Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 75557 

1Shlay, A. (2010). African American, White and 

Hispanic child care preferences: A factorial survey 

analysis of welfare leavers by race and ethnicity. 

Social Science Research, 39(1), 125–141. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Caring for Our Children Basics; 

Comment Request 

AGENCY: Administration for Children 

and Families (ACF), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: As authorized by the 2014 

Omnibus Act, ACF is requesting public 

comment on a voluntary set of 

minimum health and safety standards 

for early care and education settings 

titled, ‘‘Caring for Our Children Basics.’’ 

DATES: The deadline for receipt of 

comments is midnight, February 17, 

2015. 

ADDRESSES: Submit comments to 

cfocbasics@acf.hhs.gov. 

SUPPLEMENTARY INFORMATION: High 

quality early care and education settings 

can have significant developmental 

benefits and other positive long term 

effects for children well into their adult 

years. At the same time, poor quality 

can result in unsafe environments that 

disregard children’s basic physical and 

emotional needs leading to neglect, 

toxic stress, injury, or even death. It is 

not surprising that health and safety 

have been identified in multiple parent 

surveys as the most important factors to 

consider when evaluating child care 

options. For example, Shlay 1 found 

that, regardless of race/ethnicity, 

parents consistently prioritized health 

and safety over other quality features 

when selecting an early care 

arrangement. 

From 2009 to 2011, 27 states made 

changes to licensing regulations for 

center-based care, and more than half 

made changes to licensing requirements 

for family child care homes. With 

respect to health and safety, the largest 

increase was in the number of states that 

have requirements regarding safe sleep 

practices (Office of Child Care’s 

National Center on Child Care Quality 

Improvement & National Association for 

Regulatory Administration, 2013). A 

number of states have taken action to 

strengthen health and safety 

requirements and their enforcement in 

reaction to tragedies where children 

have been injured or died in child care 

(e.g., Lexie’s Law (Kansas, 2010) and 

Joshua’s List (Oklahoma, 2010)). 

However, more work must be done to 

ensure children can learn, play, and 

grow in settings that are safe and secure. 

Health and safety standards provide 

the foundation on which states and 

communities build a solid system of 

early care and education. Yet, states 

vary widely in the number and content 

of health and safety standards as well as 

how they monitor compliance with 

these standards. Some early care 

providers may receive no monitoring 

while others receive multiple visits. In 

addition, some early care and education 

providers who receive funding from 

multiple sources may receive repeated 

monitoring visits using conflicting 

standards. These sources can include 

Head Start, the Child Care and 

Development Fund, and the Child and 

Adult Care Food Program. 

In testimony before the United States 

House Committee on Education and the 

Workforce, the Government 

Accountability Office (GAO) called 

attention to the multiple agencies that 

administer the federal investment in 

early learning and child care through 

multiple programs that sometimes have 

similar goals and are targeted to similar 

groups of children. They added that the 

existence of multiple programs can 

increase administrative costs associated 

with meeting varying requirements. We 

acknowledge that there are differences 

in health and safety requirements by 

funding stream (e.g., Head Start, Child 

Care Development Fund, preKindergarten) and early childhood 

program type (e.g., center-based, homebased). While standards may vary 

depending on the length of the day and 

setting, there are some standards that 

must be in place to protect children no 

matter what type of variation in 

program. 

The proposed model standards are 

called ‘‘Caring for our Children Basics.’’ 

They represent the minimum standards 

experts believe must be in place 

wherever children are regularly cared 

for in non-parental care settings. 

‘‘Caring for our Children Basics’’ is the 

first attempt to reduce the conflicts and 

redundancy found in standards that are 

used to monitor early care and 

education settings. These are minimum 

standards and should not be construed 

to represent all standards that would 

need to be present to achieve the highest 

quality of care and early learning. For 

example, the caregiver training 

requirements outlined in these 

standards are designed only to prevent 

harm to children, not to ensure their 

optimal development and learning. 

This call for public comment is to 

obtain information to help HHS as we 

further develop the voluntary set of 

minimum health and safety standards 

for early care and education settings. 

Because quality care cannot be achieved 

without consistent, basic health and 

safety practices in place, ACF seeks to 

provide a helpful reference for states 

and other entities as they work to 

improve their health and safety 

standards across program type. Our 

hope is that a voluntary common 

framework will assist child care 

licensing agencies in working towards 

and achieving a more consistent 

foundation for quality across the 

country upon which families can rely. 

In addition, ACF plans to use ‘‘Caring 

for Our Children Basics’’ in aligning 

health and safety efforts in early care 

and education at the federal level. 

Public input will be helpful in 

providing HHS with practical guidance 

to aid in the refinement and application 

of ‘‘Caring for Our Children Basics.’’ 

