Proposed Data Collection Submitted for Public Comment and Recommendations, 43876-43877 [2018-18589]
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43876
Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
International panel physicians ........................
TB Indicators Excel Spreadsheet ..................
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. 2018–18588 Filed 8–27–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–18–0600; Docket No. CDC–CDC–
2008–0079]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled CDC Model Performance
Evaluation Program (MPEP) for
Mycobacterium tuberculosis
Susceptibility Testing information
collection. CDC is requesting a threeyear approval for revision to the
previously approved project used to
monitor and evaluate performances and
practices among national laboratories M.
tuberculosis susceptibility testing.
DATES: CDC must receive written
comments on or before October 29,
2018.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2008–
00791 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
SUMMARY:
daltland on DSKBBV9HB2PROD with NOTICES
Number of
respondents
Type of respondents
VerDate Sep<11>2014
20:00 Aug 27, 2018
Jkt 244001
Disease Control and Prevention, 1600
Clifton Road NE, MS–D74, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
Regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffery M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
D74, Atlanta, Georgia 30329; phone:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
336
Average
burden per
response
(in hours)
1
3
4. 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 submissions
of responses.
5. Assess information collection costs.
Proposed Project
CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium
tuberculosis Susceptibility testing (OMB
#0920–0600, expiration 3/31/2019)—
Revision—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting a revision to
the approved information collection,
CDC Model Performance for
Mycobacterium tuberculosis Drug
Susceptibility Testing (OMB Control
Number 0920–0600). Clearance is
requested for a period of three years.
Revision of this information collection
will not require changes in the scope of
the study. This revision includes (a)
modification of the Participant Biosafety
Compliance Letter of Agreement; (b)
modification of the Instructions to
Participants Letter; (c) modification of
the MPEP Mycobacterium Results
Worksheet; (d) Request for approval of
a MPEP Mycobacterium tuberculosis
Minimum Inhibitory Concentration
(MIC) Results Form for laboratories that
perform Sensititre Drug Susceptibility
Testing (DST) to record MIC results; and
(e) reduction in request for burden
hours.
While the overall number of cases of
TB in the U.S. has decreased, rates still
remain high among foreign-born
persons, prisoners, homeless
populations, and individuals infected
with HIV in major metropolitan areas.
To reach the goal of eliminating TB, the
Model Performance Evaluation Program
for Mycobacterium tuberculosis
Susceptibility Testing is used to monitor
and evaluate performance and practices
among national laboratories performing
M. tuberculosis susceptibility testing.
Participation in this program is one way
E:\FR\FM\28AUN1.SGM
28AUN1
43877
Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices
laboratories can ensure high-quality
laboratory testing, resulting in accurate
and reliable testing results.
By providing an evaluation program
to assess the ability of the laboratories
to test for drug resistant M. tuberculosis
strains, laboratories also have a selfassessment tool to aid in optimizing
their skills in susceptibility testing. The
information obtained from the
laboratories on susceptibility practices
drug concentrations, and test methods
performed by laboratories on a set of
performance evaluation (PE) samples.
The PE samples are sent to participants
twice a year. Participants also report
demographic data such as laboratory
type and the number of tests performed
annually. The total estimated annual
burden hours are 129. There is no cost
to respondents to participate other than
their time.
and procedures is used to establish
variables related to good performance,
assessing training needs, and aid with
the development of practice standards.
Participants in this program include
domestic clinical and public health
laboratories. Data collection from
laboratory participants occurs twice per
year. The data collected in this program
will include the susceptibility test
results of primary and secondary drugs,
ESTIMATED ANNUALIZED BURDEN HOURS
Domestic Laboratory .........................
Participant Biosafety Compliance
Letter of Agreement.
MPEP Mycobacterium tuberculosis
Results Worksheet.
Online Survey Instrument ................
MPEP Mycobacterium tuberculosis
Minimum Inhibitory Concentration
Results Form.
80
1
5/60
7
80
2
30/60
80
80
4
2
2
15/60
15/60
40
2
...........................................................
........................
........................
........................
129
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. 2018–18589 Filed 8–27–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3240]
List of Bulk Drug Substances for
Which There is a Clinical Need Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
developing a list of bulk drug
substances (active pharmaceutical
ingredients) for which there is a clinical
need (the 503B Bulks List). Drug
products that outsourcing facilities
compound using bulk drug substances
on the 503B Bulks List qualify for
certain exemptions from the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) provided certain conditions are
met. This notice identifies three bulk
drug substances that FDA has
considered and is proposing not to
SUMMARY:
VerDate Sep<11>2014
20:00 Aug 27, 2018
Jkt 244001
Number of
respondents
Average
burden per
response
(in hours)
Form name
Total ...........................................
