States regarding the imposition of such penalties.

(CSE)related grant programs. 8. This delegation of authority does not include the authority to approve or disapprove State requests for Federal financial participation for the costs of automated data processing equipment and services that affect more than one HHS Operating Division. 9. This delegation of authority does not include the authority to hold hearings. 10. Any redelegation shall be in writing and prompt notification must be provided to all affected managers, supervisors, and other personnel, and requires the concurrence of the Deputy Assistant Secretary for Administration.

(c)Effect on Existing Delegations As related to this delegation of authority, this delegation supersedes all previous delegations of authority involving the administration of the authorities delegated herein.

(d)Effective Date This delegation was effective upon the date of signature. I hereby affirm and ratify any actions taken by the Deputy Director/Commissioner, Office of Child Support and Enforcement, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: February 16, 2007. Wade F. Horn, Assistant Secretary for Children and Families. [FR Doc. E7-3323 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Commissioner, Administration on Children, Youth and Families the following authorities vested in me by the Secretary of Health and Human Services in memoranda dated August 20, 1991, Delegations of Authority for Social Security Act Programs; August 20, 1991, Delegations of Authority for Child Abuse Prevention and Treatment, Adoption Opportunities, and Temporary Child Care for Handicapped Children and Crisis Nurseries; August 20, 1991, Delegations of Authority for Children's Bureau, Adoption Information Clearinghouse and Abandoned Infants Assistance; September 28, 1994, Delegation of Authority for Family Preservation and Support Services under Subpart 2, Title IV-B of the Social Security Act; and April 23, 2001, Delegation of Authority Under Section 330F of the Public Health Service Act.

(a)Authorities Delegated 1. Authority to administer the Child Welfare Services Program, including the State Grant Program, the Research and Demonstration Program and the Training program pursuant to Title IV-B of the Social Security Act, and as amended now and hereafter. 2. Authority to administer the Foster Care Program and Adoption Assistance programs including the Independent Living Initiative under Title IV-E of the Social Security Act, and as amended now and hereafter. 3. Authority to administer the provisions of the Child Abuse Prevention and Treatment Act, 42 U.S.C. 5101 *et seq.* , and as amended now and hereafter. 4. Authority to administer the provisions of the Adoption Opportunities Program under Title II of the Child Abuse Prevention and Treatment and Adoption Reform Act, 42 U.S.C. 5111-5115, and as amended now and hereafter. 5. Authorities and functions vested in the Secretary under the Organic Act of the Children's Bureau (Act of April 9, 1912) 42 U.S.C. 191, *et seq.* , and as amended now and hereafter. 6. Authorities that provide for the establishment of A National Adoption Information Clearinghouse under Section 9442 of the Omnibus Budget Reconciliation Act of 1986, 42 U.S.C. 679a, and as amended now and hereafter. 7. Authorities to administer the Abandoned Infants Assistance Act of 1988, 42 U.S.C. 670 note, and as amended now and hereafter. 8. Authority under Section 13711(a)

(2)of the Omnibus Budget Reconciliation Act of 1993, Pub. L. 103-66, for the Family Preservation and Support Services program, subpart 2 of the Title IV-B, Child and Family Services, of the Social Security Act 42 U.S.C. 629, and as amended now and hereafter. 9. Authorities vested in the Secretary of Health and Human Services under Section 330F (other than Section 330F(a)(6)(C)) of the Public Health Service Act (42 U.S.C. 254c-6), as amended, titled “Certain Services for Pregnant Women.”

(b)Limitations 1. This delegation of authority shall be exercised under the Department's existing policies on delegations and regulations. 2. This delegation excludes the authority to submit reports to Congress and shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families' authorities. 3. The approval or disapproval of grant applications and the making of grant awards require concurrence of the appropriate Grants Officer. The approval or disapproval of contract proposals and awards are subject to the requirements of the Federal Acquisition Regulations and requires the concurrence of the Contracting Officer. 4. This delegation of authority does not include the authority to sign and issue notices of grant awards for Children's Bureau programs. 5. This delegation of authority does not include the authority to appoint Central Office and Regional Office Grant Officers for the administration of Children's Bureau programs. 6. This delegation of authority does not include the authority to appoint Action Officials for Audit Resolution. 7. This delegation of authority does not include the authority to approve or disapprove State requests for Federal financial participation for the costs of automated data processing equipment and services that affect more than one HHS Operating Division. 8. This delegation of authority does not include the authority to conduct hearings. 9. This delegation of authority does not include the authority under section 429 of the Social Security Act. 10. This delegation of authority does not include the authority under section 439 of the Social Security Act, Grants for Programs for Mentoring Children of Prisoners. 11. Any redelegation shall be in writing and prompt notification must be provided to all affected managers, supervisors, and other personnel and requires the concurrence of the Deputy Assistant Secretary for Administration.

(c)Effect on Existing Delegations As related to the authorities delegated herein, this delegation of authority supersedes all previous delegations of authority.

(d)Effective Date This delegation was effective upon the date of signature. I hereby affirm and ratify any actions taken by the Commissioner, Administration on Children, Youth and Families, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: February 16, 2007. Wade F. Horn, Assistant Secretary for Children and Families. [FR Doc. E7-3324 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Director, Office of Family Assistance, the following authorities vested in me by the Secretary of Health and Human Services in the memorandum dated August 20, 1991, Delegations of Authority for the Social Security Act Programs and in the memorandum dated August 20, 1991, Delegations of Authority for Title XI of the Social Security Act.

(a)Authorities Delegated 1. Authority to administer the provisions of the Adult Assistance

(AA)Programs under Titles I, X, XIV and XVI (Grants to States for Aid to the Aged, Blind and Disabled) of the Social Security Act, and as amended now and hereafter. 2. Authority under Section 1119 of the Social Security Act, and as amended now and hereafter, to approve Federal financial participation in payments for repairs to homes owned by recipients of aid or assistance under Titles I, X, XIV, or XVI.

(b)Limitations 1. This delegation of authority shall be exercised under the Department's existing policies on delegations and regulations. 2. This delegation of authority does not include the authority to submit reports to Congress and shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families' authorities. 3. The approval or disapproval of grant applications and the making of grant awards require concurrence of the appropriate Grants Officer. The approval or disapproval of contract proposals and awards are subject to the requirements of the Federal Acquisition Regulations and requires the concurrence of the Contracting Officer. 4. This delegation of authority does not include the authority to sign and issue notices of grant awards. 5. This delegation of authority does not include the authority to appoint Central Office and Regional Office Grant Officers for the administration of the adult assistance programs. 6. This delegation of authority does not include the authority to appoint Action Officials for Audit Resolution. 7. This delegation of authority does not include the authority to approve or disapprove State requests for Federal financial participation for the costs of automated data processing equipment and services which affect more than one HHS Operating Division. 8. This delegation of authority does not include the authority to make determinations on State appeals concerning audit questions or recommendations by the Department of Health and Human Services

(HHS)Audit Agency which involve ACF program practices reviewed under Titles I, X, XI and XVI of the Social Security Act. 9. This delegation of authority does not include the authority to disapprove State Plans and amendments. 10. This delegation of authority does not include the authority to hold hearings. 11. Any redelegation shall be in writing and prompt notification must be provided to all affected managers, supervisors, and other personnel, and requires the concurrence of the Deputy Assistant Secretary for Administration.

(c)Effect on Existing Delegations This delegation supersedes all previous delegations of authority involving the administration of the Adult Assistance programs or the program under Section 1119 of the Social Security Act.

(d)Effective Date This delegation was effective upon the date of signature. I hereby affirm and ratify any actions taken by the Director, Office of Family Assistance which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: February 16, 2007. Wade F. Horn, Assistant Secretary for Children and Families. [FR Doc. E7-3326 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Director, Office of Family Assistance, the following authorities vested in me by the Secretary of Health and Human Services in the memoranda dated August 20, 1991, Delegations of Authority for Social Security Act Programs and September 16, 1997, Delegations of Authority for the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (Pub. L. 104-193).

