Notices. Notice

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BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0427] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Filing Objections and Requests for a Hearing on a Regulation or Order 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 April 3, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. 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. Filing Objections and Requests for a Hearing on a Regulation or Order —(OMB Control Number 0910-0184)—Extension Under part 12 (21 CFR part 12), § 12.22, issued under section 701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(e)(2)), sets forth the instructions for filing objections and requests for a hearing on a regulation or order under § 12.20(d). Objections and requests must be submitted within the time specified in § 12.20(e). Each objection for which a hearing has been requested must be separately numbered and specify the provision of the regulation or the proposed order. In addition, each objection must include a detailed description and analysis of the factual information and any other document, with some exceptions, supporting the objection. Failure to include this information constitutes a waiver of the right to a hearing on that objection. FDA uses the description and analysis to determine whether a hearing request is justified. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under § 12.24 and do not limit the evidence that may be presented if a hearing is granted. Respondents to this information collection are those parties that may be adversely affected by an order or regulation. In the **Federal Register** of November 16, 2005 (70 FR 69577), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **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 12.22 10 1 10 20 200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3020 Filed 3-2-06; 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 May 17, 2006, from 8 a.m. to 5 p.m. *Location* : Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD, 301-977-8900. *Contact Person* : Darrell Lyons, 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, e-mail: *Darrell.Lyons@fda.hhs.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 supplemental new drug application

(NDA)20823, SE1-016, EXELON (rivastigmine tartrate) Capsules (1.5 milligrams (mg), 3.0 mg, 4.5 mg, and 6.0 mg), Novartis Pharmaceuticals Corp., for the proposed indication of the treatment of mild to moderate dementia associated with Parkinson's disease. 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.” (Click on the year 2006 and scroll down to the previously named committee). *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 May 3, 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 May 3, 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 Darrell Lyons 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: February 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-3021 Filed 3-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration

(FDA)is required, under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), to report annually in the **Federal Register** on the status of postmarketing study commitments made by sponsors of approved drug and biological products. This is the agency's report on the status of the studies sponsors have agreed to or are required to conduct. FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-796-0700; or Robert Yetter, Center for Biologics Evaluation and Research (HFM-25), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD 20852, 301-827-0373. SUPPLEMENTARY INFORMATION: I. Background Section 130(a) of the Modernization Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new provision requiring reports of certain postmarketing studies (section 506B of the act (21 U.S.C. 356b)) for human drug and biological products. Section 506B of the act provides FDA with additional authority to monitor the progress of a postmarketing study commitment that an applicant has been required or has agreed to conduct by requiring the applicant to submit a report annually providing information on the status of the postmarketing study commitment. This report must also include reasons, if any, for failure to complete the commitment. On December 1, 1999 (64 FR 67207), FDA published a proposed rule providing a framework for the content and format of the annual progress report. The proposed rule also clarified the scope of the reporting requirement and the timing for submission of the annual progress reports. The final rule, published on October 30, 2000 (65 FR 64607), modified annual report requirements for new drug applications

(NDAs)and abbreviated new drug applications (ANDAs) by revising § 314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a new annual reporting requirement for biologics license applications

(BLAs)by establishing § 601.70 (21 CFR 601.70). These regulations became effective on April 30, 2001. The regulations apply only to human drug and biological products. They do not apply to animal drug or to biological products that also meet the definition of a medical device. Sections 314.81(b)(2)(vii) and 601.70 apply to postmarketing commitments made on or before enactment of the Modernization Act (November 21, 1997) as well as those made after that date. Sections 314.81(b)(2)(vii) and 601.70 require applicants of approved drug and biological products to submit annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study that is required by FDA (e.g., accelerated approval clinical benefit studies) or that they have committed to conduct either at the time of approval or after approval of their NDA, ANDA, or BLA. The status of other types of postmarketing commitments (e.g., those concerning chemistry, manufacturing, production controls, and studies conducted on an applicant's own initiative) are not required to be reported under §§ 314.81(b)(2)(vii) and 601.70, and are not addressed in this report. It should be noted, however, that applicants are required to report to FDA on these commitments made for NDAs and ANDAs under § 314.81(b)(2)(viii). According to the regulations, once a postmarketing study commitment has been made, an applicant must report on the progress of the commitment on the anniversary of the product's approval until the postmarketing study commitment is completed or terminated, and FDA determines that the postmarketing study commitment has been fulfilled or that the postmarketing study commitment is either no longer feasible or would no longer provide useful information. The annual progress report must include a description of the postmarketing study commitment, a schedule for completing the study commitment, and a characterization of the current status of the study commitment. The report must also provide an explanation of the postmarketing study commitment's status by describing briefly the postmarketing study commitment's progress. A postmarketing study commitment schedule is expected to include the actual or projected dates for the following:

