Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards, 89947-89949 [2016-29839]
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Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
pmangrum on DSK3GDR082PROD with NOTICES
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of the USPTO may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
VerDate Sep<11>2014
15:08 Dec 12, 2016
Jkt 241001
period for a human biological product
will include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product NUCALA
(mepolizumab). NUCALA is indicated
for add-on maintenance treatment of
patients with severe asthma aged 12
years and older, and with an
eosinophilic phenotype. Subsequent to
this approval, the USPTO received a
patent term restoration application for
NUCALA (U.S. Patent No. 5,693,323)
from GlaxoSmithKline LLC, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
May 10, 2016, FDA advised the USPTO
that this human biological product had
undergone a regulatory review period
and that the approval of NUCALA
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
NUCALA is 6,862 days. Of this time,
6,496 days occurred during the testing
phase of the regulatory review period,
while 366 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: January 22, 1997. The
applicant claims January 21, 1997, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was January 22, 1997,
which was 30 days after FDA receipt of
the IND.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): November 4, 2014. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
NUCALA (BLA 125526) was initially
submitted on November 4, 2014.
3. The date the application was
approved: November 4, 2015. FDA has
verified the applicant’s claim that BLA
125526 was approved on November 4,
2015.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
89947
In its application for patent extension,
this applicant seeks 5 years of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and ask for a redetermination
(see DATES). Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period. To meet its burden, the petition
must be timely (see DATES) and contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29838 Filed 12–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0764]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Feed
Regulatory Program Standards
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 January 12,
2017.
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:
SUMMARY:
E:\FR\FM\13DEN1.SGM
13DEN1
89948
Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0760. 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
St., 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.
Animal Feed Regulatory Program
Standards—OMB 0910–0760—
Extension
I. Background
In the United States, Federal and State
Government Agencies ensure the safety
of animal feed. FDA is responsible for
ensuring that all food and feed moving
in interstate commerce, except those
under the U.S. Department of
Agriculture jurisdiction, are safe,
wholesome, and labeled properly. States
are responsible for conducting
inspections and regulatory activities
that help ensure food and feed
produced, processed, and distributed
within their jurisdictions are safe and in
compliance with State laws and
regulations. States primarily perform
inspections under their own regulatory
authority. Some States conduct
inspections of feed facilities under
contract with FDA. Because
jurisdictions may overlap, FDA and
States collaborate and share resources to
protect animal feed.
The FDA Food Safety Modernization
Act passed on January 4, 2011, calls for
enhanced partnerships and provides a
legal mandate for developing an
Integrated Food Safety System (IFSS).
FDA is committed to implementing an
IFSS thereby optimizing coordination of
food and feed safety efforts with
Federal, State, local, tribal, and
territorial regulatory and public health
Agencies. Model standards provide a
consistent, underlying foundation that
is critical for uniformity across State
and Federal Agencies to ensure
credibility of food and feed programs
within the IFSS.
II. Significance of Feed Program
Standards
The Animal Feed Regulatory Program
Standards (AFRPS) provide a uniform
and consistent approach to feed
regulation in the United States.
Implementation of the draft feed
program standards is voluntary. States
implementing the standards will
identify and maintain program
improvements that will strengthen the
safety and integrity of the U.S. animal
feed supply.
The feed standards are the framework
that each State should use to design,
manage, and improve its feed program.
The standards include the following: (1)
Regulatory foundation; (2) training; (3)
inspection program; (4) auditing; (5)
feed-related illness or death and
emergency response; (6) enforcement
program; (7) outreach activities; (8)
budget and planning; (9) assessment and
improvement; (10) laboratory services;
and (11) sampling program.
Each standard has a purpose
statement, requirement summary,
description of program elements,
projected outcomes, and a list of
required documentation. When a State
program voluntarily agrees to
implement the feed standards, it must
fully implement and maintain the
individual program elements and
documentation requirements in each
standard in order to fully implement the
standard.
The feed standards package includes
forms, worksheets, and templates to
help the State program assess and meet
the program elements in the standard.
State programs are not obligated to use
the forms, worksheets, and templates
provided with the feed standards. Other
manual or automated forms, worksheets,
and templates may be used as long as
the pertinent data elements are present.
Records and other documents specified
in the feed standards must be
maintained in good order by the State
program and must be available to verify
the implementation of each standard.
The feed standards are not intended to
address the performance appraisal
processes that a State Agency may use
to evaluate individual employee
performance.
In the first year of implementation,
the State program uses the selfassessment worksheets to determine if
the requirements for each standard are
fully met, partially met, or not met. The
self-assessments are used to develop an
improvement plan for fully
implementing the requirements of the
11 standards. Second and third-year
assessments will provide progress
evaluation.
Although FDA plans to provide
financial support to State programs that
implement the feed standards, funding
opportunities are contingent upon the
availability of funds. Funding
opportunities may be only available to
State feed regulatory programs that
currently have an FDA feed inspection
contract. State programs receiving
financial support to implement the feed
standards will be audited by FDA.
III. Electronic Access
Persons with access to the Internet
may submit requests for a single copy of
the current feed standards from OPPRA@fda.hhs.gov. Please note that due
to editorial revisions and public
comments, the final standards may
differ from the copy you receive.
