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					                                                                       Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices                                              2601

                                          Trade Association.’’ In this final                      III. Electronic Access                                    If you need special accommodations
                                          guidance, FDA is announcing that: (1)                     Persons with access to the Internet                  due to a disability, please contact Jay
                                          We intend to proceed with a                             may obtain the guidance document at                    Crowley (see Contact Person) by January
                                          Certification Referral Program to NOAA                  http://www.cfsan.fda.gov/                              30, 2009.
                                          SIP, without a 24-month test period, (2)                guidance.html.                                            Comments: Regardless of attendance
                                          we intend to expand the program to                                                                             at the public workshop, interested
                                          include all fish and fishery products for                 Dated: January 9, 2009.                              persons may submit written or
                                          export to the EU and EFTA, and (3) we                   Jeffrey Shuren,                                        electronic comments to the Division of
                                          intend to stop issuing EU Export                        Associate Commissioner for Policy and                  Dockets Management (HFA–305), Food
                                          Certificates effective February 17, 2009.               Planning.                                              and Drug Administration, 5630 Fishers
                                          The agency intends to adopt this                        [FR Doc. E9–785 Filed 1–14–09; 8:45 am]                Lane, rm. 1061, Rockville, MD 20852.
                                          approach because the industry’s                         BILLING CODE 4160–01–S                                 Submit electronic comments to http://
                                          demand for EU Export Certificates                                                                              www.regulations.gov. Submit a single
                                          continues to rise dramatically, and FDA                                                                        copy of electronic comments or two
                                          can no longer justify the use of our                    DEPARTMENT OF HEALTH AND                               paper copies of any mailed comments,
                                          limited food safety resources for                       HUMAN SERVICES                                         except that individuals may submit one
                                          issuance of EU Export Certificates. The                                                                        paper copy. Comments are to be
                                                                                                  Food and Drug Administration                           identified with the docket number
                                          implementation of this guidance should
                                          free up resources that the agency can                   [Docket No. FDA–2008–N–0661]                           found in brackets in the heading of this
                                          allocate for higher priority public health                                                                     document. The deadline for submitting
                                          activities that are intended to protect the             Unique Device Identification System;                   comments regarding this public
                                          U.S. consuming public, while still                      Public Workshop; Request for                           workshop is February 27, 2009.
                                          providing a mechanism for the industry                  Comments                                               Received comments may be seen in the
                                          to continue obtaining EU certification.                                                                        Division of Dockets Management
                                                                                                  AGENCY:    Food and Drug Administration,
                                          Seafood processors and other entities                                                                          between 9 a.m. and 4 p.m., Monday
                                                                                                  HHS.
                                          involved in the exporting of seafood to                                                                        through Friday.
                                                                                                  ACTION: Notice of public workshop;
                                          the EU may obtain EU Export                                                                                    SUPPLEMENTARY INFORMATION:
                                                                                                  request for comments.
                                          Certificates from the NOAA SIP.                                                                                I. Background
                                             FDA is issuing this guidance                           The Food and Drug Administration
                                                                                                  (FDA) is announcing a public workshop                  A. What Does Section 226 of the Food
                                          document as a level 1 guidance
                                                                                                  entitled: ‘‘Unique Device Identification               and Drug Administration Amendments
                                          consistent with FDA’s good guidance
                                                                                                  System.’’ The purpose of the public                    Act of 2007 (FDAAA) Require?
                                          practices regulation (21 CFR 10.115).
                                          This guidance represents FDA’s current                  workshop is to obtain information to                      On September 27, 2007, President
                                          thinking on this topic. It does not create              help us better understand the issues                   George W. Bush signed into law FDAAA
                                          or confer any rights for or on any person               involved in the establishment of a                     (Public Law 110–85). Section 226 of
                                          and does not operate to bind FDA,                       unique device identification system                    FDAAA amended the Federal Food,
                                          NOAA SIP, or the public. An alternative                 (UDI system) and request comments on                   Drug, and Cosmetic Act (the act) by
                                          approach may be used if such approach                   this topic.                                            requiring the establishment of a UDI
                                          satisfies the requirements of the                         Dates and Time: The public workshop                  system. Specifically, section 226(a) of
                                          applicable statutes and regulations.                    will be held on, February 12, 2009, from               FDAAA created a new section 519(f) of
                                                                                                  9 a.m. to 5 p.m. See section V of this                 the act (21 U.S.C. 360i(f)) stating that
                                          II. Comments                                            document for additional dates                          ‘‘The Secretary shall promulgate
                                                                                                  associated with registration and                       regulations establishing a unique device
                                            Interested persons may submit to the                  participation in the workshop.                         identification system for medical
                                          Division of Dockets Management (see                       Location: The public workshop will                   devices requiring the label of devices to
                                          ADDRESSES) written or electronic                        be held at the Marriott Gaithersburg                   bear a unique identifier, unless the
                                          comments regarding this document.                       Washingtonian Center, 9751                             Secretary requires an alternative
                                          Submit a single copy of electronic                      Washingtonian Blvd., Gaithersburg, MD                  placement or provides an exception for
                                          comments or two paper copies of any                     20878, 301–590–0044.                                   a particular device or type of device.
