60-day Federal Register Notice

A16_60 day FRN_published 03082021.pdf

Assessment of a Training Program to Improve Continuity of Care for Children and Families Affected by Fetal Alcohol Spectrum Disorders (FASD)

60-day Federal Register Notice

OMB: 0920-1347

Document [pdf]
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13391

Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices
operators with information to notify and
contact individuals and further
investigate this exposure by contacting
others who may have been potentially
exposed to disease. However, there
currently is no standardized tool or form
to collect pertinent information
regarding the outcome of such
investigations. To address the need to
inform CDC of additional actions that
may be needed to further protect public
health based on the outcome of the
contact investigations, CDC has
developed forms to assist health
departments and maritime conveyance

operators in reporting back to CDC. The
forms are specific to the nature of the
investigation; Tuberculosis (TB),
Measles, and Rubella, or the General
form to for other diseases of public
health concern. The purpose of the
forms is the same: to collect information
to help CDC quarantine officials to fully
understand the extent of disease spread
and transmission during travel and to
inform the development and or
refinement of investigative protocols,
aimed at reducing the spread of
communicable disease.

Respondents are state and local health
departments and maritime conveyance
operators. Respondents may use these
standardized forms to submit data
voluntarily to CDC for each individual
contacted via a secure means of their
choice, (e.g., web-based application, fax
or email). Additional respondents are
Cruise Ship Medical Staff/Cargo Ship
Managers and State/local health
department staff. There is no cost to
respondents other than their time to
complete the form and submit the data
to CDC.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Cruise Ship Physicians/Cargo Ship
Managers.

Clinically Active TB Contact Investigation
Outcome
Reporting
Form—Maritime.
Varicella Investigation Outcome Reporting Form.
Influenza Like Illness Investigation
Outcome Reporting Form.
General Contact Investigation Outcome Reporting Form—Air.
TB Contact Investigation Outcome
Reporting Form—Air.
Measles Contact Investigation Outcome Reporting Form—Air.
Rubella Contact Investigation Outcome Reporting Form—Air.
General Contact Investigation Outcome Reporting Form—Land.

Cruise Ship Physicians/Cargo Ship
Managers.
Cruise Ship Physicians/Cargo Ship
Managers.
State/Local public health staff ...........
State/Local public health staff ...........
State/Local public health staff ...........
State/Local public health staff ...........
State/Local public health staff ...........
Total ...........................................

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–04673 Filed 3–5–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–21–21DJ Docket No. CDC–2021–
0020]

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:
jbell on DSKJLSW7X2PROD with NOTICES

Number of
respondents

Type of respondent

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of

SUMMARY:

VerDate Sep<11>2014

19:05 Mar 05, 2021

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20/60

5

29

1

20/60

10

45

1

20/60

15

36,000

1

5/60

3,000

100

1

5/60

8

189

1

5/60

16

38

1

5/60

3

15

1

5/60

1

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

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

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

3,058

CDC must receive written
comments on or before May 7, 2021.
You may submit comments,
identified by Docket No. CDC–2021–
0020 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.

ADDRESSES:

Fmt 4703

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hours

1

DATES:

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Average
burden per
response

15

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 ‘‘American Academy of Pediatrics
(AAP) Resident Training Program on
Children with Fetal Alcohol Spectrum
Disorders (FASD)’’. This project will
collect data to evaluate the efficacy of a
newly developed pediatric resident
training curriculum regarding
identification, referral and care of
children with fetal alcohol spectrum
disorders (FASD) and their families.

PO 00000

Number of
responses per
respondent

Sfmt 4703

• 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: 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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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices

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.
Proposed Project
American Academy of Pediatrics
(AAP) Resident Training on Children
with Fetal Alcohol Spectrum Disorders
(FASD)—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).

Background and Brief Description
Prenatal exposure to alcohol and
other teratogens can have serious
neurodevelopmental impact including
Fetal Alcohol Spectrum Disorders
(FASD). FASD is an umbrella term that
encompasses several, more specific,
diagnoses. These conditions are
associated with lifelong physical and
neurodevelopmental abnormalities,
including growth problems and prenatal
brain damage. This brain damage may
lead to developmental, behavioral and
neurocognitive impairments. Infants
with a FASD are rarely recognized at
birth by hospital staff. Further, at later
ages, these children may be overlooked
or misdiagnosed. While there is no cure
for FASDs, early identification and
intervention can mitigate adverse
effects.
In Bright Futures, the American
Academy of Pediatrics (AAP) suggest
routinely obtaining prenatal alcohol
exposure history for all pediatric
patients. The AAP also recommends
developmental monitoring and
screening for all patients for behavioral
and neurodevelopmental issues.
Pediatricians are critical in the process
of early identification, referral and
ongoing care of children with FASDs.
Through regular well-child
appointments, addressing parental
concerns, and managing a family’s
pediatric medical home, pediatricians
are in a key position to obtain (and
document) prenatal exposure history to
alcohol and other drugs. Relatedly, their
role in monitoring development enables
them to identify issues early that in turn
facilitates timely treatment, especially
early intervention. It is important for
pediatricians to learn these skills early
in their clinical training to make them
routine throughout their clinical
practice careers.
To facilitate and strengthen
pediatricians’ role, with CDC funding,
the American Academy of Pediatrics
(AAP) has developed a curriculum and

