Notices. Notice of a New System of Records (SOR)
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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel: Monitoring and Treatment Programs for the World Trade Center, Program Announcement Number
(PA)04-038. 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 the following meeting: *Name:* Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Monitoring and Treatment Programs for the World Trade Center, PA 04-038. *Time and Date:* 8 a.m.-3 p.m., October 23, 2006 (Closed). *Place:* Embassy Suites, 7001 Yampa Street, Denver, Colorado 80249, Telephone 303.574.3000. *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 Monitoring and Treatment Programs for the World Trade Center, PA 04-038. *For Further Information Contact:* M. Chris Langub, Designated Federal Officer, 1600 Clifton Road, NE., MS E74, Atlanta, GA 30333, telephone 404.498.2543. 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: September 25, 2006. Alvin Hall, Director, Management Analysis and Services Office,Centers for Disease Control and Prevention. [FR Doc. E6-16234 Filed 9-29-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Center for Environmental Health/Agency for Toxic Substances and Disease Registry The Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health/Agency for Toxic Substances and Disease Registry(NCEH/ATSDR): Teleconference. In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), CDC, NCEH/ATSCR announces the following subcommittee meeting: *Name:* Program Peer Review Subcommittee (PPRS). *Time and Date:* 10:30 a.m.-12:30 p.m. Eastern Daylight Savings Time, October 16, 2006. *Place:* The teleconference will originate at NCEH/ATSDR in Atlanta, Georgia. To participate, dial
(877)315-6535 and enter conference code 383520. *Purpose:* Under the charge of the BSC, NCEH/ATSDR, the PPRS will provide the BSC, NCEH/ATSDR with advice and recommendations on NCEH/ATSDR program peer review. They will serve the function of organizing, facilitating, and providing a long-term perspective to the conduct of NCEH/ATSDR program peer review. *Matters to be Discussed:* A review of the previous meeting; an update on the planning of the Site Specific Activities Peer Review; a discussion of Terrorism Preparedness and Emergency Response Peer Review in February 2007, to include: revisions to the review process, revisions to the questionnaires, areas of expertise required for the review, and nominations for PPRS panel member, chairperson, and peer reviewers; and review the revised schedule for Program Peer Reviews. Agenda items are subject to change as priorities dictate. *Supplementary Information:* This meeting is scheduled to begin at 10:30 a.m. Eastern Daylight Savings Time. To participate, please dial
(877)315-6535 and enter conference code 383520. Public comment period is scheduled for 11:10-11:20 a.m. *For Further Information Contact:* Sandra Malcom, Committee Management Specialist, Office of Science,NCEH/ATSDR, MS E-28, 1600 Clifton Road, NE., Atlanta,Georgia 30333, telephone (404)498-0622. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and NCEH/ATSDR. Dated: September 25, 2006. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-16189 Filed 9-29-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). 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, “Rural Hospice Demonstration (RHD), System No. 09-70-0563.” The program is mandated by § 409 of the Medicare Prescription Drug Improvement and Modernization Act of 2003
(MMA)(Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). Section 409 authorizes the Secretary of HHS (the Secretary) to conduct a demonstration project for the delivery of hospice care to Medicare beneficiaries in rural areas. Under the demonstration, Medicare beneficiaries who are unable to receive hospice care at home for lack of an appropriate caregiver are provided such care in a facility of 20 or fewer beds that offers, within its walls, the full range of services provided by hospice programs. In order for a hospice organization or agency to participate in this demonstration, it must be Medicare certified and meet all of the Medicare Conditions of Participation as described in subparts C (General Provisions), D (Core Services), and E (Other Services) of 42 CFR 418, except it shall not be required to offer services outside the facility or meet the 20 percent inpatient cap requirements of section 1861(dd)(2)
(iii)of the Act. The purpose of this system is to collect and maintain a person-level view of identifiable data of Medicare beneficiaries who participate in the rural hospice demonstrations. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee;
(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare 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 this 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 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 September 26, 2006 . 