Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Electronic Drug Product Reporting of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 50523-50525 [2016-18048]
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50523
Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
of them, or 3,300 (= 66% × 5,000) of the
low estimate, currently engage in
retailing activities (Ref. 1) Two PRA
related comments were received in
response to the 60-day notice.
The two comments both identified
additional training options that could be
used to provide further educational
information collection activities
associated with the current guidance
document. FDA is supportive of training
programs that assist retailers in
complying with the tobacco control
laws.
FDA estimates the burden of this
collection of information as follows:
opportunities for tobacco retailers.
These comments primarily relate more
to the content and method of a retailer
training program rather than the
proposed collection of information
associated with the current guidance
document. At the same time, one
comment was supportive of the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Develop training program ....................................................
Develop written policy against sales to minors and employee acknowledgement .................................................
Develop internal compliance check program ......................
273,900
1
273,900
16
4,382,400
273,900
273,900
1
1
273,900
273,900
1
8
273,900
2,191,200
Total ..............................................................................
........................
........................
........................
........................
6,847,500
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
recordkeepers
Activity
Number of
records per
recordkeeper
Average
burden per
recordkeeper
Total annual
records
Total hours
Training program ..........................................................
Written policy against sales to minors and employee
acknowledgement.
Internal compliance check program .............................
273,900
273,900
4
4
1,095,600
1,095,600
.25 (15 minutes) ....
.10 (6 minutes) ......
279,300
109,560
273,900
2
547,800
.5 (30 minutes) ......
279,300
Total ......................................................................
........................
........................
........................
...............................
668,160
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates that the total burden
for this collection will be 7,515,660
hours (6,847,500 reporting + 668,160
recordkeeping).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reference
[Docket No. FDA–2013–N–1428]
1. Burke, Don, ‘‘Trends & Insights in the
Nicotine Delivery Category.’’ Management
Science Associates, Inc. Presentation at
NATO Show, April 23, 2015. Accessed June
2015.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Electronic Drug Product
Reporting of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
Dated: July 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18092 Filed 7–29–16; 8:45 am]
Food and Drug Administration
AGENCY:
BILLING CODE 4164–01–P
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 August 31,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Fmt 4703
Sfmt 4703
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
title. Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
Street, North Bethesda, MD 20852,
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.
Guidance for Industry: Electronic
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act;
Availability—OMB Control Number
0910—(NEW)
On November 27, 2013, the President
signed the Drug Quality and Security
Act (DQSA) into law (Pub. L. 113–54).
E:\FR\FM\01AUN1.SGM
01AUN1
sradovich on DSK3GMQ082PROD with NOTICES
50524
Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
The DQSA added a new section 503B to
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 353b). Under
section 503B(b), a compounder can
register as an outsourcing facility with
FDA. If the conditions outlined in
section 503B(a) of the FD&C Act are
satisfied, a drug compounded by or
under the direct supervision of a
licensed pharmacist in an outsourcing
facility is exempt from certain sections
of the FD&C Act, including section
502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with
adequate directions for use) and section
505 (21 U.S.C. 355) (concerning the
approval of human drug products under
new drug applications or abbreviated
new drug applications. Drugs
compounded in outsourcing facilities
are not exempt from the requirements of
section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current
good manufacturing practice for drugs).
In the Federal Register of November
24, 2014 (79 FR 69857), FDA announced
the availability of a revised draft
guidance for industry entitled
‘‘Electronic Drug Product Reporting for
Human Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Under section 503B of the FD&C Act,
and as described in the revised draft
guidance, an outsourcing facility must,
at the time of initial registration and
twice each year, in June and December,
submit to FDA a report identifying the
drugs compounded by the facility
during the previous six-month period.
For each identified drug, the
outsourcing facility must provide
certain information, which is listed in
section 503B(b)(2)(A)(ii) of the FD&C
Act and in the revised draft guidance.
Each facility that elects to register as
an outsourcing facility must report the
following information to FDA for each
product that it compounds:
• The active ingredient and strength
of active ingredient per unit;
• the source of the active ingredient
(bulk or finished drug);
• the National Drug Code (NDC)
number of the source drug or bulk active
ingredient, if available;
• the dosage form and route of
administration;
• the package description;
• the number of individual units
produced; and
• the NDC number of the final
product, if assigned.
