Draft Guidance for Industry on the Voluntary Qualified Importer Program for Food Importers and Guidelines in Consideration of the Burden of the Voluntary Qualified Importer Program Fee Amounts on Small Business; Availability, 32136-32140 [2015-13706]
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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2011–N–0362]
[Docket No. FDA–2014–N–1069]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Current Good Manufacturing Practices
for Finished Pharmaceuticals
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Blood Establishment Registration and
Product Listing, Form FDA 2830
[Docket No. FDA–2011–N–0144]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
Notice.
ACTION:
Notice.
ACTION:
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
On March
06, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Current Good Manufacturing
Practices for Finished Pharmaceuticals’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0139. The
approval expires on May 31, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: June 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: June 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13696 Filed 6–4–15; 8:45 am]
[FR Doc. 2015–13697 Filed 6–4–15; 8:45 am]
BILLING CODE 4164–01–P
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The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Current Good Manufacturing Practices
for Finished Pharmaceuticals’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Blood Establishment Registration and
Product Listing, Form FDA 2830’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
On
February 09, 2015, the Agency
submitted a proposed collection of
information entitled, ‘‘Blood
Establishment Registration and Product
Listing, Form FDA 2830’’ to OMB for
review and clearance under 44 U.S.C.
3507. An Agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. OMB has now
approved the information collection and
has assigned OMB control number
0910–0052. The approval expires on
May 31, 2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
PO 00000
AGENCY:
Food and Drug Administration,
HHS.
SUMMARY:
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Draft Guidance for Industry on the
Voluntary Qualified Importer Program
for Food Importers and Guidelines in
Consideration of the Burden of the
Voluntary Qualified Importer Program
Fee Amounts on Small Business;
Availability
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Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry on the Voluntary
Qualified Importer Program (VQIP) for
importers of human or animal food. The
draft guidance describes VQIP, which
provides for expedited review and
importation of food offered for
importation by importers who
voluntarily agree to participate in the
program. The draft guidance describes
the eligibility criteria for, and benefits
of, participation in VQIP. The draft
guidance also provides information on
submitting an application for VQIP
participation, obtaining a facility
certification for the foreign supplier of
a food imported under VQIP, the VQIP
user fee, conditions that might result in
the revocation of VQIP eligibility, and
criteria for reinstatement of eligibility.
We are issuing the draft guidance in
accordance with the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Although you may comment on
any guidance at any time (21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it completes a final
version of the guidance, submit either
electronic or written comments on the
draft guidance by August 19, 2015.
Submit either electronic or written
comments on the proposed collection of
information by August 4, 2015.
ADDRESSES: Submit written requests for
single copies of this draft guidance to
the Office of Enforcement and Import
Operations (ELEM–3108), Office of
Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Send two self-addressed adhesive labels
to assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the
draft guidance, including comments
SUMMARY:
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Federal Register / Vol. 80, No. 108 / Friday, June 5, 2015 / Notices
regarding the proposed collection of
information, to https://
www.regulations.gov. Submit written
comments on the draft guidance,
including comments regarding the
proposed collection of information, to
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance:
Domenic Veneziano, Office of
Enforcement and Import Operations
(ELEM–3108), Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857, 301–796–0356.
With regard to the proposed collection
of information: FDA PRA Staff, Office of
Operations, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14526, Silver Spring, MD 20993–
0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
I. Background
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) (FSMA)
enables FDA to better protect public
health by helping to ensure the safety
and security of the food supply. It
enables FDA to focus more on
preventing food safety problems rather
than relying primarily on reacting to
problems after they occur. FSMA
recognizes the important role industry
plays in ensuring the safety of the food
supply, including the adoption of
modern systems of preventive controls
in food production. Under FSMA, those
that import food have a responsibility to
ensure that their suppliers produce food
that meets U.S. safety standards.
FSMA also requires FDA to establish
a voluntary, fee-based program for the
expedited review and importation of
foods from importers who achieve and
maintain a high level of control over the
safety and security of their supply
chains. This control includes
importation of food from facilities that
have been certified under FDA’s
accredited third-party audit program, as
well as other measures that support a
high level of confidence in the safety
and security of the food they import.
Expedited entry incentivizes importers
to adopt a robust system of supply chain
management and further benefits public
health by allowing FDA to focus its
resources on food entries that pose a
higher risk to public health.
Section 302 of FSMA amended the
FD&C Act by adding new section 806,
Voluntary Qualified Importer Program
(21 U.S.C. 384b). Section 806(a)(1) of the
FD&C Act directs FDA to establish this
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voluntary program for the expedited
review and importation of food, and to
establish a process for the issuance of a
facility certification to accompany food
offered for importation by importers
participating in VQIP. Section 806(a)(2)
directs FDA to issue a guidance
document related to participation in,
revocation of such participation in,
reinstatement in, and compliance with
VQIP.
