
[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Notices]
[Page 2605-2608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ja09-113]

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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
