Proposed Data Collections Submitted for Public Comment and Recommendations, 39787-39788 [2017-17708]
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Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
Dated: August 14, 2017.
Allison Fahrenkopf Brigati,
Associate Administrator, Office of
Government-wide Policy, General Services
Administration.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy A.
Richardson, 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.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2017–17680 Filed 8–21–17; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60Day–17–0773; Docket No. CDC–2017–
0061]
Proposed Data Collections 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 efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comments on the information collection
extension request titled ‘‘Adverse
Events among Persons on Treatment of
Latent Tuberculosis Infection.’’
DATES: Written comments must be
received on or before October 23, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0061 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comments
should be submitted through the
Federal eRulemaking portal
(Regulations.gov) or by U.S. mail to the
address listed above.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
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 OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, Information
Collection Request Procedures Manual
33 retain, disclose or provide
information to or for a Federal agency.
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
SUPPLEMENTARY INFORMATION:
Centers for Disease Control and
Prevention
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
39787
transmit or otherwise disclose the
information.
Proposed Project
National Surveillance for Severe
Adverse Events among Persons on
Treatment of Latent Tuberculosis
Infection—(OMB Control No. 0920–
0773, expires 01/17/2018)—Extension—
Division of Tuberculosis Elimination
(DTBE), National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As part of the national tuberculosis
(TB) elimination strategy, the American
Thoracic Society and CDC have
published recommendations for targeted
testing for TB and treatment for latent
TB infection (LTBI) (Morbidity and
Mortality Weekly Report (MMWR)
2000;49[RR06];1–54). However, between
October 2000 and September 2004, the
CDC received reports of 50 patients with
severe adverse events (SAEs) associated
with the use of the two or three-month
regimen of rifampin and pyrazinamide
(RZ) for the treatment of LTBI; 12 (24%)
patients died (MMWR 2003;52[31]:735–
9). In 2004, CDC began collecting
reports of SAEs among persons on
treatment regimen for LTBI.
For surveillance purposes, an SAE
was defined as any drug-associated
reaction resulting in a patient’s
hospitalization or death after at least
one treatment dose for LTBI. During
2004–2016, CDC received 66 reports of
SAEs among recipients of isoniazid
(INH)-only (n=44), INH-rifapentine
(RPT) (n=20), rifampin (RIF) (n=1) and
INH/Levofloxacin (n=1) for LTBI.
Among INH-only recipients, seven died;
five, including one child, underwent
liver transplantation. Among INH–RPT,
RIF, and INH/Levofloxacin recipients,
length of hospitalization ranged 1–20
(median: 3) days; no liver transplants or
deaths were reported. The RIF recipient
had an acute kidney injury but
recovered after three hemodialysis
treatments [Severe Adverse Events
(Hospitalization or Death) Among
Persons on Treatment for Latent
Tuberculosis Infection, United States,
January 2004–December 2016. Presented
at the NAR/IUATLD Conference,
Vancouver, Canada, February 2017].
Ten of the SAEs were published in
Powell, K, et al. Severe Isoniazidassociated Liver Injuries among Persons
Being Treated for Latent Tuberculosis
Infection-United States, 2004–2008.
MMWR 2010; 59:224–9.
Reports of SAEs related to LTBI
treatment regimens have prompted a
need for this project—a national
E:\FR\FM\22AUN1.SGM
22AUN1
39788
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
surveillance system of such events. The
objective of the project is to determine
the annual number and temporal trends
of SAEs associated with any treatment
for LTBI in the United States.
Surveillance of such events will provide
data to support periodic evaluation or
potential revision of guidelines for
treatment of persons with LTBI.
The CDC seeks to request OMB
approval for a three-year extension of
the previously approved National
Surveillance for Severe Adverse Events
Associated with Treatment of Latent
Tuberculosis Infection—(OMB No.
0920–0773, expires January 17, 2018).
This project will continue the passive
reporting system for SAEs associated
with therapy for LTBI. The system will
rely on medical chart review and/or
onsite investigations by TB control staff.
LTBI treatment adverse events statistics
and will conduct special analyses for
publication in peer-reviewed scientific
journals to further describe and
interpret these data.
The Food and Drug Administration
(FDA) collects data on adverse events
related to drugs through the FDA
MedWatch Program. CDC is encouraging
health departments and healthcare
providers to report SAEs to FDA.
Reporting will be conducted through
telephone, email, or during CDC site
visits.
In this request, CDC is requesting
approval for approximately 36 burden
hours annually. The only cost to
respondents is time to gather medical
records and time to complete the
reporting form.
Potential respondents are any of the
60 reporting areas for the national TB
surveillance system (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean).
CDC will collect data using the data
collection form for SAEs associated with
LTBI treatment. Based on previous
reporting, CDC anticipates receiving an
average of six responses per year from
the 60 reporting areas. The data
collection form is completed by
healthcare providers and health
departments for each reported
hospitalization or death related to
treatment of LTBI and contains
demographic, clinical, and laboratory
information.
CDC will analyze and periodically
publish reports summarizing national
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
hours
Type of respondent
Form name
Physician ...........................................
Nurse .................................................
Medical Clerk ....................................
NSSAE .............................................
NSSAE .............................................
NSSAE .............................................
6
6
6
1
1
1
1
4
1
6
24
6
Total ...........................................
...........................................................
........................
........................
........................