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20:16 Jul 29, 2016
Jkt 238001
Compounded product information
must be submitted to FDA electronically
using the Structured Product Labeling
(SPL) format and in accordance with
section IV of the FDA guidance entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing,’’ available
at https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/ucm064994.htm. Under the
revised draft guidance, outsourcing
facilities may request a waiver from the
SPL electronic submission process by
submitting a written request to FDA
explaining why the use of electronic
means is not reasonable for the person
requesting the waiver.
In response to the November 24, 2014,
Federal Register notice, FDA received
three comments on the revised draft
guidance. Comments that addressed the
information collection provisions are
identified and discussed here.
One comment expressed concern
about being unable to submit a product
report within the required 30-day
reporting period because of the
extensive amount of time to create a
product report, especially for facilities
with large product portfolios. The
comment suggested that FDA did not
recognize that each outsourcing facility
will have numerous SPL entries into the
electronic reporting system to make up
a product report.
In consideration of the comment, we
have increased our burden estimate as
reflected in the tables 1 and 2. We have
also explained in the guidance that
there are ways to simplify the
submission of product reporting
information and reduce the number of
responses and total burden of
submitting product reporting
information.
Initially, the creation of product
report submissions can be time
consuming, but submissions can be
saved, updated, and resubmitted for
subsequent reporting periods instead of
creating a new submission each time. In
addition, multiple strengths of the same
drug, package sizes, and source NDC
numbers can be consolidated into a
single product submission in SPL.
Based on current data for outsourcing
facilities, we estimate approximately 55
outsourcing facilities will submit to
FDA an initial report identifying all
drugs compounded in the facility in the
previous 6 months. By our calculation,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
each product’s SPL submission is
considered a separate response and
therefore each facility’s product report
will include multiple responses. Taking
into account that a particular product
that is compounded into different
strengths from different sources of
active ingredient can be reported in a
single SPL response, we estimate that
the number of products reported per
facility will average 220 products per
facility. This estimate is based on
current data in product reports.
Concerning the comment that each
outsourcing facility will have numerous
SPL entries, again we have revised our
previous estimate to account for the fact
that each product report will consist of
multiple SPL responses per facility. We
estimate that preparing and submitting
this information electronically could
take up to approximately 2 hours for
each initial SPL response.
We also estimate that approximately
55 outsourcing facilities will submit to
FDA a report twice each year identifying
all drugs compounded at the facility in
the previous 6 months. As described
previously, we estimate on average 220
SPL responses per facility. We estimate
that preparing and submitting this
information electronically will take
approximately one half hour per
response. At the same time, we have
reduced the burden for semi-annual
product submissions reasoning that
outsourcing facilities can save each SPL
response once initially created and
submitted. For subsequent reports, an
outsourcing facility may resubmit the
same file(s) after changing only the
following data elements to appropriate
values for the reporting period (along
with other data as appropriate): RootID
and version number (both SPL
metadata); effective date (to identify the
reporting period); and the number of
units produced. Furthermore, if a
product was not compounded during a
particular reporting period, no SPL
response needs be sent for that product
during that reporting period.
Finally, we expect to receive no more
than one waiver request from the
electronic submission process for initial
product reports and semi-annual
reports, and estimate each request will
take 1 hour to prepare and submit to
FDA.
Therefore, we estimate the burden of
this collection of information as follows:
E:\FR\FM\01AUN1.SGM
01AUN1
50525
Federal Register / Vol. 81, No. 147 / Monday, August 1, 2016 / Notices
TABLE 1—ESTIMATED INITIAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Information collection activity
Average
burden per
response
Total annual
responses
Total hours
Submission of Initial Product Report ...................................
Waiver Request From Electronic Submission of Initial
Product Report .................................................................
55
220
12,100
2
24,200
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
24,201
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Submission for June Product Report ...........................
Submission for December Product Report ..................
Waiver Request From Electronic Submission of Product Reports.
55
55
1
220
220
1
12,100
12,100
1
0.5 (30 minutes) ....
0.5 (30 minutes) ....
1 ............................
6,050
6,050
1
Total ......................................................................
........................
........................
........................
...............................
12,101
1 There
are no capital costs or operating and maintenance costs associated with the information collection.
Dated: July 26, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2016–18048 Filed 7–29–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Food Safety Modernization Act
Domestic and Foreign Facility
Reinspection, Recall, and Importer
Reinspection Fee Rates for Fiscal Year
2017
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fiscal year (FY) 2017 fee rates for certain
domestic and foreign facility
reinspections, failures to comply with a
recall order, and importer reinspections
that are authorized by the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as amended by the FDA Food Safety
Modernization Act (FSMA). These fees
are effective on October 1, 2016, and
will remain in effect through September
30, 2017.
