Notices. Notice of matching fund submission dates and submission dates for statements of net outstanding campaign obligations for 2008 presidential candidates
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BILLING CODE 6712-01-M FEDERAL ELECTION COMMISSION [Notice 2007-27] 2008 Presidential Candidate Matching Fund Submission Dates and Post Date of Ineligibility Dates To Submit Statements of Net Outstanding Campaign Obligations; (Authority: 11 CFR 9036.2; 11 CFR 9034.5) AGENCY: Federal Election Commission. ACTION: Notice of matching fund submission dates and submission dates for statements of net outstanding campaign obligations for 2008 presidential candidates. SUMMARY: The Federal Election Commission is publishing matching fund submission dates for publicly funded 2008 presidential primary candidates.
Eligible candidates may present one submission and/or resubmission per month on the designated date. The Commission is also publishing the dates on which publicly funded 2008 presidential primary candidates must submit their statements of net outstanding campaign obligations (“NOCO statements”) after their dates of ineligibility (“DOI”). Candidates are required to submit a NOCO statement prior to each regularly scheduled date on which they receive Federal matching funds, on dates set forth in the Supplementary Information below.
FOR FURTHER INFORMATION CONTACT: Ms. Wanda Thomas, Audit Division, 999 E Street, NW., Washington, DC 20463,
(202)694-1200 or
(800)424-9530. SUPPLEMENTARY INFORMATION: Matching Fund Submissions Presidential candidates eligible to receive Federal matching funds may present submissions and/or resubmissions to the Federal Election Commission once a month on designated submission dates. The Commission will review the submissions/resubmissions and forward certifications for eligible candidates to the Secretary of Treasury. Because no payments can be made during 2007, submissions received during 2007 will be certified in late December 2007, for payment in 2008. 11 CFR 9036.2(c). Treasury Department regulations require that funds for the convention and general election grants be set aside before any matching fund payments are made. Information provided by the Treasury Department shows the balance in the fund as of October 31, 2007 was $165,383,063 and the Commission estimates that no funds will be available for matching payments in January 2008. As deposits are made from tax returns in the early months of 2008, matching fund payments will be made from those deposits until all certified amounts have been paid. During 2008 and 2009, certifications will be made on a monthly basis. The last date a candidate may make a submission is March 2, 2009. The submission dates specified in the following list pertain to non-threshold matching fund submissions and resubmissions after the candidate establishes eligibility. The threshold submission on which that eligibility will be determined may be filed at any time and will be processed within fifteen business days, unless review of the threshold submission determines that eligibility has not been met. NOCO Submissions Under 11 CFR 9034.5, a candidate who received Federal matching funds must submit a NOCO statement to the Commission within 15 calendar days after the candidate's date of ineligibility, as determined under 11 CFR 9033.5. The candidate's net outstanding campaign obligations is equal to the total of all outstanding obligations for qualified campaign expenses plus estimated necessary winding down costs less cash on hand, the fair market value of capital assets, and accounts receivable. 11 CFR 9034.5(a). Candidates will be notified of their DOI by the Commission. A Candidate who has net outstanding campaign obligations post-DOI may continue to submit matching payment requests as long as the candidate certifies that the remaining net outstanding campaign obligations equal or exceed the amount submitted for matching. 11 CFR 9034.5(f)(1). If the candidate so certifies, the Commission will process the request and certify the appropriate amount of matching funds. Candidates must also file revised NOCO statements in connection with each matching fund request submitted after the candidate's DOI. These statements are due just before the next regularly scheduled payment date, on a date to be determined by the Commission. They must reflect the financial status of the campaign as of the close of business three business days before the due date of the statement and must also contain a brief explanation of each change in the committee's assets and obligation from the most recent NOCO statement. 11 CFR 9034.5(f)(2). The Commission will review the revised NOCO statement and adjust the committee's certification to reflect any change in the committee's financial position that occurs after submission of the matching payment request and the date of the revised NOCO statement. The following schedule includes both matching fund submission dates and submission dates for revised NOCO statements. Schedule of Matching Fund Submission Dates and Dates To Submit Revised Statements of Net Outstanding Campaign Obligations
(NOCO)for 2008 Presidential Candidates Matching fund submission dates Revised NOCO submission dates January 2, 2008 December 24, 2007. February 1, 2008 January 25, 2008. March 3, 2008 February 25, 2008. April 1, 2008 March 25, 2008. May 1, 2008 April 24, 2008. June 2, 2008 May 23, 2008. July 1, 2008 June 24, 2008. August 1, 2008 July 25, 2008. September 2, 2008 August 25, 2008. October 1, 2008 September 25, 2008. November 3, 2008 October 27, 2008. December 1, 2008 November 21, 2008. January 5, 2009 December 26, 2008. February 2, 2009 January 26, 2009. March 2, 2009 February 23, 2009. Dated: December 17, 2007. Robert D. Lenhard, Chairman, Federal Election Commission. [FR Doc. E7-24791 Filed 12-20-07; 8:45 am] BILLING CODE 6715-07-P FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background. On June 15, 1984, the Office of Management and Budget
(OMB)delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), as per 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Request for comment on information collection proposals The following information collections, which are being handled under this delegated authority, have received initial Board approval and are hereby published for comment. At the end of the comment period, the proposed information collections, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following: a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility; b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the information to be collected; and d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology. DATES: Comments must be submitted on or before February 19, 2008. ADDRESSES: You may submit comments, identified by FR G-1, FR G-2, FR G-3, FR G-4, FR T-4, FR U-1, FR 2225, FR 2226, or FR 3016 by any of the following methods: • Agency Web Site: *http://www.federalreserve.gov.* Follow the instructions for submitting comments at *http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm.* • Federal eRulemaking Portal: *http://www.regulations.gov.* Follow the instructions for submitting comments. • E-mail: *regs.comments@federalreserve.gov.* Include docket number in the subject line of the message. • FAX: 202/452-3819 or 202/452-3102. • Mail: Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, N.W., Washington, DC 20551. All public comments are available from the Board's web site at *www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm* as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper form in Room MP-500 of the Board's Martin Building (20th and C Streets, N.W.) between 9:00 a.m. and 5:00 p.m. on weekdays. Additionally, commenters should send a copy of their comments to the OMB Desk Officer by mail to the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street, NW., Washington, DC 20503 or by fax to 202-395-6974. FOR FURTHER INFORMATION CONTACT: A copy of the PRA OMB submission including, the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public website at: *http://www.federalreserve.gov/boarddocs/reportforms/review.cfm* or may be requested from the agency clearance officer, whose name appears below. Michelle Shore, Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device for the Deaf
