Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, 18998-19000 [2020-07000]
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18998
Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. We
base our estimate of the number of
respondents in table 1 on registrations,
process filings, and reports received.
The hours per response reporting
estimates are based on our experience
with similar programs and information
received from industry. The reporting
burden for §§ 108.25(d) and 108.35(d)
and (e) is minimal because notification
of spoilage, process deviation, or
contamination of product in distribution
occurs less than once a year. Most firms
discover these problems before the
product is distributed and, therefore, are
not required to report the occurrence.
We estimate that we will receive one
report annually under §§ 108.25(d) and
108.35(d) and (e). The report is expected
to take 4 hours per response, for a total
of 4 hours.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR part
108, 113, and 114 ................................................................
1 There
10,392
Total annual
records
1
10,392
Average
burden per
recordkeeping
250
Total hours
2,598,000
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of 10,392
recordkeepers in table 2 on the number
of registered firms, excluding firms that
were inactive or out of business, yet still
registered. We estimate that 10,392
firms will each expend approximately
250 hours per year to fully satisfy the
recordkeeping requirements in parts
108, 113 and 114, for a total of 2,598,000
hours.
Finally, our regulations require that
processors mark thermally processed
low-acid foods in hermetically sealed
containers (§ 113.60(c)) and acidified
foods (§ 114.80(b)) with an identifying
code to permit lots to be traced after
distribution. No burden has been
estimated for the third-party disclosure
requirements in §§ 113.60(c) and
114.80(b) because the coding process is
done as a usual and customary part of
normal business activities. Coding is a
business practice in foods for liability
purposes, inventory control, and
process control in the event of a
problem. Under 5 CFR 1320.3(b)(2), the
time, effort, and financial resources
necessary to comply with a collection of
information are excluded from the
burden estimate if the reporting,
recordkeeping, or disclosure activities
needed to comply are usual and
customary because they would occur in
the normal course of activities.
Dated: March 30, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07007 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
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Number of
records per
recordkeeper
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1619]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Good
Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements
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 May 4,
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 0910–0606. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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
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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.
Current Good Manufacturing Practice
in Manufacturing, Packaging, Labeling,
or Holding Operations for Dietary
Supplements—21 CFR Part 111; OMB
Control Number 0910–0606—Revision
The Dietary Supplement Health and
Education Act (Pub. L. 103–417) added
section 402(g) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
342(g)), which provides, in part, that the
Secretary of Health and Human Services
may, by regulation, prescribe good
manufacturing practice for dietary
supplements. Section 402(g) of the
FD&C Act also stipulates that such
regulations will be modeled after
current good manufacturing practice
(CGMP) regulations for food and may
not impose standards for which there
are no current, and generally available,
analytical methodology. Section
402(g)(1) of the FD&C Act states that a
dietary supplement is adulterated if it
has been prepared, packed, or held
under conditions that do not meet
current good manufacturing practice
regulations.
Accordingly, we have promulgated
regulations in part 111 (21 CFR part
111) establishing minimum CGMP
requirements pertaining to the
manufacturing, packaging, labeling, or
holding of dietary supplements to
ensure their quality. Included among
the requirements is recordkeeping,
documenting, planning, control, and
improvement processes of a quality
control system. Implementation of these
processes in a manufacturing operation
serves as the backbone to CGMP. The
records must show what is being
manufactured and whether the controls
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03APN1
Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
in place ensure the product’s identity,
purity, strength, and composition, and
that limits on contaminants and
measures to prevent adulteration are
effective. Further, records must show
whether and what deviations from
control processes occurred, facilitate
evaluation and corrective action
concerning these deviations (including,
where necessary, whether associated
batches of product should be recalled
from the marketplace), and enable a
manufacturer to assure that the
corrective action was effective. We
believe the regulations in part 111
establish the minimum manufacturing
practices necessary to ensure that
dietary supplements are manufactured,
packaged, labeled, or held in a manner
that will ensure the quality of the
dietary supplements during
manufacturing, packaging, labeling, or
holding operations.