‘‘Caring for Our Children Basics’’ is 

based on ‘‘Caring for Our Children: 

National Health and Safety Performance 

Standards; Guidelines for Early Care 

and Education Programs, Third 

Edition.’’ We would like to acknowledge 

the extensive work of the American 

Academy of Pediatrics, the American 

Public Health Association, the National 

Resource Center for Health and Safety in 

Child Care and Early Education, and the 

Maternal and Child Health Bureau, 

Department of Health and Human 

Services in developing these standards. 

Caring for Our Children Basics 

Staffing 

1.2.0.2 Background Screening 

Directors of early care and education 

centers and caregivers/teachers in large 

and small family child care homes 

should conduct a complete background 

screening before employing any staff 

member (in addition to any individuals 

residing in a family child care home 

over age 18). Consent to the background 

investigation should be required for 

employment consideration. The 

comprehensive background screening 

should include: 

(a) The use of fingerprints for state 

checks of criminal history records; 

(b) The use of fingerprints for checks 

of Federal Bureau of Investigation 

criminal history records; 

(c) Clearance through the child abuse 

and neglect registry (if available); and 

(d) Clearance through sex offender 

registries (if available). 

1.4.1.1/1.4.2.3 Pre-serviceTraining/

Orientation 

Before or during the first 3 months of 

employment, training and orientation 

should detail health and safety issues 

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75558 Federal Register / Vol. 79, No. 243 / Thursday, December 18, 2014 / Notices 

for early care and education settings 

including, but not limited to, typical 

and atypical child development; first 

aid and CPR; safe sleep practices, 

including risk reduction of Sudden 

Infant Death Syndrome/Sudden 

Unexplained Infant Death (SIDS/SUID); 

infectious disease prevention; 

emergency preparedness; nutrition and 

age-appropriate feeding; medication 

administration; and care plan 

implementation for children with 

special health care needs. All directors 

or program administrators and 

caregivers/teachers should document 

receipt of training. 

1.4.3.1 First Aid and CPR Training for 

Staff 

All staff members involved in 

providing direct care to children should 

have up-to-date documentation of 

satisfactory completion of training in 

pediatric first aid and CPR skills as 

defined by the American Red Cross and 

American Heart Association. At least 

one staff person who has successfully 

completed this training should be in 

attendance at all times. Records of 

successful completion of training in 

pediatric first aid and CPR should be 

maintained in the personnel files of the 

facility. 

1.4.5.2 Child Abuse and Neglect 

Education 

Caregivers/teachers should be 

educated on child abuse and neglect 

prevention to establish child abuse and 

neglect prevention and recognition 

measures for the children, caregivers/

teachers, and parents/guardians. The 

education should address physical, 

sexual, and psychological or emotional 

abuse and neglect. Caregivers/teachers 

are mandatory reporters of child abuse 

or neglect. Caregivers/teachers should 

be trained in compliance with their 

state’s child abuse reporting laws. 

Program Activities for Healthy 

Development 

2.1.1.4 Monitoring Children’s 

Development/Obtaining Consent for 

Screening 

Programs should have a system in 

place for developmental and behavioral 

screening of all children at the 

beginning of a child’s placement in the 

program, at least yearly thereafter, and 

as developmental concerns become 

apparent to staff and/or parents/

guardians. This process should include 

parental/guardian consent and 

participation as well as connection to 

resources and support, if needed. 

2.1.2.1/2.1.3.1 PersonalCaregiver/

Teacher Relationships for Birth to FiveYear-Olds 

Programs should practice 

relationship-based philosophies that 

promote consistency and continuity of 

care, especially for infants and toddlers. 

Early care and education programs 

should provide opportunities for each 

child to build emotionally secure 

relationships with a limited number of 

caregivers/teachers. Children with 

special health care needs may require 

additional specialists to promote health 

and safety and to support learning. 

2.2.0.1 Methods of Supervision of 

Children 

Caregivers/teachers should directly 

supervise infants, toddlers, and 

preschoolers by sight and hearing at all 

times, even when the children are going 

to sleep, napping, or sleeping; are 

beginning to wake up; or are indoors or 

outdoors. Developmentally appropriate 

child-to-staff ratios should be met 

during all hours of operation, and safety 

precautions for specific areas and 

equipment should be followed. 

2.2.0.4 Supervision near Bodies of 

Water 

Constant supervision should be 

maintained when any child is in or 

around water. During any swimming/

wading activities where either an infant 

or a toddler is present, the ratio should 

always be one adult to one infant/

toddler. Caregivers/teachers should 

ensure that all pools meet the Virginia 

Graeme Baker Pool and Spa Safety Act. 

