Proposed Data Collection Submitted for Public Comment and Recommendations, 39788-39790 [2017-17699]
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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
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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
39789
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
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, 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
Medical Monitoring Project (MMP)—
(OMB Control Number 0920–0740
Expiration 6/30/2018)—Revision—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
the number of interviews conducted and
the number of persons for whom
healthcare facility staff will be asked for
contact information, assistance with
approaching for participation, and
pulling medical records.
Changes were made that did not affect
the burden, listed below:
• Sampled persons found to have
resided in a non-funded project area on
the date of sampling will be considered
ineligible for the project, because nonfunded project areas were deemed
ineligible in the first stage of sampling.
• Tracking data reports will no longer
be sent to CDC, as this information is no
longer needed.
• The average token of appreciation
for participants has been increased from
$25 to $50.
• Changes have been made to the
respondent consent form to decrease the
reading comprehension level and clarify
whom participants should contact for
different concerns.
• Forty-two data elements were
removed from the minimum data set
and forty data elements were added.
Because these data elements are
extracted from the HIV surveillance
system from which they are sampled,
these changes do not affect the burden
of the project.
This proposed data collection would
supplement the National HIV
Surveillance System (NHSS, OMB
Control No. 0920–0573, Exp. 6/30/2019)
in 23 selected state and local health
departments, which collect information
on persons diagnosed with, living with,
and dying from HIV infection and AIDS.
The participation of respondents is
voluntary. There is no cost to the
respondents other than their time.
Through their participation,
respondents will help to improve
programs to prevent HIV infection as
well as services for those who already
have HIV.
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), Division of HIV/AIDS
Prevention (DHAP) requests a revision
of the currently approved Information
Collection Request: ‘‘Medical
Monitoring Project’’ expiring June 30,
2018. This data collection addresses the
need for national estimates of access to
and utilization of HIV-related medical
care and services, the quality of HIVrelated ambulatory care, and HIVrelated behaviors and clinical outcomes.
For the proposed project, the same
data collection methods will be used as
for the currently approved project. Data
would be collected from a probability
sample of HIV-diagnosed adults in the
U.S. who consent to an interview and
abstraction of their medical records. As
for the currently approved project, deidentified information would also be
extracted from HIV case surveillance
records for a dataset, referred to as the
minimum dataset, which is used to
assess non-response bias, for quality
control, to improve the ability of MMP
to monitor ongoing care and treatment
of HIV-infected persons, and to make
inferences from the MMP sample to
HIV-diagnosed persons nationally.
No other Federal agency collects such
nationally representative populationbased information from HIV-diagnosed
adults. The data are expected to have
significant implications for policy,
program development, and resource
allocation at the state/local and national
levels.
The changes proposed in this request
update the data collection system to
meet prevailing information needs and
enhance the value of MMP data, while
remaining within the scope of the
currently approved project purpose. The
result is a 11% reduction in burden, or
a reduction of 786 total burden hours
annually. Specifically, the removal of
three unfunded project areas reduces
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average hours
per response
Total response
burden
(hours)
7,760
1,940
970
1
1
1
45/60
2/60
5/60
5,820
65
81
N/A ................................
7,760
1
3/60
388
.......................................
........................
........................
........................
6,354
Number of
respondents
Form name
Sampled, Eligible HIV-Infected Persons ..............
Facility office staff looking up contact information
Facility office staff approaching sampled persons
for enrollment.
Facility office staff pulling medical records ...........
sradovich on DSK3GMQ082PROD with NOTICES
Type of respondent
Interview Questionnaire
N/A ................................
N/A ................................
Total ...............................................................
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39790
Federal Register / Vol. 82, No. 161 / Tuesday, August 22, 2017 / Notices
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. 2017–17699 Filed 8–21–17; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Application Requirements for
the Low Income Home Energy
Assistance Program (LIHEAP) Plan.
OMB No.: 0970–0075.
Description: States, including the
District of Columbia, tribes, tribal
organizations, and U.S. territories
applying for LIHEAP block grant funds
must, prior to receiving federal funds,
submit an annual application (Model
Plan, ACF–122) that meets the LIHEAP
statutory and regulatory requirements.
In addition to the Model Plan, grantees
are also required to complete the
Mandatory Grant Application SF–424–
Mandatory, which is the first section of
the Model Plan.
The LIHEAP Model Plan is an
electronic form and is submitted to the
Administration for Children and
Families (ACF), Office of Community
Services (OCS) through the On-line Data
Collection (OLDC) system within
GrantSolutions, which is currently
being used by all LIHEAP grantees to
submit other required LIHEAP reporting
forms. In order to reduce the reporting
burden, all data entries from each
grantee’s prior year’s submission of the
Model Plan in OLDC is saved and repopulated (cloned) into the form for the
following fiscal year’s application.
OCS seeks renewal of this form
without any changes. A sample model
plan showing these proposed changes
can be found on the U.S. Department of
Health and Human Services, ACF/OCS
LIHEAP Program Resources page at:
https://www.acf.hhs.gov/ocs/resource/
funding-applications.
On April 3, 2017, ACF published a
Federal Register Notice seeking 60 days
of public comment on this proposed
information collection. One state
grantee provided comments. ACF
revised the Plan to address the
comments by ensuring that open field
boxes and attachment capability are
available if the answer choices are
insufficient to address the questions.