(1)Submission of the study protocol to FDA,

(2)completion of patient accrual or initiation of an animal study,

(3)completion of the study, and

(4)submission of the final study report to FDA. The postmarketing study commitment status must be described in the annual report according to the following definitions: • Pending: The study has not been initiated, but does not meet the criterion for delayed; • Ongoing: The study is proceeding according to or ahead of the original schedule; • Delayed: The study is behind the original schedule; • Terminated: The study was ended before completion, but a final study report has not been submitted to FDA; or • Submitted: The study has been completed or terminated, and a final study report has been submitted to FDA. Databases containing information on postmarketing study commitments are maintained at the Center for Drug Evaluation and Research

(CDER)and the Center for Biologics Evaluation and Research (CBER). Information in this report covers any postmarketing study commitment that was made, in writing, at the time of approval or after approval of an application or a supplement to an application, including those required (e.g., to demonstrate clinical benefit of a product following accelerated approval) and those agreed to with the applicant. Information summarized in this report includes:

(1)The number of applicants with open (uncompleted) postmarketing commitments,

(2)the number of open postmarketing commitments,

(3)the status of open postmarketing commitments as reported in § 314.81(b)(2)(vii) or § 601.70 annual reports,

(4)the status of concluded postmarketing studies as determined by FDA, and

(5)the number of applications with open postmarketing commitments for which sponsors did not submit an annual report within 60 days of the anniversary date of U.S. approval. Additional information about postmarketing study commitments made by sponsors to CDER and CBER are provided on FDA's Web site at *http://www.fda.gov/cder* . Like this notice, the site does not list postmarketing study commitments containing proprietary information. It is FDA policy not to post information on the Web site until it has been reviewed for accuracy. The numbers published in this notice cannot be compared with the numbers resulting from searches of the Web site. This notice incorporates totals for all postmarketing study commitments in FDA databases, including those undergoing review for accuracy. The report in this notice will be updated annually while the Web site is updated quarterly (in January, April, July, and October). II. Summary of Information From Postmarketing Study Progress Reports This report summarizes the status of postmarketing commitments as of September 30, 2005. If a commitment did not have a schedule or a postmarketing progress report was not received, the commitment is categorized according to the most recent information available to the agency. Data in table 1 of this document are numerical summaries generated from FDA databases. The data are broken out according to application type (NDAs/ANDAs or BLAs). **Table 1.—Summary of Postmarketing Study Commitments (Numbers as of September 30, 2005)** NDAs/ANDAs (% of Total) BLAs 1 (% of Total) Applicants With Open Postmarketing Commitments 154 44 Number of Open Postmarketing Commitments 1,231 321 Status of Open Postmarketing Commitments • Pending 797 (65%) 118 (37%) • Ongoing 231 (19%) 94 (29%) • Delayed 28 (2%) 53 (17%) • Terminated 3 (<1%) 0 • Submitted 172 (14%) 56 (17%) Concluded Studies (October 1, 2004 Through September 30, 2005) 156 56 • Commitment Met 136 (87%) 41 (73%) • Commitment Not Met 5 (3%) 0 • Study No Longer Needed or Feasible 15 (10%) 15 (27%) Applications With Open Postmarketing Commitments With Annual Reports Due, but Not Submitted Within 60 Days of the Anniversary Date of U.S. Approval 170 (47%) 2 37 (50%) 1 On October 1, 2003, FDA completed a consolidation of certain products formerly regulated by the CBER into the CDER. The previous association of BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year

