Federal Register Notice

37881

Federal Register / Vol. 88, No. 111 / Friday, June 9, 2023 / Notices
Proposed Project
Enterprise Laboratory Information
Management System (ELIMS) (OMB
Control No. 0920–1309, Exp. 11/30/
2023)—Revision—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The collection of specimen
information designated for testing by the
CDC occurs on a regular and recurring
basis (multiple times per day) using an
electronic PDF file called the CDC
Specimen Submission 50.34 Form or an
electronic XSLX file called the Global
File Accessioning Template. Hospitals,
doctor’s offices, medical clinics,
commercial testing labs, universities,
State public health laboratories, U.S.
Federal institutions, and foreign
institutions use the CDC Specimen
Submission Form 50.34 when
submitting a single specimen to CDC
Infectious Diseases laboratories for
testing. The CDC Specimen Submission
50.34 Form consists of over 200 data

entry fields (of which five are
mandatory fields that must be
completed by the submitter) that
captures information about the
specimen being sent to the CDC for
testing. The type of data captured on the
50.34 Form identifies the origin of the
specimen (human, animal, food,
environmental, medical device or
biologic), CDC test order name/code,
specimen information, patient
information (as applicable), animal
information (as applicable) information
about the submitting organization
requesting the testing, patient history (as
applicable), owner information and
animal history (as applicable), and
epidemiological information. The
collection of this type of data is
pertinent to ensuring a specimen’s
testing results are linked to the correct
patient and the final test reports are
delivered to the appropriate submitting
organization to aid in making proper
health-related decisions related to the
patient. Furthermore, the data provided
on this form may be used by the CDC
to identify sources of potential
outbreaks and other public-health

related events. When the form is filled
out, a user in the submitting
organization prints a hard copy of it that
will be included in the specimen’s
shipping package sent to the CDC. The
printed form has barcodes on it that
allow the CDC testing laboratory to scan
its data directly into ELIMS where the
specimen’s testing lifecycle is tracked
and managed.
Likewise, the Global File
Accessioning Template records the
same data as the 50.34 Form but
provides the capability to submit
information for a batch of specimens
(typically 50–1,000 specimens per
batch) to a specific CDC laboratory for
testing. The CDC testing laboratory
electronically uploads the Global File
Accessioning Template into ELIMS
where the batch of specimens are then
logged and are ready to be tracked
through their respective testing and
reporting workflow.
CDC requests OMB approval for an
estimated 2,153 annual burden hours.
There is no cost to respondents other
than their time for participation.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Medical Scientists, Except Epidemiologists, State Public Health
Lab, Medical Assistant, Doctor’s
Office/Hospital.
Medical Assistant, Doctor’s Office/
Hospital.

CDC Specimen Submission 50.34
Form.

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

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

[FR Doc. 2023–12360 Filed 6–8–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1333; Docket No. CDC–2023–
0045]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

2,098

15

11

20/60

55

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

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

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

2,153

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 Feeding My Baby and Me: Infant
Feeding Practices Study III (FMB&M–
IFPS III). This study is designed to
understand the current state of mothers’
intentions, behaviors, feeding decisions,
and practices from pregnancy through
their child’s first two years of life.
DATES: CDC must receive written
comments on or before August 8, 2023.

Fmt 4703

Total burden
(in hours)

5/60

Notice with comment period.

Frm 00036

Average
burden per
response
(in hours)

12

SUMMARY:

PO 00000

Number of
responses per
respondent

2,098

Global File Accessioning Template

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.

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Number of
respondents

Type of respondents

Sfmt 4703

You may submit comments,
identified by Docket No. CDC–2023–
0045 by either of the following methods:
• Federal eRulemaking Portal:
www.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 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
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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
ADDRESSES:

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37882

Federal Register / Vol. 88, No. 111 / Friday, June 9, 2023 / Notices

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;
Telephone: 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
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

follow pregnant women and their new
baby for two years. Data will be
collected using web-based surveys at
multiple time points over two years.
This includes: (1) a prenatal survey; (2)
14 follow-up surveys after the baby is
born; and (3) 2–4 maternal dietary data
recalls. The data from IFPS III will be
used to: (1) fill research gaps on how
feeding behaviors, patterns, and practice
changes over the first two years of life
and the health-related impacts; (2)
inform multiple Federal agency efforts
targeting maternal and infant and
toddler nutrition through work in
hospitals, with health care providers,
with early care and education providers,
and outreach to families and caregivers;
and (3) provide context to policy level
documents such as the U.S. Dietary
Guidelines for Americans, which will
include pregnant women and children
birth to 24 months of age for the first
time in 2020–2025.
This is an Extension of previously
approved data collection efforts. No
changes are proposed. OMB approval is
requested for one year. Participation is
voluntary, and there are no costs to
respondents other than their time. The
total estimated annualized burden hours
requested are 5,051.

