Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Foreign Supplier Verification Programs for Food Importers, 6152-6154 [2019-03282]
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6152
Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Notices
FDA is specifically seeking feedback
on the following issues:
• Please comment on the definition of
the meal content. Should meal types be
defined solely by the calorie and fat
content, or should carbohydrates and
proteins also be included?
• Please comment on the definition of
the low-fat meal. Are the 400–500
calories and 25 percent fat a sufficient
definition of a low-fat meal (refer also to
table 2)?
• Please comment on the
Biopharmaceutics Classification
System-based waiver for food-effect
trials. Does current science support this
biowaiver?
Information on fed bioequivalence
(BE) studies to be submitted in
abbreviated new drug applications
(ANDAs) can be found in the FDA draft
guidance for industry entitled
‘‘Bioequivalence Studies with
Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.’’ Specific
recommendations concerning fed
comparability trials are now found in
the FDA draft guidance for industry
entitled ‘‘Bioavailability Studies
Submitted in NDAs or INDs—General
Considerations.’’ When finalized these
guidances will represent the current
thinking of FDA on these topics.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Assessing the Effects of Food on
Drugs in INDs and NDAs—Clinical
Pharmacology Considerations.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in part 314
(21 CFR part 314), including §§ 314.50
and 314.94, have been approved under
OMB control number 0910–0001. The
collections of information in part 312
(21 CFR part 312), including § 312.23,
have been approved under OMB control
number 0910–0014. The collection of
information in 21 CFR parts 50 and 56
have been approved under OMB control
numbers 0910–0755 and 0910–0130.
The collections of information in 21
CFR 201.56 and 201.57 have been
VerDate Sep<11>2014
16:24 Feb 25, 2019
Jkt 247001
approved under OMB control number
0910–0572. The collections of
information related to
pharmacogenomic data have been
approved under OMB control number
0910–0557.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: February 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03247 Filed 2–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0143]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Foreign Supplier
Verification Programs for Food
Importers
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: Fax written comments on the
collection of information by March 28,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0752. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
North Bethesda, MD 20852, 301–796–
3794, 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.
Foreign Supplier Verification Programs
(FSVP) for Food Importers
OMB Control Number 0910–0752—
Extension
This information collection supports
FDA regulations at 21 CFR part 1,
subpart L—Foreign Supplier
Verification Programs for Food
Importers, as well as associated
guidance. As amended by the FDA Food
Safety Modernization Act (FSMA) (Pub.
L. 111–353), the Federal Food, Drug,
and Cosmetic Act (FD&C Act) enables
the Agency to better protect the public
health by helping to ensure the safety
and security of the food supply. The
regulations are intended to help ensure
that food imported into the United
States is produced in compliance with
specific processes and procedures,
including reasonably appropriate riskbased preventive controls. The
regulations establish that importers of
foods must develop, maintain, and
follow an FSVP that provides adequate
assurances that a foreign supplier is
producing the food in compliance with
processes and procedures that provide
at least the same level of public health
protection as those required under
section 418 of the FD&C Act (21 U.S.C.
350g) (regarding hazard analysis and
risk-based preventive controls for
certain foods) or 419 (21 U.S.C. 350h)
(regarding standards for produce safety),
if either is applicable, and the
implementing regulations, and is
producing the food in compliance with
sections 402 (21 U.S.C. 342) (regarding
adulteration) and 403(w) (21 U.S.C.
343(w)) (if applicable) (regarding
misbranding with respect to labeling for
the presence of major food allergens) of
the FD&C Act. The regulations also
provide for certain exemptions.
To assist respondents with
understanding the regulatory
requirements, we have developed
Agency guidance, which is available at:
https://www.fda.gov/Food/Guidance
Regulation/FSMA/ucm253380.htm.
In the Federal Register of October 22,
2018 (83 FR 53271), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden for the
information collection as follows:
E:\FR\FM\26FEN1.SGM
26FEN1
Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Notices
6153
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section(s)
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Exemption for food for research 1.501(c) ...................
