60 day FRN

Att 2_60-Day FRN.pdf

Medical Monitoring Project

60 day FRN

OMB: 0920-0740

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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

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16:32 Sep 04, 2020

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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

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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:

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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

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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.

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File Modified2020-09-07
File Created2020-09-07

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