Agency Information Collection Activities: Proposed Collection: Public Comment Request, Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB Number: 0906-0017-Revision, 5791-5793 [2018-02594]
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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
sradovich on DSK3GMQ082PROD with NOTICES
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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 drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of 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 period for
a human drug 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 drug product ONIVYDE
(irinotecan sucrose octasulfate).
ONIVYDE in combination with
fluorouracil and leucovorin, is indicated
for the treatment of patients with
metastatic adenocarcinoma of the
pancreas after disease progression
following gemcitabine-based therapy.
Subsequent to this approval, the USPTO
received patent term restoration
applications for ONIVYDE (U.S. Patent
Nos. 8,147,867 and 8,329,213) from
Merrimack Pharmaceuticals, Inc., and
the USPTO requested FDA’s assistance
in determining the patents’ eligibility
for patent term restoration. In a letter
dated August 12, 2016, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
ONIVYDE represented the first
permitted commercial marketing or use
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16:57 Feb 08, 2018
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II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
ONIVYDE is 2,536 days. Of this time,
2,354 days occurred during the testing
phase of the regulatory review period,
while 182 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 (FD&C Act) (21 U.S.C.
355(i)) became effective: November 13,
2008. FDA has verified the applicant’s
claim that November 13, 2008, is the
date the investigational new drug
application became effective.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: April 24, 2015.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
ONIVYDE (NDA 207793) was initially
submitted on April 24, 2015.
3. The date the application was
approved: October 22, 2015. FDA has
verified the applicant’s claim that NDA
207793 was approved on October 22,
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.
In its applications for patent extension,
this applicant seeks 613 days or 1,215
days 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, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), 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
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
5791
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
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: February 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02590 Filed 2–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request, Information
Collection Request Title: The Maternal,
Infant, and Early Childhood Home
Visiting Program Performance
Measurement Information System,
OMB Number: 0906–0017—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than April 10, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N39, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
E:\FR\FM\09FEN1.SGM
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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Performance Measurement Information
System, OMB Control Number: 0906–
0017—Revision.
Abstract: This clearance request is for
continued approval of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program
Performance Measurement Information
System. The MIECHV Program,
administered by HRSA in partnership
with the Administration for Children
and Families, supports voluntary,
evidence-based home visiting services
during pregnancy women and to parents
with young children up to kindergarten
entry. States, certain non-profit
organizations, and Tribal entities are
eligible to receive funding from the
MIECHV Program and have the
flexibility to tailor the program to serve
the specific needs of their communities.
HRSA is revising the data collection
forms for the MIECHV Program by
making the following changes:
• Form 1: Update all tables to include
specific guidance to account for and
report missing data.
• Form 1, Tables 1 and 2: Update
table titles to reflect ‘‘participants
served by MIECHV.’’
• Form 1, Table 5: Update to reflect
correct age categories of ‘‘<1 year’’; ‘‘1–
2 years’’; ‘‘3–4 years’’; and ‘‘5–6 years.’’
• Form 1, Table 8: Revise the category
of ‘‘Never Married’’ to read ‘‘Never
Married (excluding not married but
living together with partner).’’
• Form 1, Table 10: Delete.
• Form 1, Table 18: Delete.
• Form 1, Table 22: Revise to only
include children greater than or equal to
12 months of age. Title will be updated
to ‘‘Index Children (≥12 months of age)
by Usual Source of Dental Care.’’
• Form 1, Notes: Revise to include
Table-specific notes.
• Form 1, Definition of Key Terms:
Update definitions for Tables 1, 3, 5, 12,
13, 15, 17, 20, 21, and 22.
• Form 2: Update all measures to
include specific guidance to account for
and report missing data.
• Form 2, Measure 3: Update
denominator to reflect correct inclusion
criteria.
• Form 2, Measure 4: Update measure
to benchmark receipt of well-child visits
to specific ages.
• Form 2, Measure 9: Update
numerator to clarify that investigated
cases of maltreatment must have
occurred within the reporting period.
• Form 2, Measure 10: Update
denominator to clarify the appropriate
unit of analysis is the index child.
• Form 2, Measure 14: Update
measure to reflect current terminology
and the timing within which screenings
should be reported.
• Form 2, Measure 15: Update
measure and numerator to include
primary caregivers enrolled in middle
school.
• Form 2, Measure 16: Update
numerator to reflect correct inclusion
criteria.
• Form 2, Measure 17: Update
denominator to reflect correct inclusion
criteria.
• Form 2, Measure 19: Update
denominator to reflect correct inclusion
criteria.
• Form 2, Definitions of Key Terms:
Update definitions for measures 1–19.
HRSA is also requesting an extension
of this information collection request
through November 30, 2021.