DUNS number for filing with U.S. Customs and Border Protection 1.509, 1.511, 1.512.
36,360
56,800
40
157
1,454,400
8,917,600
0.083 (5 minutes) ...
0.02 (1.2 minutes) ..
120,715
178,352
Total ......................................................................
........................
........................
........................
................................
299,067
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Information collection activity; 21 CFR section(s)
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Controls for low-acid canned foods; 1.502(b) .............
2,443
4
9,772 1 .............................
FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and corrective actions:
Determine and document hazards; 1.504(a) .......
11,701
1
11,701 3.5 ..........................
Review hazard analysis; 1.504(d) ........................
11,701
7
81,907 0.33 (20 minutes) ...
Evaluation of food and foreign supplier;
11,701
1
11,701 4 .............................
1.505(a)(2), 1.511(c)(1).
Approval of suppliers; 1.505(b), 1.512(c)(1)(iii) ...
8,191
1
8,191 12 ...........................
Reevaluation of food and foreign supplier;
11,701
365
4,270,865 0.25 (15 minutes) ...
1.505(c), 1.512(c)(1)(ii)(A).
Confirm or change requirements of foreign sup2,340
1
2,340 2 .............................
plier
verification
activity;
1.505(c),
1.512(c)(1)(ii)(A).
Review of other entities assessments; 1.505(d),
3,510
1
3,510 1.2 ..........................
1.512(c)(1)(iii).
Written procedures for use of approved foreign
11,701
1
11,701 8 .............................
suppliers;
1.506(a)(1),
1.511(c)(2),
1.512(c)(3)(i).
Review of written procedures; 1.506(a)(2),
11,701
1
11,701 1 .............................
1.511(c)(2)(ii), 1.512(c)(3)(ii).
Written procedures for conducting verification ac11,701
1
11,701 2 .............................
tivities; 1.506(b), 1.511(c)(3).
Determination and documentation of appropriate
11,701
4
46,804 3.25 ........................
supplier verification activities; 1.506(d)(1)–(2)
1.511(c)(5)(i).
Review of appropriate supplier verification activi11,701
2
23,402 0.33 (20 minutes) ..
ties determined by another entity; 1.506(d)(3)
1.511(c)(5)(iii).
Conduct/review
audits;
1.506(e)(1)(i),
11,701
2
23,402 3 .............................
1.511(c)(4)(ii)(A).
Conduct
periodic
sampling/testing;
11,701
2
23,402 1 .............................
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 1.511(c)(4)(ii)(C)
11,701
2
23,402 1.6 ..........................
Document your review of supplier verification ac11,701
6
70,206 0.25 (15 minutes) ..
tivity records; 1.506(e)(3), 1.511(c)(4)(iii).
Document hazard controls; 1.507(a)(1) ...............
11,701
3.17
37,092 1.25 ........................
Written assurances; 1.507(a)(2), (a)(3), and
11,701
8.72
102,038 0.50 (30 minutes) ...
(a)(4).
Disclosures
that
accompany
assurances;
102,038
1
102,038 0.50 (30 minutes) ..
1.507(a)(2), (a)(3), and (a)(4).
Document assurances from customers; 1.507(c)
36,522
2.8
102,262 0.25 (15 minutes) ..
Document
corrective
actions;
1.508(a),
2,340
1
2,340 2 .............................
1.512(b)(4).
Investigate and determine FSVP adequacy;
2,340
1
2,340 5 .............................
1.508(b), 1.511(c)(1).
Subtotal for FSVP Recordkeeping Itemized
Above.
Written assurances for food produced under dietary supplement current good manufacturing
practices; 1.511(b).
Document very small importer/certain small foreign supplier status; 1.512(b)(1).
Written assurances associated with very small
importer/certain
small
foreign
supplier
1.512(b)(3).
VerDate Sep<11>2014
16:24 Feb 25, 2019
Jkt 247001
PO 00000
Total hours
9,772
40,954
27,029
46,804
928,292
1,067,716
4,680
4,212
93,608
11,701
23,402
152,113
7,723
70,206
23,402
37,443
17,552
46,365
51,019
51,019
25,566
4,680
11,700
........................