2.2.0.9 Prohibited Caregiver/Teacher 

Behaviors 

The following behaviors should be 

prohibited in all early care and 

education settings: 

(a) Use of corporal punishment; 

(b) Isolating a child where a child 

cannot be supervised; 

(c) Binding or tying to restrict 

movement or taping the mouth; 

(d) Using or withholding food as a 

punishment or reward; 

(e) Toilet learning/training methods 

that punish, demean, or humiliate a 

child; 

(f) Any form of emotional abuse, 

including rejecting, terrorizing, 

extended ignoring, or corrupting a child; 

(g) Any physical abuse or 

maltreatment of a child; 

(h) Abusive, profane, sarcastic 

language or verbal abuse, threats, or 

derogatory remarks about the child or 

child’s family; 

(i) Any form of public or private 

humiliation; and 

(j) Exclusion of physical activity/

outdoor time as punishment. 

Health Promotion and Protection 

3.1.3.1 Active Opportunities for 

Physical Activity 

Programs should demonstrate a 

commitment to active play for children, 

including infants and toddlers, indoors 

and outdoors every day. 

3.1.4.1 Safe Sleep Practices and SIDS 

Risk Reduction 

All staff, parents/guardians, 

volunteers, and others who care for 

infants in the early care and education 

setting should follow safe sleep 

practices as recommended by the 

Centers for Disease Control and 

Prevention (CDC) and the National 

Institute of Child Health and Human 

Development (NICHD). Cribs must be in 

compliance with current U.S. Consumer 

Product Safety Commission (CPSC) and 

ASTM International safety standards. 

3.1.5.1 Routine Oral Hygiene 

Activities 

Caregivers/teachers should promote 

the habit of regular tooth brushing. All 

children with teeth should brush or 

have their teeth brushed at least once 

during the hours the child is in an early 

care and education program. 

3.2.1.4 Diaper Changing Procedure 

The following diaper changing 

procedure should be posted in the 

changing area and followed to protect 

the health and safety of children and 

staff: 

Step 1: Before bringing the child to the 

diaper changing area, perform hand 

hygiene and bring supplies to the 

diaper changing area. 

Step 2: Carry the child to the changing 

table, keeping soiled clothing away 

from you and any surfaces you cannot 

easily clean and sanitize after the 

change. Always keep a hand on the 

child. 

Step 3: Clean the child’s diaper area. 

Step 4: Remove the soiled diaper and 

clothing without contaminating any 

surface not already in contact with 

stool or urine. 

Step 5: Put on a clean diaper and dress 

the child. 

Step 6: Wash the child’s hands and 

return the child to a supervised area. 

Step 7: Clean and disinfect the diaperchanging surface. Dispose of the 

disposable paper liner used on the 

diaper changing surface in a plasticlined, hands-free, covered can. If 

clothing was soiled, securely tie the 

plastic bag used to store the clothing 

and send home. 

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2McPherson M., Arango P., Fox H., Lauver C., 

McManus M., Newacheck P., . . . Strickland B. 

(1998). A new definition of children with special 

health care needs. Pediatrics, 102(1), 137–140. 

Step 8: Perform hand hygiene and 

record the diaper change, diaper 

contents, and/or any problems. 

Caregivers/teachers should never 

leave a child unattended on a table or 

countertop. A safety strap or harness 

should not be used on the diaper 

changing table. 

3.2.2.1 Situations that Require Hand 

Hygiene 

All staff, volunteers, and children 

should abide by the following 

procedures for hand washing, as defined 

by the CDC: 

A. Upon arrival for the day, after 

breaks, or when moving from one group 

to another; 

B. Before and after: 

• Preparing food or beverages; 

• Eating, handling food, or feeding a 

child; 

• Giving medication or applying a 

medical ointment or cream in which a 

break in the skin (e.g., sores, cuts, or 

scrapes) may be encountered; 

• Playing in water (including 

swimming) that is used by more than 

one person; 

• Diapering. 

C. After: 

• Using the toilet or helping a child 

use a toilet; 

• Handling bodily fluid (mucus, 

blood, vomit); 

• Handling animals or cleaning up 

animal waste; 

• Playing in sand, on wooden play 

sets, and outdoors; 

• Cleaning or handling the garbage. 

Situations or times that children and 

staff should perform hand hygiene 

should be posted in all food 

preparation, hand hygiene, diapering, 

and toileting areas. 

3.2.3.4 Prevention of Exposure to 

Blood and Body Fluids 

Early care and education programs 

should adopt the use of Standard 

Precautions, developed by the CDC, to 

handle potential exposure to blood and 

other potentially infectious fluids. 

Caregivers and teachers are required to 

be educated regarding Standard 

Precautions before beginning to work in 

the program and annually thereafter. 

