Agency Forms Undergoing Paperwork Reduction Act Review, 35646-35648 [2018-16090]
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35646
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
variability in success rates across ART
programs and individuals.
Each ART program reports its annual
ART cycle data to CDC in midDecember. The annual data reporting
consists of information about all ART
cycles that were initiated in the
previous calendar year. For example,
the December 2017 reports described
ART cycles that were initiated between
January 1, 2016, and December 31, 2016.
Data elements and definitions currently
in use reflect CDC’s prior consultations
with representatives of the Society for
Assisted Reproductive Technology
(SART), the American Society for
Reproductive Medicine, and RESOLVE:
The National Infertility Association (a
national, nonprofit consumer
organization), as well as a variety of
individuals with expertise and interest
in this field.
The estimated number of respondents
(ART programs or clinics) is 464, based
on the number of clinics that provided
information in 2015; the estimated
average number of responses (ART
cycles) per respondent is 350.
Additionally, approximately 5–10% of
responding clinics will be randomly
selected each year to participate in data
validation and quality control activities;
an estimated 35 clinics will be selected
to report validation data on 70 cycles
each on average. Finally, respondents
may provide feedback to CDC about the
usability and utility of the reporting
system. The option to participate in the
feedback survey is presented to
respondents when they complete their
required data submission. Participation
in the feedback survey is voluntary and
is not required by the FCSRCA. CDC
estimates that 75% of ART programs
will participate in the feedback survey.
The collection of ART cycle
information allows CDC to publish an
annual report to Congress as specified
by the FCSRCA and to provide
information needed by consumers. OMB
approval is requested for three years.
The estimated annualized Burden Hours
are 114,631 which is a decrease of 1,794
from the current OMB-approved
collection. There are no costs to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
ART Clinics .....................................................
NASS ..............................................................
Data Validation ...............................................
Feedback Survey ...........................................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–16091 Filed 7–26–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0222]
amozie on DSK3GDR082PROD with NOTICES1
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Collaborating
Center for Questionnaire Design and
Evaluation Research (CCQDER), to the
Office of Management and Budget
(OMB) for review and approval. CDC
previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on March 1, 2018 to obtain
comments from the public and affected
agencies. CDC did not receive comments
related to the previous notice. This
notice serves to allow an additional 30
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Number of
responses
per
respondent
464
35
348
350
70
1
Average
burden per
response
(in hours)
42/60
23/60
2/60
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
Collaborating Center for Questionnaire
Design and Evaluation Research
(CCQDER) (OMB Control Number 0920–
0222, Expiration 07/31/2018)—
Revision—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC)
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall undertake
and support (by grant or contract)
research, demonstrations, and
evaluations respecting new or improved
methods for obtaining current data to
support statistical and epidemiological
activities for the purpose of improving
the effectiveness, efficiency, and quality
of health services in the United States.
The Collaborating Center for
Questionnaire Design and Evaluation
Research (CCQDER) is the focal point
within NCHS for questionnaire and
survey development, pre-testing, and
evaluation activities for CDC surveys
(such as the NCHS National Health
E:\FR\FM\27JYN1.SGM
27JYN1
35647
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Interview Survey, OMB No. 0920–0214)
and other federally sponsored surveys.
NCHS is requesting 3 years of OMB
Clearance for this generic submission.
The CCQDER and other NCHS
programs conduct cognitive interviews,
focus groups, in-depth or ethnographic
interviews, usability tests, field tests/
pilot interviews, and experimental
research in laboratory and field settings,
both for applied questionnaire
development and evaluation as well as
more basic research on measurement
errors and survey response.
Various techniques to evaluate
interviewer administered, selfadministered, telephone, Computer
Assisted Personal Interviewing (CAPI),
Computer Assisted Self-Interviewing
(CASI), Audio Computer-Assisted SelfInterviewing (ACASI), and web-based
questionnaires are used.
The most common questionnaire
evaluation method is the cognitive
interview. These evaluations are
conducted by the CCQDER and
contractors, as needed. The interview
structure consists of respondents first
answering a draft survey question and
then providing textual information to
reveal the processes involved in
answering the test question.
