Proposed Data Collection Submitted for Public Comment and Recommendations, 55457-55458 [2020-19745]
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55457
Federal Register / Vol. 85, No. 174 / Tuesday, September 8, 2020 / Notices
specimen (human, animal, food,
environmental, medical device or
biologic), CDC test order name/code,
specimen information, patient
information (as applicable), animal
information (as applicable) information
about the submitting organization
requesting the testing, patient history (as
applicable), owner information and
animal history (as applicable) and
epidemiological information. The
collection of this type of data is
pertinent in ensuring a specimen’s
testing results are linked to the correct
patient and the final test reports are
delivered to the appropriate submitting
organization to aid in making proper
health-related decisions related to the
patient. Furthermore, the data provided
on this form may be used by the CDC
to identify sources of potential
outbreaks and other public-health
related events. When the form is filled
out, a user in the submitting
organization prints a hard copy of it that
will be included in the specimen’s
shipping package sent to the CDC. The
printed form has barcodes on it that
allow the CDC testing laboratory to scan
its data directly into ELIMS where the
specimen’s testing lifecycle is tracked
and managed.
Likewise, the Global File
Accessioning Template records the
same data as the 50.34 Form but
provides the capability to submit
information for a batch of specimens
(typically 50–1,000 specimens per
batch) to a specific CDC laboratory for
testing. The CDC testing laboratory
electronically uploads the Global File
Accessioning Template into ELIMS
where the batch of specimens are then
logged and are ready to be tracked
through their respective testing and
reporting workflow. There is no cost to
respondents other than their time. The
total burden hours are 2,131 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Form name
Medical Assistant, Doctor’s Office/Hospital ....
19–1042 Medical Scientists, Except Epidemiologists, State Public Health Lab.
Medical Assistant, Doctor’s Office/Hospital ....
CDC Specimen Submission 50.34 Form .......
CDC Specimen Submission 50.34 Form .......
2,000
98
3
193
5/60
5/60
Global File Accessioning Template ...............
15
11
20/60
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–19743 Filed 9–4–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–FY–0740; Docket No. CDC–2020–
0095]
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 Medical Monitoring Project
(MMP). The purpose of this data
collection is to describe the health-
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Number of
respondents
Type of respondents
VerDate Sep<11>2014
16:32 Sep 04, 2020
Jkt 250001
related behaviors, experiences and
needs of adults diagnosed with HIV in
the United States. Data will be used to
guide national and local HIV-related
service organization and delivery, and
monitor receipt of HIV treatment and
prevention services and clinical
outcomes.
DATES: CDC must receive written
comments on or before November 9,
2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0095 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 Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS–
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
D74, Atlanta, Georgia 30329; phone:
404–639–7118; Email: omb@cdc.gov.
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08SEN1.SGM
08SEN1
55458
Federal Register / Vol. 85, No. 174 / Tuesday, September 8, 2020 / Notices
Changes made, that did not affect the
burden, listed below:
• Non-substantive changes have been
made to the respondent consent form to
decrease the reading comprehension
level and make the form more visual.
• Nine data elements were removed
from, and three data elements were
added to the Minimum Dataset. 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.
• Seven data elements were added to
the medical record abstraction data
elements to collect information on
SARS-CoV–2 (COVID–19) testing.
Because the medical records are
abstracted by MMP staff, 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. 11/30/
2022) 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. Total estimated annual
burden requested is 5,707 hours.
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 10% reduction in burden, or
a reduction of 647 total burden hours
annually. The reduction in burden was
a result of revisions to the interview
questionnaire that were made to
improve coherence, boost the efficiency
of the data collection, and increase the
relevance and value of the information,
which decreased the time of interview
from 45 minutes to 40 minutes.
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
Medical Monitoring Project (MMP)
(OMB Control No. 0920–0740, Exp. 6/
30/2021)—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’’ which expires June
30, 2021. 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 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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
hours per
response
Total
response
burden
(hours)
Form name
Sampled, Eligible HIV-Infected Persons ..............
7,760
1
45/60
5,173
1,940
1
2/60
65
Facility office staff approaching sampled persons
for enrollment.
Facility office staff pulling medical records ..........
Interview Questionnaire
(Att. 5a).
Look up contact information.
Approach persons for
enrollment.
Pull medical records .....
970
1
5/60
81
7,760
1
3/60
388
Total ...............................................................
.......................................
........................
........................
........................
5,707
Facility office staff looking up contact information
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–19745 Filed 9–4–20; 8:45 am]
BILLING CODE 4163–18–P
jbell on DSKJLSW7X2PROD with NOTICES
Number of
respondents
Type of respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day-20–20KW]
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
VerDate Sep<11>2014
16:32 Sep 04, 2020
Jkt 250001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
collection request titled ‘‘School Health
Profiles Test-Retest Reliability Study’’ 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 16, 2020 to obtain
comments from the public and affected
agencies. CDC received two comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
E:\FR\FM\08SEN1.SGM
08SEN1
]]>Agencies
[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55457-55458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19745]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-FY-0740; Docket No. CDC-2020-0095]
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 Medical Monitoring Project (MMP).
The purpose of this data collection is to describe the health-related
behaviors, experiences and needs of adults diagnosed with HIV in the
United States. Data will be used to guide national and local HIV-
related service organization and delivery, and monitor receipt of HIV
treatment and prevention services and clinical outcomes.
DATES: CDC must receive written comments on or before November 9, 2020.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0095 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 Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; 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
[[Page 55458]]
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
Medical Monitoring Project (MMP) (OMB Control No. 0920-0740, Exp.
6/30/2021)--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''
which expires June 30, 2021. 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, 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 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 10% reduction in burden, or a
reduction of 647 total burden hours annually. The reduction in burden
was a result of revisions to the interview questionnaire that were made
to improve coherence, boost the efficiency of the data collection, and
increase the relevance and value of the information, which decreased
the time of interview from 45 minutes to 40 minutes.
Changes made, that did not affect the burden, listed below:
Non-substantive changes have been made to the respondent
consent form to decrease the reading comprehension level and make the
form more visual.
Nine data elements were removed from, and three data
elements were added to the Minimum Dataset. 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.
Seven data elements were added to the medical record
abstraction data elements to collect information on SARS-CoV-2 (COVID-
19) testing. Because the medical records are abstracted by MMP staff,
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. 11/30/2022)
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. Total estimated annual burden requested is 5,707 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Total
Number of Number of Average hours response
Type of respondent Form name respondents responses per per response burden
respondent (hours)
----------------------------------------------------------------------------------------------------------------
Sampled, Eligible HIV-Infected Interview 7,760 1 45/60 5,173
Persons. Questionnaire
(Att. 5a).
Facility office staff looking Look up contact 1,940 1 2/60 65
up contact information. information.
Facility office staff Approach persons 970 1 5/60 81
approaching sampled persons for enrollment.
for enrollment.
Facility office staff pulling Pull medical 7,760 1 3/60 388
medical records. records.
---------------------------------------------------------------------------------
Total..................... ................ .............. .............. .............. 5,707
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2020-19745 Filed 9-4-20; 8:45 am]
BILLING CODE 4163-18-P
