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

Trade Association.’’ In this final 

guidance, FDA is announcing that: (1) 

We intend to proceed with a 

Certification Referral Program to NOAA 

SIP, without a 24-month test period, (2) 

we intend to expand the program to 

include all fish and fishery products for 

export to the EU and EFTA, and (3) we 

intend to stop issuing EU Export 

Certificates effective February 17, 2009. 

The agency intends to adopt this 

approach because the industry’s 

demand for EU Export Certificates 

continues to rise dramatically, and FDA 

can no longer justify the use of our 

limited food safety resources for 

issuance of EU Export Certificates. The 

implementation of this guidance should 

free up resources that the agency can 

allocate for higher priority public health 

activities that are intended to protect the 

U.S. consuming public, while still 

providing a mechanism for the industry 

to continue obtaining EU certification. 

Seafood processors and other entities 

involved in the exporting of seafood to 

the EU may obtain EU Export 

Certificates from the NOAA SIP. 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA, 

NOAA SIP, or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The guidance 

and received comments may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document at 

http://www.cfsan.fda.gov/ 

guidance.html. 

Dated: January 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–785 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0661] 

Unique Device Identification System; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled: ‘‘Unique Device Identification 

System.’’ The purpose of the public 

workshop is to obtain information to 

help us better understand the issues 

involved in the establishment of a 

unique device identification system 

(UDI system) and request comments on 

this topic. 

Dates and Time: The public workshop 

will be held on, February 12, 2009, from 

9 a.m. to 5 p.m. See section V of this 

document for additional dates 

associated with registration and 

participation in the workshop. 

Location: The public workshop will 

be held at the Marriott Gaithersburg 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD 

20878, 301–590–0044. 

Contact Person: Jay Crowley, Food 

and Drug Administration, Center for 

Devices and Radiological Health (HFZ– 

500), 1350 Piccard Dr., Rockville, MD 

20852, 240–276–2389, or Stephen 

Ripley, Food and Drug Administration, 

Center for Biologics Evaluation and 

Research (HFM–17), 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852, 

301–827–6210. 

Registration: Register electronically at 

http://www.fda.gov/cdrh/ocd/udi/ 

index.htmlby January 30, 2009. There is 

no registration fee for the public 

workshop. Early registration is 

recommended because seating is 

limited. Registration on the day of the 

public workshop will be provided on a 

space available basis beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please contact Jay 

Crowley (see Contact Person) by January 

30, 2009. 

Comments: Regardless of attendance 

at the public workshop, interested 

persons may submit written or 

electronic comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. The deadline for submitting 

comments regarding this public 

workshop is February 27, 2009. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. What Does Section 226 of the Food 

and Drug Administration Amendments 

Act of 2007 (FDAAA) Require? 

On September 27, 2007, President 

George W. Bush signed into law FDAAA 

(Public Law 110–85). Section 226 of 

FDAAA amended the Federal Food, 

Drug, and Cosmetic Act (the act) by 

requiring the establishment of a UDI 

system. Specifically, section 226(a) of 

FDAAA created a new section 519(f) of 

the act (21 U.S.C. 360i(f)) stating that 

‘‘The Secretary shall promulgate 

regulations establishing a unique device 

identification system for medical 

devices requiring the label of devices to 

bear a unique identifier, unless the 

Secretary requires an alternative 

placement or provides an exception for 

a particular device or type of device. 

The unique identifier shall adequately 

identify the device through distribution 

and use, and may include information 

on the lot or serial number.’’ 

A UDI system may provide for early 

detection of the warning signs of a 

defective device and facilitate device 

recalls (Ref. 1) and other possible 

benefits of a UDI system have been 

suggested. 

B. Why Are We Holding a Public 

Workshop? 

The enactment of section 519(f) of the 

act has raised many questions for our 

consideration. For example, the statute 

requires the UDI to go on the device’s 

label, but it also allows for ‘‘alternative 

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 

alternative placement of the UDI, and 

which devices should receive an 

exception from a UDI requirement? 

