Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.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: 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.* *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. *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. 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?
                    ( print page 81476) 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 2Population
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 post-partum 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
MeasuresMaternal health outcomes [health risk] in:➢ Pregnancy.
                             ➢ Postpartum.Anemia, Iron deficiency, Iron-deficiency anemia, Nutritional anemiasGestational 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.( print page 81477)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 ageLarge for gestational ageBirth 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
MeasuresHealth 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