(a)Authorities Delegated 1. Authority to administer Income and Eligibility Verification Systems (IEVS), as they pertain to the Administration for Children and Families' programs, under the provisions of Title XI, Section 1137 of the Social Security Act, and as amended now and hereafter. 2. Authority to administer the provisions of Title I, Block Grants for Temporary Assistance for Needy Families

(TANF)under Sections 101-103, 106-110, 112, 115, and 116 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, 42 U.S.C. 1305 note, 42 U.S.C. 601 *et seq.* , and as amended now and hereafter. In addition, in exercising authority under Section 103, “Section 413, Research, Evaluations, and National Studies,” of the Social Security Act, the Director, Office of Family Assistance, Administration for Children and Families, is expected to consult with the Department of Health and Human Services, Assistant Secretary for Planning and Evaluation.

(b)Limitations 1. This delegation of authority shall be exercised under the Department's existing policies on delegations and regulations. 2. This delegation of authority does not include the authority to submit reports to Congress and shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families' authorities. 3. The approval or disapproval of grant applications requires concurrence of the appropriate Grants Officer. The approval or disapproval of contract proposals and awards is subject to the requirements of the Federal Acquisition Regulations and requires the concurrence of the Contracting Officer. 4. The authority to approve/disapprove under 45 CFR 205.55(d) State applications to use alternate sources of information for income and eligibility ( *i.e.* , IEVS) requires consultation with the Office of the Deputy Assistant Secretary for Administration and with the other programs affected by the request. 5. This delegation of authority does not include the authority to issue annual rankings of States' most and least successful work programs and out-of-wedlock birth ratios under Sections 413(d)(1) and 413(e)(1) of the Social Security Act. 6. This delegation of authority does not include the authority under section 409(a)(8) of the Social Security Act to make determinations regarding State compliance or performance and technical noncompliance and to impose penalties and the authority under section 410(a) of the Social Security Act to issue notices to States regarding the imposition of such penalties. 7. This delegation of authority does not include the authority to sign and issue notices of grant awards for family assistance programs. 8. This delegation of authority does not include the authority to appoint Central Office and Regional Office Grant Officers for the administration of family assistance grant programs. 9. This delegation of authority does not include the authority to appoint Action Officials for Audit Resolution. 10. This delegation of authority does not include the authority to conduct research under sections 413(a), (b), and

(h)of the Social Security Act or to review proposals and approve State funding for evaluations of Title IV-A programs under section 413(f) of the Social Security Act. 11. This delegation of authority excludes the authority to hold hearings. 12. Any redelegation shall be in writing and prompt notification must be provided to all affected managers, supervisors, and other personnel, and requires the concurrence of the Deputy Assistant Secretary for Administration.

(c)Effect on Existing Delegations As related to the authorities delegated herein, this delegation of authority supersedes all previous delegations of authority.

(d)Effective Date This delegation of authority is effective upon the date of signature. I hereby affirm and ratify any actions taken by the Director, Office of Family Assistance which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: February 16, 2007. Wade F. Horn, Assistant Secretary for Children and Families. [FR Doc. E7-3302 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Director, Office of Family Assistance, the following authorities vested in me by the Secretary of Health and Human Services in the memorandum dated August 20, 1991, pertaining to the Head Start Program and the Child Development Associate Scholarship Assistance Grants Program, in the memorandum dated August 20, 1991, pertaining to the Omnibus Budget Reconciliation Act of 1981, in the memorandum dated August 20, 1991, pertaining to the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990, Pub. L. 101-508), and in the memorandum dated September 16, 1997, pertaining to the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA, Pub. L. 104-193).

(a)Authorities Delegated 1. Authority to administer the provisions of the Child Development Associate Scholarship Assistance Act, 42 U.S.C. 10901-10905, and as amended now and hereafter. 2. Authority to administer the provisions of Subchapter D—Grants for Planning and Development of Dependent Care Programs and for other purposes (Chapter 8, Title VI of the Omnibus Budget Reconciliation Act of 1981, Pub. L. 97-35, 42 U.S.C. 9871 *et seq.* ) and as amended now and hereafter. 3. Authority for the Child Care and Development Block Grants, under Section 5082 of OBRA 1990, (42 U.S.C. 9858 *et seq.* ), and as amended now and hereafter. 4. Authority to administer the provisions of the Child Care and Development Block Grant Amendments of 1996, 42 U.S.C. 9801 note, under Sections 601-615 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, 42 U.S.C. 1305 note, 42 U.S.C. 601 *et seq.* , and as amended now and hereafter.

(b)Limitations 1. This delegation shall be exercised under the Department's existing policies on delegations and regulations. 2. This delegation does not include the authority to submit reports to Congress and shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families authorities. 3. The approval or disapproval of grant applications and the making of grant awards require concurrence of the appropriate Grants Officer. The approval or disapproval of contract proposals and awards are subject to the requirements of the Federal Acquisition Regulations and requires the concurrence of the Contracting Officer. 4. This delegation of authority does not include the authority to sign and issue notices of grant awards. 5. This delegation of authority does not include the authority to appoint Action Officials for Audit Resolution. 6. This delegation of authority does not include the authority to appoint Central Office or Regional Office Grant Officers for the administration of the child care related programs. 7. This delegation of authority does not include the authority to hold hearings. 8. This delegation of authority does not include the authority to approve or disapprove awards for grants or contracts for research, demonstration, or evaluations relating to child care. 9. Any redelegation shall be in writing and prompt notification must be provided to all affected managers, supervisors, and other personnel, and requires the concurrence of the Deputy Assistant Secretary for Administration.

(c)Effect on Existing Delegations This delegation supersedes any previous delegation of authority pertaining to authorities delegated herein.

(d)Effective Date This delegation was effective upon the date of signature. I hereby affirm and ratify any actions taken by the Director, Office of Family Assistance, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation. Dated: February 16, 2007. Wade F. Horn, Assistant Secretary for Children and Families. [FR Doc. E7-3306 Filed 2-26-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have delegated to the Director, Office of Family Assistance, the following authorities vested in me by the Secretary of Health and Human Services in the memorandum dated August 20, 1991, pertaining to the Head Start Program and the Child Development Associate Scholarship Assistance Grants Program, in the memorandum dated August 20, 1991, pertaining to the Omnibus Budget Reconciliation Act of 1981, in the memorandum dated August 20, 1991, pertaining to the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990, Pub. L. 101-508), and in the memorandum dated September 16, 1997, pertaining to the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA, Pub. L. 104-193).

(c)Effect on Existing Delegations This delegation supersedes any previous delegation of authority pertaining to authorities delegated herein.

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions in FDA's food labeling regulations. DATES: Submit written or electronic comments on the collection of information by April 30, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Food Labeling Regulations—21 CFR Parts 101, 102, 104, and 105 (OMB Control Number 0910-0381)—Extension FDA regulations require food producers to disclose to consumers and others specific information about themselves or their products on the label or labeling of their products. Related regulations require that food producers retain records establishing the basis for the information contained in the label or labeling of their products and provide those records to regulatory officials. Finally, certain regulations provide for the submission of food labeling petitions to FDA. FDA's food labeling regulations under parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) were issued under the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (the FPLA) (15 U.S.C. 1453, 1454, and 1455) and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most of these regulations derive from section 403 of the act, which provides that a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. The disclosure requirements and other collections of information in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that food products produced or sold in the United States are in compliance with the labeling provisions of the act and the FPLA. Section 101.3 of FDA's food labeling regulations requires that the label of a food product in packaged form bear a statement of identity (i.e., the name of the product), including, as appropriate, the form of the food or the name of the food imitated. Section 101.4 prescribes requirements for the declaration of ingredients on the label or labeling of food products in packaged form. Section 101.5 requires that the label of a food product in packaged form specify the name and place of business of the manufacturer, packer, or distributor and, if the food producer is not the manufacturer of the food product, its connection with the food product. Section 101.9 requires that nutrition information be provided for all food products intended for human consumption and offered for sale, unless an exemption in § 101.9(j) applies to the product. Section 101.9(g)(9) also provides for the submission to FDA of requests for alternative approaches to nutrition labeling. Finally, § 101.9(j)(18) provides for the submission to FDA of notices from firms claiming the small business exemption from nutrition labeling. Section 101.10 requires that restaurants provide nutrition information, upon request, for any food or meal for which a nutrient content claim or health claim is made. Section 101.12(b) provides the reference amount that is used for determining the serving sizes for specific products, including baking powder, baking soda, and pectin. Section 101.12(e) provides that a manufacturer that adjusts the reference amount customarily consumed