(TDD)users may contact (202-263-4869), Board of Governors of the Federal Reserve System, Washington, DC 20551. Proposal to approve under OMB delegated authority the extension for three years, without revision, of the following reports: *1. Report titles:* Registration Statement for Persons Who Extend Credit Secured by Margin Stock (Other Than Banks, Brokers, or Dealers); Deregistration Statement for Persons Registered Pursuant to Regulation U; Statement of Purpose for an Extension of Credit Secured by Margin Stock by a Person Subject to Registration Under Regulation U;Annual Report; Statement of Purpose for an Extension of Credit by a Creditor; and Statement of Purpose for an Extension of Credit Secured by Margin Stock. *Agency form numbers:* FR G-1, FR G-2, FR G-3, FR G-4, FR T-4, FR U-1 *OMB control numbers:* 7100-0011: FR G-1, FR G-2, FR G-4; 7100-0018: FR G-3; 7100-0019: FR T-4; and 7100-0115: FR U-1 *Frequency:* FR G-1, FR G-2, FR G-3, FR T-4, and FR U-1: on occasion FR G-4: annual *Reporters:* Individuals and business *Annual reporting hours:* 1,366 reporting; 107,757 recordkeeping *Estimated average hours per response:* FR G-1: 2.5 hours; FR G-2: 15 minutes; FR G-3: 10 minutes; FR G-4: 2.0 hours; FR T-4: 10 minutes; and FR U-1: 10 minutes *Number of respondents:* FR G-1: 61; FR G-2: 36; FR G-3: 602; FR G-4: 602;FR T-4: 5,100; and FR U-1: 6,931 *General description of report:* These information collections are mandatory (15 U.S.C. § § 78g). The information in the FR G-1 and FR G-4 is given confidential treatment under the Freedom of Information Act (5 U.S.C. § § 552(b)(4) and (6)). The FR G-2 does not contain confidential information. The FR G-3, FR T-4, and FR U-1 are not submitted to the Federal Reserve and, as such, no issue of confidentiality arises. *Abstract:* The Securities Exchange Act of 1934 authorizes the Federal Reserve to regulate securities credit extended by brokers and dealers, banks, and other lenders. The purpose statements, FR T-4, FR U-1, and FR G-3, are recordkeeping requirements for brokers and dealers, banks, and other lenders, respectively, to document the purpose of their loans secured by margin stock. Margin stock is defined as
(1)stocks that are registered on a national securities exchange or any over-the-counter security designated for trading in the National Market System,
(2)debt securities (bonds) that are convertible into margin stock, and
(3)shares of most mutual funds. Lenders other than brokers and dealers and banks must register and deregister with the Federal Reserve using the FR G-1 and FR G-2, respectively, and they must file an annual report (FR G-4) while registered. The Federal Reserve uses the data to identify lenders subject to Regulation U, to verify their compliance with the regulation, and to monitor margin credit. *2. Report title:* Annual Daylight Overdraft Capital Report for U.S. Branches and Agencies of Foreign Banks *Agency form number:* FR 2225 *OMB control number:* 7100-0216 *Frequency:* Annual *Reporters:* Foreign banks with U.S. branches or agencies *Annual reporting hours:* 54 *Estimated average hours per response:* 1.0 hour *Number of respondents:* 54 *General description of report:* This information collection is required to respond in order to obtain or retain a benefit, i.e., in order for the U.S. branch or agency of an FBO to establish and maintain a non-zero net debit cap. The information submitted by respondents is not confidential; however, respondents may request confidential treatment for portions of the report. Data may be considered confidential and exempt from disclosure under section (b)(4) of the Freedom of Information Act if it constitutes commercial or financial information and it would customarily not be released to the public by the person from whom it was obtained (5 U.S.C. § 552(b)(4)). *Abstract:* This report was implemented in March 1986 as part of the procedures used to administer the Federal Reserve's Payments System Risk
(PSR)policy. A key component of the PSR policy is a limit, or a net debit cap, on an institution's negative intraday balance in its Reserve Bank account. The Federal Reserve calculates an institution's net debit cap by applying the multiple associated with the net debit cap category to the institution's capital. For foreign banking organizations (FBOs), a percentage of the FBO's capital measure, known as the U.S. capital equivalency, is used to calculate the FBO's net debit cap. Currently, an FBO with U.S. branches or agencies may voluntarily file the FR 2225 to provide the Federal Reserve with its capital measure. Because an FBO that files the FR 2225 may be able to use its total capital in determining its U.S capital equivalency measure, which is then used to calculate its net debit cap, an FBO seeking to maximize its daylight overdraft capacity may find it advantageous to file the FR 2225. An FBO that does not file FR 2225 may use an alternative capital measure based on its nonrelated liabilities. *3. Report title:* Ongoing Intermittent Survey of Households *Agency form number:* FR 3016 *OMB control number:* 7100-0150 *Frequency:* On occasion *Reporters:* Households and individuals *Annual reporting hours:* 683 hours *Estimated average hours per response:* Division of Research & Statistics, 1.58 minutes; Division of Consumer & Community Affairs, 3 minutes; Other divisions, 5 minutes; and Non-SRC surveys, 90 minutes *Number of respondents:* 600 *General description of report:* This information collection is voluntary (12 U.S.C. 225a, 263, and 15 U.S.C. 1691b). No issue of confidentiality normally arises because names and any other characteristics that would permit personal identification of respondents are not reported to the Federal Reserve Board. However, exemption 6 of the Freedom of Information Act (5 U.S.C. 552(b)(6)) would exempt this information from disclosure. *Abstract:* The Federal Reserve uses this voluntary survey to obtain household-based information specifically tailored to the Federal Reserve's policy, regulatory, and operational responsibilities. Currently, the University of Michigan's Survey Research Center
(SRC)includes survey questions on behalf of the Federal Reserve in an addendum to their regular monthly Survey of Consumer Attitudes and Expectations. The SRC conducts the survey by telephone with a sample of 500 households and asks questions of special interest to Federal Reserve Board staff intermittently, as needed. The frequency and content of the questions depend on changing economic, regulatory, and legislative developments. Proposal to approve under OMB delegated authority the extension for three years, with revision, of the following report: *Report title:* Report of Net Debit Cap *Agency form number:* FR 2226 *OMB control number:* 7100-0217 *Frequency:* Annual *Reporters:* Depository institutions, Edge and agreement corporations, U.S. branches and agencies of foreign banks *Annual reporting hours:* 1,623 hours *Estimated average hours per response:* 1.0 hour *Number of respondents:* 1,623 *General description of report:* This information collection is mandatory (12 U.S.C. 248(i), 248-1, and 464). The information submitted by respondents for the payments system risk reduction program may be accorded confidential treatment under the Freedom of Information Act
(FOIA)(5 U.S.C. § 552 (b)(4)). In addition, information reported in connection with the second and third resolutions may be protected under Section (b)(8) of FOIA, to the extent that such information is based on the institution's CAMELS rating, and thus is related to examination reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. § 552(b)(8)). *Abstract:* Federal Reserve Banks collect these data annually to provide information that is essential for their administration of the Federal Reserve's Payments System Risk