The revised model plan can be
viewed on the OCS Web site at: https://
www.acf.hhs.gov/programs/ocs/
programs/liheap.
Respondents: State, the District of
Columbia, U.S. Territories and Tribal
governments.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Detailed Model Plan ..........................................................................
sradovich on DSK3GMQ082PROD with NOTICES
Instrument
210
1
0.50
105
Estimated Total Annual Burden
Hours (all respondents): 105.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201.
Attention Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2017–17681 Filed 8–21–17; 8:45 am]
BILLING CODE 4184–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4885]
Pediatric Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Pediatric Advisory Committee (PAC).
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comments.
DATES: The meeting will be held on
September 11, 2017, from 8:30 a.m. to
5:30 p.m. and September 12, 2017, from
8:30 a.m. to 1 p.m.
ADDRESSES: Hilton Washington DC/
Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville,
MD 20852. The hotel’s telephone
SUMMARY:
PO 00000
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number is 301–468–1100. Answers to
commonly asked questions including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at https://www3.hilton.com/
en/hotels/maryland/hilton-washingtondc-rockville-hotel-and-executivemeeting-ctr-IADMRHF/.
FDA is establishing a docket for
public comment on this document. The
docket number is FDA–2017–N–4885.
The docket will close on September 13,
2017. Submit either electronic or
written comments on this public
meeting by that date. Late, untimely
comments will not be considered.
Electronic comments must be submitted
on or before September 13, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of September 13, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before
August 28, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
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]]>Agencies
[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39788-39790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17699]
-----------------------------------------------------------------------
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
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 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 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 HIV-
related 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.
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.
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 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
[[Page 39789]]
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, 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
Medical Monitoring Project (MMP)--(OMB Control Number 0920-0740
Expiration 6/30/2018)--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 Centers for Disease Control and Prevention (CDC), Division of
HIV/AIDS Prevention (DHAP) requests a revision of the currently
approved Information Collection Request: ``Medical Monitoring Project''
expiring June 30, 2018. This data collection addresses the need for
national estimates of access to and utilization of HIV-related medical
care and services, the quality of HIV-related ambulatory care, and HIV-
related behaviors and clinical outcomes.
For the proposed project, the same data collection methods will be
used as for the currently approved project. Data would be collected
from a probability sample of HIV-diagnosed adults in the U.S. who
consent to an interview and abstraction of their medical records. As
for the currently approved project, de-identified information would
also be extracted from HIV case surveillance records for a dataset,
referred to as the minimum dataset, which is used to assess non-
response bias, for quality control, to improve the ability of MMP to
monitor ongoing care and treatment of HIV-infected persons, and to make
inferences from the MMP sample to HIV-diagnosed persons nationally.
No other Federal agency collects such nationally representative
population-based information from HIV-diagnosed adults. The data are
expected to have significant implications for policy, program
development, and resource allocation at the state/local and national
levels.
The changes proposed in this request update the data collection
system to meet prevailing information needs and enhance the value of
MMP data, while remaining within the scope of the currently approved
project purpose. The result is a 11% reduction in burden, or a
reduction of 786 total burden hours annually. Specifically, the removal
of three unfunded project areas reduces the number of interviews
conducted and the number of persons for whom healthcare facility staff
will be asked for contact information, assistance with approaching for
participation, and pulling medical records.
Changes were made that did not affect the burden, listed below:
Sampled persons found to have resided in a non-funded
project area on the date of sampling will be considered ineligible for
the project, because non-funded project areas were deemed ineligible in
the first stage of sampling.
Tracking data reports will no longer be sent to CDC, as
this information is no longer needed.
The average token of appreciation for participants has
been increased from $25 to $50.
Changes have been made to the respondent consent form to
decrease the reading comprehension level and clarify whom participants
should contact for different concerns.
Forty-two data elements were removed from the minimum data
set and forty data elements were added. Because these data elements are
extracted from the HIV surveillance system from which they are sampled,
these changes do not affect the burden of the project.
This proposed data collection would supplement the National HIV
Surveillance System (NHSS, OMB Control No. 0920-0573, Exp. 6/30/2019)
in 23 selected state and local health departments, which collect
information on persons diagnosed with, living with, and dying from HIV
infection and AIDS.
The participation of respondents is voluntary. There is no cost to
the respondents other than their time. Through their participation,
respondents will help to improve programs to prevent HIV infection as
well as services for those who already have HIV.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Total response
Type of respondent Form name Number of responses per Average hours burden
respondents respondent per response (hours)
----------------------------------------------------------------------------------------------------------------
Sampled, Eligible HIV-Infected Interview 7,760 1 45/60 5,820
Persons. Questionnaire.
Facility office staff looking N/A............. 1,940 1 2/60 65
up contact information.
Facility office staff N/A............. 970 1 5/60 81
approaching sampled persons
for enrollment.
Facility office staff pulling N/A............. 7,760 1 3/60 388
medical records.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 6,354
----------------------------------------------------------------------------------------------------------------
[[Page 39790]]
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. 2017-17699 Filed 8-21-17; 8:45 am]
BILLING CODE 4163-18-P