In accordance with section 806 of the
FD&C Act, we are announcing the
availability of a draft guidance for
industry on VQIP. The draft guidance
provides information on all aspects of
VQIP participation, including the
following:
• Benefits of VQIP participation;
• Eligibility criteria;
• Instructions for obtaining facility
certifications for foreign suppliers;
• Instructions for completing a VQIP
application;
• VQIP user fees;
• Conditions that might result in
revocation of VQIP benefits; and
• Criteria for reinstatement of VQIP
benefits.
When this program begins, we
encourage food importers with robust
supplier verification programs to apply
for participation in VQIP. We believe
that the benefits of VQIP participation,
including expedited entry and reduced
sampling by FDA, will be of substantial
value to importers. We also anticipate
that VQIP will benefit the public health
by incentivizing the adoption of robust
supplier verification programs and by
allowing FDA to focus its resources on
food shipments that pose a higher risk
to public health and will facilitate riskbased admissibility practices.
We anticipate that VQIP application
review will need to be limited in the
program’s first year of operation due to
the demands on Agency resources
necessitated by the initial establishment
of the program and review of
applications. For the purpose of
calculating the fee, we have estimated
that we would receive 200 notices of
intent to participate and be able to
review 200 applications in the first year.
However, depending on the amount of
resources needed in initiating the
program, it might be possible that we
will be able to review fewer or more
than 200 applications in the first year.
Applications will be reviewed in the
order that they are submitted. We
request comment on this potential
limitation on participation in the initial
year of VQIP.
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32137
II. Guidelines in Consideration of the
Burden of the VQIP Fee Amounts on
Small Business
FSMA directs FDA to collect fees to
fund the VQIP program. Under the
process established by FSMA, FDA
must issue a proposed set of guidelines
that consider the burden of the VQIP fee
on small businesses and provide for a
period of public comment on these
guidelines. It is important to note that
these guidelines have no binding effect
on the Agency or the industry; instead
they provide an opportunity for FDA to
consider the burden of VQIP fee
amounts on small businesses, and for
the public to comment. By publishing
these guidelines, FDA intends to gather
the necessary information to determine
if the fee will burden small businesses.
After we issue these guidelines and
consider the comments, FDA will
publish a Federal Register notice with
information about the actual fee
schedule for the program at least 60
days prior to the start of the program in
accordance with section 743(b)(1) of the
FD&C Act.
More specifically, section 107 of
FSMA amended the FD&C Act by
adding new section 743, Authority to
Collect and Use Fees (21 U.S.C. 379j–
31). Section 743(a) of the FD&C Act
authorizes FDA to assess and collect
fees from each importer participating in
VQIP to cover the administrative costs
of the program. Each fiscal year, fees are
to be established based on an estimate
of 100 percent of the costs for the year.
The fee rates must be published in a
Federal Register notice not later than 60
days before the start of each fiscal year
(section 743(b)(1) of the FD&C Act).
Consistent with section
743(b)(2)(B)(iii) of the FD&C Act, this
notice sets forth a proposed set of
guidelines in consideration of the
burden of fee amounts on small
business. These guidelines provide an
opportunity for public comment.
In order for small businesses to
comment effectively, FDA has
preliminarily estimated a possible fee
amount based on an estimate of the
number of importers we expect to
participate in VQIP (200 in Fiscal Year
(FY) 2018) and our estimate of 100
percent of the costs of administering the
program, which we anticipate will be
$3.4 million in FY 2018. The total
estimated administrative costs of the
program includes the costs of the
application review process for 200
applications, the costs of conducting
inspections of importers (both foreign
and domestic) accepted into the
program, the costs of our final
determination of eligibility into the
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program, and annual Information
Technology (IT) maintenance costs.
Using these assumptions, FDA
estimates, at this time, that the annual
fee would be approximately $16,400, if
an equal fee were assessed on each of
200 participants. This number is only a
preliminary estimate and intended to
provide small businesses with an
estimate of what the program might cost
so that they can comment on any
burden the fee might impose. After
considering all comments on these
guidelines, we will publish the actual
fee in a Federal Register notice
published in accordance with section
743(b)(1) of the FD&C Act prior to the
fiscal year when we begin program
benefits.
We estimate a flat $16,400 fee to be
paid by all VQIP participants. We have
used this model for this estimate in light
of the voluntary nature of this program.
There is no requirement for an importer
to pay a fee unless the importer decides
to participate in the program. We do not
anticipate that fees charged as part of a
voluntary program that provides the
benefit of expedited review and
importation of foods would present a
burden on small businesses because a
business will choose to apply only if the
anticipated benefit exceeds the fee
amount.
Based upon our current estimate of
approximately $16,400 for the annual
VQIP fee, we are requesting comment on
whether and how this fee might be a
burden on small business. Please
provide as detailed information as
possible regarding any potential burden.
In addition, we seek comment on the
following questions:
• If the fee does create a burden on
small business, should FDA consider a
reduction in the fee?
• If FDA were to consider a reduction
in the fee, how should FDA define a
small business for purposes of
determining who is eligible for a fee
reduction? Should FDA consider annual
gross sales or value of the import entry
(based on U.S. Customs and Border
Protection data)? What other criteria
could be used?