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 comment to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, 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: Cindy Massuda, Project Officer, Division of Deliver System Demonstration, Office of Research Development & Information, Mail Stop C4-18-03, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-0652 or e-mail *Cindy.Massuda@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: The demonstration will be offered to up to three hospice programs and will not exceed a period of 5 years. The demonstration will test whether provisions of hospice services provided by a demonstration hospice program to Medicare beneficiaries who lack an appropriate caregiver and who reside in rural areas results in wider access, improved hospice services, benefits to the community, and a sustainable pattern of care. Hospice provides palliative care to individuals who have a terminal illness with a prognosis of 6 months or less. The care is provided typically in the individual's home or place of residence with family members present. Individuals who lack family or someone to serve as the primary caregiver need proportionately more support from hospice staff. Due to long distances and difficult terrain, it can be particularly difficult to provide the Medicare hospice benefit efficiently in rural areas. There may be situations where the hospice benefit could be provided to beneficiaries who would not otherwise be able to receive these services if the location of hospice care is altered. This demonstration will allow a hospice with up to 20 beds to provide all levels of hospice services within its walls to individuals who reside in rural areas and lack an appropriate caregiver, while not having to provide services outside of the hospice facility or comply with the 20-percent cap on inpatient care days. While the demonstration provider will not have to meet the limit on inpatient care days or provide care outside of the facility, it will not alter the level of care requirements for general inpatient care. In order to provide general inpatient care to hospice patients, a hospice participating in the demonstration must assure that the need for general inpatient care is met according to Medicare guidelines. The demonstration will test whether hospice services provided by a facility that does not meet the limit on inpatient care days or provide services outside of the facility for hospice individuals residing in rural areas who lack an appropriate caregiver results in wider access, improved hospice services, benefits to the rural community, and a sustainable pattern of care. The demonstration is designed for a demonstration hospice to provide the full range of services within its facility to Medicare beneficiaries who reside in rural areas and lack an appropriate caregiver. If a demonstration hospice provides care to any patient who either lives outside a rural area or has an appropriate caregiver, then the hospice must comply with all of Medicare hospice requirements at § 1861(dd) of the SSA for these patients since they are not considered part 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 the provisions of § 409 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 and § 1861(dd) of the Social Security Act. This program is codified at Title 42 United States Code 1395x (dd). B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries and their providers who provide service to such beneficiaries who participate in this demonstration. Data will be collected from Medicare administrative and claims records, patient medical charts, physician records, and via survey instruments administered to beneficiaries and providers. The collected information will include, but is not limited to Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. 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 RHD 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 RHD. 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 a person-level view of identifiable data of Medicare beneficiaries who participate in the rural hospice demonstrations. 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 support 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 assist another Federal or State agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare 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 RHD information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To assist 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 RHD data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policies that govern their care. 4. To support 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 assist 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 assist 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, and 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, and abuse in such programs. Other agencies may require RHD 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 FR 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 because of the small size, use of this information could allow for the deduction of the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors of 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. 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: September 19, 2006. John R. Dyer, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0563 System Name: “Rural Hospice Demonstration (RHD),” HHS/CMS/ORDI. Security Classification: Level Three Privacy Act Sensitive Data. System Location: CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850, and at various contractor locations. Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries and their providers who provide service to such beneficiaries who participate in this demonstration. Categories of Records in the System: Data will be collected from Medicare administrative and claims records, patient medical charts, physician records, and via survey instruments administered to beneficiaries and providers. The collected information will include, but is not limited to Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Authority for Maintenance of the System: The statutory authority for this system is given under the provisions of § 409 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003 and § 1861(dd) of the Social Security Act. This program is codified at Title 42 United States Code 1395x (dd). Purpose(s) of the System: The purpose of this system is to collect and maintain a person-level view of identifiable data of Medicare beneficiaries who participate in the rural hospice demonstrations. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee;
