Notices. Notice

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

BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0696] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

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

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

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

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project HIV Prevention Program Evaluation and Monitoring System for Health Departments and Community-Based Organizations (PEMS)—Reinstatement (0920-0696)—National Center for HIV, STD, and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description This is an extension of a data collection that is being incrementally implemented. The initial PEMS OMB request was approved October 6, 2005 for one year. However, delays in the development of the data collection software and requests by grantees for additional time to modify their data collection procedures have prevented the initial data collection originally anticipated for 2006. The purpose of this data collection is to collect HIV prevention evaluation data from health department and community-based organization

(CBO)grantees using the electronic Program Evaluation and Monitoring System (PEMS). This data collection incorporates data elements from two previously approved data collections: Evaluating CDC Funded Health Department HIV Prevention Programs, OMB No. 0920-0497 (discontinued 4/31/2006); and Assessing the Effectiveness of CBOs for the Delivery of HIV Prevention Programs, OMB No. 0920-0525 (discontinued 12/17/2004). Per HIV prevention cooperative agreements, CDC requires non-identifying, client-level, standardized evaluation data from health department and CBO grantees to:

(1)More accurately determine the extent to which HIV prevention efforts have been carried out, what types of agencies are providing services, what resources are allocated to those services, to whom services are being provided, and how these efforts have contributed to a reduction in HIV transmission;

(2)improve ease of reporting to better meet these data needs; and

(3)be accountable to stakeholders by informing them of efforts made and use of funds in HIV prevention nationwide. Although CDC receives evaluation data from grantees, the data received to date are insufficient for evaluation and accountability. Furthermore, there has not been standardization of required evaluation data from both health departments and CBOs. Changes to the evaluation and reporting process have become necessary to ensure CDC receives standardized, accurate, thorough evaluation data from both health department and CBO grantees. For these reasons, CDC developed PEMS and consulted with representatives from health departments, CBOs, and national partners (e.g., The National Alliance of State and Territorial AIDS Directors, Urban Coalition of HIV/AIDS Prevention Services, and National Minority AIDS Council). Respondents will collect, enter, and report general agency information, program model and budget data, and client demographics and behavioral characteristics. (After initial set-up of the PEMS, data collection will include searching existing data sources, gathering and maintaining data, document compilation, review of data, and data entry into the web-based system.) Agents will submit data quarterly. There are no costs to respondents. The total estimated annual burden hours are 181,512. Estimate Of Annualized Burden Hours Respondents Number of respondents Form name Number of responses per respondent Average burden per response (in hours) Health jurisdictions 59 PEMS Data Variables and Values

(HD)4 137 Health jurisdictions (CTR-scan) 30 Counseling, Testing and Referral Form 4 509 Health jurisdictions (CTR non-scan) 30 PEMS Data Variables and Values

(HD)4 165 Health jurisdictions (Training) 59 PEMS Data Variables and Values

(HD)4 10 Community-Based Organizations 160 PEMS Data Variables and Values

(CBO)4 84 Community-Based Organizations

(CTR)70 Counseling, Testing and Referral Form 4 23 Community-Based Organizations (Training) 160 PEMS Data Variables and Values

(CBO)4 10 Dated: May 15, 2007. Maryam Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-9795 Filed 5-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [FOA IP07-006] Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Economic Studies of Vaccines and Immunization Policies, Programs, and Practices, Funding Opportunity Announcement

(FOA)IP07-013, and Costs Medical Practices Incur Ordering, Storing, and Delivering Vaccines to Adult Patients: Does Reimbursement Cover Costs? In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces a meeting of the aforementioned Special Emphasis Panel. *Time and Date:* 12 p.m.-4 p.m., June 14, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters To Be Discussed:* The meeting will include the review, discussion, and evaluation of research grant applications in response to FOA IP07-013, “Economic Studies of Vaccines and Immunization Policies, Programs, and Practices”, and FOA IP07-006, “Costs Medical Practices Incur Ordering, Storing, and Delivering Vaccines to Adult Patients: Does Reimbursement Cover Costs?”. *Contact Person for More Information:* Trudy Messmer, Ph.D., Designated Federal Official, 1600 Clifton Road, Mailstop C-19, Atlanta, GA 30333, telephone