FOR FURTHER INFORMATION CONTACT:
Jason Lewis, Office of Resource
Management, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rm. 2046,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
20:16 Jul 29, 2016
Jkt 238001
Rockville, MD 20857, 301–796–5957,
email: Jason.Lewis@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 107 of FSMA (Pub. L. 111–
353) added section 743 to the FD&C Act
(21 U.S.C. 379j–31) to provide FDA with
the authority to assess and collect fees
from, in part: (1) The responsible party
for each domestic facility and the U.S.
agent for each foreign facility subject to
a reinspection, to cover reinspectionrelated costs; (2) the responsible party
for a domestic facility and an importer
who does not comply with a recall
order, to cover food 1 recall activities
associated with such order; and (3) each
importer subject to a reinspection to
cover reinspection-related costs
(sections 743(a)(1)(A), (B), and (D) of the
FD&C Act). Section 743 of the FD&C Act
directs FDA to establish fees for each of
these activities based on an estimate of
100 percent of the costs of each activity
for each year (sections 743(b)(2)(A)(i),
(ii), and (iv)), and these fees must be
made available solely to pay for the
costs of each activity for which the fee
was incurred (section 743(b)(3)). These
fees are effective on October 1, 2016,
and will remain in effect through
September 30, 2017. Section
743(b)(2)(B)(iii) of the FD&C Act directs
FDA to develop a proposed set of
guidelines in consideration of the
burden of fee amounts on small
businesses. As a first step in developing
1 The term ‘‘food’’ for purposes of this document
has the same meaning as such term in section 201(f)
of the FD&C Act (21 U.S.C. 321(f)).
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
these guidelines, FDA invited public
comment on the potential impact of the
fees authorized by section 743 of the
FD&C Act on small businesses (76 FR
45818, August 1, 2011). The comment
period for this request ended November
30, 2011. As stated in FDA’s September
2011 ‘‘Guidance for Industry:
Implementation of the Fee Provisions of
Section 107 of the FDA Food Safety
Modernization Act,’’ (https://
www.fda.gov/Food/
GuidanceRegulation/
GuidanceDocuments
RegulatoryInformation/FoodDefense/
ucm274176.htm), because FDA
recognizes that for small businesses the
full cost recovery of FDA reinspection
or recall oversight could impose severe
economic hardship, FDA intends to
consider reducing certain fees for those
firms. FDA does not intend to issue
invoices for reinspection or recall order
fees until FDA publishes a guidance
document outlining the process through
which firms may request a reduction in
fees.
In addition, as stated in the
September 2011 Guidance, FDA is in
the process of considering various
issues associated with the assessment
and collection of importer reinspection
fees. The fee rates set forth in this notice
will be used to determine any importer
reinspection fees assessed in FY 2017.
II. Estimating the Average Cost of a
Supported Direct FDA Work Hour for
FY 2017
FDA is required to estimate 100
percent of its costs for each activity in
order to establish fee rates for FY 2017.
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 81, Number 147 (Monday, August 1, 2016)]
[Notices]
[Pages 50523-50525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18048]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Electronic Drug Product Reporting of Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act
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 August
31, 2016.
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 title. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown Street, North Bethesda, MD 20852, 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.
Guidance for Industry: Electronic Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act; Availability--OMB Control Number 0910--
(NEW)
On November 27, 2013, the President signed the Drug Quality and
Security Act (DQSA) into law (Pub. L. 113-54).
[[Page 50524]]
The DQSA added a new section 503B to the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 353b). Under section 503B(b), a
compounder can register as an outsourcing facility with FDA. If the
conditions outlined in section 503B(a) of the FD&C Act are satisfied, a
drug compounded by or under the direct supervision of a licensed
pharmacist in an outsourcing facility is exempt from certain sections
of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1))
(concerning the labeling of drugs with adequate directions for use) and
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications or abbreviated new drug
applications. Drugs compounded in outsourcing facilities are not exempt
from the requirements of section 501(a)(2)(B) of the FD&C Act (21
U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice
for drugs).
In the Federal Register of November 24, 2014 (79 FR 69857), FDA
announced the availability of a revised draft guidance for industry
entitled ``Electronic Drug Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' Under section 503B of the FD&C Act, and as
described in the revised draft guidance, an outsourcing facility must,
at the time of initial registration and twice each year, in June and
December, submit to FDA a report identifying the drugs compounded by
the facility during the previous six-month period. For each identified
drug, the outsourcing facility must provide certain information, which
is listed in section 503B(b)(2)(A)(ii) of the FD&C Act and in the
revised draft guidance.