                                          mailed comments, except that                              Contact Person: Jay Crowley, Food                    The unique identifier shall adequately
                                          individuals may submit one paper copy.                  and Drug Administration, Center for                    identify the device through distribution
                                          Comments are to be identified with the                  Devices and Radiological Health (HFZ–                  and use, and may include information
                                          docket number found in brackets in the                  500), 1350 Piccard Dr., Rockville, MD                  on the lot or serial number.’’
                                          heading of this document. The guidance                  20852, 240–276–2389, or Stephen                           A UDI system may provide for early
                                          and received comments may be seen in                    Ripley, Food and Drug Administration,                  detection of the warning signs of a
                                          the Division of Dockets Management                      Center for Biologics Evaluation and                    defective device and facilitate device
                                          between 9 a.m. and 4 p.m., Monday                       Research (HFM–17), 1401 Rockville                      recalls (Ref. 1) and other possible
                                          through Friday.                                         Pike, suite 200N, Rockville, MD 20852,                 benefits of a UDI system have been
                                            Please note that on January 15, 2008,                 301–827–6210.                                          suggested.
                                          the FDA Division of Dockets                               Registration: Register electronically at
                                          Management Web site transitioned to                     http://www.fda.gov/cdrh/ocd/udi/                       B. Why Are We Holding a Public
                                          the Federal Dockets Management                          index.htmlby January 30, 2009. There is                Workshop?
                                          System (FDMS). FDMS is a                                no registration fee for the public                       The enactment of section 519(f) of the
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                                          Government-wide, electronic docket                      workshop. Early registration is                        act has raised many questions for our
                                          management system. Electronic                           recommended because seating is                         consideration. For example, the statute
                                          comments or submissions will be                         limited. Registration on the day of the                requires the UDI to go on the device’s
                                          accepted by FDA only through FDMS at                    public workshop will be provided on a                  label, but it also allows for ‘‘alternative
                                          http://www.regulations.gov.                             space available basis beginning at 8 a.m.              placement’’ and for exceptions. Thus,


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                                          2602                         Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices

                                          what circumstances would justify                        technologies, which could be used with                    d. Should the UDI include a
                                          alternative placement of the UDI, and                   medical devices, to display these                      component that represents package size
                                          which devices should receive an                         technologies. Questions about whether                  or packaging level?
                                          exception from a UDI requirement?                       your product or technology would fall                     e. To what extent would or should the
                                          Consequently, we are issuing this notice                within the scope of this vendor display                list of unique device characteristics vary
                                          to announce that we will hold a public                  should be directed to the contact                      depending on the type of device?
                                          workshop to discuss and to invite                       persons listed at the beginning of this
                                                                                                                                                         3. What should be the UDI’s
                                          comment on the questions set out in                     notice.
                                                                                                                                                         components?
                                          section II. B of this document.                            You may register to present at the
                                                                                                  public workshop or participate in the                     a. Could existing standards, such as
                                          II. Issues to Be Considered                             vendor display at http://www.fda.gov/                  the standards used by GS1, Health
                                          A. Organization and Basic Instructions                  cdrh/ocd/udi/index.html. Because of                    Industry Business Communications
                                                                                                  time constraints, vendors may register                 Council (HIBCC), or others be used as a
                                             We invite comments on the questions                  either to present at the public workshop               model for the UDI system? What are the
                                          presented in this section. We intend to                 or participate in the vendor display.                  advantages and disadvantages of these
                                          discuss these same questions at the                     You may not register for both. If you                  existing organizations and standards?