(404)639-2176. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-9794 Filed 5-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following committee meeting: *Name:* Advisory Board on Radiation and Worker Health and Subcommittee for Dose Reconstruction Reviews (SDRR). *Committee Meeting Times and Dates:* 9 a.m.-5 p.m., June 11, 2007. 8 a.m.-3 p.m., June 12, 2007. *Public Comment Times and Dates:* 5:30 p.m.-6:30 p.m., June 11, 2007. Place: Westin Westminster, 10600 Westminster Boulevard, Westminster, Colorado 80020, Phone 303.410.5000, Fax 303.410.5005. *Status:* Open to the public, limited only by the space available. The meeting space accommodates approximately 75 people. *Background:* The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program (EEOICP) Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines which have been promulgated by the Department of Health and Human Services

(HHS)as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to the CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2007. *Purpose:* This Advisory Board is charged with

(a)providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179;

(b)providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and

(c)upon request by the Secretary, HHS, advise the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. *Matters To Be Discussed:* The agenda for the Advisory Board meeting includes Selection of 8th Round of Dose Reconstruction Cases for Review; SEC Petitions for Rocky Flats, Bethlehem Steel, Sandia Livermore, Chapman Valve, and Dow-Madison; Use of Data from Other Sites; Timeliness of Program Activities; and Board Schedule and Board Working Time. The agenda is subject to change as priorities dictate. In the event an individual cannot attend, written comments may be submitted. Any written comments received will be provided at the meeting and should be submitted to the contact person below well in advance of the meeting. *Contact Person for More Information:* Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226, Telephone 513.533.6825, Fax 513.533.6826. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: May 15, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-9798 Filed 5-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Medicaid Program; Notice of Single Source Grant Award to the State of Louisiana for the Grant Entitled “Deficit Reduction Act—Hurricane Katrina Healthcare Related Professional Workforce Supply” AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. *Funding Amount:* $15,000,000. *Period of Performance:* March 1, 2007-September 30, 2009. SUMMARY: On March 1, 2007, this grant program was made available to the State of Louisiana to fund State payments for professional healthcare workforce fulfillment in Greater New Orleans, which has continued to face unique health professional shortages as a result of Hurricane Katrina and its subsequent floods. With nearly 4,500 doctors displaced and approximately 50 percent of the physicians who worked in Region 1 before Hurricane Katrina, no longer practicing there, Greater New Orleans is experiencing a shortage of primary care doctors to see Medicaid and uninsured patients. Funding recently awarded under this grant program must be used by the State to make payments for purposes of recruitment and retention of professional healthcare staff for the impacted communities. For purposes of this grant, impacted communities are those four parishes located in the State of Louisiana that comprise Region 1, as defined by the Louisiana Department of Health and Hospitals, namely, Orleans, Jefferson, St. Bernard, and Plaquemines. The grant funds must be used only for purposes of recruitment or retention of healthcare workforce professionals in Greater New Orleans. The State has been given flexibility in determining the payment methodology, the scope and type of activities, criteria for awarding payment, and the amount of payments to be made to such professionals. Payment recipients are limited to licensed healthcare professionals. Activities include those that were recommended by the Louisiana Health Care Redesign Collaborative (LHCRC) in their concept paper submitted to the Secretary on October 20, 2006. These activities include but are not limited to: Income guarantees, annual medical malpractice payment relief, loan repayments, and incentive payments (relocation expenses and sign-on bonuses). Grant funds may not be distributed to staff who are no longer providing professional healthcare services in the Greater New Orleans area at the time of the disbursement of grant funds. All payments must be made under this grant program by the end of federal fiscal year 2009. Payments to physicians and other professional healthcare workforce staff under this program are not allowed to be considered payments for Medicare, Medicaid or other specific services, and are not available as the non-Federal share of expenditures or for supplemental disproportionate share hospital payments. Payments cannot be made conditional on the provision of any particular items or services by the professionals. Grant applications requesting funds to be used for the non-Federal share of Medicaid or other federal grant expenditures or for supplemental Medicaid disproportionate share hospital payments will not be considered. This award was made based on the authority granted by section 6201 of the Deficit Reduction Act (DRA). In particular, section 6201(a)(4) of the DRA provides authority to the Secretary, Department of Health and Human Services (DHHS), to make payments to States to restore access to healthcare in communities impacted by Hurricane Katrina. *Justification For Exception To Competition:* The Secretary invoked his authority to restore healthcare in impacted communities affected by Hurricane Katrina by offering this unique funding opportunity which will give further incentive to the retention and recruitment of healthcare workforce professionals in Greater New Orleans. Louisiana is the only State with knowledge and ability to administer a grant designed to affect impacted Louisiana communities. For this reason, the Secretary has directed the Centers for Medicare & Medicaid Services to issue a single-source award to the State of Louisiana to increase access to healthcare services and to relieve economic pressures suffered by healthcare providers resulting from both the hurricane and its subsequent flooding. FOR FURTHER INFORMATION CONTACT: Wendy J. Taparanskas, Ph.D., Health Insurance Specialist, Office of the Center Director, Centers for Medicaid and State Operations, Centers for Medicare & Medicaid Services, Mail Stop S2-26-12, 7500 Security Boulevard, Baltimore, MD 21244,