• If FDA were to consider a reduction
in the fee, should the fee be increased
for larger importers to ensure full
reimbursement of FDA costs for the
program?
• If FDA were to consider a reduction
in the fee, how should any reduction be
structured? Should the reduction be an
established percentage of the full fee for
all small businesses? What percentage
would be appropriate? Should it vary
based on annual gross sales or the value
of the import entry?
• Should FDA consider an alternative
structure that might indirectly reduce
fees for small businesses by charging
different fee amounts to different VQIP
participants depending on the number
of facilities included in the application
and/or the number of products included
in the application? Would such an
approach result in small businesses
paying lower fees than larger
businesses?
III. Paperwork Reduction Act of 1995
The draft VQIP guidance document
contains information collection
provisions that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520). A description of these provisions
is given below with estimates of the
annual recordkeeping and reporting
burdens. Included in the estimate is the
time for reviewing instructions,
searching existing data sources,
gathering and maintaining the data
needed, and completing and reviewing
each collection of information.
We invite comments on these topics:
(1) Whether the proposed collection of
information is necessary for the proper
performance of FDA’s functions,
including whether the information will
have practical utility; (2) the accuracy of
FDA’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Title: Draft Guidance for Industry:
FDA’s Voluntary Qualified Importer
Program.
Description: This draft guidance
document describes the FDA policy
regarding requests for participation by
food importers in the Agency’s
Voluntary Qualified Importer Program
(VQIP). The VQIP provides for
expedited review and importation of
food offered for importation by
importers who voluntarily agree to
participate in VQIP. An importer who
has voluntarily agreed to participate in
VQIP will meet the application and
inspection criteria outlined in the
guidance document, including a facility
certification for the VQIP food offered
for import.
Description of respondents: FDA
anticipates a need to limit the number
of applications for the VQIP program to
200 applicants for FY 2018, which is the
first year that VQIP will be operational.
Each applicant will be an importer of
record (IOR), the manufacturer, owner,
or consignee. This limit will enable FDA
to conduct a timely and efficient review
of the applications to ensure that
approved applicants begin receiving the
benefits of participation in VQIP by
October 2018.
Information collection burden
estimate: The burden of this information
collection consists of preparation of
documents for VQIP application,
completion of VQIP application
package, annual renewal of VQIP status,
and development of written procedures
and other documentation of the VQIP
Quality Assurance Program (QAP).
Recordkeeping Burden: In summary,
the total one-time recordkeeping burden
on importers under VQIP is estimated at
32,000 hours (see table 1). The annual
recordkeeping burden of complying
with the draft VQIP guidance document
is estimated at 3,200 hours (see table 2).
TABLE 1—ESTIMATED ONE-TIME RECORDKEEPING BURDEN 1
Number of
recordkeepers
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Guidance document provision
Number of
records per
recordkeeper
Total one-time
records
Average
burden per
recordkeeping
(in hours)
Total hours
QAP preparation ..................................................................
200
1
200
160
32,000
Total One-Time Recordkeeping Burden .......................
........................
........................
........................
........................
32,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Guidance document provision
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
(in hours)
Total hours
QAP modification .................................................................
200
1
200
16
3,200
Total Annual Recordkeeping Burden ...........................
........................
........................
........................
........................
3,200
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The draft guidance describes how
VQIP applicants will prepare and
document implementation of a QAP.
Written policies and procedures related
to the QAP are to be organized and
submitted with the VQIP application
(see Section F of the draft guidance
document). The QAP will include
information on the applicant’s company
profile, organization structure, and
quality policy statement. The QAP will
also include information on the
applicant’s company food safety system,
food defense system, training,
documentation of contracts that fulfill
any task within the QAP, and
procedures for record retention.
The majority of provisions in the QAP
Food Safety Policies and Procedures
section are similar to proposed
requirements for food safety plans in
FDA’s proposed rule on Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Prevention
Controls for Human Food (PC proposed
rule) (78 FR 3646, January 16, 2013), or
proposed requirements in FDA’s
proposed rule on Focused Mitigation
Strategies to Protect Food Against
Intentional Adulteration (IA proposed
rule) (78 FR 78014, December 24, 2013).
The QAP Food Safety Policies and
Procedures section states that the VQIP
applicant should provide the following:
(1) Analysis of the regulations and
requirements that apply to the imported
food, the processor, grower, transporter
and importer; (2) risk analysis that
identifies the safety and security
vulnerabilities and the preventive
controls that should be instituted to
ensure product safety (similar to the
hazard analysis requirement in the PC
proposed rule (§ 117.130)); (3)
mitigation strategies for each safety
vulnerability identified during your risk
analysis (similar to the corrective
actions requirement in the PC proposed
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rule (§ 117.145) and mitigation strategies
in the IA proposed rule (§ 121.135(b));
(4) mechanism for verifying food and
firm compliance throughout the supply
chain; (5) process for periodic review of
food and firm compliance (similar to
verification requirements in the PC
proposed rule (§ 117.150)); (6)
procedures for communicating
information; (7) corrective action
procedures (similar to corrective actions
requirements in the PC proposed rule
(§ 117.145)); and (8) training plan.
