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					                                                                                Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices                                                  37129

                                                applicant for extension acted with due                  Drug Administration, 10903 New                         fluoride F–18) injection, 10 to 200 mCi/
                                                diligence during the regulatory review                  Hampshire Ave., Bldg. 51, rm. 6238,                    mL, and in a letter dated May 2, 2011,
                                                period by December 21, 2011. To meet                    Silver Spring, MD 20993–0002, 301–                     the NDA holder requested that FDA
                                                its burden, the petition must contain                   796–7577.                                              move the product to the ‘‘Discontinued
                                                sufficient facts to merit an FDA                        SUPPLEMENTARY INFORMATION: In 1984,                    Drug Product List’’ section of the Orange
                                                investigation. (See H. Rept. 857, part 1,               Congress enacted the Drug Price                        Book. In previous instances (see, e.g., 72
                                                98th Cong., 2d sess., pp. 41–42, 1984.)                 Competition and Patent Term                            FR 9763, March 5, 2007; 61 FR 25497,
                                                Petitions should be in the format                       Restoration Act of 1984 (Pub. L. 98–417)               May 21, 1996), the Agency has
                                                specified in 21 CFR 10.30.                              (the 1984 amendments), which                           determined that, for purposes of
                                                   Interested persons may submit to the                 authorized the approval of duplicate                   §§ 314.161 and 314.162, never
                                                Division of Dockets Management (see                     versions of drug products under an                     marketing an approved drug product is
                                                ADDRESSES) electronic or written                        ANDA procedure. ANDA applicants                        equivalent to withdrawing the drug
                                                comments and written petitions. It is                   must, with certain exceptions, show that               from sale.
                                                only necessary to send one set of                       the drug for which they are seeking                       FDA has reviewed its records and,
                                                comments. It is no longer necessary to                  approval contains the same active                      under § 314.161, has determined that
                                                send three copies of mailed comments.                   ingredient in the same strength and                    SODIUM FLUORIDE F 18 (sodium
                                                However, if you submit a written                        dosage form as the ‘‘listed drug,’’ which              fluoride F–18) injection, 10 to 200 mCi/
                                                petition, you must submit three copies                  is a version of the drug that was                      mL, was not withdrawn from sale for
                                                of the petition. Identify comments with                 previously approved. ANDA applicants                   reasons of safety or effectiveness.
                                                the docket number found in brackets in                  do not have to repeat the extensive                    Accordingly, the Agency will continue
                                                the heading of this document.                           clinical testing otherwise necessary to                to list SODIUM FLUORIDE F 18
                                                   Comments and petitions that have not                 gain approval of a new drug application                (sodium fluoride F–18) injection, 10 to
                                                been made publicly available on                         (NDA). The only clinical data required                 200 mCi/mL, in the ‘‘Discontinued Drug
                                                http://www.regulations.gov may be                       in an ANDA are data to show that the                   Product List’’ section of the Orange
                                                viewed in the Division of Dockets                       drug that is the subject of the ANDA is                Book. The ‘‘Discontinued Drug Product
                                                Management between 9 a.m. and 4 p.m.,                   bioequivalent to the listed drug.                      List’’ delineates, among other items,
                                                Monday through Friday.                                     The 1984 amendments include what                    drug products that have been
                                                                                                        is now section 505(j)(7) of the Federal                discontinued from marketing for reasons
                                                  Dated: June 2, 2011.
                                                                                                        Food, Drug, and Cosmetic Act (21 U.S.C.                other than safety or effectiveness.
                                                Jane A. Axelrad,                                        355(j)(7)), which requires FDA to                      ANDAs that refer to SODIUM
                                                Associate Director for Policy, Center for Drug          publish a list of all approved drugs.
                                                Evaluation and Research.