Training should comply with 

requirements of the Occupational Safety 

and Health Administration. 

3.3.0.1 Routine Cleaning, Sanitizing, 

and Disinfecting 

Programs should follow a routine 

schedule of cleaning, sanitizing, and 

disinfecting. Cleaning, sanitizing, and 

disinfecting products should not be 

used in close proximity to children, and 

adequate ventilation should be 

maintained during use. 

3.4.1.1 Use of Tobacco, Alcohol, and 

Illegal Drugs 

Tobacco use, alcohol, and illegal 

drugs should be prohibited on the 

premises (both indoor and outdoor 

environments) and in any vehicles used 

by the program at all times. Caregivers 

and teachers should not use tobacco, 

alcohol, or illegal drugs off the premises 

during the early care and education 

program’s paid time, including break 

time. 

3.4.3.1 Emergency Procedures 

Programs should have a procedure for 

responding to situations when an 

immediate emergency medical response 

is required. Child-to-staff ratio should 

be maintained, and staff may need to be 

called in to maintain the required ratio. 

Programs should develop contingency 

plans for emergencies or disaster 

situations when it may not be possible 

to follow standard emergency 

procedures. All staff should be trained 

to manage an emergency until 

emergency medical care becomes 

available. 

3.4.4.1 Recognizing and Reporting 

Suspected Child Abuse, Neglect, and 

Exploitation 

Because caregivers/teachers are 

mandated reporters of child abuse and 

neglect, each program should have a 

written policy for reporting child abuse 

and neglect. The program should report 

to the child abuse reporting hotline, the 

Department of Social Services, child 

protective services, or the police as 

required by state and local laws, in any 

instance where there is reasonable cause 

to believe that child abuse and neglect 

has occurred. 

3.4.4.3 Preventing and Identifying 

Shaken Baby Syndrome/Abusive Head 

Trauma 

All programs should have a policy 

and procedure to identify and prevent 

shaken baby syndrome/abusive head 

trauma. All caregivers/teachers who are 

in direct contact with children, 

including substitute caregivers/teachers 

and volunteers, should receive training 

on preventing shaken baby syndrome/

abusive head trauma; recognition of 

potential signs and symptoms of shaken 

baby syndrome/abusive head trauma; 

strategies for coping with a crying, 

fussing, or distraught child; and the 

development and vulnerabilities of the 

brain in infancy and early childhood. 

3.4.5.1 Sun Safety Including 

Sunscreen 

Caregivers/teachers should ensure sun 

safety for themselves and children 

under their supervision by keeping 

infants younger than 6 months out of 

direct sunlight, limiting sun exposure 

when UV rays are strongest, wearing 

shatter resistant sunglasses with UV 

protection and hats, and applying 

sunscreen. Written permission from the 

parent/guardian for use of sunscreen 

should be required, and manufacturer 

instructions should be followed. 

3.4.6.1 Strangulation Hazards 

Strings and cords on toys and window 

coverings long enough to encircle a 

child’s neck should not be accessible to 

children in early care and education 

programs. 

3.5.0.1 Care Plan for Children with 

Special Health Care Needs 

Children with special health care 

needs are defined as 

. . . those who have or are at increased risk 

for a chronic physical, developmental, 

behavioral, or emotional condition and who 

also require health and related services of a 

type or amount beyond that required by 

children generally.2

Any child who meets these criteria in 

an early care and education setting 

should have an up-to-date Routine and 

Emergent Care Plan, completed by their 

primary care provider with input from 

parents/guardians, included in their onsite health record. The child care health 

consultant should be involved to ensure 

adequate information, training, and 

monitoring is available for early care 

and education staff. 

3.6.1.1 Inclusion/Exclusion/Dismissal 

of Children 

Staff should notify the parent/

guardian when children develop new 

signs or symptoms of illness. Parent/

guardian notification should be 

immediate for emergency or urgent 

issues. Staff should notify parents/

guardians of children who have 

symptoms that require exclusion, and 

parents/guardians should remove 

children from the early care and 

education setting as soon as possible. 

For children whose symptoms do not 

require exclusion, verbal or written 

notification to the parent/guardian at 

the end of the day is acceptable. Most 

conditions that require exclusion do not 

require a primary care provider visit 

before re-entering care. 

When a child becomes ill but does not 

require immediate medical help, a 

determination should be made regarding 

whether the child should be sent home. 

The caregiver/teacher should determine 

if the illness: 

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(a) Prevents the child from 

participating comfortably in activities; 

(b) Results in a need for care that is 

greater than the staff can provide 

without compromising the health and 

safety of other children; 

(c) Poses a risk of spread of harmful 

diseases to others; 

(d) Causes a fever (temperature above 

101 °F [38.3 °C] orally, or 100 °F 

[37.8 °C] or higher taken axillary 

[armpit]) and behavior change or other 

signs and symptoms (e.g., sore throat, 

rash, vomiting, diarrhea). An 

unexplained temperature above 100 °F 

(37.8 °C) (armpit) in a child younger 

than 6 months should be medically 

evaluated. Any infant younger than 2 

months of age with fever should get 

urgent medical attention. 