The QAP Implementation section
directs the VQIP applicant to describe
its procedures for auditing and updating
the QAP, and its procedures for
ensuring its VQIP QAP is current and
appropriately implemented (similar to
the verification implementation and
effectiveness requirements in the PC
proposed rule (§ 117.150(d)).
Under the PC proposed rule, the food
safety plan requirements include
written hazard analysis, description of
preventive controls, monitoring the
implementation of the preventive
controls, corrective action procedures,
verification procedures, and recall plan.
In the PRA analysis for the PC proposed
rule, the recordkeeping burden for
preparing a food safety plan is estimated
at 110 hours (Ref. 1). We use the
recordkeeping burden of preparing a
food safety plan, 110 hours, as a proxy
for the burden to prepare QAP Food
Safety Policies and Procedures.
The VQIP food defense security
criterion is similar to the Food Defense
Plan requirement under proposed
§ 121.126 in the IA proposed rule.
Under the IA proposed rule, the food
defense plan must include the written
identification of actionable process
steps, focused mitigation strategies,
procedures for monitoring, corrective
action procedures, and verification
procedures. In the Preliminary
Regulatory Impact Analysis (PRIA) of
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the IA proposed rule, we estimated that,
on average, it would take an operations
manager and a legal counsel 20 hours
each to prepare a food defense plan (Ref.
2). Therefore, we estimate that, on
average, it would take 40 hours for an
applicant to prepare the food defense
portion of the VQIP QAP.
We expect that it will take a VQIP
applicant no longer than 10 hours to
provide its company profile,
organization structure, quality policy
statement, documentation of contracts,
and procedures for record retention. On
average, the preparation of a QAP by a
VQIP applicant is estimated at
approximately 160 hours (110 + 40 +
10). In estimation of the one-time
recordkeeping burden to prepare a QAP
manual, we assume that VQIP importers
do not already have a similar manual in
place (e.g., food safety plan under the
PC proposed rule, food defense plan
under the IA proposed rule). The onetime recordkeeping burden for 200 VQIP
applicants to prepare QAPs is estimated
at 32,000 hours (200 applicants × 160
hours/applicant) (see table 1). To the
extent that some importers do have QAP
manuals in place, the burden would be
overestimated.
A VQIP importer is expected to
update its QAP on an on-going basis.
We estimate that it would take 10
percent of the effort to prepare the QAP,
or 16 hours, to update the QAP each
year. Therefore, we estimate the annual
recordkeeping burden of modification of
the QAP for 200 VQIP importers at
3,200 hours (200 importers × 16 hours/
importer) (see table 2).
Reporting Burden: In summary, the
total one-time reporting burden of
participation in VQIP by 200 importers
is estimated at 18,000 hours (see table
3). Total annual recordkeeping burden
for VQIP importers is estimated at 4,000
hours (see table 4).
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TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Guidance document provision
Number of
responses per
respondent
Total one-time
responses
Average
burden per
response
(in hours)
Total hours
Initial VQIP application .........................................................
Initial VQIP application with re-submissions ........................
100
100
1
1
100
100
80
100
8,000
10,000
Total One-Time Reporting Burden ...............................
........................
........................
........................
........................
18,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
responses
Guidance document provision
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Renewal of VQIP application ...............................................
200
1
200
20
4,000
Total Annual Reporting Burden ....................................
........................
........................
........................
........................
4,000
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The draft guidance document allows
for food importers to apply for VQIP.
We estimate that up to 200 qualified
importers will be accepted in the first
year of VQIP. We estimate that it will
take 80 person-hours to compile all the
relevant information and complete the
application for the VQIP program. For
the purpose of this analysis, we assume
that 50 percent of all applications
received will require additional
information and it would take an
additional 20 person-hours by the
importer to provide that information.
Therefore, we estimate that 100
importers will spend 8,000 hours (80
hours/importer × 100 importers) and
100 importers will spend 10,000 hours
(100 hours/importer × 100 importers) to
submit their initial VQIP applications
for a total one-time reporting burden of
18,000 hours (see table 3).
The draft guidance document states
that each VQIP participant will submit
to FDA a notice of intent to maintain its
participation in VQIP and update
information on its original application
on an annual basis. We expect that each
of the expected 200 importers in VQIP
would apply to renew their intent to
maintain their participation in VQIP.
We expect that annual applications to
renew participation in VQIP will take
significantly less time to prepare than
initial applications. We use 25 percent
of the amount of effort to prepare and
submit the initial application for
acceptance in VQIP. Therefore, it is
expected that, on average, each VQIP
importer will spend 20 hours every year
to complete and submit an application
for renewal of its VQIP status. The
annual burden of completing the
renewal application for VQIP status by
VerDate Sep<11>2014
18:31 Jun 04, 2015
Jkt 235001
200 importers is estimated at 4,000
hours (200 applications × 20 hours/
application) (see table 4). For the
purposes of the PRA analysis of the
draft guidance document, we have
estimated costs assuming that, during
the annual application process, affected
importers will do their paperwork
properly and completely the first time.