........................
4,984,046
................................
1,917,186
11,701
2.88
33,699
2.25 ........................
75,823
50,450
1
50,450
1 .............................
50,450
50,450
2.8
141,260
2.25 ........................
317,835
Frm 00027
Fmt 4703
Sfmt 4703
E:\FR\FM\26FEN1.SGM
26FEN1
6154
Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Information collection activity; 21 CFR section(s)
Total ..............................................................
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
........................
........................
........................
................................
Total hours
2,361,294
are no capital costs or operating and maintenance costs associated with the information collection.
We are retaining the currently
approved burden estimates. The FSVP
requirements became effective May 30,
2017, and we continue to evaluate
associated burden.
Dated: February 21, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–03282 Filed 2–25–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice of Opportunity To Co-Sponsor
OMH National Minority Health Month
Steps Challenge
Office of the Secretary, Office
of the Assistant Secretary for Health,
Office of Minority Health (OMH),
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
OMH announces the
opportunity for public and non-profit
entities to co-sponsor the National
Minority Health Month National Steps
Challenge for April 2019. Potential cosponsors must have a demonstrated
interest in reducing health disparities
among minority communities,
advancing the HHS Physical Activity
Guidelines and improving the health of
Americans through promoting regular
physical activity.
DATES: To receive consideration for this
opportunity, a two-page proposal to
participate as a co-sponsor must be
received by OMH by 5 p.m. EST on
March 7, 2019 at the address listed
below. Co-sponsorship proposals will
meet the deadline if they are either (1)
received or (2) postmarked on or before
the deadline. Privately metered
postmarks will not be accepted as proof
of timely mailing. Proposals received
after the established deadline will not
be considered.
ADDRESSES: Proposals for cosponsorship should be sent to Mr.
Anthony Welch, HHS Office of Minority
Health, 1101 Wootton Parkway, Suite
600, Tower Building, Rockville,
Maryland 20852. Requests may also be
emailed to Anthony.Welch@hhs.gov.
SUMMARY:
VerDate Sep<11>2014
16:24 Feb 25, 2019
Jkt 247001
Mr.
Anthony Welch, HHS Office of Minority
Health Quality, 1101 Wootton Parkway,
Suite 600, Tower Building, Rockville,
Maryland 20852; (240) 453–2882.
SUPPLEMENTARY INFORMATION: The
mission of the Office of Minority Health
(OMH) at the U.S. Department of Health
and Human Services (HHS) is to
improve the health of racial and ethnic
minority populations through the
development of health policies and
programs that will help eliminate health
disparities. Key strategies of the OMH
mission include:
• Developing and promoting policies,
programs and practices to achieve
health equity;
• Funding demonstration programs at
the regional, state and local level that
can contribute to health policy and the
effectiveness of strategies for improving
health;
• Improving data collection, reporting
and sharing for ethnic and racial
minority populations;
• Fostering research and evaluation;
and
• Establishing and strengthening
networks, coalitions and partnerships to
identify and solve health problems.
OMH observes National Minority
Health Month every year in April to
highlight the health disparities that
persist among racial and ethnic minority
populations and the ways in which
policies, programs and partnerships can
help advance health equity. The HHS
OMH establishes the national theme and
serves as the lead HHS office for the
observance of National Minority Health
Month.
The theme for 2019 is Active &
Healthy and is intended to help promote
the second edition of the HHS Physical
Activity Guidelines and the Move Your
Way Campaign from the HHS Office of
Disease Prevention and Health
Promotion, especially among racial and
ethnic minorities. OMH’s main activity
for this year’s observance is the National
Minority Health Month Steps Challenge
(Challenge). The Challenge will occur
throughout the month of April and
OMH will enlist teams and individuals
to participate from federal, state and
local governments, community-based
organizations and tribal communities,
who want to show their commitment to
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
an active lifestyle. Activities and
materials throughout the month will
highlight the overall message that
physical activity promotes health and
reduces the risk of chronic disease.
