Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification Requests and Recordkeeping, 45890-45892 [2020-16534]
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khammond on DSKJM1Z7X2PROD with NOTICES
45890
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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–
2017–D–0829 for ‘‘Expiration Dating of
Unit-Dose Repackaged Solid Oral
Dosage Form Drug Products.’’ Received
comments 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://
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.
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You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Bill
Harvey, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 51, Rm. 4214, Silver Spring,
MD 20993–0002, 240–402–4180.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Expiration Dating of Unit-Dose
Repackaged Solid Oral Dosage Form
Drug Products.’’ The last few decades
have seen an increasing demand in
various health care settings for solid oral
dosage form drug products repackaged
into unit-dose containers, which hold a
quantity of drug for administration as a
single dose. The increase in unit-dose
repackaging has led to questions
regarding stability studies and
appropriate expiration dates for these
repackaged products. This guidance
describes the circumstances under
which FDA generally does not intend to
take action regarding required stability
studies for these repackaged products
and appropriate expiration dates under
those circumstances.
This guidance finalizes the revised
draft guidance of the same name issued
in August 2017 (82 FR 37229). FDA
received a few comments on the revised
draft guidance and has modified this
guidance by: (1) Describing why liquid
dosage forms are excluded, (2)
indicating approaches that may be used
when conducting stability studies, and
(3) making editorial changes to update
references and improve clarity. Liquid
dosage forms are substantially more
susceptible to degradation than solid
dosage forms. Because of the inherent
stability risks, FDA does not intend to
exercise enforcement discretion
regarding the stability and expiration
dating requirements in 21 CFR 211.137
and 211.166 for repackaging liquid
dosage forms.
In conjunction with the publication of
this guidance, FDA withdraws
Compliance Policy Guide 480.200,
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
‘‘Expiration Dating of Unit-Dose
Repackaged Drugs,’’ issued February 1,
1984, revised March 1995.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Expiration Dating
of Unit-Dose Repackaged Solid Oral
Dosage Form Drug Products.’’ 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.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this guidance refers to
previously approved collections of
information that are subject to review by
the OMB under the PRA. The
collections of information in 21 CFR
parts 210 and 211 have been approved
under OMB control number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–16526 Filed 7–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0622]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Color Additive
Certification Requests and
Recordkeeping
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.
SUMMARY:
E:\FR\FM\30JYN1.SGM
30JYN1
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
Submit written comments
(including recommendations) on the
collection of information by August 31,
2020.
DATES:
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 0910–0216. 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
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Color Additive Certification Requests
and Recordkeeping—21 CFR Part 80
OMB Control Number 0910–0216—
Extension
We have regulatory oversight for color
additives used in foods, drugs,
cosmetics, and medical devices. Section
721(a) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
379e(a)) provides that a color additive
shall be deemed to be unsafe unless it
meets the requirements of a listing
regulation, including any requirement
for batch certification, and is used in
accordance with the regulation. We list
color additives that have been shown to
be safe for their intended uses in Title
21 of the Code of Federal Regulations
(CFR). We require batch certification for
all color additives listed in 21 CFR part
74 and for all color additives
provisionally listed in 21 CFR part 82.
Color additives listed in 21 CFR part 73
are exempted from certification.
The requirements for color additive
certification are described in 21 CFR
part 80. In the certification procedure, a
representative sample of a new batch of
color additive, accompanied by a
‘‘request for certification’’ that provides
information about the batch, must be
submitted to FDA’s Office of Cosmetics
and Colors. FDA personnel perform
chemical and other analyses of the
representative sample and, providing
the sample satisfies all certification
requirements, issue a certification lot
number for the batch. We charge a fee
for certification based on the batch
weight and require manufacturers to
keep records of the batch pending and
after certification.
Under § 80.21 (21 CFR 80.21), a
request for certification must include:
name of color additive, manufacturer’s
batch number and weight in pounds,
name and address of manufacturer,
storage conditions, statement of use(s),
certification fee, and signature of person
requesting certification. Under § 80.22
(21 CFR 80.22), a request for
certification must include a sample of
the batch of color additive that is the
subject of the request. The sample must
be labeled to show: name of color
additive, manufacturer’s batch number
and quantity, and name and address of
person requesting certification. Under
§ 80.39 (21 CFR 80.39), the person to
whom a certificate is issued must keep
complete records showing the disposal
of all of the color additive covered by
the certificate. Such records are to be
made available upon request to any
accredited representative of FDA until
at least 2 years after disposal of all of the
color additive.
The purpose for collecting this
information is to help us assure that
only safe color additives will be used in
foods, drugs, cosmetics, and medical
devices sold in the United States. The
required information is unique to the
batch of color additive that is the subject
of a request for certification. The
manufacturer’s batch number is used for
temporarily identifying a batch of color
additive until FDA issues a certification
45891
lot number and for identifying a
certified batch during inspections. The
manufacturer’s batch number also aids
in tracing the disposal of a certified
batch or a batch that has been denied
certification for noncompliance with the
color additive regulations.
The manufacturer’s batch weight is
used for assessing the certification fee.
The batch weight also is used to account
for the disposal of a batch of certified or
certification-denied color additive. The
batch weight can be used in a recall to
determine whether all unused color
additive in the batch has been recalled.
The manufacturer’s name and address
and the name and address of the person
requesting certification are used to
contact the person responsible should a
question arise concerning compliance
with the color additive regulations.
Information on storage conditions
pending certification is used to evaluate
whether a batch of certified color
additive is inadvertently or
intentionally altered in a manner that
would make the sample submitted for
certification analysis unrepresentative
of the batch. We check storage
information during inspections.
Information on intended uses for a batch
of color additive is used to assure that
a batch of certified color additive will be
used in accordance with the
requirements of its listing regulation.