Because we assume that importers will
have learned about supporting
documentation they need to submit
during the initial application process,
we have not estimated an additional
burden for less than complete annual
applications. If we assumed a less
consistent outcome, the annual burden
might be slightly higher.
1. U.S. Food and Drug Administration.
Proposed Analysis of Economic
Impacts—Current Good Manufacturing
Practice and Hazard Analysis and RiskBased Preventive Controls for Human
Food, available under Docket No. FDA–
2011–N–0920.
2. U.S. Food and Drug Administration.
Focused Mitigation Strategies to Protect
Food Against Intentional Adulteration
(78 FR 78014, December 24, 2013).
IV. Comments
BILLING CODE 4164–01–P
Interested persons may submit either
electronic comments regarding this draft
guidance to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments 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, and
will be posted to the docket at https://
www.regulations.gov.
Persons with access to the Internet
may obtain this draft guidance at either
https://www.fda.gov/Food/
GuidanceRegulation/FSMA/
ucm253380.htm or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
Frm 00059
Fmt 4703
VI. References
Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–13706 Filed 6–4–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0126]
Authorizations of Emergency Use of In
Vitro Diagnostic Devices for Detection
of Ebola Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of two Emergency Use
Authorizations (EUAs) (the
Authorizations), one of which was
amended after initial issuance, for in
vitro diagnostic devices for detection of
the Ebola virus in response to the Ebola
virus outbreak in West Africa. FDA
SUMMARY:
V. Electronic Access
PO 00000
find the most current version of the
guidance.
Sfmt 4703
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 80, Number 108 (Friday, June 5, 2015)]
[Notices]
[Pages 32136-32140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13706]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0144]
Draft Guidance for Industry on the Voluntary Qualified Importer
Program for Food Importers and Guidelines in Consideration of the
Burden of the Voluntary Qualified Importer Program Fee Amounts on Small
Business; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry on the Voluntary
Qualified Importer Program (VQIP) for importers of human or animal
food. The draft guidance describes VQIP, which provides for expedited
review and importation of food offered for importation by importers who
voluntarily agree to participate in the program. The draft guidance
describes the eligibility criteria for, and benefits of, participation
in VQIP. The draft guidance also provides information on submitting an
application for VQIP participation, obtaining a facility certification
for the foreign supplier of a food imported under VQIP, the VQIP user
fee, conditions that might result in the revocation of VQIP
eligibility, and criteria for reinstatement of eligibility. We are
issuing the draft guidance in accordance with the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Although you may comment on any guidance at any time (21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it completes a final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 19, 2015. Submit either electronic or written
comments on the proposed collection of information by August 4, 2015.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Office of Enforcement and Import Operations (ELEM-
3108), Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.
Submit electronic comments on the draft guidance, including
comments
[[Page 32137]]
regarding the proposed collection of information, to https://www.regulations.gov. Submit written comments on the draft guidance,
including comments regarding the proposed collection of information, to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
With regard to this draft guidance: Domenic Veneziano, Office of
Enforcement and Import Operations (ELEM-3108), Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., Rockville, MD 20857, 301-796-0356.
With regard to the proposed collection of information: FDA PRA
Staff, Office of Operations, Food and Drug Administration, 8455
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
(FSMA) enables FDA to better protect public health by helping to ensure
the safety and security of the food supply. It enables FDA to focus
more on preventing food safety problems rather than relying primarily
on reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production. Under FSMA, those that import food have a responsibility to
ensure that their suppliers produce food that meets U.S. safety
standards.
FSMA also requires FDA to establish a voluntary, fee-based program
for the expedited review and importation of foods from importers who
achieve and maintain a high level of control over the safety and
security of their supply chains. This control includes importation of
food from facilities that have been certified under FDA's accredited
third-party audit program, as well as other measures that support a
high level of confidence in the safety and security of the food they
import. Expedited entry incentivizes importers to adopt a robust system
of supply chain management and further benefits public health by
allowing FDA to focus its resources on food entries that pose a higher
risk to public health.
Section 302 of FSMA amended the FD&C Act by adding new section 806,
Voluntary Qualified Importer Program (21 U.S.C. 384b). Section
806(a)(1) of the FD&C Act directs FDA to establish this voluntary
program for the expedited review and importation of food, and to
establish a process for the issuance of a facility certification to
accompany food offered for importation by importers participating in
VQIP. Section 806(a)(2) directs FDA to issue a guidance document
related to participation in, revocation of such participation in,
reinstatement in, and compliance with VQIP.
In accordance with section 806 of the FD&C Act, we are announcing
the availability of a draft guidance for industry on VQIP. The draft
guidance provides information on all aspects of VQIP participation,
including the following:
Benefits of VQIP participation;
Eligibility criteria;
Instructions for obtaining facility certifications for
foreign suppliers;
Instructions for completing a VQIP application;
VQIP user fees;
Conditions that might result in revocation of VQIP
benefits; and
Criteria for reinstatement of VQIP benefits.