Consequently, we are issuing this notice 

to announce that we will hold a public 

workshop to discuss and to invite 

comment on the questions set out in 

section II. B of this document. 

II. Issues to Be Considered 

A. Organization and Basic Instructions 

We invite comments on the questions 

presented in this section. We intend to 

discuss these same questions at the 

public workshop. If you wish to 

comment in writing on a particular 

question, please identify the question 

that you are addressing before providing 

your response to the question. For 

example, your comment could take the 

following format: 

‘‘Question 1—[Quote the question].’’ 

‘‘Response—[Insert your response].’’ 

You do not have to address each 

question. Additionally, for those 

questions pertaining to economic issues 

or the prevalence of a particular 

problem or action, please provide data 

and/or references so that we may 

understand the basis for your comment, 

figures, and any assumptions that you 

used. 

As this workshop will only take place 

over the course of a single day, in order 

to most effectively use this time and 

obtain as much information from as 

many diffferent points of view as 

possible, the public workshop will be 

divided into sessions that focus on each 

of the main topic areas. Each session 

will begin with an invited presentation 

to describe the issue. This will be 

followed by a moderated question and 

comment session. Following this 

discussion, the moderator will open up 

the discussion to questions and 

comments on the topic from the 

audience. Though limited, at the end of 

the day there will be time for other 

presentations. 

Because of the workshop’s format, we 

will only have a short time for 

additional presentations. We encourage 

attendees to raise their issues and 

concerns during the discussion portion 

of the main topic areas. We also 

encourage persons and groups having 

similar interests to consolidate their 

information and present it through a 

single representative. 

Additionally, through this public 

workshop, we hope to gain greater 

understanding of various automatic 

identification technologies. Therefore, 

we invite manufacturers and 

organizations that market or have in 

development automatic identification 

technologies, which could be used with 

medical devices, to display these 

technologies. Questions about whether 

your product or technology would fall 

within the scope of this vendor display 

should be directed to the contact 

persons listed at the beginning of this 

notice. 

You may register to present at the 

public workshop or participate in the 

vendor display at http://www.fda.gov/ 

cdrh/ocd/udi/index.html. Because of 

time constraints, vendors may register 

either to present at the public workshop 

or participate in the vendor display. 

You may not register for both. If you 

choose to participate in the vendor 

display, you will have the opportunity 

to share information about your 

products with FDA and other attendees 

when they visit your display. 

B. Questions Pertaining to the UDI 

System 

1. Which types of devices or particular 

devices should be subject to the 

requirements of a UDI system? Which 

types of devices or particular devices 

should be excepted? 

Section 519(f) of the act states that the 

Secretary of Health and Human Services 

may provide ‘‘an exception for a 

particular device or type of device.’’ 

However, the statute does not specify 

any criteria for an exception, nor does 

it describe the scope of an exception. 

a. Should all devices be subject to the 

requirements of a UDI system? Please 

explain your reasoning. 

b. Are there types of devices or 

particular devices that should receive an 

exception from the requirements of a 

UDI system? If so, what types of devices 

or particular devices should receive an 

exception and why? 

2. What are the characteristics or aspects 

necessary to uniquely identify a device? 

Section 519(f) of the act states that the 

UDI ‘‘shall adequately identify the 

device through distribution and use, 

and may include information on the lot 

or serial number.’’ The statutory 

language does not describe the 

characteristics or features that make a 

device ‘‘unique’’ or that ‘‘adequately 

identify the device through distribution 

and use.’’ 

a. What characteristics are needed to 

uniquely identify a device? 

b. What core attributes, elements, or 

characteristics of a device should 

constitute a minimum data set for a 

device identifier? 

c. What changes to an attribute, 

element, or characteristic associated 

with the unique identification of a 

device change should result in a new 

UDI? 

d. Should the UDI include a 

component that represents package size 

or packaging level? 

e. To what extent would or should the 

list of unique device characteristics vary 

depending on the type of device? 

