Summary of Public Comments and CDC Response

Attachment 3b – Program Response to Comments to 60 Day FRN

Comments in response to the Federal Register Notice
A 60-day Notice was published in the Federal Register on July 5, 2022, Vol. 87, No. 127, pp.
39838-39839 with the title “Pregnancy Risk Assessment Monitoring System (PRAMS)”
(Attachment 3a). CDC received two comments related to this notice (Attachment 3b). CDC did
not provide a response to one comment because it fell outside the scope of this information
collection. The other comment was submitted by The National Lactation Consultant Alliance
(NLCA), an organization outside of the CDC. NLCA commented on the importance of including
additional survey questions to PRAMS on lactation support and care and formula
supplementation of breastfed infants, which CDC has addressed in response, along with
additional comments related to utility, accuracy, quality, burden and additional areas of concern
related to this information collection request (Attachment 3b).
Standard
Area/Topic

Description

Comments

Date
Received by
CDC

CDC’s Response

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.

To collect
jurisdictionspecific,
population-based
data on maternal
behaviors and
experiences
before, during,
and short after
pregnancy
To collect
jurisdictionspecific,
population-based
data on maternal
behaviors and
experiences
before, during,
and shortly after
pregnancy

A comment from
Jean Publiee
suggests that
CDC, as an
agency before
more transparent
with providing
health data to the
public.

07/14/2022

No reply (outside scope of project)

The National
Lactation
Consultant
Alliance (NLCA)
suggests that
PRAMS add two
questions on
which sources
mothers used for
lactation support
and care and two
questions around
formula
supplementation
among breastfed
infants.

07/05/2022

CDC appreciates the work that NLCA does to
provide proper support and care for
breastfeeding families and the
recommendations made for questions to be
added to the PRAMS survey.
The Phase 9 Core survey reflects a balance
between the need to address competing health
research priorities (at CDC and among 50
PRAMS jurisdictions) and to limit survey length
to minimize respondents’ burden. The Core
survey covers a variety of topics, which
includes but is not limited to preconception,
prenatal, and postpartum care, access and
barriers to care, chronic health conditions,
mental health, experiences of racism and
discrimination, intimate partner violence,
contraception use, and breastfeeding initiation
and duration.
In addition to the Core survey, PRAMS
jurisdictions also have the option to expand on
the breastfeeding topic by selecting questions
from the Standard breastfeeding module. The
PRAMS breastfeeding module includes 14
questions. Questions on sources for
breastfeeding planning before pregnancy (B9),
sources for breastfeeding information and
support during and after pregnancy (B17),
baby-friendly hospital breastfeeding practices
(B3), the kinds of breastfeeding help mothers
needed after delivery (B14) and on timing of

Attachment 3b – Program Response to Comments to 60 Day FRN
formula introduction (B10) and timing of solid
foods (B11) are very similar to the questions
that NLCA is proposing. Additionally, the
breastfeeding module includes questions on
barriers to starting and continuing
breastfeeding, and the use of and sources for
obtaining a breast pump.
Because of limited space on the PRAMS survey
and the proposed questions overlap
substantially with the planned Phase 9
breastfeeding module which has completed
cognitive and field testing, the CDC will retain
the current questions around breastfeeding
without adding additional ones.
CDC has added NLCA to our PRAMS partners
list and will contact NLCA to provide an
opportunity for input and question
recommendations as part of the next PRAMS
questionnaire revision process.

Comments on Docket No. CDC–2022– 0080]
The National Lactation Consultant Alliance (NLCA) is pleased to submit these comments in response to
the Notice from the CDC regarding the proposed information collection for the Pregnancy Risk
Assessment Monitoring System (PRAMS). As a trusted healthcare advocate, NLCA routinely provides
comments on policies that impact public health through breastfeeding and the provision of human milk.
NLCA is the advocacy organization for the International Board Certified Lactation Consultant (IBCLC).1
The Women’s Preventive Services Initiative (a cooperative agreement between the American College of
Obstetricians and Gynecologists (ACOG) and the Health Resources and Services Administration (HRSA)
defines the IBCLC as a clinical lactation professional along with nurses, physicians, and midwives, as
contrasted with lactation personnel that provide counseling, education, or peer support.2
The American Academy of Pediatrics (AAP) identify breastfeeding and human milk as the normative
standards for infant feeding and nutrition.3 The enhanced short- and long-term medical and
neurodevelopmental outcomes from breastfeeding and the provision of human milk, the reduction in
disease burden for both mothers and infants, and the considerable cost savings to the US healthcare
system, make breastfeeding a public health imperative. It is therefore important that breastfeeding
families receive the level of lactation care they need if they are to breastfeed exclusively for 6 months
and with appropriate complementary foods up to 2 years thereafter. It has been found that women who
received IBCLC care and services were more than 4 times as likely to exclusively breastfeed their infant
at 1 month and nearly 3 times more likely to do so at 3 months compared with a control group.4
However, breastfeeding families and mothers may not be able to distinguish from whom they receive
lactation help. There exists a bewildering array of lactation certificates that may be confused with the
lactation certification of an IBCLC.5 Families and clinicians need to be able to access and refer to the
appropriate lactation personnel for the level of expertise needed. Breastfeeding counselors and
educators provide basic support and education while the IBCLC handles acute and complex
1

www.nlca.us
Women’s Preventive Services Initiative. (2022). Breastfeeding services and supplies updated January 2022.
https://www.womenspreventivehealth.org/recommendations/breastfeeding-services-and-supplies/
3
Meek, J.Y., Noble, L.; Section on Breastfeeding. (2022). Policy statement: Breastfeeding and the use of human
milk. Pediatrics, 150(1), e2022057988. https://doi.org/10.1542/peds.2022-057988.
4
Bonuck, K., Stuebe, A., Barnett, J., Labbok, M.H., Fletcher, J., & and Bernstein, P.S. (2014). Effect of primary care
intervention on breastfeeding duration and intensity. American Journal of Public Health, 104, S119-S127.
https://doi.org/10.2105/AJPH.2013.301360
2