If any of the above criteria are met, the 

child should be removed from direct 

contact with other children and 

monitored and supervised by a staff 

member known to the child until 

dismissed to the care of a parent/

guardian or primary care provider. The 

local or state health department will be 

able to provide specific guidelines for 

exclusion. 

3.6.1.4 Infectious Disease Outbreak 

Control 

During the course of an identified 

outbreak of any reportable illness at the 

program, a child or staff member should 

be excluded if the health department 

official or primary care provider 

suspects that the child or staff member 

is contributing to transmission of the 

illness, is not adequately immunized 

when there is an outbreak of a vaccinepreventable disease, or the circulating 

pathogen poses an increased risk to the 

individual. The child or staff member 

should be readmitted when the official 

or primary care provider who made the 

initial determination decides that the 

risk of transmission is no longer present. 

3.6.3.1/3.6.3.2 Medication 

Administration and Storage 

The administration of medicines at 

the facility should be limited to: 

(a) Prescription or non-prescription 

medication (over-the-counter) ordered 

by the prescribing health professional 

for a specific child with written 

permission of the parent/guardian. 

Written orders from the prescribing 

health professional should specify 

medical need, medication, dosage, and 

length of time to give medication; 

(b) Labeled medications brought to 

the early care and education facility by 

the parent/guardian in the original 

container (with a label that includes the 

child’s name; date filled; prescribing 

clinician’s name; pharmacy name and 

phone number; dosage/instructions; 

relevant warnings as well as specific, 

legible instructions for administration; 

storage; and disposal). 

Programs should never administer a 

medication that is prescribed for one 

child to another child. Documentation 

that the medicine/agent is administered 

to the child as prescribed is required. 

Medication should not be used beyond 

the date of expiration. Unused 

medications should be returned to the 

parent/guardian for disposal. 

All medications, refrigerated or 

unrefrigerated, should: 

(a) Have child-resistant caps; 

(b) Be kept in an organized fashion; 

(c) Be stored away from food; 

(d) Be stored at the proper 

temperature; 

(e) Be completely inaccessible to 

children. 

3.6.3.3 Training of Caregivers/

Teachers to Administer Medication 

Any caregiver/teacher who 

administers medication should 

complete a standardized training course 

that includes skill and competency 

assessment in medication 

administration. The trainer in 

medication administration should be a 

licensed health professional. The course 

should be repeated according to state 

and/or local regulation. At a minimum, 

skill and competency should be 

monitored annually or whenever an 

administration error occurs. 

Nutrition and Food Service 

4.2.0.3 Use of U.S. Department of 

Agriculture (USDA), Child and Adult 

Care Food Program (CACFP) Guidelines 

All meals and snacks and their 

preparation, service, and storage should 

meet the requirements for meals of the 

child care component of the USDA, 

CACFP, and 7 CFR 226.20. 

4.2.0.6 Availability of Drinking Water 

Clean, sanitary drinking water should 

be readily available in indoor and 

outdoor areas, throughout the day. 

4.2.0.10 Care for Children with Food 

Allergies 

Each child with a food allergy should 

have a care plan prepared for the facility 

by the child’s primary care provider and 

parents/guardians, to include: 

(a) Written instructions regarding the 

food(s) to which the child is allergic and 

steps to be taken to avoid that food; 

(b) A detailed treatment plan to be 

implemented in the event of an allergic 

reaction, including the names, doses, 

and methods of prompt administration 

of any medications. The plan should 

include specific symptoms that would 

indicate the need to administer one or 

more medications. 

Based on the child’s care plan, the 

child’s caregivers/teachers should 

receive training for, demonstrate 

competence in, and implement 

measures for: 

(a) Preventing exposure to the specific 

food(s) to which the child is allergic; 

(b) Recognizing the symptoms of an 

allergic reaction; 

(c) Treating allergic reactions. 

The written child care plan, a mobile 

phone, and the proper medications for 

appropriate treatment if the child 

develops an acute allergic reaction 

should be routinely carried on field 

trips or transport out of the early care 

and education setting. 

The program should notify the 

parents/guardians immediately of any 

suspected allergic reactions, as well as 

the ingestion of or contact with the 

problem food even if a reaction did not 

occur. The program should contact the 

emergency medical services system 

immediately whenever epinephrine has 

been administered. 

Individual child’s food allergies 

should be posted prominently in the 

classroom and/or wherever food is 

served. 