When this program begins, we encourage food importers with robust
supplier verification programs to apply for participation in VQIP. We
believe that the benefits of VQIP participation, including expedited
entry and reduced sampling by FDA, will be of substantial value to
importers. We also anticipate that VQIP will benefit the public health
by incentivizing the adoption of robust supplier verification programs
and by allowing FDA to focus its resources on food shipments that pose
a higher risk to public health and will facilitate risk-based
admissibility practices.
We anticipate that VQIP application review will need to be limited
in the program's first year of operation due to the demands on Agency
resources necessitated by the initial establishment of the program and
review of applications. For the purpose of calculating the fee, we have
estimated that we would receive 200 notices of intent to participate
and be able to review 200 applications in the first year. However,
depending on the amount of resources needed in initiating the program,
it might be possible that we will be able to review fewer or more than
200 applications in the first year. Applications will be reviewed in
the order that they are submitted. We request comment on this potential
limitation on participation in the initial year of VQIP.
II. Guidelines in Consideration of the Burden of the VQIP Fee Amounts
on Small Business
FSMA directs FDA to collect fees to fund the VQIP program. Under
the process established by FSMA, FDA must issue a proposed set of
guidelines that consider the burden of the VQIP fee on small businesses
and provide for a period of public comment on these guidelines. It is
important to note that these guidelines have no binding effect on the
Agency or the industry; instead they provide an opportunity for FDA to
consider the burden of VQIP fee amounts on small businesses, and for
the public to comment. By publishing these guidelines, FDA intends to
gather the necessary information to determine if the fee will burden
small businesses. After we issue these guidelines and consider the
comments, FDA will publish a Federal Register notice with information
about the actual fee schedule for the program at least 60 days prior to
the start of the program in accordance with section 743(b)(1) of the
FD&C Act.
More specifically, section 107 of FSMA amended the FD&C Act by
adding new section 743, Authority to Collect and Use Fees (21 U.S.C.
379j-31). Section 743(a) of the FD&C Act authorizes FDA to assess and
collect fees from each importer participating in VQIP to cover the
administrative costs of the program. Each fiscal year, fees are to be
established based on an estimate of 100 percent of the costs for the
year. The fee rates must be published in a Federal Register notice not
later than 60 days before the start of each fiscal year (section
743(b)(1) of the FD&C Act).
Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, this
notice sets forth a proposed set of guidelines in consideration of the
burden of fee amounts on small business. These guidelines provide an
opportunity for public comment.
In order for small businesses to comment effectively, FDA has
preliminarily estimated a possible fee amount based on an estimate of
the number of importers we expect to participate in VQIP (200 in Fiscal
Year (FY) 2018) and our estimate of 100 percent of the costs of
administering the program, which we anticipate will be $3.4 million in
FY 2018. The total estimated administrative costs of the program
includes the costs of the application review process for 200
applications, the costs of conducting inspections of importers (both
foreign and domestic) accepted into the program, the costs of our final
determination of eligibility into the
[[Page 32138]]
program, and annual Information Technology (IT) maintenance costs.
Using these assumptions, FDA estimates, at this time, that the annual
fee would be approximately $16,400, if an equal fee were assessed on
each of 200 participants. This number is only a preliminary estimate
and intended to provide small businesses with an estimate of what the
program might cost so that they can comment on any burden the fee might
impose. After considering all comments on these guidelines, we will
publish the actual fee in a Federal Register notice published in
accordance with section 743(b)(1) of the FD&C Act prior to the fiscal
year when we begin program benefits.
We estimate a flat $16,400 fee to be paid by all VQIP participants.
We have used this model for this estimate in light of the voluntary
nature of this program. There is no requirement for an importer to pay
a fee unless the importer decides to participate in the program. We do
not anticipate that fees charged as part of a voluntary program that
provides the benefit of expedited review and importation of foods would
present a burden on small businesses because a business will choose to
apply only if the anticipated benefit exceeds the fee amount.
Based upon our current estimate of approximately $16,400 for the
annual VQIP fee, we are requesting comment on whether and how this fee
might be a burden on small business. Please provide as detailed
information as possible regarding any potential burden. In addition, we
seek comment on the following questions:
If the fee does create a burden on small business, should
FDA consider a reduction in the fee?
If FDA were to consider a reduction in the fee, how should
FDA define a small business for purposes of determining who is eligible
for a fee reduction? Should FDA consider annual gross sales or value of
the import entry (based on U.S. Customs and Border Protection data)?
What other criteria could be used?
If FDA were to consider a reduction in the fee, should the
fee be increased for larger importers to ensure full reimbursement of
FDA costs for the program?
If FDA were to consider a reduction in the fee, how should
any reduction be structured? Should the reduction be an established
percentage of the full fee for all small businesses? What percentage
would be appropriate? Should it vary based on annual gross sales or the
value of the import entry?
