Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Notices 81475 

Compliance, MaryJosie_Blanchard@

ios.doi.gov, 202–208–3406. 

State of Alabama 

Blankenship, Christopher, 

Commissioner of Conservation and 

Natural Resources, 

Chris.blankenship@dcnr.alabama.gov, 

334–242–3486. 

Environmental Protection Agency 

Wyatt, Marc, Director, Gulf of Mexico 

Division, Wyatt.marc@epa.gov, 228– 

679–5915. 

State of Texas 

Baker, Toby, Texas Commission of 

Environmental Quality, Toby.Baker@

tceq.texas.gov, 512–239–5515. 

Keala Hughes, 

Director of External Affairs & Tribal Relations, 

Gulf Coast Ecosystem Restoration Council. 

[FR Doc. 2020–27617 Filed 12–15–20; 8:45 am] 

BILLING CODE 6560–58–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Maternal and Childhood 

Outcomes Associated With the Special 

Supplemental Nutrition Program for 

Women, Infants and Children (WIC) 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Maternal and Childhood Outcomes 

Associated with the Special 

Supplemental Nutrition Program for 

Women, Infants and Children (WIC), 

which is currently being conducted by 

the AHRQ’s Evidence-based Practice 

Centers (EPC) Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. 

DATES: Submission Deadline on or 

before January 15, 2021. 

ADDRESSES: Email submissions: epc@

ahrq.hhs.gov. 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers Lane, 

Mail Stop 06E77D, Rockville, MD 

20857. 

FOR FURTHER INFORMATION CONTACT: 

Jenae Benns, Telephone: 301–427–1496 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Maternal and Childhood 

Outcomes Associated with the Special 

Supplemental Nutrition Program for 

Women, Infants and Children (WIC). 

AHRQ is conducting this systematic 

review pursuant to Section 902 of the 

Public Health Service Act, 42 U.S.C. 

299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Maternal and Childhood 

Outcomes Associated with the Special 

Supplemental Nutrition Program for 

Women, Infants and Children (WIC), 

including those that describe adverse 

events. The entire research protocol is 

available online at: https://

effectivehealthcare.ahrq.gov/products/ 

outcomes-nutrition/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Maternal and Childhood 

Outcomes Associated with the Special 

Supplemental Nutrition Program for 

Women, Infants and Children (WIC) 

helpful: 

D A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements: Study number, study period, 

design, methodology, indication and 

diagnosis, proper use instructions, 

inclusion and exclusion criteria, 

primary and secondary outcomes, 

baseline characteristics, number of 

patients screened/eligible/enrolled/lost 

to follow-up/withdrawn/analyzed, 

effectiveness/efficacy, and safety results. 

D A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://

www.effectivehealthcare.ahrq.gov/ 

email-updates. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. 

Key Questions (KQs) 

KQ 1: Among women who are eligible 

to participate in WIC, how is WIC 

participation during pregnancy 

associated with maternal and infant 

birth outcomes? 

a. Does the association vary by 

gestational age at WIC enrollment or 

duration of mother’s WIC participation? 

b. Does the association vary by 

participant factors such as: 

i. Age of the mother at delivery 

ii. Race/ethnicity of mother 

iii. Geographic location (e.g. region, 

urban vs. rural) 

iv. Education of the mother 

v. Employment status of the mother 

vi. Marital status 

vii. Housing (e.g. public), homelessness 

KQ 2: Among infants and children 

eligible to participate in WIC, how is 

WIC participation associated with 

dietary and health outcomes in 

childhood? 

a. Does the association vary by age or 

duration of WIC participation? 


khammond on DSKJM1Z7X2PROD with NOTICES
81476 Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Notices 

b. Does the association vary by 

participant factors such as: 

i. Age of the mother at delivery 

ii. Race/ethnicity of child 

iii. Geographic location (e.g. region, 

urban vs. rural) 

iv. Education of the mother 

v. Employment status of the mother 

vi. Marital status of the mother 

vii. Housing (e.g. public, private), 

homelessness 

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) 

PICOTS elements KQ 1 KQ 2 

Population ................ Women who participated in WIC during pregnancy and 

their infants at birth up to 28 days.

Infants/children who participated in WIC (age from 29 days 

up to age 5). 