4.3.1.3 Preparing, Feeding, and Storing 

Human Milk 

Programs should develop and follow 

procedures for the preparation and 

storage of expressed human milk that 

ensures the health and safety of all 

infants, as outlined by the CDC, and 

prohibits the use of infant formula for a 

breastfed infant without parental 

consent. The bottle or container should 

be properly labeled with the infant’s full 

name and date. 

4.3.1.5 Preparing, Feeding, and Storing 

Infant Formula 

Programs should develop and follow 

procedures for the preparation and 

storage of infant formula that ensures 

the health and safety of all infants. 

Formula provided by parents/guardians 

or programs should come in factorysealed containers. The caregiver/teacher 

should always follow manufacturer’s 

instructions for mixing and storing of 

any formula preparation. If instructions 

are not readily available, caregivers/

teachers should obtain information from 

the World Health Organization’s Safe 

Preparation, Storage and Handling of 

Powdered Infant Formula Guidelines. 

Bottles of prepared or ready-to-feed 

formula should be labeled with the 

child’s full name and time and date of 

preparation. 

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3Family Child Care is exempt. 

4.3.1.9 Warming Bottles and Infant 

Foods 

Bottles and infant foods can be served 

cold from the refrigerator and do not 

have to be warmed. If a caregiver/

teacher chooses to warm them, bottles 

should be warmed under running, warm 

tap water or by placing them in 

container of warm water. Bottles should 

never be warmed in microwaves. 

4.5.0.10 Foods that Are Choking 

Hazards 

Caregivers/teachers should not offer 

foods that are associated with young 

children’s choking incidents to children 

under 4 years of age (round, hard, small, 

thick and sticky, smooth, compressible 

or dense, or slippery). Food for infants 

should be cut into pieces 1⁄4 inch or 

smaller, food for toddlers should be cut 

into pieces 1⁄2 inch or smaller to prevent 

choking. Children should be supervised 

while eating, to monitor the size of food 

and that they are eating appropriately. 

4.8.0.1 Food Preparation Area Access 

Infants and toddlers should not have 

access to the kitchen in early care and 

education programs. Access by older 

children to the kitchen, or areas where 

hot food is prepared, should be 

permitted only when supervised by 

adults who are qualified to follow 

sanitation and safety procedures. 

4.9.0.1 Compliance with U.S. Food 

and Drug Administration (FDA) Food 

Code and State and Local Rules 

The program should conform to 

applicable portions of the FDA Food 

Code and all applicable state and local 

food service rules and regulations for 

centers and family child care homes 

regarding safe food protection and 

sanitation practices. If the federal code 

and local regulations are in conflict, the 

health authority with jurisdiction 

should determine which requirement 

the facility must meet. 

Facilities, Supplies, Equipment, 

Environmental Health 

5.1.1.2 Inspection of Buildings 

Existing and/or newly constructed, 

renovated, remodeled, or altered 

buildings should be inspected by a 

public inspector to ensure compliance 

with applicable building and fire codes 

before the building can be made 

accessible to children. 

5.1.1.3 Compliance with Fire 

Prevention Code 

Every 12 months, the early care and 

education facility should obtain written 

documentation to submit to the 

regulatory licensing authority that the 

facility complies with a state-approved 

or nationally recognized Fire Prevention 

Code, such as the National Fire 

Protection Association (NFPA) 1: Fire 

Code. 

5.1.1.5 Environmental Audit of Site 

Location 3

An environmental audit should be 

conducted before construction of a new 

building; renovation or occupation of an 

older building; or after a natural 

disaster, to properly evaluate and, 

where necessary, remediate or avoid 

sites where children’s health could be 

compromised. The environmental audit 

should include assessments of: 

(a) Potential air, soil, and water 

contamination on early care and 

education facility sites and outdoor play 

spaces; 

(b) Potential toxic or hazardous 

materials in building construction; and 

(c) Potential safety hazards in the 

community surrounding the site. 

A written environmental audit report 

that includes any remedial action taken 

should be kept on file. 

5.2.4.2 Safety Covers and Shock 

Protection Devices for Electrical Outlets 

All accessible electrical outlets should 

be ‘‘tamper-resistant electrical outlets’’ 

that contain internal shutter 

mechanisms to prevent children from 

sticking objects into receptacles. In 

settings that do not have ‘‘tamperresistant electrical outlets,’’ outlets 

should have ‘‘safety covers’’ that are 

attached to the electrical outlet by a 

screw or other means to prevent easy 

removal by a child. 

5.2.4.4 Location of Electrical Devices 

near Water 

No electrical device or apparatus 

accessible to children should be located 

so it could be plugged into an electrical 

outlet while a person is in contact with 

a water source, such as a sink, tub, 

shower area, water table, or swimming 

pool. 

