60-day Federal Register Notice

Att. B - Published 60-day FRN-12.23.2019.pdf

Information Collection for Tuberculosis Data from Referring Entities to CureTB

60-day Federal Register Notice

OMB: 0920-1186

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70555

Federal Register / Vol. 84, No. 246 / Monday, December 23, 2019 / Notices
Findings from MMRCs indicate that
more than half of maternal deaths are
preventable.
Maternal Mortality Review is a
process by which a multidisciplinary
committee at the jurisdiction level
identifies and reviews cases of maternal
death within one year of end of
pregnancy. Members of MMRCs
typically represent public health,
obstetrics and gynecology, maternalfetal medicine, nursing, midwifery,
forensic pathology, mental and
behavioral health, and other relevant
stakeholders. Through a partnership
among the MMRC, state vital records
office, and epidemiologists, deaths
among women of reproductive age are
examined to determine if they occurred
during pregnancy or within one year of
the end of pregnancy (i.e., pregnancyassociated deaths). Through this
process, potential cases of pregnancyrelated deaths (i.e., maternal death from
any cause related to or aggravated by
pregnancy or its management) are then
identified. Review committees access
multiple sources of clinical and nonclinical information to understand the

circumstances surrounding a maternal
death in order to develop
recommendations for action to prevent
similar deaths in the future.
MMRIA is a standardized data
collection system designed to collect
timely, accurate, and standardized
information about deaths to women
during pregnancy and within one year
of end of pregnancy, including
opportunities for prevention, within and
across jurisdictions. Data will be
abstracted and entered into MMRIA
from various sources, including death
certificates, autopsy reports, birth
certificates, prenatal care records,
emergency room visit records,
hospitalization records, records from
other medical office visits, medical
transport records, social and
environmental profiles, mental health
profiles, and informant interviews. Case
narratives for committee reviews are
auto-populated from the abstracted data
entered into MMRIA to facilitate
committee review, and committee
decisions will also be entered into
MMRIA.

The data collected in MMRIA will be
used to facilitate an understanding of
the drives of maternal mortality and
complications of pregnancy and
associated disparities; determine what
interventions at patient, provider,
facility, system, and community levels
will have the most impact; and
implement data driven
recommendations.
The burden estimates presented here
are applicable to the estimated 25
awardees of the cooperative agreement
Preventing Maternal Deaths: Supporting
Maternal Mortality Review Committees
(CDC–RFA–DP19–1908); these awardees
are required to compile a defined set of
information about maternal deaths into
MMRIA. It is estimated that information
will be collected for a total of 740
pregnancy-associated deaths on average,
annually, among the 25 awardees.
Burden is estimated based on each
awardee’s total staff time to enter the
abstracted data into MMRIA and enter
the committee decision. The annual
burden is estimated to be 11,550 hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Awardees ........................................................

Data abstraction .............................................
Committee decision ........................................

Jeffery M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–27551 Filed 12–20–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60–Day–20–1186; Docket No. CDC–2019–
0098]

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:

lotter on DSKBCFDHB2PROD with NOTICES

Number of
respondents

Types of respondents

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

SUMMARY:

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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 Information Collection for
Tuberculosis Data from Referring
Entities to CureTB, which enables CDC
to coordinate continuity of care services
for individuals with tuberculosis.
DATES: CDC must receive written
comments on or before February 21,
2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0098 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

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25
25

Number of
responses per
respondent

Average hours
per response
(in hours)

30
30

15
24/60

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, of
the 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

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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
Information Collection for
Tuberculosis Data from Referring
Entities to CureTB (OMB Control No.
0920–1186, Exp. 06/30/2020)—
Revision—National Center for Emerging
Zoonotic and Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).

correctional facilities, and foreign
national TB programs. All 50 U.S. states
and territories may refer TB patients to
the CureTB program. To date, CureTB
has also received referrals from Mexico
and Guatemala.
Registered nurses or nurse
practitioners will submit CureTB
referral forms as they request referral
services. The number of referrals varies
widely between respondents. To ensure
adequate referral to treatment occurs,
CDC CureTB may need to follow-up
with an individual to complete missing
data fields concerning clinical or
contact information. This is done to
ensure continuity of care. Therefore,
individuals with TB are also
respondents in this information
collection. CDC’s CureTB program will
also continue working with our public
health partners in notifications and
referrals for contacts of TB cases. This
is a lesser used function of CureTB, but
burden is included below. These
respondents are registered nurses or
nurse practitioners working in health
departments.
Finally, CDC staff in the CureTB
program also contact the new treating
physicians to determine patient
outcomes using CureTB Clinician Public
Health Department Follow-up Script.
The physicians are generally contacted
every two months over the course of
standard six month TB treatment, for a
total of three follow-up contacts per
patient. There are no costs to
respondents other than the time
required to complete the referral
documents and respond to CDC requests
for TB patient outcomes. The total
burden requested is 1,117 hours.

Background and Brief Description
CureTB at the Centers for Disease
Control and Prevention (CDC), works
with domestic and international
programs to protect the U.S. public by
preventing TB disease transmission
domestically and internationally, as
well as preventing the development of
drug resistant TB. These goals are
accomplished through CureTB referral
and continuity of care services for
mobile TB patients.
Lack of treatment adherence and
inappropriate selection of medications
are prime reasons for the continued
emergence and spread of resistant
strains of tuberculosis. To combat this,
CureTB ensures that patients
understand how to remain adherent to
treatment regimens, despite moving
between nations. CureTB also provides
information to the health care team that
will be continuing care about each
patient’s TB strain and tailored
medication regimen. CureTB gathers
demographic and clinical information
for each patient and connects that
individual to appropriate clinical care.
This information is also provided on a
real-time basis to medical providers and
public health authorities in receiving
nations so follow-up with the patient
can be expedited.
The respondents for the CureTB
referral services are nurse practitioners,
registered nurses, and physicians
working for organizations within the
United States and other countries who
provide diagnostic and treatment
services to individuals affected by TB.
The organizations are primarily state
and local health departments, but
include immigration detention centers,

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total
burden hours

Form name

Registered Nurses/Nurse Practitioners
TB patients ...........................................
TB patients (ICE referrals) ...................
TB treating physicians ..........................

CureTB Transnational Notification
CureTB Transnational Notification
CureTB Transnational Notification
Clinician Public Health Department Follow-up Script.
CureTB Contact/Source Investigation (CI/SI) Notification.

100
200
600
900

3
1
1
3

30/60
5/60
45/60
10/60

150
17
450
450

20

5

30/60

50

.......................................................

........................

........................

........................

1,117

Registered Nurses/Nurse Practitioners
Total ...............................................
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Number of
respondents

Type of respondents

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–27559 Filed 12–20–19; 8:45 am]
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