                                          public workshop. If you wish to                         choose to participate in the vendor                       b. Some identification systems
                                          comment in writing on a particular                      display, you will have the opportunity                 currently in use employ a combination
                                          question, please identify the question                  to share information about your                        of a device identifier (meaning
                                          that you are addressing before providing                products with FDA and other attendees                  information that identifies the
                                          your response to the question. For                      when they visit your display.                          manufacturer, make, and/or model of
                                          example, your comment could take the                                                                           the device) and a production identifier
                                          following format:                                       B. Questions Pertaining to the UDI                     (meaning information that relates to the
                                             ‘‘Question 1—[Quote the question].’’                 System                                                 lot or serial number). What should the
                                             ‘‘Response—[Insert your response].’’                 1. Which types of devices or particular                device ‘‘identifier’’ component of the
                                             You do not have to address each                      devices should be subject to the                       UDI cover or contain?
                                          question. Additionally, for those                       requirements of a UDI system? Which                       c. With respect to the production
                                          questions pertaining to economic issues                 types of devices or particular devices                 identifier, we note that the statute says
                                          or the prevalence of a particular                       should be excepted?                                    that the UDI may include information
                                          problem or action, please provide data                                                                         on the device’s lot or serial number.
                                          and/or references so that we may                           Section 519(f) of the act states that the
                                                                                                  Secretary of Health and Human Services                 When should lot or serial number
                                          understand the basis for your comment,                                                                         information be required for a device?
                                          figures, and any assumptions that you                   may provide ‘‘an exception for a
                                                                                                  particular device or type of device.’’                 Are there particular devices for which
                                          used.                                                                                                          serial numbers should be required? If
                                             As this workshop will only take place                However, the statute does not specify
                                                                                                  any criteria for an exception, nor does                yes, what particular devices should be
                                          over the course of a single day, in order                                                                      labeled with a serial number? Please
                                          to most effectively use this time and                   it describe the scope of an exception.
                                                                                                     a. Should all devices be subject to the             explain your reasoning.
                                          obtain as much information from as                                                                                d. How might we ensure that UDIs,
                                          many diffferent points of view as                       requirements of a UDI system? Please
                                                                                                  explain your reasoning.                                regardless of the manufacturers or
                                          possible, the public workshop will be                                                                          devices associated with those UDIs, are
                                                                                                     b. Are there types of devices or
                                          divided into sessions that focus on each                                                                       uniform or standardized in their
                                                                                                  particular devices that should receive an
                                          of the main topic areas. Each session                   exception from the requirements of a                   structure or composition? For example,
                                          will begin with an invited presentation                 UDI system? If so, what types of devices               the NDC (National Drug Code) number
                                          to describe the issue. This will be                     or particular devices should receive an                is always 10 digits long and always
                                          followed by a moderated question and                    exception and why?                                     presents the labeler code first, followed
                                          comment session. Following this                                                                                by the product code and then the
                                          discussion, the moderator will open up                  2. What are the characteristics or aspects             package code. Should we limit the
                                          the discussion to questions and                         necessary to uniquely identify a device?               number of ways that the UDI can be
                                          comments on the topic from the                             Section 519(f) of the act states that the           created or the standards to be used?
                                          audience. Though limited, at the end of                 UDI ‘‘shall adequately identify the                       e. How should the UDI be created to
                                          the day there will be time for other                    device through distribution and use,                   ensure that UDIs are unique?
                                          presentations.                                          and may include information on the lot
                                             Because of the workshop’s format, we                                                                        4. Where should the UDI be placed?
                                                                                                  or serial number.’’ The statutory                      What should be the criteria for
                                          will only have a short time for                         language does not describe the
                                          additional presentations. We encourage                                                                         alternative placement of the UDI?
                                                                                                  characteristics or features that make a
                                          attendees to raise their issues and                     device ‘‘unique’’ or that ‘‘adequately                    The statute requires the label of
                                          concerns during the discussion portion                  identify the device through distribution               devices to bear a unique identifier,
                                          of the main topic areas. We also                        and use.’’                                             unless we require an ‘‘alternative
                                          encourage persons and groups having                        a. What characteristics are needed to               placement’’ or provide an exception.