Specifically, cognitive interview
respondents are asked to describe how
and why they answered the question as
they did. Through the interviewing
process, various types of questionresponse problems that would not
normally be identified in a traditional
survey interview, such as interpretive
errors and recall accuracy, are
uncovered. By conducting a
comparative analysis of cognitive
interviews, it is also possible to
determine whether particular
interpretive patterns occur within
particular sub-groups of the population.
Interviews are generally conducted in
small rounds totaling 40–100
interviews; ideally, the questionnaire is
re-worked between rounds, and
revisions are tested iteratively until
interviews yield relatively few new
insights.
Cognitive interviewing is inexpensive
and provides useful data on
questionnaire performance while
minimizing respondent burden.
Cognitive interviewing offers a detailed
depiction of meanings and processes
used by respondents to answer
questions—processes that ultimately
produce the survey data. As such, the
method offers an insight that can
transform understanding of question
validity and response error.
Documented findings from these studies
represent tangible evidence of how the
question performs. Such documentation
also serves CDC data users, allowing
them to be critical users in their
approach and application of the data.
In addition to cognitive interviewing,
a number of other qualitative and
quantitative methods are used to
investigate and research measurement
error and the survey response process.
These methods include conducting
focus groups, usability tests, in-depth or
ethnographic interviews, and the
administration and analysis of questions
in both representative and nonrepresentative field tests. Focus groups
are conducted by the CCQDER and
contractors, as needed. They are group
discussions whose primary purpose is
to elicit the basic sociocultural
understandings and terminology that
form the basis of questionnaire design.
Each group typically consists of one
moderator and 4 to 10 participants,
depending on the research question. Indepth or ethnographic interviews are
one-on-one interviews designed to elicit
the understandings or terminology that
are necessary for question design, as
well as to gather detailed information
that can contribute to the analysis of
both qualitative and quantitative data.
Usability tests are typically one-on-one
interviews that are used to determine
how a given survey or information
collection tool functions in the field,
and how the mode and layout of the
instrument itself may contribute to
survey response error and the survey
response process.
In addition to these qualitative
methods, NCHS also uses various tools
to obtain quantitative data, which can
be analyzed alone or analyzed alongside
qualitative data to give a much fuller
accounting of the survey response
process. For instance, phone, internet,
mail, and in-person follow-up
interviews of previous NCHS survey
respondents may be used to test the
validity of survey questions and
questionnaires and to obtain more
detailed information that cannot be
gathered on the original survey.
Additionally, field or pilot tests may be
conducted on both representative and
non-representative samples, including
those obtained from commercial survey
and web panel vendors. Beyond looking
at traditional measures of survey errors
(such as item missing and non-response
rates, and response latency), these pilot
tests can be used to run experimental
designs in order to capture how
different questions function in a field
setting.
Similar methodology has been
adopted by other federal agencies, as
well as by academic and commercial
survey organizations. There are no costs
to respondents other than their time.
The total estimated annual burden
hours are 7,783.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
amozie on DSK3GDR082PROD with NOTICES1
Individuals
Individuals
Individuals
Individuals
or
or
or
or
VerDate Sep<11>2014
households
households
households
households
...............................
...............................
...............................
...............................
17:38 Jul 26, 2018
Jkt 244001
Number of
respondents
Form name
Eligibility Screening ........................................
Questionnaire Development Studies .............
Respondent Data Collection Sheet ................
Focus groups .................................................
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\27JYN1.SGM
4,000
7,300
7,300
100
27JYN1
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hours)
5/60
55/60
5/60
90/60
35648
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Jeffery M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–16090 Filed 7–26–18; 8:45 am]
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
BILLING CODE 4163–18–P
Dia Taylor,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2018–16103 Filed 7–26–18; 8:45 am]
BILLING CODE 4163–19–P
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention (CDC)—Health Disparities
Subcommittee (HDS)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Advisory Committee to the
Director, Centers for Disease Control
and Prevention—Health Disparities
Subcommittee (ACD, CDC–HDS). This
meeting is open to the public, limited
only by the 50 audio phone lines. The
public is also welcome to listen to the
meeting by teleconference. Please dial
(866) 918–8397 and enter code 9346283.
