60 Day FRN

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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices

Services Association; universities;
foundations; and other private sector
organizations such as the Alzheimer’s
Association, the AARP Public Policy
Institute, and the National Academies of
Sciences, Engineering, and Medicine.

rate. Two-year clearance is requested to
cover the collection of data. The
estimated annual burden hours for the
collection are 4,534. There is no cost to
respondents other than their time to
participate.

Expected burden from data collection
for eligible cases is 30 minutes per
respondent, except small RCCs that will
have an additional five minutes for a
contact confirmation call. We calculated
the burden based on a 100% response

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Small RCC Director/Designated
Member.
RCC
Director/Designated
Member.
RCC
Director/Designated
Member.
ADSC Director/Designated
Member.
ADSC Director/Designated
Member.

Number of
responses per
respondent

Number of
respondents

Form name

Average
burden per
response
(in hours)

Total
burden
(in hours)

Staff

Contact Confirmation Call ................

3,100

1

5/60

258

Staff

RCC Questionnaire Version A .........

2,900

1

30/60

1,450

Staff

RCC Questionnaire Version B .........

2,900

1

30/60

1,450

Staff

ADSC Questionnaire Version A .......

1,375

1

30/60

688

Staff

ADSC Questionnaire Version B .......

1,375

1

30/60

688

Total ...........................................

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

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

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

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

4,534

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–23368 Filed 10–24–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–1072; Docket No. CDC–2019–
0091]

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 ‘‘The Enhanced STD surveillance
Network (SSuN)’’, which is the only
source for enhanced and sentinel STD
surveillance data in the United States
that serves to strengthen national and
local surveillance capacity, collects

SUMMARY:

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information on populations at risk for
STDs attending healthcare facilities, and
provides more accurate estimates of the
burden of disease, incidence of disease,
trends and impact of STDs at the
population level.
DATES: CDC must receive written
comments on or before December 24,
2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0091 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:
404–639–7570; Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies

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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
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.

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Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices
Proposed Project
The Enhanced STD surveillance
Network (SSuN), (OMB Control No.
0920–1072, Exp. 09/30/2021)—
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 National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention
is requesting revision of the information
collection entitled ‘‘Enhanced STD
Surveillance Network (SSuN)’’.
Revisions to this submission include
adding reported adult syphilis cases to
enhanced case-based surveillance
records, addition of 87 new data
elements, removal of 115 data elements
associated with a discontinued
neurosyphilis surveillance activity, and
revision of methods to include Health
Department surveillance HIV registry
matching activities for patients
presenting for care in STD clinical
facilities. This revision also includes
changes to the number and identity of
collaborating jurisdictions from 10 to 11
sites as a result of a recent notice of
funding opportunity. The estimate of
annualized burden hours for this data
collection increases modestly from
3,479 hours to 6,303 hours for the
revised project as a result of revisions
and expanding the project from 10 to 11
awardees for the current data collection
cycle.
The purpose of this project is to
enhance capacity for STD surveillance
and better meet CDC’s disease
surveillance mandate by; (1) providing
more comprehensive information on
reported cases of notifiable STDs to
enhance the ability of public health
authorities to interpret trends in case
incidence, assess inequalities in the
burden of disease by population
characteristics and to monitor STD
treatment and selected adverse health
outcomes of STDs, and (2) monitoring
STD and HIV co-infection, screening,
uptake of high-impact HIV prevention
and health care access trends among
patients seeking care and those
diagnosed with STDs in specific clinical
settings.
Routine STD surveillance activities
are ongoing in all US states and
jurisdictions, and cases are reported to
CDC through the National Notifiable
Disease Surveillance System (NNDSS).
However, case reports are often missing
critical patient demographics and are of
limited scope with respect to risk
behavior, provider and clinical
information, treatment, co-infection and
partner characteristics—data that are

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needed to appropriately direct disease
control activities. Enhanced SSuN is the
only current surveillance infrastructure
providing information on patient and
partner characteristics, clinical
presentation, screening and uptake of
HIV testing, treatment patterns, provider
compliance with treatment
recommendations, HIV co-infection
among persons diagnosed with STDs
and use of high impact STD-related HIV
prevention interventions such as preexposure prophylaxis.
The precursor to Enhanced SSuN was
the STD Surveillance Network (SSuN),
which was established in 2005 as a
network of six collaborating state and
local public health agencies providing
more comprehensive STD case-level and
clinical facility information. In 2008,
SSuN was expanded to 12 awardees to
add important geographic diversity and
to include visit-level data on a full
census of patients being seen in
categorical STD clinics. Activities of the
previously funded SSuN were
subsumed under the network’s scope in
establishing enhanced SSuN in 2013,
which funded 10 awardees to conduct
core data collection activities.
The revised project, SSuN—Cycle 4,
comprises 11 US local/state health
departments, including Baltimore City
Health Department, California
Department of Public Health, City of
Columbus Public Health Department,
Florida Department of Health, Indiana
Department of Public Health,
Multnomah County Health Department,
New York City Department of Health &
Mental Hygiene, Philadelphia
Department of Public Health, San
Francisco Department of Public Health,
Utah Department of Public Health and
Washington State Department of Health.
Subsequent to reinstatement of OMB
approval in 2018, enhanced SSuN
continues to provide ongoing data
addressing CDC’s Division of Sexually
Transmitted Disease and Prevention
priorities (DSTDP), including
contributing to CDC’s annual STD
surveillance report, CDC’s quarterly and
annual progress indicators, and has
informed policy discussions on
expedited partner therapy, pre-exposure
prophylaxis to prevent HIV infection
(PrEP), documented critical clinical
services provided by categorical STD
clinics, and provided information on the
proportion of cases treated with
appropriate antimicrobial regimens,
which is an essential indicator of
compliance with CDC treatment
recommendations and critical for
addressing the emergence of
antimicrobial resistance. The major data
collection components of the network
are grouped into two primary strategies,