(RACC)of an aerated food for the difference in density of the aerated food relative to the density of the appropriate nonaerated reference food must be prepared to show FDA detailed protocols and records of all data that were used to determine the density-adjusted RACC. Section 101.12(g) requires that the label or labeling of a food product disclose the serving size that is the basis for a claim made for the product if the serving size on which the claim is based differs from the RACC. Section 101.12(h) provides for the submission of petitions to FDA to request changes in the reference amounts defined by regulation. Section 101.13 requires that nutrition information be provided in accordance with § 101.9 for any food product for which a nutrient content claim is made. Under some circumstances, § 101.13 also requires the disclosure of other types of information as a condition for the use of a nutrient content claim. For example, under § 101.13(j), if the claim compares the level of a nutrient in the food with the level of the same nutrient in another “reference” food, the claim must also disclose the identity of the reference food, the amount of the nutrient in each food, and the percentage or fractional amount by which the amount of the nutrient in the labeled food differs from the amount of the nutrient in the reference food. It also requires that when this comparison is based on an average of food products, this information must be provided to consumers or regulatory officials upon request. Section 101.13(q)(5) requires that restaurants document and provide to appropriate regulatory officials, upon request, the basis for any nutrient content claims they have made for the foods they sell. Section 101.14(d)(2) and (d)(3) provides for the disclosure of nutrition information in accordance with § 101.9 and, under some circumstances, certain other information as a condition for making a health claim for a food product. Section 101.15 provides that, if the label of a food product contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in both the foreign language and in English. Section 101.22 contains labeling requirements for the disclosure of spices, flavorings, colorings, and chemical preservatives in food products. Section 101.22(i)(4) sets forth reporting and recordkeeping requirements pertaining to certifications for flavors designated as containing no artificial flavor. Section 101.30 specifies the conditions under which a beverage that purports to contain any fruit or vegetable juice must declare the percentage of juice present in the beverage and the manner in which the declaration is to be made. Section 102.33 specifies the common or usual name for beverages that contain fruit or vegetable juice. Section 101.36 requires that nutrition information be provided for dietary supplements offered for sale, unless an exemption in § 101.36(h) applies. Section 101.36(f)(2) cross-references the provisions in § 101.9(g)(9) for the submission to FDA of requests for alternative approaches to nutrition labeling. Also, § 101.36(h)(2) cross-references the provisions in § 101.9(j)(18) for the submission of small business exemption notices. Section 101.42 requests that food retailers voluntarily provide nutrition information for raw fruits, vegetables, and fish at the point of purchase, and § 101.45 contains guidelines for providing such information. Also, § 101.45(c) provides for the submission of nutrient data bases and proposed nutrition labeling values for raw fruit, vegetables, and fish to FDA for review and approval. Sections 101.54, 101.56, 101.60, 101.61, and 101.62 specify information that must be disclosed as a condition for making particular nutrient content claims. Section 101.67 provides for the use of nutrient content claims for butter, and cross-references requirements in other regulations for ingredient declaration (§ 101.4) and disclosure of information concerning performance characteristics (§ 101.13(d)). Section 101.69 provides for the submission of a petition requesting that FDA authorize a particular nutrient content claim by regulation. Section 101.70 provides for the submission of a petition requesting that FDA authorize a particular health claim by regulation. Section 101.77(c)(2)(ii)(D) requires the disclosure of the amount of soluble fiber per serving in the nutrition labeling of a food bearing a health claim about the relationship between soluble fiber and a reduced risk of coronary heart disease. Section 101.79(c)(2)(iv) requires the disclosure of the amount of folate per serving in the nutrition labeling of a food bearing a health claim about the relationship between folate and a reduced risk of neural tube defects. Section 101.100(d) provides that any agreement that forms the basis for an exemption from the labeling requirements of section 403(c), (e), (g), (h), (i), (k), and

(q)of the act be in writing and that a copy of the agreement be made available to FDA upon request. Section 101.100 also contains reporting and disclosure requirements as conditions for claiming certain labeling exemptions (e.g., § 101.100(h)). Section 101.105 specifies requirements for the declaration of the net quantity of contents on the label of a food in packaged form and prescribes conditions under which a food whose label does not accurately reflect the actual quantity of contents may be sold, with appropriate disclosures, to an institution operated by Federal, State, or local government. Section 101.108 provides for the submission to FDA of a written proposal requesting a temporary exemption from certain requirements of §§ 101.9 and 105.66 for the purpose of conducting food labeling experiments with FDA's authorization. Regulations in part 102 define the information that must be included as part of the statement of identity for particular foods and prescribe related labeling requirements for some of these foods. For example, § 102.22 requires that the name of a protein hydrolysate shall include the identity of the food source from which the protein was derived. Part 104, which pertains to nutritional quality guidelines for foods, cross-references several labeling provisions in part 101 but contains no separate information collection requirements. Part 105 contains special labeling requirements for hypoallergenic foods, infant foods, and certain foods represented as useful in reducing or maintaining body weight. The disclosure and other information collection requirements in the previously mentioned regulations are placed primarily upon manufacturers, packers, and distributors of food products. Because of the existence of exemptions and exceptions, not all of the requirements apply to all food producers or to all of their products. Some of the regulations affect food retailers, such as supermarkets and restaurants. The purpose of the food labeling requirements is to allow consumers to be knowledgeable about the foods they purchase. Nutrition labeling provides information for use by consumers in selecting a nutritious diet. Other information enables a consumer to comparison shop. Ingredient information also enables consumers to avoid substances to which they may be sensitive. Petitions or other requests submitted to FDA provide the basis for the agency to permit new labeling statements or to grant exemptions from certain labeling requirements. Recordkeeping requirements enable FDA to monitor the basis upon which certain label statements are made for food products and whether those statements are in compliance with the requirements of the act or the FPLA. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section/Part No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Operating & Maintenance Costs 101.3, 101.22, part 102, and part 104 25,000 1.03 25,750 .5 12,875 0 101.4, 101.22, 101.100, part 102, part 104, and part 105 25,000 1.03 25,750 1 25,750 0 101.5 25,000 1.03 25,750 0.25 6,438 0 101.9, 101.13(n), 101.14(d)(3), 101.62, and part 104 25,000 1.03 25,750 4 103,000 0 101.9(g)(9) and 101.36(f)(2) 12 1 12 4 48 0 101.9(j)(18) and 101.36(h)(2) 10,000 1 10,000 8 80,000 0 101.10 300,000 1.5 450,000 0.25 112,500 0 101.12(b) 29 2.3 67 1 67 0 101.12(e) 25 1 25 1 25 0 101.12(g) 5,000 1 5,000 1 5,000 0 101.12(h) 5 1 5 80 400 $533,600 101.13(d)(1) and 101.67 200 1 200 1 200 0 101.13(j)(2), 101.13(k), 101.54, 101.56, 101.60, 101.61, and 101.62 5,000 1 5,000 1 5,000 0 101.13(q)(5) 300,000 1.5 450,000 0.75 337,500 0 101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 0 101.15 160 10 1,600 8 12,800 0 101.22(i)(4) 25 1 25 1 25 0 101.30 and 102.33 1,500 5 7,500 1 7,500 0 101.36 300 40 12,000 4 48,000 0 101.42 and 101.45 1,000 1 1,000 0.5 500 0 101.45(c) 5 4 20 4 80 0 101.69 3 1 3 25 75 0 101.70 5 1 5 80 400 $889,332 101.79(c)(2)(ii)(D) 1,000 1 1,000 0.25 250 0 101.79(c)(2)(iv) 100 1 100 0.25 25 0 101.100(d) 1,000 1 1,000 1 1,000 0 101.105 and 101.100(h) 25,000 1.03 25,750 0.5 12,875 0 101.108 0 0 40 0 0 Total 1,109,833 $1,422,932 1 There are no capital costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 101.12(e) 25 1 25 1 25 101.13(q)(5) 300,000 1.5 450,000 0.75 337,500 101.14(d)(2) 300,000 1.5 450,000 0.75 337,500 101.22(i)(4) 25 1 25 1 25 101.100(d)(2) 1,000 1 1,000 1 1,000 101.105(t) 100 1 100 1 100 Total 676,150 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting and recordkeeping burdens are based on agency communications with industry and FDA's knowledge of and experience with food labeling and the submission of petitions and requests to the agency. Where an agency regulation implements an information collection requirement in the act or the FPLA, only any additional burden attributable to the regulation has been included in FDA's burden estimate. No burden has been estimated for those requirements where the information to be disclosed is information that has been supplied by FDA. Also, no burden has been estimated for information that is disclosed to third parties as a usual and customary part of a food producer's normal business activities. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not a collection of information. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities. Dated: February 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-3257 Filed 2-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products 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 (the PRA). DATES: Fax written comments on the collection of information by March 29, 2007. 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: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance: Reporting and Recordkeeping Requirements and Availability of Sample Electronic Products for Manufacturers and Distributors of Electronic Products (OMB Control Number 0910-0025)—Extension Under sections 532 through 542 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ii through 360ss), FDA has the responsibility to protect the public from unnecessary exposure of radiation from electronic products. The regulations issued under these authorities are listed in the Code of Federal Regulations, title 21, chapter I, subpart J. Specifically, 1410.10 of the FDA Staff Manual Guide delegates administrative authorities to FDA. Section 532 of the act directs the Secretary of Health and Human Services (the Secretary), to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards to control the emission of electronic product radiation from electronic products. The program is designed to protect the public health and safety from electronic radiation, and the act authorizes the Secretary to procure (by negotiation or otherwise) electronic products for research and testing purposes and to sell or otherwise dispose of such products. Section 534(g) of the act directs the Secretary to review and evaluate industry testing programs on a continuing basis; and section 535(e) and