(410)786-5245. Authority: Section 6201(a)(4) of the Deficit Reduction Act of 2005 (DRA). Dated: May 7, 2007. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Grant Award-Louisiana [FR Doc. E7-9792 Filed 5-21-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers For Medicare & Medicaid Services Privacy Act of 1974: CMS Computer Match No. 2007-02; HHS Computer Match No. 0701 AGENCY: Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of Computer Matching Program (CMP). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Health Administration Center

(HAC)of the Department of Veteran Affairs. We have provided background information about the proposed matching program in the “Supplementary Information” section below. The Privacy Act provides an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See EFFECTIVE DATES section below for comment period. EFFECTIVE DATES: CMS filed a report of the CMP with the Chair of the House Committee on Oversight and Government Reform, the Chair of the Senate Committee on Governmental Affairs, and the Acting Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on 05/16/2007. We will not disclose any information under a matching agreement until 40 days after filing a report to OMB and Congress or 30 days after publication in the **Federal Register** , whichever is later. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to: Walter Stone, CMS Privacy Officer, Division of Privacy Compliance (DPC), Enterprise Architecture and Strategy Group (EASG), Office of Information Services (OIS), CMS, Mailstop 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 daylight time. FOR FURTHER INFORMATION CONTACT: Cheryl Sample, Senior Privacy Specialist, DPC, EASG, OIS, CMS, Mailstop N2-04-27, 7500 Security Boulevard, N2-04-27, Baltimore, Maryland 21244-1850. The telephone number is

(410)786-7185, facsimile

(410)786-5636, or e-mail *cheryl.sample@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Description of the Matching Program A. General The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records

(SOR)are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to: 1. Negotiate written agreements with the other agencies participating in the matching programs; 2. Obtain the Data Integrity Board approval of the match agreements; 3. Furnish detailed reports about matching programs to Congress and OMB; 4. Notify applicants and beneficiaries that the records are subject to matching; and, 5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments. B. CMS Computer Matches Subject to the Privacy Act CMS has taken action to ensure that all CMPs that this Agency participates in comply with the requirements of the Privacy Act of 1974, as amended. Dated: May 8, 2007. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. Computer Match No. 2007-02 HHS Computer Match No. 0701 Name: Computer Matching Agreement Between the Centers for Medicare & Medicaid Services

(CMS)and the Health Administration Center

(HAC)of the Department of Veterans Affairs for Verification of CHAMPVA Eligibility”. Security Classification: Level Three Privacy Act Sensitive. Participating Agencies: The Centers for Medicare & Medicaid Services, and Health Administration Center

(HAC)of the Department of Veterans Affairs. Authority for Conducting Matching Program: This Computer Matching Program

