[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37055-37058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0656]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Secure Supply Chain 
Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 
20, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the title Secure Supply Chain Pilot 
Program. Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr. 
PIFO-400W, Rockville, MD 20850, (301) 796-7651.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance: ``Secure Supply Chain Pilot Program.''
    The Secure Supply Chain Pilot Program (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 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.
    Title: Secure Supply Chain Pilot Program.
    Description of Respondents: Respondents to this collection of 
information are sponsors and foreign manufacturers of finished drug 
products and active pharmaceutical ingredients (APIs) intended for 
human use.
    Burden Estimate: In the Federal Register of January 15, 2009 (74 FR 
2605) (the January 2009 notice), FDA announced an opportunity for 
sponsors and foreign manufacturers of finished drug products and APIs 
intended for human use imported via a secure supply chain to apply to 
participate in a voluntary SSCPP to be conducted by FDA's Center for 
Drug Evaluation and Research (CDER) and Office of Regulatory Affairs 
(ORA). The goal of the SSCPP 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. An SSCPP 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. A limited number of applications that meet 
criteria established by FDA will be selected by FDA based largely on 
information submitted in the SSCPP application.
    Because there is information collection under the PRA associated 
with the SSCPP, this Federal Register notice is being issued as part of 
the process for OMB approval to collect this information. After OMB 
approval, FDA will accept applications to participate in the program 
and 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 has considered 
all PRA and Non-PRA comments received. This FR notice responds only to 
the PRA-related comments.
    The information collection associated with the SSCPP consists of 
the following:
    (1) Secure Supply Chain Pilot Program application form. Proposed 
Form FDA 3676 will request the following: (a) Identification and 
contact information for sponsors and foreign manufacturers wishing to 
participate in the SSCPP; (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) 796-7651. The SSCPP application form may 
not be submitted to FDA until OMB has approved the information 
collection associated with the SSCPP.
    (2) Changes to information contained in the SSCPP. If there are 
changes to the information contained in the SSCPP 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 SSCPP, 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 SSCPP 
applications and make these records available to FDA if requested. 
While these records must be maintained for the duration of the 
applicant's participation in the program, FDA requests that they be 
maintained and be readily available when requested by FDA for a period 
of at least 3 years after the pilot ends or the

[[Page 37056]]

