Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking, 9514-9516 [2021-03017]
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9514
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at: https://www.fda.gov/
advisory-committees/medical-devicesadvisory-committee/general-and-plasticsurgery-devices-panel. Select the link
for the 2021 Meeting Materials. The
meeting will include slide presentations
with audio components to allow the
presentation of materials in a manner
that most closely resembles an in-person
advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 9, 2021. Oral
presentations from the public and
organizations will be scheduled on
March 23, 2021, between approximately
12:40 p.m. Eastern Time to 1:40 p.m.
Eastern Time. Those individuals
interested in making formal oral
presentations should notify the contact
person (see FOR FURTHER INFORMATION
CONTACT). The notification should
include a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants, and
an indication of the approximate time
requested to make their presentation on
or before March 11, 2021. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing sessions. The contact person
will notify interested persons regarding
their request to speak by March 12,
2021.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
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FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
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If you require accommodations due to a
disability, please contact Artair Mallet
at artair.mallett@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting. FDA is committed to the
orderly conduct of its advisory
committee meetings. Please visit our
website at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
VerDate Sep<11>2014
17:04 Feb 12, 2021
Jkt 253001
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03066 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
lower urinary oxalate levels in pediatric
and adult patients.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about OXLUMO
(lumasiran) injection, go to the ‘‘Drugs@
FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: February 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03012 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that OXLUMO
(lumasiran) injection, manufactured by
Alnylam Pharmaceuticals Inc., meets
the criteria for a priority review
voucher.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, email: althea.cuff@
fda.hhs.gov.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that OXLUMO
(lumasiran) injection, manufactured by
Alnylam Pharmaceuticals Inc., meets
the criteria for a priority review
voucher. OXLUMO (lumasiran)
injection is indicated for the treatment
of primary hyperoxaluria type 1 to
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Device Tracking
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 March 18,
2021.
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 0910–0442. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
SUMMARY:
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16FEN1
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Medical Devices; Device Tracking—21
CFR Part 821
OMB Control Number 0910–0442—
Extension
Section 519(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
360i(e)(1)), as amended by Food and
Drug Administration Modernization Act
(Pub. L. 105–115), provides that FDA
may require by order that a
manufacturer adopt a method for
tracking a class II or III medical device,
if the device meets one of the three
following criteria: (1) The failure of the
device would be reasonably likely to
have serious adverse health
consequences, (2) the device is intended
to be implanted in the human body for
more than 1 year (referred to as a
‘‘tracked implant’’), or (3) the device is
life-sustaining or life-supporting
(referred to as a ‘‘tracked l/s-l/s device’’)
and is used outside a device user
facility.
Tracked device information is
collected to facilitate identifying the
current location of medical devices and
patients possessing those devices, to the
extent that patients permit the
collection of identifying information.
Manufacturers and FDA (where
necessary) use the data to: (1) Expedite
the recall of distributed medical devices
that are dangerous or defective and (2)
facilitate the timely notification of
patients or licensed practitioners of the
risks associated with the medical
device.
In addition, the regulations include
provisions for: (1) Exemptions and
variances; (2) system and content
requirements for tracking; (3)
obligations of persons other than device
manufacturers, e.g., distributors; (4)
records and inspection requirements; (5)
confidentiality; and (6) record retention
requirements.
Respondents for this collection of
information are medical device
manufacturers, importers, and
distributors of tracked implants or
tracked l/s-l/s devices used outside a
device user facility. Distributors include
multiple and final distributors,
including hospitals.
The annual hourly burden for
respondents involved with medical
device tracking is estimated to be
615,380 hours per year. The burden
estimates cited in tables 1 through 3 are
based on the approximate number of
device tracking orders, 12 annually.
FDA estimates that approximately
22,000 respondents may be subject to
tracking reporting requirements.
Under § 821.25(a) (21 CFR 821.25(a)),
device manufacturers subject to FDA
tracking orders must adopt a tracking
method that can provide certain device,
patient, and distributor information to
FDA within 3 to 10 working days.
Assuming one occurrence per year, FDA
estimates it would take a firm 20 hours
to provide FDA with location data for
all tracked devices and 56 hours to
identify all patients and/or multiple
distributors possessing tracked devices.
Under § 821.25(d) manufacturers must
notify FDA of distributor
noncompliance with reporting
requirements. Based on the number of
audits manufacturers conduct annually,
FDA estimates it would receive no more
than one notice in any year, and that it
would take 1 hour per incident.
Under § 821.30(c)(2) (21 CFR
821.30(c)(2)), multiple distributors must
provide data on current users of tracked
devices, current device locations, and
other information, upon request from a
manufacturer or FDA. FDA has not
made such a request and is not aware of
any manufacturer making a request.
Assuming one multiple distributor
receives one request in a year from
either a manufacturer or FDA, and that
lists may be generated electronically,
the Agency estimates a burden of 1 hour
to comply.