3. What should be the UDI’s 

components? 

a. Could existing standards, such as 

the standards used by GS1, Health 

Industry Business Communications 

Council (HIBCC), or others be used as a 

model for the UDI system? What are the 

advantages and disadvantages of these 

existing organizations and standards? 

b. Some identification systems 

currently in use employ a combination 

of a device identifier (meaning 

information that identifies the 

manufacturer, make, and/or model of 

the device) and a production identifier 

(meaning information that relates to the 

lot or serial number). What should the 

device ‘‘identifier’’ component of the 

UDI cover or contain? 

c. With respect to the production 

identifier, we note that the statute says 

that the UDI may include information 

on the device’s lot or serial number. 

When should lot or serial number 

information be required for a device? 

Are there particular devices for which 

serial numbers should be required? If 

yes, what particular devices should be 

labeled with a serial number? Please 

explain your reasoning. 

d. How might we ensure that UDIs, 

regardless of the manufacturers or 

devices associated with those UDIs, are 

uniform or standardized in their 

structure or composition? For example, 

the NDC (National Drug Code) number 

is always 10 digits long and always 

presents the labeler code first, followed 

by the product code and then the 

package code. Should we limit the 

number of ways that the UDI can be 

created or the standards to be used? 

e. How should the UDI be created to 

ensure that UDIs are unique? 

4. Where should the UDI be placed? 

What should be the criteria for 

alternative placement of the UDI? 

The statute requires the label of 

devices to bear a unique identifier, 

unless we require an ‘‘alternative 

placement’’ or provide an exception. 

Section 201(k) of the act defines ‘‘label’’ 

‘‘as a display of written, printed, or 

graphic matter upon the immediate 

container of any article; and a 

requirement made by or under authority 

of this act that any word, statement, or 

other information appear on the label 

shall not be considered to be complied 

with unless such word, statement, or 

other information also appears on the 


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outside container or wrapper, if any 

there be, of the retail package of such 

article, or is easily legible through the 

outside container or wrapper.’’ 

a. Should we specify where on the 

label the UDI must appear? If so, where 

should the UDI appear on the label? 

Please explain your reasoning. 

i. Should we allow the components of 

the UDI to be placed separately on the 

same package or on different levels of 

packaging? For example, if the UDI 

consists of a device identifier 

component and a production identifier 

component, should we allow the device 

identifier component of the UDI to be 

placed in one location and allow the 

production identifier component to be 

placed elsewhere on the label or on the 

device? Please explain your reasoning. 

As another example, some devices are 

packaged individually and then 

packaged again in a larger container 

(such as a ‘‘shelf pack’’). We are aware 

that some manufacturers would prefer 

placing both the device identifier 

component of the UDI and the 

production identifier component of the 

UDI on the larger container and placing 

only the device identifier component of 

the UDI on the individual packages. 

Separating UDI components or allowing 

part (rather than all) of the UDI on 

package labels may provide for 

flexibility in product labeling, but also 

generate confusion as to which UDI to 

read or scan (if the UDI components are 

separated) or limit the usefulness of the 

UDI if a component of the UDI is not 

present. 

ii. For barcodes (whether linear or 

two-dimensional (2D)), should we 

require the UDI to be expressed in a 

concatenated manner (whereby the 

components of the UDI are expressed on 

the same line adjacent to each other) or 

in a stacked manner (whereby one 

component of the UDI rests atop the 

other component)? 

b. Are there devices where we should 

require the UDI to appear on the device 

itself (direct part marking)? For 

example, it might be beneficial to put 

the UDI on the device itself if the device 

is re-processed because this might help 

firms identify or record how many times 

a particular device has been 

reprocessed. Similarly, certain single 

use devices (SUDs) sometimes are 

reprocessed, so a UDI on the device 

itself could facilitate the mandatory and 

voluntary MedWatch reporting relating 

to such reprocessed devices or facilitate 

other activities (such as documenting 

sterilization reprocessing of SUDs and 

validation studies) associated with 

SUDs. Conversely, are there devices 

where the UDI cannot or should not go 

on the device itself? If so, please 

describe those devices and explain why 

the UDI cannot or should not go on the 

device. 