(CMP)is executed to comply with the provisions of Public Laws (Pub. L.) 93-82, 94-581, 102-190, and 107-14 (codified at Title 38 United States Code (U.S.C.) 1713, renumbered Title 38 U.S.C. 1781), which restrict CHAMPVA eligibility for benefits dependent upon a beneficiary's Medicare Part A and Part B status. This computer match will match CHAMPVA applicants and beneficiaries with Medicare Parts A and B beneficiaries. Purpose(S) of the Matching Program: The purpose of this computer matching agreement is to establish the conditions, safeguards and procedures under which the CMS and HAC will conduct a computer-matching program to determine entitlement to CHAMPVA benefits. Under the terms of this matching agreement, HAC will provide to CMS a list of social security numbers

(SSN)for all CHAMPVA eligible beneficiaries who may also be eligible for Medicare benefits. This information is maintained in HAC's System of Records

(SOR)entitled “Health Administration Center Civilian Health and Medical Program Records-VA.” CMS agrees to conduct a computer match of the SSNs of beneficiaries provided by HAC against the information found in CMS's Enrollment Database

(EDB)SOR. HAC will receive the results of the computer match in order to determine a beneficiary's eligibility for care under CHAMPVA. Categories of Records and Individuals Covered by the Match: Upon establishment of the CHAMPVA program under Public Law 93-82, CHAMPVA entitlement will be terminated when any individual becomes eligible for Medicare Part A (Hospital Insurance) on a non-premium basis. Public Law 94-581 provided for reinstatement of CHAMPVA as second payer for beneficiaries aged 65 and over who exhausted a period of Medicare Part (Hospital Insurance). These beneficiaries must also be enrolled in Medicare Part B (Medical Insurance) in order to retain their CHAMPVA entitlement. Public Law 102-190 extended CHAMPVA benefit to age 65 for any beneficiary eligible for Medicare Part A on the basis of disability/end stage renal disease

(ESRD)only if that individual is also enrolled in Medicare Part B. Public Law 107-14 provided for extending benefit coverage for beneficiaries over the age of 65 years if the beneficiary is in receipt of Medicare Part A and Medicare Part B. Description Of Records To Be Used In The Matching Program: *Systems of Records* *Records Maintained by HAC* The information used in this matching program is maintained in the HAC system identified as 54VA16, entitled “Health Administration Center Civilian Health and Medical Program Records-VA,” last published at 68 FR 53784 (September 12, 2003). SSNs of CHAMPVA beneficiaries will be released to CMS pursuant to the routine use number 21 as set forth in the system notice. Records Maintained by CMS The matching program will be conducted with data maintained by CMS in the EDB, System No. 09-70-0502, published at 67 FR 3203 (January 23, 2002). Matched data will be released to HAC pursuant to the routine use number 2 as set forth in the system notice. Inclusive Dates of the Match: The CMP shall become effective no sooner than 40 days after the report of the Matching Program is sent to OMB and Congress, or 30 days after publication in the **Federal Register** , whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met. [FR Doc. E7-9789 Filed 5-21-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Notice To Award a Grant *Program Office:* Administration on Children, Youth and Families (ACYF)/ Family and Youth Services Bureau (FYSB). *Recipient Name:* Medical Institute for Sexual Health. *Announcement Type:* Notice to Award a Grant. *CFDA Number:* 93.235. *Amount of Award:* $207,400. *Project Period:* 5/1/2007-4/30/2008. *Summary:* This is a notice to award a grant to the Medical Institute for Sexual Health, Austin, TX, in the amount of $207,400 to support the development of online medical accuracy training for abstinence education providers. *Background:* The Medical Institute for Sexual Health proposes to develop an online instructor-led workshop to train abstinence education providers in methods to access medically accurate sexual health information via the internet. Participants will learn to identify credible internet resources for sexual health information, efficiently and effectively search the internet, and answer most questions on sexual health topics. The proposal is within the scope of technical assistance activities that the Abstinence Education Division of the Family and Youth Services Bureau

(FYSB)provides to grantees with regard to integrating medical and scientific information into abstinence education programming. The Congress, in appropriating funds for the program, has directed the Administration for Children and Families