There are 50 lines available. The public
comment period is from 3:15 p.m.–3:20
p.m.
DATES: The meeting will be held on
October 9, 2018, 1:30 p.m. to 3:30 p.m.,
EDT.
ADDRESSES: Teleconference phone
(866) 918–8397 and enter code 9346283.
FOR FURTHER INFORMATION CONTACT:
Leandris Liburd, Ph.D., M.P.H., M.A.,
Designated Federal Officer, Health
Disparities Subcommittee, Advisory
Committee to the Director, CDC, 1600
Clifton Road NE, M/S K–77, Atlanta,
Georgia 30329. Telephone (404) 498–
6482, Email: ACDirector@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Subcommittee will
provide counsel to the CDC Director
through the ACD on strategic and other
health disparities and health equity
issues and provide guidance on
opportunities for CDC.
Matters to be Considered: The agenda
will include discussions on new
member orientation. This meeting will
provide information to new members
regarding their role & duties on this
subcommittee. Agenda items are subject
to change as priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:38 Jul 26, 2018
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–P–1283]
Determination That Metaxalone
Tablets, 640 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that metaxalone tablets, 640
milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
metaxalone tablets, 640 mg, if all other
legal and regulatory requirements are
met.
FOR FURTHER INFORMATION CONTACT: Glen
Cheng, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave. Bldg. 51, Rm. 6217, Silver Spring,
MD 20993–0002, 301–796–1494.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Metaxalone tablets, 640 mg, are the
subject of NDA 22–503, held by Primus
Pharmaceuticals, Inc., and initially
approved on June 1, 2015. Metaxalone
tablets, 640 mg, are indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute,
painful musculoskeletal conditions.
In a letter dated September 30, 2015,
the previous NDA holder CorePharma,
LLC notified FDA that metaxalone
tablets, 640 mg, were discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Sovereign Pharmaceuticals, LLC
submitted a citizen petition dated
March 26, 2018 (Docket No. FDA–2018–
P–1283), under 21 CFR 10.30,
requesting that the Agency determine
whether metaxalone tablets, 640 mg,
were withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that metaxalone tablets, 640
mg, were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that metaxalone
tablets, 640 mg, were withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
metaxalone tablets, 640 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that this drug product was
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35646-35648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16090]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0222]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Collaborating Center for Questionnaire Design
and Evaluation Research (CCQDER), to the Office of Management and
Budget (OMB) for review and approval. CDC previously published a
``Proposed Data Collection Submitted for Public Comment and
Recommendations'' notice on March 1, 2018 to obtain comments from the
public and affected agencies. CDC did not receive comments related to
the previous notice. This notice serves to allow an additional 30 days
for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
Collaborating Center for Questionnaire Design and Evaluation Research
(CCQDER) (OMB Control Number 0920-0222, Expiration 07/31/2018)--
Revision--National Center for Health Statistics (NCHS), Centers for
Disease Control and Prevention (CDC)
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall undertake and support (by
grant or contract) research, demonstrations, and evaluations respecting
new or improved methods for obtaining current data to support
statistical and epidemiological activities for the purpose of improving
the effectiveness, efficiency, and quality of health services in the
United States.
The Collaborating Center for Questionnaire Design and Evaluation
Research (CCQDER) is the focal point within NCHS for questionnaire and
survey development, pre-testing, and evaluation activities for CDC
surveys (such as the NCHS National Health
[[Page 35647]]
Interview Survey, OMB No. 0920-0214) and other federally sponsored
surveys. NCHS is requesting 3 years of OMB Clearance for this generic
submission.
The CCQDER and other NCHS programs conduct cognitive interviews,
focus groups, in-depth or ethnographic interviews, usability tests,
field tests/pilot interviews, and experimental research in laboratory
and field settings, both for applied questionnaire development and
evaluation as well as more basic research on measurement errors and
survey response.
