[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Notices]
[Pages 2605-2608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-791]


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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.

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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

[[Page 2606]]

FDA-3676. An applicant must be the holder of the New Drug Application 
(NDA) or Abbreviated New Drug Application (ANDA) or the foreign 
manufacturer of the imported finished drug product or API.
    2. If the Ultimate Consignee identified in the SSC pilot 
application is an establishment subject to section 510 of the Federal 
Food, Drug, and Cosmetic Act (the act), then it must be in compliance 
with FDA's registration, drug listing, and current good manufacturing 
practice (cGMP) requirements and must have been in compliance over the 
past 3 years.
    3. If the drug product identified in the SSC pilot application is a 
finished dosage form, then the firm identified as the Ultimate 
Consignee for the drug product must be identified in the NDA or ANDA.
    4. If the drug product identified in the SSC pilot application is 
an API, then it must be used in the manufacture of an FDA approved drug 
product.
    5. The importation of the finished drug product or API must: (a) Be 
from the foreign manufacturer identified in the SSC pilot application, 
(b) arrive through the identified port of entry and port of arrival, 
(c) use the identified Broker/Customs Broker/Filer, and (d) be intended 
for the identified Ultimate Consignee.
    6. The foreign manufacturer identified in the SSC pilot application 
must be in compliance with requirements of the act relating to drugs.
    7. The SSC applicant must have either a pending application or be 
certified with the CBP Customs-Trade Partnership Against Terrorism 
(CTPAT) Tier II certified secure supply chain. Both applicants to the 
SSC pilot program and firms identified in the SSC application must be 
CTPAT Tier II certified or Tier II pending certification at the time an 
application is submitted for participation in the pilot program.
    8. The primary and secondary contacts identified in the SSC 
application must be able to answer questions and resolve issues raised 
by FDA.
    9. The applicant must have a plan in place for promptly correcting 
any concerns that FDA identifies regarding its secure supply chain or 
specific importations.
    10. The applicant must have a sufficient plan in place for 
recalling or correcting any finished drug products or APIs that do not 
meet, or are discovered not to have been manufactured in accordance 
with, FDA requirements. Deviations from the recall procedures for 
products associated with the SSC pilot program must be reported to FDA 
within 3 business days of identification by the applicant.
    11. Applicants must comply with recordkeeping requirements of the 
act and its implementing regulations. For the purposes of participating 
in this pilot, applicants must make these records readily available to 
FDA upon request. Regardless of whether required by law, applicants 
must also maintain records that confirm the information provided in 
their SSC pilot applications, including documentation of their CTPAT 
certification status. These records must be maintained for the duration 
of the applicant's participation in the program and be readily 
available when requested by FDA. FDA requests, however, that these 
records be maintained and be readily available when requested by FDA 
for a period of at least 3 years after the pilot ends or the 
applicant's participation in the pilot ends. In addition, regardless of 
whether required by law, for each shipment of finished drug product or 
API, applicants must maintain records that document the product's 
movement through the secure supply chain from the point of manufacture 
to the point of receipt by the Ultimate Consignee. These records must 
be maintained for the duration of the applicant's participation in the 
program and be readily available when requested by FDA.
    12. The Broker/Customs Broker/Filer identified in the SSC pilot 
application must be qualified for paperless entry filing to FDA's 
Operational and Administrative System for Import Support (OASIS).
    Participation in the SSC pilot program described in this notice is 
voluntary. FDA plans to substantially increase the rate at which 
entries of the finished drug products and APIs selected for the SSC 
pilot program are given a ``May Proceed'' without human entry review or 
examination at the time of entry. As with all entries, FDA will, 
however, perform full electronic entry review of products included in 
the SSC pilot program. Some entries covered by the SSC pilot program 
will receive further FDA review or examination after the electronic 
entry review. In addition, FDA does not intend to issue a ``May 
Proceed'' after electronic entry review if it has information that a 
problem may exist with the product. Nothing in this notice restricts 
FDA, CBP, or any other agency from examining or inspecting any product 
or establishment, or affects the legal responsibilities of participants 
or the legal requirements of products that they are importing. FDA 
intends to regularly examine records and review whether participants in 
the SSC pilot program continue to meet the program's criteria.
    FDA will assign a qualifier (a unique identifier) to each selected 
SSC pilot program application, and the Broker/Customs Broker/Filer will 
transmit the qualifier when filing entry for the product. The qualifier 
will accompany an AofC code, which FDA has designated as ``SSC.'' The 
AofC code identifies the drug product as being part of the SSC pilot 
program. In the event of any changes to the information contained in 
the SSC pilot program application, the pilot program applicant must 
submit a modified application detailing those changes and obtain FDA 
authorization of those changes in order to continue participation in 
the program. FDA will attempt to respond to the applicant's modified 
application within 15 business days after receipt.
    The pilot program participants must be in full compliance with all 
requirements of the act relating to drug products. FDA may withdraw its 
selection of an application if the applicant, foreign manufacturer, or 
Ultimate Consignee receives a Warning Letter citing violations of the 
act relating to drug products or that FDA otherwise deems to have 
violated any requirements of the act relating to drug products. If the 
pilot program's criteria are no longer met, FDA intends to withdraw its 
selection of the relevant application. Termination of participation in 
the SSC pilot program will result in a return to the general rate at 
which entries of the finished drug products and APIs are given a ``May 
Proceed'' without human entry review or examination at the time of 
entry.
    If FDA withdraws its selection of an application it will provide 
notice to the applicant. The applicant may provide information to show 
the program's criteria are met and, upon FDA review, participation in 
the SSC pilot program could continue or be resumed.