(ACF)to devote up to five percent of appropriated funds for technical assistance and capacity-building for abstinence education grantees. In addition, the proposed activities of this awardee are outside the scope of the ACF's previous or proposed abstinence education competitive program announcements and would not qualify for any other existing grant opportunities. *For Further Information Contact:* Stanley Koutstaal, Ph.D., Acting Director, Division of Abstinence Education, 1250 Maryland Ave., SW., Washington, DC 20024,

(202)401-9205, *Nina.Degeorge@ACF.hhs.gov.* Dated: May 16, 2007. Harry Wilson, Associate Commissioner, Family and Youth Services Bureau. [FR Doc. E7-9824 Filed 5-21-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005E-0248] Determination of Regulatory Review Period for Purposes of Patent Extension; FOSRENOL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for FOSRENOL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product FOSRENOL (lanthanum carbonate hydrate). FOSRENOL is indicated to reduce serum phosphate in patients with end stage renal disease. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for FOSRENOL (U.S. Patent No. 5,968,976) from Shire International Licensing, B.V., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated July 8, 2005, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of FOSRENOL represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for FOSRENOL is 2,449 days. Of this time, 1,538 days occurred during the testing phase of the regulatory review period, while 911 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : February 13, 1998. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 13, 1998. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : April 30, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)for FOSRENOL (NDA 21-468) was initially submitted on April 30, 2002. 3. *The date the application was approved* : October 26, 2004. FDA has verified the applicant's claim that NDA 21-468 was approved on October 26, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 951 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 23, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 19, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-9787 Filed 5-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Infant Mortality; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Infant Mortality (ACIM). *Dates and Times:* June 13, 2007, 9 a.m.-5 p.m. June 14, 2007, 8:30 a.m.-3 p.m. *Place:* Four Points by Sheraton Washington DC Downtown Hotel, 1201 K Street, NW., Washington, DC 20005, (202)-289-7600. *Status:* The meeting is open to the public with attendance limited to space availability. *Purpose:* The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following: Department of Health and Human Services' programs that focus on reducing infant mortality and improving the health status of pregnant women and infants, and factors affecting the continuum of care with respect to maternal and child health care. It includes outcomes following childbirth; strategies to coordinate the variety of Federal, State, local and private programs and efforts that are designed to deal with the health and social problems impacting on infant mortality; and the implementation of the Healthy Start Program and *Healthy People 2010* infant mortality objectives. *Agenda:* Topics that will be discussed include the following: Cesarean section and its effect on pre-term and infant mortality, SIDS and related causes of infant death and Preconceptional care. Proposed agenda items are subject to change as priorities indicate. Time will be provided for public comments limited to five minutes each; comments are to be submitted no later than June 1, 2007. *For Further Information Contact:* Anyone requiring information regarding the Committee should contact Peter C. van Dyck, M.D., M.P.H., Executive Secretary, ACIM, Health Resources and Services Administration (HRSA), Room 18-05, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, *Telephone:*

(301)443-2170. Individuals who are submitting public comments or who have questions regarding the meeting and location should contact David S. de la Cruz, PhD, M.P.H., HRSA, Maternal and Child Health Bureau, *telephone:*

(301)443-6332, *e-mail: David.delaCruz@hrsa.hhs.gov.* Dated: May 15, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-9784 Filed 5-21-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Statement of Organization, Functions and Delegations of Authority This notice amends Part R of the Statement of Organization, Functions and Delegations of Authority of the Department of Health and Human Services (HHS), Health Resources and Services Administration

(HRSA)(60 FR 56605-56606 as amended November 6, 1995; and as last amended at 72 FR 19540-19544, April 18, 2007.) This notice reflects organizational changes in the Health Resources and Services Administration, Bureau of Primary Health Care (RC). Specifically, this notice updates the mission statement of the Bureau of Primary Health Care

(RC)and the functional statement of the Office of the Associate Administrator (RC), and deleted the Office of Administrative Management (RCM). Chapter RC, Bureau of Primary Health Care Section RC, 00 Mission Delete in its entirety and replace with the following: The mission of the Bureau of Primary Health Care is to improve the health of the Nation's underserved communities and vulnerable populations by assuring access to comprehensive, culturally competent, quality primary health care services. Section RC-10, Organization Delete in its entirety and replace with the following: The Bureau of Primary Health Care