program to provide first year pediatric
resident trainees with strategies, tools
and resources necessary for; (1)
obtaining prenatal history of exposure to
alcohol and other drugs for all their
patients, (2) recognizing clinical
manifestation of FASD in pediatric
primary care settings to expedite
diagnostic evaluation referrals, and (3)
caring for affected children and their
families in the pediatric medical home.
This program builds upon a pilot effort
that was approved under GenIC
Clearance for CDC/ATSDR Formative
Research and Tool Development title:
American Academy of Pediatrics
Resident Training in Developmental
Continuity Clinics with OMB Control
Number 0920–1154.
The curriculum is presented in two
phases. Phase One is a one-day, inperson, train-the-trainers session for
attending physicians who oversee
medical resident training in pediatrics.
Training will be provided by experts in
identification, diagnosis and care of
children with FASD. For Phase Two, the
trainer attending physicians will
implement a curriculum of continuing
medical education activities with their
first year pediatric residents. The
curriculum contains both required and
option activities that residents complete
with support and facilitation from
attending physicians. Evaluations are
conducted only for required activities. It
is estimated that 10 clinics will
participate in the project which could
include up to 10 attending physicians
and an average of 25 pediatric residents
per clinic (∼260 respondents/year).
Participant clinics are selected by a brief
application to the AAP. All
participation is voluntary. CDC requests
approval for an estimated 32 annual
burden hours. There is no cost to
respondents other than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Pediatricians ..................

Attending physicians Screening & Diagnosis
Pretest.
Attending physicians Screening & Diagnosis
Posttest.
Attending physicians Treatment Across Lifespan
Pretest.
Attending physicians Treatment Across Lifespan
Posttest.
Attending physicians Overcoming Social Attitudes Pretest.
Attending physicians Overcoming Social Attitudes Posttest.

Pediatricians ..................
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Number of
respondents

Type of respondents

Pediatricians ..................
Pediatricians ..................
Pediatricians ..................
Pediatricians ..................

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Burden per
response
(hours)

Number of
responses

Burden in
hours

10

1

10/60

2

10

1

10/60

2

10

1

10/60

2

10

1

10/60

2

10

1

10/60

2

10

1

10/60

2

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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Pediatricians ..................
Pediatricians ..................
Pediatricians ..................

Attending physicians Educational Care Pretest ..
Attending physicians Educational Care Posttest
Attending physicians Training Program Evaluation.
Resident Overall Effects & Prevalence Video
Pretest.
Resident Overall Effects & Prevalence Video
Posttest.
Resident Overall Program Evaluation .................
Attending physicians Overall Program Evaluation.

Pediatricians ..................
Pediatricians ..................
Pediatricians ..................
Pediatricians ..................
Total ........................

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

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–04670 Filed 3–5–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–21–21DI; Docket No. CDC–2021–
0018]

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 CryptoNet Case Report Form. The
CryptoNet Case Report Form will be
used by federal, state, and local public
health officials responsible for
conducting interviews with reported
cases of cryptosporidiosis in their
jurisdiction in order to systematically
assess core exposure elements and risk
factors among cases of
cryptosporidiosis.

SUMMARY:

jbell on DSKJLSW7X2PROD with NOTICES

Number of
respondents

Type of respondents

CDC must receive written
comments on or before May 7, 2021.

DATES:

VerDate Sep<11>2014

19:05 Mar 05, 2021

Jkt 253001

PO 00000

Frm 00115

Fmt 4703

Sfmt 4703

Burden in
hours

10
10
10

1
1
1

10/60
10/60
15/60

2
2
3

25

1

15/60

3

25

1

15/60

3

25
10

1
1

15/60
20/60

3
4

175

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

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

32

You may submit comments,
identified by Docket No. CDC–2021–
0018 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
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
ADDRESSES:

Burden per
response
(hours)

Number of
responses

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
CryptoNet Case Report Form—New—
National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Waterborne Disease Prevention
Branch (WDPB) in the Division of
Foodborne, Waterborne, and
Environmental Diseases (DFWED) works
to prevent domestic and global water,
sanitation, and hygiene (WASH) related
disease. The WDPB is comprised of four
teams, including the Domestic WASH
Epidemiology Team, which focuses on
the prevention and control of
waterborne and WASH-related disease
and outbreaks in the United States. One
of the diseases included in the team’s

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