B. Selection of Participants for the Pilot

    The Secure Supply Chain application form may not be submitted to 
FDA until the Office of Management and Budget (OMB) has approved the 
information collection associated with the SSC pilot program (see 
section IV of this document). After OMB approval, FDA will accept 
applications to participate in the program and FDA will select 
qualified applications. FDA will announce in the Federal Register OMB's 
approval, the date that applications may be submitted, and application 
submission procedures. FDA plans to select applications to participate 
in the SSC pilot program from not more than 100 qualified

[[Page 2607]]

applicants and not more than 5 drug products per applicant. FDA may, at 
its discretion, increase or decrease the number of applications that it 
selects or the number of products per applicant. The application to 
participate in the SSC pilot program is available for review and 
comment on the FDA Web site athttp://www.fda.gov/cder/fedreg/fda-3676.pdf. Applications will be processed as they are received, on a 
first-come, first-served basis. All fields must be completed on the 
application; incomplete applications will be returned to the U.S. 
primary contact named in the application. Applicants will be notified 
in writing as to whether their applications have been selected.

C. Duration of the Pilot

    The Secure Supply Chain application form may not be submitted to 
FDA until OMB has approved the information collection associated with 
the SSC pilot program. After OMB approval, FDA will accept applications 
to participate in the program and begin selecting applications for 
participation. FDA plans to finish selecting applications and begin the 
SSC pilot program 180 days after the date FDA announces that it is 
accepting applications. FDA plans to continue the SSC pilot program for 
2 years after it begins. At its discretion, FDA may terminate the SSC 
pilot program before the close of the 2-year period, or FDA may extend 
the SSC pilot program beyond 2 years. Such decisions will be announced 
in the Federal Register.