(BPHC)is headed by an Associate Administrator, who reports directly to the Administrator, Health Resources and Services Administration. The Bureau of Primary Health Care includes the following components:

(1)Office of the Associate Administrator (RC);

(2)Office of Minority and Special Populations (RCG);

(3)Office of Policy and Program Development (RCH);

(4)Office of Quality and Data (RCK);

(5)Eastern Division (RCN);

(6)Central Mid-Atlantic Division (RCP);

(7)Western Division (RCQ);

(8)Division of National Hansen's Disease Programs (RC7); and

(9)Division Immigration Health Service (RC9). Section RC-20, Functions

(1)Delete the functional statement for the Office of the Associate Administrator

(RC)and replace in its entirety; and

(2)Delete the functional statement for the Office of Administrative Management (RCM). Office of the Associate Administrator

(RC)Provides overall leadership, direction, coordination, and planning in support of Bureau of Primary Health Care programs that are designed to improve the health of the Nation's underserved communities and vulnerable populations by assuring access to comprehensive, culturally competent, quality primary health care services. Specifically,

(1)Establishes program goals, objectives and priorities, and provides oversight as to their execution;

(2)plans, directs, coordinates and evaluates Bureau-wide management activities;

(3)maintains effective relationships within HRSA and with other Department of Health and Human Services

(HHS)organizations, other Federal agencies, State and local governments, and other public and private organizations concerned with primary health care, eliminating health disparities, and improving the health status of the Nation's underserved and vulnerable populations; and

(4)plans, directs, and coordinates Bureau-wide administrative management activities, *i.e.* , budget, finance, personnel, procurements, delegations of authority, emergency planning, training, executive secretariat, and has responsibilities related to the awarding of BPHC grant and contract funds. Section RC-30, Delegations of Authority All delegations of authority and re-delegations of authority made to HRSA officials that were in effect immediately prior to this reorganization, and that are consistent with this reorganization, shall continue in effect pending further re-delegation. This reorganization is effective upon the date of signature. Dated: May 15, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-9786 Filed 5-21-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Compositions and Methods for Increasing Recombinant Protein Yields Through the Modification of Cellular Properties *Description of Technology:* This technology relates to compositions and methods for improving the growth characteristics of cells engineered to produce biologically active products such as antibodies or glycosylated proteins. Featured is a method that uses gene candidates (e.g., cdkl3, siat7e, or lama4), or their expressed or inhibited products in cell lines, such as Human Embryonic Kidney (including HEK-293), HeLa, or Chinese Hamster Ovary (CHO). The gene expression modulates growth characteristics, such as adhesion properties, of the cell lines thereby increasing recombinant protein yields and reducing product production costs. *Applications:* This technology may be used to improve production of therapeutic and/or diagnostic compounds, including therapeutic proteins or monoclonal antibodies from mammalian cells. Optimization of mammalian cells for use as expression systems in the production of biologically active products is very difficult. For certain applications, anchorage-independent cell lines may be preferred, whereas for other applications, a cell line that adheres to a surface, e.g. is anchorage-dependent, may be preferable. This technology provides a method for identifying a gene whose expression modulates such cellular adhesion characteristics. This method thus leads to an increase in the expression or yield of polypeptides, including therapeutic biologicals, such as antibodies, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, glycosylated proteins, secreted proteins, and DNA sequences encoding such polypeptides and a reduction in the associated costs of such biological products. *Advantages:* This technology offers the ability to improve yields and reduce the cost associated with the production of recombinant protein products through the selection of cell lines having: Altered growth characteristics; altered adhesion characteristics; altered rate of proliferation; improvement in cell density growth; improvement in recombinant protein expression level. *Market:* Biopharmaceuticals, including recombinant therapeutic proteins and monoclonal antibody-based products used for in vivo medical purposes and nucleic acid based medicinal products now represent approximately one in every four new pharmaceuticals on the market. The market size has been estimated at $33 billion in 2004 and is projected to reach $70 billion by the end of the decade. The list of approved biopharmaceuticals includes recombinant hormones and growth factors, mAB-based products and therapeutic enzymes as well as recombinant vaccines and nucleic acid based products. Mammalian cells are widely used expression systems for the production of biopharmaceuticals. Human embryo kidney (including HEK-293) and Chinese hamster ovary

