Federal Register Vol No Tuesday February Notices MD by FDADocs


									                                         6284                         Federal Register / Vol. 71, No. 25 / Tuesday, February 7, 2006 / Notices

                                         health. FDA said that the proposed                      MD 20852. Submit electronic comments                     • Potential alternative approaches to
                                         changes would be an important step                      to http://www.fda.gov/dockets/                        donor screening and testing.
                                         toward global harmonization of safety                   ecomments.                                               Transcripts: Transcripts of the public
                                         reporting requirements and additional                      Contact Person: Rhonda Dawson,                     workshop may be requested in writing
                                         efforts are underway within the                         Center for Biologics Evaluation and                   from the Freedom of Information Office
                                         Department of Health and Human                          Research (HFM–302), Food and Drug                     (HFI–35), Food and Drug
                                         Services to harmonize the reporting                     Administration, 1401 Rockville Pike,                  Administration, 5600 Fishers Lane, rm.
                                         requirements of U.S. Federal agencies                   Rockville, MD 20852–1448, 301–827–                    12A–16, Rockville, MD 20857,
                                         (e.g., FDA and the National Institutes of               6129, FAX: 301–827–2843, e-mail:                      approximately 15 working days after the
                                         Health are continuing to work together                  Rhonda.Dawson@fda.hhs.gov.                            public workshop at a cost of 10 cents
                                         to address the best ways to streamline                     Registration: Mail, fax, or e-mail your            per page. A transcript of the public
                                         information sharing and to harmonize,                   registration information (including                   workshop will be available on the
                                         to the extent possible, the safety                      name, title, firm name, address, and                  Internet at http://www.fda.gov/cber/
                                         reporting requirements of the two                       telephone and fax numbers) to Rhonda                  minutes/workshop-min.htm.
                                         agencies).                                              Dawson (see Contact Person) by
                                                                                                 February 17, 2006. There is no                          Dated: January 31, 2006.
                                           Dated: January 30, 2006.                              registration fee for the public workshop.             Jeffrey Shuren,
                                         Jeffrey Shuren,                                         Early registration is recommended                     Assistant Commissioner for Policy.
                                         Assistant Commissioner for Policy.                      because seating is limited. Registration              [FR Doc. E6–1588 Filed 2–6–06; 8:45 am]
                                         [FR Doc. E6–1587 Filed 2–6–06; 8:45 am]                 on the day of the public workshop will                BILLING CODE 4160–01–S
                                         BILLING CODE 4160–01–S                                  be provided on a space-available basis
                                                                                                 beginning at 7:15 a.m.
                                                                                                    If you need special accommodations                 DEPARTMENT OF HEALTH AND
                                         DEPARTMENT OF HEALTH AND                                due to a disability, please contact                   HUMAN SERVICES
                                         HUMAN SERVICES                                          Rhonda Dawson (see Contact Person) at
                                                                                                 least 7 days in advance.                              Food and Drug Administration
                                         Food and Drug Administration                               Comments: Regardless of attendance
                                                                                                 at the public workshop, interested                    Independent Evaluation of the Food
                                         [Docket No. 2006N–0045]                                                                                       and Drug Administration’s First Cycle
                                                                                                 persons may submit to the Division of
                                                                                                 Dockets Management (see Addresses)                    Review Performance—Retrospective
                                         Behavior-Based Blood Donor Deferrals
                                                                                                 written or electronic comments                        Analysis Final Report; Availability
                                         in the Era of Nucleic Acid Testing;
                                         Public Workshop; Request for                            regarding the public workshop. Submit                 AGENCY:    Food and Drug Administration,
                                         Comments                                                electronic comments to http://                        HHS.
                                         AGENCY:    Food and Drug Administration,                Submit a single copy of electronic                    ACTION:   Notice of availability.
