Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation, 1167-1169 [2020-00144]
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Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Application No.
Drug
ANDA 088897 .........
ANDA 089514 .........
Promethazine VC Plain (phenylephrine HCl and
promethazine HCl) Syrup, 5 mg/5 mL and 6.25 mg/5 mL.
Aerolate (theophylline) Oral Solution, 150 mg/15 mL ...........
Methocarbamol Tablets USP, 500 mg ..................................
Methocarbamol Tablets USP, 750 mg ..................................
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Trihexyphenidyl HCl Elixir, 2 mg/5 mL ..................................
ANDA 089726 .........
Prednisone Oral Solution, 5 mg/5 mL ...................................
ANDA 204472 .........
Fludeoxyglucose F–18 Injection USP, 20–300 mCi/mL .......
ANDA 204517 .........
ANDA 204535 .........
Sodium Fluoride F–18 Injection, 10–200 mCi/mL .................
Ammonia N–13 Injection USP, 3.75–37.5 mCi/mL ...............
ANDA
ANDA
ANDA
ANDA
089141
089417
089418
089478
.........
.........
.........
.........
ANDA 089479 .........
lotter on DSKBCFDHB2PROD with NOTICES
ANDA 089480 .........
Therefore, under §§ 314.150(b)(1) and
314.200 (21 CFR 314.150(b)(1) and
314.200), notice is given to the holders
of the approved ANDAs listed in the
table and to all other interested persons
that the Director of CDER proposes to
issue an order under section 505(e) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(e))
withdrawing approval of the ANDAs
and all amendments and supplements to
them on the grounds that the ANDA
holders have failed to submit reports
required under §§ 314.81 and 314.98.
In accordance with section 505 of the
FD&C Act and part 314 (21 CFR part
314), the ANDA holders are hereby
provided an opportunity for a hearing to
show why the applications listed
previously should not be withdrawn
and an opportunity to raise, for an
administrative determination, all issues
relating to the legal status of the drug
products covered by these ANDAs.
An ANDA holder who decides to seek
a hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES and
ADDRESSES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
hearing (see DATES and ADDRESSES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
the notice of participation and request
for a hearing; the information and
analyses to justify a hearing, other
comments, and a grant or denial of a
hearing are contained in § 314.200 and
in 21 CFR part 12.
The failure of an ANDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
VerDate Sep<11>2014
20:20 Jan 08, 2020
Jkt 250001
Applicant
Do.
Fleming and Co. Pharmaceuticals, Inc.
American Therapeutics, Inc.
Do.
Do.
Do.
Do.
Pharmaceutical Ventures, Ltd., P.O. Box D3700, Pomona,
NY 10970.
Wockhardt EU Operations (Swiss) AG, c/o Morton Grove
Pharmaceuticals, Inc.
MIPS Cyclotron and Radiochemistry Facility, 1201 Welch
Rd., Rm. PS049, Stanford, CA 94305.
Do.
Do.
ANDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the ANDAs and constitutes a waiver
of any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the ANDAs,
and the drug products may not
thereafter be lawfully introduced or
delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved ANDA is subject to regulatory
action at any time.
A request for a hearing may not rest
upon mere allegations or denials but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All submissions under this notice of
opportunity for a hearing must be filed
in four copies. Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen at the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday, and will
be posted to the docket at https://
www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
PO 00000
Frm 00031
1167
Fmt 4703
Sfmt 4703
Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00120 Filed 1–8–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0797]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Human Tissue
Intended for Transplantation
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 February
10, 2020.
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 0910–0302. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
E:\FR\FM\09JAN1.SGM
09JAN1
1168
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
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:
Human Tissue Intended for
Transplantation—21 CFR Part 1270
OMB Control Number 0910–0302—
Extension
Under section 361 of the Public
Health Services Act (42 U.S.C. 264),
FDA issued regulations under part 1270
(21 CFR part 1270) to prevent the
transmission of human
immunodeficiency virus, hepatitis B,
and hepatitis C, through the use of
human tissue for transplantation. The
regulations provide for inspection by
FDA of persons and tissue
establishments engaged in the recovery,
screening, testing, processing, storage,
or distribution of human tissue. These
facilities are required to meet provisions
intended to ensure appropriate
screening and testing of human tissue
donors and to ensure that records are
kept documenting that the appropriate
screening and testing have been
completed.
Section 1270.31(a) through (d) (21
CFR 1270.31(a) through (d)) requires
written procedures to be prepared and
followed for the following steps: (1) All
significant steps in the infectious
disease testing process under § 1270.21
(21 CFR 1270.21); (2) all significant
steps for obtaining, reviewing, and
assessing the relevant medical records
of the donor as prescribed in § 1270.21;
(3) designating and identifying
quarantined tissue; and (4) for
prevention of infectious disease
contamination or cross-contamination
by tissue during processing. Section
1270.31(a) and (b) also requires
recording and justification of any
deviation from the written procedures.