In the Federal Register of April 12,
2016 (81 FR 21578), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment. However, this comment did
not address the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
pmangrum on DSK3GDR082PROD with NOTICES
Type of
respondent
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
State Employee ....................................................................
40
1
40
3,000
120,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to
3,000 hours per respondent. This
burden was determined by capturing the
average amount of time for each
VerDate Sep<11>2014
15:08 Dec 12, 2016
Jkt 241001
respondent to assess the current state of
the program and work toward
implementation of each of the 11
standards contained in AFRPS. FDA
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
recognizes that full use and
implementation of the feed standards by
State feed programs will occur over
many years and the number of years to
E:\FR\FM\13DEN1.SGM
13DEN1
Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices
fully implement the feed standards will
vary among States.
Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–29839 Filed 12–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2836]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Donor Risk
Assessment Questionnaire for the
Food and Drug Administration/National
Heart, Lung, and Blood InstituteSponsored Transfusion-Transmissible
Infections Monitoring System—Risk
Factor Elicitation
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 January 12,
2017.
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—New and
title ‘‘Donor Risk Assessment
Questionnaire for the Food and Drug
Administration/National Heart, Lung,
and Blood Institute-sponsored
Transfusion-Transmissible Infections
Monitoring System—Risk Factor
Elicitation.’’ 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
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:08 Dec 12, 2016
Jkt 241001
collection of information to OMB for
review and clearance.
Donor Risk Assessment Questionnaire
for FDA/National Heart, Lung, and
Blood Institute (NHLBI)-sponsored
Transfusion-Transmissible Infections
Monitoring System (TTIMS)—Risk
Factor Elicitation OMB Control
Number—New
FDA intends to interview blood
donors to collect risk factor information
associated with testing positive for a
Transfusion-Transmissible Infection
(TTI). This collection of information is
part of a larger initiative called TTIMS,
which is a collaborative project funded
by FDA, the NHLBI of the National
Institutes of Health (NIH), and the
Department of Health and Human
Services (HHS) Office of the Assistant
Secretary of Health with input from
other Agencies in HHS, including the
Centers for Disease Control and
Prevention (CDC). FDA will use these
scientific data collected through such
interview-based risk factor elicitation of
blood donors to monitor and help
ensure the safety of the U.S. blood
supply.
Previous assessments of risk factor
profiles among blood donors found to be
positive for human immunodeficiency
virus (HIV) were funded by CDC for
approximately 10 years after
implementation of HIV serologic
screening of blood donors in the mid1980s; whereas studies of Hepatitis C
virus (HCV) seropositive donors, funded
by NIH, were conducted in the early
1990s. Information on current risk
factors in blood donors as assessed
using analytical study designs was next
evaluated by the TransfusionTransmitted Retrovirus and Hepatitis
Virus Rates and Risk Factors Study
conducted by the NHLBI Retrovirus
Epidemiology Donor Study-II (REDS–II)
approved under OMB control number
0925–0630. Through a risk factor
questionnaire, this study elicited risk
factors in blood donors who tested
confirmed positive for one of four
transfusion-transmissible infections:
HIV, HCV, Hepatitis B virus (HBV), and
Human T-cell Lymphotropic virus. The
study also elicited risk factors from
donors who did not have any infections
(controls) and compared their responses
to those of the donors with confirmed
infection (cases). Results from the
REDS–II study were published in 2015.
FDA issued a document entitled
‘‘Revised Recommendations for
Reducing the Risk of Human
Immunodeficiency Virus Transmission
by Blood and Blood Products, Guidance
for Industry’’ dated December 2015
(https://www.fda.gov/downloads/
BiologicsBloodVaccines/Guidance
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
89949
ComplianceRegulatoryInformation/
Guidances/Blood/UCM446580.pdf) that
changed the blood donor criterion for
men who have sex with men (MSM)
from an indefinite (permanent) deferral
to a 12-month deferral since last MSM
contact. The impact of this change in
the deferral criteria requires a national
monitoring effort as part of TTIMS to
assess if the relative proportions of risk
factors for infection in blood donors
have changed following the adoption of
the 12-month donor deferral for MSM.
TTIMS will use similar procedures as
the ones used in the REDS–II study to
monitor and evaluate risk factors among
HIV-positive donors and recently HCV
or HBV infected donors as well as
controls.
This study will help identify the
specific risk factors for TTI and their
prevalence in blood donors, and help
inform FDA on the proportion of
incident (new) infections among all HIV
positive blood donors. Donations with
incident infections have the greatest
potential transmission risk because they
could be missed during routine blood
screening. The study will help FDA
evaluate the effectiveness of screening
strategies in reducing the risk of HIV
transmission from at-risk donors and to
evaluate if there are unexpected
consequences associated with the recent
change in donor deferral policy such as
an increase in HIV incidence among
donors. These data also will inform FDA
regarding future blood donor deferral
policy options to reduce the risk of HIV
transmission, including the feasibility of
moving from the existing time-based
deferrals related to risk behaviors to
alternate deferral options, such as the
use of individual risk assessments, and
to inform the design of potential studies
to evaluate the feasibility and
effectiveness of such alternative deferral
options.