                                         HHS.                                                    comments or two paper copies of any                   SUMMARY: The Food and Drug
                                         ACTION: Notice of public workshop;                      mailed comments, except that                          Administration (FDA) is announcing the
                                         request for comments.                                   individuals may submit one paper copy.                availability of a report entitled
                                                                                                 Comments are to be identified with the                ‘‘Independent Evaluation of FDA’s First
                                            The Food and Drug Administration                     docket number found in brackets in the
                                         (FDA) is announcing a public workshop                                                                         Cycle Review Performance—
                                                                                                 heading of this document. Received                    Retrospective Analysis Final Report.’’
                                         entitled ‘‘Behavior-Based Blood Donor                   comments may be seen in the Division
                                         Deferrals in the Era of Nucleic Acid                                                                          This report describes an independent
                                                                                                 of Dockets Management between 9 a.m.                  evaluation of the issues associated with
                                         Testing (NAT).’’ The purpose of the                     and 4 p.m., Monday through Friday.
                                         public workshop is to address                                                                                 FDA’s conduct of first cycle reviews of
                                                                                                 SUPPLEMENTARY INFORMATION: The                        new molecular entities for new drug
                                         regulatory and scientific challenges and                purpose of the public workshop is to
                                         opportunities in the development of                                                                           applications (NMEs for NDAs), and
                                                                                                 address regulatory and scientific                     biological license applications (BLAs).
                                         policy concerning protection of the                     challenges and opportunities in the
                                         blood supply from transfusion-                                                                                Applications covered by the report are
                                                                                                 development of policy concerning                      those submitted to FDA in fiscal years
                                         transmissible diseases by deferring                     protection of the blood supply from
                                         blood donors based on high-risk                                                                               2002 to 2004. This independent study
                                                                                                 transfusion-transmissible diseases by                 was conducted in relation to the
                                         behavior, and to request comments on                    deferring blood donors based on high-
                                         this topic.                                                                                                   Prescription Drug User Fee
                                                                                                 risk behavior. The public workshop will               Amendments of 2002 (PDUFA III). This
                                            Date and Time: The public workshop                   feature presentations by national and
                                         will be held on March 8, 2006, from 8                                                                         assessment includes a detailed
                                                                                                 international experts from government                 evaluation of the events that occurred
                                         a.m. to 5:30 p.m. The deadline for                      and academic institutions and industry.
                                         registration via mail, fax, or e-mail is                                                                      during the review process with a focus
                                                                                                 The following discussions will be                     on identifying the best practices by FDA
                                         February 17, 2006 (see Registration).                   included:
                                         Written or electronic comments will be                                                                        and industry that facilitated that
                                                                                                    • Current practices in the United                  process.
                                         accepted until May 8, 2006 (see                         States and in foreign countries regarding
                                         Comments).                                              blood donor deferrals based on high-risk              ADDRESSES:   Submit written requests for
                                            Addresses: The public workshop will                  behavior,                                             single copies of this report to the Office
                                         be held at the National Institutes of                      • Comparison of selected tissue donor              of Planning (HFP–10), Food and Drug
                                         Health, Lister Hill Auditorium, Bldg.                   deferral policies to blood donor deferral             Administration, 5600 Fishers Lane,
erjones on PROD1PC68 with NOTICES

                                         38A, 8600 Rockville Pike, Bethesda, MD                  policies,                                             Rockville, MD 20857. Send one self-
                                         20894. Submit written comments to the                      • Behavioral risks for transfusion-                addressed adhesive label to assist that
                                         Division of Dockets Management (HFA–                    transmitted diseases,                                 office in processing your requests.
                                         305), Food and Drug Administration,                        • Residual risks of infection from                 Submit electronic requests to
                                         5630 Fishers Lane, rm. 1061, Rockville,                 transfusion, and                                      Carolyn.Staples@fda.hhs.gov. This

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                                                                      Federal Register / Vol. 71, No. 25 / Tuesday, February 7, 2006 / Notices                                               6285

                                         report will be available on FDA’s Web                   DEPARTMENT OF HEALTH AND                              ACTION:   Request for applications.