(PSR)policy. The reporting panel includes all financially healthy depository institutions with access to the discount window. The Report of Net Debit Cap comprises three resolutions, which are filed by a depository institution's board of directors depending on its needs. The first resolution is used to establish a de minimis net debit cap and the second resolution is used to establish a self-assessed net debit cap. The third resolution is used to establish simultaneously a self-assessed net debit cap and maximum daylight overdraft capacity. Copies of the model resolutions are located in Appendix B, of the PSR policy, that can be found at *http://www.federalreserve.gov/paymentsystems/psr/relpol.htm.* *Current actions:* In an effort to streamline the resolutions filed by institutions eligible for maximum daylight overdraft capacity, two former resolutions were combined into one: resolution 3a, collateralized capacity, and resolution 3b, in-transit securities. These resolutions were replaced by the maximum daylight overdraft capacity resolution that combines the board of directors' approval of the institution's self-assessment as well as its maximum daylight overdraft capacity level. Board of Governors of the Federal Reserve System, December 17, 2007. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E7-24785 Filed 12-20-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 18, 2008. **A. Federal Reserve Bank of Kansas City** (Todd Offenbacker, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. Ambage, Inc.* , Las Vegas, Nevada; to become a bank holding company by acquiring 100 percent of the voting shares of First Financial Services, Inc., and thereby acquire First National Bank and Trust Company, both in Falls City, Nebraska. Board of Governors of the Federal Reserve System, December 18, 2007. Jennifer J. Johnson, Secretary of the Board. [FR Doc.E7-24832 Filed 12-20-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): Ten-Year Anniversary Symposium and Five-Year Plan AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Announcement of public symposium and availability of document. SUMMARY: NICEATM invites attendance at a public symposium to mark the tenth anniversary of ICCVAM. The symposium, entitled “Celebrating Ten Years of Advancing Public Health and Animal Welfare With Sound Science: Envisioning New Directions in Toxicology” will be held February 5, 2008, at the U.S. Consumer Product Safety Commission
(CPSC)Headquarters in Bethesda, MD. The NICEATM-ICCVAM Five-Year Plan (2008-2012) will also be discussed and made available on February 5. DATES: The symposium will be held on February 5, 2008. Those interested in attending the symposium are encouraged to register with NICEATM by February 1, 2008, although registration will also be available on-site. ADDRESSES: The symposium will be held in the CPSC Hearing Room, located at CPSC Headquarters, Bethesda Towers Bldg., 4330 East West Highway, Bethesda, MD. Registration information and other details about the symposium can be found on the NICEATM-ICCVAM Web site at *http://iccvam.niehs.nih.gov/meetings/10thAnnivSymp/10thAnnivSymp.htm* or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below). The NICEATM-ICCVAM Five-Year Plan will be available at the symposium and electronically on the NICEATM-ICCVAM Web site at *http://iccvam.niehs.nih.gov/docs/5yearplan.htm* after February 5. Print copies may be obtained by contacting NICEATM. FOR FURTHER INFORMATION CONTACT: Ms. Debbie McCarley, NICEATM, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709, (telephone) 919-541-2384,
(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* SUPPLEMENTARY INFORMATION: Background The Director of the NIEHS established an *ad hoc* ICCVAM in September 1994 to respond to requirements in the NIH Revitalization Act of 1993 (42 U.S.C. 285 *l* -1, Public Law 103-43). This Act required NIEHS to establish criteria for the validation and regulatory acceptance of alternative toxicological testing methods. NIEHS was also required to recommend a process to achieve the regulatory acceptance of scientifically valid alternative test methods. The *ad hoc* ICCVAM was comprised of representatives from 15 Federal agencies, which are now represented on ICCVAM. In 1997, the *ad hoc* ICCVAM published its final report, *Validation and Regulatory Acceptance of Toxicological Test Methods.* In the same year, NIEHS established a standing ICCVAM committee to implement a process by which new test methods of interagency interest could be evaluated and to coordinate cross-agency issues on development, validation, acceptance, and national and international harmonization of toxicological test methods. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285 *l* -3, Public Law 106-545) established ICCVAM as a permanent interagency committee of NIEHS under NICEATM. The law was enacted “To establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness.” Over the last 10 years, ICCVAM, with scientific support from NICEATM, has evaluated over 185 test methods with the potential to reduce, refine or replace the use of animals in regulatory safety testing. ICCVAM has developed and transmitted recommendations to Federal agencies for alternative methods for the four most commonly used toxicity tests. These science-based technical evaluations have been used to support adoption of test methods as guidelines by the Organisation for Economic Co-operation and Development and other international organizations. NICEATM and ICCVAM have also worked with Federal agencies and other stakeholders to link research and development activities to the standardization and validation of alternative test methods that may be used in regulatory testing. The symposium on February 5, 2008, will recognize the 10-year anniversary of ICCVAM and discuss future directions in toxicology testing and the NICEATM-ICCVAM Five-Year Plan. Preliminary Agenda • Welcome • ICCVAM and NICEATM: The First Ten Years • A Vision Towards the Future: The NICEATM-ICCVAM Five-Year Plan • The Evolution and Future of Toxicology: Where We've Come From and Future Prospects • Toxicology Testing in the 21st Century: A Vision and a Strategy—A Report of the National Research Council of the National Academies • Future Directions in Test Method Development—Toxicology Research, Development, Translation, and Validation: Insights and Activities from selected ICCVAM Agencies: NIEHS/NTP, EPA, FDA • Panel Discussion—Toxicology Research, Development, Translation, and Validation: The Way Forward for ICCVAM and Its Stakeholders • Closing Remarks Symposium Attendance and Registration The symposium will be held on Tuesday, February 5, 2008, from 1-5 p.m., in the CPSC Hearing Room, located at CPSC Headquarters, Bethesda Towers Bldg., 4330 East West Highway, Bethesda, MD. The symposium is open to the public and there is no charge to attend; attendance is limited only by the available space. Individuals who plan to attend are encouraged to register in advance with NICEATM. Registration information is available on the NICEATM-ICCVAM Web site at *http://iccvam.niehs.nih.gov/meetings/10thAnnivSymp/10thAnnivSymp.htm* or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above). Persons needing special assistance in order to attend, such as sign language interpretation or other reasonable accommodation, should contact 919-541-2475 voice, 919-541-4644 TTY (text telephone, through the Federal TTY Relay System at 800-877-8339), or e-mail to *niehsoeeo@niehs.nih.gov.* Requests should be made at least seven days in advance of the event. NICEATM-ICCVAM Five-Year Plan NICEATM and ICCVAM, working in conjunction with Federal agency program offices, have prepared the NICEATM-ICCVAM Five-Year Plan. The plan describes how NICEATM and ICCVAM will facilitate the research, development, translation (activities carried out to characterize if there is evidence of relevance and applicability of a test method for a specific testing purpose), validation, and regulatory acceptance of alternative test methods. Acceptance of such methods will reduce, refine, and replace the use of animals in testing, while maintaining scientific quality and the protection of human health, animal health, and the environment. Development of the plan took place over a 14-month period during which there were multiple opportunities for comment on the plan by ICCVAM stakeholders, the public, and the Scientific Advisory Committee on Alternative Toxicological Methods (see **Federal Register** notices: Vol. 71, No. 218, pp. 66172-73, November 13, 2006; Vol. 72, No. 83, pp. 23831-32, May 1, 2007; and Vol. 72, No. 83, pp. 23832-33, May 1, 2007). The plan addresses ICCVAM's vision to play a leading role in fostering and promoting the development, validation, and regulatory acceptance of scientifically sound alternative test methods both within the Federal government and internationally. Implementing this plan involves four key challenges. The first challenge is to identify priority areas for the next five years and to conduct and facilitate activities in those areas. The second challenge involves identifying and promoting research initiatives that are expected to support the future development of innovative alternative test methods. The third challenge is to foster the acceptance and appropriate use of alternative test methods through outreach and communication. The last challenge is to develop partnerships and strengthen interactions with ICCVAM stakeholders in order to facilitate meaningful progress. The NICEATM-ICCVAM Five-Year Plan will be presented at the February symposium and copies will be available. The NICEATM-ICCVAM Five-Year Plan will also be available electronically after February 5 on the NICEATM-ICCVAM Web site at *http://iccvam.niehs.nih.gov/docs/5yearplan.htm.* Print copies may be obtained by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT above). Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (available at *http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf)* establishes ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of Federal agencies. Additional information about ICCVAM and NICEATM is available on the NICEATM-ICCVAM Web site at *http://iccvam.niehs.nih.gov.* Dated: December 12, 2007. Samuel H. Wilson, Acting Director, National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-24799 Filed 12-20-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Money Follows the Person