5.2.8.1 Integrated Pest Management 

Programs should adopt an integrated 

pest management program to ensure 

long-term, environmentally sound pest 

suppression through a range of practices 

including pest exclusion, sanitation and 

clutter control, and elimination of 

conditions that are conducive to pest 

infestations. 

5.2.9.1 Use and Storage of Toxic 

Substances 

All toxic substances should be used as 

recommended by the manufacturer and 

stored in the original labeled containers. 

All toxic substances should be 

inaccessible to children. The telephone 

number for the poison center should be 

posted in a location where it is readily 

available in emergency situations. 

5.2.9.5 Carbon Monoxide Detectors 

Programs should meet state or local 

laws regarding carbon monoxide 

detectors, including circumstances 

when detectors are necessary. Detectors 

should be tested monthly. Batteries 

should be changed at least yearly. 

Detectors should be replaced at least 

every 5 years. 

5.3.1.1/5.5.0.6/5.5.0.7 Safety of 

Equipment, Materials, and Furnishings 

Equipment, materials, furnishings, 

and play areas should be sturdy, safe, in 

good repair, and meet the 

recommendations of the CPSC. 

Programs should attend to, including, 

but not limited to, the following safety 

hazards: 

(a) Openings that could entrap a 

child’s head or limbs; 

(b) Elevated surfaces that are 

inadequately guarded; 

(c) Lack of specified surfacing and fall 

zones under and around climbable 

equipment; 

(d) Mismatched size and design of 

equipment for the intended users; 

(e) Insufficient spacing between 

equipment; 

(f) Tripping hazards; 

(g) Components that can pinch, sheer, 

or crush body tissues; 

(h) Equipment that is known to be of 

a hazardous type; 

(i) Sharp points or corners; 

(j) Splinters; 

(k) Protruding nails, bolts, or other 

parts that could entangle clothing or 

snag skin; 

(l) Loose, rusty parts; 

(m) Hazardous small parts that may 

become detached during normal use or 

reasonably foreseeable abuse of the 

equipment and that present a choking, 

aspiration, or ingestion hazard to a 

child; 

(n) Strangulation hazards (e.g., straps, 

strings, etc.); 

(o) Flaking paint; 

(p) Paint that contains lead or other 

hazardous materials; and 

(q) Tip-over hazards, such as chests, 

bookshelves, and televisions. 

Plastic bags, matches, candles, and 

lighters should not be accessible to 

children. 

5.4.5.2 Cribs 

Before purchase and use, cribs must 

be in compliance with current CPSC 

and ASTM International safety 

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standards that include ASTM F1169– 

10a Standard Consumer Safety 

Specification for Full-Size Baby Cribs, 

F406–10b Standard Consumer Safety 

Specification for Non-Full-Size Baby 

Cribs/Play Yards, or the CPSC 16 CFR 

1219, 1220, and 1500—Safety Standards 

for Full-Size Baby Cribs and Non-FullSize Baby Cribs; Final Rule. 

As soon as a child can stand up, the 

mattress should be adjusted to its lowest 

position. When an infant is able to reach 

crib latches or potentially climb out of 

a crib, they should be transitioned to a 

different sleeping environment (such as 

a cot or sleeping mat). Children should 

never be kept in their crib by placing, 

tying, or wedging various fabrics, mesh, 

or other strong coverings over the top of 

the crib. 

Cribs intended for evacuation purpose 

should be designed for carrying up to 

five non-ambulatory children less than 

2 years of age to a designated evacuation 

area in the event of fire or other 

emergency. 

Staff should only use cribs for sleep 

purposes and should ensure that each 

crib is a safe sleep environment as 

defined by the CDC and the NICHD. No 

child of any age should be placed in a 

crib for a time-out or for disciplinary 

reasons. Cribs should be placed away 

from window blinds or draperies. 

5.5.0.8 Firearms 

Early care and education programs 

should not have firearms, pellet or BB 

guns, darts, cap pistols, stun guns, paint 

ball guns, or objects manufactured for 

play as toy guns on the premises at any 

time. If present in a family child care 

home, parents should be notified and 

these items should be unloaded, 

equipped with child protective devices, 

and kept under lock and key with the 

ammunition locked separately in areas 

inaccessible to the children. Parents/ 

guardians should be informed about this 

policy. 

Play Areas/Playgrounds and 

Transportation 

6.1.0.6/6.1.0.8/6.3.1.1 Location of Play 

Areas near Bodies of Water/ Enclosures 

for Outdoor Play Areas/Enclosure of 

Bodies of Water 

The outdoor play area should be 

enclosed with a fence or natural 

barriers. Fences and barriers should not 

prevent the observation of children by 

caregivers/teachers. If a fence is used, it 

should conform to applicable local 

building codes in height and 

construction. Fence posts should be 

outside the fence where allowed by 

local building codes. These areas should 

have at least two exits, with at least one 

being remote from the buildings. 

