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E6 3019

VIEWS: 2 PAGES: 2

									                                        10978                           Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices

                                           Date and Time: The meeting will be                   a disability, please contact Darrell Lyons            providing information on the status of
                                        held on May 17, 2006, from 8 a.m. to 5                  at least 7 days in advance of the                     the postmarketing study commitment.
                                        p.m.                                                    meeting.                                              This report must also include reasons, if
                                           Location: Hilton Washington DC                                                                             any, for failure to complete the
                                        North/Gaithersburg, The Ballrooms, 620                    Notice of this meeting is given under               commitment.
                                        Perry Pkwy., Gaithersburg, MD, 301–                     the Federal Advisory Committee Act (5                    On December 1, 1999 (64 FR 67207),
                                        977–8900.                                               U.S.C. app. 2).                                       FDA published a proposed rule
                                           Contact Person: Darrell Lyons, Center                  Dated: February 24, 2006.                           providing a framework for the content
                                        for Drug Evaluation and Research (HFD–                  Jason Brodsky,                                        and format of the annual progress
                                        21), Food and Drug Administration,                                                                            report. The proposed rule also clarified
                                                                                                Acting Associate Commissioner for External
                                        5600 Fishers Lane (for express delivery,                                                                      the scope of the reporting requirement
                                                                                                Relations.
                                        5630 Fishers Lane, rm. 1093), Rockville,                                                                      and the timing for submission of the
                                                                                                [FR Doc. E6–3021 Filed 3–2–06; 8:45 am]
                                        MD 20857, 301–827–7001, e-mail:                                                                               annual progress reports. The final rule,
                                                                                                BILLING CODE 4160–01–S
                                        Darrell.Lyons@fda.hhs.gov or FDA                                                                              published on October 30, 2000 (65 FR
                                        Advisory Committee Information Line,                                                                          64607), modified annual report
                                        1–800–741–8138 (301–443–0572) in the                                                                          requirements for new drug applications
                                        Washington, DC area), code                              DEPARTMENT OF HEALTH AND
                                                                                                                                                      (NDAs) and abbreviated new drug
                                        3014512543. Please call the information                 HUMAN SERVICES
                                                                                                                                                      applications (ANDAs) by revising
                                        line for up-to-date information on this                 Food and Drug Administration                          § 314.81(b)(2)(vii) (21 CFR
                                        meeting.                                                                                                      314.81(b)(2)(vii)). The rule also created
                                                                                                Report on the Performance of Drug                     a new annual reporting requirement for
                                           Agenda: The committee will discuss                   and Biologics Firms in Conducting                     biologics license applications (BLAs) by
                                        supplemental new drug application                       Postmarketing Commitment Studies;                     establishing § 601.70 (21 CFR 601.70).
                                        (NDA) 20823, SE1–016, EXELON                            Availability                                          These regulations became effective on
                                        (rivastigmine tartrate) Capsules (1.5                                                                         April 30, 2001. The regulations apply
                                        milligrams (mg), 3.0 mg, 4.5 mg, and 6.0                AGENCY:    Food and Drug Administration,              only to human drug and biological
                                        mg), Novartis Pharmaceuticals Corp., for                HHS.                                                  products. They do not apply to animal
                                        the proposed indication of the treatment                ACTION:   Notice of availability.                     drug or to biological products that also
                                        of mild to moderate dementia associated                                                                       meet the definition of a medical device.
                                        with Parkinson’s disease. The                           SUMMARY: The Food and Drug
                                                                                                                                                         Sections 314.81(b)(2)(vii) and 601.70
                                        background material will become                         Administration (FDA) is required, under               apply to postmarketing commitments
                                        available no later than the day before                  the Food and Drug Administration                      made on or before enactment of the
                                        the meeting and will be posted on                       Modernization Act of 1997                             Modernization Act (November 21, 1997)
                                        FDA’s Web site at http://www.fda.gov/                   (Modernization Act), to report annually               as well as those made after that date.
                                        ohrms/dockets/ac/acmenu.htm under                       in the Federal Register on the status of              Sections 314.81(b)(2)(vii) and 601.70
                                        the heading ‘‘Peripheral and Central                    postmarketing study commitments                       require applicants of approved drug and
                                        Nervous System Drugs Advisory                           made by sponsors of approved drug and                 biological products to submit annually a
                                        Committee.’’ (Click on the year 2006                    biological products. This is the agency’s             report on the status of each clinical
                                        and scroll down to the previously                       report on the status of the studies                   safety, clinical efficacy, clinical
                                        named committee).                                       sponsors have agreed to or are required               pharmacology, and nonclinical
                                           Procedure: Interested persons may                    to conduct.                                           toxicology study that is required by FDA
                                        present data, information, or views,                    FOR FURTHER INFORMATION CONTACT: Beth                 (e.g., accelerated approval clinical
                                        orally or in writing, on issues pending                 Duvall-Miller, Center for Drug                        benefit studies) or that they have
                                        before the committee. Written                           Evaluation and Research, Food and                     committed to conduct either at the time
                                        submissions may be made to the contact                  Drug Administration, 10903 New                        of approval or after approval of their
                                        person by May 3, 2006. Oral                             Hampshire Ave., Bldg. 22, rm. 6466,                   NDA, ANDA, or BLA. The status of
                                        presentations from the public will be                   Silver Spring, MD 20993–0002, 301–                    other types of postmarketing
                                        scheduled between approximately 1                       796–0700; or Robert Yetter, Center for                commitments (e.g., those concerning
                                        p.m. and 2 p.m. Time allotted for each                  Biologics Evaluation and Research                     chemistry, manufacturing, production
                                        presentation may be limited. Those                      (HFM–25), Food and Drug                               controls, and studies conducted on an
                                        desiring to make formal oral                            Administration, 1400 Rockville Pike,                  applicant’s own initiative) are not
                                        presentations should notify the contact                 Rockville, MD 20852, 301–827–0373.                    required to be reported under
                                        person before May 3, 2006, and submit                   SUPPLEMENTARY INFORMATION:                            §§ 314.81(b)(2)(vii) and 601.70, and are
                                        a brief statement of the general nature of                                                                    not addressed in this report. It should be
                                                                                                I. Background                                         noted, however, that applicants are
                                        the evidence or arguments they wish to
                                        present, the names and addresses of                        Section 130(a) of the Modernization                required to report to FDA on these
                                        proposed participants and an indication                 Act (Public Law 105–115) amended the                  commitments made for NDAs and
                                        of the approximate time requested to                    Federal Food, Drug, and Cosmetic Act                  ANDAs under § 314.81(b)(2)(viii).
                                        make their presentation.                                (the act) by adding a new provision                      According to the regulations, once a
                                           Persons attending FDA’s advisory                     requiring reports of certain                          postmarketing study commitment has
                                        committee meetings are advised that the                 postmarketing studies (section 506B of                been made, an applicant must report on
                                        agency is not responsible for providing                 the act (21 U.S.C. 356b)) for human drug              the progress of the commitment on the
                                        access to electrical outlets.                           and biological products. Section 506B of              anniversary of the product’s approval
                                           FDA welcomes the attendance of the                   the act provides FDA with additional                  until the postmarketing study
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                                        public at its advisory committee                        authority to monitor the progress of a                commitment is completed or
                                        meetings and will make every effort to                  postmarketing study commitment that                   terminated, and FDA determines that
                                        accommodate persons with physical                       an applicant has been required or has                 the postmarketing study commitment
                                        disabilities or special needs. If you                   agreed to conduct by requiring the                    has been fulfilled or that the
                                        require special accommodations due to                   applicant to submit a report annually                 postmarketing study commitment is