Specifically, the recordkeeping
requirements of the regulations in part
111 include establishing written
procedures and maintaining records
pertaining to: (1) Personnel; (2)
sanitation; (3) calibration of instruments
and controls; (4) calibration, inspection,
or checks of automated, mechanical, or
electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and
utensils and other contact surfaces; (6)
water used that may become a
component of the dietary supplement;
(7) production and process controls; (8)
quality control; (9) components,
packaging, labels, and product received
for packaging and labeling; (10) master
manufacturing and batch production;
(11) laboratory operations; (12)
manufacturing operations; (13)
packaging and labeling operations; (14)
holding and distributing operations; (15)
returned dietary supplements; and (16)
product complaints.
Section 111.75 (21 CFR 111.75)
reflects FDA’s determination that
manufacturers that test or examine 100
percent of the incoming dietary
ingredients for identity can be assured
of the identity of the ingredient.
However, we recognize that it may be
possible for a manufacturer to
demonstrate, through various methods
and processes in use over time for its
particular operation, that a system of
less than 100 percent identity testing
would result in no material diminution
of assurance of the identity of the
dietary ingredient as compared to the
assurance provided by 100 percent
identity testing. Section 111.75 provides
an opportunity for a manufacturer to
make such a showing and reduce the
frequency of identity testing of
components that are dietary ingredients
from 100 percent to some lower
frequency. Section 111.75 sets forth the
18999
information a manufacturer is required
to submit for an exemption from the
requirement of 100 percent identity
testing when a manufacturer petitions
the Agency for such an exemption to
100 percent identity testing under 21
CFR 10.30, and the Agency grants such
exemption. This reporting burden is
currently accounted for under OMB
control number 0910–0608, Petition to
Request an Exemption from 100 Percent
Identity Testing of Dietary Ingredients:
CGMP in Manufacturing, Packaging,
Labeling or Holding Operations for
Dietary Supplements. With this notice,
we propose to consolidate information
collection under § 111.75 into the
instant and related information
collection.
Description of Respondents:
Manufacturers, dietary supplement
manufacturers, packagers and
repackagers, labelers and re-labelers,
holders, distributors, warehousers,
exporters, importers, large businesses,
and small businesses engaged in the
dietary supplement industry.
In the Federal Register of December 5,
2019 (84 FR 66678), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
jbell on DSKJLSW7X2PROD with NOTICES
21 CFR section; activity
111.14; records of personnel practices, including
documentation of training.
111.23; records of physical plant sanitation practices, including pest control and water quality.
111.35; records of equipment and utensils calibration and sanitation practices.
111.95; records of production and process control systems.
111.140; records that quality control personnel
must make and keep.
111.180; records associated with components,
packaging, labels, and product received for
packaging and labeling as a dietary supplement.
111.210; requirements for what the master manufacturing record must include.
111.260; requirements for what the batch record
must include.
111.325; records that quality control personnel
must make and keep for laboratory operations.
111.375; records of the written procedures established for manufacturing operations.
111.430; records of the written procedures for
packaging and labeling operations.
111.475; records of product distribution and procedures for holding and distributing operations.
111.535; records for returned dietary supplements.
111.570; records regarding product complaints ...
VerDate Sep<11>2014
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Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
15,000
4
60,000
1 ....................................
60,000
15,000
1
15,000
0.2 (12 minutes) ...........
3,000
400
1
400
12.5 ...............................
5,000
250
1
250
45 ..................................
11,250
240
1,163
279,120
1 ....................................
279,120
240
1,163
279,120
1 ....................................
279,120
240
1
240
2.5 .................................
600
145
1,408
204,160
1 ....................................
204,160
120
1
120
15 ..................................
1,800
260
1
260
2 ....................................
520
50
1
50
12.6 ...............................
630
15,000
1
15,000
0.4 (24 minutes) ...........
6,000
110
4
440
13.5 ...............................