Should FDA consider an alternative structure that might
indirectly reduce fees for small businesses by charging different fee
amounts to different VQIP participants depending on the number of
facilities included in the application and/or the number of products
included in the application? Would such an approach result in small
businesses paying lower fees than larger businesses?
III. Paperwork Reduction Act of 1995
The draft VQIP guidance document contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). A description of these provisions is given below with
estimates of the annual recordkeeping and reporting burdens. Included
in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Draft Guidance for Industry: FDA's Voluntary Qualified
Importer Program.
Description: This draft guidance document describes the FDA policy
regarding requests for participation by food importers in the Agency's
Voluntary Qualified Importer Program (VQIP). The VQIP provides for
expedited review and importation of food offered for importation by
importers who voluntarily agree to participate in VQIP. An importer who
has voluntarily agreed to participate in VQIP will meet the application
and inspection criteria outlined in the guidance document, including a
facility certification for the VQIP food offered for import.
Description of respondents: FDA anticipates a need to limit the
number of applications for the VQIP program to 200 applicants for FY
2018, which is the first year that VQIP will be operational. Each
applicant will be an importer of record (IOR), the manufacturer, owner,
or consignee. This limit will enable FDA to conduct a timely and
efficient review of the applications to ensure that approved applicants
begin receiving the benefits of participation in VQIP by October 2018.
Information collection burden estimate: The burden of this
information collection consists of preparation of documents for VQIP
application, completion of VQIP application package, annual renewal of
VQIP status, and development of written procedures and other
documentation of the VQIP Quality Assurance Program (QAP).
Recordkeeping Burden: In summary, the total one-time recordkeeping
burden on importers under VQIP is estimated at 32,000 hours (see table
1). The annual recordkeeping burden of complying with the draft VQIP
guidance document is estimated at 3,200 hours (see table 2).
Table 1--Estimated One-Time Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total one-time per
Guidance document provision recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
QAP preparation................. 200 1 200 160 32,000
-------------------------------------------------------------------------------
Total One-Time Recordkeeping .............. .............. .............. .............. 32,000
Burden.....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 32139]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Guidance document provision recordkeepers records per records recordkeeping Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
QAP modification................ 200 1 200 16 3,200
-------------------------------------------------------------------------------
Total Annual Recordkeeping .............. .............. .............. .............. 3,200
Burden.....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The draft guidance describes how VQIP applicants will prepare and
document implementation of a QAP. Written policies and procedures
related to the QAP are to be organized and submitted with the VQIP
application (see Section F of the draft guidance document). The QAP
will include information on the applicant's company profile,
organization structure, and quality policy statement. The QAP will also
include information on the applicant's company food safety system, food
defense system, training, documentation of contracts that fulfill any
task within the QAP, and procedures for record retention.
The majority of provisions in the QAP Food Safety Policies and
Procedures section are similar to proposed requirements for food safety
plans in FDA's proposed rule on Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Prevention Controls for Human Food (PC
proposed rule) (78 FR 3646, January 16, 2013), or proposed requirements
in FDA's proposed rule on Focused Mitigation Strategies to Protect Food
Against Intentional Adulteration (IA proposed rule) (78 FR 78014,
December 24, 2013). The QAP Food Safety Policies and Procedures section
states that the VQIP applicant should provide the following: (1)
Analysis of the regulations and requirements that apply to the imported
food, the processor, grower, transporter and importer; (2) risk
analysis that identifies the safety and security vulnerabilities and
the preventive controls that should be instituted to ensure product
safety (similar to the hazard analysis requirement in the PC proposed
rule (Sec. 117.130)); (3) mitigation strategies for each safety
vulnerability identified during your risk analysis (similar to the
corrective actions requirement in the PC proposed rule (Sec. 117.145)
and mitigation strategies in the IA proposed rule (Sec. 121.135(b));
(4) mechanism for verifying food and firm compliance throughout the
supply chain; (5) process for periodic review of food and firm
compliance (similar to verification requirements in the PC proposed
rule (Sec. 117.150)); (6) procedures for communicating information;
(7) corrective action procedures (similar to corrective actions
requirements in the PC proposed rule (Sec. 117.145)); and (8) training
plan.
The QAP Implementation section directs the VQIP applicant to
describe its procedures for auditing and updating the QAP, and its
procedures for ensuring its VQIP QAP is current and appropriately
implemented (similar to the verification implementation and
effectiveness requirements in the PC proposed rule (Sec. 117.150(d)).
Under the PC proposed rule, the food safety plan requirements
include written hazard analysis, description of preventive controls,
monitoring the implementation of the preventive controls, corrective
action procedures, verification procedures, and recall plan. In the PRA
analysis for the PC proposed rule, the recordkeeping burden for
preparing a food safety plan is estimated at 110 hours (Ref. 1). We use
the recordkeeping burden of preparing a food safety plan, 110 hours, as
a proxy for the burden to prepare QAP Food Safety Policies and
Procedures.