                                          similar interests to consolidate their                  uniquely identify a device?                            Section 201(k) of the act defines ‘‘label’’
                                          information and present it through a                       b. What core attributes, elements, or               ‘‘as a display of written, printed, or
                                          single representative.                                  characteristics of a device should                     graphic matter upon the immediate
                                             Additionally, through this public                    constitute a minimum data set for a                    container of any article; and a
                                          workshop, we hope to gain greater                       device identifier?                                     requirement made by or under authority
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                                          understanding of various automatic                         c. What changes to an attribute,                    of this act that any word, statement, or
                                          identification technologies. Therefore,                 element, or characteristic associated                  other information appear on the label
                                          we invite manufacturers and                             with the unique identification of a                    shall not be considered to be complied
                                          organizations that market or have in                    device change should result in a new                   with unless such word, statement, or
                                          development automatic identification                    UDI?                                                   other information also appears on the


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                                                                       Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices                                             2603

                                          outside container or wrapper, if any                    describe those devices and explain why                 would enable hospitals and other
                                          there be, of the retail package of such                 the UDI cannot or should not go on the                 parties who might read or use a UDI to
                                          article, or is easily legible through the               device.                                                make specific investments in scanning
                                          outside container or wrapper.’’                            c. If we allow for ‘‘alternative                    or reading equipment, but the
                                             a. Should we specify where on the                    placement’’ of the UDI for some                        technology chosen might not be easily
                                          label the UDI must appear? If so, where                 particular devices or types of devices,                applied to all devices (if we require the
                                          should the UDI appear on the label?                     what should be the general criteria for                UDI to be placed somewhere other than
                                          Please explain your reasoning.                          requiring ‘‘alternative placement’’ of the             the label.) For this question, we are
                                             i. Should we allow the components of                 UDI, e.g., such as on the device itself or             particularly interested in hearing from
                                          the UDI to be placed separately on the                  other location that is not on the label?               parties who might use UDIs as well as
                                          same package or on different levels of                     d. What specific challenges or                      entities that may have already adopted
                                          packaging? For example, if the UDI                      limitations exist regarding ‘‘alternative              or installed device identification
                                          consists of a device identifier                         placement?’’ For example, placing a UDI                systems.
                                          component and a production identifier                   in an automatic identification form on                    c. Should we allow the use of
                                          component, should we allow the device                   an implantable device may present                      different automatic identification
                                          identifier component of the UDI to be                   issues as to whether the automatic                     technologies to express different parts of
                                          placed in one location and allow the                    identification technology affects the                  the UDI? For example, the device
                                          production identifier component to be                   device’s integrity or function. As                     identifier component might be
                                          placed elsewhere on the label or on the                 another example, certain devices, such                 expressed in a linear bar code and the
                                          device? Please explain your reasoning.                  as software, may pose particular                       production identifier component might
                                             As another example, some devices are                 challenges for how to label with a UDI.                be expressed in a 2D bar code. Allowing
                                          packaged individually and then                                                                                 the use of different technologies for
                                          packaged again in a larger container                    5. How should the UDI be presented?
                                                                                                                                                         different components of the UDI may
                                          (such as a ‘‘shelf pack’’). We are aware                   We are aware of several automatic                   enable manufacturers to make more
                                          that some manufacturers would prefer                    identification technologies in use, such               efficient use of label space or space on
                                          placing both the device identifier                      as linear bar codes, 2D bar codes, and                 the device itself, but it also could
                                          component of the UDI and the                            radio frequency identification. We also                generate confusion as to which
                                          production identifier component of the                  note that various FDA regulations and                  identifier to read or scan and could
                                          UDI on the larger container and placing                 initiatives have required or                           necessitate the purchase of several types
                                          only the device identifier component of                 recommended one or more automatic                      of reading and scanning equipment.
                                          the UDI on the individual packages.                     identification technologies (see 21 CFR                   d. Are there existing standards or
                                          Separating UDI components or allowing                   201.25 (bar code label requirement for                 systems we should consider in
                                          part (rather than all) of the UDI on                    human drug products); 21 CFR 610.67                    establishing the requirements for how
                                          package labels may provide for                          (bar code label requirement for                        the UDI must be presented? For
                                          flexibility in product labeling, but also               biological products); Ref. 2; and section              example, we are aware of various
                                          generate confusion as to which UDI to                   505D of the act (21 U.S.C. 355e)                       standards organizations, such as GS1
                                          read or scan (if the UDI components are                 (regarding ‘‘pharmaceutical security’’                 and the HIBCC, that exist and have
                                          separated) or limit the usefulness of the               and specifying ‘‘promising                             specific formats or specifications for
                                          UDI if a component of the UDI is not                    technologies’’ such as RFID (radio-                    automatic identifiers for products.