Section 1270.33(a) (21 CFR 1270.33(a))
requires records to be maintained
concurrently with the performance of
each significant step required in the
performance of infectious disease
screening and testing of human tissue
donors. Section 1270.33(f) requires
records to be retained regarding the
determination of the suitability of the
donors and of the records required
under § 1270.21. Section 1270.33(h)
requires all records to be retained for at
least 10 years beyond the date of
transplantation, if known, distribution,
disposition, or expiration of the tissue,
whichever is the latest. Section
1270.35(a) through (d) (21 CFR
1270.35(a) through (d)) requires specific
records to be maintained to document
the following: (1) The results and
interpretation of all required infectious
disease tests; (2) information on the
identity and relevant medical records of
the donor; (3) the receipt and/or
distribution of human tissue, and (4) the
destruction or other disposition of
human tissue.
Respondents to this collection of
information are manufacturers of human
tissue intended for transplantation.
Based on information from the Center
for Biologics Evaluation and Research’s
(CBER’s) database system, we estimate
383 tissue establishments, of which 262
are conventional tissue banks and 121
are eye tissue banks. Based on
information provided by industry, we
estimate a total of 2,141,960
conventional tissue products, and
130,987 eye tissue products distributed
per year with an average of 25 percent
of the tissue discarded due to
unsuitability for transplant. In addition,
we estimate 29,799 deceased donors of
conventional tissue and 70,027
deceased donors of eye tissue each year.
Accredited members of the American
Association of Tissue Banks (AATB)
and Eye Bank Association of America
(EBAA) adhere to standards of those
organizations that are comparable to the
recordkeeping requirements in part
1270. Based on information included in
CBER’s database system, 90 percent of
the conventional tissue banks are
members of AATB (262 × 90 percent =
236), and 95 percent of eye tissue banks
are members of EBAA (121 × 95 percent
= 115). Therefore, we exclude burden
for recordkeeping by these 351
establishments (236 + 115 = 351) from
our estimate as we believe such
recordkeeping is usual and customary
business activity (5 CFR 1320.3(b)(2)).
The recordkeeping burden, thus, is
estimated for the remaining 32
establishments, which is 8.36 percent of
all establishments (383 ¥ 351 = 32, or
32/383 = 8.36 percent).
We assume that all current tissue
establishments have developed written
procedures in compliance with part
1270. Therefore, our estimated burden
includes the general review and update
of written procedures (an annual
average of 24 hours), and the recording
and justifying of any deviations from the
written procedures under § 1270.31(a)
and (b) (an annual average of 1 hour).
The information collection burden for
maintaining records concurrently with
the performance of each significant
screening and testing step and for
retaining records for 10 years under
§ 1270.33(a), (f), and (h) include
documenting the results and
interpretation of all required infectious
disease tests and results and the identity
and relevant medical records of the
donor required under § 1270.35(a) and
(b). Therefore, the burden under these
provisions is calculated together in table
1 of this document. The recordkeeping
estimates for the number of total annual
records and hours per record are based
on information provided by industry
and our experience with the information
collection.
In the Federal Register of September
24, 2019 (84 FR 50039), 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
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR part 1270; human tissue intended for
transplantation
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
lotter on DSKBCFDHB2PROD with NOTICES
Subpart C—Procedures and Records
1270.31(a) through (d) 2 .......................................................
1270.31(a) and (b) 3 .............................................................
1270.33(a), (f), and (h), and 1270.35(a) and (b) .................
1270.35(c) ............................................................................
1270.35(d) ............................................................................
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PO 00000
32
32
32
32
32
I
Frm 00032
Fmt 4703
Sfmt 4703
1
2
6,198.84
11,876.12
1,484.50
I
32
64
198,363
380,036
47,504
E:\FR\FM\09JAN1.SGM
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1
1
1
1
I
768
64
198,363
380,036
47,504
Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
1169
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
21 CFR part 1270; human tissue intended for
transplantation
Total ..............................................................................
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
........................
........................
........................
........................
Total hours
626,735
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Review and update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
Based on a review of the information
collection since our last OMB approval,
we have made no adjustments to our
burden estimate.
Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00144 Filed 1–8–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6085]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General
Administrative Practice and
Procedures
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed 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 information
collection associated with our General
Administrative Practice and Procedures
regulations.
DATES: Submit either electronic or
written comments on the collection of
information by March 9, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 9,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 9, 2020. Comments
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:20 Jan 08, 2020
Jkt 250001
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
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.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–6085 for ‘‘General
Administrative Practice and
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Procedures.’’ 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.
• 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.
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1167-1169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00144]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0797]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Tissue Intended
for Transplantation
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
February 10, 2020.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0302.
Also include the FDA docket number found in brackets in the heading of
this document.
[[Page 1168]]
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.
Human Tissue Intended for Transplantation--21 CFR Part 1270
OMB Control Number 0910-0302--Extension
Under section 361 of the Public Health Services Act (42 U.S.C.
264), FDA issued regulations under part 1270 (21 CFR part 1270) to
prevent the transmission of human immunodeficiency virus, hepatitis B,
and hepatitis C, through the use of human tissue for transplantation.
