Notices. Notice

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BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS-1318-N] Medicare Program; Meeting of the Practicing Physicians Advisory Council, March 6, 2006 AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS. ACTION: Notice. SUMMARY: This notice announces a quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Council will meet to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary of Health and Human Services (the Secretary).

This meeting is open to the public. DATES: The Council meeting is scheduled for Monday, March 6, 2006, from 8 a.m. until 5 p.m. e.s.t. ADDRESS: The meeting will be held in Room 705A 7th floor, in the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. MEETING REGISTRATION: Persons wishing to attend this meeting must register by contacting Kelly Buchanan, the Designated Federal Official

(DFO)by e-mail at *PPAC@cms.hhs.gov* or by telephone at

(410)786-6132, at least 72 hours in advance of the meeting. This meeting will be held in a Federal Government Building, Hubert H. Humphrey Building, and persons attending the meeting will be required to show a photographic identification, preferably a valid driver's license, and will be listed on an approved security list before persons are permitted entrance. Persons not registered in advance will not be permitted into the Hubert H. Humphrey Building and will not be permitted to attend the Council meeting. FOR FURTHER INFORMATION CONTACT: Kelly Buchanan,

(410)786-6132, or e-mail *PPAC@cms.hhs.gov* . News media representatives must contact the CMS Press Office,

(202)690-6145. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free),

(410)786-9379 local) or the Internet at *http://www.cms.hhs.gov/faca/ppac/default.asp* for additional information and updates on committee activities. SUPPLEMENTARY INFORMATION: In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces the quarterly meeting of the Practicing Physicians Advisory Council (the Council). The Secretary is mandated by section 1868(a)(1) of the Social Security Act (the Act) to appoint a Practicing Physicians Advisory Council based on nominations submitted by medical organizations representing physicians. The Council meets quarterly to discuss certain proposed changes in regulations and carrier manual instructions related to physicians' services, as identified by the Secretary. To the extent feasible and consistent with statutory deadlines, the Council's consultation must occur before **Federal Register** publication of the proposed changes. The Council submits an annual report on its recommendations to the Secretary and the Administrator of the Centers for Medicare and Medicaid Services

(CMS)not later than December 31 of each year. The Council consists of 15 physicians, including the Chair. Members of the Council include both participating and nonparticipating physicians, and physicians practicing in rural and underserved urban areas. At least 11 members of the Council must be physicians as described in section 1861(r)(1) of the Act; that is, State-licensed doctors of medicine or osteopathy. The remaining 4 members may include dentists, podiatrists, optometrists and chiropractors. Members serve for overlapping 4-year terms; terms of more than 2 years are contingent upon the renewal of the Council by appropriate action prior to its termination. Section 1868(a)(2) of the Act provides that the Council meet quarterly to discuss certain proposed changes in regulations and manual issuances that relate to physicians' services, identified by the Secretary. Council members are expected to participate in all meetings. Section 1868(a)(3) of the Act provides for payment of expenses and a per diem allowance for Council members at a rate equal to payment provided members of other advisory committees. In addition to making these payments, the Department of Health and Human Services and CMS provide management and support services to the Council. The Secretary will appoint new members to the Council from among those candidates determined to have the expertise required to meet specific agency needs in a manner to ensure appropriate balance of the Council's membership. The Council held its first meeting on May 11, 1992. *The current members are:* Ronald Castellanos, M.D., Chairperson; Jose Azocar, M.D.; M. Leroy Sprang, M.D.; Rebecca Gaughan, M.D.; Peter Grimm, D.O.; Carlos R. Hamilton, M.D.; Dennis K. Iglar, M.D.; Joe Johnson, D.C.; Christopher Leggett, M.D.; Barbara McAneny, M.D.; Geraldine O'Shea, D.O.; Laura B. Powers, M.D.; Gregory J. Przybylski, M.D.; Anthony Senagore, M.D.; and Robert L. Urata, M.D. The meeting will commence with the Council's Executive Director providing a status report and the CMS responses to the recommendations made by the Council at the December 5, 2005 meeting as well as prior meeting recommendations. Additionally, an update will be provided on the Physician Regulatory Issues Team. In accordance with the Council charter, we are requesting assistance with the following agenda topics: • Moving Towards Pay for Performance. • Update on Implementation of Part D Drug Program. • Medicare Contractor Reform. • Medicare Health Support. For additional information and clarification on these topics, contact the DFO as provided in the For Further Information Contact section of this notice. Individual physicians or medical organizations that represent physicians wishing to make a 5-minute oral presentation on agenda issues must contact the DFO by 12 noon, e.s.t., February 17, 2006, to be scheduled. Testimony is limited to agenda topics only. The number of oral presentations may be limited by the time available. A written copy of the presenter's oral remarks must be submitted to Kelly Buchanan, DFO, no later than 12 noon, e.s.t., February 17, 2006, for distribution to Council members for review prior to the meeting. Physicians and medical organizations not scheduled to speak may also submit written comments to the DFO for distribution no later than noon, e.s.t., February 17, 2006. The meeting is open to the public, but attendance is limited to the space available. *Special Accommodations:* Individuals requiring sign language interpretation or other special accommodation must contact the DFO by e-mail at *PPAC@cms.hhs.gov* or by telephone at