                                                                                                                                                               FLUORIDE F 18 (sodium fluoride F–18)
                                                                                                        FDA publishes this list as part of the                 injection, 10 to 200 mCi/mL, may be
                                                [FR Doc. 2011–15905 Filed 6–23–11; 8:45 am]             ‘‘Approved Drug Products With                          approved by the Agency as long as they
                                                BILLING CODE 4160–01–P                                  Therapeutic Equivalence Evaluations,’’                 meet all other legal and regulatory
                                                                                                        which is known generally as the                        requirements for the approval of
                                                                                                        ‘‘Orange Book.’’ Under FDA regulations,                ANDAs. If FDA determines that labeling
                                                DEPARTMENT OF HEALTH AND                                drugs are removed from the list if the
                                                HUMAN SERVICES                                                                                                 for this drug product should be revised
                                                                                                        Agency withdraws or suspends                           to meet current standards, the Agency
                                                                                                        approval of the drug’s NDA or ANDA                     will advise ANDA applicants to submit
                                                Food and Drug Administration                            for reasons of safety or effectiveness or              such labeling.
                                                [Docket No. FDA–2011–N–0428]                            if FDA determines that the listed drug
                                                                                                        was withdrawn from sale for reasons of                   Dated: June 20, 2011.
                                                Determination That SODIUM                               safety or effectiveness (§ 314.162 (21                 Leslie Kux,
                                                FLUORIDE F 18 (Sodium Fluoride F–                       CFR 314.162)).                                         Acting Assistant Commissioner for Policy.
                                                18) Injection, 10 to 200 Millicuries per                   A person may petition the Agency to                 [FR Doc. 2011–15815 Filed 6–23–11; 8:45 am]
                                                Milliliter, Was Not Withdrawn From                      determine, or the Agency may                           BILLING CODE 4160–01–P
                                                Sale for Reasons of Safety or                           determine on its own initiative, whether
                                                Effectiveness                                           a listed drug was withdrawn from sale
                                                                                                        for reasons of safety or effectiveness.                DEPARTMENT OF HEALTH AND
                                                AGENCY:    Food and Drug Administration,                This determination may be made at any                  HUMAN SERVICES
                                                HHS.                                                    time after the drug has been withdrawn
                                                ACTION:   Notice.                                       from sale but must be made prior to                    Food and Drug Administration
                                                                                                        approving an ANDA that refers to the                   [Docket No. FDA–2009–D–0012]
                                                SUMMARY:   The Food and Drug
                                                                                                        listed drug (21 CFR 314.161). FDA may
                                                Administration (FDA) has determined                     not approve an ANDA that does not
                                                that SODIUM FLUORIDE F 18 (sodium                                                                              International Conference on
                                                                                                        refer to a listed drug.                                Harmonisation; Guidance on Q4B
                                                fluoride F–18) injection, 10 to 200                        SODIUM FLUORIDE F 18 (sodium
                                                millicuries per milliliter (mCi/mL), was                                                                       Evaluation and Recommendation of
                                                                                                        fluoride F–18) injection, 10 to 200 mCi/               Pharmacopoeial Texts for Use in the
                                                not withdrawn from sale for reasons of                  mL, is the subject of NDA 22–494, held
                                                safety or effectiveness. This                                                                                  International Conference on
                                                                                                        by National Cancer Institute, National                 Harmonisation Regions; Annex 7(R2)
                                                determination will allow FDA to                         Institutes of Health, and initially
                                                approve abbreviated new drug                                                                                   on Dissolution Test General Chapter;
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                                                                                                        approved on January 26, 2011. SODIUM                   Availability
                                                applications (ANDAs) for SODIUM                         FLUORIDE F 18 (sodium fluoride F–18)
                                                FLUORIDE F 18 injection, 10 to 200                      is indicated for diagnostic positron                   AGENCY:   Food and Drug Administration,
                                                mCi/mL, if all other legal and regulatory               emission tomography imaging of bone to                 HHS.
                                                requirements are met.                                   define areas of altered osteogenic                     ACTION:   Notice.