c. If we allow for ‘‘alternative 

placement’’ of the UDI for some 

particular devices or types of devices, 

what should be the general criteria for 

requiring ‘‘alternative placement’’ of the 

UDI, e.g., such as on the device itself or 

other location that is not on the label? 

d. What specific challenges or 

limitations exist regarding ‘‘alternative 

placement?’’ For example, placing a UDI 

in an automatic identification form on 

an implantable device may present 

issues as to whether the automatic 

identification technology affects the 

device’s integrity or function. As 

another example, certain devices, such 

as software, may pose particular 

challenges for how to label with a UDI. 

5. How should the UDI be presented? 

We are aware of several automatic 

identification technologies in use, such 

as linear bar codes, 2D bar codes, and 

radio frequency identification. We also 

note that various FDA regulations and 

initiatives have required or 

recommended one or more automatic 

identification technologies (see 21 CFR 

201.25 (bar code label requirement for 

human drug products); 21 CFR 610.67 

(bar code label requirement for 

biological products); Ref. 2; and section 

505D of the act (21 U.S.C. 355e) 

(regarding ‘‘pharmaceutical security’’ 

and specifying ‘‘promising 

technologies’’ such as RFID (radiofrequency identification), 

nanotechnology, encryption 

technologies, and other ‘‘track-and-trace 

or authentication technologies’’) ). 

Therefore: 

a. Should we require human-readable 

UDIs or automatic identification of UDIs 

or both? Are there devices where it 

would be sufficient to have humanreadable UDIs alone? Please explain 

your reasoning. For example, devices 

used in a home care setting might not 

need an automatic identification UDI 

because the home might not be 

equipped to read the automatic 

identifier. Are there situations where we 

should require both human-readable 

and automatic identification UDIs? 

Please explain your reasoning. 

b. Should we specify a particular type 

of automatic identification technology 

or should we allow the automatic 

identification technology to vary 

depending on the type of device? 

Should we identify automatic 

identification standards (as opposed to 

specific technologies) that can be used? 

Please explain your reasoning. 

Specifying a particular type of 

automatic identification technology 

would enable hospitals and other 

parties who might read or use a UDI to 

make specific investments in scanning 

or reading equipment, but the 

technology chosen might not be easily 

applied to all devices (if we require the 

UDI to be placed somewhere other than 

the label.) For this question, we are 

particularly interested in hearing from 

parties who might use UDIs as well as 

entities that may have already adopted 

or installed device identification 

systems. 

c. Should we allow the use of 

different automatic identification 

technologies to express different parts of 

the UDI? For example, the device 

identifier component might be 

expressed in a linear bar code and the 

production identifier component might 

be expressed in a 2D bar code. Allowing 

the use of different technologies for 

different components of the UDI may 

enable manufacturers to make more 

efficient use of label space or space on 

the device itself, but it also could 

generate confusion as to which 

identifier to read or scan and could 

necessitate the purchase of several types 

of reading and scanning equipment. 

d. Are there existing standards or 

systems we should consider in 

establishing the requirements for how 

the UDI must be presented? For 

example, we are aware of various 

standards organizations, such as GS1 

and the HIBCC, that exist and have 

specific formats or specifications for 

automatic identifiers for products. 

Should we allow any or all of these 

standards to be used? 

6. How should the UDI Database be 

developed and maintained? 