Participant factors include; age of mother at delivery, race/ 

ethnicity of mother, geographic location, education of 

mother, employment status of mother, marital status of 

mother, housing, parity, and maternal nutritional status at 

enrollment.

Participant factors include; age of mother at delivery, race/ 

ethnicity of child (or mother), geographic location, education of mother, employment status of mother, marital 

status of mother, housing, parity of mother, and maternal 

and/or child nutritional status at enrollment. 

Intervention .............. Participation in WIC with service provisions from 2009 onwards (year and location), defined at a minimum as enrolling in WIC for one month or more.Participation in WIC with service provisions from 2009 onwards (year and location), defined at a minimum as enrolling in WIC for one month or more. 

Comparison ............. Women who were eligible for WIC, but did not participate 

during pregnancy, and their infants at birth up to 28 

days; duration of WIC participation.

Infants/children who were eligible for WIC, but did not participate at the age studied (ages from 29 days up to 5 

years); duration of WIC participation. 

Outcomes * .............. Dietary practices of infants and mothers, diet quality, 

household food security, food purchasing.

Dietary practices of infants and children, diet quality, 

household and child food security, food purchasing. 

Anthropometric status: Weight status (e.g. BMI, underweight, obesity).

Maternal: E.g. anemia, weight gain, health care utilization 

(prenatal, postpartum), mode of delivery, intra- and postpartum complications, morbidity and mortality.

Anthropometric status: E.g. weight-for-age, length- or 

height-for-age, weight-for-length, or weight-for-height percentile or Z-score, BMI-for-age percentile or Z-score, underweight, and obesity), growth velocity. 

Infant birth outcomes: E.g. gestational age, birth weight, 

small/large for gestational age, birth complications such 

as preterm delivery, hospitalization.

Infant and child outcomes: Anemia, iron deficiency anemia, 

iron deficiency, primary health care utilization, immunization status, morbidity and mortality. 

Child development/school performance (e.g., cognitive development, behavioral development, educational performance, school-related factors (e.g. attendance, behavior)). 

Timing ** .................. Studies published 2009 onwards .......................................... Studies published 2009 onwards. 

Setting ..................... Any jurisdiction served by a WIC State or Local Agency ..... Any jurisdiction served by a WIC State or Local Agency. 

Study Design ........... Intervention trials (randomized and non-randomized), observational studies, quasi-experimental, before-after, interrupted time series.Intervention trials (randomized and non-randomized), observational studies, quasi-experimental, before-after, interrupted time series. 

* Please see appendix A for the detailed list of outcomes. 

** Only for specific key outcomes (maternal mortality, infant mortality, child development/school performance) will studies prior to 2009 be 

included. 

Appendix A: Detailed List of Outcomes 

by Key Question 

Key Question 1: Among women who 

are eligible to participate in WIC, how 

is WIC participation during pregnancy 

associated with maternal and infant 

birth outcomes? 

Outcomes Measures 

Maternal health outcomes [health risk] in: 

➢ Pregnancy. 

➢ Postpartum. 

Anemia, Iron deficiency, Iron-deficiency anemia, Nutritional anemias.

Gestational weight gain .............................................. Total gestational weight gain; IOM rec by BMI: under, within, over. 

Weight status (e.g., BMI, underweight, overweight, 

obesity).

Pregnancy, Postpartum obesity, Postpartum weight retention. 

Health care utilization ................................................. Utilization of recommended prenatal care, postpartum care and other health maintenance recommendations Inter-pregnancy interval. 

Morbidity ...................................................................... GDM, Pre-eclampsia, Gestational hypertension, Mental Health (symptoms), Smoking, 

alcohol, risk behaviors. 

Mode of delivery ......................................................... Cesarean/Vaginal. 

Intra- and post-partum complications ......................... Prolonged labor, PROM, Postpartum hemorrhage, transfusion. 

Mortality ....................................................................... Fetal death (stillbirth), pregnancy-related death (while pregnant or within a year of 

the pregnancy ending). 

Dietary outcomes ...............................................................

Diet intake, practices and quality (infant and mother) 

(Diet quality measure, Dietary intake (method), Diet 

quality score).

Breastfeeding (intention, initiation, and duration of any breastfeeding), Dietary intake 

(nutrient intake); diet quality measures (HEI, AHEI, DASH/Medical); glycemic load; 

servings of food groups, variety, adequacy and moderation components, SSB, sodium/salt, EFA); nutrient density (% fat, and by type; %CHO). 