                                                FOR FURTHER INFORMATION CONTACT:                        activity.
                                                Reena Raman, Center for Drug                               The NDA holder has never marketed                   SUMMARY: The Food and Drug
                                                Evaluation and Research, Food and                       SODIUM FLUORIDE F 18 (sodium                           Administration (FDA) is announcing the


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                                                37130                           Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices

                                                availability of a guidance entitled ‘‘Q4B               Regarding the Guidance                                 observers from the World Health
                                                Evaluation and Recommendation of                          Robert H. King, Sr., Center for Drug                 Organization, Health Canada, and the
                                                Pharmacopoeial Texts for Use in the                     Evaluation and Research, Food and                      European Free Trade Area.
                                                ICH Regions; Annex 7(R2): Dissolution                   Drug Administration, 10903 New                            In the Federal Register of April 5,
                                                Test General Chapter’’ (Q4B Annex                       Hampshire Ave., Bldg. 51, rm. 4150,                    2010 (75 FR 17148), FDA published a
                                                7(R2)). The guidance was prepared                                                                              notice announcing the availability of
                                                                                                        Silver Spring, MD 20993–0002, 301–
                                                under the auspices of the International                                                                        Q4B Annex 7. In September 2010, the
                                                                                                        796–1242, or Christopher Joneckis,
                                                Conference on Harmonisation of                                                                                 April 2010 guidance was revised to add
                                                                                                        Center for Biologics Evaluation and
                                                Technical Requirements for Registration                                                                        guidance on Health Canada
                                                                                                        Research (HFM–25), Food and Drug
                                                of Pharmaceuticals for Human Use                                                                               consideration. This second revision,
                                                                                                        Administration, 1401 Rockville Pike,
                                                (ICH). The Q4B Annex 7(R2) is a                                                                                Q4B Annex 7(R2), specifies additional
                                                                                                        suite 200N, Rockville, MD 20852–1448,
                                                revision of the previously published                                                                           dissolution apparatuses to which
                                                                                                        301–827–0373.
                                                ICH guidance, ‘‘Q4B Evaluation and                                                                             interchangeability applies in the three
                                                Recommendation of Pharmacopoeial                        Regarding the ICH                                      ICH regions: The Basket Apparatus
                                                Texts for Use in the ICH Regions; Annex                   Michelle Limoli, Office of                           (Apparatus 1), the Paddle Apparatus
                                                7: Dissolution Test General Chapter’’                   International Programs (HFG–1), Food                   (Apparatus 2), and the Flow-Through
                                                (Q4B Annex 7). The revised guidance                     and Drug Administration, 5600 Fishers                  Cell. Q4B Annex 7(R2) also updates the
                                                specifies additional dissolution                        Lane, Rockville, MD 20857, 301–827–                    considerations for implementation for
                                                apparatuses to which interchangeability                 4480.                                                  FDA, EU, and MHLW. In addition, it
                                                applies in the three ICH regions,                                                                              updates the references used for the Q4B
                                                                                                        SUPPLEMENTARY INFORMATION:                             evaluation.
                                                updates the considerations for
                                                implementation, and updates the                         I. Background                                             Following changes made by the three
                                                references used for the Q4B evaluation.                                                                        pharmacopeias and after review of the
                                                                                                           In recent years, many important                     changes by the ICH Q4B Expert Working
                                                The guidance is intended to recognize                   initiatives have been undertaken by
                                                the interchangeability between the local                                                                       Group, the ICH Steering Committee,
                                                                                                        regulatory authorities and industry                    with the endorsement of the three
                                                regional pharmacopoeias, thus avoiding                  associations to promote international
                                                redundant testing in favor of a common                                                                         participating regulatory agencies,
                                                                                                        harmonization of regulatory                            approved Q4B Annex 7(R2) in
                                                testing strategy in each regulatory                     requirements. FDA has participated in
                                                region. The guidance is in the form of                                                                         November 2010.