TTIMS will include a comprehensive
interview based epidemiological study
of risk factor information for viral
infection-positive blood donors at the
American Red Cross (ARC), Blood
Systems, Inc. (BSI), New York Blood
Center (NYBC), and OneBlood that will
identify the current predominant risk
factors and reasons for virus-positive
donations. The TTIMS program
establishes a new, ongoing donor
hemovigilance capacity that currently
does not exist in the United States.
Using procedures developed by the
REDS–II study, TTIMS will establish
this capacity in greater than 50 percent
of all blood donations collected in the
country.
As part of the TTIMS project, a
comprehensive hemovigilance database
will be created that integrates the risk
E:\FR\FM\13DEN1.SGM
13DEN1
]]>Agencies
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89947-89949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29839]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0764]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Animal Feed
Regulatory Program Standards
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 January
12, 2017.
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:
[[Page 89948]]
202-395-7285, or emailed to oira_submission@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0760. 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 St., 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.
Animal Feed Regulatory Program Standards--OMB 0910-0760--Extension
I. Background
In the United States, Federal and State Government Agencies ensure
the safety of animal feed. FDA is responsible for ensuring that all
food and feed moving in interstate commerce, except those under the
U.S. Department of Agriculture jurisdiction, are safe, wholesome, and
labeled properly. States are responsible for conducting inspections and
regulatory activities that help ensure food and feed produced,
processed, and distributed within their jurisdictions are safe and in
compliance with State laws and regulations. States primarily perform
inspections under their own regulatory authority. Some States conduct
inspections of feed facilities under contract with FDA. Because
jurisdictions may overlap, FDA and States collaborate and share
resources to protect animal feed.
The FDA Food Safety Modernization Act passed on January 4, 2011,
calls for enhanced partnerships and provides a legal mandate for
developing an Integrated Food Safety System (IFSS). FDA is committed to
implementing an IFSS thereby optimizing coordination of food and feed
safety efforts with Federal, State, local, tribal, and territorial
regulatory and public health Agencies. Model standards provide a
consistent, underlying foundation that is critical for uniformity
across State and Federal Agencies to ensure credibility of food and
feed programs within the IFSS.
II. Significance of Feed Program Standards
The Animal Feed Regulatory Program Standards (AFRPS) provide a
uniform and consistent approach to feed regulation in the United
States. Implementation of the draft feed program standards is
voluntary. States implementing the standards will identify and maintain
program improvements that will strengthen the safety and integrity of
the U.S. animal feed supply.
The feed standards are the framework that each State should use to
design, manage, and improve its feed program. The standards include the
following: (1) Regulatory foundation; (2) training; (3) inspection
program; (4) auditing; (5) feed-related illness or death and emergency
response; (6) enforcement program; (7) outreach activities; (8) budget
and planning; (9) assessment and improvement; (10) laboratory services;
and (11) sampling program.
Each standard has a purpose statement, requirement summary,
description of program elements, projected outcomes, and a list of
required documentation. When a State program voluntarily agrees to
implement the feed standards, it must fully implement and maintain the
individual program elements and documentation requirements in each
standard in order to fully implement the standard.
The feed standards package includes forms, worksheets, and
templates to help the State program assess and meet the program
elements in the standard. State programs are not obligated to use the
forms, worksheets, and templates provided with the feed standards.
Other manual or automated forms, worksheets, and templates may be used
as long as the pertinent data elements are present. Records and other
documents specified in the feed standards must be maintained in good
order by the State program and must be available to verify the
implementation of each standard. The feed standards are not intended to
address the performance appraisal processes that a State Agency may use
to evaluate individual employee performance.
In the first year of implementation, the State program uses the
self-assessment worksheets to determine if the requirements for each
standard are fully met, partially met, or not met. The self-assessments
are used to develop an improvement plan for fully implementing the
requirements of the 11 standards. Second and third-year assessments
will provide progress evaluation.
Although FDA plans to provide financial support to State programs
that implement the feed standards, funding opportunities are contingent
upon the availability of funds. Funding opportunities may be only
available to State feed regulatory programs that currently have an FDA
feed inspection contract. State programs receiving financial support to
implement the feed standards will be audited by FDA.
III. Electronic Access
Persons with access to the Internet may submit requests for a
single copy of the current feed standards from OP-PRA@fda.hhs.gov.
Please note that due to editorial revisions and public comments, the
final standards may differ from the copy you receive.
In the Federal Register of April 12, 2016 (81 FR 21578), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment. However, this
comment did not address the information collection.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Employee..................................................... 40 1 40 3,000 120,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The burden has been calculated to 3,000 hours per respondent. This
burden was determined by capturing the average amount of time for each
respondent to assess the current state of the program and work toward
implementation of each of the 11 standards contained in AFRPS. FDA
recognizes that full use and implementation of the feed standards by
State feed programs will occur over many years and the number of years
to
[[Page 89949]]
fully implement the feed standards will vary among States.
Dated: December 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29839 Filed 12-12-16; 8:45 am]
BILLING CODE 4164-01-P