(MFP)Demonstration (MFPD), System No. 09-70-0593.” The demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), provides to states a total of $1.75 billion in competitive grants. MFP demonstration grants have been awarded to 30 states and the District of Columbia. The states and the District of Columbia are using the grant funding to transition Medicaid beneficiaries who need long-term care services from institutional-based care to community-based care. The purpose of the demonstration is to help states continue their efforts to restructure their long-term care systems and shift the historical emphasis from institutional care to community-based care. The demonstration is based on the premise that many Medicaid beneficiaries currently residing in institutions want to live in the community and could do so if they had the adequate support, and that it would cost less than Medicaid currently spends to care for institutional care. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFP demonstration and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFP demonstration. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the “Supplementary Information” section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See “Effective Dates” section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on December 14, 2007. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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 time. FOR FURTHER INFORMATION CONTACT: Effie Shockley, Division of Advocacy and Special Initiatives, Disabled and Elderly Health Programs Group, Center for Medicaid and State Operations, Mail Stop S2-14-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-8639, or via e-mail at *Effie.Shockley@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: The demonstration, created by section 6071 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), provides states a total of $1.75 billion in competitive grants to transition Medicaid beneficiaries who need long-term care services from institutional-based care to community-based care and to use enhanced matching funds to continue their work to restructure their long-term care systems. The purpose of the demonstration is to help states continue their efforts to restructure their long-term care systems and shift the historical emphasis from institutional care to community-based care. The demonstration is based on the premise that many Medicaid beneficiaries currently residing in institutions want to live in the community and could do so if they had adequate support, and it would cost less than Medicaid currently spends to care for institutional care. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under Section 6071 of the Deficit Reduction Act of 2005. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicaid recipients and state grantees who voluntarily participate in the MFP demonstration as well as program-level information. The individual-level information collected will include but is not limited to: name, address, telephone number, health insurance claims number, Medicaid identification number, social security number, race/ethnicity, gender, date of birth, Medicaid and Medicare eligibility and claims records, and self-reported quality of life (including living situation, choice and control, respect and dignity, access to personal care, community integration and inclusion, satisfaction with quality of life, and health status). The program-level information will include, but is not limited to: program performance measures for mandatory and state-specific benchmarks. States will also report progress on outreach and enrollment in the demonstration, informed consent and guardianship, benefits and services, self-direction programs, quality management systems, housing, and organization factors. This information will be primarily narrative, qualitative information, but will include some aggregate data. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. The Privacy Act permits 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 disclosure of data is known as a “routine use.” The Government will only release MFPD information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of MFPD. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected; e.g., to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFP demonstration and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFP demonstration. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. 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 proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicaid benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require MFPD information in order to support evaluations and monitoring of Medicaid claims information of beneficiaries, including proper reimbursement for services provided. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The MFPD data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicaid beneficiaries. CMS anticipates that researchers may have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicaid beneficiaries and the policies that govern their care. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require MFPD information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Proposed System of Records on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: December 12, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0593 SYSTEM NAME: Money Follows the Person
(MFP)Demonstration (MFPD),” HHS/CMS/CMSO. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: This system will collect and maintain individually identifiable and other data collected on Medicaid recipients and state grantees who voluntarily participate in the MFPD demonstration and evaluation as well as program-level information. CATEGORIES OF RECORDS IN THE SYSTEM: The individual-level information collected will include but is not limited to: name, address, telephone number, health insurance claims number (HICN), Medicaid identification number, social security number (SSN), race/ethnicity, gender, date of birth, Medicaid and Medicare eligibility and claims records, and self-reported quality of life (including living situation, choice and control, respect and dignity, access to personal care, community integration and inclusion, satisfaction with quality of life, and health status). The program-level information will include, but is not limited to: program performance measures for mandatory and state-specific benchmarks. States will also report progress on outreach and enrollment in the demonstration, informed consent and guardianship, benefits and services, self-direction programs, quality management systems, housing, and organization factors. This information will be primarily narrative, qualitative information, but will include some aggregate data. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for this system is given under section 6071 of the Deficit Reduction Act of 2005. PURPOSE(S) OF THE SYSTEM: The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, those who participate in the MFPD and other comparable Medicaid recipients, and to collect and maintain program level information on grantee implementation of the MFPD. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. 