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 their 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. FDA intends to accept applications from no more than 100 qualified 
applicants and for no more than 5 drugs per applicant to participate in 
the SSCPP. As indicated in Table 1 of this document, FDA estimates that 
no more than 500 SSCPP 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 SSCPP, and that each modified application will take 
approximately 60 minutes to complete and submit to FDA (this estimate 
includes the time for an applicant to also submit a copy of its Customs 
Trade Partnership Against Terrorism (C-TPAT) application). FDA 
anticipates that it will need to withdraw its selection of only one 
SSCPP application, 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 SSCPP will be kept, and for 
submitting the FDA-assigned qualifier code and Affirmation of 
Compliance code for each imported drug.
    As indicated in Table 2 of this document, FDA estimates that 
approximately 500 records associated with the SSCPP will be kept by 
approximately 100 applicants, and that each record will take about 60 
minutes to maintain.
    Because FDA intends to continue the SSCPP for 2 years, these burden 
estimates are for a one-time burden over a 2-year period.
    In the January 2009 notice, FDA requested public comment on the 
proposed collection of information. We received comments from 11 
different companies that pertained to the information collection 
resulting from the SSCPP. A summary of the comments and FDA's response 
are as follows:
    (1) Several comments stated that foreign manufacturers, with the 
exception of manufactures in Canada and Mexico, are not eligible for 
Customs Trade Partnership Against Terrorism (C-TPAT) program and 
therefore would be unable to meet the criteria in the SSCPP.
    To clarify the C-TPAT program eligibility requirements, only 
business entities who handle cargo that enter the United States are 
eligible to be a member of the C-TPAT program. Foreign manufacturers, 
with the exception of those located in Canada and Mexico, cannot apply 
to be members of the C-TPAT program, but would be visited by the C-TPAT 
program as part of the validation process for a C-TPAT partner. C-TPAT 
partners must adhere to the security requirements and ensure that 
requirements are met by their business partners throughout the 
international supply chain. The January 2009 notice states that firms 
identified in the SSCPP application must be either C-TPAT Tier II 
certified or Tier II pending certification at the time the application 
is submitted. After further review and discussion with the U.S. Customs 
and Border Protection (CBP) about the C-TPAT program, FDA is revising 
the C-TPAT criteria to permit firms to participate in the SSCPP if the 
supply chain has been validated as Tier II or Tier III. Tier II 
validated means that CBP has visited a site in the firm's supply chain 
and has validated its security procedures as meeting the requirements 
set forth by C-TPAT. Tier III means that a firm has exceeded C-TPAT's 
security criteria and implemented their own best practices. FDA intends 
to revise the SSCPP application to reflect the change in the criteria 
from Tier II certified or Tier II pending to require validated as Tier 
II or Tier III.
    (2) Several comments stated that the January 2009 notice does not 
contain sufficient detail to determine how FDA will identify the 
ultimate consignee for purposes of this pilot program, and that further 
clarification is needed.
    The January 2009 notice specifically defines ``ultimate 
consignee,'' for the purposes of the SSCPP, as ``[t]he 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.''
    (3) Several comments stated that clarification is needed regarding 
the data that will be required for individual shipments by program 
participants, the automated systems that will be used, and the 
modifications participants must make to those systems for imported 
drugs under the program.
    FDA will be using the current systems for receiving and reviewing 
entry information. FDA will assign a unique identifier to each selected 
SSCPP application, and the Broker/Customs--Broker/Filer will transmit 
the identifier when filing entry for the product, which will enable FDA 
to verify the drug product as being part of the SSCPP. Otherwise, the 
FDA data requirements to submit a drug import entry will not change.
    (4) Several comments expressed concern that the SSCPP requires the 
primary and secondary points of contact to respond directly to all 
questions posed by FDA regarding an applicant's status in the SSCPP. In 
addition, comments made suggest that FDA identify primary and secondary 
points of contact, within the Agency, with whom the applicants can 
raise concerns and discuss issues.
    The intent in the SSCPP is to identify appropriate individuals who 
can obtain information to respond to Agency questions and requests for 
information. Those contacts can obtain assistance within the firm and 
then contact the Agency with the response. This will eliminate 
contacting multiple people potentially within several firms to obtain a 
response. FDA intends to identify primary and secondary points of 
contact within the Agency and will publish this information in a 
subsequent Federal Register notice.
    (5) Several comments stated that under the Primary and Secondary 
contacts requirement on the SSCPP application, the term ``any 
concerns'' is too broad and the scope should be limited to 
``concerns.'' In addition, the comments suggested that the applicant 
provide a corrective action plan ``if needed,'' but that this should 
not be a necessary requirement.
    FDA will change ``any concerns'' to ``concerns'' with the 
understanding that the Agency will raise concerns related to the SSCPP. 
FDA believes a corrective action plan should be kept as a required 
element for participation in this program.
    (6) Several comments request that prior notification be given to 
applicants when an audit check analysis is performed.
    FDA does not agree with this position. Audits of the SSCPP will not 
be announced in advance and will be administered in intervals chosen by 
the agency.
    (7) Several comments stated that the Secure Supply Chain (SSC) 
Affirmation of Compliance (A of C) code should be submitted in place of 
(and not in addition to) the A of C codes currently transmitted during 
entry processing.

[[Page 37057]]