                                                                                                        many meetings designed to enhance                         The guidance provides specific
                                                an annex to the core guidance on the                    harmonization and is committed to                      evaluation outcomes from the ICH Q4B
                                                Q4B process entitled ‘‘Q4B Evaluation                   seeking scientifically based harmonized                process for the Dissolution Test Chapter
                                                and Recommendation of                                   technical procedures for pharmaceutical                harmonization proposal originating
                                                Pharmacopoeial Texts for Use in the                     development. One of the goals of                       from the three-party PDG. The guidance
                                                ICH Regions’’ (core ICH Q4B guidance).                  harmonization is to identify and then                  is in the form of an annex to the core
                                                DATES:  Submit either electronic or                     reduce differences in technical                        ICH Q4B guidance made available in the
                                                written comments on Agency guidances                    requirements for drug development                      Federal Register of February 21, 2008
                                                at any time.                                            among regulatory agencies.                             (73 FR 9575). When implemented, the
                                                ADDRESSES:   Submit written requests for                   ICH was organized to provide an                     annex will provide guidance for
                                                single copies of the guidance to the                    opportunity for tripartite harmonization               industry and regulators on the use of the
                                                Division of Drug Information (HFD–                      initiatives to be developed with input                 specific pharmacopoeial texts evaluated
                                                240), Center for Drug Evaluation and                    from both regulatory and industry                      by the ICH Q4B process.
                                                Research, Food and Drug                                 representatives. FDA also seeks input                     FDA is issuing Q4B Annex 7(R2) as
                                                Administration, 10903 New Hampshire                     from consumer representatives and                      Level 2 guidance under FDA’s good
                                                Ave., Bldg. 51, rm. 2201, Silver Spring,                others. ICH is concerned with                          guidance practices regulation (21 CFR
                                                MD 20993–0002, or the Office of                         harmonization of technical                             10.115). Consistent with FDA’s good
                                                Communication, Outreach and                             requirements for the registration of                   guidance practices regulation, the
                                                Development (HFM–40), Center for                        pharmaceutical products among three                    Agency will accept comments on the
                                                Biologics Evaluation and Research                       regions: The European Union (EU),                      guidance at any time. The guidance
                                                (CBER), Food and Drug Administration,                   Japan, and the United States. The six                  represents the Agency’s current thinking
                                                1401 Rockville Pike, suite 200N,                        ICH sponsors are the European                          on this topic. It does not create or confer
                                                Rockville, MD 20852–1448. Send one                      Commission; the European Federation                    any rights for or on any person and does
                                                self-addressed adhesive label to assist                 of Pharmaceutical Industries                           not operate to bind FDA or the public.
                                                the office in processing your requests.                 Associations; the Japanese Ministry of                 An alternative approach may be used if
                                                The guidance may also be obtained by                    Health, Labour and Welfare (MHLW);                     such approach satisfies the
                                                mail by calling CBER at 1–800–835–                      the Japanese Pharmaceutical                            requirements of the applicable statutes
                                                4709 or 301–827–1800. See the                           Manufacturers Association; the Centers                 and regulations.
                                                SUPPLEMENTARY INFORMATION section for
                                                                                                        for Drug Evaluation and Research and
                                                                                                        Biologics Evaluation and Research,                     II. Comments
                                                electronic access to the guidance
                                                                                                        FDA; and the Pharmaceutical Research                      Interested persons may submit to the
                                                document.
                                                                                                        and Manufacturers of America. The ICH                  Division of Dockets Management (see
                                                  Submit electronic comments on the                     Secretariat, which coordinates the                     ADDRESSES) either electronic or written
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                                                guidance to http://www.regulations.gov.                 preparation of documentation, is                       comments regarding this document. It is
                                                Submit written comments to the                          provided by the International                          only necessary to send one set of
                                                Division of Dockets Management (HFA–                    Federation of Pharmaceutical                           comments. It is no longer necessary to
                                                305), Food and Drug Administration,                     Manufacturers Associations (IFPMA).                    send two copies of mailed comments.