(f)of the act directs the Secretary to immediately notify manufacturers of, and ensure correction of, radiation defects or noncompliances with performance standards. Section 537(b) of the act contains the authority to require manufacturers of electronic products to establish and maintain records (including testing records), make reports, and provide information to determine whether the manufacturer has acted in compliance. Parts 1002 through 1010 (21 CFR parts 1002 through 1010) specify reports to be provided by manufacturers and distributors to FDA and records to be maintained in the event of an investigation of a safety concern or a product recall. FDA conducts laboratory compliance testing of products covered by regulations for product standards in parts 1020, 1030, 1040, and 1050 (21 CFR parts 1020, 1030, 1040, and 1050). FDA details product-specific performance standards that specify information to be supplied with the product or require specific reports. The information collections are either specifically called for in the act or were developed to aid the agency in performing its obligations under the act. The data reported to FDA and the records maintained are used by FDA and the industry to make decisions and take actions that protect the public from radiation hazards presented by electronic products. This information refers to the identification of, location of, operational characteristics of, quality assurance programs for, and problem identification and correction of electronic products. The data provided to users and others are intended to encourage actions to reduce or eliminate radiation exposures. FDA uses the following forms to aid respondents in the submission of information for this information collection: FDA Form 2579 “Report of Assembly of a Diagnostic X-ray System” FDA Form 2767 “Notice of Availability of Sample Electronic Product” FDA Form 2877 “Declaration for Imported Electronic Products Subject To Radiation Control Standards” FDA Form 3649 “Accidental Radiation Occurrence” FDA Form 3626 “A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components” FDA Form 3627 “Diagnostic X-ray CT Products Radiation Safety Report” FDA Form 3628 “General Annual Report (Includes Medical, Analytical, and Industrial X-ray Products Annual Report)” FDA Form 3629 “Abbreviated Report” FDA Form 3630 “Guide for Preparing Product Reports on Sunlamps and Sunlamp Products” FDA Form 3631 “Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products” FDA Form 3632 “Guide for Preparing Product Reports on Lasers and Products Containing Lasers” FDA Form 3633 “General Variance Request” FDA Form 3634 “Television Products Annual Report” FDA Form 3635 “Laser Light Show Notification” FDA Form 3636 “Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products” FDA Form 3637 “Laser Original Equipment Manufacturer

(OEM)Report” FDA Form 3638 “Guide for Filing Annual Reports for X-ray Components and Systems” FDA Form 3639 “Guidance for the Submission of Cabinet X-ray System Reports Pursuant to 21 CFR 1020.40” FDA Form 3640 “Reporting Guide for Laser Light Shows and Displays” FDA Form 3147 “Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device” FDA Form 3641 “Cabinet X-ray Annual Report” FDA Form 3642 “General Correspondence” FDA Form 3643 “Microwave Oven Products Annual Report” FDA Form 3644 “Guide for Preparing Product Reports for Ultrasonic Therapy Products” FDA Form 3645 “Guide for Preparing Annual Reports for Ultrasonic Therapy Products” FDA Form 3646 “Mercury Vapor Lamp Products Radiation Safety Report” FDA Form 3647 “Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps” In the **Federal Register** of November 3, 2006 (71 FR 64714), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. The most likely respondents to this information collection will be electronic product and X-ray manufacturers, importers, and assemblers. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section FDA Form Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 1002.3 10 1 10 12 120 1002.10 3626—Diagnostic X-ray 540 1.6 850 24 20,400 3627—CT X-ray 3639—Cabinet X-ray 3632—Laser 3640—Laser Light Show 3630—Sunlamp 3646—Mercury Vapor Lamp 3644—Ultrasonic Therapy 1002.11 1,000 1.5 1,500 0.5 750 1002.12 3629—Abbreviated Report 150 1 150 5 750 1002.13 3628—General 900 1 900 26 23,400 3634—TV 3638—Diagnostic X-ray 3641—Cabinet X-ray 3643—Microwave Oven 3636—Laser 3631—Sunlamp 3647—Mercury Vapor Lamp 3645—Ultrasonic Therapy 1002.13 250 2.4 600 0.5 300 1002.20 3649—ARO 40 1 40 2 80 1002.41(a) 1 1 1 1 1 1002.50(a) and 1002.51 3642—General Correspondence 10 1.5 15 1 15 1005.10 2767—Sample Product 145 11.03 1,600 0.09 144 1005.25(b) 1 1 1 1 1 2877—Imports Declaration 600 32 19,200 0.2 3,840 1010.2 and 1010.3 1 1 1 5 5 1010.4(b) 3633—General Variance Request 1 1 1 120 120 3147—Laser Show Variance Request 3635—Laser Show Notification 1010.5(c) and

(d)2 1 2 22 44 1010.13 1 1 1 10 10 1020.20(c)(4) 1 1 1 1 1 1020.30(d), (d)(1), and (d)(2) 2579—Assembler Report 2,345 8.96 21,000 0.30 6,300 1020.30(g) 200 1.33 265 35 9,275 1020.30(h)(1) through (h)(4) and 1020.32(a)(1) and