    There will be one code for products subject to the SSCPP. This will 
be an SSC A of C, which will be required at the time of entry and will 
identify the drug product as being part of the SSCPP.
    (8) Several comments requested clarification as to whether multiple 
dosage forms of a drug covered under a single new drug application 
(NDA) are considered one SSCPP application.
    Each individual dosage form will require a separate application for 
the SSCPP. One API used in multiple drug products' NDAs would require 
the submission of one application.
    (9) Some comments requested clarification regarding the product 
entry process when an application, which has been modified to reflect a 
change in information, is under review by FDA for continued 
participation in the program.
    The firm must notify FDA of the change before its implementation. 
If the firm implements the change before FDA authorizes the change, FDA 
will revert to the normal drug entry process for the product.
    (10) Several comments requested that the SSCPP criteria for use of 
one port of entry be amended to allow for multiple ports of entry 
because of changes associated with airline landing requirements.
    At this time, the Agency will not consider amending this 
requirement. Any deviations from the applicant's SSC distribution 
practices, as identified in the SSCPP application, would cause that 
individual shipment to be screened under general import processing 
procedure. Included in such deviations are changes to airline landings, 
which would require a different port of arrival and entry from that 
which is defined in a participant's SSCPP application.
    (11) Several comments suggested that selection for participation in 
the pilot program should be based on the Agency's satisfaction that the 
importer will not deviate from the details of its application and that 
the importer will continue to abide by applicable regulations, and not 
based on a regular examination of relevant records. The comments 
suggested that there would be no benefit to regular examination but 
that examinations of records on a random basis would ensure compliance.
    The Agency believes that the pilot is consistent with the approach 
recommended by this comment. As part of this pilot program, the Agency 
believes it is important to have the ability to examine records on a 
random basis as determined by the Agency.
    (12) Several comments expressed concern with the manner in which 
FDA will determine that an applicant should be withdrawn from the 
SSCPP. Several comments further suggested that withdrawing an applicant 
if they receive a ``Warning Letter citing violations of the act 
relating to drug products'' (see the January 2009 notice) is too broad 
because the Warning Letter may be unrelated to the products covered by 
the SSCPP application or to imports in general. The comments suggested 
narrowing the statement and making it specific to Warning Letters 
related to the product covered by the application.
    FDA disagrees. The Agency intends to fully evaluate an applicant's 
compliance status and associated risk posed by violations relating to 
drug products.
    (13) Several comments stated that the SSCPP should be evaluated in 
terms of FDA resource conservation, impact on consumer safety, economic 
benefit to the trade community, and supply chain facilitation. Some 
comments further suggested expanding the program to be account-based 
(along the lines of a ``Qualified Trusted Importer Program'') rather 
than product-based.
    FDA agrees with this comment with respect to evaluating the 
program. Evaluation of the SSCPP will be based on several factors 
including, but not limited to, those identified in the comment. 
However, we have decided that this voluntary program should be product-
based at this time.
    (14) Several comments requested clarification on the question of 
whether an API source is required to be disclosed for applicants 
importing finished dosage form drug products in their SSCPP 
applications.
    Yes, the SSCPP application (Section E, Details of Your Secure 
Supply Chain) requests this information for both applicants importing 
finished dosage form drug products and/or APIs.
    (15) Several comments suggested changing the language in Box 15, 
Logistics, on the SSCPP application to read, ``U.S. Port(s) of Entry'' 
and in Box 16, Logistics, to read, ``U.S. Port(s) of Arrival (if 
different from Port(s) of Entry).'' In addition, in Box 22, Other 
Information, it was suggested that it is important for FDA to recognize 
current normal transportation and trade compliance practice, because 
some transportation records are kept at a foreign shipping location and 
not in the United States.
    FDA disagrees with changing the language to allow for multiple 
ports at this time; therefore, the pilot program will be limited to the 
one port of entry and one port of arrival (if different) listed in the 
application. In addition, the transportation records must be readily 
available, regardless of where they are physically located. The Agency 
will revise the SSCPP application form to clearly state that 
transportation records may be located either in the United States or 
outside the country, provided the records are made readily available to 
FDA upon request.
    (16) Some comments asked whether the data collected during the 
pilot program as described in Section D of the SSCPP application will 
be shared with participants and the public, and if so, at what 
frequency. In addition, the comments questioned how industry 
participants in the program establish themselves as having best 
practices for securing a supply chain.
    The Agency recognizes that at this time there is no industry-wide 
standard for best practices to secure the drug supply chain. However, 
there is a draft Good Importer Practices guidance document that was 
issued in January of 2009 that may be of assistance. Although 
participation in this pilot program will not establish a firm as having 
those best practices, at the end of the SSCPP, FDA intends to make 
summary information about the program publicly available. The Agency 
does not intend to publicly disclose information submitted in Section D 
of the SSCPP application that can be associated with a specific 
individual or entity, unless doing so is required by law.
    FDA estimates the burden of this collection of information as 
follows:

                                     Table 1--Estimated Reporting Burden \1\
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                                                     Number of                        Average
    Secure Supply Chain Pilot        Number of     responses per       Total        burden per      Total hours
             Program                respondents     respondent       responses       response
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Secure Supply Chain application              100               5             500             3.5           1,750
 form...........................
Modified Secure Supply Chain                   5               1               5               1               5
 application form...............
Information submitted in                       1               1               1               1               1
 response to termination of
 participation..................
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[[Page 37058]]

 
    Total.......................  ..............  ..............  ..............  ..............           1,756
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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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                                                                        Number of                      Average  burden
         Secure Supply Chain Pilot Program             Number of       records per      Total annual         per          Total hours/   Total hours per
                                                     recordkeepers     recordkeeper       records       recordkeeping         week             year
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Secure Supply Chain Pilot Program Records.........             100                5              500                1              500           26,000
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\1\ There are no capital or operating costs associated with this recordkeeping.


    Dated: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14990 Filed 6-19-12; 8:45 am]
BILLING CODE 4160-01-P