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                                                                        Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices                                                 10979

                                        either no longer feasible or would no                      Additional information about                            TABLE 1.—SUMMARY OF POST-
                                        longer provide useful information. The                  postmarketing study commitments                           MARKETING STUDY COMMITMENTS
                                        annual progress report must include a                   made by sponsors to CDER and CBER                         (NUMBERS AS OF SEPTEMBER 30,
                                        description of the postmarketing study                  are provided on FDA’s Web site at                         2005)—Continued
                                        commitment, a schedule for completing                   http://www.fda.gov/cder. Like this
                                        the study commitment, and a                             notice, the site does not list                                                  NDAs/
                                        characterization of the current status of                                                                                                           BLAs1
                                                                                                postmarketing study commitments                                                 ANDAs       (% of
                                        the study commitment. The report must                   containing proprietary information. It is                                        (% of      Total)
                                        also provide an explanation of the                                                                                                       Total)
                                                                                                FDA policy not to post information on
                                        postmarketing study commitment’s                        the Web site until it has been reviewed                 Concluded Studies            156          56
                                        status by describing briefly the                        for accuracy. The numbers published in                    (October 1, 2004
                                        postmarketing study commitment’s                        this notice cannot be compared with the                   Through Sep-
                                        progress. A postmarketing study                         numbers resulting from searches of the                    tember 30, 2005)
                                        commitment schedule is expected to                      Web site. This notice incorporates totals               • Commitment Met             136   41 (73%)
                                        include the actual or projected dates for               for all postmarketing study                                                        (87%)
                                        the following: (1) Submission of the                                                                            • Commitment Not          5 (3%)             0
                                                                                                commitments in FDA databases,                             Met
                                        study protocol to FDA, (2) completion of                including those undergoing review for                   • Study No Longer       15 (10%)   15 (27%)
                                        patient accrual or initiation of an animal              accuracy. The report in this notice will                  Needed or Fea-
                                        study, (3) completion of the study, and                 be updated annually while the Web site                    sible
                                        (4) submission of the final study report                is updated quarterly (in January, April,                Applications With            170   37 (50%)
                                        to FDA. The postmarketing study                         July, and October).                                       Open Post-              (47%)2
                                        commitment status must be described in                                                                            marketing Commit-
                                        the annual report according to the                      II. Summary of Information From                           ments With Annual
                                        following definitions:                                  Postmarketing Study Progress Reports                      Reports Due, but
                                           • Pending: The study has not been                                                                              Not Submitted
                                                                                                  This report summarizes the status of                    Within 60 Days of
                                        initiated, but does not meet the criterion
                                                                                                postmarketing commitments as of                           the Anniversary
                                        for delayed;                                                                                                      Date of U.S. Ap-
                                           • Ongoing: The study is proceeding                   September 30, 2005. If a commitment
                                                                                                                                                          proval
                                        according to or ahead of the original                   did not have a schedule or a
                                        schedule;                                               postmarketing progress report was not                     1 On October 1, 2003, FDA completed a