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 proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicaid benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures—To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on electronic media. RETRIEVABILITY: The collected data are retrieved by the name or other identifying information of the participating beneficiary or grantee, and may be retrieved by a distinct identifier such as the HICN, Medicare identification number, or SSN at the individual beneficiary level. At the program level, data are retrieved by state name. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records will be retained for a period of 10 years after the demonstration and evaluation project has completed. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER AND ADDRESS Director, Division of Advocacy and Special Initiatives, Disabled and Elderly Health Programs Group, Center for Medicaid and State Operations, Mail Stop S2-14-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicaid administrative and claims records, and from grantee progress reports. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-24786 Filed 12-20-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers For Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Home and Community-Based Alternatives
(CBA)to Psychiatric Residential Treatment Facilities
(PRTF)Demonstration (CBA-PRTF), System No. 09-70-0594.” The demonstration, created by section 6063 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), allows up to 10 states (as defined for purposes of title XIX of the Social Security Act (the Act)) to provide home and community-based services to youth as alternatives to PRTFs. The purpose of the demonstration is to test the effectiveness in improving or maintaining a child's functional level and cost effectiveness of providing coverage of home and community-based alternatives to psychiatric residential treatment for children enrolled in the Medicaid program under title XIX of the Act. The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See “Effective Dates” section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on *December 14, 2007* . To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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 time. FOR FURTHER INFORMATION CONTACT: Effie Shockley, Division of Advocacy and Special Initiatives, Disabled and Elderly Health Programs Group, Center for Medicaid and State Operations, Mail Stop S2-14-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-8639, or via e-mail at *Effie.Shockley@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: The demonstration, created by section 6063 of the Deficit Reduction Act of 2005 (Pub. L. 109-171), allows up to 10 states (as defined for purposes of title XIX of the Act) to provide home and community-based services to youth as alternatives to PRTFs. The purpose of the demonstration is to test the effectiveness in improving or maintaining a child's functional level and cost effectiveness of providing coverage of home and community-based alternatives to psychiatric residential treatment for children enrolled in the Medicaid program under title XIX of the Act. Participating states will acquire approved functional outcomes on participants across the following life domains: community living, school functioning, juvenile justice, family functioning, alcohol and other drug use, mental health, social support, program satisfaction and environmental variables. The overall evaluation must directly address the two primary questions posed in the statutes: Does the provision of home and community-based services to youth under this demonstration
(1)result in the maintenance or improvement in a child's functional status; and
(2)on average, cost no more than anticipated aggregate PRTF expenditures in the absence of the demonstration? I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under Section 6063 of the Deficit Reduction Act of 2005. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. The collected information will include, but is not limited to: name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, patient medical charts, physician records, community living, school functioning, juvenile justice activity, alcohol and other drug use, mental health, social support, family functioning outcomes, program satisfaction and changes in the patient's environment. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. The Privacy Act permits 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 disclosure of data is known as a “routine use.” The Government will only release CBA-PRTF information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of CBA-PRTF. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected; e.g., to collect and maintain individually identifiable information on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. 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 proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicaid benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require CBA-PRTF information in order to support evaluations and monitoring of Medicaid claims information of beneficiaries, including proper reimbursement for services provided. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The CBA-PRTF data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicaid beneficiaries. CMS anticipates that researchers may have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicaid beneficiaries and the policies that govern their care. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require CBA-PRTF information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a) (1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of The Proposed System of Records on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: December 7, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0594 SYSTEM NAME: • “Home and Community-Based Alternatives
(CBA)to Psychiatric Residential Treatment Facilities
(PRTF)Demonstration (CBA-PRTF),” HHS/CMS/CMM. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: This system will collect and maintain individually identifiable and other data collected on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. CATEGORIES OF RECORDS IN THE SYSTEM: The collected information will include, but is not limited to: name, address, telephone number, health insurance claims number (HICN), race/ethnicity, gender, date of birth, patient medical charts, physician records, community living, school functioning, juvenile justice activity, alcohol and other drug use, mental health, social support, family functioning outcomes, program satisfaction and changes in the patient's environment. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for this system is given under Section 6063 of the Deficit Reduction Act of 2005. PURPOSE(S) OF THE SYSTEM: The purpose of this system is to collect and maintain individually identifiable information on Medicaid recipients, and providers of services who voluntarily participate in the national evaluation of the CBA-PRTF. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, or consultant;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicaid benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES: A. 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 proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. contribute to the accuracy of CMS's proper payment of Medicaid benefits; b. enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. the agency or any component thereof, or b. any employee of the agency in his or her official capacity, or c. any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. the United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, and abuse in such program. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, Subparts A and E) 65 Fed. Reg. 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals could, because of the small size, use this information to deduce the identity of the beneficiary). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on electronic media. RETRIEVABILITY: The collected data are retrieved by the name or other identifying information of the participating provider or beneficiary, and may be retrieved by a distinct identifier such as the HICN, at the individual beneficiary level. SAFEGUARDS: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002; the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. RETENTION AND DISPOSAL: Records will be retained for a period of 10 years after the demonstration and evaluation project has completed. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. SYSTEM MANAGER AND ADDRESS: Director, Division of Advocacy and Special Initiatives, Disabled and Elderly Health Programs Group, Center for Medicaid and State Operations, Mail Stop S2-14-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. NOTIFICATION PROCEDURE: For purpose of access, the subject individual should write to the system manager who will require the system name, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). RECORD ACCESS PROCEDURE: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5