                                         site at a later date.                                   HUMAN SERVICES
                                                                                                                                                       SUMMARY: The Coast Guard seeks
                                         FOR FURTHER INFORMATION CONTACT:                        Substance Abuse and Mental Health                     applications for membership on the
                                         Carolyn Staples, Office of Planning                     Services Administration                               Towing Safety Advisory Committee
                                         (HFP–10), Food and Drug                                                                                       (TSAC). TSAC advises the Coast Guard
                                         Administration, 5600 Fishers Lane,                      Center for Substance Abuse                            on matters relating to shallow-draft
                                         Rockville, MD 20857, 301–827–5274, or                   Prevention; Notice of Meeting                         inland and coastal waterway navigation
                                         William Hagan, Office of Planning                                                                             and towing safety.
                                                                                                   Pursuant to Public Law 92–463,
                                         (HFP–1), Food and Drug                                                                                        DATES: Application forms should reach
                                                                                                 notice is hereby given of the meeting of
                                         Administration, 5600 Fishers Lane,                      the SAMHSA Center for Substance                       us on or before April 30, 2006.
                                         Rockville, MD 20857, 301–827–8816.                      Abuse Prevention (CSAP) National                      ADDRESSES: You may request an
                                         SUPPLEMENTARY INFORMATION:                              Advisory Council on February 14, 2006.                application form by writing to
                                                                                                   The meeting will be open and will                   Commandant (G–PSO–1); U.S. Coast
                                         I. Background                                           include a Director’s Report; discussions              Guard, Room 1210; 2100 Second Street,
                                                                                                 related to National Outcome Measures;                 SW., Washington, DC 20593–0001; by
                                            On June 12, 2002, the President
                                                                                                 an update on SAMHSA’s Drug Free                       calling 202–267–0214; or by faxing 202–
                                         signed into law the Public Health
                                                                                                 Communities programs; and a panel                     267–4570. Send your original completed
                                         Security and Bioterrorism Preparedness                  presentation on the roles of Project                  and signed application in written form
                                         and Response Act of 2002, which                         Officers, Grants Management staff and                 to the above street address. Be sure to
                                         includes PDUFA III. In conjunction with                 Contracts Management staff.                           sign and include the short page that
                                         the passage of PDUFA III, FDA agreed                      A roster of Council members may be                  allows us to keep political affiliation on
                                         to certain performance goals and                        obtained either by accessing the                      file. This notice is available on the
                                         procedures that were described in an                    SAMHSA Council Web site, http://                      Internet at http://dms.dot.gov in docket
                                         enclosure to a June 4, 2002, letter from                www.samhsa.gov/council/csap/                          USCG–2006–23795 and the application
                                         the Secretary of Health and Human                       csapnac.aspx or by communicating with                 form is also available at http://
                                         Services, Tommy Thompson, to                            the contact listed below. Substantive                 www.uscg.mil/hq/g-m/advisory/
                                         Congress entitled ‘‘PDUFA                               program information, a summary of the                 index.htm. (Click on ‘‘ACM
                                         Reauthorization Performance Goals and                   meeting, and the transcript for the open              Application’’.)
                                         Procedures’’ (PDUFA Goals and                           session will also be available on the
                                                                                                                                                       FOR FURTHER INFORMATION CONTACT:   Mr.
                                         Procedures).                                            SAMHSA CSAP Council Web site as
                                                                                                                                                       Gerald Miante; Assistant Executive
                                            One of the goals relates to FDA’s                    soon as possible after the meeting.
                                                                                                                                                       Director of TSAC, telephone 202–267–
                                         performance of first cycle reviews of                   Attendance by the public will be limited
                                                                                                                                                       0214, fax 202–267–4570, or e-mail
                                                                                                 to space available.
