Federal Register Notice

16859

Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
industry using PFAS chemicals in its
manufacturing process). Likewise,
children whose birth mothers were
occupationally exposed will not be
eligible. ATSDR assumes that 5 percent
of the people who volunteer will not
meet eligibility requirements; therefore,
a total of 8,400 people will be screened.
To complete the data collection in three
years, annualized estimates for
eligibility screening are 2,800 people
(2,100 adults and 700 children) and an
annual time burden of 467 hours. The
recipients will provide appointment
reminder calls for each eligible person
who agrees to be enrolled (n = 2,667 per
year) for a time burden of 222 hours per
year.
At enrollment, each recipient will
obtain adult consent, parental
permission, and child assent before data
collection begins. For each participant,
the recipient will take body measures,
collect blood samples to measure PFAS
serum levels and several effect
biomarkers such as lipids, and thyroid,
kidney, immune and liver function. The
recipient will also obtain urine samples
from participants to measure PFAS
levels and kidney function biomarkers.

The study will archive leftover serum
and urine samples for additional
analyses of PFAS chemicals and specific
effect biomarkers. The National Center
for Environmental Health (NCEH)
laboratory will perform blood and urine
PFAS analyses for all Multi-site Study
participants. Thus, issues of interlaboratory variability for exposure
measures will be eliminated.
Adult participants and a parent of
child participants will complete a
questionnaire that includes residential
history, medical history, occupational
history, and water consumption habits
(n=2,000 adults and 667 children per
year). Ideally, the parent will be the
child’s birth mother, as ATSDR will ask
details about the child’s exposure,
pregnancy, and breastfeeding history.
For purposes of time burden
estimation, ATSDR assumes that 20
percent of parents will also enroll as
adults and can take the child short form
questionnaire (n=133 per year);
therefore, 534 parents will take the child
long form questionnaire per year.
Parents and children, with
administration by trained professionals,
will also complete neurobehavioral

assessments of the child’s attention and
behaviors (n=667 per year).
To facilitate access to medical and
school records, each recipient will reach
out to local medical societies, public
school systems, and private schools, to
enlist their cooperation with the study.
The recipient will ask for permission to
abstract participants’ medical records to
confirm self-reported health outcomes.
The recipient will also seek permission
to abstract and compare children’s
school records to their behavioral
assessment results. Based on ATSDR’s
experience from the Pease proof of
concept study, ATSDR estimates that it
will take 48 education specialists and
150 adult and 50 pediatric medical
record specialists to complete record
abstractions across all study sites. Given
the goal to enroll at least 2,000 adults
and 667 children per year, the annual
time burden for medical and
educational record abstraction is
estimated to be 1,091 hours.
The total annualized time burden
requested is 5,269 hours. There is no
cost to the respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Multi-site Study Participants ..............................

Eligibility Screening Script ................................
Appointment Reminder Telephone Script .........
Update Contact Information Hardcopy Form ....
Medication List ..................................................
Body and Blood Pressure Measures Form ......
Blood Draw and Urine Collection Form ............
Adult Questionnaire ..........................................
Child Questionnaire—Long Form .....................
Child Questionnaire—Short Form .....................
Parent Neurobehavioral Test Battery ...............
Child Neurobehavioral Test Battery ..................
Child School Record Abstraction Form ............
Medical Record Abstraction Form—Adult ........
Medical Record Abstraction Form—Child ........

2,800
2,667
2,667
2,667
2,667
2,667
2,000
537
133
667
667
48
150
50

1
1
1
1
1
1
1
1
1
1
1
14
13
13

10/60
5/60
5/60
3/60
5/60
10/60
30/60
30/60
15/60
15/60
90/60
20/60
20/60
20/60

467
222
222
133
222
444
1,000
268
33
167
1,000
224
650
217

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

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

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

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

5,269

Education Specialists ........................................
Medical Record Specialists ...............................
Total ............................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08150 Filed 4–22–19; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

BILLING CODE 4163–18–P

[60-Day–19–0457; Docket No. CDC–2019–
0032]

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Number of
responses per
respondent

Type of respondents

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:

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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
Aggregate Reports for Tuberculosis
Program Evaluation. The goal of the
study is to allow CDC to collect and
monitor indicators for key program
activities, such as finding tuberculosis
infections in recent contacts of cases

SUMMARY:

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices

and in other high-risk persons likely to
be infected and providing therapy for
latent tuberculosis infection in an effort
to eliminate Tuberculosis in the United
States. CDC is requesting approval for
268 burden hours. This is an increase of
42 hour from the previously approved
226 hours.
DATES: CDC must receive written
comments on or before June 24, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0032 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Ph.D.,
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
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