                                          present.                                                frequency identification),                             Should we allow any or all of these
                                             ii. For barcodes (whether linear or                  nanotechnology, encryption                             standards to be used?
                                          two-dimensional (2D)), should we                        technologies, and other ‘‘track-and-trace
                                          require the UDI to be expressed in a                    or authentication technologies’’) ).                   6. How should the UDI Database be
                                          concatenated manner (whereby the                        Therefore:                                             developed and maintained?
                                          components of the UDI are expressed on                     a. Should we require human-readable                    For parties to benefit from UDI
                                          the same line adjacent to each other) or                UDIs or automatic identification of UDIs               information, it would seem necessary
                                          in a stacked manner (whereby one                        or both? Are there devices where it                    for those parties to know, at a minimum,
                                          component of the UDI rests atop the                     would be sufficient to have human-                     the UDIs that exist, the specific device
                                          other component)?                                       readable UDIs alone? Please explain                    associated with each UDI, and the
                                             b. Are there devices where we should                 your reasoning. For example, devices                   information associated with each UDI. It
                                          require the UDI to appear on the device                 used in a home care setting might not                  might be efficient for one entity to
                                          itself (direct part marking)? For                       need an automatic identification UDI                   collect the UDIs, associate those UDIs
                                          example, it might be beneficial to put                  because the home might not be                          with specific devices, and make the
                                          the UDI on the device itself if the device              equipped to read the automatic                         information associated with those UDIs
                                          is re-processed because this might help                 identifier. Are there situations where we              publicly available. However, it is also
                                          firms identify or record how many times                 should require both human-readable                     conceivable (but perhaps less efficient
                                          a particular device has been                            and automatic identification UDIs?                     or more costly) that the information
                                          reprocessed. Similarly, certain single                  Please explain your reasoning.                         could rest with individual
                                          use devices (SUDs) sometimes are                           b. Should we specify a particular type              manufacturers themselves (rather than
                                          reprocessed, so a UDI on the device                     of automatic identification technology                 FDA) or with a third party or third
                                          itself could facilitate the mandatory and               or should we allow the automatic                       parties. Consequently:
                                          voluntary MedWatch reporting relating                   identification technology to vary                         a. How and when should we require
                                          to such reprocessed devices or facilitate               depending on the type of device?                       UDIs and associated information to be
                                          other activities (such as documenting                   Should we identify automatic                           entered into a database? How frequently
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                                          sterilization reprocessing of SUDs and                  identification standards (as opposed to                should we require changes to a UDI or
                                          validation studies) associated with                     specific technologies) that can be used?               to the information associated with or
                                          SUDs. Conversely, are there devices                     Please explain your reasoning.                         linked to a UDI to be reported?
                                          where the UDI cannot or should not go                   Specifying a particular type of                           b. Aside from information that is
                                          on the device itself? If so, please                     automatic identification technology                    necessary to uniquely identify a device,


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                                          2604                         Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices

                                          what other information (if any) should                  standardized identifier? Please describe               adverse event reporting? Please describe
                                          be part of a UDI system database or                     any plans you have to change these                     the magnitude of the problems you have
                                          otherwise linked to the UDIs?                           practices in the near future.                          encountered.
                                            c. If variable data (such as a lot or                    b. Changing current identifiers. If you
                                          serial number) is necessary to uniquely                 were to add a UDI or change the                        III. References
                                          identify a device, should such data be                  presentation of your current identifier,                  The following references have been
                                          included in a UDI system database?                      please describe your approximate                       placed on display in the Division of
                                                                                                  expected capital and operating costs                   Dockets Management (see Comments)
                                          C. Questions Pertaining to Possible                                                                            and may be seen by interested persons
                                                                                                  (including labor) to plan for, implement,
                                          Impacts of a UDI System                                                                                        between 9 a.m. and 4 p.m., Monday
                                                                                                  and apply a UDI to product labeling. To
                                             Many production situations that                      provide context for your estimate,                     through Friday.
                                          might be affected by UDI requirements                   please explain your expected approach                    1. 153 Cong. Rec. H10597 (daily ed.,
                                          are complex. In its basic form, a device                to adding a UDI, considering the                       September 19, 2007) (statement of Rep.