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
Type of
respondents
include on the list: Bumetanide,
nicardipine hydrochloride, and
vasopressin. Additional bulk drug
substances nominated by the public for
inclusion on this list are currently under
consideration and will be the subject of
future notices.
DATES: Submit either electronic or
written comments on the notice by
October 29, 2018 to ensure that the
Agency considers your comment on this
notice before it begins work on a notice
reflecting the Agency’s final decision
about whether to include these
substances on the 503B Bulks List.
ADDRESSES: You may submit comments
at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Total burden
(in hours)
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
Written/Paper Submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3240 for ‘‘List of Bulk Drug
Substances For Which There Is a
Clinical Need Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 83, Number 167 (Tuesday, August 28, 2018)]
[Notices]
[Pages 43876-43877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18589]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-18-0600; Docket No. CDC-CDC-2008-0079]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies the opportunity to comment on a proposed and/or
continuing information collection, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled CDC Model Performance Evaluation
Program (MPEP) for Mycobacterium tuberculosis Susceptibility Testing
information collection. CDC is requesting a three-year approval for
revision to the previously approved project used to monitor and
evaluate performances and practices among national laboratories M.
tuberculosis susceptibility testing.
DATES: CDC must receive written comments on or before October 29, 2018.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2008-
00791 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE, MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to Regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (regulations.gov) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffery M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
[email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
collection before submitting the collection to the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected; and
4. 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
submissions of responses.
5. Assess information collection costs.
Proposed Project
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium
tuberculosis Susceptibility testing (OMB #0920-0600, expiration 3/31/
2019)--Revision--National Center for HIV/AIDS, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The CDC is requesting a revision to the approved information
collection, CDC Model Performance for Mycobacterium tuberculosis Drug
Susceptibility Testing (OMB Control Number 0920-0600). Clearance is
requested for a period of three years. Revision of this information
collection will not require changes in the scope of the study. This
revision includes (a) modification of the Participant Biosafety
Compliance Letter of Agreement; (b) modification of the Instructions to
Participants Letter; (c) modification of the MPEP Mycobacterium Results
Worksheet; (d) Request for approval of a MPEP Mycobacterium
tuberculosis Minimum Inhibitory Concentration (MIC) Results Form for
laboratories that perform Sensititre Drug Susceptibility Testing (DST)
to record MIC results; and (e) reduction in request for burden hours.
While the overall number of cases of TB in the U.S. has decreased,
rates still remain high among foreign-born persons, prisoners, homeless
populations, and individuals infected with HIV in major metropolitan
areas. To reach the goal of eliminating TB, the Model Performance
Evaluation Program for Mycobacterium tuberculosis Susceptibility
Testing is used to monitor and evaluate performance and practices among
national laboratories performing M. tuberculosis susceptibility
testing. Participation in this program is one way
[[Page 43877]]
laboratories can ensure high-quality laboratory testing, resulting in
accurate and reliable testing results.
By providing an evaluation program to assess the ability of the
laboratories to test for drug resistant M. tuberculosis strains,
laboratories also have a self-assessment tool to aid in optimizing
their skills in susceptibility testing. The information obtained from
the laboratories on susceptibility practices and procedures is used to
establish variables related to good performance, assessing training
needs, and aid with the development of practice standards.
Participants in this program include domestic clinical and public
health laboratories. Data collection from laboratory participants
occurs twice per year. The data collected in this program will include
the susceptibility test results of primary and secondary drugs, drug
concentrations, and test methods performed by laboratories on a set of
performance evaluation (PE) samples. The PE samples are sent to
participants twice a year. Participants also report demographic data
such as laboratory type and the number of tests performed annually. The
total estimated annual burden hours are 129. There is no cost to
respondents to participate other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Domestic Laboratory........... Participant 80 1 5/60 7
Biosafety
Compliance
Letter of
Agreement.
MPEP 80 2 30/60 80
Mycobacterium
tuberculosis
Results
Worksheet.
Online Survey 80 2 15/60 40
Instrument.
MPEP 4 2 15/60 2
Mycobacterium
tuberculosis
Minimum
Inhibitory
Concentration
Results Form.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 129
----------------------------------------------------------------------------------------------------------------
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. 2018-18589 Filed 8-27-18; 8:45 am]
BILLING CODE 4163-18-P
