[Federal Register Volume 78, Number 161 (Tuesday, August 20, 2013)]
[Notices]
[Pages 51192-51194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20215]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the start of the Secure Supply Chain Pilot Program (SSCPP). 
The SSCPP is intended to assist FDA 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 may pose risks. Such a program would increase the 
likelihood of expedited entry for specific finished drug products and 
active pharmaceutical ingredients (APIs) imported into the United 
States that meet the criteria for selection under the program. This 
notice outlines the

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eligibility requirements and the process for applying for participation 
in the SSCPP.

DATES: FDA will be accepting applications for participation in the 
SSCPP beginning September 16, 2013, and continuing through December 31, 
2013. The SSCPP will be piloted for 2 years, from February 2014 through 
February 2016.

FOR FURTHER INFORMATION CONTACT: Katharine Neckers, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3339, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Participation in the SSCPP described in this notice is voluntary. 
FDA plans to increase the rate at which entries of the finished drug 
products and APIs selected for the pilot program are given a ``May 
Proceed'' without human entry review or examination; thus, the Agency 
anticipates that participation in the program will increase the 
likelihood of expedited entry when products covered by the program are 
offered for importation into the United States.
    This pilot program is closely related to section 713(4)(B)(i) of 
the recently enacted Food and Drug Administration Safety and Innovation 
Act (FDASIA). Section 713 of FDASIA authorizes FDA to require the 
submission of drug compliance information as a condition of granting 
admission to imported drugs, and subsection (4)(B)(i) specifically 
states that in issuing the implementing regulations FDA ``may, as 
appropriate, take into account differences among importers and types of 
imports, and based on the level of risk posed by the imported drug, 
provide for expedited clearance for those importers that volunteer to 
participate in partnership programs for highly compliant companies and 
pass a review of internal controls. . . .'' Thus, the information 
provided through this pilot program will help inform the Agency's 
approach to implementing the program mentioned in section 713(4)(B) of 
FDASIA.
    To the extent allowed by law, and in a manner consistent with 
applicable laws and policies, the Agency intends to share the names of 
the participants and information related to these companies with other 
Federal Agencies, such as Customs and Border Protection (CBP). FDA is 
collaborating with CBP regarding the Customs-Trade Partnership Against 
Terrorism (C-TPAT) portion of the application. 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 announced this pilot program in the Federal Register of January 
15, 2009 (74 FR 2605), requesting comments on the program and proposed 
collection of information. A subsequent request for comments on the 
collection of information was issued June 20, 2012 (77 FR 37055). The 
2009 and 2012 notices contain further background and clarification 
regarding the pilot program. FDA has made a few changes to the pilot 
program announced in 2009, and this notice describes the requirements 
to participate and other aspects of the program.
    To help determine whether participants in the SSCPP continue to 
meet the program's criteria and help evaluate the program, FDA intends 
to periodically examine records and conduct random field examinations 
to audit shipments. FDA may withdraw its selection of an application if 
the applicant, foreign manufacturer, or Ultimate Consignee: (1) 
Receives communications, such as an Untitled Letter, Cyber Letter, or 
Warning Letter, that cite violations of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) relating to drug products that FDA 
otherwise deems to have violated any requirements of the FD&C Act 
relating to drug products or (2) fails to comply with the SSCPP. 
Termination of participation in the SSCPP will result in a return to 
the routine manual drug entry review process.