                                          identifier is a series of digits and/or                                                                        Hooley).
                                                                                                  possibility that a UDI might be a static
                                          letters associated with a specific device.                                                                       2. FDA, ‘‘FDA Counterfeit Drug Task Force
                                                                                                  number (e.g., a manufacturer/product                   Report: 2006 Update,’’ p. 12, (http://
                                          At a minimum, a system can be thought                   code) or that it might include a variable              www.fda.gov/oc/initiatives/counterfeit/
                                          of as the set of procedures that allow                  number (e.g., manufacturer/product/lot                 report6l06.pdf) (advocating use of RFID).
                                          stakeholders to use an identifier.                      code).
                                          Through public consultation, however,                      c. Encoding variable data. If you were              IV. Where and When Will the Public
                                          FDA has found that there are many                       to add a UDI bar code with variable data               Workshop Occur?
                                          different views as to the purpose of a                  (such as lot or serial number) to medical                 We will hold the public workshop on
                                          UDI system and different opinions about                 device labeling, please describe how                   February 12, 2009, from 9 a.m. to 5 p.m.,
                                          how to describe and implement a UDI                     you would print the variable bar coded                 at the Marriott Gaithersburg
                                          system. Because of the diversity of                     information. For example, do you                       Washingtonian Center, 9751
                                          affected devices and manufacturing                      foresee using on-line label printing,                  Washingtonian Blvd., Gaithersburg, MD
                                          processes, we expect that affected                      other in-house printing, or contract                   20878.
                                          entities might comply with UDI                          printers to add a UDI bar code?                        V. Do You Have To Register To Attend
                                          requirements in a variety of ways. If you                  d. Production line impacts.
                                                                                                                                                         a Public Workshop or To Make a
                                          respond to the following questions                      Considering your operations, are there
                                                                                                                                                         Presentation?
                                          about the costs and benefits of a UDI                   products where adding a UDI (human
                                          system, we encourage you to provide as                  readable or barcode; static or variable) to              If you wish to make a presentation at
                                          much detail and context as possible. For                labeling would not be feasible without                 or to attend the public workshop, please
                                          example, if you identify exceptional                    major capital investment or overhauling                register online at http://www.fda.gov/
                                          costs related to incorporating a UDI in                 production lines? If so, please describe               cdrh/ocd/udi/index.html by January 30,
                                          certain production lines, we need to                    the products and suggest alternatives or               2009. The online registration form will
                                          understand the production process                       solutions.                                             instruct you as to the information you
                                          details. In addition, we specifically                      e. Small devices and small packages.                should provide. Space may be limited,
                                          invite small businesses to provide                      A UDI could present a challenge for                    and we will close on-site registration
                                          information about a UDI’s potential                     some small packages. What percentage                   when the maximum seating capacity is
                                          impact.                                                 of your product line consists of devices               reached.
                                                                                                  whose small size could make placing a                    We will try to accommodate all
                                          1. What is the magnitude of the problem                                                                        persons who wish to make a
                                                                                                  UDI on a label problematic? Of those
                                          to be addressed by the establishment of                                                                        presentation. The time allotted for
                                                                                                  devices identified, what ‘‘alternative
                                          a UDI system?                                                                                                  presentations will depend on the
                                                                                                  placement’’ of the UDI would be
                                             Please describe and provide                          feasible? Please explain your reasoning.               number of people who wish to speak on
                                          qualitative or quantitative evidence of                 Please describe the nature of the                      a given topic, and the public workshop
                                          the incidence of deaths, injuries and                   problems and costs to solve such                       schedule. Similarly, the time allotted to
                                          illnesses associated with medical                       problems. Please suggest alternatives or               each topic may vary depending on the
                                          devices. What role would a UDI system                   solutions.                                             expressed interests of persons
                                          play in helping to reduce the incidence                                                                        registering for the public workshop. To
                                          of such deaths, injuries, and illnesses                 3. Questions for hospitals, nursing                    obtain updates on the public workshop,
                                          and how might the structure of a UDI                    homes, and clinics                                     please visit http://www.fda.gov/cdrh/
                                          system facilitate this role?                               a. Using a UDI. If UDIs were placed                 ocd/udi/index.html. Additionally,
                                                                                                  on at least some medical devices, what                 regardless of whether you wish to make
                                          2. Questions for manufacturers                                                                                 a presentation or simply attend the
                                                                                                  functions could a UDI serve in your
                                             a. Current practices. Describe your                  institution?                                           public workshop, if you need any
                                          current practices for applying standards                   b. Expenses. What expenses do you                   special accommodations (such as
                                          to medical devices, marking identifiers                 foresee in attempting to capture and use               wheelchair access or a sign language
                                          on medical device labeling and                          UDIs placed on medical devices? If you                 interpreter), please notify Jay Crowley
                                          managing medical device identifier                      foresee using UDIs, how would you                      (see Contact Person) by January 30,
                                          data. For example, how do you                           modify operations in your facility?                    2009.