Eligibility for Co-Sponsorship
To be eligible, a potential co-sponsor
shall: (1) Have a demonstrated
understanding, commitment, and
experience in conducting large-scale
steps challenges; (2) be knowledgeable
about strategies to promote health &
active lifestyles; (3) have a track record
and the ability to manage an online
platform to host multiple teams in the
challenge; (4) participate substantively
in the co-sponsored activity, not just
provide logistical support; and (5) have
an organizational mission that is
consistent with OMH and HHS. The
selected co-sponsoring organization
shall furnish the necessary personnel,
materials, services, and facilities to
administer its proposed portion of the
responsibility for the Challenge. These
duties will be outlined in a cosponsorship agreement with OMH that
will set forth the details of the cosponsored activity.
Co-Sponsorship Proposal
Each co-sponsorship proposal shall
contain a description of: (1) The entity
or organization’s background and
history; (2) its ability to satisfy the cosponsorship criteria detailed above; and
(3) its proposed involvement in the cosponsored activity. The co-sponsorship
proposal should not exceed two (2)
pages in length and should be doublespaced in Times New Roman.
Evaluation Criteria
After engaging in exploratory
discussions with potential co-sponsors
that respond to this notice,
representatives of OMH will select the
co-sponsor using the following
evaluation criteria:
(1) Qualifications and capability to
fulfill co-sponsorship responsibilities;
(2) Creativity related to enhancing the
National Minority Health Month event;
(3) Potential for reaching and
generating participants from among key
stakeholders, including federal, state
and local organizations, member-based
organizations and the general public.
E:\FR\FM\26FEN1.SGM
26FEN1
]]>Agencies
[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Pages 6152-6154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03282]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0143]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Foreign Supplier
Verification Programs for Food Importers
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: Fax written comments on the collection of information by March
28, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0752.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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.
Foreign Supplier Verification Programs (FSVP) for Food Importers
OMB Control Number 0910-0752--Extension
This information collection supports FDA regulations at 21 CFR part
1, subpart L--Foreign Supplier Verification Programs for Food
Importers, as well as associated guidance. As amended by the FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food,
Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect
the public health by helping to ensure the safety and security of the
food supply. The regulations are intended to help ensure that food
imported into the United States is produced in compliance with specific
processes and procedures, including reasonably appropriate risk-based
preventive controls. The regulations establish that importers of foods
must develop, maintain, and follow an FSVP that provides adequate
assurances that a foreign supplier is producing the food in compliance
with processes and procedures that provide at least the same level of
public health protection as those required under section 418 of the
FD&C Act (21 U.S.C. 350g) (regarding hazard analysis and risk-based
preventive controls for certain foods) or 419 (21 U.S.C. 350h)
(regarding standards for produce safety), if either is applicable, and
the implementing regulations, and is producing the food in compliance
with sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w)
(21 U.S.C. 343(w)) (if applicable) (regarding misbranding with respect
to labeling for the presence of major food allergens) of the FD&C Act.
The regulations also provide for certain exemptions.
To assist respondents with understanding the regulatory
requirements, we have developed Agency guidance, which is available at:
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.
In the Federal Register of October 22, 2018 (83 FR 53271), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden for the information collection as follows:
[[Page 6153]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section(s) Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research 1.501(c)..... 36,360 40 1,454,400 0.083 (5 minutes)........................ 120,715
DUNS number for filing with U.S. Customs and 56,800 157 8,917,600 0.02 (1.2 minutes)....................... 178,352
Border Protection 1.509, 1.511, 1.512.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity; 21 CFR Number of records per Total annual Average burden per recordkeeping Total hours
section(s) recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for low-acid canned foods; 1.502(b). 2,443 4 9,772 1........................................ 9,772
FSVP Recordkeeping, including hazard determination, written procedures, reevaluation; audits; and corrective actions:
Determine and document hazards; 1.504(a). 11,701 1 11,701 3.5...................................... 40,954
Review hazard analysis; 1.504(d)......... 11,701 7 81,907 0.33 (20 minutes)........................ 27,029
Evaluation of food and foreign supplier; 11,701 1 11,701 4........................................ 46,804
1.505(a)(2), 1.511(c)(1).