5

Dodgson, J.E. (2020). Lactation-specific certifications: A comparison of independently accredited credentials.
Journal of Human Lactation, 36(1), 119-125. https://doi.org/10.1177/0890334419888217

breastfeeding scenarios. It is important that breastfeeding mothers know who to access for basic help
and who to contact with more acute or complex challenges. Receiving support from lactation personnel
who are not trained, equipped, or skilled in assessment of complex situations place mothers and infants
at risk of poor health outcomes.
We therefore feel it is important to include questions within the PRAMS surveys that help determine if
mothers know from whom they receive lactation support and care. Such data would assist policy makers
in the identification of populations at high risk for health problems and provide data for planning
programs and policies that would enhance breastfeeding outcomes. Questions could include the
following:
Did you see or talk about breastfeeding with any of the following
- doctor
- nurse
- midwife
- International Board Certified Lactation Consultant (IBCLC)
- doula
- peer counselor
- breastfeeding educator or breastfeeding counselor
- dietitian
- don't know
If you talked with or saw any of the following for a breastfeeding problem, indicate who you saw or
spoke with and if your problem was resolved
- doctor
- nurse
- midwife
- International Board Certified Lactation Consultant (IBCLC)
- doula
- peer counselor
- breastfeeding educator or breastfeeding counselor
- dietitian
- yes
- no
The term “lactation specialist” used in the current PRAMS questions is too vague to allow clarification of
who is delivering care and if it is effective.
Infant formula supplementation of breastfed infants
Up to 25% of breastfed infants receive formula before 2 days of age.6 Such an intervention can result in
perturbations of the infant gut microbiome, altered infant health outcomes, and early abandonment of
breastfeeding. In a breastfed infant, consumption of one bottle of formula per day for the first week of
life is enough to shift the gastrointestinal microbiology toward proinflammatory taxa.7 Avoiding cow’s
6

Centers for Disease Control and Prevention. (2022). Breastfeeding report card United States, 2022.
https://www.cdc.gov/breastfeeding/pdf/2022-Breastfeeding-Report-Card-H.pdf
7
O'Sullivan, A., Farver, M., & Smilowitz, J. T. (2015). The influence of early infant-feeding practices on the intestinal
microbiome and body composition in infants. Nutrition and Metabolic Insights, 8 (Suppl 1), 1–9.

milk formula supplementation in the first three days of life has the potential to reduce the risk of
asthma or recurrent wheeze in young children. 8Avoiding exposure to cow’s milk formula for at least
three days of life decreased the risk of sensitization to cow’s milk and cow’s milk allergy compared with
supplementing with cow’s milk formula from the first day of life.9 In-hospital formula supplementation
halved the likelihood of following a breastfeeding trajectory characterized by sustained exclusive
breastfeeding, it decreased the likelihood of breastfeeding initiation with a subsequent child by >66%,
and reduced the average duration of breastfeeding any subsequent children by >6 weeks.10 Infants
exposed to in-hospital formula supplementation are at a 2.5 to 6 times higher risk of early weaning than
infants exclusively breastfed.11 In-hospital formula supplementation often leads to continued
supplementation after discharge.12
Questions regarding formula supplementation of breastfed infants would yield data on the extent of the
practice and aid policy makers in planning for the reduction of a practice that can result in poor
breastfeeding and health outcomes. Questions such as:
If your breastfed baby was supplemented with formula while in the hospital or early days at home, did
you feel pressured to give your baby bottles of formula? If so, by whom were you so advised?
-

Family
Friends
Nurse
Pediatrician
Midwife
Doula
WIC
Social media
Yes
No

Were you offered any other options to using infant formula?
- Yes
- More intense breastfeeding support
- Referral to an International Board Certified Lactation Consultant (IBCLC)
- Pumping or hand expressing colostrum/milk
- Banked donor human milk
- No
8

Tachimoto, H., Imanari, E., Mezawa, H., Okuyama, M., Urashima, T., Hirano, D., Gocho, N., & Urashima, M. (2020).
Effect of avoiding cow's milk formula at birth on prevention of asthma or recurrent wheeze among young children:
Extended follow-up from the ABC Randomized Clinical Trial. JAMA Network Open, 3(10), e2018534.
9
Urashima, M., Mezawa, H., Okuyama, M., Urashima, T., Hirano, D., Gocho, N., & Tachimoto, H. (2019). Primary
prevention of cow's milk sensitization and food allergy by avoiding supplementation with cow's milk formula at
birth: A randomized clinical trial. JAMA Pediatrics, 173(12), 1137–1145.
10
Whipps, M.D.M., Yoshikawa, H., Demirci, J.R., & Hill, J. (2021). Estimating the impact of in-hospital infant formula
supplementation on breastfeeding success. Breastfeeding Medicine, 16(7), 530-538.
11
McCoy, M.B., & Heggie, P. (2020). In-hospital formula feeding and breastfeeding duration. Pediatrics, 146,
e20192946.
12
Pérez-Escamilla, R., Buccini, G.S., Segura-Pérez, S., & Piwoz, E. (2019). Perspective: Should exclusive
breastfeeding still be recommended for 6 months? Advances in Nutrition, 10, 931–943.

We thank you for the opportunity to comment. Please feel free to contact us with any questions or if we
may be of further help.