                                          currently use classification standards                     c. Adverse event reporting and recalls.               Please note that on January 15, 2008,
                                          such as UNSPSC (United Nations                          How would capturing the UDI change                     the FDA Division of Dockets
                                          Standard Products Service Code),                        your recall management or adverse                      Management Web site transitioned to
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                                          nomenclature standards such as GMDN                     event reporting? For recalls or adverse                the Federal Dockets Management
                                          (Global Medical Device Nomenclature),                   events involving the most serious device               System (FDMS). FDMS is a
                                          and identification standards such as                    malfunctions or failures, how have                     Government-wide, electronic docket
                                          GS1 or HIBCC? What percent of your                      problems in device identification                      management system. Electronic
                                          devices are not currently marked with a                 impaired your recall management or                     comments or submissions will be


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                                                                       Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices                                             2605

                                          accepted by FDA only through FDMS at                    ADDRESSES:  Submit written comments                       • Automated Broker Interface (ABI):
                                          http://www.regulations.gov.                             regarding this SSC pilot program to the                An integral part of the Automated
                                             Transcripts: Transcripts of the public               Division of Dockets Management (HFA–                   Commercial System, ABI is the means
                                          workshop may be requested in writing                    305), Food and Drug Administration,                    by which brokers or importers transmit
                                          from the Freedom of Information Office                  5630 Fishers Lane, rm. 1061, Rockville,                entry data to the U.S. Customs and
                                          (HFI–35), Food and Drug                                 MD 20852. Submit electronic comments                   Border Protection (CBP).
                                          Administration, 5600 Fishers Lane, rm.                  to http://www.regulations.gov. Submit                     • Automated Commercial System
                                          6–30, Rockville, MD 20857,                              written comments on the collection of                  (ACS): The system used by CBP to track,
                                          approximately 15 working days after the                 information to the Division of Dockets                 control, and process all commercial
                                          public workshop at a cost of 10 cents                   Management (HFA–305), Food and Drug                    goods imported into the United States.
                                          per page. A transcript of the public                    Administration, 5630 Fishers Lane, rm.                    • Broker/Customs Broker/Filer: A
                                          workshop will be available on the                       1061, Rockville, MD 20852. Submit                      licensed Customs broker hired to file
                                          Internet at http://www.fda.gov/cdrh/                    electronic comments on the collection                  entries for another party or a Customs
                                          ocd/udi.index.html.                                     of information to http://                              ABI participant that files its own
                                            Dated: January 6, 2009.                               www.regulations.gov. All comments                      entries.
                                          Jeffrey Shuren,                                         should be identified with the docket                      • Customs-Trade Partnership Against
                                          Associate Commissioner for Policy and                   number found in brackets in the                        Terrorism (CTPAT): CTPAT is the CBP
                                          Planning.                                               heading of this document.                              initiative that partners with members of
                                          [FR Doc. E9–784 Filed 1–14–09; 8:45 am]                 FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                         the trade community on a voluntary
                                          BILLING CODE 4160–01–S                                  Kathleen Anderson, Office of                           basis to better secure the international
                                                                                                  Compliance, Division of New Drugs and                  product supply chain to the United
                                                                                                  Labeling Compliance, Food and Drug                     States.
                                          DEPARTMENT OF HEALTH AND                                Administration, Center for Drug                           • Foreign Shipper: The firm
                                          HUMAN SERVICES                                          Evaluation and Research, 10903 New                     identified or declared as the shipper at
                                                                                                  Hampshire Ave., Bldg. 51, rm. 5182,                    time of entry into the United States.
                                          Food and Drug Administration                                                                                      • Importer of Record: The person,
                                                                                                  Silver Spring, MD 20993, 301–796–
                                                                                                                                                         establishment, or representative
                                          [Docket No. FDA–2008–N–0656]                            3110.