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;
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
Feeding My Baby and Me: Infant
Feeding Practices Study III (FMB&M–
IFPS III) (OMB Control No. 0920–1333,
Exp. 4/30/2024)—Extension—National
Center for Chronic Disease Prevention
and Health Promotions (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Infant Feeding Practices Study (IFPS)
III is a longitudinal study that will

lotter on DSK11XQN23PROD with NOTICES1

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total
annualized
burden hours

Respondents

Form name

Pregnant/Postpartum Women ...........

Study Screener ................................
Study Consent ..................................
Prenatal Survey ................................
24-Hour Dietary Recall—Prenatal ....
Replicate 24-Hour Dietary Recall—
Prenatal.
Request for notification of child’s
birth.
Birth Screener ..................................
1-Month Survey ................................
2-Month Survey ................................
3-Month Survey ................................
24-Hour Dietary Recall—Month 3 ....
Replicate 24-Hour Dietary Recall—
Month 3.
4-Month Survey ................................
5-Month Survey ................................
6-Month Survey ................................
8-Month Survey ................................
10-Month Survey ..............................
12-Month Survey ..............................
15-Month Survey ..............................
18-Month Survey ..............................
21-Month Survey ..............................
24-Month Survey ..............................

7,477
4,711
4,239
2,756
269

1
1
1
1
1

3/60
5/60
20/60
24/60
24/60

125
131
471
367
36

4,239

1

2/60

47

4,103
3,693
3,575
3,460
2,249
219

1
1
1
1
1
1

2/60
20/60
15/60
15/60
24/60
24/60

46
410
298
288
300
29

3,350
3,243
3,139
3,038
2,941
2,847
2,756
2,668
2,582
2,500

1
1
1
1
1
1
1
1
1
1

15/60
15/60
15/60
15/60
20/60
15/60
15/60
15/60
15/60
15/60

279
270
262
253
327
237
230
222
215
208

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

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

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

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

5,051

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

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Federal Register / Vol. 88, No. 111 / Friday, June 9, 2023 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–12361 Filed 6–8–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–23–23AH]

Agency Forms Undergoing Paperwork
Reduction Act Review

lotter on DSK11XQN23PROD with NOTICES1

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘Community
Health Workers for COVID Response
and Resilient Communities (CCR)
National Evaluation’’ 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 October
21, 2022 to obtain comments from the
public and affected agencies. CDC
received two non-substantive 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 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.

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To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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
Community Health Workers for
COVID Response and Resilient
Communities (CCR) National
Evaluation—New—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is requesting approval for a New
data collection entitled ‘‘Community
Health Workers for COVID Response
and Resilient Communities (CCR)
National Evaluation.’’ OMB approval is
requested for three years.
In 2021, CDC funded DP21–2109,
‘‘Community Health Workers for COVID
Response and Resilient Communities
(CCR)’’. DP21–2109 funds 68 CCR
recipients across the United States to
train and deploy community health
workers (CHWs) to support COVID–19
response efforts and to build and
strengthen community resilience to fight
COVID–19 through addressing existing
health disparities. DP21–2109 is funded
for a three-year period, from September
2021 through August 2024. At the same
time, CDC also funded two recipients
under CDC–RFA–DP21–2110,
‘‘Community Health Workers for COVID
Response and Resilient Communities
(CCR)—Evaluation and Technical
Assistance’’ (CCR–ETA recipients) to
design and conduct the national
evaluation of DP21–2109 CCR. These
two recipients will lead the information
collection described in this request.
Both DP21–2109 and DP21–2110 were
funded through the Coronavirus Aid,
Relief, and Economic Security (CARES)
Act of 2020 funds allocated to CDC to