The VQIP food defense security criterion is similar to the Food
Defense Plan requirement under proposed Sec. 121.126 in the IA
proposed rule. Under the IA proposed rule, the food defense plan must
include the written identification of actionable process steps, focused
mitigation strategies, procedures for monitoring, corrective action
procedures, and verification procedures. In the Preliminary Regulatory
Impact Analysis (PRIA) of the IA proposed rule, we estimated that, on
average, it would take an operations manager and a legal counsel 20
hours each to prepare a food defense plan (Ref. 2). Therefore, we
estimate that, on average, it would take 40 hours for an applicant to
prepare the food defense portion of the VQIP QAP.
We expect that it will take a VQIP applicant no longer than 10
hours to provide its company profile, organization structure, quality
policy statement, documentation of contracts, and procedures for record
retention. On average, the preparation of a QAP by a VQIP applicant is
estimated at approximately 160 hours (110 + 40 + 10). In estimation of
the one-time recordkeeping burden to prepare a QAP manual, we assume
that VQIP importers do not already have a similar manual in place
(e.g., food safety plan under the PC proposed rule, food defense plan
under the IA proposed rule). The one-time recordkeeping burden for 200
VQIP applicants to prepare QAPs is estimated at 32,000 hours (200
applicants x 160 hours/applicant) (see table 1). To the extent that
some importers do have QAP manuals in place, the burden would be
overestimated.
A VQIP importer is expected to update its QAP on an on-going basis.
We estimate that it would take 10 percent of the effort to prepare the
QAP, or 16 hours, to update the QAP each year. Therefore, we estimate
the annual recordkeeping burden of modification of the QAP for 200 VQIP
importers at 3,200 hours (200 importers x 16 hours/importer) (see table
2).
Reporting Burden: In summary, the total one-time reporting burden
of participation in VQIP by 200 importers is estimated at 18,000 hours
(see table 3). Total annual recordkeeping burden for VQIP importers is
estimated at 4,000 hours (see table 4).
[[Page 32140]]
Table 3--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Guidance document provision Number of responses per Total one-time per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Initial VQIP application........ 100 1 100 80 8,000
Initial VQIP application with re- 100 1 100 100 10,000
submissions....................
-------------------------------------------------------------------------------
Total One-Time Reporting .............. .............. .............. .............. 18,000
Burden.....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Guidance document provision Number of responses per Total annual per response Total hours
responses respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
Renewal of VQIP application..... 200 1 200 20 4,000
-------------------------------------------------------------------------------
Total Annual Reporting .............. .............. .............. .............. 4,000
Burden.....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The draft guidance document allows for food importers to apply for
VQIP. We estimate that up to 200 qualified importers will be accepted
in the first year of VQIP. We estimate that it will take 80 person-
hours to compile all the relevant information and complete the
application for the VQIP program. For the purpose of this analysis, we
assume that 50 percent of all applications received will require
additional information and it would take an additional 20 person-hours
by the importer to provide that information. Therefore, we estimate
that 100 importers will spend 8,000 hours (80 hours/importer x 100
importers) and 100 importers will spend 10,000 hours (100 hours/
importer x 100 importers) to submit their initial VQIP applications for
a total one-time reporting burden of 18,000 hours (see table 3).
The draft guidance document states that each VQIP participant will
submit to FDA a notice of intent to maintain its participation in VQIP
and update information on its original application on an annual basis.
We expect that each of the expected 200 importers in VQIP would apply
to renew their intent to maintain their participation in VQIP. We
expect that annual applications to renew participation in VQIP will
take significantly less time to prepare than initial applications. We
use 25 percent of the amount of effort to prepare and submit the
initial application for acceptance in VQIP. Therefore, it is expected
that, on average, each VQIP importer will spend 20 hours every year to
complete and submit an application for renewal of its VQIP status. The
annual burden of completing the renewal application for VQIP status by
200 importers is estimated at 4,000 hours (200 applications x 20 hours/
application) (see table 4). For the purposes of the PRA analysis of the
draft guidance document, we have estimated costs assuming that, during
the annual application process, affected importers will do their
paperwork properly and completely the first time. Because we assume
that importers will have learned about supporting documentation they
need to submit during the initial application process, we have not
estimated an additional burden for less than complete annual
applications. If we assumed a less consistent outcome, the annual
burden might be slightly higher.
IV. Comments
Interested persons may submit either electronic comments regarding
this draft guidance to https://www.regulations.gov or written comments
to the Division of Dockets Management (see ADDRESSES). It is only
necessary to send one set of comments. Identify comments 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, and will be posted to
the docket at https://www.regulations.gov.
V. Electronic Access
Persons with access to the Internet may obtain this draft guidance
at either https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm
or https://www.regulations.gov. Use the FDA Web site listed in the
previous sentence to find the most current version of the guidance.
VI. References
1. U.S. Food and Drug Administration. Proposed Analysis of Economic
Impacts--Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Human Food, available under
Docket No. FDA-2011-N-0920.
2. U.S. Food and Drug Administration. Focused Mitigation Strategies
to Protect Food Against Intentional Adulteration (78 FR 78014,
December 24, 2013).
Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13706 Filed 6-4-15; 8:45 am]
BILLING CODE 4164-01-P