(g)200 1.33 265 35 9,275 1020.30(h)(5) and (h)(6) and 1020.32(j)(4) 20 5 100 180 18,000 1020.32(g) and 1020.33(c), (d), and (g)(4) 9 1.00 9 40 360 1020.40(c)(9)(i) and (c)(9)(ii) 8 1.00 8 40 320 1030.10(c)(4) 41 1.61 66 20 1,320 1030.10(c)(5)(i) through (c)(5)(iv) 41 1.61 66 20 1,320 1030.10(c)(6)(iii) and (c)(6)(iv) 1 1 1 1 1 1040.10(a)(3)(i) 3637—OEM Report 83 1 83 3 249 1040.10(h)(1)(i) through (h)(1)(vi) 805 1.00 805 8 6,440 1040.10(h)(2)(i) and (h)(2)(ii) 100 1.00 100 8 800 1040.11(a)(2) 190 1.00 190 10 1,900 1040.20(d)(1)(ii) through (d)(1)(vi) and (e)(1) and (e)(2) 110 1.00 110 10 1,100 1040.30(c)(1)(ii) 1 1.00 1 1 1 1040.30(c)(2) 7 1.00 7 1 7 1050.10(d)(1) through (d)(4) and (f)(1) through (f)(2)(iii) 10 1.00 10 56 560 Total 107,209 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 1002.30 and 1002.31(a) 1,150 1,655.5 1,903,825 198.7 228,505 1002.40 and 1002.41 2,950 49.2 145,140 2.4 7,080 1020.30(g) 22 1 22 0.5 11 1040.10(a)(3)(ii) 83 1 83 1.0 83 Totals 235,679 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The information collection requirements under OMB control number 0910-0564 and Form FDA 3626, the data collection instrument for this collection, have been consolidated under the information collection activity of OMB control number 0910-0025, thus resulting in an adjustment (increase) in the current burden estimate. The burden estimates were derived by consultation with FDA and industry personnel and actual data collected from industry. An evaluation of the type and scope of information requested was also used to derive some time estimates. For example, disclosure information primarily requires time only to update and maintain existing manuals. Initial development of manuals has been performed except for new firms entering the industry. When information is generally provided to users, assemblers, or dealers in the same manual, they have been grouped together in the “Estimated Annual Reporting Burden” table (table 1 of this document). The following information collection requirements are not subject to review by OMB because they do not constitute a “collection of information” under the PRA: Sections 1002.31(c); 1003.10(a), (b), and (c); 1003.11(a)(3) and (b); 1003.20(a) through (h); 1003.21(a) through (d); 1003.22(a) and (b); 1003.30(a) and (b); 1003.31(a) and (b); 1004.2(a) through (i); 1004.3(a) through (i); 1004.4(a) through (h); 1005.21(a) through (c); and 1005.22(b). These requirements “apply to the collection of information during the conduct of general investigations or audits” (5 CFR 1320.4(b)). The following labeling requirements are also not subject to review under the PRA because they are a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (1410.10 of the FDA Staff Manual Guide and §§ 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1)). Dated: February 20, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-3258 Filed 2-26-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0051] Safety of Fresh Produce; Public Hearings; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public hearings; request for comments. SUMMARY: The Food and Drug Administration

(FDA)is announcing two public hearings concerning the safety of fresh produce. The purpose of the hearings is for FDA to share information about recent outbreaks of foodborne illness associated with microbial contamination of fresh produce, and to solicit comments, data, and other scientific information about current agricultural and manufacturing practices used to produce, harvest, pack, cool, process, and transport fresh produce; risk factors for contamination of fresh produce associated with these practices; and possible measures by FDA to enhance the safety of fresh produce. DATES: The first public hearing will be held on March 20, 2007, from 9 a.m. to 5 p.m. The second public hearing will be held on April 13, 2007, from 9 a.m. to 5 p.m. See section V of this document for additional dates on how to participate in the hearings. Submit written or electronic comments (i.e., submissions other than notices of participation and the text, comprehensive outline, or summary of an oral presentation) by June 13, 2007. ADDRESSES: The first public hearing will be held at the Ronald V. Dellums Federal Building, Edward Roybal Auditorium, 1301 Clay St., 3d floor, Oakland, CA 94612. The second public hearing will be held at the Harvey W. Wiley Federal Building, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD, 20740-3835 (Metro stop: College Park on the Green Line). Submit electronic notices of participation for either hearing to *http://www.cfsan.fda.gov/~comm/register.html* . We encourage you to use this method of registration, if possible. You may also submit oral or written notices of participation by phone, by fax, or by e-mail, or submit the written full text, comprehensive outline, or summary of any oral presentation by fax or by e-mail to Isabelle Howes, U.S. Department of Agriculture Graduate School, 202-314-4713, FAX: 202-479-6801, or e-mail: *Isabelle_Howes@grad.usda.gov* . Submit written comments 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* . *Instructions* : All submissions and comments received must include the agency name and docket number found in brackets in the heading of this document. All submissions and comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see section VI in the SUPPLEMENTARY INFORMATION section of this document. Transcripts of the hearings will be available for review at the Division of Dockets Management and on the Internet at *http://www.fda.gov/ohrms/dockets/default.htm* approximately 30 days after the hearing. FOR FURTHER INFORMATION CONTACT: *To submit an oral or written notice of participation by phone, by fax, or by e-mail, or the written full text, comprehensive outline, or summary of any oral presentation by fax or by e-mail* : Isabelle Howes, U.S. Department of Agriculture Graduate School, 202-314-4713, FAX: 202-479-6801, or e-mail: *Isabelle_Howes@grad.usda.gov* . All participants must complete registration. Following registration, you will receive a confirmation notice which also includes hotel and parking information. *For all other questions about the hearings or if you need special accommodations due to a disability* : Juanita Yates, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 301-436-1731, e-mail: *Juanita.Yates@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background A. Food Safety and Fresh Produce FDA is responsible for ensuring the safety of all domestic and imported fresh and fresh-cut fruits and vegetables consumed in the United States. Fresh fruits and vegetables are those that are likely to be sold to consumers in an unprocessed or minimally processed (i.e., raw) form. Fresh fruits and vegetables may be intact and whole, such as whole apples, or cut in the act of harvest, such as heads of lettuce and bunches of broccoli. As used in this document, the term “fresh-cut produce” refers to minimally processed fruits and vegetables that have been altered in form by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or retail establishment. Examples of fresh-cut products are shredded lettuce, sliced tomatoes, salad mixes, peeled baby carrots, broccoli florets, and cut melons. Fresh-cut produce does not require additional preparation, processing, or cooking before consumption, with the possible exception of washing or the addition of salad dressing or seasoning. In this document, we use the term “fresh produce” to describe all fresh and fresh-cut fruits and vegetables consumed in the United States. Because most fresh produce is grown in a natural environment, it is vulnerable to contamination with pathogens (i.e., bacteria or other organisms that can cause disease). Factors that may affect the occurrence of such contamination include agricultural and/or processing water quality, the use of manure as fertilizer, the presence of wild or domestic animals in or near fields or packing areas, worker health and hygiene, environmental conditions, production activities, and equipment and facility sanitation. Consequently, the manner in which fresh produce is grown, harvested, packed, processed, transported, distributed, and prepared is crucial to minimizing the risk of microbial contamination. (We use the term “microbial contamination” to refer to contamination with any microorganism.) Data reported to the U.S. Centers for Disease Control and Prevention

