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
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
jlentini on PROD1PC65 with NOTICES
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.
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
jlentini on PROD1PC65 with NOTICES
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
jlentini on PROD1PC65 with NOTICES
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
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
jlentini on PROD1PC65 with NOTICES
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.
• ‘‘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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