[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Notices]
[Pages 13391-13393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04670]


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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

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: 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 ``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.

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

ADDRESSES: 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.
     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: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies

[[Page 13392]]

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, 
in-person, 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
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                                                                                                                            Burden per
              Type of respondents                               Form name                    Number of       Number of       response        Burden in
                                                                                            respondents      responses        (hours)          hours
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Pediatricians..................................  Attending physicians Screening &                     10               1           10/60               2
                                                  Diagnosis Pretest.
Pediatricians..................................  Attending physicians Screening &                     10               1           10/60               2
                                                  Diagnosis Posttest.
Pediatricians..................................  Attending physicians Treatment Across                10               1           10/60               2
                                                  Lifespan Pretest.
Pediatricians..................................  Attending physicians Treatment Across                10               1           10/60               2
                                                  Lifespan Posttest.
Pediatricians..................................  Attending physicians Overcoming Social               10               1           10/60               2
                                                  Attitudes Pretest.
Pediatricians..................................  Attending physicians Overcoming Social               10               1           10/60               2
                                                  Attitudes Posttest.

[[Page 13393]]

 
Pediatricians..................................  Attending physicians Educational Care                10               1           10/60               2
                                                  Pretest.
Pediatricians..................................  Attending physicians Educational Care                10               1           10/60               2
                                                  Posttest.
Pediatricians..................................  Attending physicians Training Program                10               1           15/60               3
                                                  Evaluation.
Pediatricians..................................  Resident Overall Effects & Prevalence                25               1           15/60               3
                                                  Video Pretest.
Pediatricians..................................  Resident Overall Effects & Prevalence                25               1           15/60               3
                                                  Video Posttest.
Pediatricians..................................  Resident Overall Program Evaluation....              25               1           15/60               3
Pediatricians..................................  Attending physicians Overall Program                 10               1           20/60               4
                                                  Evaluation.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             175  ..............  ..............              32
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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