Need and Proposed Use of the
Information: HRSA uses performance
information to demonstrate program
accountability with legislative and
program requirements and continuously
monitor and provide oversight to
MIECHV Program awardees. The
information is also used to provide
quality improvement guidance and
technical assistance to awardees and
help inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
revise demographic, service utilization,
and select clinical indicators for
participants enrolled in home visiting
services. In addition, HRSA will collect
a set of standardized performance and
outcome indicators that correspond
with the statutorily identified
benchmark areas. In the future, HRSA
anticipates that MIECHV funding
decisions may be allocated, in part,
based on this data. This notice is subject
to the appropriation of funds, and is a
contingency action taken to ensure that,
should funds become available for this
purpose, information can be collected in
a timely manner.
Likely Respondents: MIECHV Program
awardees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Form 1: Demographic, Service Utilization, and Select Clinical Indicators ...................................................................
Form 2: Performance Indicators and Systems Outcome
Measures ..........................................................................
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Jkt 244001
Frm 00039
Average
burden per
response
(in hours)
Total burden
hours
1
56
560
31,360
56
1
56
200
11,200
56
........................
56
........................
42,560
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
PO 00000
Total
responses
56
Total ..............................................................................
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
Number of
responses per
respondent
Fmt 4703
Sfmt 4703
technology to minimize the information
collection burden.
E:\FR\FM\09FEN1.SGM
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Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
decision by HHS to add the class to the
SEC.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2018–02594 Filed 2–8–18; 8:45 am]
BILLING CODE 4165–15–P
[FR Doc. 2018–02675 Filed 2–8–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Designation of a Class of Employees
for Addition to the Special Exposure
Cohort
Health Resources and Services
Administration
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services (HHS).
AGENCY:
ACTION:
Notice.
HHS gives notice of a
decision to designate a class of
employees from the Ames Laboratory in
Ames, Iowa, as an addition to the
Special Exposure Cohort (SEC) under
the Energy Employees Occupational
Illness Compensation Program Act of
2000.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
NIOSH, 1090 Tusculum Avenue, MS C–
46, Cincinnati, OH 45226–1938,
Telephone 1–877–222–7570.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 7384q(b). 42 U.S.C.
7384l(14)(C).
On February 1, 2018, as provided for
under 42 U.S.C. 7384l(14)(C), the
Secretary of HHS designated the
following class of employees as an
addition to the SEC:
sradovich on DSK3GMQ082PROD with NOTICES
All employees of the Department of
Energy, its predecessor agencies, and their
contractors or subcontractors who worked in
any area of the Ames Laboratory in Ames,
Iowa, during the period from January 1, 1971,
through December 31, 1989, for a number of
work days aggregating at least 250 work days,
occurring either solely under this
employment or in combination with work
days within the parameters established for
one or more other classes of employees
included in the Special Exposure Cohort.
This designation will become
effective on March 3, 2018, unless
Congress provides otherwise prior to the
effective date. After this effective date,
HHS will publish a notice in the
Federal Register reporting the addition
of this class to the SEC or the result of
any provision by Congress regarding the
VerDate Sep<11>2014
16:57 Feb 08, 2018
Jkt 244001
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: National
Survey of Organ Donation Attitudes
and Practices, OMB No. 0915–0290—
Reinstatement With Change
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). The
ICR is for reinstatement with change of
a previously approved information
collection, assigned OMB control
number 0915–0290, which expired on
March 31, 2015. Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate below or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than April 10, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, 14N39, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
National Survey of Organ Donation
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
5793
Attitudes and Practices, OMB No. 0915–
0290—Reinstatement With Change
Abstract: HRSA is requesting
approval from OMB for a reinstatement
with change of a previously approved
collection of information (OMB control
number 0915–0290). The National
Survey of Organ Donation Attitudes and
Practices (NSODAP) is conducted
approximately every 6–7 years and
serves a critical role in providing HRSA
and the donation community with data
regarding why Americans choose to
donate organs, current barriers to
donation, and potential new approaches
to increasing donations. Survey data
and derived analytic insights inform
HRSA’s public outreach and
educational initiatives. HRSA is
improving the quality and relevance of
the data collected by making the
following changes:
(1) HRSA is increasing the ability to
produce more precise results by
targeting 10,000 completed surveys
(increased from 3,250 in 2012). This
increase will allow for a more accurate
and robust analysis of the attitudes and
donation practices of important
subgroups such as Americans over the
age of 50 and various minority
populations. While the precision of the
results from the survey will increase,
respondent burden will be reduced and
survey completion costs will be lower
resulting in a cost neutral change.
(2) HRSA is streamlining the data
collection process to minimize
respondent burden. Of the 10,000
targeted completed surveys, 8,000 will
be completed online by a nationally
representative web panel composed of
Americans over the age of 18 who have
already agreed to participate in a survey.