(410)786-6132 at least 10 days before the meeting. Authority: Section 1868 of the Social Security Act (42 U.S.C. 1395ee) and section 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, section 10(a)). Dated: January 5, 2006. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E6-702 Filed 1-26-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0314] Determination of Regulatory Review Period for Purposes of Patent Extension; SPIRIVA HANDIHALER AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for SPIRIVA HANDIHALER 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: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. 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 SPIRIVA HANDIHALER (tiotropium bromide monohydrate). SPIRIVA HANDIHALER is indicated for the long-term, once daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SPIRIVA HANDIHALER (U.S. Patent No. 5,610,163) from Boehringer Ingelheim Corporation, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 31, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of SPIRIVA HANDIHALER represented the first permitted commercial marketing or use of the product. 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 SPIRIVA HANDIHALER is 3,318 days. Of this time, 2,557 days occurred during the testing phase of the regulatory review period, while 761 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective* : January 1, 1995. The applicant claims February 2, 1995, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was January 1, 1995, 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 of the act* : December 31, 2001. FDA has verified the applicant's claim that the new drug application

(NDA)for Spiriva HandiHaler (NDA 21-395) was initially submitted on December 31, 2001. 3. *The date the application was approved* : January 30, 2004. FDA has verified the applicant's claim that NDA 21-395 was approved on January 30, 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 1,421 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may, on or before March 28, 2006, submit to the Division of Dockets Management (see ADDRESSES ) written comments and ask for a redetermination. Furthermore, any interested person may petition FDA, on or before July 26, 2006, for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. 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: January 5, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-1050 Filed 1-26-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration

(FDA)is announcing an amendment to the notice of meeting of the Oncologic Drugs Advisory Committee. This meeting was announced in the **Federal Register** of January 6, 2006 (71 FR 943). The amendment is being made to reflect a change in the *Date and Time* portion of the document. The date of this meeting is being changed. There are no other changes. FOR FURTHER INFORMATION CONTACT: Johanna Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301 827-7001, FAX: 301-827-6776, e-mail: *cliffordj@cder.fda.gov* , or the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512542. Please call the information line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of January 6, 2006, FDA announced that a meeting of the Oncologic Drugs Advisory Committee would be held on March 15, 2006, from 8 a.m. to 5 p.m. On page 943, in the 2d column, the *Date and Time* portion of the document is amended to read as follows: *Date and Time* : The meeting will be held on March 13, 2006, from 8 a.m. to 5 p.m. 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: January 17, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-1003 Filed 1-26-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Peripheral and Central Nervous System Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on March 7, 2006, from 8 a.m. to 5 p.m. *Location* : Holiday Inn Gaithersburg, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. *Contact Person* : Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *mosaddeghs@cder.fda.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512543. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss TYSABRI (natalizumab) biologic license application 125104/15; Biogen Idec Inc., for an indication in patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of multiple sclerosis relapses and/or disability, its possible return to the marketplace, and its proposed risk management plan(s). The background material will become available no later than the day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* under the heading “Peripheral and Central Nervous System Drugs Advisory Committee (PCNS)” (click on the year 2006 and scroll down to PCNS meetings.) *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 28, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 28, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Sohail Mosaddegh at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 17, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-1006 Filed 1-26-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Request for Generic Clearance To Conduct Voluntary Customer/Partner Surveys SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health