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37883

achieve the goal of protecting the
American people from the public health
impacts of COVID–19. The novel
Coronavirus Disease 2019 has impacted
communities nationwide. Racial and
ethnic minority groups, economically
disadvantaged persons, justice-involved
individuals, people experiencing
homelessness, and people who use
drugs and/or have certain underlying
medical conditions have a higher risk of
having severe COVID–19 illness and
adverse outcomes. Thus, these groups
represent the CCR populations of focus.
The purpose of the DP21–2109 CCR
national evaluation is to monitor
implementation and evaluate
implementation and outcomes of CCR.
CDC will use resulting information to
describe the implementation of CCR at
the national level, inform future
community-based and CHW-led COVID
response programs, and, in conjunction
with secondary data sources, assess
some important health outcomes,
including vaccination rates among
populations of focus. This request
includes the following information
collections:
• CCR Recipient Survey: The survey
will collect information about: (1)
program management; (2) organizational
infrastructure; (3) populations of focus
served by CCR funded efforts; (4) CHW
hiring and compensation; (5) CHW
training, certification, and integration
into community-based and care COVID
response teams; (6) CHW referral
tracking systems; (7) non-CDC resources
supporting the program; and (8) other
aspects of program implementation. The
survey will be administered once—at
the end of program Year 3—in both
English and Spanish using web-based
survey software.
• CHW Survey: The survey will
collect information about: (1) CHW
compensation and benefits; (2) core
CHW roles during CCR implementation;
(3) integration of CHWs into
community-based and care COVID
response teams; (4) core competency
training; (5) supervision; (6) CHWinitiated referrals; and (7) CHW
involvement in decision-making. The
survey will be administered once—at
the end of program Year 3—in English
and Spanish using web-based survey
software.
CDC requests OMB approval for an
estimated 194 annual burden hours.
There is no cost to respondents other
than their time to participate.

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Docket No. CDC–2023– 0045
Understanding more about how mothers make infant feeding choices is important for improving
nutri!on and health for our na!on’s children.
We wish to comment on Form 0920-20FO; 4d-Month 1 survey-Revised. B32. Aer coming home from
the hospital, did any of the following people help you with breaseeding by showing you how or
talking to you about breaseeding?
The choices of providers in answer to this ques!on should be more specific. The term “lacta!on support
provider” is too generic and does not adequately differen!ate among the various categories of lacta!on
personnel. There is no such thing as a “cer!fied lacta!on consultant.” There is only one kind of lacta!on
consultant—the Interna!onal Board Cer!fied Lacta!on Consultant (IBCLC®). The Women’s Preven!ve
Services Ini!a!ve (WPSI) clearly specifies the differences between clinical lacta!on care providers and
breas=eeding educators or counselors.1
Clinical lacta on professionals providing clinical care include, but are not limited to, licensed
lacta on consultants, the IBCLC®, cer fied midwives, cer fied nurse-midwives, cer fied
professional midwives, nurses, physician assistants, nurse prac oners, and physicians. Lacta on
personnel providing counseling, educa on or peer support include lacta on
counselors/breas"eeding educators and peer supporters.
The delivery of risk appropriate care allows the proper matching of provider to pa!ent and problem. It is
important for policy makers to recognize that they may not get a clear picture of who is helping
breas=eeding mothers or the efficacy of such help unless they specify the various categories from which
the mothers can choose their answer. The IBCLC® provides clinical lacta!on care while
breas=eeding/lacta!on educators, counselors, and doulas provide basic educa!on and support. There
should be a ques!on regarding the effec!veness of breas=eeding care that was received based on the
type of provider delivering the care. It is important to know if the breas=eeding interven!ons received
were effec!ve and who provided it. These interven!ons are directly related to the ini!a!on, dura!on,
and exclusivity of breas=eeding. Differen!a!ng lacta!on personnel can help direct Federal agencies to
target breas=eeding improvement interven!ons that provide op!mal health outcomes.
Con!nua!on of this survey can aid policy makers, legislators, public health efforts, and government
agencies to beCer direct funding and develop programs to improve breas=eeding ini!a!on, dura!on,
and exclusivity as a means to reduce maternal/infant morbidity and mortality.

1

hCps://www.womenspreven!vehealth.org/recommenda!ons/breas=eeding-services-and-supplies/

September 7, 2023

National Lactation Consultant Alliance:

Thank you for providing your comment on Form 0920-20FO; 4d-Month 1 survey-Revised. B32.
The Feeding My Baby and Me: Infant Feeding Practices Study III is currently in the field.
Because of this, we are not able to change a question on surveys at this time because it would not
allow us to have similar data collection efforts for all study participants. We can consider these
comments for questions on future studies.

Sincerely,

Heather C. Hamner PhD, MS, MPH
Centers for Disease Control and Prevention