II. Secure Supply Chain Pilot Program Requirements

    To be selected to participate in the SSCPP, an applicant must meet 
the following criteria:
    1. The applicant must submit a complete application using Form FDA 
3676 and be the sponsor of the New Drug Application (NDA) or the 
Abbreviated New Drug Application (ANDA), or be the foreign manufacturer 
of the imported finished drug product or API.
    2. If the Ultimate Consignee identified in the SSCPP application is 
an establishment subject to section 510 of the FD&C Act (21 U.S.C. 
360), then it must be in compliance with FDA's registration, drug 
listing, and current good manufacturing practice requirements, and must 
have been in compliance over the past 3 years.
    3. If the drug product identified in the SSCPP is a finished dosage 
form, then the firm identified as the Ultimate Consignee for the drug 
product must be identified in the approved NDA or ANDA.
    4. If the drug identified in the SSCPP application is an API, then 
the source must be an acceptable source per the approved NDA or ANDA, 
and the API must be used in the manufacture of the FDA-approved drug 
product.
    5. The importation of the finished drug product or API must: (a) Be 
from the foreign manufacturer identified in the SSCPP application; (b) 
arrive through the identified port of entry and port of arrival; (c) 
use the identified Customs House Broker/Entry Filer; and (d) be 
intended for the identified Ultimate Consignee.
    6. The foreign manufacturer and the finished drug product or API 
identified in the SSCPP application must be in compliance with 
requirements of the FD&C Act relating to drugs.
    7. The SSCPP importer of record must have a validated Tier II or 
Tier III secure supply chain per the CBP Customs-C-TPAT Program.
    8. The primary and secondary contacts identified in the SSCPP 
application must be able to answer questions and resolve issues raised 
by FDA. The primary contact must be the sponsor or the U.S. agent for 
the sponsor.
    9. The applicant must have a plan in place for promptly correcting 
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 SSCPP must be reported to FDA within 3 
business days of identification by the applicant.
    11. Applicants must comply with recordkeeping requirements of the 
FD&C 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 SSCPP applications, including documentation of their 
C-TPAT validation 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

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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, for the 
duration of the applicant's participation, 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.
    12. The Customs House Broker/Entry Filer identified in the SSC 
pilot application must be qualified for paperless entry filing to FDA's 
Operational and Administrative System for Import Support.

III. 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.
     Automated Commercial System (ACS): The system used by CBP 
to track, control, and process all commercial goods imported into the 
United States.
     Customs House Broker/Entry 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: C-TPAT 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: 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.

IV. Process for Applying To Participate in the Pilot

    Due to resource constraints, FDA intends to limit the SSCPP to no 
more than 100 qualified applicants, with no 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 (Form FDA 3676) to participate in the SSCPP 
can be found at http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm.
    The SSCPP application should be submitted electronically as a 
document in Portable Document Format (PDF) and using the Electronic 
Common Technical Document (eCTD) format and the Electronic Submissions 
Gateway (ESG). The SSCPP application form should be referenced and 
placed in the 1.2 Cover Letter section. The PDF file name should 
contain ``3676'' as part of the file name, and the eCTD leaf title 
should include ``3676,'' the sponsor name, and the drug name, e.g., 
``3676 Form--ABC Drug Company for XYZ Pain Pill.'' If a firm is unable 
to submit the application electronically, it should submit a hard copy 
of the application form via mail to: U.S. Food and Drug Administration, 
Attention: OC Office of Drug Security, Integrity, and Recalls, Central 
Document Room, 5901B Ammendale Rd., Beltsville, MD 20705-1266.
    For further information regarding eCTD, please refer to the Web 
site at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm. For 
communications other than the submission of the SSCPP application (Form 
FDA 3676), please contact the CDER SSCPP mailbox at 
[email protected].
    FDA will be accepting applications for participation in the SSCPP 
(see DATES). Applications will be processed as they are received, on a 
first-come, first-served basis. FDA anticipates finishing its review of 
the applications and selection of the participants by February 2014. 
All required fields must be completed on the application; incomplete 
applications will be returned to the U.S. primary contact named in the 
application. Please do not attach additional documents to the 
application submission. For the narrative sections of the application, 
please use the space provided to respond to the question. Applicants 
will be notified in writing as to whether their application has been 
selected.
    FDA will assign a qualifier to each selected SSCPP application. 
Each Customs House Broker/Entry Filer will transmit the qualifier when 
filing the entry for the product. The qualifier will accompany an AofC 
code, which FDA has designated as a Secure Supply Chain (SSC). Once 
accepted into the SSCPP, the applicant must notify FDA of any changes 
to the information contained in Form FDA 3676 by email to the SSCPP 
mailbox at [email protected]. FDA anticipates responding to the 
applicant's modified application within 15 business days after receipt. 
Continued participation in the SSCPP is dependent on FDA's 
authorization of those changes.

V. Evaluation

    FDA intends to evaluate the SSCPP based on several factors, 
including, but not limited to, the following: Timeframes for passage of 
drugs through the imports entry process, the level of adherence by the 
program participants to the program's criteria, and the impact of the 
SSCPP. This evaluation will help FDA determine whether establishment of 
an SSC program is supported and, if so, the parameters of such a 
program. FDA may also determine that it should extend the pilot program 
to continue its evaluation, or may terminate the pilot program before 
the close of the 2-year period. Such decisions will be announced in the 
Federal Register.

    Dated: August 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20215 Filed 8-19-13; 8:45 am]
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