(NIH)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget

(OMB)for review and approval. Proposed Collection *Title:* Voluntary Customer Satisfaction Surveys. *Type of Information Collection Request:* Extension. OMB Control No. 0925-0476, with an expiration date of May 31, 2006. *Need and Use of Information Collection:* Executive Order 12962 directed agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Additionally, since 1994, the NLM has been a “Federal Reinvention Laboratory” with a goal of improving its methods of delivering information to the public. An essential strategy in accomplishing reinvention goals is the ability to periodically receive input and feedback from customers about the design and quality of the services they receive. The NLM provides significant services directly to the public including health providers, researchers, universities, other federal agencies, state and local governments, and to others through a range of mechanisms, including publications, technical assistance, and Web sites. These services are primarily focused on health and medical information dissemination activities. The purpose of this submission is to obtain OMB's generic approval to continue to conduct satisfaction surveys of NLM's customers. The NLM will use the information provided by individuals and institutions to identify strengths and weaknesses in current services and to make improvements where feasible. The ability to periodically surveys NLM's customers is essential to continually update and upgrade methods of providing high quality service. *Frequency of Response:* Annually or biennially. *Affected Public:* Individuals or households; businesses or other for profit; State or local governments; Federal agencies; non-profit institutions; small businesses or organizations. *Type of Respondents:* Organizations, medical researchers, physicians and other health care providers, librarians, students, and the general public. Annual reporting burden is as follows: Title of survey Type of survey Number of respondents Estimated response time Burden hours ClinicalTrials.gov and Protocol Registration System Web-based 2000 .167 334 Consumer Information Health Seeking Process Web-based 500 .5 250 Consumer Knowledge of Health-Related Concepts Interviews/Questionnaires (in person) 200 .5 100 Comprehension of Consumer Health Materials Online Interviews/Scenarios (in person) 40 1 40 Patient Information Seeking and Symptom Management Decision Making Interview/Observation (in person) 150 (15 × 10 sessions) .5 75 18 (3 × 6 sessions) .5 9 84 Evaluation of Genetics Home Reference Survey Web-based 950 (200 + 500 + 250) .5 .4175 .4175 100 209 104 413 PubMed Web-based 2,000 .0835 167 Entrez Web-based 1,500 .0835 128 NCBI Web Site Web-based 1,500 .0835 128 NLM Service Desk Survey Interactive Voice Response telephone 400 .0835 33 NLM Electronic Mail Customer Survey Electronic Mail 1,000 .0835 84 Exhibition Surveys

(3)Exit Interview 1500 (500 × 3 sessions) .167 251 AIDSinfo and HIV/AIDS Web sites Web-based 2,000 .0835 167 TOXNET and related Web sites Web-based 2,000 .0835 167 SIS Web site Web-based 2,000 .0835 167 NLM outreach services Web-based 2,000 .0835 167 Total 19,758 2,680 There are no capital costs to report. There are no operating or maintenance costs to report. Request for Comments Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

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

(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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request additional information on the proposed collection of information contact Carol Vogel, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call 301-402-9680 (not a toll-free number). You also may e-mail your request to *vogelc@mail.nih.gov.* Comments Due Date Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: January 20, 2006. Todd Danielson, Executive Officer, National Library of Medicine, National Institutes of Health. [FR Doc. 06-772 Filed 1-26-06; 8:45 am]

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