(a)(2)). CONTESTING RECORD PROCEDURES: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). RECORDS SOURCE CATEGORIES: Data will be collected from Medicaid administrative and claims records, patient medical charts, and physician records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-24788 Filed 12-20-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pulmonary-Allergy Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on February 20, 2008, from 8 a.m to 5 p.m. *Location* : National Labor College, Lane Kirkland Center, Solidarity Hall, 10000 New Hampshire Avenue, Silver Spring, MD, 301-431-6400. *Contact Person* : Teresa A. Watkins, Center for Drug Evaluation and Research, HFD-21, Food and Drug Administration, 5630 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-7001, fax: 301-827-6776, e-mail: *teresa.watkins@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512545. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The committee will discuss the new drug application
(NDA)22-150, icatibant solution for injection (proposed tradename FIRAZYR), by Jerini, for the proposed indication of treatment of attacks of hereditary angioedema. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 5, 2008. Oral presentations from the public will be scheduled between approximately 12:30 p.m. and 1:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 29, 2008. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Teresa A. Watkins at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 12, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-24812 Filed 12-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0464] Health Claims and Qualified Health Claims; Dietary Lipids and Cancer, Soy Protein and Coronary Heart Disease, Antioxidant Vitamins and Certain Cancers, and Selenium and Certain Cancers; Reevaluation; Opportunity for Public Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids
(fat)and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement discretion (antioxidant vitamins and risk of certain cancers; selenium and certain cancers). The agency is undertaking a reevaluation of the scientific basis for these authorized health claims and qualified health claims because of new scientific evidence that has emerged for these substance-disease relationships. The new scientific evidence may have the effect of weakening the substance-disease relationship for these authorized health claims and either strengthening or weakening the scientific support for the substance-disease relationship for these qualified health claims. DATES: Submit written or electronic comments by February 19, 2008. ADDRESSES: You may submit comments, identified by Docket No. 2007N-0464, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and docket number for this notice. All 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 the “How to Submit Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Claudine Kavanaugh, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450, FAX: 301-436-2636. SUPPLEMENTARY INFORMATION: I. Background The Nutrition Labeling and Education Act of 1990
(NLEA)(Public Law 101-553) was designed to give consumers more scientifically valid information about foods they eat. Among other provisions, the NLEA directed FDA to issue regulations providing for the use of statements that describe the relationship between a substance and a disease (health claims) in the labeling of foods, including dietary supplements, after such statements have been reviewed and authorized by FDA. 1 For these health claims, that is, statements about substance-disease relationships, FDA has defined the term “substance” by regulation as a specific food or food component (§ 101.14(a)(2) (21 CFR 101.14(a)(2))). An authorized health claim may be used on both conventional foods and dietary supplements, provided that the substance in the product and the product itself meet the appropriate standards in the authorizing regulation. Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. 1 In 1997, Congress enacted the Food and Drug Administration Modernization Act, which established an alternative authorization procedure for health claims based on authoritative statements of certain federal scientific bodies or the National Academy of Sciences. This notice does not address that alternative procedure. Under section 403(r)(4)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(i)), any person may petition FDA to issue a health claim regulation. In evaluating the petition, FDA considers whether there is “significant scientific agreement”
(SSA)based on the totality of publicly available scientific evidence concerning the relationship that is the subject of the claim. This standard derives from section 403(r)(3)(B)(i) of the act (21 U.S.C. 343(r)(3)(B)(i)), which provides that FDA shall authorize a health claim to be used on conventional foods if the agency “determines based on the totality of the publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.” This scientific standard was prescribed by statute for conventional food health claims; by regulation, FDA adopted the same standard for dietary supplements health claims (see § 101.14(c)). In evaluating a petition for an authorized health claim, if FDA concludes that the evidence supporting the relationship that is the subject of the claim does not meet the SSA standard, the agency considers whether there is credible evidence to support a qualified health claim. FDA may issue a letter of enforcement discretion for a qualified health claim where the totality of scientific evidence supporting the relationship that is the subject of the claim is credible but does not meet the SSA standard. Qualified health claims contain qualifying language about the level of scientific evidence to ensure consumers receive accurate information about the claim. The genesis of qualified health claims was the court of appeals decision in *Pearson* v. *Shalala* (Pearson). In that case, the plaintiffs challenged FDA's decision not to authorize health claims for four specific substance-disease relationships in the labeling of dietary supplements. Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998)), the U.S. Court of Appeals for the D.C. Circuit reversed the lower court's decision (164 F.3d 650 (D.C. Cir.1999)). The appeals court held that the First Amendment does not permit FDA to reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that a disclaimer would not eliminate the potential deception. In the **Federal Register** of October 26, 1999 (64 FR 57700), the agency authorized a health claim for soy protein and risk of coronary heart disease (21 CFR 101.82). Since authorizing this health claim, numerous studies have evaluated the relationship between soy protein and coronary heart disease, and the findings of these studies are inconsistent. The Agency for Healthcare Research and Quality
(AHRQ)released a report in July 2005 outlining the effects of soy products on health outcomes including cardiovascular disease and concluded that soy products appear to exert a small benefit on low-density lipoprotein (LDL)-cholesterol (Ref. 1). However, it is not clear whether soy protein (versus other types of soy products) was responsible for such a benefit. The AHRQ report included studies that evaluated substances in addition to soy protein (e.g., isoflavones). In addition, the AHRQ report used markers of cardiac function (e.g., triglycerides, endothelial function, oxidized LDL) that are not validated surrogate endpoints recognized by the agency for heart disease risk. The agency intends to evaluate the scientific evidence on soy protein and the risk of coronary heart disease to determine if the totality of the scientific evidence continues to meet the significant scientific agreement standard. In the **Federal Register** of January 6, 1993 (58 FR 2787), FDA authorized a health claim on dietary lipids