Each facility that elects to register as an outsourcing facility
must report the following information to FDA for each product that it
compounds:
The active ingredient and strength of active ingredient
per unit;
the source of the active ingredient (bulk or finished
drug);
the National Drug Code (NDC) number of the source drug or
bulk active ingredient, if available;
the dosage form and route of administration;
the package description;
the number of individual units produced; and
the NDC number of the final product, if assigned.
Compounded product information must be submitted to FDA
electronically using the Structured Product Labeling (SPL) format and
in accordance with section IV of the FDA guidance entitled ``Providing
Regulatory Submissions in Electronic Format--Drug Establishment
Registration and Drug Listing,'' available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064994.htm. Under
the revised draft guidance, outsourcing facilities may request a waiver
from the SPL electronic submission process by submitting a written
request to FDA explaining why the use of electronic means is not
reasonable for the person requesting the waiver.
In response to the November 24, 2014, Federal Register notice, FDA
received three comments on the revised draft guidance. Comments that
addressed the information collection provisions are identified and
discussed here.
One comment expressed concern about being unable to submit a
product report within the required 30-day reporting period because of
the extensive amount of time to create a product report, especially for
facilities with large product portfolios. The comment suggested that
FDA did not recognize that each outsourcing facility will have numerous
SPL entries into the electronic reporting system to make up a product
report.
In consideration of the comment, we have increased our burden
estimate as reflected in the tables 1 and 2. We have also explained in
the guidance that there are ways to simplify the submission of product
reporting information and reduce the number of responses and total
burden of submitting product reporting information.
Initially, the creation of product report submissions can be time
consuming, but submissions can be saved, updated, and resubmitted for
subsequent reporting periods instead of creating a new submission each
time. In addition, multiple strengths of the same drug, package sizes,
and source NDC numbers can be consolidated into a single product
submission in SPL.
Based on current data for outsourcing facilities, we estimate
approximately 55 outsourcing facilities will submit to FDA an initial
report identifying all drugs compounded in the facility in the previous
6 months. By our calculation, each product's SPL submission is
considered a separate response and therefore each facility's product
report will include multiple responses. Taking into account that a
particular product that is compounded into different strengths from
different sources of active ingredient can be reported in a single SPL
response, we estimate that the number of products reported per facility
will average 220 products per facility. This estimate is based on
current data in product reports.
Concerning the comment that each outsourcing facility will have
numerous SPL entries, again we have revised our previous estimate to
account for the fact that each product report will consist of multiple
SPL responses per facility. We estimate that preparing and submitting
this information electronically could take up to approximately 2 hours
for each initial SPL response.
We also estimate that approximately 55 outsourcing facilities will
submit to FDA a report twice each year identifying all drugs compounded
at the facility in the previous 6 months. As described previously, we
estimate on average 220 SPL responses per facility. We estimate that
preparing and submitting this information electronically will take
approximately one half hour per response. At the same time, we have
reduced the burden for semi-annual product submissions reasoning that
outsourcing facilities can save each SPL response once initially
created and submitted. For subsequent reports, an outsourcing facility
may resubmit the same file(s) after changing only the following data
elements to appropriate values for the reporting period (along with
other data as appropriate): RootID and version number (both SPL
metadata); effective date (to identify the reporting period); and the
number of units produced. Furthermore, if a product was not compounded
during a particular reporting period, no SPL response needs be sent for
that product during that reporting period.
Finally, we expect to receive no more than one waiver request from
the electronic submission process for initial product reports and semi-
annual reports, and estimate each request will take 1 hour to prepare
and submit to FDA.
Therefore, we estimate the burden of this collection of information
as follows:
[[Page 50525]]
Table 1--Estimated Initial Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submission of Initial Product 55 220 12,100 2 24,200
Report.........................
Waiver Request From Electronic 1 1 1 1 1
Submission of Initial Product
Report.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 24,201
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Information collection activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission for June Product Report............ 55 220 12,100 0.5 (30 minutes)........................ 6,050
Submission for December Product Report........ 55 220 12,100 0.5 (30 minutes)........................ 6,050
Waiver Request From Electronic Submission of 1 1 1 1....................................... 1
Product Reports.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 12,101
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.
Dated: July 26, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-18048 Filed 7-29-16; 8:45 am]
BILLING CODE 4164-01-P
