Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Qualified Importer Program, 6556-6559 [2020-02248]
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6556
Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
Number of
recordkeepers
21 CFR Section; activity
120.11(b) and (c); and 120.12(a)(5) and (b); require
that every processor record the validation that the
HACCP plan is adequate to control food hazards
that are likely to occur.
120.11(c) and 120.12(a)(5) and (b); require documentation of revalidation of the hazard analysis
upon any changes that might affect the original hazard analysis (applies when a firm does not have a
HACCP plan because the original hazard analysis
did not reveal hazards likely to occur).
120.14(a)(2), (c), and (d) and 120.12(b); require that
importers of fruit or vegetable juices, or their products used as ingredients in beverages, have written
procedures to ensure that the food is processed in
accordance with our regulations in part 120.
120.8(a) and (b), and 120.12(a)(3), (b), and (c); require written HACCP plan.
Total ........................................................................
1 There
Total
annual
records
Average
burden per
recordkeeping
Total hours
1,840
1
1,840
4
7,360
1,840
1
1,840
4
7,360
308
1
308
4
1,232
1,560
1.1
1,716
60
102,960
........................
........................
21,980,369
..............................
461,426
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the
total annual recordkeeping burden of
our regulations in part 120. Our estimate
remains unchanged since last review of
the information collection. We base our
estimate of the average burden per
recordkeeping on our experience with
the application of HACCP principles in
food processing. We base our estimate of
the number of recordkeepers on our
estimate of the total number of juice
manufacturing plants affected by the
regulations (plants identified in our
official establishment inventory plus
very small apple juice and very small
orange juice manufacturers). These
estimates assume that every processor
will prepare sanitary standard operating
procedures and an HACCP plan and
maintain the associated monitoring
records, and that every importer will
require product safety specifications. In
fact, there are likely to be some small
number of juice processors that, based
upon their hazard analysis, determine
that they are not required to have an
HACCP plan under these regulations
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02243 Filed 2–4–20; 8:45 am]
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Number of
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0144]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary Qualified
Importer Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on FDA’s Voluntary
Qualified Importer Program (VQIP).
DATES: Submit either electronic or
written comments on the collection of
information by April 6, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 6, 2020.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 6, 2020. Comments
SUMMARY:
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received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
E:\FR\FM\05FEN1.SGM
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Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0144 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; FDA’s
Voluntary Qualified Importer Program.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
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.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
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.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; FDA’s Voluntary
Qualified Importer Program OMB
Control Number 0910–0840—Extension.
The FDA Food Safety Modernization
Act (FSMA) (Pub. L. 111–353) enables
FDA to better protect public health by
FSMA also requires FDA to establish
a voluntary, fee-based program for the
expedited review and importation of
foods by 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 certification
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.
SUPPLEMENTARY INFORMATION:
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Section 302 of FSMA amended the
Federal Food, Drug, and Cosmetic Act
(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. Accordingly, in the Federal
Register of November 14, 2016 (81 FR
79502), FDA published a notice
announcing the availability of a final
guidance for industry entitled ‘‘FDA’s
Voluntary Qualified Importer Program.’’
The guidance is available from our
website at: https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-fdas-voluntary-qualifiedimporter-program.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ONE-TIME RECORDKEEPING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total
hours
Quality Assurance Program (QAP) preparation ..................
200
1
200
160
32,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our one-time
recordkeeping burden estimate. 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
Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based
Preventive Controls for Human Food
regulation (21 CFR part 117); food
defense plan under the Focused
Mitigation Strategies to Protect Food
Against Intentional Adulteration
regulation (IA regulation) (21 CFR part
121)). We continue to use the
recordkeeping burden of preparing a
food safety plan under part 117, 110
hours, as a proxy for the burden to
prepare QAP Food Safety Policies and
Procedures. We continue to estimate
that, on average, it would take 40 hours
for an applicant to prepare the food
defense portion of the VQIP QAP,
similar to the estimated burden for
preparing a food defense plan under the
IA regulation. We also continue to
estimate it will take a VQIP applicant no
longer than 10 hours to develop the
portion of its QAP that includes
compiling its company profile,
organizational structure, corporate
quality policy statement, documentation
of contracts, and procedures for record
retention. Therefore, the one-time
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.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
QAP Modification .................................................................
200
1
200
16
3,200
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
adjustments to our annual
recordkeeping burden estimate. We
estimate it would take 10 percent of the
effort to prepare the QAP, or 16 hours,
to update the QAP each year. Therefore,
A VQIP importer is expected to
update its QAP on an ongoing basis.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
we estimate the annual recordkeeping
burden of modification of the QAP for
200 VQIP importers at 3,200 hours (200
importers × 16 hours/importer).
TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total
annual
responses
Average
burden per
response
Total
hours
Initial VQIP application .........................................................
Initial VQIP application w/additional information .................
100
100
1
1
100
100
80
100
8,000
10,000
Total ..............................................................................
........................
........................
........................
........................
18,000
1 There
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are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance informs food importers
of application procedures for VQIP.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our one-time reporting
burden estimate. As we are still in the
process of implementing this program,
we continue to estimate that up to 200
qualified importers will be accepted in
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the upcoming 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
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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).
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Federal Register / Vol. 85, No. 24 / Wednesday, February 5, 2020 / Notices
TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Total
annual
responses
Average
burden per
response
Total
hours
Subsequent Year VQIP Application .....................................
Request to Reinstate Participation ......................................
200
2
1
1
200
2
20
10
4,000
20
Total ..............................................................................
........................
........................
........................
........................