                                                5630 Fishers Lane, rm. 1061, Rockville,                    The ICH Steering Committee includes                 Identify comments with the docket
                                                MD 20852.                                               representatives from each of the ICH                   number found in brackets in the
                                                FOR FURTHER INFORMATION CONTACT:                        sponsors and the IFPMA, as well as                     heading of this document. Received


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                                                                                Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices                                                  37131

                                                comments may be seen in the Division                    area. Please call the Information Line for               Persons attending FDA’s advisory
                                                of Dockets Management between 9 a.m.                    up-to-date information on this meeting.                committee meetings are advised that the
                                                and 4 p.m., Monday through Friday.                      A notice in the Federal Register about                 agency is not responsible for providing
                                                                                                        last minute modifications that impact a                access to electrical outlets.
                                                III. Electronic Access
                                                                                                        previously announced advisory                            FDA welcomes the attendance of the
                                                   Persons with access to the Internet                  committee meeting cannot always be                     public at its advisory committee
                                                may obtain the document at http://                      published quickly enough to provide                    meetings and will make every effort to
                                                www.regulations.gov, http://                            timely notice. Therefore, you should                   accommodate persons with physical
                                                www.fda.gov/Drugs/Guidance                              always check the Agency’s Web site and                 disabilities or special needs. If you
                                                ComplianceRegulatoryInformation/                        call the appropriate advisory committee                require special accommodations due to
                                                Guidances/default.htm, or http://                       hot line/phone line to learn about                     a disability, please contact Kristine T.
                                                www.fda.gov/BiologicsBloodVaccines/                     possible modifications before coming to                Khuc at least 7 days in advance of the
                                                GuidanceComplianceRegulatory                            the meeting.                                           meeting.
                                                Information/Guidances/default.htm.                        Agenda: The meeting will be open to                    FDA is committed to the orderly
                                                  Dated: June 20, 2011.                                 the public from 8 a.m. to 9 a.m., unless               conduct of its advisory committee
                                                Leslie Kux,                                             public participation does not last that                meetings. Please visit our Web site at
                                                Acting Assistant Commissioner for Policy.               long; from 9 a.m. to 1 p.m., the meeting               http://www.fda.gov/
                                                [FR Doc. 2011–15814 Filed 6–23–11; 8:45 am]             will be closed to permit discussion and                AdvisoryCommittees/
                                                                                                        review of trade secret and/or                          AboutAdvisoryCommittees/
                                                BILLING CODE 4160–01–P
                                                                                                        confidential commercial information.                   ucm111462.htm for procedures on
                                                                                                          FDA generally makes background                       public conduct during advisory
                                                DEPARTMENT OF HEALTH AND                                material available to the public no later              committee meetings.
                                                HUMAN SERVICES                                          than 2 business days before the meeting                   Dated: June 21, 2011.
                                                                                                        or follows other procedures to make                    Jill Hartzler Warner,
                                                Food and Drug Administration                            such material available to the public.                 Acting Associate Commissioner for Special
                                                [Docket No. FDA–2011–N–0002]
                                                                                                        There is no background material that is                Medical Programs.