Under § 821.30(d) distributors must
verify data or make required records
available for auditing, if a manufacturer
provides a written request. FDA’s
estimate of the burden for distributor
audit responses assumes that
manufacturers audit database entries for
5 percent of tracked devices distributed.
Each audited database entry prompts
one distributor audit response. Because
lists may be generated electronically,
FDA estimates a burden of 1 hour to
comply.
In the Federal Register of November
5, 2020 (85 FR 70634), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity; 21 CFR part
Average
burden per
response
Total annual
responses
Total hours
Discontinuation of business—821.1(d) ................................
Exemption or variance—821.2 and 821.30(e) .....................
Notification of failure to comply—821.25(d) ........................
Multiple distributor data—821.30(c)(2) ................................
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
4
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; 21 CFR part
Tracking information—821.25(a) .........................................
Record of tracking data—821.25(b) ....................................
Standard operating procedures—821.25(c) 2 ......................
Manufacturer data audit—821.25(c)(3) ................................
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Number of
records per
recordkeeper
12
12
12
12
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1
46,260
1
1,124
Total annual
records
12
555,120
12
13,488
E:\FR\FM\16FEN1.SGM
16FEN1
Average
burden per
recordkeeping
76
1
63
1
Total hours
912
555,120
756
13,488
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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
Activity; 21 CFR part
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
22,000
1
22,000
1
22,000
Total ..............................................................................
........................
........................
........................
........................
592,276
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
burden.
2 One-time
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity; 21 CFR part
Acquisition of tracked devices and final distributor data—
821.30(a) and (b) .............................................................
Multiple distributor data and distributor tracking records—
821.30(c)(2) and (d) .........................................................
Total ..............................................................................
1 There
Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03017 Filed 2–12–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Sixth Amendment to Declaration Under
the Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19
Notice of amendment.
The Acting Secretary issues
this amendment pursuant to section
319F–3 of the Public Health Service Act
to add additional categories of Qualified
Persons authorized to prescribe,
dispense, and administer covered
countermeasures under section VI of
this Declaration.
SUMMARY:
This amendment to the
Declaration is effective as of February
16, 2021.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Total annual
disclosures
Average
burden per
disclosure
Total hours
22,000
1
22,000
1
22,000
1,100
1
1,100
1
1,100
........................
........................
........................
........................
23,100
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden estimate for this
information collection has not changed
since the last OMB approval.
ACTION:
Number of
disclosures
per
respondent
L.
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health andHuman
Services, 200 Independence Avenue
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
18:04 Feb 12, 2021
Jkt 253001
SW, Washington, DC 20201; 202–260–
0365, paige.ezernack@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of Health and Human
Services (the Secretary) to issue a
Declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
manufacture, distribution,
administration, or use of medical
countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, section 2. It amended
the Public Health Service (PHS) Act,
adding section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified at 42 U.S.C.
247d–6d and 42 U.S.C. 247d–6e,
respectively. Section 319F–3 of the PHS
Act has been amended by the Pandemic
and All-Hazards Preparedness
Reauthorization Act (PAHPRA), Public
Law 113–5, enacted on March 13, 2013
and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public
Law 116–136, enacted on March 27,
2020, to expand Countermeasures under
the PREP Act.
On January 31, 2020, former
Secretary, Alex M. Azar II, declared a
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
public health emergency pursuant to
section 319 of the PHS Act, 42 U.S.C.
247d, effective January 27, 2020, for the
entire United States to aid in the
response of the nation’s health care
community to the COVID–19 outbreak.
Pursuant to section 319 of the PHS Act,
the Secretary renewed that declaration
effective on April 26, 2020, July 25,
2020, October 23, 2020, and January 21,
2021.
On March 10, 2020, former Secretary
Azar issued a Declaration under the
PREP Act for medical countermeasures
against COVID–19 (85 FR 15198, Mar.
17, 2020) (the Declaration). On April 10,
the former Secretary amended the
Declaration under the PREP Act to
extend liability immunity to covered
countermeasures authorized under the
CARES Act (85 FR 21012, Apr. 15,
2020). On June 4, the former Secretary
amended the Declaration to clarify that
covered countermeasures under the
Declaration include qualified
countermeasures that limit the harm
COVID–19 might otherwise cause. (85
FR 35100, June 8, 2020). On August 19,
the former Secretary amended the
declaration to add additional categories
of Qualified Persons and amend the
category of disease, health condition, or
threat for which he recommended the
administration or use of the Covered
Countermeasures. (85 FR 52136, August
24, 2020). On December 3, 2020, the
former Secretary amended the
declaration to incorporate Advisory
Opinions of the General Counsel
interpreting the PREP Act and the
Secretary’s Declaration and
E:\FR\FM\16FEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9514-9516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03017]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5569]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices;
Device Tracking
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 March 18, 2021.
