Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program, 35937-35939 [2020-12755]
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35937
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
Dated: June 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12750 Filed 6–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0144]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary Qualified
Importer Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by July 13,
2020.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0840. Also include
the FDA docket number found in
ADDRESSES:
brackets in the heading of this
document.
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.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
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
(VQIP) (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-voluntaryqualified-importer-program.
In the Federal Register of February 5,
2020 (85 FR 6556) we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received. We estimate the burden of the
information collection as follows:
TABLE 1—ONE-TIME RECORDKEEPING BURDEN 1
Number of
respondents
Information collection activity
Quality Assurance Program (QAP) preparation ..................
jbell on DSKJLSW7X2PROD with NOTICES
1 There
Number of
responses per
respondent
200
Total annual
responses
1
200
Average
burden per
response
160
Total hours
32,000
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
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Jkt 250001
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12JNN1.SGM
12JNN1
35938
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
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
Number of
respondents
Information collection activity
QAP Modification .................................................................
1 There
Number of
responses per
respondent
200
Total annual
responses
1
200
Average
burden per
response
16
Total hours
3,200
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 × 16 hours/importer).
TABLE 3—ESTIMATED ONE-TIME REPORTING BURDEN 1
Number of
respondents
Information collection activity
Number of
responses per
respondent
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
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 × 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).
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
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
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
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17:43 Jun 11, 2020
Jkt 250001
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
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Frm 00043
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12JNN1.SGM
12JNN1
Federal Register / Vol. 85, No. 114 / Friday, June 12, 2020 / Notices
estimate that reflects this. Upon
implementation of the VQIP, we will
reevaluate our estimate for future OMB
submission and revise it accordingly.
Dated: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–12755 Filed 6–11–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0536]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
User Fee Cover Sheet, Form FDA 3601
and Device Facility User Fee Cover
Sheet, Form FDA 3601a
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 revision of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments revising the
information collection by adding Form
FDA 3601a, entitled ‘‘Device Facility
User Fee Cover Sheet,’’ which is
submitted along with registration and
listing fee payments.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by August 11, 2020.
DATES:
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 August 11,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 11, 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.
jbell on DSKJLSW7X2PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:43 Jun 11, 2020
Jkt 250001
Electronic Submissions
35939
comments only as a written/paper
submission. You should submit two
Submit electronic comments in the
copies total. One copy will include the
following way:
• Federal eRulemaking Portal: https:// information you claim to be confidential
with a heading or cover note that states
www.regulations.gov. Follow the
‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments.
CONFIDENTIAL INFORMATION.’’ The
Comments submitted electronically,
Agency will review this copy, including
including attachments, to https://
the claimed confidential information, in
www.regulations.gov will be posted to
its consideration of comments. The
the docket unchanged. Because your
second copy, which will have the
comment will be made public, you are
claimed confidential information
solely responsible for ensuring that your
redacted/blacked out, will be available
comment does not include any
for public viewing and posted on
confidential information that you or a
https://www.regulations.gov. Submit
third party may not wish to be posted,
both copies to the Dockets Management
such as medical information, your or
Staff. If you do not wish your name and
anyone else’s Social Security number, or
contact information to be made publicly
confidential business information, such
available, you can provide this
as a manufacturing process. Please note
information on the cover sheet and not
that if you include your name, contact
in the body of your comments and you
information, or other information that
must identify this information as
identifies you in the body of your
‘‘confidential.’’ Any information marked
comments, that information will be
as ‘‘confidential’’ will not be disclosed
posted on https://www.regulations.gov.
except in accordance with 21 CFR 10.20
• If you want to submit a comment
and other applicable disclosure law. For
with confidential information that you
more information about FDA’s posting
do not wish to be made available to the
of comments to public dockets, see 80
public, submit the comment as a
FR 56469, September 18, 2015, or access
written/paper submission and in the
the information at: https://
manner detailed (see ‘‘Written/Paper
www.govinfo.gov/content/pkg/FR-2015Submissions’’ and ‘‘Instructions’’).
09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
Written/Paper Submissions
read background documents or the
Submit written/paper submissions as
electronic and written/paper comments
follows:
received, go to https://
• Mail/Hand delivery/Courier (for
www.regulations.gov and insert the
written/paper submissions): Dockets
docket number, found in brackets in the
Management Staff (HFA–305), Food and
heading of this document, into the
Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852.
and/or go to the Dockets Management
• For written/paper comments
Staff, 5630 Fishers Lane, Rm. 1061,
submitted to the Dockets Management
Rockville, MD 20852, 240–402–7500.
Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
well as any attachments, except for
Amber Sanford, Office of Operations,
information submitted, marked and
Food and Drug Administration, Three
identified, as confidential, if submitted
White Flint North, 10A–12M, 11601
as detailed in ‘‘Instructions.’’
Instructions: All submissions received Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
must include the Docket No. FDA–
fda.hhs.gov.
2012–N–0536 for ‘‘Agency Information
SUPPLEMENTARY INFORMATION: Under the
Collection Activities; Proposed
PRA (44 U.S.C. 3501–3521), Federal
Collection; Comment Request; Medical
Device User Fee Cover Sheet, Form FDA Agencies must obtain approval from the
3601 and Device Facility User Fee Cover Office of Management and Budget
(OMB) for each collection of
Sheet, Form FDA 3601(a).’’ Received
information they conduct or sponsor.
comments, those filed in a timely
manner (see ADDRESSES), will be placed ‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
in the docket and, except for those
1320.3(c) and includes Agency requests
submitted as ‘‘Confidential
or requirements that members of the
Submissions,’’ publicly viewable at
public submit reports, keep records, or
https://www.regulations.gov or at the
provide information to a third party.
Dockets Management Staff between 9
Section 3506(c)(2)(A) of the PRA (44
a.m. and 4 p.m., Monday through
U.S.C. 3506(c)(2)(A)) requires Federal
Friday.
Agencies to provide a 60-day notice in
• Confidential Submissions—To
the Federal Register concerning each
submit a comment with confidential
proposed collection of information,
information that you do not wish to be
including each proposed revision of an
made publicly available, submit your
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 85, Number 114 (Friday, June 12, 2020)]
[Notices]
[Pages 35937-35939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12755]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0144]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary Qualified
Importer Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 13, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0840. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (VQIP) (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.
In the Federal Register of February 5, 2020 (85 FR 6556) we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received. We estimate the
burden of the information collection as follows:
Table 1--One-Time Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Quality Assurance Program (QAP) 200 1 200 160 32,000
preparation....................
----------------------------------------------------------------------------------------------------------------
\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
[[Page 35938]]
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 Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses 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 Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses 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).
Table 4--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Information collection activity Number of responses per Total annual burden per Total hours
respondents respondent responses 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
[[Page 35939]]
estimate that reflects this. Upon implementation of the VQIP, we will
reevaluate our estimate for future OMB submission and revise it
accordingly.
Dated: June 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12755 Filed 6-11-20; 8:45 am]
BILLING CODE 4164-01-P