(CDC)indicate that between 1973 and 1997 reported outbreaks of foodborne illness in the United States associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne outbreaks (Ref. 1). (By “outbreak,” we mean the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.) Unpublished data compiled by FDA indicate that from 1996 to 2006 there were approximately 72 reported outbreaks of foodborne illness associated with approximately 20 fresh produce commodities. Of this total, 12 outbreaks were associated with tomatoes, 11 outbreaks were associated with melons, and 24 outbreaks were associated with leafy greens such as lettuce and spinach (Ref. 2). These outbreaks involved a number of pathogens, including *Escherichia coli* ( *E. coli* ) O157:H7 and *Salmonella* species, and both domestic and imported produce. These totals include only those outbreaks in which our investigation has indicated that the contamination of the produce was not a result of exposure to an infected food handler or other unsafe food handling practice at the place of preparation and consumption (i.e., home or restaurant). When there is an outbreak of foodborne illness, we work with Federal, State, and local agencies to identify the source of the outbreak and minimize the public health impact. For example, on September 14, 2006, we issued a news release alerting consumers about an outbreak of *E. coli* O157:H7 in multiple States and advising the public not to eat bagged fresh spinach because it had been implicated in the outbreak (Ref. 3). We continued to issue updated press releases for approximately four weeks. During the course of the outbreak, approximately 200 illnesses were reported to the CDC, including more than 30 cases of hemolytic uremic syndrome (HUS, a condition occurring mainly in children that can result in kidney failure), more than 100 hospitalizations, and 3 deaths (Ref. 4). In addition to working to identify the food involved in the outbreak, we worked with others to trace the source of the implicated product to packing, cooling and processing facilities involved and to the farm to identify practices or conditions that may have contributed to the contamination of the produce. One challenge faced by public health officials during an outbreak is to quickly identify through traceback the sources of contamination. FDA's regulations require the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States (21 CFR 1.326-1.368). Such records allow for the identification of the immediate previous sources and immediate subsequent recipients of food, and thereby help FDA and other authorities determine the source and cause of the event. Farms and restaurants are excluded from these requirements. Traceback can be particularly problematic when fresh produce is involved. Eating fruits and vegetables is an important part of a healthy diet (Ref. 5). We place a high priority on identifying and implementing measures that can reduce the incidence of foodborne illness associated with fresh produce. B. Guidance Documents and Letters Issued by FDA to Enhance the Safety of Fresh Produce In 1998, FDA issued guidance to industry entitled “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables” (GAPs/GMPs Guide) (Ref. 6). This guide recommends good agricultural practices

(GAPs)and good manufacturing practices

(GMPs)that growers, packers, and shippers can undertake to address common risk factors in their operations and thereby minimize food safety hazards potentially associated with fresh produce. Implementation of risk reduction measures is critical; as the GAPs/GMPs Guide notes, current technologies cannot eliminate all potential food safety hazards associated with fresh produce that will be eaten raw. On February 5, 2004, FDA issued a letter to firms that grow, pack, or ship fresh lettuce and fresh tomatoes, expressing concern regarding outbreaks of foodborne illness associated with the consumption of fresh lettuce and fresh tomatoes, and recommending actions to enhance the safety of these products (Ref. 7). On November 4, 2005, FDA issued a second letter to firms that grow, pack, process or ship fresh and fresh-cut lettuce, reiterating concerns about continuing outbreaks (Ref. 8). In the November 2005 letter, FDA strongly encouraged applicable firms to review their current operations in light of the GAPs\GMPs Guide, as well as other available information regarding the reduction or elimination of pathogens on fresh produce. FDA encouraged firms to consider modifying their operations to ensure that they were taking the appropriate measures to provide a safe product to the consumer. FDA recommended that firms from the farm level through the distribution level undertake these steps. On March 1, 2006, FDA issued a draft entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (the Fresh-cut Guide) (Ref. 9). The draft Fresh-cut Guide is intended to be used in conjunction with the GAPs/GMPs Guide, which covers stages prior to fresh-cut processing, with the current GMPs in part 110 (21 CFR part 110), which contain food safety practices applicable to processors who manufacture, process, pack, or hold processed food, and with the FDA Food Code (Ref. 10), which focuses on activities at subsequent stages, such as retail. The FDA Food Code gives State and local governments a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores and institutions such as nursing homes). State, local, tribal, and Federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy. (For more information on the FDA Food Code, see *http://www.cfsan.fda.gov/~dms/foodcode.html* .) FDA is currently working to finalize the Fresh-cut Guide. C. Produce Safety Action Plan In October 2004, FDA issued the “Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption” or Produce Safety Action Plan

(PSAP)(Ref. 11). The PSAP expands on the areas covered by the GAPs/GMPs Guide for farms and packing, to extend to all parts of the food supply chain from farm through retail or consumer preparation and consumption. The PSAP does not cover frozen fruits and vegetables, fruit and vegetable juices, or other commodities, such as tree nuts, that are neither fruits nor vegetables and not typically regarded as produce. The PSAP has four main objectives which are to:

(1)Prevent contamination of fresh produce with pathogens;

(2)minimize the public health impact when contamination of fresh produce occurs;

(3)improve communication with producers, packers, processors, transporters, distributors, preparers, consumers, and other government entities about the safety of fresh produce; and

(4)facilitate and support research relevant to the contamination of fresh produce. For each objective, the PSAP identifies steps or actions that could contribute to the achievement of that objective. The PSAP has measurable goals and outcomes, and several steps outlined in the PSAP are already in progress or have been completed. For example, we issued the draft Fresh-cut Guide as part of the PSAP objective regarding prevention of contamination. D. Partnerships and Collaborations Because following the GAPs/GMPs Guide is voluntary, FDA and food safety partners in the public and private sectors have stressed education and outreach to industry to promote adoption of the guidance. Buyer requirements that producers and other suppliers provide self- or third-party audit verification that they are following the GAPs/GMPs Guide have further promoted adoption of the guidance. We have worked with the fresh produce industry since the release of the GAPs/GMPs Guide to promote its recommendations and to advance the scientific knowledge applicable to enhancing the safety of fresh produce. For example, in conjunction with the PSAP, we have provided technical assistance to industry in developing several commodity specific guidelines that cover the entire supply chain. Commodity-specific industry guidelines exist for three foods: Melons, lettuce and leafy greens, and tomatoes (see Refs. 12, 13, and 14). An additional industry guideline on green onions and herbs is in progress. Between 1996 and 2006, these commodities together accounted for approximately 80 percent of the foodborne outbreaks associated with produce (Ref. 2). In August 2006 we launched the “Lettuce and Leafy Greens Initiative,” which involved assessments of practices and conditions at select farms and facilities in California. The initiative, conducted in collaboration with the California Department of Health Services and the California Department of Food and Agriculture, is intended to be a multi-year effort and may be a model for other initiatives in the future. E. Other Food Safety Measures The provisions in part 110 (Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food) establish requirements and recommendations as follows that apply in determining whether a food is adulterated:

(1)Within the meaning of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 341(a)(3)), in that the food has been manufactured under such conditions that it is unfit for food; or