(CHO)are host cell of choice. The genes identified in this technology (e.g., cdkl3, sia7e, or lama4) can be used to modify these important cell based systems. This technology is ready for use in drug/vaccine discovery, production and development. The technology provides methods for identification of specific gene targets useful for altering the production properties of either existing cell lines to improve yields or with new cell lines for the production of therapeutic and or diagnostic compounds from mammalian cells. Companies that are actively seeking production platforms based on mammalian cell lines that offer high efficiency, high throughput systems for protein production or analysis at lower cost and ease of scale-up would be potential licensors of this technology. *Development Status:* Late Stage—Ready for Production. *Inventors:* Joseph Shiloach (NIDDK), Pratik Jaluria (NIDDK). *Related Publication:* P Jaluria et al.Application of microarrays to identify and characterize genes involved in attachment dependence in HeLa cells. Metab Eng. 2006 Dec 13, Epub ahead of print, doi:10.1016/j.ymben.2006.12.001. *Patent Status:* U.S. Provisional Application No. 60/840,381 filed 24 Aug 2006 (HHS Reference No. E-149-2006/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institute of Diabetes and Digestive and Kidney Diseases, Biotechnology Core Laboratory, is seeking parties interested in collaborative research projects directed toward the use of this technology with cells for drug and vaccine production and development, including growth optimization, production and product recovery processes. For more information, please contact Dr. Joseph Shiloach, *josephs@intra.niddk.nih.gov,* or Rochelle S. Blaustein at Rochelle.Blaustein@nih.gov. In Vitro Model for Hepatitis C Virion Production *Description of Technology:* This invention provides an in vitro hepatitis C virus

(HCV)replication system that is capable of producing viral particles in a culture medium. Hepatitis C is a major public health problem, the development of therapeutics for which has been hampered by a lack of a robust model system to study the complete viral life cycle. This invention provides a new model system for the complete replication cycle of hepatitis C virus and virion production, assembly and release. The model is useful for screening antiviral agents against HCV. A full length HCV construct, CG1b of genotype 1b which is known to be infectious, was placed between two ribozymes designed to generate the exact 5′ and 3′ ends of HCV when cleaved. Using this system, HCV proteins and positive and negative RNA strands have been shown to reproduce intracellularly, and viral particles that resemble authentic HCV virions are produced and secreted into the culture medium. The patent application includes claims directed toward the following: a construct comprising specific nucleic acid sequences including HCV genotype 1b, genotype 1a, genotype 2a or potentially other genotypes; a method for identifying a cell line that is permissive for infection with HCV; a method for propagating HCV in vitro; a method for screening agents capable of modulating HCV replication or activity; a method for testing the level of HCV replication or activity; a HCV vaccine comprising HCV virus particles. *Applications:* The model offers a novel method for investigating the entire HCV life cycle including replication and pathogenesis and is useful for high-throughput antiviral screening. This technique may also be useful for making infectious particles that are useful in the production of HCV vaccines. *Advantages:* This system provides a new, stable and efficient cell culture model to further study the life cycle and biology of HCV, and to test potential therapeutic targets for hepatitis C. This model has also been used to generate in cell culture HCV strains infectious for chimpanzees, the only experimental animal susceptible to infection with the hepatitis C virus, a critical step in the development of new vaccines for Hepatitis C. *Market:* Hepatitis C virus