5,940
240
600
144,000
0.5 (30 minutes) ...........
72,000
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19000
Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
21 CFR section; activity
Total ...............................................................
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
........................
........................
.......................................
Total hours
929,140
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
111.75; petition for exemption from 100 percent identity
testing ...........................................................................
1
1
1
8
8
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have made no changes to our
estimate of the information collection
based on our most recent review.
However, in consolidating burden from
information collection previously
accounted for under OMB control
number 0910–0608, the information
collection reflects an increase of 8 hours
and one response annually.
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–07000 Filed 4–2–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute on Deafness and
Other Communication Disorders;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the Board of Scientific
Counselors, NIDCD, March 30, 2020,
8:15 a.m. to March 31, 2020, 4:15 p.m.,
PORTER NEUROSCIENCE RESEARCH
CENTER, Building 35A, 35 Convent
Drive, Bethesda, MD 20892 which was
published in the Federal Register on
March 4, 2020, 85 FR 12796.
This notice is being amended to
change the meeting location from Bldg.
35A to a virtual meeting. The URL link
to this meeting is: https://
nih.webex.com/nih/j.php?MTID=mf
89176f712a4e0c93a5c0bb2ea70d9ad.
Any member of the public may submit
written comments no later than 15 days
after meeting. The meeting is partially
Closed to the public.
VerDate Sep<11>2014
17:45 Apr 02, 2020
Jkt 250001
Dated: March 30, 2020.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06942 Filed 4–2–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the Microbiology and
Infectious Diseases Research Committee,
June 04, 2020, 09:00 a.m. to June 05,
2020, 06:00 p.m., Embassy Suites Hotel,
4300 Military Road, Washington, DC
20015 which was published in the
Federal Register on January 16, 2020, 85
FR 515.
This meeting notice is amended to
change the meeting type from regular in
person to teleconference.
The meeting is closed to the public.
Dated: March 30, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–06970 Filed 4–2–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
PO 00000
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The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Drug
Repositioning and Combination Therapy for
AD.
Date: May 6, 2020.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building 2C/212, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 496–9666,
parsadaniana@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Alzheimer’s
Disease Drug Development.
Date: May 13, 2020.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Alexander Parsadanian,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building, 2C/212, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 496–9666,
parsadaniana@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 85, Number 65 (Friday, April 3, 2020)]
[Notices]
[Pages 18998-19000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07000]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1619]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations
for Dietary Supplements
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 May 4, 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 0910-0606. 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.
Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111; OMB Control Number 0910-0606--Revision
The Dietary Supplement Health and Education Act (Pub. L. 103-417)
added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practice for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
current good manufacturing practice (CGMP) regulations for food and may
not impose standards for which there are no current, and generally
available, analytical methodology. Section 402(g)(1) of the FD&C Act
states that a dietary supplement is adulterated if it has been
prepared, packed, or held under conditions that do not meet current
good manufacturing practice regulations.
Accordingly, we have promulgated regulations in part 111 (21 CFR
part 111) establishing minimum CGMP requirements pertaining to the
manufacturing, packaging, labeling, or holding of dietary supplements
to ensure their quality. Included among the requirements is
recordkeeping, documenting, planning, control, and improvement
processes of a quality control system. Implementation of these
processes in a manufacturing operation serves as the backbone to CGMP.
The records must show what is being manufactured and whether the
controls
[[Page 18999]]
in place ensure the product's identity, purity, strength, and
composition, and that limits on contaminants and measures to prevent
adulteration are effective. Further, records must show whether and what
deviations from control processes occurred, facilitate evaluation and
corrective action concerning these deviations (including, where
necessary, whether associated batches of product should be recalled
from the marketplace), and enable a manufacturer to assure that the
corrective action was effective. We believe the regulations in part 111
establish the minimum manufacturing practices necessary to ensure that
dietary supplements are manufactured, packaged, labeled, or held in a
manner that will ensure the quality of the dietary supplements during
manufacturing, packaging, labeling, or holding operations.