(fat)and cancer (21 CFR 101.73). In the years since authorizing this health claim, numerous studies have been published evaluating this substance-disease relationship. The Institute of Medicine
(IOM)of the National Academy of Sciences, an authoritative body, published a report that reviewed the evidence on dietary lipid consumption and cancer risk (Ref. 2). The IOM reported in its review of the literature that the association between diets high in fat and increased cancer risk has been weakened by recent epidemiological studies. The IOM report set an acceptable macronutrient distribution range
(AMDR)for total fat, however, it was not set based on cancer as a disease outcome because of insufficient scientific evidence linking consumption of fat with cancer risk. One factor in determining the AMDR is the long-term intake level of a nutrient that can minimize the potential for chronic disease. The agency intends to reevaluate the scientific evidence on dietary lipids and cancer risk and determine if the totality of the evidence continues to meet the significant scientific agreement standard. Section 10.25(b) (21 CFR 10.25(b)) states that the Commissioner of Food and Drugs may initiate a proceeding to issue, amend, or revoke a regulation or take or refrain from taking any other form of administrative action. FDA intends to evaluate whether the currently available scientific evidence concerning the substance-disease relationship for the authorized health claims, dietary lipids and cancer and soy protein and coronary heart disease, continues to support its previous decisions on these authorized health claims. If the agency decides to take action to amend or revoke one or both of these health claims, after completing its review of the current scientific evidence, the agency will publish its findings and solicit comments on them before the agency takes any action with respect to revising the particular health claim. Interested persons may submit scientific information about these two specific health claims in response to this notice. In 2003, FDA issued two letters on the use of the agency's enforcement discretion for qualified health claims on antioxidant vitamins (vitamins E and C) and risk of certain cancers (Ref. 3) and selenium and certain cancers and anticarcinogenic effects in the body (Ref. 4). In May 2006, AHRQ issued a report evaluating the use of multivitamin/mineral supplements and the risk of chronic disease (Ref. 5). The report did not identify any studies on the efficacy of vitamin C supplements and cancer risk. In addition, the report concluded that the overall strength of the evidence for vitamin E and selenium supplements on cancer risk is very low (vitamin E) and low (selenium). The agency intends to reevaluate the scientific evidence on these two qualified health claims and determine if the scientific evidence continues to support the qualified health claim, and if so, whether the qualified health claim language should be modified to reflect a stronger or weaker relationship. If the agency decides a change may be needed with respect to one or both of these claims, the agency intends to publish its findings and solicit comments on them. Interested persons may submit scientific information about these two specific qualified health claims in response to this notice. Reevaluating Cancer Health Claims by Cancer Site In the final rule authorizing a health claim for dietary fat and cancer, FDA considered whether such a claim should specifically address the types of cancer affected by a diet that is low in total fat, or whether the claim should not be site-specific (58 FR 2787 at 2788 through 2789). FDA ultimately decided that the identification of specific sites of affected cancers would not be appropriate due, in part, to weaker data on the relationship between dietary fat and breast cancer and the possibility of a wider variety of affected sites for the dietary fat and cancer relationship. Therefore, FDA required that the terms “some types of cancer” or “some cancers” be used in specifying the disease for this health claim relationship (id.). The antioxidant and cancer and selenium and cancer qualified health claims also contain similar language, i.e., “certain forms of cancer,” to be used in specifying the disease. However, in other qualified health claims for a substance and cancer relationship (Refs. 6, 7, and 8), the agency considered separate qualified health claims for each type of cancer. Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells (Ref. 9). Cancer is categorized into different types of diseases based on the organ and tissue sites (Ref. 10). Cancers at different organ sites have different risk factors, treatment modalities, and mortality risk (Ref. 9). Both genetic and environmental (including diet) risk factors may affect the risk of different types of cancers. Risk factors may include a family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, exposure to ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors. The etiology, risk factors, diagnosis, and treatment for each type of cancer are unique (Refs. 11 and 12). Because each form of cancer is a unique disease based on organ site, risk factors, treatment options, and mortality risk, FDA's current approach is to evaluate each form of cancer individually in a health claim or qualified health claim petition to determine whether the scientific evidence supports the potential substance-disease relationship for any type of cancer, each of which constitutes a disease under § 101.14(a)(5). The agency intends to consider, as part of its reevaluation of the scientific evidence for dietary fat, antioxidant, and selenium and their association with a reduced risk of cancer, claim language to reflect specific types of cancer rather than “certain forms of cancer” (or similar language). II. How to Submit Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individual may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008, the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date, electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. III. References The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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 we are not responsible for subsequent changes to the Web sites after this document publishes in the **Federal Register** .) 1. Balk E, Chung M, Chew P, Ip S, Raman G, Kupelnick B, Tatsioni A, Sun Y, Wolk B, DeVine D, Lau J. Effects of Soy on Health Outcomes. Summary, Evidence Report/Technology Assessment No. 126. (Prepared by the Tufts-New England Medical Center Evidence-based Practice Center under Contract No. 290-02-0022.) AHRQ Publication No. 05-E024-1. Rockville, MD: Agency for Healthcare Research and Quality. July 2005. 2. Institute of Medicine, National Academy of Sciences. *Dietary Referece Intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids, Chapter 11 page 808* . National Academy Press. Washington, D.C. 2005. 3. Antioxidant vitamins and risk of certain cancers, April 1, 2003, *http://www.cfsan.fda.gov/~dms/ds-ltr34.html* . 4. Selenium and certain cancers, February 21, 2003, Docket No. 2002P-0457 (formerly Docket No. 02P-0457), *http://www.cfsan.fda.gov/~dms/ds-ltr35.html* . 5. Huang HY, Caballero B, Chang S, Alberg A, Semba R, Schneyer C, Wilson RF, Cheng TY, Prokopowicz G, Barnes II GJ, Vassy J, Bass EB. Multivitamin/Mineral Supplements and Prevention of Chronic Disease. Evidence Report/Technology Assessment No. 139. (Prepared by The Johns Hopkins University Evidence-based Practice Center under Contract No. 290-02-0018). AHRQ Publication No. 06-E012. Rockville, MD: Agency for Healthcare Research and Quality. May 2006. 6. Tomatoes and prostate, ovarian, gastric and pancreatic cancers, November 8, 2005, Docket No. 2004Q-0201, *http://www.cfsan.fda.gov/~dms/qhclyco.html* . 7. Green tea and prostate and breast cancer risk, June 30, 2005, Docket No. 2004Q-0083, *http://www.cfsan.fda.gov/~dms/qhc-gtea.html* . 8. Calcium and colon/rectal, breast and prostate cancers and recurrent polyps, October 12, 2005, Docket No. 2004Q-0097, *http://www.cfsan.fda.gov/~dms/qhcca2.html* . 9. American Cancer Society, Cancer Facts and Figures, 2004. 10. National Cancer Institute, Dictionary of Cancer Terms, *http://www.cancer.gov/Templates/db_alpha.aspx?CdrID=45333* . 11. Hord NG, Fenton JI. Context is everything: mining the normal and preneoplastic microenvironment for insights into the diet and cancer risk conundrum. *Molecular Nutrition and Food Research* , 2007, 51:100-106. 12. Milner JA. Diet and Cancer: Facts and Controversies. *Nutrition and Cancer* , 2006, 56:216-224. Dated: December 6, 2007. Barbara Schneeman, Director, Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition. [FR Doc. E7-24813 Filed 12-20-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Announcement of Potential Eligibility for Compensation Under Public Readiness and Emergency Preparedness Act Declaration and Filing Deadlines AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice. SUMMARY: This Notice provides notification that individuals who have been injured by pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-6d) have one
