60-day Federal Register Notice

AttB_60_day_FRN.pdf

[NCBDDD] Birth Defects Study to Evaluate Pregnancy exposureS (BD-STEPS)

60-day Federal Register Notice

OMB: 0920-0010

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Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices

other than their time. Based on a
maximum of 12 EIs per year and 100

participants each, the total estimated
annualized burden hours are 600.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Exposure Investigation Participants ................

Chemical Exposure Questions .......................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–04189 Filed 2–28–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

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 Birth Defects Study To Evaluate
Pregnancy exposureS (BD–STEPS). Data
from BD–STEPS will play an important
part in the decision-making process that
determines federal research agendas,
birth defect prevention activities, and
the direction of funding programs such
as cooperative agreements.
DATES: CDC must receive written
comments on or before May 2, 2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0030 by either 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
SUMMARY:

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Clifton Road NE, MS H21–8, 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.
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
H21–8, Atlanta, Georgia 30329; phone:
404–639–7570; Email: [email protected].

FOR FURTHER INFORMATION CONTACT:

[60Day–22–0010; Docket No. CDC–2022–
0030]

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Number of
respondents

Type of respondents

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;

SUPPLEMENTARY INFORMATION:

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Number of
responses per
respondent

1,200

1

Average
burden
per response
(in hours)
30/60

3. Enhance the quality, utility, and
clarity of the information to be
collected;
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; and
5. Assess information collection costs.
Proposed Project
Birth Defects Study to Evaluate
Pregnancy exposureS (BD–STEPS)
(OMB Control No. 0920–0010, Exp. 2/
28/2023)—Extension—National Center
on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Birth defects are associated with
substantial morbidity and mortality in
the United States. About one in every 33
babies is born with a birth defect. Birth
defects contributed to more than one
million hospital stays in the U.S. in
2013, resulting in $22.9 billion in
hospital costs. Birth defects are the
leading cause of infant mortality and the
fifth leading cause of loss of potential
years of life before age 65. One in five
infant deaths is due to birth defects.
For most birth defects, the causes are
not known, making prevention efforts
challenging to develop. However, to
date, primary preventive measures are
available for only a few birth defects.
For example, vaccination programs have
reduced the incidence of congenital
rubella syndrome, Rh hemolytic disease
of the newborn can be prevented by
appropriate medical practices, and
genetic counseling can provide parents
with information about the increased
risk of Down syndrome associated with
advanced maternal age. Perhaps most
importantly, folic acid intake before and
during pregnancy can prevent many
cases of fatal or permanently disabling
neural tube defects such as anencephaly
and spina bifida.
This continued burden justifies
reasonable attempts to reduce the

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Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices
prevalence of birth defects. To help
reduce birth defects among U.S. babies,
in 1996 Congress directed the CDC to
establish Centers of Excellence for Birth
Defects Research and Prevention. The
mandate was formalized with passage of
the Birth Defects Prevention Act of
1998. The Act amended Section 317C of
the Public Health Service Act (42 U.S.C.
247b–4) and authorized CDC to (1)
collect, analyze, and make available
data on birth defects; (2) operate
regional centers that will conduct
applied epidemiological research for the
prevention of birth defects; and (3)
provide the public with information on
preventing birth defects.
In response to this mandate, the
Division of Birth Defects and Infant
Disorders (DBDID) obtained OMB
clearance for data collection that is
carried out by the Centers for Birth
Defects Research and Prevention
(CBDRP). The CBDRP’s first research
effort was the National Birth Defects
Prevention Study (NBDPS), which
began data collection in 1997 and ended
in 2013. The CBDRPs transitioned from
NBDPS to the Birth Defects Study To
Evaluate Pregnancy exposures (BD–
STEPS), which began data collection in
2014. One of the main activities for each
Center is to conduct BD–STEPS in their
state.
BD–STEPS is made up of a number of
information collection activities. The
interview is estimated to take
approximately 55 minutes and is titled
‘‘Birth Defects Prevention Study:
Computer Assisted Telephone
Interview.’’ For the five Centers not
participating in the stillbirth component
of the study, a maximum of 370

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.
CDC requests the release of reportable
infectious diseases information from all
women who complete the CATI except
for women who experienced a stillbirth
without a birth defect. A maximum of
2,590 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 reportable infectious
diseases information is 648 hours
annually.
In the two Centers participating in the
supplemental interview, mothers of
infants with or without birth defects
that are stillborn and controls are asked
to participate in a supplemental
telephone interview. The 25-minute
supplemental interview includes the
time for informed consent. Based on a
maximum of 640 women to be
interviewed with the supplemental
questionnaire, the maximum burden
time would be 267 hours annually.
Although participation rates may
vary, the total estimates of annual
burden hours for all activities, all
individuals, and all Centers is 4,433
hours. There is no cost to respondents
other than their time to participate.