For parties to benefit from UDI 

information, it would seem necessary 

for those parties to know, at a minimum, 

the UDIs that exist, the specific device 

associated with each UDI, and the 

information associated with each UDI. It 

might be efficient for one entity to 

collect the UDIs, associate those UDIs 

with specific devices, and make the 

information associated with those UDIs 

publicly available. However, it is also 

conceivable (but perhaps less efficient 

or more costly) that the information 

could rest with individual 

manufacturers themselves (rather than 

FDA) or with a third party or third 

parties. Consequently: 

a. How and when should we require 

UDIs and associated information to be 

entered into a database? How frequently 

should we require changes to a UDI or 

to the information associated with or 

linked to a UDI to be reported? 

b. Aside from information that is 

necessary to uniquely identify a device, 


jlentini on PROD1PC65 with NOTICES
2604 Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / Notices 

what other information (if any) should 

be part of a UDI system database or 

otherwise linked to the UDIs? 

c. If variable data (such as a lot or 

serial number) is necessary to uniquely 

identify a device, should such data be 

included in a UDI system database? 

C. Questions Pertaining to Possible 

Impacts of a UDI System 

Many production situations that 

might be affected by UDI requirements 

are complex. In its basic form, a device 

identifier is a series of digits and/or 

letters associated with a specific device. 

At a minimum, a system can be thought 

of as the set of procedures that allow 

stakeholders to use an identifier. 

Through public consultation, however, 

FDA has found that there are many 

different views as to the purpose of a 

UDI system and different opinions about 

how to describe and implement a UDI 

system. Because of the diversity of 

affected devices and manufacturing 

processes, we expect that affected 

entities might comply with UDI 

requirements in a variety of ways. If you 

respond to the following questions 

about the costs and benefits of a UDI 

system, we encourage you to provide as 

much detail and context as possible. For 

example, if you identify exceptional 

costs related to incorporating a UDI in 

certain production lines, we need to 

understand the production process 

details. In addition, we specifically 

invite small businesses to provide 

information about a UDI’s potential 

impact. 

1. What is the magnitude of the problem 

to be addressed by the establishment of 

a UDI system? 

Please describe and provide 

qualitative or quantitative evidence of 

the incidence of deaths, injuries and 

illnesses associated with medical 

devices. What role would a UDI system 

play in helping to reduce the incidence 

of such deaths, injuries, and illnesses 

and how might the structure of a UDI 

system facilitate this role? 

2. Questions for manufacturers 

a. Current practices. Describe your 

current practices for applying standards 

to medical devices, marking identifiers 

on medical device labeling and 

managing medical device identifier 

data. For example, how do you 

currently use classification standards 

such as UNSPSC (United Nations 

Standard Products Service Code), 

nomenclature standards such as GMDN 

(Global Medical Device Nomenclature), 

and identification standards such as 

GS1 or HIBCC? What percent of your 

devices are not currently marked with a 

standardized identifier? Please describe 

any plans you have to change these 

practices in the near future. 

b. Changing current identifiers. If you 

were to add a UDI or change the 

presentation of your current identifier, 

please describe your approximate 

expected capital and operating costs 

(including labor) to plan for, implement, 

and apply a UDI to product labeling. To 

provide context for your estimate, 

please explain your expected approach 

to adding a UDI, considering the 

possibility that a UDI might be a static 

number (e.g., a manufacturer/product 

code) or that it might include a variable 

number (e.g., manufacturer/product/lot 

code). 

c. Encoding variable data. If you were 

to add a UDI bar code with variable data 

(such as lot or serial number) to medical 

device labeling, please describe how 

you would print the variable bar coded 

information. For example, do you 

foresee using on-line label printing, 

other in-house printing, or contract 

printers to add a UDI bar code? 

d. Production line impacts. 

Considering your operations, are there 

products where adding a UDI (human 

readable or barcode; static or variable) to 

labeling would not be feasible without 

major capital investment or overhauling 

production lines? If so, please describe 

the products and suggest alternatives or 

solutions. 

e. Small devices and small packages. 

A UDI could present a challenge for 

some small packages. What percentage 

of your product line consists of devices 

whose small size could make placing a 

UDI on a label problematic? Of those 

devices identified, what ‘‘alternative 

placement’’ of the UDI would be 

feasible? Please explain your reasoning. 