Food purchasing behavior at the participant level ..... Benefit redemption, purchasing surveys. 

Household food security ............................................. E.g., 18-item USDA Household Food Security Scale. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Notices 81477 

Outcomes Measures 

Infant birth outcomes: 

Gestational age ........................................................... Preterm, late preterm, early term, term and late term. 

Birth weight ................................................................. Very low birth weight, Low birth weight, Normal birth weight, High birth weight. 

Small for gestational age.

Large for gestational age.

Birth complications ...................................................... Preterm delivery, hospitalization, NICU stay, congenital malformations, neonatal (live 

birth and death within 28 days) or infant (within first year of life after live birth) 

death. 

BMI = Body mass index; GDM = Gestational diabetes mellitus; PIH = pregnancy-induced hypertension; PROM = Prelabor rupture of the membranes; USDA = United States Department of Agriculture; AHEI = Alternative Healthy Eating Index; DASH = Dietary, Approaches to Stop Hypertension; HEI = Healthy Eating Index; SSB = sugar-sweetened beverage; EFA = Essential Fatty Acids; CHO = Carbohydrates; NICU= Neonatal 

Intensive Care Unit; WIC = Special Supplemental Nutrition Program for Women, Infants and Children. 

Key Question 2: Among infants and 

children eligible to participate in WIC, 

how is WIC participation associated 

with dietary and health outcomes in 

childhood (to age 17 years)? 

Outcomes Measures 

Health outcomes: 

Anemia, Iron deficiency anemia, nutritional anemias, 

iron deficiency. 

Child growth, anthropometric status ........................... Weight-for-age, length- or height-for-age, weight-for-length, or weight-for-height percentile or Z-score, BMI-for-age percentile or Z-score, underweight, overweight, 

obese; growth velocity (change in size/status or z-score over time). 

Healthcare Utilization .................................................. Well child visits, Immunization status. 

Morbidity ...................................................................... Otitis media, allergies, gastrointestinal respiratory infections, asthma, immunization 

status, 

Pre-diabetes, Diabetes mellitus, elevated blood pressure/hypertension, 

hyperlipidemia. 

Mortality ....................................................................... Infant mortality. 

Child mortality. 

Dietary outcomes: 

Dietary practices of infants and children .................... Infants: Maternal intention to breastfeed; Ever breastfed or any breastfeeding; Exclusive breastfeeding (initiation and duration); Duration of any breastfeeding; introduction of formula (timing); timing of solids introduction (<4 months, <6 months); cereal in the bottle; timing of cow’s milk introduction (<12 months); food group 

servings; nutrient intakes. 

Children (1–2): Food group servings, groups for variety, adequacy and moderation; 

added sugars, SSB, type of milk; fruit juice; dietary diversity; nutrient intakes, nutrient density measures (iron, zinc, calcium, %fat (total and by type)) energy density. 

Diet quality .................................................................. Children 2–5: [HEI, AHEI, food group servings (adequacy and moderation, added 

sugars, SSB), type of milk; fruit juice]. 

Nutrient intakes and nutrient density measures (iron, zinc, calcium, %fat (total and by 

type)) energy density. 

Food purchasing behavior at the participant level ..... Benefit redemption, purchasing surveys. 

Household and child food security ............................. 18-item USDA Household Food Security Scale. 

Child development/school performance: 

Academic development ............................................... Pre-school or Head Start (e.g., attendance, behavior). 

K–12 educational performance, school-related factors (e.g. attendance, behavior). 

ADHD, conduct disorders, mental health. 

Child development (behavioral development, cognitive development; cognitive performance).BSID II/III; WPPSI, WISC, other standardized measures or specific constructs. 

ADHD = Attention deficit hyperactivity disorder; AHEI = Alternative Healthy Eating Index; HEI = Healthy Eating Index; SSB = sugar-sweetened 

beverage; WISC = Wechsler Intelligence Scale for Children; BSID = Bayley Scales of Infant Development; WPPSI = Wechsler Preschool and Primary Scale of Intelligence. 

Dated: December 10, 2020. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2020–27645 Filed 12–15–20; 8:45 am] 

BILLING CODE 4160–90–P 


khammond on DSKJM1Z7X2PROD with NOTICES