Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Secure Supply Chain Pilot Program, 37055-37058 [2012-14990]
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Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Notices
494; Harris, R. J. (1977) Comprehension of
pragmatic implication in advertising.
‘‘Journal of Applied Psychology,’’ 62, 603–
608; Jacoby, J. and Hoyer, W. (1987). ‘‘The
comprehension and miscomprehension of
print communications.’’ New York: The
Advertising Educational Foundation.
5. Guidance for Industry: Patient Reported
Outcome Measures: Use in Medical Product
Development to Support Labeling Claims.
Available at https://www.fda.gov/downloads/
Drugs/GuidanceComplianceRegulatory
Information/Guidances/ucm071975.pdf. Last
accessed November 16, 2011.
6. Transcript available at https://
www.fda.gov/downloads/Advisory
Committees/CommitteesMeetingMaterials/
RiskCommunicationAdvisoryCommittee/
UCM283132.pdf. Last accessed January 4,
2012.
Dated: June 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14989 Filed 6–19–12; 8:45 am]
BILLING CODE 4160–01–P
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.
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
oira_submission@omb.eop.gov. 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
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SUMMARY:
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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
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37055
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 NonPRA 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 https://
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
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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
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(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.
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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.
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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:
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TABLE 1—ESTIMATED REPORTING BURDEN 1
Secure Supply Chain application form ................................
Modified Secure Supply Chain application form .................
Information submitted in response to termination of participation ................................................................................
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Number of
responses per
respondent
Number of
respondents
Secure Supply Chain Pilot Program
Frm 00076
Average
burden per
response
Total
responses
Total hours
100
5
500
5
3.5
1
1,750
5
1
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5
1
1
1
1
1
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Federal Register / Vol. 77, No. 119 / Wednesday, June 20, 2012 / Notices
TABLE 1—ESTIMATED REPORTING BURDEN 1—Continued
Number of
respondents
Number of
responses per
respondent
Total
responses
Average
burden per
response
........................
........................
........................
........................
Secure Supply Chain Pilot Program
Total ..............................................................................
1 There
Total hours
1,756
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Secure Supply Chain Pilot Program
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours/
week
Total hours
per year
Secure Supply Chain Pilot Program
Records ................................................
100
5
500
1
500
26,000
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2012–D–0304]
Draft Guidance for Industry and Food
and Drug Administration Staff; Class II
Special Controls Guidance Document:
Implanted Blood Access Devices for
Hemodialysis; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Class II Special Controls
Guidance Document: Implanted Blood
Access Devices for Hemodialysis.’’ This
draft guidance document describes a
means by which implanted blood access
devices may comply with the
requirement of special controls for class
II devices. This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 18,
2012.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘Class II Special
Controls Guidance Document:
Implanted Blood Access Devices for
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SUMMARY:
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Hemodialysis’’ to the Division of Small
Manufacturers, International and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the draft guidance.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Melissa Burns, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1646, Silver Spring,
MD 20993–0002, 301–796–5616.
I. Background
This draft guidance document was
developed as a special control guidance
to support the reclassification of
implanted blood access devices into
class II (special controls). This draft
guidance document will serve as the
special control for implanted blood
access devices. Section 513(f)(3) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) provides that the
Agency may initiate the reclassification
of a device. This classification will be a
reclassification of the device. FDA must
publish a notice in the Federal Register
announcing this reclassification.
Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed
rule to reclassify this device type from
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class III into class II (special controls),
under section 513(e) of the FD&C Act
(21 U.S.C. 360c(e)).
FDA is issuing this guidance
document as a level 1 draft guidance
document. FDA will consider any
comments that are received within 90
days of the issuance of this notice to
determine whether to revise the
guidance document.
II. Significance of Special Controls
Guidance Document
FDA believes that adherence to the
recommendations described in this draft
guidance document, when finalized, in
addition to the general controls, will
provide reasonable assurance of the
safety and effectiveness of implanted
blood access devices classified under
§ 876.5540(b)(1) (21 CFR
876.5540(b)(1)). If classified as a class II
device under § 876.5540(b)(1),
implanted blood access devices will
need to comply with the requirement for
special controls; manufacturers will
need to address the issues requiring
special controls as identified in the
guidance document or by some other
means that provides equivalent
assurances of safety and effectiveness.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Class II Special Controls
Guidance Document: Implanted Blood
Access Devices for Hemodialysis,’’ you
may either send an email request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 301–847–8149 to receive
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]]>Agencies
[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Notices]
[Pages 37055-37058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14990]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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 https://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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Secure Supply Chain Pilot Number of responses per Total burden per Total hours
Program respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Secure Supply Chain Pilot Program Records......... 100 5 500 1 500 26,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