Specifically, the recordkeeping requirements of the regulations in
part 111 include establishing written procedures and maintaining
records pertaining to: (1) Personnel; (2) sanitation; (3) calibration
of instruments and controls; (4) calibration, inspection, or checks of
automated, mechanical, or electronic equipment; (5) maintaining,
cleaning, and sanitizing equipment and utensils and other contact
surfaces; (6) water used that may become a component of the dietary
supplement; (7) production and process controls; (8) quality control;
(9) components, packaging, labels, and product received for packaging
and labeling; (10) master manufacturing and batch production; (11)
laboratory operations; (12) manufacturing operations; (13) packaging
and labeling operations; (14) holding and distributing operations; (15)
returned dietary supplements; and (16) product complaints.
Section 111.75 (21 CFR 111.75) reflects FDA's determination that
manufacturers that test or examine 100 percent of the incoming dietary
ingredients for identity can be assured of the identity of the
ingredient. However, we recognize that it may be possible for a
manufacturer to demonstrate, through various methods and processes in
use over time for its particular operation, that a system of less than
100 percent identity testing would result in no material diminution of
assurance of the identity of the dietary ingredient as compared to the
assurance provided by 100 percent identity testing. Section 111.75
provides an opportunity for a manufacturer to make such a showing and
reduce the frequency of identity testing of components that are dietary
ingredients from 100 percent to some lower frequency. Section 111.75
sets forth the information a manufacturer is required to submit for an
exemption from the requirement of 100 percent identity testing when a
manufacturer petitions the Agency for such an exemption to 100 percent
identity testing under 21 CFR 10.30, and the Agency grants such
exemption. This reporting burden is currently accounted for under OMB
control number 0910-0608, Petition to Request an Exemption from 100
Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing,
Packaging, Labeling or Holding Operations for Dietary Supplements. With
this notice, we propose to consolidate information collection under
Sec. 111.75 into the instant and related information collection.
Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
In the Federal Register of December 5, 2019 (84 FR 66678), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section; activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
111.14; records of personnel 15,000 4 60,000 1............... 60,000
practices, including
documentation of training.
111.23; records of physical 15,000 1 15,000 0.2 (12 minutes) 3,000
plant sanitation practices,
including pest control and
water quality.
111.35; records of equipment 400 1 400 12.5............ 5,000
and utensils calibration and
sanitation practices.
111.95; records of production 250 1 250 45.............. 11,250
and process control systems.
111.140; records that quality 240 1,163 279,120 1............... 279,120
control personnel must make
and keep.
111.180; records associated 240 1,163 279,120 1............... 279,120
with components, packaging,
labels, and product received
for packaging and labeling as
a dietary supplement.
111.210; requirements for what 240 1 240 2.5............. 600
the master manufacturing
record must include.
111.260; requirements for what 145 1,408 204,160 1............... 204,160
the batch record must include.
111.325; records that quality 120 1 120 15.............. 1,800
control personnel must make
and keep for laboratory
operations.
111.375; records of the 260 1 260 2............... 520
written procedures
established for manufacturing
operations.
111.430; records of the 50 1 50 12.6............ 630
written procedures for
packaging and labeling
operations.
111.475; records of product 15,000 1 15,000 0.4 (24 minutes) 6,000
distribution and procedures
for holding and distributing
operations.
111.535; records for returned 110 4 440 13.5............ 5,940
dietary supplements.
111.570; records regarding 240 600 144,000 0.5 (30 minutes) 72,000
product complaints.
[[Page 19000]]
Total..................... .............. .............. .............. ................ 929,140
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.75; petition for exemption from 100 percent identity testing. 1 1 1 8 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have made no changes to our estimate of the information
collection based on our most recent review. However, in consolidating
burden from information collection previously accounted for under OMB
control number 0910-0608, the information collection reflects an
increase of 8 hours and one response annually.
Dated: March 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07000 Filed 4-2-20; 8:45 am]
BILLING CODE 4164-01-P