                                                                                                                                                         responsible for making entry of
                                          Secure Supply Chain Pilot Program;                      SUPPLEMENTARY INFORMATION:                             imported goods in accordance with all
                                          Notice of Pilot Program                                                                                        laws affecting such importation.
                                                                                                  I. Background
                                                                                                                                                            • ‘‘May Proceed’’: This term means
                                          AGENCY:    Food and Drug Administration,                   The SSC pilot program is part of                    that an FDA-regulated imported product
                                          HHS.                                                    FDA’s risk-based approach to regulating                may proceed into domestic commerce
                                          ACTION:   Notice.                                       drug imports, and it follows the                       after the electronic screening. This is
                                                                                                  President’s charge to the Interagency                  not a decision by FDA about the
                                          SUMMARY: The Food and Drug
                                                                                                  Working Group on Import Safety to                      product’s regulatory status, and it does
                                          Administration (FDA) is announcing an
                                                                                                  better assure that imported products are               not preclude FDA action at a later time.
                                          opportunity for sponsors and foreign
                                                                                                  safe.                                                     • Manufacturer ID (MID):
                                          manufacturers of finished drug products
                                                                                                     The goal of the pilot program is to                 Manufacturer identification code
                                          and active pharmaceutical ingredients
                                                                                                  allow FDA to determine the practicality                constructed with specific segments of
                                          (APIs) intended for human use imported
                                          by a secure supply chain to apply to                    of developing a secure supply chain                    the manufacturer’s or shipper’s name
                                          participate in a voluntary Secure Supply                program. The information obtained from                 and address. Refer to CBP Customs
                                          Chain (SSC) pilot program to be                         this pilot program will assist FDA in its              Directive Number 3550–055 (Old
                                          conducted by FDA’s Center for Drug                      determination. A Secure Supply Chain                   Number 3500–13), dated November 24,
                                          Evaluation and Research (CDER) and                      program would assist the agency in its                 1986, for instructions on determining
                                          Office of Regulatory Affairs (ORA). The                 efforts to prevent the importation of                  the manufacturer ID.
                                          goal of the pilot program is to allow                   adulterated, misbranded, or unapproved                    • Ultimate Consignee: The party in
                                          FDA to determine the practicality of                    drugs by allowing the agency to focus its              the United States, at the time of entry or
                                          developing a secure supply chain                        resources on imported drugs that fall                  release, to whom the overseas shipper
                                          program. The information obtained from                  outside the program and that may pose                  sold the imported merchandise. If at the
                                          this pilot program will assist FDA in its               such risks. Such a program would                       time of entry the imported merchandise
                                          determination. A Secure Supply Chain                    increase the likelihood of expedited                   has not been sold, then the Ultimate
                                          program would assist the agency in its                  entry for specific finished drug products              Consignee at the time of entry or release
                                          efforts to prevent the importation of                   and APIs imported into the United                      is defined as the party in the United
                                          adulterated, misbranded, or unapproved                  States that meet the criteria for selection            States to whom the overseas shipper
                                          drugs by allowing the agency to focus its               under the program.                                     consigned the imported merchandise.
                                          resources on imported drugs outside the                                                                        III. SSC Pilot Program
                                                                                                  II. Definitions for the Purposes of This
                                          program that may pose such risks. Such
                                                                                                  Program                                                A. Description
                                          a program would increase the likelihood
                                          of expedited entry for specific finished                  • Affirmation of Compliance (AofC)                     The SSC pilot program will be jointly
                                          drug products and APIs imported into                    Code: A code designated by FDA for use                 administered by the Office of
                                          the United States that meet the criteria                by filers to convey information related                Compliance in CDER and the Division
                                          for selection under the program.                        to product or firm compliance with                     of Import Operations and Policy (DIOP)
jlentini on PROD1PC65 with NOTICES




                                          DATES: Submit written or electronic                     agency requirements, used to help                      in ORA. To be selected to participate in
                                          comments on this pilot program by                       expedite entry processing. Some AofC                   the SSC pilot program, an application
                                          March 16, 2009. Submit written or                       codes require a qualifier to provide                   must meet the following criteria:
                                          electronic comments on the collection                   additional information to aid in                         1. The applicant must submit a
                                          of information by March 16, 2009.                       expedited processing.                                  complete application, which is Form


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