36
Leroy A. Richardson,
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. 2017–17708 Filed 8–21–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–0740; Docket No. CDC–2017–
0060]
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.
sradovich on DSK3GMQ082PROD with NOTICES
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 to take this opportunity to
comment on proposed and/or
SUMMARY:
VerDate Sep<11>2014
18:00 Aug 21, 2017
Jkt 241001
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Medical Monitoring
Project, which collects interview and
medical record data on a probability
sample of HIV-diagnosed persons in
order to provide national estimates of
access to and utilization of HIV-related
medical care and services, the quality of
HIV-related ambulatory care, and HIVrelated behaviors and clinical outcomes.
DATES: Written comments must be
received on or before October 23, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2017–
0060 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
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. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Please note: All public comment
should be submitted through the
Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Leroy Richardson,
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.
FOR FURTHER INFORMATION CONTACT:
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 OMB for approval. To
comply with this requirement, we are
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39787-39788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17708]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-17-0773; Docket No. CDC-2017-0061]
Proposed Data Collections 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 efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comments on the information
collection extension request titled ``Adverse Events among Persons on
Treatment of Latent Tuberculosis Infection.''
DATES: Written comments must be received on or before October 23, 2017.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0061 by any of the following methods:
Federal eRulemaking Portal: Regulations.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, 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. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
Please note: All public comments should be submitted 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 Leroy A. Richardson, 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 OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain,
Information Collection Request Procedures Manual 33 retain, disclose or
provide information to or for a Federal agency. 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.
Proposed Project
National Surveillance for Severe Adverse Events among Persons on
Treatment of Latent Tuberculosis Infection--(OMB Control No. 0920-0773,
expires 01/17/2018)--Extension--Division of Tuberculosis Elimination
(DTBE), National Center for HIV, Viral Hepatitis, STD, and TB
Prevention NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
As part of the national tuberculosis (TB) elimination strategy, the
American Thoracic Society and CDC have published recommendations for
targeted testing for TB and treatment for latent TB infection (LTBI)
(Morbidity and Mortality Weekly Report (MMWR) 2000;49[RR06];1-54).
However, between October 2000 and September 2004, the CDC received
reports of 50 patients with severe adverse events (SAEs) associated
with the use of the two or three-month regimen of rifampin and
pyrazinamide (RZ) for the treatment of LTBI; 12 (24%) patients died
(MMWR 2003;52[31]:735-9). In 2004, CDC began collecting reports of SAEs
among persons on treatment regimen for LTBI.
For surveillance purposes, an SAE was defined as any drug-
associated reaction resulting in a patient's hospitalization or death
after at least one treatment dose for LTBI. During 2004-2016, CDC
received 66 reports of SAEs among recipients of isoniazid (INH)-only
(n=44), INH-rifapentine (RPT) (n=20), rifampin (RIF) (n=1) and INH/
Levofloxacin (n=1) for LTBI. Among INH-only recipients, seven died;
five, including one child, underwent liver transplantation. Among INH-
RPT, RIF, and INH/Levofloxacin recipients, length of hospitalization
ranged 1-20 (median: 3) days; no liver transplants or deaths were
reported. The RIF recipient had an acute kidney injury but recovered
after three hemodialysis treatments [Severe Adverse Events
(Hospitalization or Death) Among Persons on Treatment for Latent
Tuberculosis Infection, United States, January 2004-December 2016.
Presented at the NAR/IUATLD Conference, Vancouver, Canada, February
2017]. Ten of the SAEs were published in Powell, K, et al. Severe
Isoniazid-associated Liver Injuries among Persons Being Treated for
Latent Tuberculosis Infection-United States, 2004-2008. MMWR 2010;
59:224-9.
Reports of SAEs related to LTBI treatment regimens have prompted a
need for this project--a national
[[Page 39788]]
surveillance system of such events. The objective of the project is to
determine the annual number and temporal trends of SAEs associated with
any treatment for LTBI in the United States. Surveillance of such
events will provide data to support periodic evaluation or potential
revision of guidelines for treatment of persons with LTBI.
The CDC seeks to request OMB approval for a three-year extension of
the previously approved National Surveillance for Severe Adverse Events
Associated with Treatment of Latent Tuberculosis Infection--(OMB No.
0920-0773, expires January 17, 2018). This project will continue the
passive reporting system for SAEs associated with therapy for LTBI. The
system will rely on medical chart review and/or onsite investigations
by TB control staff.
Potential respondents are any of the 60 reporting areas for the
national TB surveillance system (the 50 states, the District of
Columbia, New York City, Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean).
CDC will collect data using the data collection form for SAEs
associated with LTBI treatment. Based on previous reporting, CDC
anticipates receiving an average of six responses per year from the 60
reporting areas. The data collection form is completed by healthcare
providers and health departments for each reported hospitalization or
death related to treatment of LTBI and contains demographic, clinical,
and laboratory information.
CDC will analyze and periodically publish reports summarizing
national LTBI treatment adverse events statistics and will conduct
special analyses for publication in peer-reviewed scientific journals
to further describe and interpret these data.
The Food and Drug Administration (FDA) collects data on adverse
events related to drugs through the FDA MedWatch Program. CDC is
encouraging health departments and healthcare providers to report SAEs
to FDA. Reporting will be conducted through telephone, email, or during
CDC site visits.
In this request, CDC is requesting approval for approximately 36
burden hours annually. The only cost to respondents is time to gather
medical records and time to complete the reporting form.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Physician..................... NSSAE........... 6 1 1 6
Nurse......................... NSSAE........... 6 1 4 24
Medical Clerk................. NSSAE........... 6 1 1 6
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 36
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
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. 2017-17708 Filed 8-21-17; 8:45 am]
BILLING CODE 4163-18-P