The statement of the fee on a
certification request is used for
accounting purposes so that a person
requesting certification can be notified
promptly of any discrepancies.
Description of Respondents: The
respondents include businesses engaged
in the manufacture of color additives
used in FDA-regulated foods, drugs,
cosmetics, and medical devices.
Respondents are from the private sector
(for-profit businesses).
In the Federal Register of April 16,
2020 (85 FR 21250), 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 REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR section; activity
Total annual
responses
Average burden per response
Total hours
80.21; Request for certification .........
80.22; Sample to accompany request.
38
38
198
198
7,524
7,524
0.17 (10 minutes) .............................
0.05 (3 minutes) ...............................
1,279
376
Total ...........................................
........................
........................
........................
0.22 (13 minutes) .............................
1,655
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
80.39; Record of distribution .............
1 There
38
Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16534 Filed 7–29–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2010–N–0493]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Additional Criteria
and Procedures for Classifying Overthe-Counter Drugs as Generally
Recognized as Safe and Effective and
Not Misbranded—Time and Extent
Applications for Nonprescription Drug
Products
Food and Drug Administration,
HHS.
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 collection of
information associated with the criteria
and procedures for classifying over-thecounter (OTC) drugs as generally
recognized as safe and effective and not
misbranded.
DATES: Submit either electronic or
written comments on the collection of
information by September 28, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
198
7,524
Average burden per recordkeeping
0.25 (15 minutes) .............................
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
be submitted on or before September 28,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of September 28, 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total annual
records
Total hours
1,881
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 burden estimate.
AGENCY:
Number of
records per
recordkeeper
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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include Docket No. FDA–2010–N–
0493 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded; Guidance
for Industry—Time and Extent
Applications for Nonprescription Drug
Product.’’ 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, 240–402–7500.
• 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
E:\FR\FM\30JYN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45890-45892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0622]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Color Additive
Certification Requests and Recordkeeping
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.
[[Page 45891]]
DATES: Submit written comments (including recommendations) on the
collection of information by August 31, 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 0910-0216. 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.
Color Additive Certification Requests and Recordkeeping--21 CFR Part 80
OMB Control Number 0910-0216--Extension
We have regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379e(a)) provides
that a color additive shall be deemed to be unsafe unless it meets the
requirements of a listing regulation, including any requirement for
batch certification, and is used in accordance with the regulation. We
list color additives that have been shown to be safe for their intended
uses in Title 21 of the Code of Federal Regulations (CFR). We require
batch certification for all color additives listed in 21 CFR part 74
and for all color additives provisionally listed in 21 CFR part 82.
Color additives listed in 21 CFR part 73 are exempted from
certification.
The requirements for color additive certification are described in
21 CFR part 80. In the certification procedure, a representative sample
of a new batch of color additive, accompanied by a ``request for
certification'' that provides information about the batch, must be
submitted to FDA's Office of Cosmetics and Colors. FDA personnel
perform chemical and other analyses of the representative sample and,
providing the sample satisfies all certification requirements, issue a
certification lot number for the batch. We charge a fee for
certification based on the batch weight and require manufacturers to
keep records of the batch pending and after certification.
Under Sec. 80.21 (21 CFR 80.21), a request for certification must
include: name of color additive, manufacturer's batch number and weight
in pounds, name and address of manufacturer, storage conditions,
statement of use(s), certification fee, and signature of person
requesting certification. Under Sec. 80.22 (21 CFR 80.22), a request
for certification must include a sample of the batch of color additive
that is the subject of the request. The sample must be labeled to show:
name of color additive, manufacturer's batch number and quantity, and
name and address of person requesting certification. Under Sec. 80.39
(21 CFR 80.39), the person to whom a certificate is issued must keep
complete records showing the disposal of all of the color additive
covered by the certificate. Such records are to be made available upon
request to any accredited representative of FDA until at least 2 years
after disposal of all of the color additive.
The purpose for collecting this information is to help us assure
that only safe color additives will be used in foods, drugs, cosmetics,
and medical devices sold in the United States. The required information
is unique to the batch of color additive that is the subject of a
request for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been denied
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the
certification fee. The batch weight also is used to account for the
disposal of a batch of certified or certification-denied color
additive. The batch weight can be used in a recall to determine whether
all unused color additive in the batch has been recalled.
The manufacturer's name and address and the name and address of the
person requesting certification are used to contact the person
responsible should a question arise concerning compliance with the
color additive regulations. Information on storage conditions pending
certification is used to evaluate whether a batch of certified color
additive is inadvertently or intentionally altered in a manner that
would make the sample submitted for certification analysis
unrepresentative of the batch. We check storage information during
inspections. Information on intended uses for a batch of color additive
is used to assure that a batch of certified color additive will be used
in accordance with the requirements of its listing regulation. The
statement of the fee on a certification request is used for accounting
purposes so that a person requesting certification can be notified
promptly of any discrepancies.
Description of Respondents: The respondents include businesses
engaged in the manufacture of color additives used in FDA-regulated
foods, drugs, cosmetics, and medical devices. Respondents are from the
private sector (for-profit businesses).
In the Federal Register of April 16, 2020 (85 FR 21250), 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 Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
80.21; Request for 38 198 7,524 0.17 (10 1,279
certification. minutes).
80.22; Sample to accompany 38 198 7,524 0.05 (3 minutes) 376
request.
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. 0.22 (13 1,655
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 45892]]
Table 2--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
----------------------------------------------------------------------------------------------------------------
80.39; Record of distribution. 38 198 7,524 0.25 (15 1,881
minutes).
----------------------------------------------------------------------------------------------------------------
\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 burden
estimate.
Dated: July 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16534 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P