(2)within the meaning of section 402(a)(4) of the act, in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Under § 110.19(a), establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities (as defined in section 201(r) of the act (21 U.S.C. 321)), are not subject to the requirements of part 110. However, under § 110.19(b), we may issue special regulations if it is necessary to cover these excluded operations. In addition, the GAPs/GMPs Guide recommends that operations excluded from the provisions of part 110 consider implementing the current GMPs required or recommended in part 110 as appropriate. For foods other than fresh produce, we have issued regulations designed to enhance food safety, including safety related to microbial pathogens (see, e.g., 21 CFR part 113, concerning thermally processed low-acid foods packaged in hermetically sealed containers; 21 CFR part 114, concerning acidified foods; 21 CFR 15.51, concerning refrigeration of shell eggs held for retail distribution; 21 CFR part 120, concerning hazard analysis and critical control point (HACCP) systems for juice; and 21 CFR part 123, concerning HACCP requirements for fish and fishery products). Some FDA regulations to enhance the safety of particular food products (e.g., the HACCP requirements in 21 CFR part 120 for juice and in 21 CFR part 123 for fish and fishery products) contain training and other requirements for performing particular functions. For some food products, we have augmented our regulations with nonbinding guidance to assist industry in complying with the regulations (e.g., FDA's Juice HACCP Hazards and Controls Guidance (available at *http://www.cfsan.fda.gov/~dms/guidance.html* ) and Fish And Fisheries Products Hazards And Controls Guidance (available at *http://www.cfsan.fda.gov/~dms/guidance.html* )). F. Next Steps We believe that the measures outlined in the PSAP, the GAPs/GMPs Guide, and other public and private sector actions, when implemented, have or can be effective in reducing the risk of microbial contamination of fresh produce. In particular, the GAPs/GMPs Guide has been used as a basis for a number of food safety programs, both in the United States and internationally. However, the fact that outbreaks of foodborne illness associated with fresh produce continue to occur supports a close examination of the extent to which these measures have been implemented; whether they have been effective, if implemented properly; and what additional or different interventions might be appropriate to reduce the risk of future outbreaks. As a next step, we intend to hold two public hearings regarding the safety of fresh produce. The purpose and scope of the hearings, each of which will be governed by part 15 (21 CFR part 15) of FDA's regulations, are described in section II of this document. II. Purpose and Scope of the Hearings We want to share information about recent outbreaks of foodborne illness associated with microbial contamination of fresh produce, and to invite comments, data, and other scientific information about: Current agricultural and manufacturing practices used to produce, harvest, pack, cool, process, and transport fresh produce; risk factors for contamination of fresh produce associated with these practices; and possible measures by FDA to enhance the safety of fresh produce. This notice describes the scope of the hearings. We invite information and comment on the issues and questions in section III of this document. If you are interested in these hearings or this subject, you may address as many of the following questions as you wish. We do not expect you to address all questions. When possible, please provide scientific information and data in support of your comments. In addition, to the extent possible, please provide as specific information as is feasible about the estimated costs and benefits associated with your responses (e.g., the costs and benefits of current practices and/or the cost and benefits of any recommendations you may make). III. Issues and Questions for Discussion Issue 1: In the supply chain for fresh produce (e.g., farms, packing houses, cooling facilities, and fresh-cut processing facilities), various factors can contribute to the risk of microbial contamination of fresh produce. We request information to enable us to identify and understand such factors more fully. Question 1. For each stage in the supply chain, and for each industry sector, what are the risks or practices that could lead to microbial contamination of fresh produce? Question 2. How can or should current practices be changed to reduce the risk of contamination? Question 3. For each stage in the supply chain, and for each industry sector, what current practices (including, for example, following the GAPs/GMPs Guide) reduce the risk of microbial contamination of fresh produce? What data are available to support a conclusion that the risk of such contamination is lower than it would be without the practice in place? Question 4. Is fresh produce, or inputs such as agricultural water, sampled and tested for pathogens or indicator organisms at any stage of the supply chain? If yes, please describe the sampling and testing done. Issue 2: As described more fully in sections I.B through I.E of this document, we already have implemented several measures to enhance the safety of fresh produce and other foods within FDA's jurisdiction. Question 5. Beyond the Federal actions described in sections I.B. through I.E, what new Federal actions, if any, are needed to enhance the safety of fresh produce? On what aspects of the produce supply chain should the measures focus? Question 6. In identifying possible Federal interventions or actions, to what extent can or should we take into account the wide variation within the fresh produce industry with respect to, e.g., the size and type of establishments, the nature of the commodity produced, the practices used in production, and the vulnerability of particular commodities to contamination? To what extent should such measures apply to specific products, sectors of the industry, regions, or businesses? For example, is there a need for special treatment for different commodity groups? Issue 3: Traceback can be problematic when unpackaged fresh produce is involved in an outbreak, especially for products which may undergo several packing and repacking steps in the supply chain with multiple opportunities for commingling. Even with respect to packaged and labeled products, traceback is difficult if there are insufficient records to identify the specific farm, field, or block of origin; if the records lack sufficient specificity about where the fresh produce went after leaving the packing or processing facility; or if there are discrepancies between records of incoming and outgoing product. Question 7. What types of records and other information, from what types of facilities, are or would be most useful in facilitating traceback efforts? Issue 4: Written food safety plans, sanitation standard operating procedures (SSOPs), and monitoring records can serve as useful tools for both industry and regulators. Such records can assist operators in conducting operations in a manner that could enhance the safety of fresh produce. For growers, an assessment of factors such as the field environment and agricultural inputs could contribute to the development of written food safety plans and SSOPs, and also could help to determine which factors should be monitored and the frequency of monitoring. (In the following questions we use the term “assessment” when referring to an evaluation conducted by, or on behalf of, a grower or operator to identify measures to enhance food safety.) Written food safety plans, SSOPs, and monitoring records also can assist regulators in verifying that certain practices are being followed consistently and properly over time. Onsite inspections, either alone, or in conjunction with records review, are another approach to such verification. (We use the term “inspection” when referring to an evaluation conducted by, or on behalf of, a regulator to evaluate compliance and the term “audit” to refer to a self- or third-party evaluation of whether operations adhere to, for example, voluntary guidelines or written food safety plans or SSOPs developed by the grower, operator, or buyer.) Question 8. Are written food safety plans, written SSOPs, periodic assessments, training, and/or the establishment and maintenance of records useful for risk identification and risk mitigation or management purposes? If yes, to what extent are these practices in place, and in what sectors of the industry? Issue 5: As noted in section II.D of this document, some buyers require that producers and other suppliers provide self- or third-party audit verification that they are following the GAPs/GMPs Guide. However, the extent to which these verifications reflect adherence to the guidance is not well-established. Question 9. How should adherence to the GAPs/GMPs Guide or new produce safety guidance(s) be measured and verified by the grower or operator, government regulators, or third-party auditors, in the event of any new recommended Federal action or in the event you are not recommending any new Federal action? Question 10. If you are recommending any new Federal measures, please describe how they might affect certain small businesses, such as roadside stands, farm gate operations, farmers' markets, or other small businesses involved in direct sales. IV. Notice of Hearings Under 21 CFR Part 15 By delegation from the Commissioner of Food and Drugs (the Commissioner) (Staff Manual Guide 1420.21, section 1(b)), the Associate Commissioner for Policy and Planning finds that it is in the public interest to permit persons to present information and views at a public hearing regarding the safety of fresh produce and is announcing that the public hearings will be held in accordance with part 15. The presiding officer will be the Commissioner or his designee. The presiding officer will be accompanied by a panel of FDA employees with relevant expertise. Persons who wish to participate in either hearing (either by making a presentation or as a member of the audience) must file a notice of participation (see ADDRESSES , DATES , FOR FURTHER INFORMATION CONTACT , and “How to Participate in the Hearings” in section V of this document). By delegation from the Commissioner (Staff Manual Guide 1420.21, section 1(b)), the Associate Commissioner for Policy and Planning has determined under § 15.20(c) that advance submissions of oral presentations are necessary for the panel to formulate useful questions to be posed at the hearings under § 15.30(e), and that the submission of a comprehensive outline or summary is an acceptable alternative to the submission of the full text of the oral presentation. Because we anticipate attendance at the hearings to be high, we request that individuals and organizations with common interests consolidate their requests for oral presentation and request time for a joint presentation through a single representative. After reviewing the notices of participation and accompanying information, we will schedule each oral presentation and notify each participant of the time allotted to the presenter and the approximate time that the presentation is scheduled to begin. If time permits, we may allow interested persons who attend one or both hearings but did not submit a notice of participation in advance to make an oral presentation at the conclusion of one or both hearings. The hearing schedules will be available at the