(1)year from the time they receive the covered countermeasure to file requests for compensation for injuries directly resulting from administration or use of covered countermeasures under the Public Readiness and Emergency Preparedness Act (PREP Act). DATES: This Notice is effective on December 21, 2007. FOR FURTHER INFORMATION CONTACT: Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857; toll-free telephone number 1-888-496-0338. Electronic inquiries should be sent via Tamara Overby at *toverby@hrsa.gov.* SUPPLEMENTARY INFORMATION: The PREP Act, which is a part of the “Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006” (Pub. L. 109-148), was enacted on December 30, 2005, and confers broad liability protections on covered persons, as defined in section 319F-3(i)(2) of the PHS Act, and compensation to individuals injured by the receipt of covered countermeasures, as defined in section 319F-3(i)(1) of the PHS Act, in the event of designated public health emergencies. A covered countermeasure means:
(A)A qualified pandemic or epidemic product (as defined in section 319F-3(i)(7) of the PHS Act);
(B)a security countermeasure (as defined in section 319F-2(c)(1)(B) of the PHS Act); or
(C)a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 351(i) of this Act), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564 of the Federal Food, Drug and Cosmetic Act. Passed primarily to address the pandemic influenza threat, the PREP Act provides liability protections after a Secretarial declaration of covered countermeasures for any disease or health condition that the Secretary views as constituting a public health emergency, either presently or in the future. Liability protections cover the manufacture, testing, development, distribution, or use of the designated covered countermeasure absent willful misconduct as defined in section 319F-3(c)(1) of the PHS Act. A Secretarial declaration specifies the categories of health threats or conditions for which countermeasures are recommended, the period liability protections are in effect, the population of individuals protected, and the geographic areas for which the protections are in effect. In addition to liability protections, the PREP Act provides the Secretary the authority, which was delegated by the Secretary on November 8, 2006 to the Administrator of the Health Resources and Services Administration, to compensate eligible individuals for covered injuries from a covered countermeasure. The first Declaration under the PREP Act was published in the **Federal Register** on February 1, 2007 (72 FR 4710). It designated the pandemic influenza A
(H5N1)vaccine as a covered countermeasure, with an effective time period of December 1, 2006-February 28, 2010. As a result of this Declaration, individuals injured by this vaccine can file a request for compensation. Individuals have one
(1)year from the time they receive the vaccine to apply for compensation. Currently, no funds have been appropriated to provide compensation. However, all potential claims must still be filed within the one
(1)year limit. This Declaration specifies that the following individuals with covered injuries may be eligible to receive compensation under the PREP Act:
(1)All persons who use a covered countermeasure or to whom such a covered countermeasure is administered as an Investigational New Drug in a human clinical trial conducted directly by the Federal Government, or pursuant to a contract, grant or cooperative agreement with the Federal Government;
(2)all persons who use a covered countermeasure or to whom such a countermeasure is administered in a pre-pandemic phase; and/or
(3)all persons who use a covered countermeasure, or to whom such a covered countermeasure is administered in a pandemic phase. The Pre-Pandemic Phase means the following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006):
(0)New Domestic Animal Outbreak in At-Risk Country;
(1)Suspected Human Outbreak Overseas;
(2)Confirmed Human Outbreak Overseas; and
(3)Widespread Human Outbreaks in Multiple Locations Overseas. The Pandemic Phase means the following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006):
(4)First Human Case in North America; and
(5)Spread Throughout United States. Eligible individuals may be compensated for out-of-pocket medical expenses, lost employment income, and survivor death benefits. Reasonable and necessary medical items and services may be paid or reimbursed to treat a covered countermeasure-related injury of an eligible individual. The payments or reimbursements for services or benefits are secondary to other forms of coverage. The individual may receive compensation for loss of employment income incurred as a result of the covered countermeasure injury. The amount of compensation is based on income at the time of injury. Death benefits may be paid to certain survivors of covered countermeasures recipients who have died as a direct result of the covered countermeasure injury. Since HHS is payer of last resort, payments are reduced by those of other third party payers. Interested parties may obtain request packages that contain copies of all necessary forms and instructions by writing to the Healthcare Systems Bureau, Health Resources and Services Administration, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857, calling at 1-888-496-0338, or downloading them from the HRSA Web site at *http://www.hrsa.gov/countermeasurescomp.* Completed request packages must be postmarked by the U.S. Postal Service, a commercial carrier, or a private courier service. HRSA will not accept request packages electronically or by hand-delivery. The postmark date is used to determine whether the filing deadline of one year from receipt of the countermeasure has been met. Paperwork Reduction Act of 1995 HRSA will submit to the Office of Management and Budget
(OMB)an Information Collection Request
(ICR)for approval of the required forms. Dated: December 18, 2007. Elizabeth M. Duke, Administrator. [FR Doc. 07-6180 Filed 12-19-07; 1:36 pm]
Connectionstraces to 18
Traces to 18 documents
CFR
- Additional submissions for matching fund payments.§ 9036.2
- Net outstanding campaign obligations.§ 9034.5
- Determination of ineligibility date.§ 9033.5
- Health claims: general requirements.§ 101.14
- Health claims: Soy protein and risk of coronary heart disease (CHD).§ 101.82
- Health claims: dietary lipids and cancer.§ 101.73
- Initiation of administrative proceedings.§ 10.25
U.S. Code
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Maintenance of long run growth of monetary and credit aggregates§ 225a
- Promulgation of regulations by the Bureau§ 1691b
- Enumerated powers§ 248
- Definitions§ 1841
- Acquisition of bank shares or assets§ 1842
- Interests in nonbanking organizations§ 1843
- Purpose of Institute§ 285
- Misbranded food§ 343
- Targeted liability protections for pandemic and epidemic products and security countermeasures§ 247d–6d
- Definitions; generally§ 321
14 references not yet in our index
- 5 CFR 1320.16
- 5 CFR 1320
- 12 CFR 225
- Pub. L. 103-43
- Pub. L. 106-545
- Pub. L. 109-171
- 65 FR 82462
- 45 CFR 164.512(a)(1)
- 45 CFR 5
- 45 CFR 164.512(a)
- Pub. L. 101-553
- 14 F. Supp. 2d 10
- 164 F.3d 650
- Pub. L. 109-148
Citation graph
cites case law
Notices
Notice of matching fund submission dates and submission dates for statements of net outstanding campaign obligations for 2008 presidential candidates
F. Supp.14 F. Supp. 2d 10
F. App'x164 F.3d 650
Cite5 CFR 1320.16
Cites 32 · showing 12Cited by 0 across 0 sources