(2)assist another Federal or State agency with information to contribute to the accuracy of CMS's proper payment of Medicare 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 support 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 assist another Federal or State agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare 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 support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease, disability, or quality care projects, the restoration or maintenance of health, and payment related projects. 4. To support 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 assist 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 assist 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, and 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, and 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 FR 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 because of the small size, use of this information could allow for the deduction of 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 an individual identifier; *e.g.,* beneficiary name or HICN, and unique provider identification number. 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: CMS will retain information for a total period not to exceed 25 years. 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 Deliver Systems Demonstration, Office of Research Development and Information, Mail Stop C4-18-03, 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, provider's tax identification number, national provider number, and for verification purposes, or 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: Information maintained in this system will be collected from physicians volunteering to participate in the RHD. Additional data will be collected from Medicare claims payment records. Systems Exempted from Certain Provisions of the Act: None. [FR Doc. E6-16107 Filed 9-29-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0211] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Proposed Collection; Comment Request; Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 1, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds—(OMB Control Number 0910-0445—(Extension) Section 117 of the Food and Drug Administration Modernization Act (Public Law 105-115), signed into law by the President on November 21, 1997, provides that a written request to FDA from the applicant of an investigation that a clinical hold be removed shall receive a decision in writing, specifying the reasons for that decision, within 30 days after receipt of such request. A clinical hold is an order issued by FDA to the applicant to delay a proposed clinical investigation or to suspend an ongoing investigation for a drug or biologic. An applicant may respond to a clinical hold. Under section 505(i)(3)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(3)(C)), any written request to FDA from the sponsor of an investigation that a clinical hold be removed must receive a decision, in writing and specifying the reasons, within 30 days after receipt of the request. The request must include sufficient information to support the removal of the clinical hold. In the **Federal Register** of May 14, 1998 (63 FR 26809), FDA published a notice of availability of a guidance that described how applicants should submit responses to clinical holds so that they may be identified as complete responses and the agency can track the time to respond. FDA issued a revised guidance in October 2000 which states that FDA will respond in writing within 30-calendar days of receipt of a sponsor's request to release a clinical hold and a complete response to the issue(s) that led to the clinical hold. An applicant's complete response to an investigational new drug
(IND)clinical hold is a response in which all clinical hold issues identified in the clinical hold letter have been addressed. The guidance requests that applicants type “Clinical Hold Complete Response” in large, bold letters at the top of the cover letter of the complete response to expedite review of the response. The guidance also requests that applicants submit the complete response letter in triplicate to the IND, and that they fax a copy of the cover letter to the FDA contact listed in the clinical hold letter who is responsible for the IND. The guidance requests more than an original and 2 copies of the cover letter in order to ensure that the submission is received and handled in a timely manner. Based on data concerning the number of complete responses to clinical holds received by the Center for Drug Evaluation and Research
(CDER)in 2004 and 2005, CDER estimates that approximately 88 responses are submitted annually from approximately 67 applicants, and that it takes approximately 284 hours to prepare and submit to CDER each response. Based on data concerning the number of complete responses to clinical holds received by the Center for Biologics Evaluation and Research
(CBER)in 2004 and 2005, CBER estimates that approximately 92 responses are submitted annually from approximately 60 applicants, and that it takes approximately 284 hours to prepare and submit to CBER each response. ** Table 1—Estimated Annual Reporting Burden 1 ** Complete Responses to Clinical Holds No. of Respondents No. of Responses Per Respondent Total Annual Responses Hours Per Response Total Hours CDER 67 .76 88 284 24,992 CBER 60 1.53 92 284 26,128 Total 51,120 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In the **Federal Register** of May 25, 2006 (71 FR 30142), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Dated: September 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-16225 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0382] Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing information collection, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for Postmarket Surveillance under 21 CFR part 822. DATES: Submit written or electronic comments on the collection of information by December 1, 2006. ADDRESSES: Submit electronic comments on the collection of information to *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:
(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;
(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Postmarket Surveillance—21 CFR Part 822 (OMB Control Number 0910-0449)—Extension Section 522(a) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360(l)) authorizes FDA to require manufacturers to conduct postmarket surveillance of any device that meets the criteria set forth in the statute. The postmarket surveillance (PS), regulation establishes procedures that FDA uses to approve and disapprove PS plans. The regulation provides specific, clear, and flexible instructions to manufacturers so they know what information is required in a postmarket surveillance plan submission. FDA reviews submissions in accordance with part 822 (21 CFR part 822) in §§ 822.15 to 822.18 of the regulation, which describe the grounds for approving or disapproving a PS plan. If this information is not collected, FDA would not be able to ensure that the PS plan could result in the collection of useful data which could reveal unforeseen adverse events or other information necessary to protect the public health. Respondents to this collection of information are those manufacturers who require postmarket surveillance of their products. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Reporting Burden 1 ** 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 822.9, 822.10 5 1 5 120 600 822.21 3 1 3 40 120 822.26 1 1 1 8 8 822.27 1 1 1 40 40 822.28 1 1 1 40 40 822.29 1 1 1 120 120 822.30 1 1 1 40 40 822.34 1 1 1 20 20 822.38 10 2 20 120 2,400 Total 3,338 1 There are no capital costs or operating and maintenance costs associated with this collection of information. ** Table 2.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours 822.31 10 1 10 20 200 822.32 30 1 30 10 300 Total 500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA estimates that, based on current staffing and resources and experience with five actual postmarket surveillance actions over the past 3 years, five PS actions will be issued for generic devices, comprised of approximately five manufacturers. Each manufacturer will be required to submit a PS plan (§§ 822.9 and 822.10) and interim and final reports on the progress of the PS (§ 822.38). FDA anticipates that, on a case-by-case basis, requests for additional information may be made from a manufacturer. FDA expects that a small number of respondents will propose changes to their PS plans (§ 822.21), request a waiver of a specific requirement of this regulation (§ 822.29), or request exemption from the requirement to conduct PS of their device (§ 822.30). FDA's experience has shown that a few respondents will go out of business (§ 822.26) or cease marketing the device subject to PS (§ 822.28) each year. In addition, manufacturers must certify transfer of records when ownership changes § 822.34. FDA expects that at least some of the manufacturers will be able to satisfy the PS requirement using information or data they already have. For purposes of calculating burden, however, FDA has assumed that each PS order can only be satisfied by a 3-year clinically-based PS plan, using three investigators. These estimates are based on FDA's knowledge and experience with limited implementation of section 522 under the Safe Medical Devices Act of 1990. Therefore, FDA would expect that the recordkeeping requirements would apply to a maximum of 10 manufacturers (3 to 4 added each year) and 30 investigators (three per PS plan). After 3 years, FDA would expect these numbers to remain level as the PS plans conducted under the earliest orders reach completion and new orders are issued. Dated: September 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-16231 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is requesting nominations for voting and nonvoting consumer representatives to serve on its advisory committees/panels that are under the purview of the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the National Center for Toxicological and Research (NCTR). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups. DATES: Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2006. Because vacancies occur on various dates throughout the year, there is no cutoff date for the receipt of nominations. ADDRESSES: Send all nominations and curricula vitae to the following contact persons listed in table 1 of this document: **Table 1.** Contact Person Committee/Panel Jan Johannessen, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, rm. 14B-08, Rockville, MD 20857, 301-827-6687, e-mail: *jan.johannessen@fda.hhs.gov* Pediatric Advisory Committee Igor Cerny, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20857, 301-827-6763, e-mail: *igor.cerny@fda.hhs.gov* Arthritis Advisory Committee Collin L. Figueroa, Center for Devices and Radiological Health (HFZ-342), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850 Device Good Manufacturing Practice Advisory Committee Geretta Wood, Center for Devices and Radiological Health (HFZ-400), Food and Drug Administration, 9200 Corporate Blvd., rm. 110D, Rockville, MD 20850, 301-594-2022, x 133, e-mail: *geretta.wood@fda.hhs.gov* General Hospital and Personal Use Devices Panel, Gastroenterology-Urology Devices Panel, General and Plastic Surgery Devices Panel, and the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Leonard M. Schechtman, National Center for Toxicological Research (HFT-10), Food and Drug Administration, 5600 Fishers Lane, rm. 16-85, Rockville, MD 20857, 301-827-6696, e-mail: *leonard.schechtman@fda.hhs.gov* Science Advisory Board to NCTR FOR FURTHER GENERAL INFORMATION CONTACT: Doreen Brandes, Office of the Commissioner (HF-4), Food and Drug Administration, 5600 Fishers Lane, rm. 15A-12, Rockville, MD 20853, 301-827-1220, e-mail *doreen.brandes@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and nonvoting consumer representatives for the vacancies listed in table 2 of this document. **Table 2.