(FY)statistics for CDER BLA postmarketing study commitments will continue to be counted under BLA totals in this table. 2 The search strategy was improved for the FY 2005 report and may explain, in part, the increased number of applications categorized as having overdue annual reports. Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in FY 2005 for 170/170 (100 percent) of NDAs/ANDAs and 19/37 (51 percent) of BLAs. Dated: February 23, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-3019 Filed 3-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Intent To Prepare an Environmental Impact Statement SUMMARY: In accordance with the National Environmental Policy Act, 42 U.S.C. 4321-4347, the NIH is issuing this notice to advise the public that an environmental impact statement will be prepared for the Rocky Mountain Laboratories Campus Master Plan, Hamilton, Ravalli County, Montana. FOR FURTHER INFORMATION CONTACT: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2W64, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; fax 301-480-8056; or e-mail *nihnepa@mail.nih.gov.* SUPPLEMENTARY INFORMATION: Rocky Mountain Laboratories

(RML)is located on 33 acres in the City of Hamilton, a small community in southwestern Montana. The laboratory is a component of the National Institute of Allergy and Infectious Diseases (NIAID), which is one of the 27 Institutes or Centers that comprise the NIH, one of the world's largest biomedical research facilities and the Federal government's focal point for medical and behavioral research. RML conducts and supports research of infectious diseases and the human immune system, with an emphasis on vector-borne transmission of infectious diseases and prion diseases. RML's mission also includes biomedical research into diseases caused by the intentional release of biological agents into civilian populations, as well as advancing basic knowledge about biological agents. Total building space on the campus amounts to approximately 207,000 gsf. Approximately 260 people work at the RML site. A Master Plan is an integrated series of documents that present in graphic, narrative, and tabular form the current composition of NIH campuses and the plan for their orderly and comprehensive development over a 20-year period. The plan provides guidance in coordinating the physical development of NIH campuses, including building locations, utility capacities, road alignments, parking facilities, and the treatment of open spaces. General design guidelines are also used to provide detailed guidance for the placement and design of physical improvements. The proposed action is to develop a long-range physical master plan for RML. The plan will cover a 20-year planning period and address the future development of the RML site, including placement of future construction; vehicular and pedestrian circulation on- and off-campus; parking within the property boundaries; open space in and around the campus; required setbacks; historic properties; natural and scenic resources; noise; and lighting. The plan will examine potential growth in RML personnel, possible land acquisitions, and consequent construction of space over the planning period. Future construction on the site could include such facilities as new animal holding, research laboratories, and support facilities. In accordance with 40 CFR parts 1500-1508 and DHHS environmental procedures, NIH will prepare an Environmental Impact Statement

(EIS)for the proposed master plan. The EIS will evaluate the impacts of the master plan should development occur as proposed. Among the items the EIS will examine are the implications of the master plan on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in the planning and environmental review process, NIH in inviting oral and written comments on the master plan and related environmental issues. The NIH will be sponsoring a public Scoping Meeting to provide individuals an opportunity to share their ideas on the master planning effort, including recommended alternatives and environmental issues the EIS should consider. The meeting is planned for 7 p.m. on March 23, 2006 at the Hamilton High School commons in Hamilton, Montana. All interested parties are encouraged to attend. NIH has established a 45-day public comment period for the scoping process. Scoping comments must be postmarked *no later than* April 18, 2006 to ensure they are considered. All comments and questions on the EIS should be directed to Valerie Nottingham at the address listed above, telephone 301-496-7775; fax 301-480-8056; or e-mail *nihnepa@mail.nih.gov.* Dated: February 24, 2006. Juanita Holler-Mildenberg, FAIA, Acting Director, Office of Research Facilities Development and Operations, National Institutes of Health. [FR Doc. 06-2015 Filed 3-2-06; 8:45 am]

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