D. Evaluation

    FDA intends to evaluate the SSC pilot program based on several 
factors, including the following: Time frames for passage of goods 
through the entry process; the level of adherence by the SSC pilot 
program participants to the program's criteria; and the impact of the 
SSC pilot program. This evaluation will help FDA determine whether it 
should establish an SSC program and, if so, the parameters of such a 
program. FDA may also determine that it should extend the pilot 
program, perhaps with modifications, to continue its evaluation.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from OMB for each 
collection of information that they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires 
Federal agencies to provide a 60-day notice in the Federal Register for 
each proposed collection of information before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing this notice of the proposed collection of information set 
forth in this document.
    With respect to the collection of information associated with the 
SSC pilot program, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    FDA is announcing an opportunity for sponsors and foreign 
manufacturers of finished drug products and APIs intended for human use 
imported via a secure supply chain to participate in a voluntary SSC 
pilot program. A limited number of applications that meet criteria 
established by FDA will be selected by FDA based largely on information 
submitted in the Secure Supply Chain application. Because there is an 
information collection under the PRA associated with the SSC pilot 
program, FDA must first obtain OMB approval to collect this information 
before accepting applications to participate in the program and before 
selecting qualified applications.
    The information collection associated with the SSC pilot program 
consists of the following:
    1. Secure Supply Chain application form. Proposed Form FDA-3676 
will request:
    (a) Identification and contact information for sponsors and foreign 
manufacturers wishing to participate in the SSC pilot program, (b) 
information about each drug to be imported, (c) logistical information 
associated with the importation and a description of the process by 
which the drug will be brought into the United States, and (d) A 
description of procedures that the applicant will follow to remedy any 
deficiencies that FDA may identify with the importation, including 
recall procedures. A draft of proposed Form FDA-3676 may be obtained at 
http://www.fda.gov/cder/fedreg/fda-3676.pdf, or by calling 301-827-
1482. As explained previously, the Secure Supply Chain application form 
may not be submitted to FDA until OMB has approved the information 
collection associated with the SSC pilot program.
    2. Changes to information contained in SSC pilot program. If there 
are changes to the information contained in the SSC pilot program 
application, then the applicant would be expected to submit to FDA a 
modified application detailing those changes and obtain FDA 
authorization before implementing them.
    3. FDA withdrawal of selection. If FDA withdraws its selection of 
an application from participating in the SSC pilot program, the 
applicant would be given an opportunity to provide information to FDA 
to show that the program's criteria are met and participation should 
continue or be resumed. FDA will consider and act on this information 
at its sole discretion.
    4. Recordkeeping requirements. Applicants will be expected to 
maintain records that confirm the information provided in their SSC 
pilot program applications, as well as records that document the drugs' 
movement through the secure supply chain from the point of manufacture 
to the point of receipt by the Ultimate Consignee, and make these 
records available to FDA if requested.
    FDA intends to accept applications from no more than 100 qualified 
applicants and no more than 5 drugs per applicant to participate in the 
SSC pilot program. As indicated in table 1 of this document, FDA 
estimates that no more than 500 Secure Supply Chain application forms 
will be submitted by approximately 100 applicants, and that it will 
take approximately 3.5 hours to complete and submit each application 
form to FDA. FDA anticipates that approximately 5 applicants will need 
to submit a modified Secure Supply Chain application form, and that 
each modified application will take approximately 60 minutes to 
complete and submit to FDA. FDA anticipates that it will need to 
withdraw its selection of only one application under the SSC pilot 
program, and that it will take approximately 1 hour for an applicant to 
submit information in response. The reporting burden estimated in table 
1 also includes the time for submitting the address where records 
associated with the SSC pilot program will be kept, and for submitting 
the FDA assigned qualifier code and Affirmation of Compliance code for 
each imported drug.

[[Page 2608]]

    As indicated in table 2 of this document, FDA estimates that 
approximately 500 records associated with the SSC pilot program will be 
kept by approximately 100 applicants, and that each record will take 
about 15 minutes to maintain.
    Because FDA intends to continue the SSC pilot program for 2 years, 
these burden estimates are for a one-time burden over a 2-year period.
    FDA estimates the burden of this collection of information as 
follows:

                                                         Table 1.--Estimated Reporting Burden\1\
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                                                              No. of       No. of Responses per                         Hours per
                   SSC Pilot Program                       Respondents          Respondent        Total Responses        Response         Total Hours
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Secure Supply Chain application form                                  100                     5                500                3.5              1,750
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Modified Secure Supply Chain application form                           5                     1                  5         60 minutes                  5
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Information submitted in response to termination of                     1                     1                  1                  1                  1
 participation
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Total                                                                                                                                              1,755
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                                       Table 2.--Estimated Recordkeeping Burden\1\
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                                                              No. of        No. of Records per
                   SSC Pilot Program                      Recordkeepers        Recordkeeper        Total Records     Hours per Record     Total Hours
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SSC Pilot Program records                                             100                     5                500         15 minutes                125
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Total                                                                                                                                                125
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

V. 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. 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 submissions will be accepted by FDA through FDMS 
only.

    Dated: January 8, 2009.
Jeffrey Shuren,
Associate Comissioner for Policy and Planning.
[FR Doc. E9-791 Filed 1-14-09; 8:45 am]
BILLING CODE 4160-01-S