** Committee/Panel Expertise Needed Current and Upcoming Vacancies Approximate Date Needed Pediatric Advisory Committee—knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics 1—Voting Consumer Representative Immediately Arthritis Advisory Committee—knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties 1—Voting Consumer Representative Immediately Certain Panels of the Medical Devices Advisory Committee Anesthesiology and Respiratory Therapy Devices Panel—anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia 1—Nonvoting Consumer Representative Immediately General Hospital and Personal Use Devices Panel—internists, pediatricians, neonatologists, endocrinologists, gerontologists, nurses, bio-medical engineers, or microbiologists/infection control practioners or experts 1—Nonvoting Consumer Representative Immediately Gastroenterology-Urology Devices Panel—gastroenterologists, urologists, and nephrologists 1—Nonvoting Consumer Representative January 1, 2007 General and Plastic Surgery Devices Panel—surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians 1—Nonvoting Consumer Representative Immediately Science Advisory Board to NCTR—toxicologists, chemists, or public health background as it relates to foods, drugs, etc. 1—Voting Consumer Representative July 1, 2007 I. Functions A. Pediatric Advisory Committee The Committee advises and makes recommendations to the Commissioner of Food and Drugs (the Commissioner) regarding the following topics:
(1)Pediatric research conducted under sections 351, 409I, and 499 of the Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and sections 501, 502, 505, 505A, and 505B of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351, 352, 355, 355a, and 355c);
(2)identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions;
(3)the ethics, design, and analysis of clinical trials related to pediatric therapeutics;
(4)pediatric labeling disputes as specified in section 3 of the Best Pharmaceuticals for Children Act
(BPCA)(Public Law 107-109);
(5)pediatric labeling changes as specified in section 5 of the BPCA;
(6)adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur as specified in section 17 of the BPCA;
(7)any other pediatric issue or pediatric labeling dispute involving FDA regulated products;
(8)research involving children as subjects as specified in 21 CFR 50.54; and
(9)any other matter involving pediatrics for which FDA has regulatory responsibility. B. Arthritis Advisory Committee The committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases and makes appropriate recommendations to the Commissioner. C. Certain Panels of the Medical Devices Advisory Committee The committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the act envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner regarding recommended classification or reclassification of devices into one of three regulatory categories, advises on any possible risks to health associated with the use of devices, advises on formulation of product development protocols, reviews premarket approval applications for medical devices, reviews guidelines and guidance documents, recommends exemption of certain devices from application of portions of the act, advises on the necessity to ban a device, and responds to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. D. NCTR The Science Advisory Board to the committee is responsible for examining the biological effects of potentially toxic substances found in the environment through fundamental investigations aimed at understanding the mechanisms of actions of those substances in animals and developing a better understanding of what these data in animals mean for man. II. Criteria for Members Persons nominated for membership as consumer representatives on the committees/panels must meet the following criteria:
(1)Demonstrate ties to consumer and community-based organizations,
(2)be able to analyze technical data,
(3)understand research design,
(4)discuss benefits and risks, and
(5)evaluate the safety and efficacy of products under review. The consumer representatives must be able to represent the consumer perspective on issues and actions before the advisory committee, serve as liaisons between the committee and interested consumers, associations, coalitions, and consumer organizations, and facilitate dialogue with the advisory committees on scientific issues that affect consumers. III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and consumer advocacy groups. The organizations have the responsibility of recommending candidates of the agency's selection. IV. Nomination Procedures All nominations must include a cover letter, a curriculum vitae or resume (that includes the nominee's office address, telephone number, and e-mail address), and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations will specify the advisory panel(s) or committee(s) for which the nominee is recommended. Nominations will include confirmation that the nominee is aware of the nomination, is willing to serve as a member of the advisory committee if selected, and appears to have no conflict of interest that would preclude membership. Any interested person or organization may nominate one or more qualified persons for membership as consumer representatives on one or more of the advisory committees/panels. Self-nominations are also accepted. Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of a conflict of interest. The nomination should specify the committee(s)/panel(s) of interest. The term of office is up to 4 years, depending on the appointment date. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: September 25, 2006. Randall Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-16216 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0050] Determination of Regulatory Review Period for Purposes of Patent Extension; BYETTA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for BYETTA 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 that 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-7), 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 BYETTA (exenatide injection). BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for BYETTA (U.S. Patent No. 5,424,286) from Amylin Pharmaceuticals, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of BYETTA 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 BYETTA is 2,271 days. Of this time, 1,968 days occurred during the testing phase of the regulatory review period, while 303 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 10, 1999. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 10, 1999. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : June 30, 2004. The applicant claims June 29, 2004, as the date the new drug application
(NDA)for BYETTA (NDA 21-773) was initially submitted. However, FDA records indicate that NDA 21-773 was submitted on June 30, 2004. 3. *The date the application was approved* : April 28, 2005. FDA has verified the applicant's claim that NDA 21-773 was approved on April 28, 2005. 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 1,286 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 December 1, 2006. 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 April 2, 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: September 1, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-16086 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0008] Determination of Regulatory Review Period for Purposes of Patent Extension; DRAXXIN AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for DRAXXIN 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 animal 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-7), 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 animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal 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 animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA recently approved for marketing the animal drug product DRAXXIN (tulathromycin). DRAXXIN is indicated for control of respiratory disease in cattle at high risk of developing bovine respiratory disease
(BRD)and for treatment of BRD associated with *Mannheimia haemolytica* , *Pasteurella multocida* , and *Histophilus somni* . It is also indicated for the treatment of swine respiratory disease associated with *Actinobacillus pleuropneumoniae* , *P. multocida* , *Bordetella bronchiseptica* , and *Haemophilus parasuis* . Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for DRAXXIN (U.S. Patent No. 6,420,536) from Pfizer, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 24, 2006, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of DRAXXIN 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 DRAXXIN is 2,451 days. Of this time, 2,414 days occurred during the testing phase of the regulatory review period, while 37 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(j)) became effective* : September 9, 1998. FDA has verified the applicant's claim that the date the investigational new animal drug application (INADA) became effective was on September 9, 1998. 2. *The date the application was initially submitted with respect to the animal drug product under section 512(b) of the Federal Food, Drug, and Cosmetic Act* : April 18, 2005. FDA has verified the applicant's claim that the new animal drug application
(NADA)for DRAXXIN (NADA 141-244) was initially submitted on April 18, 2005. 3. *The date the application was approved* : May 24, 2005. FDA has verified the applicant's claim that NADA 141-244 was approved on May 24, 2005. 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 360 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 December 1, 2006. 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 April 2, 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: September 1, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-16087 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006E-0204] Determination of Regulatory Review Period for Purposes of Patent Extension; NATRECOR AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for NATRECOR 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 that 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-7), 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 drug 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 NATRECOR (nesiritide). NATRECOR is indicated for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for NATRECOR (U.S. Patent No. 5,114,923) from Scios, Inc., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 19, 2006, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of NATRECOR 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 NATRECOR is 2,790 days. Of this time, 1,588 days occurred during the testing phase of the regulatory review period, while 1,202 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* : December 22, 1993. The applicant claims November 22, 1993, as the date the investigational new drug application