Web panels target a representative
section of a population used by other
approved surveys. HRSA will complete
the remaining 2,000 surveys by
telephone. In 2012, all 3,250 surveys
were conducted by telephone and
respondents were contacted using
random-digit dialing, a process that
yielded a low response rate. Contacting
respondents by telephone will remain a
part of the survey protocol to compare
current data to the 2012 data. However,
for this survey, identification of a
sample of adults over the age of 18 for
a telephone survey will be from a
national list of home addresses. Prior to
contact, those selected for the telephone
survey will receive a mailed prenotification letter with information
about the survey. This mailing will
improve survey cooperation and reduce
the number of people contacted for the
survey. Additionally, it is more time
and cost effective to take the survey
online than taking the survey by phone
E:\FR\FM\09FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Notices]
[Pages 5791-5793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02594]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request, Information Collection Request Title: The
Maternal, Infant, and Early Childhood Home Visiting Program Performance
Measurement Information System, OMB Number: 0906-0017--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR), described below, to the Office of Management and Budget
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than April 10,
2018.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, 14N39, 5600 Fishers Lane,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
[[Page 5792]]
Information Collection Request Title: The Maternal, Infant, and
Early Childhood Home Visiting Program Performance Measurement
Information System, OMB Control Number: 0906-0017--Revision.
Abstract: This clearance request is for continued approval of the
Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program
Performance Measurement Information System. The MIECHV Program,
administered by HRSA in partnership with the Administration for
Children and Families, supports voluntary, evidence-based home visiting
services during pregnancy women and to parents with young children up
to kindergarten entry. States, certain non-profit organizations, and
Tribal entities are eligible to receive funding from the MIECHV Program
and have the flexibility to tailor the program to serve the specific
needs of their communities. HRSA is revising the data collection forms
for the MIECHV Program by making the following changes:
Form 1: Update all tables to include specific guidance to
account for and report missing data.
Form 1, Tables 1 and 2: Update table titles to reflect
``participants served by MIECHV.''
Form 1, Table 5: Update to reflect correct age categories
of ``<1 year''; ``1-2 years''; ``3-4 years''; and ``5-6 years.''
Form 1, Table 8: Revise the category of ``Never Married''
to read ``Never Married (excluding not married but living together with
partner).''
Form 1, Table 10: Delete.
Form 1, Table 18: Delete.
Form 1, Table 22: Revise to only include children greater
than or equal to 12 months of age. Title will be updated to ``Index
Children (>=12 months of age) by Usual Source of Dental Care.''
Form 1, Notes: Revise to include Table-specific notes.
Form 1, Definition of Key Terms: Update definitions for
Tables 1, 3, 5, 12, 13, 15, 17, 20, 21, and 22.
Form 2: Update all measures to include specific guidance
to account for and report missing data.
Form 2, Measure 3: Update denominator to reflect correct
inclusion criteria.
Form 2, Measure 4: Update measure to benchmark receipt of
well-child visits to specific ages.
Form 2, Measure 9: Update numerator to clarify that
investigated cases of maltreatment must have occurred within the
reporting period.
Form 2, Measure 10: Update denominator to clarify the
appropriate unit of analysis is the index child.
Form 2, Measure 14: Update measure to reflect current
terminology and the timing within which screenings should be reported.
Form 2, Measure 15: Update measure and numerator to
include primary caregivers enrolled in middle school.
Form 2, Measure 16: Update numerator to reflect correct
inclusion criteria.
Form 2, Measure 17: Update denominator to reflect correct
inclusion criteria.
Form 2, Measure 19: Update denominator to reflect correct
inclusion criteria.
Form 2, Definitions of Key Terms: Update definitions for
measures 1-19.
HRSA is also requesting an extension of this information collection
request through November 30, 2021.
Need and Proposed Use of the Information: HRSA uses performance
information to demonstrate program accountability with legislative and
program requirements and continuously monitor and provide oversight to
MIECHV Program awardees. The information is also used to provide
quality improvement guidance and technical assistance to awardees and
help inform the development of early childhood systems at the national,
state, and local level. HRSA is seeking to revise demographic, service
utilization, and select clinical indicators for participants enrolled
in home visiting services. In addition, HRSA will collect a set of
standardized performance and outcome indicators that correspond with
the statutorily identified benchmark areas. In the future, HRSA
anticipates that MIECHV funding decisions may be allocated, in part,
based on this data. This notice is subject to the appropriation of
funds, and is a contingency action taken to ensure that, should funds
become available for this purpose, information can be collected in a
timely manner.
Likely Respondents: MIECHV Program awardees.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Form 1: Demographic, Service 56 1 56 560 31,360
Utilization, and Select
Clinical Indicators............
Form 2: Performance Indicators 56 1 56 200 11,200
and Systems Outcome Measures...
-------------------------------------------------------------------------------
Total....................... 56 .............. 56 .............. 42,560
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
[[Page 5793]]
Amy McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-02594 Filed 2-8-18; 8:45 am]
BILLING CODE 4165-15-P