hearings. After the hearings, the schedules will be placed on file in the Division of Dockets Management (see ADDRESSES ) under the docket number listed in brackets in the heading of this notice. To ensure timely handling of any mailed notices of participation, presentations, or comments, any outer envelope should be clearly marked with the docket number listed in brackets in the heading of this notice along with the statement “Safety of Fresh Produce; Public Hearing.” Under § 15.30(f), the hearings are informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to the procedures and limitations in § 10.206, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearings will be transcribed as stipulated in § 15.30(b). The transcript will be available on the Internet at *http://www.fda.gov/ohrms/dockets/default.htm* , and orders for copies of the transcript can be placed at the hearing or through the Division of Dockets Management (see ADDRESSES ). Any handicapped persons requiring special accommodations to attend the hearings should direct those needs to the contact person (see FOR FURTHER INFORMATION CONTACT ). To the extent that the conditions for the hearings, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of these provisions as specified in §§ 10.19 and 15.30(h). In particular, § 15.21(a) states that the notice of hearing will provide persons an opportunity to file a written notice of participation with the Division of Dockets Management within a specified period of time. If the public interest requires, e.g., if a hearing is to be conducted within a short period of time, the notice may name a specific FDA employee and telephone number to whom an oral notice of participation may be given. If the public interest requires, the notice may also provide for submitting notices of participation at the time of the hearing. In this document, the conditions for the hearings specify that notices of participation be submitted electronically to an agency Internet site, to a contact person (outside of FDA) who will accept notices of participation by mail, telephone, fax, or e-mail, or in person on the day of the hearing (as space permits). We are using these procedures for submitting notices of participation, rather than provide for the submission of notices of participation to the Division of Dockets Management, because the hearing is to be conducted within a short period of time and these procedures are more efficient. In addition, these procedures provide more flexibility to persons who wish to participate in the hearings than would be provided if participants were required to submit the notice of participation in writing to the Division of Dockets Management. By delegation from the Commissioner (Staff Manual Guide 1420.21, section 1(f)(2)(i)), the Associate Commissioner for Policy and Planning finds under § 10.19 that no participant will be prejudiced, the ends of justice will thereby be served, and the action is in accordance with law if notices of participation are submitted by the procedures listed in this notice rather than to the Division of Dockets Management. V. How to Participate in the Hearings Registration by submission of a notice of participation is necessary to ensure participation and will be accepted on a first-come, first-served basis. The notice of participation may be submitted electronically (see ADDRESSES ). The notice of participation also may be submitted orally, by fax, or by e-mail (see ADDRESSES and FOR FURTHER INFORMATION CONTACT ). We encourage you to submit your notice of participation electronically. A single copy of any notice of participation is sufficient, except that any person who wishes to participate in both hearings must submit a separate notice of participation for each hearing. The notice of participation must include your name, title, business affiliation (if applicable), address, telephone number, fax number (if available), and e-mail address (if available). If you wish to request an opportunity to make an oral presentation during the open public comment period of the hearing, your notice of participation also must include the title of your presentation, the sponsor of the oral presentation (e.g., the organization paying travel expenses or fees), if any; and the approximate amount of time requested for the presentation. Presentations will be limited to the questions and subject matter identified in section III of this document, and, depending on the number of requests received, we may be obliged to limit the time allotted for each presentation. Persons who wish to request an opportunity to make an oral presentation at the March 20, 2007, public hearing must submit a notice of participation (register) by March 2, 2007. All other persons wishing to register to attend the March 20, 2007, public hearing must submit a notice of participation by March 12, 2007. Persons who request an opportunity to make an oral presentation at the March 20, 2007, public hearing also must submit either the full text of the oral presentation, or a comprehensive outline or summary of the oral presentation, by March 12, 2007. Persons requiring special accommodations due to a disability must register by March 6, 2007. Persons who wish to request an opportunity to make an oral presentation at the April 13, 2007, public hearing must submit a notice of participation by March 23, 2007. All other persons wishing to register to attend the April 13, 2007, public hearing must submit a notice of participation by April 6, 2007. Persons who request an opportunity to make an oral presentation at the second public hearing also must submit either the full text of the oral presentation, or a comprehensive outline or summary of the oral presentation, by April 6, 2007. Under § 15.20(c), if you request an opportunity to make an oral presentation you must submit your presentation (either as the full text of the presentation, or as a comprehensive outline or summary) by e-mail or by fax. See ADDRESSES and FOR FURTHER INFORMATION CONTACT for information on where to send your presentation. Individuals who request an opportunity to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. Depending on the number of oral presentations, we may need to limit the time allotted for each oral presentation (e.g., 5 minutes each). As stated earlier, we request that interested persons and groups having similar interests consolidate their requests for oral presentation and present them through a single representative. If you need special accommodations due to a disability, please inform us (see FOR FURTHER INFORMATION CONTACT ). We will also accept registration onsite; however, space is limited and will be closed when the maximum seating capacity is reached. If space is available, on-site registration will be accepted on a first-come, first-served basis. Requests for an opportunity to make a presentation from individuals or organizations that did not register to make an oral presentation may be granted if time permits. Persons who registered for the hearing should check in at the on-site registration desk between 8:30 and 9 a.m. Persons who wish to register onsite on the day of the hearing should do so at the registration desk between 8:30 and 9 a.m. We encourage all participants to attend the entire day. Because the hearings will be held in Federal buildings, hearing participants must present photo identification and plan adequate time to pass through the security system. VI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments in response to this document and notice of hearings for consideration at or after the hearings in addition to, or in place of, a request for an opportunity to make an oral presentation (see section V of this document). Submit two paper copies of any written comments, except that individuals may submit one 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. FDA is inviting public comment in writing and at the public hearings. These comments are sought to inform FDA decisionmaking about possible regulatory action with respect to the safety of fresh produce. Written or electronic comments (i.e., submissions other than notices of participation and the text, comprehensive outline, or summary of an oral presentation) may be submitted until June 13, 2007. The administrative record of the hearing will remain open until June 13, 2007. VII. References The following references have been placed on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the **Federal Register** . 1. Sivapalasingam, S., et al. “Fresh Produce: A Growing Cause of Outbreaks of Foodborne Illness in the United States, 1973 through 1997,” *Journal of Food Protection* 67(10): 2342-53, 2004. 2. U.S. Food and Drug Administration, 1996-2006 Produce Outbreaks (unpublished compilation). 3. U.S. Food and Drug Administration, FDA News Release, “FDA Warning on Serious Foodborne *E. coli* O157:H7 Outbreak,” P06-131, September 14, 2006, available at *http://www.fda.gov/po/indexes/2006news.html* . 4. U.S. Centers for Disease Control and Prevention, “Update on Multi-State Outbreak of *E. coli* O157:H7 Infections From Fresh Spinach, October 6, 2006, available at *http://www.cdc.gov/ecoli/2006/september/updates/100606.htm* . 5. U.S. Department of Health and Human Services and U.S. Department of Agriculture, “Dietary Guidelines for Americans 2005,” January 2005, available at *http://www.healthierus.gov/dietaryguidelines/* . 6. U.S. Food and Drug Administration, “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,” October 26, 1998, available at *http://www.cfsan.fda.gov/~dms/prodguid.html* . 7. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods, “Letter to Firms that Grow, Pack, or Ship Fresh Lettuce and Fresh Tomatoes,” February 5, 2004, available at *http://www.cfsan.fda.gov/~dms/prodltr.html* . 8. U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods, “Letter to California Firms that Grow, Pack, Process, or Ship Fresh and Fresh-cut Lettuce,” November 4, 2005, available at *http://www.cfsan.fda.gov/~dms/prodltr2.html* . 9. U.S. Food and Drug Administration, “Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables,” March 2006, available at *http://www.cfsan.fda.gov/~dms/prodgui2.html* . 10. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, FDA Food Code, 2005, available at *http://www.cfsan.fda.gov/~dms/foodcode.html* . 11. U.S. Food and Drug Administration, “Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated With Fresh Produce Consumption,” October 2004, available at *http://www.cfsan.fda.gov/~dms/prodpla2.html* . 12. Produce Marketing Association and United Fresh Fruit and Vegetable Association, “Commodity Specific Food Safety Guidelines for the Melon Supply Chain,” November 7, 2005, available at *http://www.cfsan.fda.gov/~dms/melonsup.html* or *http://www.cfsan.fda.gov/~acrobat/melonsup.pdf* . 13. International Fresh-Cut Produce Association, Produce Marketing Association, United Fresh Fruit and Vegetable Association, Western Growers Association; Commodity Specific Food Safety Guidelines for the Lettuce and Leafy Greens Supply Chain; April 25, 2006, available at *http://www.cfsan.fda.gov/~dms/lettsup.html* or *http://www.cfsan.fda.gov/~acrobat/lettsup.pdf* . 14. North American Tomato Trade Work Group, “Commodity Specific Food Safety Guidelines for the Fresh Tomato Supply Chain, May 2006, available at *http://www.cfsan.fda.gov/~dms/tomatsup.html* or *http://www.cfsan.fda.gov/~acrobat/tomatsup.pdf* . Dated: February 21, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 07-891 Filed 2-23-07; 8:45 am]

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