The regulations provide for inspection by FDA of persons and tissue
establishments engaged in the recovery, screening, testing, processing,
storage, or distribution of human tissue. These facilities are required
to meet provisions intended to ensure appropriate screening and testing
of human tissue donors and to ensure that records are kept documenting
that the appropriate screening and testing have been completed.
Section 1270.31(a) through (d) (21 CFR 1270.31(a) through (d))
requires written procedures to be prepared and followed for the
following steps: (1) All significant steps in the infectious disease
testing process under Sec. 1270.21 (21 CFR 1270.21); (2) all
significant steps for obtaining, reviewing, and assessing the relevant
medical records of the donor as prescribed in Sec. 1270.21; (3)
designating and identifying quarantined tissue; and (4) for prevention
of infectious disease contamination or cross-contamination by tissue
during processing. Section 1270.31(a) and (b) also requires recording
and justification of any deviation from the written procedures. Section
1270.33(a) (21 CFR 1270.33(a)) requires records to be maintained
concurrently with the performance of each significant step required in
the performance of infectious disease screening and testing of human
tissue donors. Section 1270.33(f) requires records to be retained
regarding the determination of the suitability of the donors and of the
records required under Sec. 1270.21. Section 1270.33(h) requires all
records to be retained for at least 10 years beyond the date of
transplantation, if known, distribution, disposition, or expiration of
the tissue, whichever is the latest. Section 1270.35(a) through (d) (21
CFR 1270.35(a) through (d)) requires specific records to be maintained
to document the following: (1) The results and interpretation of all
required infectious disease tests; (2) information on the identity and
relevant medical records of the donor; (3) the receipt and/or
distribution of human tissue, and (4) the destruction or other
disposition of human tissue.
Respondents to this collection of information are manufacturers of
human tissue intended for transplantation. Based on information from
the Center for Biologics Evaluation and Research's (CBER's) database
system, we estimate 383 tissue establishments, of which 262 are
conventional tissue banks and 121 are eye tissue banks. Based on
information provided by industry, we estimate a total of 2,141,960
conventional tissue products, and 130,987 eye tissue products
distributed per year with an average of 25 percent of the tissue
discarded due to unsuitability for transplant. In addition, we estimate
29,799 deceased donors of conventional tissue and 70,027 deceased
donors of eye tissue each year.
Accredited members of the American Association of Tissue Banks
(AATB) and Eye Bank Association of America (EBAA) adhere to standards
of those organizations that are comparable to the recordkeeping
requirements in part 1270. Based on information included in CBER's
database system, 90 percent of the conventional tissue banks are
members of AATB (262 x 90 percent = 236), and 95 percent of eye tissue
banks are members of EBAA (121 x 95 percent = 115). Therefore, we
exclude burden for recordkeeping by these 351 establishments (236 + 115
= 351) from our estimate as we believe such recordkeeping is usual and
customary business activity (5 CFR 1320.3(b)(2)). The recordkeeping
burden, thus, is estimated for the remaining 32 establishments, which
is 8.36 percent of all establishments (383 - 351 = 32, or 32/383 = 8.36
percent).
We assume that all current tissue establishments have developed
written procedures in compliance with part 1270. Therefore, our
estimated burden includes the general review and update of written
procedures (an annual average of 24 hours), and the recording and
justifying of any deviations from the written procedures under Sec.
1270.31(a) and (b) (an annual average of 1 hour). The information
collection burden for maintaining records concurrently with the
performance of each significant screening and testing step and for
retaining records for 10 years under Sec. 1270.33(a), (f), and (h)
include documenting the results and interpretation of all required
infectious disease tests and results and the identity and relevant
medical records of the donor required under Sec. 1270.35(a) and (b).
Therefore, the burden under these provisions is calculated together in
table 1 of this document. The recordkeeping estimates for the number of
total annual records and hours per record are based on information
provided by industry and our experience with the information
collection.
In the Federal Register of September 24, 2019 (84 FR 50039), 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 information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR part 1270; human tissue Number of records per Total annual burden per Total hours
intended for transplantation recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Subpart C--Procedures and Records
----------------------------------------------------------------------------------------------------------------
1270.31(a) through (d) \2\...... 32 1 32 24 768
1270.31(a) and (b) \3\.......... 32 2 64 1 64
1270.33(a), (f), and (h), and 32 6,198.84 198,363 1 198,363
1270.35(a) and (b).............
1270.35(c)...................... 32 11,876.12 380,036 1 380,036
1270.35(d)...................... 32 1,484.50 47,504 1 47,504
-------------------------------------------------------------------------------
[[Page 1169]]
Total....................... .............. .............. .............. .............. 626,735
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Review and update of standard operating procedures (SOPs).
\3\ Documentation of deviations from SOPs.
Based on a review of the information collection since our last OMB
approval, we have made no adjustments to our burden estimate.
Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00144 Filed 1-8-20; 8:45 am]
BILLING CODE 4164-01-P
