60-day Federal Register Notice

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Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–19–0010; Docket No. CDC–2019–
0005]

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 efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the Birth Defects Study To
Evaluate Pregnancy exposureS (BD–
STEPS). The purpose of BD–STEPS is to
identify modifiable maternal exposures
in pregnancy that may increase the risk
for having a pregnancy affected by
certain major, structural birth defects.
This revision proposes to add stillbirths
without defects to the study population
for two Centers and implement a
supplemental telephone interview for
these two Centers’ stillbirths (with and
without birth defects) and their controls.
DATES: Written comments must be
received on or before May 3, 2019.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0005 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, Lead,
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
SUMMARY:

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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: [email protected].
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
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
Birth Defects Study To Evaluate
Pregnancy exposures (BD–STEPS)
(formerly titled The National Birth
Defects Prevention Study (NBDPS)),
(OMB Control No. 0920–0010,
Expiration 02/29/2020)—Revision—
National Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and

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genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects
currently covering three counties in
Metropolitan Atlanta. Since 1997, CDC
has funded case-control studies of major
birth defects that utilize existing birth
defect surveillance registries (including
MACDP) to identify cases and study
birth defects causes in participating
states/municipalities across the United
States.
The current study, BD–STEPS, is a
case-control study that is similar to the
previous CDC-funded birth defects casecontrol study, NBDPS, which stopped
interviewing participants in 2013. As
with NBDPS, BD–STEPS control infants
are randomly selected from birth
certificates or birth hospital records;
mothers of case and control infants are
interviewed using a computer-assisted
telephone interview.
The results from NBDPS have
improved understanding of the causes
of birth defects. Over 200 articles have
been written in professional journals
using the data from NBDPS, and BD–
STEPS data will soon be added to
NBDPS data for analysis. The current
BD–STEPS revision is an addition to the
study population for two BD–STEPS
Centers. Specifically, in these two
Centers mothers of stillbirths without
major birth defects will be added to the
study population for BD–STEPS and
mothers of all stillbirths (with and
without birth defects) and all controls in
these two Centers will be asked to
participate in a supplemental telephone
interview.
The BD–STEPS interview takes
approximately 55 minutes to complete
and is 10 minutes longer than the
previously OMB-approved interview
(the burden estimate includes both the
introductory telephone script/consent
and questionnaire). For the five Centers
not participating in the stillbirth
component of the study, a maximum of
370 interviews are planned per year per
center, 270 cases and 100 controls; for
the two Centers participating in
additional stillbirth interviews, 590
interviews are planned per Center, 270
cases with birth defects, 100 controls,
and 220 stillbirths without birth defects.
With seven Centers and a maximum of
3,040 interviews, the maximum
interview burden for all centers
combined would be 2,787 hours per

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7375

Federal Register / Vol. 84, No. 42 / Monday, March 4, 2019 / Notices
the online questionnaire (selected based
on reporting occupations queried in the
questionnaire), a maximum of 830
women would receive the online
questionnaire. Completion of the online
questionnaire is estimated to take 20
minutes including reading introductory
communication. The anticipated
maximum burden for the online
questionnaire is 277 hours annually.
We will request the release of
reportable infectious diseases
information from all women who
complete the CATI. Of the 2,600
interviews planned annually, a
maximum of 2,600 women would
receive the infectious disease
information request. Based on
experience with consent forms, we
expect the review, signing and mailing
of the release of reportable infectious
diseases information to take a maximum
of 15 minutes for participants. The
anticipated maximum burden for the

year over three years. The 55 minute
burden includes the time for the
telephone consent script which is
reviewed with the mother at the
beginning of the call to collect the
information via the CATI interview.
Five of the seven BD–STEPS Centers
request consent for retrieval of leftover
newborn bloodspots. If a maximum of
2,600 interviews would be expected for
seven Centers, a maximum of 1,850
would be expected for five Centers
(excluding stillbirths, for which
newborn bloodspots are not available).
A maximum of 15 minutes would be
expected for the participant to read the
bloodspot retrieval consent request and
to read and sign the consent form. The
anticipated maximum burden for
bloodspot consent would be 463 hours
annually.
With a maximum of 2,600 interviews
planned annually, and approximately
one third of the respondents eligible for

reportable infectious diseases
information is 650 hours annually.
In the two Centers participating in the
supplemental interview, mothers of
infants with or without birth defects
that are stillborn and controls will be
asked to participate in a supplemental
telephone interview. The 25 minute
supplemental interview will include the
time for informed consent (Attachment
Z). Based on a maximum of 640 women
to be interviewed with the supplemental
questionnaire, the maximum burden
time would be 267 hours annually.
The total estimates of annual burden
hours for all activities for all individuals
for all Centers is 4,443 hours. The
estimates of annualized burden hours
represent the total population however
due to lower participation rates (no
more than 60%, the actual burden will
be lower as well. There are no costs to
the respondents other than their time.

ESTIMATES OF ANNUALIZED BURDEN HOURS
Form name

Mothers (interview) ...........................

Mothers (online occupational questionnaire).
Mothers (infectious disease release
review).
Mothers of all AR/MA stillbirths and
controls (supplemental telephone
interview).

Telephone Consent Script (Attachment S1/S2)/BD–STEPS Computer Assisted Telephone Interview (Attachment C1/C2).
Written consent for bloodspot retrieval (Attachment T1/T2 and U1/
U2).
Online Occupational Questionnaire
(Attachment M1–8).
Infectious Disease Request Form
(Attachment D1/D2).
Telephone consent and supplemental interview (Attachment N1/
N2).

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

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

Mothers (consent for bloodspot retrieval).

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–03772 Filed 3–1–19; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–0017]

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)

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Number of
responses
per
respondent

Number of
respondents *

Respondents

Frm 00050

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Total
burden hours

3,040

1

55/60

2,787

1,850

1

15/60

463

830

1

20/60

277

2,600

1

15/60

650

640

1

25/60

267

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

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

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

4,443

has submitted the information
collection request titled Application for
Training (OMB Control No. 0920–0017)
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 December 10, 2018 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:

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Average
burden per
response
(In hours)

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(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
other forms of information technology,

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