Please describe the nature of the 

problems and costs to solve such 

problems. Please suggest alternatives or 

solutions. 

3. Questions for hospitals, nursing 

homes, and clinics 

a. Using a UDI. If UDIs were placed 

on at least some medical devices, what 

functions could a UDI serve in your 

institution? 

b. Expenses. What expenses do you 

foresee in attempting to capture and use 

UDIs placed on medical devices? If you 

foresee using UDIs, how would you 

modify operations in your facility? 

c. Adverse event reporting and recalls. 

How would capturing the UDI change 

your recall management or adverse 

event reporting? For recalls or adverse 

events involving the most serious device 

malfunctions or failures, how have 

problems in device identification 

impaired your recall management or 

adverse event reporting? Please describe 

the magnitude of the problems you have 

encountered. 

III. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see Comments) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. 153 Cong. Rec. H10597 (daily ed., 

September 19, 2007) (statement of Rep. 

Hooley). 

2. FDA, ‘‘FDA Counterfeit Drug Task Force 

Report: 2006 Update,’’ p. 12, (http:// 

www.fda.gov/oc/initiatives/counterfeit/ 

report6l06.pdf) (advocating use of RFID). 

IV. Where and When Will the Public 

Workshop Occur? 

We will hold the public workshop on 

February 12, 2009, from 9 a.m. to 5 p.m., 

at the Marriott Gaithersburg 

Washingtonian Center, 9751 

Washingtonian Blvd., Gaithersburg, MD 

20878. 

V. Do You Have To Register To Attend 

a Public Workshop or To Make a 

Presentation? 

If you wish to make a presentation at 

or to attend the public workshop, please 

register online at http://www.fda.gov/ 

cdrh/ocd/udi/index.html by January 30, 

2009. The online registration form will 

instruct you as to the information you 

should provide. Space may be limited, 

and we will close on-site registration 

when the maximum seating capacity is 

reached. 

We will try to accommodate all 

persons who wish to make a 

presentation. The time allotted for 

presentations will depend on the 

number of people who wish to speak on 

a given topic, and the public workshop 

schedule. Similarly, the time allotted to 

each topic may vary depending on the 

expressed interests of persons 

registering for the public workshop. To 

obtain updates on the public workshop, 

please visit http://www.fda.gov/cdrh/ 

ocd/udi/index.html. Additionally, 

regardless of whether you wish to make 

a presentation or simply attend the 

public workshop, if you need any 

special accommodations (such as 

wheelchair access or a sign language 

interpreter), please notify Jay Crowley 

(see Contact Person) by January 30, 

2009. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 


jlentini on PROD1PC65 with NOTICES
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accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Transcripts: Transcripts of the public 

workshop may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

6–30, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. A transcript of the public 

workshop will be available on the 

Internet at http://www.fda.gov/cdrh/ 

ocd/udi.index.html. 

Dated: January 6, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–784 Filed 1–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0656] 

Secure Supply Chain Pilot Program; 

Notice of Pilot Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for sponsors and foreign 

manufacturers of finished drug products 

and active pharmaceutical ingredients 

(APIs) intended for human use imported 

by a secure supply chain to apply to 

participate in a voluntary Secure Supply 

Chain (SSC) pilot program to be 

conducted by FDA’s Center for Drug 

Evaluation and Research (CDER) and 

Office of Regulatory Affairs (ORA). The 

goal of the pilot program is to allow 

FDA to determine the practicality of 

developing a secure supply chain 

program. The information obtained from 

this pilot program will assist FDA in its 

determination. A Secure Supply Chain 

program would assist the agency in its 

efforts to prevent the importation of 

adulterated, misbranded, or unapproved 

drugs by allowing the agency to focus its 

resources on imported drugs outside the 

program that may pose such risks. Such 

a program would increase the likelihood 

of expedited entry for specific finished 

drug products and APIs imported into 

the United States that meet the criteria 

for selection under the program. 