Approval of suppliers; 1.505(b), 8,191 1 8,191 12....................................... 928,292
1.512(c)(1)(iii).
Reevaluation of food and foreign 11,701 365 4,270,865 0.25 (15 minutes)........................ 1,067,716
supplier; 1.505(c), 1.512(c)(1)(ii)(A).
Confirm or change requirements of foreign 2,340 1 2,340 2........................................ 4,680
supplier verification activity;
1.505(c), 1.512(c)(1)(ii)(A).
Review of other entities assessments; 3,510 1 3,510 1.2...................................... 4,212
1.505(d), 1.512(c)(1)(iii).
Written procedures for use of approved 11,701 1 11,701 8........................................ 93,608
foreign suppliers; 1.506(a)(1),
1.511(c)(2), 1.512(c)(3)(i).
Review of written procedures; 11,701 1 11,701 1........................................ 11,701
1.506(a)(2), 1.511(c)(2)(ii),
1.512(c)(3)(ii).
Written procedures for conducting 11,701 1 11,701 2........................................ 23,402
verification activities; 1.506(b),
1.511(c)(3).
Determination and documentation of 11,701 4 46,804 3.25..................................... 152,113
appropriate supplier verification
activities; 1.506(d)(1)-(2)
1.511(c)(5)(i).
Review of appropriate supplier 11,701 2 23,402 0.33 (20 minutes)........................ 7,723
verification activities determined by
another entity; 1.506(d)(3)
1.511(c)(5)(iii).
Conduct/review audits; 1.506(e)(1)(i), 11,701 2 23,402 3........................................ 70,206
1.511(c)(4)(ii)(A).
Conduct periodic sampling/testing; 11,701 2 23,402 1........................................ 23,402
1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
Review records; 1.506(e)(1)(iii), 11,701 2 23,402 1.6...................................... 37,443
1.511(c)(4)(ii)(C).
Document your review of supplier 11,701 6 70,206 0.25 (15 minutes)........................ 17,552
verification activity records;
1.506(e)(3), 1.511(c)(4)(iii).
Document hazard controls; 1.507(a)(1).... 11,701 3.17 37,092 1.25..................................... 46,365
Written assurances; 1.507(a)(2), (a)(3), 11,701 8.72 102,038 0.50 (30 minutes)........................ 51,019
and (a)(4).
Disclosures that accompany assurances; 102,038 1 102,038 0.50 (30 minutes)........................ 51,019
1.507(a)(2), (a)(3), and (a)(4).
Document assurances from customers; 36,522 2.8 102,262 0.25 (15 minutes)........................ 25,566
1.507(c).
Document corrective actions; 1.508(a), 2,340 1 2,340 2........................................ 4,680
1.512(b)(4).
Investigate and determine FSVP adequacy; 2,340 1 2,340 5........................................ 11,700
1.508(b), 1.511(c)(1).
----------------------------------------------------------------------------------------------------------
Subtotal for FSVP Recordkeeping .............. .............. 4,984,046 ......................................... 1,917,186
Itemized Above.
Written assurances for food produced 11,701 2.88 33,699 2.25..................................... 75,823
under dietary supplement current good
manufacturing practices; 1.511(b).
Document very small importer/certain 50,450 1 50,450 1........................................ 50,450
small foreign supplier status;
1.512(b)(1).
Written assurances associated with very 50,450 2.8 141,260 2.25..................................... 317,835
small importer/certain small foreign
supplier 1.512(b)(3).
----------------------------------------------------------------------------------------------------------
[[Page 6154]]
Total................................ .............. .............. .............. ......................................... 2,361,294
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
We are retaining the currently approved burden estimates. The FSVP
requirements became effective May 30, 2017, and we continue to evaluate
associated burden.
Dated: February 21, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03282 Filed 2-25-19; 8:45 am]
BILLING CODE 4164-01-P