(HCV)chronically infects approximately 200 million people worldwide and increases the risk of developing cirrhosis and hepatocellular carcinoma. This technology would be useful for studying the HCV life cycle, screening for therapeutic agents against multiple HCV strains, including Genotype 1a, 1b and 2a, and the development of HCV vaccines. HCV genotypes 1 and 2 are the major genotypes with worldwide distribution; they are known to be associated with different clinical profiles and therapeutic responses. Hence, the model may be used to screen for varying levels of effectiveness of therapeutics against the major HCV genotypes. *Development Status:* This technology is available for use in diagnostics, drug/vaccine discovery, production and development. Current work is directed toward studies into the HCV life cycle and replication and the pathogenesis of HCV screening for antiviral agents against multiple HCV strains. This model has been used to generate in cell culture HCV strains infectious for chimpanzees, the only experimental animal susceptible to infection with the hepatitis C virus, a critical step in the development of new vaccines for Hepatitis C. Future work may be directed toward the use of this system for development of vaccine candidates against HCV. *Inventors:* T. Jake Liang (NIDDK), Theo Heller (NIDDK) *Related Publications:* 1. Z Hu *et al.* Altered proteolysis and global gene expression in hepatitis B virus X transgenic mouse liver. J Virol. 2006 Feb;80(3):1405-1413. 2. T Heller *et al.* An in vitro model of hepatitis C virion production. Proc Natl Acad Sci USA. 2005 Feb 15;102(7):2579-2583. *Patent Status:* PCT Application No. PCT/US2005/035487 filed 30 Sep 2005 (HHS Reference No. E-324-2004/3-PCT-01), based on: U.S. Provisional Application No. 60/615,301 filed 30 Sep 2004 (HHS Reference No. E-324-2004/0-US-01), now abandoned; U.S. Provisional Application No. 60/642,210 filed 06 Jan 2005 (HHS Reference No. E-324-2004/1-US-01), now abandoned; and U.S. Provisional Application No. 60/720,692 filed 26 Sep 2005 (HHS Reference No. E-324-2004/2-US-01), now abandoned. *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institute of Diabetes and Digestive and Kidney Diseases, Liver Diseases Branch, is seeking parties interested in collaborative research directed toward molecular strategies for vaccine and antiviral development, and animal models of viral hepatitis C. Please contact Dr. T. Jake Liang at 301-496-1721, *jliang@nih.gov* or Rochelle S. Blaustein at *Rochelle.Blaustein@nih.gov* for more information. Dated: May 14 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-9845 Filed 5-21-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Special Emphasis Panel, Comprehensive Minority Institution Cancer Center Partnership. *Date:* June 10-12, 2007. *Time:* 7 p.m. to 11 p.m. (June 10), 8 a.m. to 5 p.m. (June 11 and 12). *Agenda:* To review and evaluate grant applications. *Place:* Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. *Contact Person:* Gerald G. Lovinger, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 8101, Bethesda, MD 20892-8329, 301-496-7897, *lovingeg@mail.nih.gov.* *Name of Committee:* National Cancer Institute Special Emphasis Panel, Clinical Studies Special Emphasis Panel. *Date:* June 18-19, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. *Contact Person:* Majed M. Hamawy, PhD, MBA, Scientific Review Administrator, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8135, Bethesda, MD 20852, 301-594-5659, *mh101v@nih.gov.* *Name of Committee:* National Cancer Institute Special Emphasis Panel, Cancer Sample Preparation/Detection and Diagnosis. *Date:* June 21, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. *Contact Person:* Lalita D. Palekar, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 7141, Bethesda, MD 20892-7405, 301-496-7575, *palekarl@mail.nih.gov.* *Name of Committee:* National Cancer Institute Special Emphasis Panel, Innovations in Cancer Sample Preparation. *Date:* June 21, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. *Contact Person:* Lalita D. Palekar, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 7141, Bethesda, MD 20892-7405, 301-496-7575, *palekarl@mail.nih.gov.* *Name of Committee:* National Cancer Institute Special Emphasis Panel, Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis (U01). *Date:* July 10-11, 2007. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Marriott Bethesda Suites, 6711 Democracy Blvd., Bethesda, MD 20817. *Contact Person:* C. Michael Kerwin, PhD, MPH, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Blvd., Room 8057, Bethesda, MD 20892-8329, 301-496-7421, *kerwinm@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: May 15, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-2541 Filed 5-21-07; 8:45 am]

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