                                                                                                received, the commitment is categorized                consolidation of certain products formerly reg-
                                           • Delayed: The study is behind the                                                                          ulated by the CBER into the CDER. The pre-
                                        original schedule;                                      according to the most recent                           vious association of BLA reviews only with
                                           • Terminated: The study was ended                    information available to the agency.                   CBER is no longer valid; BLAs are now re-
                                        before completion, but a final study                      Data in table 1 of this document are                 ceived by both CBER and CDER. Fiscal year
                                                                                                                                                       (FY) statistics for CDER BLA postmarketing
                                        report has not been submitted to FDA;                   numerical summaries generated from                     study commitments will continue to be counted
                                        or                                                      FDA databases. The data are broken out                 under BLA totals in this table.
                                           • Submitted: The study has been                      according to application type (NDAs/                      2 The search strategy was improved for the

                                        completed or terminated, and a final                                                                           FY 2005 report and may explain, in part, the
                                                                                                ANDAs or BLAs).                                        increased number of applications categorized
                                        study report has been submitted to FDA.                                                                        as having overdue annual reports. Note that
                                           Databases containing information on                         TABLE 1.—SUMMARY OF POST-                       this statistic counts all annual reports sub-
                                        postmarketing study commitments are                                                                            mitted more than 60 days after the anniver-
                                                                                                      MARKETING STUDY COMMITMENTS                      sary date of U.S. approval as overdue, includ-
                                        maintained at the Center for Drug                             (NUMBERS AS OF SEPTEMBER 30,                     ing reports that may have been submitted on
                                        Evaluation and Research (CDER) and the                        2005)                                            a modified reporting schedule in accordance
                                        Center for Biologics Evaluation and                                                                            with prior FDA agreement. Of the applications
                                        Research (CBER). Information in this                                                                           categorized as having overdue annual reports
                                                                                                                              NDAs/                    using this definition, annual reports were sub-
                                        report covers any postmarketing study                                                               BLAs1
                                                                                                                              ANDAs                    sequently submitted in FY 2005 for 170/170
                                                                                                                                            (% of
                                        commitment that was made, in writing,                                                  (% of        Total)     (100 percent) of NDAs/ANDAs and 19/37 (51
                                        at the time of approval or after approval                                              Total)                  percent) of BLAs.
                                        of an application or a supplement to an
                                                                                                 Applicants With                   154           44      Dated: February 23, 2006.
                                        application, including those required
                                                                                                   Open Post-                                          Jeffrey Shuren,
                                        (e.g., to demonstrate clinical benefit of                  marketing Commit-
                                        a product following accelerated                                                                                Assistant Commissioner for Policy.
                                                                                                   ments
                                        approval) and those agreed to with the                                                                         [FR Doc. E6–3019 Filed 3–2–06; 8:45 am]
                                        applicant. Information summarized in                     Number of Open                  1,231          321    BILLING CODE 4160–01–S
                                        this report includes: (1) The number of                    Postmarketing
                                        applicants with open (uncompleted)                         Commitments
                                        postmarketing commitments, (2) the                                                                             DEPARTMENT OF HEALTH AND
                                        number of open postmarketing                             Status of Open Post-                                  HUMAN SERVICES
                                        commitments, (3) the status of open                        marketing Commit-
                                                                                                   ments                                               National Institutes of Health
                                        postmarketing commitments as reported
                                                                                                 • Pending                         797          118
                                        in § 314.81(b)(2)(vii) or § 601.70 annual                                                (65%)        (37%)    Notice of Intent To Prepare an
                                        reports, (4) the status of concluded                     • Ongoing                         231     94 (29%)    Environmental Impact Statement
                                        postmarketing studies as determined by                                                   (19%)
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                                        FDA, and (5) the number of applications                  • Delayed                     28 (2%)     53 (17%)    SUMMARY: In accordance with the
                                        with open postmarketing commitments                      • Terminated                  3 (<1%)            0    National Environmental Policy Act, 42
                                        for which sponsors did not submit an                     • Submitted                       172     56 (17%)    U.S.C. 4321–4347, the NIH is issuing
                                        annual report within 60 days of the                                                      (14%)                 this notice to advise the public that an
                                        anniversary date of U.S. approval.                                                                             environmental impact statement will be


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