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					                                       Federal Register / Vol. 69, No. 44 / Friday, March 5, 2004 / Notices                                            10457

      III. Comments                                              Date and Time: The meeting will be                 Meeks, Conference Management Staff, at
                                                              held on March 25, 2004, from 8 a.m. to                301–594–1283, ext. 105, at least 7 days
        The administrative record of this
                                                              5 p.m.                                                in advance of the meeting.
      public meeting will remain open for 30
                                                                 Location: Hilton Washington, DC                      Notice of this meeting is given under
      days after the public meeting. Interested               North/Gaithersburg, Ballroom Salons A,                the Federal Advisory Committee Act (5
      persons may submit to the Division of                   B, C, and D, 620 Perry Pkwy.,                         U.S.C. app. 2).
      Dockets Management (HFA–305), Food                      Gaithersburg, MD.
      and Drug Administration, 5630 Fishers                                                                           Dated: March 1, 2004.
                                                                 Contact Person: David Krause, Center
      Lane, rm. 1061, Rockville, MD 20852,                                                                          Peter J. Pitts,
                                                              for Devices and Radiological Health
      written or electronic comments by June                  (HFZ–410), Food and Drug                              Associate Commissioner for External
      11, 2004. You may also send comments                                                                          Relations.
                                                              Administration, 9200 Corporate Blvd.,
      to the Division of Dockets Management                   Rockville, MD 20850, 301–594–3090,                    [FR Doc. 04–4983 Filed 3–4–04; 8:45 am]
      via e-mail to FDADockets@oc.fda.gov.                    ext. 141, or FDA Advisory Committee                   BILLING CODE 4160–01–S
      Submit two paper copies of comments,                    Information Line, 1–800–741–8138
      identified with the docket number                       (301–443–0572 in the Washington, DC
      found in brackets in the heading of this                area), code 3014512519. Please call the               DEPARTMENT OF HEALTH AND
      document. Individuals may submit one                    Information Line or access the Internet               HUMAN SERVICES
      paper copy. Received comments may be                    address of http://www.fda.gov/cdrh/
      seen in the Division of Dockets                                                                               Food and Drug Administration
                                                              panelmtg.html for up-to-date
      Management between 9 a.m. and 4 p.m.,                   information on this meeting.                          [Docket No. 2000D–1350]
      Monday through Friday. Comments may                        Agenda: The committee will discuss,
      be placed on the Internet and, if so, will              make recommendations, and vote on a                   Draft Guidance for Industry on
      be available for public viewing.                        premarket approval application (PMA)                  Labeling for Combined Oral
                                                              for an injectable device intended for use             Contraceptives; Availability
      IV. Meeting Notes
                                                              in the correction of lipoatrophy of the               AGENCY:    Food and Drug Administration,
         You may request a copy of the notes                  face in human immunodeficiency virus                  HHS.
      of the public meeting in writing from                   (HIV) positive patients. Background
      the Freedom of Information Office (HFI–                                                                       ACTION:   Notice.
                                                              information for this PMA, including the
      35), Food and Drug Administration,                      agenda and questions for the committee,               SUMMARY: The Food and Drug
      5600 Fishers Lane, rm. 12A–16,                          will be available to the public 1                     Administration (FDA) is announcing the
      Rockville, MD 20857, approximately 15                   business day before the meeting on the                availability of a draft guidance for
      working days after the public meeting,                  Internet at http://www.fda.gov/cdrh/                  industry entitled ‘‘Labeling for
      at a cost of 10 cents per page. You may                 panelmtg.html. The material for this                  Combined Oral Contraceptives.’’ The
      examine the notes of the public meeting                 meeting will be posted on March 24,                   draft guidance contains recommended
      after June 11, 2004, at the Division of                 2004.                                                 labeling for combined oral
      Dockets Management between 9 a.m.                          Procedure: Interested persons may                  contraceptives. This is the second draft
      and 4 p.m., Monday through Friday.                      present data, information, or views,                  of a guidance being issued on this topic.
        Dated: February 27, 2004.                             orally or in writing, on issues pending
                                                                                                                    DATES: Submit written or electronic
                                                              before the committee. Written
      Jeffrey Shuren,                                                                                               comments on the draft guidance by May
                                                              submissions may be made to the contact
      Assistant Commissioner for Policy.                                                                            4, 2004. General comments on agency
                                                              person by March 15, 2004. On March
      [FR Doc. 04–4888 Filed 3–4–04; 8:45 am]                                                                       guidance documents are welcome at any
                                                              25, 2004, oral presentations from the
      BILLING CODE 4160–01–S                                                                                        time.
                                                              public will be scheduled for
                                                                                                                    ADDRESSES: Submit written requests for
                                                              approximately 1 hour at the beginning
                                                              of committee deliberations and for                    single copies of the draft guidance to the
      DEPARTMENT OF HEALTH AND                                approximately 1 hour near the end of                  Division of Drug Information (HFD–
      HUMAN SERVICES                                          the committee deliberations. Time                     240), Center for Drug Evaluation and
                                                              allotted for oral public presentations                Research, Food and Drug
      Food and Drug Administration                                                                                  Administration, 5600 Fishers Lane,
                                                              may be limited. Those desiring to make
                                                              formal oral presentations should notify               Rockville, MD 20857. Send one self-
      General and Plastic Surgery Devices                                                                           addressed adhesive label to assist that
      Panel of the Medical Devices Advisory                   the contact person before March 15,
                                                              2004, and submit a brief statement of                 office in processing your requests.
      Committee; Notice of Meeting                                                                                  Submit written comments on the draft
                                                              the general nature of the evidence or
      AGENCY:    Food and Drug Administration,                arguments they wish to present, the                   guidance to the Division of Dockets
      HHS.                                                    names and addresses of proposed                       Management (HFA–305), Food and Drug
      ACTION:   Notice.                                       participants, and an indication of the                Administration, 5630 Fishers Lane, rm.
                                                              approximate time requested to make                    1061, Rockville, MD 20852. Submit
        This notice announces a forthcoming                   their presentation.                                   electronic comments to http://
      meeting of a public advisory committee                     Persons attending FDA’s advisory                   www.fda.gov/dockets/ecomments. See
      of the Food and Drug Administration                     committee meetings are advised that the               the SUPPLEMENTARY INFORMATION section
      (FDA). The meeting will be open to the                  agency is not responsible for providing               for electronic access to the draft
      public.                                                 access to electrical outlets.                         guidance document.
        Name of Committee: General and                           FDA welcomes the attendance of the                 FOR FURTHER INFORMATION CONTACT:
      Plastic Surgery Devices Panel of the                    public at its advisory committee                      Margaret Kober, Center for Drug
      Medical Devices Advisory Committee.                     meetings and will make every effort to                Evaluation and Research (HFD–580),
        General Function of the Committee:                    accommodate persons with physical                     Food and Drug Administration, 5600
      To provide advice and                                   disabilities or special needs. If you                 Fishers Lane, Rockville, MD 20857,
      recommendations to the agency on                        require special accommodations due to                 301–827–4260.
      FDA’s regulatory issues.                                a disability, please contact Shirley                  SUPPLEMENTARY INFORMATION:



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