                                         original NMEs for NDAs and BLAs                                                                               gmiante@comdt.uscg.mil.
                                         (PDUFA Goals and Procedures, section                      Committee Name: Substance Abuse and
                                                                                                 Mental Health Services Administration,                SUPPLEMENTARY INFORMATION:     The
                                         10). Related to this goal, FDA was to                                                                         Towing Safety Advisory Committee
                                                                                                 Center for Substance Abuse Prevention
                                         retain an independent expert consultant                 National Advisory Council.                            (TSAC) is a Federal advisory committee
                                         to undertake a study to evaluate issues                   Date/Time: Tuesday, February 14, 2006, 12           mandated by Congress and operates
                                         associated with the agency’s conduct of                 p.m. to 5 p.m.                                        under 5 U.S.C. App. 2, (Pub. L. 92–463,
                                         first cycle reviews. The study was to                     Place: Washington DC Convention Center,             86 Stat. 770, as amended). It advises the
                                         assess the following objectives: (1)                    801 Mount Vernon Place, NW., Room 204 B,              Secretary of Homeland Security on
                                         Current first cycle review performance                  Washington, DC 20001.
                                                                                                   Type: Open.
                                                                                                                                                       matters relating to shallow-draft inland
                                         and any changes that occur after FDA                                                                          and coastal waterway navigation and
                                                                                                   Contact: Tia Haynes, Committee
                                         publishes guidance on Good Review                       Management Specialist, 1 Choke Cherry                 towing safety. This advice also assists
                                         Management Principles (GRMPs), (2) the                  Road, Room 4–1066, Rockville, Maryland                the Coast Guard in formulating the
                                         first cycle review history of all NDAs for              20857. Telephone: (240) 276–2436. Fax: (240)          position of the United States in advance
                                         new molecular entities and all BLAs                     276–2430 E-mail:                                      of meetings of the International
                                         during PDUFA III, and (3) the                           Tia.haynes@samhsa.hhs.gov.                            Maritime Organization.
                                         effectiveness of FDA’s staff training                     Dated: February 1, 2006.                               TSAC meets at least once a year at
                                         regarding GRMPs. FDA awarded a                          Toian Vaughn,                                         Coast Guard Headquarters, Washington,
                                         contract to an independent expert to                    Committee Management Officer, Substance               DC, or another location selected by the
                                         study these issues. The report referred                 Abuse and Mental Health Services                      Coast Guard. It may also meet for
                                         to in this document covers the                          Administration.                                       extraordinary purposes. Its working
                                         retrospective portion of objectives (1)                 [FR Doc. E6–1623 Filed 2–6–06; 8:45 am]               groups may meet to consider specific
                                         and (2) listed previously.                              BILLING CODE 4162–20–P
                                                                                                                                                       issues as required. The 16-person
                                                                                                                                                       membership includes 7 representatives
                                            In accordance with the PDUFA goal,                                                                         of the Barge and Towing Industry
                                         the report is being made available to the                                                                     (reflecting a regional geographical
                                         public.                                                 DEPARTMENT OF HOMELAND
                                                                                                 SECURITY                                              balance); 1 member from the Offshore
                                           Dated: January 30, 2006.                                                                                    Mineral and Oil Supply Vessel Industry;
                                         Jeffrey Shuren,                                         Coast Guard                                           and 2 members from each of the
                                                                                                                                                       following areas: Maritime Labor;
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                                         Assistant Commissioner for Policy.                      [USCG–2006–23795]                                     Shippers (of whom at least one shall be
                                         [FR Doc. E6–1605 Filed 2–6–06; 8:45 am]
                                                                                                 Towing Safety Advisory Committee;                     engaged in the shipment of oil or
                                         BILLING CODE 4160–01–S                                                                                        hazardous materials by barge); Port
                                                                                                                                                       Districts, Authorities, or Terminal
                                                                                                 AGENCY:    Coast Guard, DHS.                          Operators; and the General Public.

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