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 0910-0442. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
[[Page 9515]]
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Medical Devices; Device Tracking--21 CFR Part 821
OMB Control Number 0910-0442--Extension
Section 519(e)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360i(e)(1)), as amended by Food and Drug Administration
Modernization Act (Pub. L. 105-115), provides that FDA may require by
order that a manufacturer adopt a method for tracking a class II or III
medical device, if the device meets one of the three following
criteria: (1) The failure of the device would be reasonably likely to
have serious adverse health consequences, (2) the device is intended to
be implanted in the human body for more than 1 year (referred to as a
``tracked implant''), or (3) the device is life-sustaining or life-
supporting (referred to as a ``tracked l/s-l/s device'') and is used
outside a device user facility.
Tracked device information is collected to facilitate identifying
the current location of medical devices and patients possessing those
devices, to the extent that patients permit the collection of
identifying information. Manufacturers and FDA (where necessary) use
the data to: (1) Expedite the recall of distributed medical devices
that are dangerous or defective and (2) facilitate the timely
notification of patients or licensed practitioners of the risks
associated with the medical device.
In addition, the regulations include provisions for: (1) Exemptions
and variances; (2) system and content requirements for tracking; (3)
obligations of persons other than device manufacturers, e.g.,
distributors; (4) records and inspection requirements; (5)
confidentiality; and (6) record retention requirements.
Respondents for this collection of information are medical device
manufacturers, importers, and distributors of tracked implants or
tracked l/s-l/s devices used outside a device user facility.
Distributors include multiple and final distributors, including
hospitals.
The annual hourly burden for respondents involved with medical
device tracking is estimated to be 615,380 hours per year. The burden
estimates cited in tables 1 through 3 are based on the approximate
number of device tracking orders, 12 annually. FDA estimates that
approximately 22,000 respondents may be subject to tracking reporting
requirements.
Under Sec. 821.25(a) (21 CFR 821.25(a)), device manufacturers
subject to FDA tracking orders must adopt a tracking method that can
provide certain device, patient, and distributor information to FDA
within 3 to 10 working days. Assuming one occurrence per year, FDA
estimates it would take a firm 20 hours to provide FDA with location
data for all tracked devices and 56 hours to identify all patients and/
or multiple distributors possessing tracked devices.
Under Sec. 821.25(d) manufacturers must notify FDA of distributor
noncompliance with reporting requirements. Based on the number of
audits manufacturers conduct annually, FDA estimates it would receive
no more than one notice in any year, and that it would take 1 hour per
incident.
Under Sec. 821.30(c)(2) (21 CFR 821.30(c)(2)), multiple
distributors must provide data on current users of tracked devices,
current device locations, and other information, upon request from a
manufacturer or FDA. FDA has not made such a request and is not aware
of any manufacturer making a request. Assuming one multiple distributor
receives one request in a year from either a manufacturer or FDA, and
that lists may be generated electronically, the Agency estimates a
burden of 1 hour to comply.
Under Sec. 821.30(d) distributors must verify data or make
required records available for auditing, if a manufacturer provides a
written request. FDA's estimate of the burden for distributor audit
responses assumes that manufacturers audit database entries for 5
percent of tracked devices distributed. Each audited database entry
prompts one distributor audit response. Because lists may be generated
electronically, FDA estimates a burden of 1 hour to comply.
In the Federal Register of November 5, 2020 (85 FR 70634), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity; 21 CFR part Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Discontinuation of business-- 1 1 1 1 1
821.1(d).......................
Exemption or variance--821.2 and 1 1 1 1 1
821.30(e)......................
Notification of failure to 1 1 1 1 1
comply--821.25(d)..............
Multiple distributor data-- 1 1 1 1 1
821.30(c)(2)...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4
----------------------------------------------------------------------------------------------------------------
\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 Average burden
Activity; 21 CFR part Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Tracking information--821.25(a). 12 1 12 76 912
Record of tracking data-- 12 46,260 555,120 1 555,120
821.25(b)......................
Standard operating procedures-- 12 1 12 63 756
821.25(c) \2\..................
Manufacturer data audit-- 12 1,124 13,488 1 13,488
821.25(c)(3)...................
[[Page 9516]]
Multiple distributor data and 22,000 1 22,000 1 22,000
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 592,276
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One-time burden.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; 21 CFR part Number of disclosures Total annual per Total hours
respondents per respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
Acquisition of tracked devices 22,000 1 22,000 1 22,000
and final distributor data--
821.30(a) and (b)..............
Multiple distributor data and 1,100 1 1,100 1 1,100
distributor tracking records--
821.30(c)(2) and (d)...........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 23,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The burden estimate for this information collection has not changed
since the last OMB approval.
Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03017 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P