                                                                                                        publicly available for this meeting.                   [FR Doc. 2011–15823 Filed 6–23–11; 8:45 am]
                                                Joint Meeting of the Gastrointestinal                     Procedure: On July 20, 2011, from                    BILLING CODE 4160–01–P
                                                Drugs Advisory Committee and the                        8 a.m. to 9 a.m., the meeting is open to
                                                Drug Safety and Risk Management                         the public. Interested persons may
                                                Advisory Committee; Notice of Meeting                   present data, information, or views,                   DEPARTMENT OF HEALTH AND
                                                                                                        orally or in writing, on issues pending                HUMAN SERVICES
                                                AGENCY:    Food and Drug Administration,                before the committee. Written
                                                HHS.                                                    submissions may be made to the contact                 Food and Drug Administration
                                                ACTION:   Notice.                                       person on or before July 6, 2011. Oral
                                                                                                                                                               [Docket No. FDA–2011–N–0013]
                                                                                                        presentations from the public will be
                                                  This notice announces a forthcoming
                                                                                                        scheduled between approximately                        Statement of Organizations, Functions,
                                                meeting of a public advisory committee
                                                                                                        8 a.m. to 9 a.m. Those individuals                     and Delegations of Authority
                                                of the Food and Drug Administration
                                                                                                        interested in making formal oral
                                                (FDA). At least one portion of the                                                                             AGENCY:   Food and Drug Administration,
                                                                                                        presentations should notify the contact
                                                meeting will be closed to the public.                                                                          HHS.
                                                  Name of Committees: Gastrointestinal                  person and submit a brief statement of
                                                Drugs Advisory Committee and the Drug                   the general nature of the evidence or                  ACTION:   Notice.
                                                Safety and Risk Management Advisory                     arguments they wish to present, the
                                                                                                        names and addresses of proposed                        SUMMARY:    The Food and Drug
                                                Committee.                                                                                                     Administration (FDA) is announcing
                                                  General Function of the Committees:                   participants, and an indication of the
                                                                                                        approximate time requested to make                     that it has reorganized the Center for
                                                To provide advice and
                                                                                                        their presentation on or before June 27,               Drug Evaluation and Research (CDER),
                                                recommendations to the Agency on
                                                                                                        2011. Time allotted for each                           Office of Compliance. This
                                                FDA’s regulatory issues.
                                                  Date and Time: The meeting will be                    presentation may be limited. If the                    reorganization includes the
                                                held on July 20, 2011, from 8 a.m. to                   number of registrants requesting to                    organizations and substructure
                                                1 p.m.                                                  speak is greater than can be reasonably                components as listed in this document.
                                                  Location: Hilton Washington DC/                       accommodated during the scheduled                      This document is announcing
                                                Silver Spring, The Ballrooms, 8727                      open public hearing session, FDA may                   availability of the Staff Manual Guide
                                                Colesville Rd., Silver Spring, MD. The                  conduct a lottery to determine the                     that explains the details of this
                                                hotel telephone number is 301–589–                      speakers for the scheduled open public                 reorganization.
                                                5200.                                                   hearing session. The contact person will               FOR FURTHER INFORMATION CONTACT:
                                                  Contact Person: Kristine T. Khuc,                     notify interested persons regarding their              Karen Koenick, Center for Drug
                                                Center for Drug Evaluation and                          request to speak by June 28, 2011.                     Evaluation and Research (HFD–063),
                                                Research, Food and Drug                                   Closed Committee Deliberations: On                   Food and Drug Administration, 11919
                                                Administration, 10903 New Hampshire                     July 20, 2011, from 9 a.m. to 1 p.m., the              Rockville Pike, Rockville, MD 20852,
                                                Ave., Bldg. 31, rm. 2417, Silver Spring,                meeting will be closed to permit
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                                                                                                                                                               301–796–4422.
                                                MD 20993–0002, 301–796–9001, Fax:                       discussion and review of trade secret
                                                301–847–8533, e-mail:                                   and/or confidential commercial                         I. Summary
                                                GIDAC@fda.hhs.gov, or FDA Advisory                      information (5 U.S.C. 552b(c)(4)).                       The Statement of Organization,
                                                Committee Information Line, 1–800–                      During this session, the committees will               Functions, and Delegations of Authority
                                                741–8138 (301–443–0572 in the                           discuss the drug development program                   for CDER (35 FR 3685, February 25,
                                                Washington, DC area), and follow the                    of an investigational gastroenterology                 1970, 60 FR 56605, November 9, 1995,
                                                prompts to the desired center or product                drug.                                                  64 FR 36361, July 6, 1999, 72 FR 50112,


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