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57433

reflecting different sentinel and
enhanced population-based surveillance
methods.
The first, Strategy A, includes sentinel
surveillance in STD clinics to monitor
patient care, screening and diagnostic
practices, HIV co-infection, treatment
and assess the delivery of high impact,
STD-related HIV prevention services.
Participating local/state health
departments are implementing common
protocols to abstract demographic,
clinical, risk behaviors from existing
health records for patients presenting
for care in 15 selected local STD Clinics.
Data for this strategy is abstracted from
existing electronic medical records at
the participating STD clinics, leveraging
information that is routinely collected
in the provision of clinical care. A brief
10-item de-identified survey will be
administered at registration to 350
patients presenting consecutively to the
clinics once annually to assess
demographics not collected in the
course of routine patient care. All
survey and medical records are fully deidentified by collaborating health
departments and transmitted to CDC
through secure file transport
mechanisms six times annually (every
two months). The estimated time for the
STD clinic data managers to abstract
data from electronic health records and
process patient surveys is four hours
every two months.
The second surveillance activity in
SSuN—Cycle 4, Strategy B, includes
abstraction of all reported gonorrhea
and adult syphilis cases from the
jurisdiction’s routine STD surveillance
data management system, recoding case
data to conform with common protocols
and performance of a registry match
with the jurisdictions HIV case
surveillance system. A random sample
of gonorrhea cases is selected, and
enhanced investigations conducted on
the gonorrhea cases selected in the
random sample. Enhanced
investigations include clinical data
collection from reporting providers,
searching existing health department
disease and laboratory registries for
additional diagnostic and laboratory
data, and attempting to obtain brief
patient behavioral and demographic
interviews on patients selected in the
random sample. Estimated time for
patients to complete these interviews is
10 minutes or less depending on skip
patterns. For these activities,
jurisdictions follow consensus protocols
for all data collection to provide
uniformly coded data on demographic
characteristics, behavioral risk factors,
clinical care, laboratory data and health
care seeking behaviors.

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57434

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Notices

There were 164,177 cases of
gonorrhea diagnosed and reported
across the 10 participating enhanced
SSuN jurisdictions funded in 2018.
Approximately 10.6%, or 17,512 cases
were randomly sampled for enhanced
investigation and full enhanced
investigations were completed for 7,132
(40.7%). The remaining cases were lost
to follow-up due to insufficient contact
information, or the patient failed to
respond to multiple contact attempts.
Similar performance is anticipated in
the revised project, which includes
eleven jurisdictions which reported
173,605 gonorrhea cases in 2017.
Approximately 17,360 cases will be

additional data management burden of
1,320 hours (11 sites × 6 annual matches
× 20 hours).
The estimated annual burden hours
for data management staff in funded
jurisdiction is 4,488 hours (3,168 +
1,320) for the revised information
collection. Respondents from local/state
health departments receive federal
funds to participate in this project.
Participation of patients and of facility
staff is voluntary. The total estimated
annual burden hours for which CDC
seeks approval is 6,303. There are no
additional costs to respondents other
than their time.

sampled and 7,380 completed patient
investigations are anticipated.
Data managers at each of the 11 local/
state health departments are responsible
for transmitting validated datasets to
CDC every month, alternating between
strategies A and B each month. This
reflects 3,168 burden hours for data
management (11 respondents × 12 data
transmissions × 24 hours). Data
managers will also be responsible for
conducting HIV registry matching
bimonthly; registry matches are
estimated to take 20 hours for matching,
cleaning and recoding records into
approved data formats. Across all 11
jurisdictions, this represents an

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondents

Form name

Data managers at sentinel STD clinics.
General Public—Adults (persons diagnosed with gonorrhea).
Data Managers: 11 local/state health
department.

Electronic Clinical Record Abstraction.
Patient interviews for a random
sample of gonorrhea cases.
Data cleaning/validation, HIV registry matching and data transmission for Strategy A and Strategy B.
Clinic Survey ....................................

General Public—Adults (persons visiting STD clinics and participating
in the clinic survey).
Total ...........................................

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

Jeffery Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–23369 Filed 10–24–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–19ARD]

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
collection request titled ‘‘Evaluation of
CDC’s STEADI Older Adult Fall
Prevention Initiative in a Primary Care
Setting’’ 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 May 24,

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Average
burden per
response
(in hours)

Total burden
(in hours)

11

6

4

264

7,380

1

10/60

1,230

11

12

44

4,488

3850

1

5/60

321

11,274

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

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

6,303

2019, to obtain comments from the
public and affected agencies. CDC
received one comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) 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;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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

PO 00000

Number of
responses per
respondent

other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
An Evaluation of CDC’s STEADI
Older Adult Fall Prevention Initiative in
a Primary Care Setting—New—National
Center for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Falls are the leading cause of both
fatal and non-fatal injuries among older
adults, defined as age 65 and older.

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