(IND)became effective. However, FDA records indicate that the IND effective date was December 22, 1993, which was 30 days after FDA receipt of the IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : April 27, 1998. FDA has verified the applicant's claim that the new drug application
(NDA)for NATRECOR (NDA 20-920) was initially submitted on April 27, 1998. 3. *The date the application was approved* : August 10, 2001. FDA has verified the applicant's claim that NDA 20-920 was approved on August 10, 2001. 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 5 years 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 December 1, 2006. 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 April 2, 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: September 1, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-16091 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0443] Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance for industry entitled “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.” This guidance explains FDA's current thinking regarding advances that have been made in the quality and manufacturing sciences since the current good manufacturing practice
(CGMP)regulations were issued in 1978. The guidance describes the key elements of a robust quality systems model and shows how persons implementing such a model can achieve compliance with the CGMP regulations. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Monica Caphart, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-827-9047; Robert Sausville, Center for Biologics Evaluation and Research (HFM-610), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6205; June Liang, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-8789; or Patricia Maroney Benassi, Office of Regulatory Affairs (HFC-240), 15800 Crabbs Branch Way, Rockville MD 20855, 240-632-6819. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations.” This guidance was developed by the quality systems working group formed as part of the Pharmaceutical CGMPs for the 21st Century: A Risk Based Approach initiative (the initiative) now the Council on Pharmaceutical Quality. The guidance is intended to encourage the use of modern quality management system principles by the regulated industry and foster innovation and continuous improvements in pharmaceutical manufacturing. The initiative was announced in August 2002 ( *http://www.fda.gov/cder/gmp/2ndprogressrept_plan.htm* ). Among the many issues identified at that time were:
(1)The increase in the number of pharmaceutical products and in the role of medicines in health care;
(2)the decrease in the frequency of FDA manufacturing inspections resulting from fewer resources available for pharmaceutical manufacturing inspections;
(3)FDA's increasing experience with, and lessons learned from, various approaches to the regulation of product quality;
(4)advances in the pharmaceutical sciences and manufacturing technologies;
(5)the increasing application of biotechnology in drug discovery and manufacturing;
(6)advances in the science and management of quality; and
(7)the globalization of the pharmaceutical industry. At the outset, the agency established a set of guiding principles for the initiative: • Maintain a risk-based orientation, • Policies and standards must be science-based, • The agency's orientation must be toward integrated quality systems, • International cooperation is very important, and • Protection of the public health must remain the top priority. The initiative's announcement stated that 21 CFR parts 210, 211, 600, and 610 are flexible and will allow the agency to embark on a science-based risk management approach to CGMPs. This guidance, developed by a cross-center working group established by the initiative, is key in achieving the agency's goals. By showing how modern quality systems approaches relate to the existing CGMP regulations, the agency can help manufacturers meet the requirements of the agency's CGMPs while using a robust quality systems approach to the production of human and animal medical products. Such a comprehensive approach should foster flexibility and allow for continued innovation, while maintaining the principles of the CGMP regulations. On October 4, 2004, FDA issued a draft of this guidance (69 FR 59256). Comments were received and considered carefully as the agency finalized the guidance. No substantive changes were made to the final guidance, although a number of clarifying edits were made throughout the guidance based on the comments received. In addition, the reference list and the graphic depicting a quality management systems approach were updated. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on a quality systems approach to pharmaceutical CGMP regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: September 7, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-16215 Filed 9-29-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notification of a Class Deviation of Grants Policy Directive Part 2.04 AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Notice. SUMMARY: In accordance with the Grants Policy Directive Part 1.03, the Office of Health Information Technology
(OHIT)has been granted a class deviation from the competition requirements contained in the Grants Policy Directive Part 2.04 to provide an additional year of funding without competition for Health Center Controlled Network