4,020
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The guidance states that each VQIP
participant will submit to FDA a notice
of intent to participate in VQIP on an
annual basis. Based on a review of the
information collection since our last
request for OMB approval, we have
made no adjustments to our annual
reporting burden estimate. We expect
that each of the expected 200 importers
in VQIP would apply in the subsequent
year to participate in VQIP. We expect
that an application to participate in
VQIP in a subsequent year will take
significantly less time to prepare than
the initial application. 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 to complete and submit a VQIP
application for each subsequent year.
The annual burden of completing a
subsequent year application to
participate in VQIP status by 200
importers is estimated at 4,000 hours
(200 applications × 20 hours/
application) (see table 4).
Finally, we have added to the VQIP
estimated annual reporting burden an
estimate of the burden associated with
importers’ requests to reinstate
participation in VQIP after their
participation is revoked. We believe
most participants will not need to use
this provision, and we have included an
estimate that reflects this. Upon
implementation of the VQIP, we will
reevaluate our estimate for future OMB
submission and revise it accordingly.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02248 Filed 2–4–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0257]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food and Drug
Administration Rapid Response
Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the use of rapid
response surveys to obtain data on
safety information to support quick
turnaround decision making about
potential safety problems or risk
management solutions from healthcare
professionals, hospitals, and other user
facilities (i.e., nursing homes, etc.);
consumers; manufacturers of biologics,
drugs, food, dietary supplements,
cosmetics, animal food and feed, and
medical devices; distributors; and
importers, when FDA must quickly
determine whether or not a problem
with a biologic, drug, food, cosmetic,
dietary supplement, animal food and
feed, or medical device impacts the
public health.
DATES: Submit either electronic or
written comments on the collection of
information by April 6, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 6, 2020.
SUMMARY:
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The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 6, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
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]]>Agencies
[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6556-6559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02248]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0144]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Voluntary Qualified Importer Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on FDA's Voluntary Qualified Importer Program
(VQIP).
DATES: Submit either electronic or written comments on the collection
of information by April 6, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
[[Page 6557]]
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-N-0144 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; FDA's Voluntary Qualified
Importer Program.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites 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.
Agency Information Collection Activities; Proposed Collection;
Comment Request; FDA's Voluntary Qualified Importer Program OMB Control
Number 0910-0840--Extension.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
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 by 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 certification 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 Federal Food, Drug, and Cosmetic
Act (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.
Accordingly, in the Federal Register of November 14, 2016 (81 FR
79502), FDA published a notice announcing the availability of a final
guidance for industry entitled ``FDA's Voluntary Qualified Importer
Program.'' The guidance is available from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-fdas-voluntary-qualified-importer-program.
FDA estimates the burden of this collection of information as
follows:
[[Page 6558]]
Table 1--One-Time Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Quality Assurance Program (QAP) preparation........................ 200 1 200 160 32,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our one-time
recordkeeping burden estimate. 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 Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Human Food regulation (21 CFR part 117); food defense plan
under the Focused Mitigation Strategies to Protect Food Against
Intentional Adulteration regulation (IA regulation) (21 CFR part 121)).
We continue to use the recordkeeping burden of preparing a food safety
plan under part 117, 110 hours, as a proxy for the burden to prepare
QAP Food Safety Policies and Procedures. We continue to estimate that,
on average, it would take 40 hours for an applicant to prepare the food
defense portion of the VQIP QAP, similar to the estimated burden for
preparing a food defense plan under the IA regulation. We also continue
to estimate it will take a VQIP applicant no longer than 10 hours to
develop the portion of its QAP that includes compiling its company
profile, organizational structure, corporate quality policy statement,
documentation of contracts, and procedures for record retention.
Therefore, 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.
Table 2--Estimated Annual Recordkeeping Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
QAP Modification................................................... 200 1 200 16 3,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
A VQIP importer is expected to update its QAP on an ongoing basis.
Based on a review of the information collection since our last request
for OMB approval, we have made no adjustments to our annual
recordkeeping burden estimate. We estimate 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).
Table 3--Estimated One-Time Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Initial VQIP application........ 100 1 100 80 8,000
Initial VQIP application w/ 100 1 100 100 10,000
additional information.........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 18,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The guidance informs food importers of application procedures for
VQIP. Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our one-time
reporting burden estimate. As we are still in the process of
implementing this program, we continue to estimate that up to 200
qualified importers will be accepted in the upcoming 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).
[[Page 6559]]
Table 4--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Subsequent Year VQIP Application 200 1 200 20 4,000
Request to Reinstate 2 1 2 10 20
Participation..................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,020
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The guidance states that each VQIP participant will submit to FDA a
notice of intent to participate in VQIP on an annual basis. Based on a
review of the information collection since our last request for OMB
approval, we have made no adjustments to our annual reporting burden
estimate. We expect that each of the expected 200 importers in VQIP
would apply in the subsequent year to participate in VQIP. We expect
that an application to participate in VQIP in a subsequent year will
take significantly less time to prepare than the initial application.
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 to complete
and submit a VQIP application for each subsequent year. The annual
burden of completing a subsequent year application to participate in
VQIP status by 200 importers is estimated at 4,000 hours (200
applications x 20 hours/application) (see table 4).
Finally, we have added to the VQIP estimated annual reporting
burden an estimate of the burden associated with importers' requests to
reinstate participation in VQIP after their participation is revoked.
We believe most participants will not need to use this provision, and
we have included an estimate that reflects this. Upon implementation of
the VQIP, we will reevaluate our estimate for future OMB submission and
revise it accordingly.
Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02248 Filed 2-4-20; 8:45 am]
BILLING CODE 4164-01-P