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
3,030 interviews, the maximum
interview burden for all Centers
combined would be 2,778 hours per
year. 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 computer assisted
telephone interview (CATI).
Five of the seven BD–STEPS Centers
request consent for retrieval of leftover
newborn bloodspots. If a maximum of
2,590 interviews would be expected for
seven Centers (not including interviews
of stillbirths without birth defects), a
maximum of 1,850 would be expected
for five Centers requesting consent for
retrieval of leftover newborn bloodspots
(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
sign the consent form. The anticipated
maximum burden for bloodspot consent
would be 463 hours annually.
With a maximum of 2,590 interviews
planned annually (not including
interviews of stillbirths without birth
defects since they are not eligible for the
online questionnaire), and
approximately one-third of the
respondents eligible for the online
questionnaire (selected based on
reporting occupations queried in the

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Mother’s Interview .............................

Telephone
Consent
Script/BD–
STEPS Computer Assisted Telephone Interview.
Consent for bloodspot retrieval ........

Mother’s Consent for Bloodspot Retrieval.
Mother’s Online Occupational Questionnaire.
Mothers Infectious Disease Release
Review.
Mothers of AR/MA Stillbirths and
Controls (Supplemental Telephone
Interview).
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Number of
respondents

Type of respondents

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

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Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

3,030

1

55/60

2,778

1,850

1

15/60

463

830

1

20/60

277

Infectious Disease Request Form ....

2,590

1

15/60

648

Telephone Consent and Supplemental Interview.

640

1

25/60

267

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

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

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

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

4,433

Online Occupational Questionnaire

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Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–04191 Filed 2–28–22; 8:45 am]
BILLING CODE 4163–18–P

Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–04262 Filed 2–28–22; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

BILLING CODE 4163–18–P

Centers for Disease Control and
Prevention

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Notice of Closed Meeting

Centers for Disease Control and
Prevention

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
SIP22–005, Building Resilience Against
Climate Effects (BRACE): Enhancing
Practical Guidance to Support Climate
and Health Adaptation Planning.
Date: May 4, 2022.
Time: 11:00 a.m.–6:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
Jaya
Raman, Ph.D., Scientific Review Officer,
National Center for Chronic Disease
Prevention and Health Promotion, CDC,
4770 Buford Highway, Mailstop S107–
B, Atlanta, Georgia 30341, Telephone:
(770) 488–6511, email: JRaman@
cdc.gov.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and

jspears on DSK121TN23PROD with NOTICES1

FOR FURTHER INFORMATION CONTACT:

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19:01 Feb 28, 2022

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Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)RFA–CK-22–001, Investigation of
Monkeypox and Other Zoonotic
Diseases in the Democratic Republic of
the Congo (DRC); RFA–CK–22–002,
Technological Advancement of Global
Rabies Surveillance and Control; and
RFA–CK–22–004, Optimization and
Standardization of Methods to Suppress
Ixodes scapularis and Disrupt Enzootic
Pathogen Transmission in Settings
Posing an Elevated Risk to Humans.
Date: April 28, 2022.
Time: 10:00 a.m.–5:00 p.m. (EDT).
Place: Teleconference, Centers for
Disease Control and Prevention, Room
1080, 8 Corporate Square Blvd., Atlanta,
GA 30329.
Agenda: To review and evaluate grant
applications.
For Further Information Contact:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, National
Center for HIV, Viral Hepatitis, STD,
and TB Prevention, CDC, 1600 Clifton
Road NE, Mailstop US8–1, Atlanta,

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Georgia 30329, (404) 718–8833,
[email protected].
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–04261 Filed 2–28–22; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
PAR 20–297, NIOSH Centers of
Excellence for Total Worker Health
(TWH).
Date: April 21, 2022.
Time: 1:00 p.m.–4:00 p.m., EDT.
Place: Video-Assisted Meeting.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Dan
Hartley, Ed.D., Scientific Review
Officer, Office of Extramural Programs,
National Institute for Occupational
Safety and Health, CDC, 1095
Willowdale Road, Morgantown, West

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