(HCCN)Initiatives funded under Section 330 of the Public Health Service Act, as amended. FOR FURTHER INFORMATION CONTACT: Susan Lumsden, Director, Division of Health Information Technology State and Community Assistance, Office of Health Information Technology, Health Resources and Services Administration, 5600 Fishers Lane, 7C-22, Rockville, Maryland 20857; telephone number: 301-594-4472; fax number: 301-443-1330. SUPPLEMENTARY INFORMATION: In accordance with Public Health Service Act, Title III, Section 330(e)(1)(C), 42 U.S.C.254b (as amended). Background OHIT serves as the HRSA Administrator's principal advisor for promoting the adoption of and implementing health care information technology for the medically uninsured, underserved and other vulnerable populations, ensuring that key issues affecting the public and private adoption of health information technology are addressed ( *e.g.* , privacy and security issues, standardization, and interoperability). The HCCNs are key partners in enabling HRSA to help adopt and implement the President's Health Information Technology Initiative in the safety net community. The HCCNs support the creation, development, and operation of networks of safety net providers to ensure access to health care for the medically underserved populations through the enhancement of health center operations. The HCCNs routinely perform core business functions for their safety net members across their marketplace, State, or region. The core business functions range from electronic health records, credentialing and privileging programs, utilization review and management, and clinical quality improvement. They provide these functions at or below marketplace cost to their members to increase efficiencies, reduce costs, and improve health care quality for underserved and uninsured populations. As such, the HCCNs are key to achieving the President's goal of assuring that every American in the Nation will have an electronic health record by 2014. Justification for the Exception to Competition The creation of OHIT was part of HRSA's new priorities related to HIT and it is necessary that HRSA have an opportunity to ensure that its new HIT strategy and resources are reflected in its grant programs. Because OHIT was just established on December 27, 2005, and only became fully staffed in May 2006, there has been inadequate time to develop a new strategy to promote HIT in the safety net community and to establish funding priorities that are in line with the new office's goals. The OHIT has granted 18 HCCN grants a one-time 12-month extension (with funds) of the current budget period, which expires August 31, 2006. This will avoid disruption of the HCCNs infrastructure and any impairment to the accomplishment of their work plans that would likely result from a competitive reallocation of funds without careful planning and advanced notice. All future funding for these activities will be based on a full and open competition that will focus on the most effective utilization of available resources in support of the Administration's new HIT objectives. Grantee name State 12 month extension South Cove CHC, Inc. MA $86,788 SW Virginia Community Health System VA 57,859 Keystone Rural Health Center PA 70,611 Aaron E. Henry CHC MS 57,859 Cook Area Health Services MN 62,487 Horizon Health Care, Inc. SD 86,788 Mariposa Community Health Center AZ 57,859 Asian Health Services CA 86,788 Southwest Virginia Community Health VA 167,742 Health Choice Network FL 173,576 Neighborhood Health Care Network MN 173,576 Central Oklahoma Integrated Network System OK 88,900 Colorado Community Managed Care Network CO 128,646 Community Health Center Network CA 173,576 Klamath Health Partnership OR 173,576 Collier Health Services, Inc. FL 82,237 Wasatch Homeless Health Care, Inc. UT 159,111 Oregon Primary Care Association OR 162,022 2,050,000 Dated: August 30, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-16088 Filed 9-29-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Office of AIDS Research Advisory Council. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable le accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* Office of AIDS Research Advisory Council. *Date:* October 25, 2006. *Time:* 8:30 a.m. to 5 p.m. *Agenda:* A Report of the Director addressing OAR initiatives. The topic of the meeting will focus on the newly restructured NIH-Sponsored AIDS Clinical Trials Networks as a national resource. *Place:* National Institutes of Health, 5635 Fishers Lane, Terrace Level Conference Center, Rockville, MD 20852. *Contact Person:* Christina Brackna, Executive Secretary, Office of Aids Research, Office of the Director, NIH, 2 Center Drive, MSC 0255, Building 2, Room 4W15, Bethesda, MD 20892,
(301)402-3555, *cm53v@nih.gov.* Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute's/Center's home page: *http://www.nih.gov/od/oar/index.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program;93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: September 25, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-8412 Filed 9-29-06; 8:45 am]
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Traces to 13 documents
U.S. Code
- Public information collection activities; submission to Director; approval and delegation§ 3507
- New drugs§ 355
- Definitions§ 3502
- Federal agency responsibilities§ 3506
- Registration of producers of drugs or devices§ 360
- Regulation of biological products§ 262
- Adulterated drugs and devices§ 351
- Extension of patent term§ 156
- New animal drugs§ 360b
- Health centers§ 254b
13 references not yet in our index
- Pub. L. 92-463
- 42 CFR 418
- 45 CFR 164.512(a)
- 45 CFR 164.512(a)(1)
- 45 CFR 5
- Pub. L. 105-115
- 21 CFR 822
- 44 USC 3501-3520
- 5 CFR 1320.3(c)
- Pub. L. 107-109
- 21 CFR 14
- Pub. L. 98-417
- Pub. L. 100-670
Citation graph
cites case law
Notices
Notice of a New System of Records (SOR)
Pub. L.Pub. L. 92-463
Cite42 CFR 418
Cite45 CFR 164.512(a)
Cites 26 · showing 12Cited by 0 across 0 sources