DATES: Submit written or electronic 

comments on this pilot program by 

March 16, 2009. Submit written or 

electronic comments on the collection 

of information by March 16, 2009. 

ADDRESSES: Submit written comments 

regarding this SSC pilot program to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. Submit 

written comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the collection 

of information to http:// 

www.regulations.gov. All comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Anderson, Office of 

Compliance, Division of New Drugs and 

Labeling Compliance, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, rm. 5182, 

Silver Spring, MD 20993, 301–796– 

3110. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The SSC pilot program is part of 

FDA’s risk-based approach to regulating 

drug imports, and it follows the 

President’s charge to the Interagency 

Working Group on Import Safety to 

better assure that imported products are 

safe. 

The goal of the pilot program is to 

allow FDA to determine the practicality 

of developing a secure supply chain 

program. The information obtained from 

this pilot program will assist FDA in its 

determination. A Secure Supply Chain 

program would assist the agency in its 

efforts to prevent the importation of 

adulterated, misbranded, or unapproved 

drugs by allowing the agency to focus its 

resources on imported drugs that fall 

outside the program and that may pose 

such risks. Such a program would 

increase the likelihood of expedited 

entry for specific finished drug products 

and APIs imported into the United 

States that meet the criteria for selection 

under the program. 

II. Definitions for the Purposes of This 

Program 

• Affirmation of Compliance (AofC) 

Code: A code designated by FDA for use 

by filers to convey information related 

to product or firm compliance with 

agency requirements, used to help 

expedite entry processing. Some AofC 

codes require a qualifier to provide 

additional information to aid in 

expedited processing. 

• Automated Broker Interface (ABI): 

An integral part of the Automated 

Commercial System, ABI is the means 

by which brokers or importers transmit 

entry data to the U.S. Customs and 

Border Protection (CBP). 

• Automated Commercial System 

(ACS): The system used by CBP to track, 

control, and process all commercial 

goods imported into the United States. 

• Broker/Customs Broker/Filer: A 

licensed Customs broker hired to file 

entries for another party or a Customs 

ABI participant that files its own 

entries. 

• Customs-Trade Partnership Against 

Terrorism (CTPAT): CTPAT is the CBP 

initiative that partners with members of 

the trade community on a voluntary 

basis to better secure the international 

product supply chain to the United 

States. 

• Foreign Shipper: The firm 

identified or declared as the shipper at 

time of entry into the United States. 

• Importer of Record: The person, 

establishment, or representative 

responsible for making entry of 

imported goods in accordance with all 

laws affecting such importation. 

• ‘‘May Proceed’’: This term means 

that an FDA-regulated imported product 

may proceed into domestic commerce 

after the electronic screening. This is 

not a decision by FDA about the 

product’s regulatory status, and it does 

not preclude FDA action at a later time. 

• Manufacturer ID (MID): 

Manufacturer identification code 

constructed with specific segments of 

the manufacturer’s or shipper’s name 

and address. Refer to CBP Customs 

Directive Number 3550–055 (Old 

Number 3500–13), dated November 24, 

1986, for instructions on determining 

the manufacturer ID. 

• Ultimate Consignee: The party in 

the United States, at the time of entry or 

release, to whom the overseas shipper 

sold the imported merchandise. If at the 

time of entry the imported merchandise 

has not been sold, then the Ultimate 

Consignee at the time of entry or release 

is defined as the party in the United 

States to whom the overseas shipper 

consigned the imported merchandise. 

III. SSC Pilot Program 

A. Description 

The SSC pilot program will be jointly 

administered by the Office of 

Compliance in CDER and the Division 

of Import Operations and Policy (DIOP) 

in ORA. To be selected to participate in 

the SSC pilot program, an application 

must meet the following criteria: 

1. The applicant must submit a 

complete application, which is Form 


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