Various techniques to evaluate interviewer administered, self-
administered, telephone, Computer Assisted Personal Interviewing
(CAPI), Computer Assisted Self-Interviewing (CASI), Audio Computer-
Assisted Self-Interviewing (ACASI), and web-based questionnaires are
used.
The most common questionnaire evaluation method is the cognitive
interview. These evaluations are conducted by the CCQDER and
contractors, as needed. The interview structure consists of respondents
first answering a draft survey question and then providing textual
information to reveal the processes involved in answering the test
question. Specifically, cognitive interview respondents are asked to
describe how and why they answered the question as they did. Through
the interviewing process, various types of question-response problems
that would not normally be identified in a traditional survey
interview, such as interpretive errors and recall accuracy, are
uncovered. By conducting a comparative analysis of cognitive
interviews, it is also possible to determine whether particular
interpretive patterns occur within particular sub-groups of the
population. Interviews are generally conducted in small rounds totaling
40-100 interviews; ideally, the questionnaire is re-worked between
rounds, and revisions are tested iteratively until interviews yield
relatively few new insights.
Cognitive interviewing is inexpensive and provides useful data on
questionnaire performance while minimizing respondent burden. Cognitive
interviewing offers a detailed depiction of meanings and processes used
by respondents to answer questions--processes that ultimately produce
the survey data. As such, the method offers an insight that can
transform understanding of question validity and response error.
Documented findings from these studies represent tangible evidence of
how the question performs. Such documentation also serves CDC data
users, allowing them to be critical users in their approach and
application of the data.
In addition to cognitive interviewing, a number of other
qualitative and quantitative methods are used to investigate and
research measurement error and the survey response process. These
methods include conducting focus groups, usability tests, in-depth or
ethnographic interviews, and the administration and analysis of
questions in both representative and non-representative field tests.
Focus groups are conducted by the CCQDER and contractors, as needed.
They are group discussions whose primary purpose is to elicit the basic
sociocultural understandings and terminology that form the basis of
questionnaire design. Each group typically consists of one moderator
and 4 to 10 participants, depending on the research question. In-depth
or ethnographic interviews are one-on-one interviews designed to elicit
the understandings or terminology that are necessary for question
design, as well as to gather detailed information that can contribute
to the analysis of both qualitative and quantitative data. Usability
tests are typically one-on-one interviews that are used to determine
how a given survey or information collection tool functions in the
field, and how the mode and layout of the instrument itself may
contribute to survey response error and the survey response process.
In addition to these qualitative methods, NCHS also uses various
tools to obtain quantitative data, which can be analyzed alone or
analyzed alongside qualitative data to give a much fuller accounting of
the survey response process. For instance, phone, internet, mail, and
in-person follow-up interviews of previous NCHS survey respondents may
be used to test the validity of survey questions and questionnaires and
to obtain more detailed information that cannot be gathered on the
original survey. Additionally, field or pilot tests may be conducted on
both representative and non-representative samples, including those
obtained from commercial survey and web panel vendors. Beyond looking
at traditional measures of survey errors (such as item missing and non-
response rates, and response latency), these pilot tests can be used to
run experimental designs in order to capture how different questions
function in a field setting.
Similar methodology has been adopted by other federal agencies, as
well as by academic and commercial survey organizations. There are no
costs to respondents other than their time. The total estimated annual
burden hours are 7,783.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Individuals or households............. Eligibility Screening... 4,000 1 5/60
Individuals or households............. Questionnaire 7,300 1 55/60
Development Studies.
Individuals or households............. Respondent Data 7,300 1 5/60
Collection Sheet.
Individuals or households............. Focus groups............ 100 1 90/60
----------------------------------------------------------------------------------------------------------------
[[Page 35648]]
Jeffery M. Zirger,
Acting Chief, Information Collection Review Office, Office of
Scientific Integrity, Office of the Associate Director for Science,
Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2018-16090 Filed 7-26-18; 8:45 am]
BILLING CODE 4163-18-P