optional data collection elements, will
help programs assess high-risk
populations served, and evaluate the
adaptation and effectiveness of new
diagnostic tests and drug regimens in
treating LTBI.
To ensure the elimination of
tuberculosis in the United States, CDC
monitors indicators for key program
activities, such as finding tuberculosis
infections in recent contacts of cases
and in other persons likely to be
infected and providing therapy for
latent tuberculosis infection. In 2000,
CDC implemented two program
evaluation reports for annual
submission: Aggregate report of followup and treatment for contacts of
tuberculosis cases, and Aggregate report
of targeted testing and treatment for
latent tuberculosis infection (OMB No.
0920–0457). The respondents for these
reports are the 67 state and local
tuberculosis control programs receiving
federal cooperative agreement funding
through the CDC Division of
Tuberculosis Elimination (DTBE). These
reports emphasize treatment outcomes,
high-priority target populations
vulnerable to tuberculosis, and
electronic report entry and submission
to CDC through the National
Tuberculosis Indicators Project (NTIP), a
secure web-based system for program
evaluation data. No other federal agency
collects this type of national
tuberculosis data, and the aggregate
report of follow-up and treatment for
contacts of tuberculosis cases, and
aggregate report of targeted testing and
treatment for latent tuberculosis
infection are the only data source about
latent tuberculosis infection for
monitoring national progress toward
tuberculosis elimination with these
activities. CDC provides ongoing
assistance in the preparation and
utilization of these reports at the local
and state levels of public health
jurisdiction. CDC also provides
respondents with technical support for
the NTIP software. The estimated
annualized burden hours are 268. There
is no cost to respondents other than
their time.

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
Aggregate Reports for Tuberculosis
Program Evaluation (OMB No. 0920–
0457, Expiration date 2/29/2020)—
Revision—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC requests approval of this revision
of the Aggregate Reports for
Tuberculosis Program Evaluation,
previously approved under OMB No.
0920–0457, for three years. There are
minor revisions to the report forms, data
definitions, and reporting instructions.
CDC is requesting approval for 268
burden hours. This is an increase of 42
hours from the previously approved 226
hours. The minor revisions that
contributed to an increase in data
collection burden address the change in
the national strategies for TB control
and prevention, emphasizing treatment
of individuals with latent TB infection
(LTBI), and at high risk of progression
to TB disease. The revisions, which are

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Form name

Data clerks and Program Managers
(electronic).

Follow-up and Treatment of Contacts to Tuberculosis Cases Form
(3a).

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Number of
responses per
respondent

67

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1

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Average
burden per
response
(in hours)

Total burden
hours
2

134

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Federal Register / Vol. 84, No. 78 / Tuesday, April 23, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Form name

Data clerks and Program Managers
(electronic).

Targeted Testing and Treatment for
Latent Tuberculosis Infection (3b).

67

1

2

134

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

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

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

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

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

268

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–08151 Filed 4–22–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–19–1170]

Agency Forms Undergoing Paperwork
Reduction Act Review

jbell on DSK3GLQ082PROD with NOTICES

Number of
respondents

Type of respondent

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Canine
Leptospirosis Surveillance in Puerto
Rico 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 January 29, 2019 to obtain
comments from the public and affected
agencies. CDC did not receive comments
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

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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 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
Canine Leptospirosis Surveillance in
Puerto Rico (OMB Control No. 0920–
1170, Exp. Date 03/31/2019)—
Reinstatement with Change—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Division of HighConsequence Pathogens and Pathology
(DHCPP), Bacterial Special Pathogens
Branch (BSPB), requests three years of
OMB approval for a reinstatement to the
approved ICR ‘‘Canine Leptospirosis
Surveillance in Puerto Rico.’’ Approved
methods of information collection will
not change.
Active surveillance allows for the
collection of prospective data on acute
cases to determine the incidence and
distribution of leptospirosis in dogs,
assess risk factors for infection,
characterize circulating Leptospira
serovars and species, assess
applicability of vaccines currently in
use based on serovar determination, and
assess rodent, livestock, and wildlife
reservoirs of leptospirosis based on

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infecting serovars found in dogs.
Findings from this study will aid in the
development of evidence-based,
targeted interventions for the prevention
of canine leptospirosis, be used to focus
human leptospirosis surveillance
efforts, and guide future investigations
on leptospirosis in humans and animals
in Puerto Rico.
The information collection for which
approval is sought is in accordance with
BSPB’s mission to prevent illness,
disability, or death caused by bacterial
zoonotic diseases through surveillance,
epidemic investigations, epidemiologic
and laboratory research, training and
public education. Authorizing
Legislation comes from Section 301 of
the Public Health Service Act (42 U.S.C.
241). Successful execution of BSPB’s
public health mission requires data
collection activities in collaboration
with the state health department in
Puerto Rico and with local veterinary
clinics and animal shelters participating
in the study.
These activities include collecting
information about dogs that meet the
study case definition for a suspect case
of leptospirosis seen at participating
veterinary clinics and shelters.
Participating veterinarians and their
veterinary staff collect information by
interviewing the dog owner (shelters are
an exception as dog will not have an
owner) and reviewing medical and
administrative records, as necessary.
Basic information about the
participating sites will also be collected
for study management and to enhance
data analysis.
Information will be collected using
paper forms and provided in Spanish.
Staff at participating sites find it easier
to complete a paper copy when
abstracting medical record information
and interviewing owners for
information about their dog’s risk
factors and symptoms. Study
coordinators will enter collected data
into an electronic database.
The types of information being
collected include information about the
dog’s signalment, location of residence,
environmental risk factors, vaccination
history, clinical signs and symptoms,

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