Outside play areas should be free 

from bodies of water. If present, all 

water hazards should be enclosed with 

a fence that is 4 to 6 feet high or higher 

and comes within 31⁄2 inches of the 

ground. Gates should be equipped with 

self-closing and positive self-latching 

closure mechanisms that are high 

enough or of a type such that children 

cannot open it. The openings in the 

fence and gates should be no larger than 

31⁄2 inches. The fence and gates should 

be constructed to discourage climbing. 

Play areas should be secured against 

inappropriate use when the facility is 

closed. 

6.2.3.1 Prohibited Surfaces for Placing 

Climbing Equipment 

Equipment used for climbing should 

not be placed over, or immediately next 

to, hard surfaces such as asphalt, 

concrete, dirt, grass, or flooring covered 

by carpet or gym mats not intended for 

use as surfacing for climbing equipment. 

All pieces of playground equipment 

should be placed over a shock-absorbing 

material that is either the unitary or the 

loose-fill type, as defined by the CPSC 

guidelines and ASTM International 

Standards ASTM F1292–13 and ASTM 

F2223–10, extending at least 6 feet 

beyond the perimeter of the stationary 

equipment. Organic materials that 

support colonization of molds and 

bacteria should not be used. This 

standard applies whether the equipment 

is installed outdoors or indoors. 

6.2.5.1 Inspection of Indoor and 

Outdoor Play Areas and Equipment 

The indoor and outdoor play areas 

and equipment should be inspected 

daily for basic health and safety, 

including, but not limited to: 

(a) Missing or broken parts; 

(b) Protrusion of nuts and bolts; 

(c) Rust and chipping or peeling 

paint; 

(d) Sharp edges, splinters, and rough 

surfaces; 

(e) Stability of handholds; 

(f) Visible cracks; 

(g) Stability of non-anchored large 

play equipment (e.g., playhouses); 

(h) Wear and deterioration. 

Observations should be documented 

and filed, and the problems corrected 

before the playground is used by 

children. 

6.3.2.1 Lifesaving Equipment 

Each swimming pool more than 6 feet 

in width, length, or diameter should be 

provided with a ring buoy and rope, a 

rescue tube, or a throwing line and a 

shepherd’s hook that will not conduct 

electricity. This equipment should be 

long enough to reach the center of the 

pool from the edge of the pool, should 

be kept in good repair, and should be 

stored safely and conveniently for 

immediate access. Caregivers/teachers 

should be trained on the proper use of 

this equipment. Children should be 

familiarized with the use of the 

equipment based on their 

developmental level. 

6.3.5.2 Water in Containers 

Bathtubs, buckets, diaper pails, and 

other open containers of water should 

be emptied immediately after use. 

6.5.1.2 Qualifications for Drivers 

In addition to meeting the general 

staff background check standards, any 

driver or transportation staff member 

who transports children for any purpose 

should be at least 21 years of age and 

have: 

(a) A valid driver’s license that 

authorizes the driver to operate the type 

of vehicle being driven; 

(b) A safe driving record for more than 

5 years, with no crashes where a citation 

was issued, as evidenced by the state 

Department of Motor Vehicles records; 

(c) No tobacco, alcohol, or drug use 

before or while driving; 

(d) No medical condition that would 

compromise driving, supervision, or 

evacuation capability; 

(e) Valid pediatric CPR and first aid 

certificate if transporting children alone. 

The driver’s license number and date 

of expiration, vehicle insurance 

information, and verification of current 

state vehicle inspection should be on 

file in the facility. 

6.5.2.2 Child Passenger Safety 

When children are driven in a motor 

vehicle other than a bus, all children 

should be transported only if they are 

restrained in a developmentally 

appropriate car safety seat, booster seat, 

seat belt, or harness that is suited to the 

child’s weight, age, and/or 

psychological development in 

accordance with state and federal laws 

and regulations. The child should be 

securely fastened, according to the 

manufacturer’s instructions. The child 

passenger restraint system should meet 

the federal motor vehicle safety 

standards contained in 49 CFR 571.213 

and carry notice of compliance. Child 

passenger restraint systems should be 

installed and used in accordance with 

the manufacturer’s instructions and 

should be secured in back seats only. 

Car safety seats should be replaced if 

they have been recalled, are past the 

manufacturer’s ‘‘date of use’’ expiration 

date, or have been involved in a crash 

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4Family Child Care is exempt. 

that meets the U.S. Department of 

Transportation crash severity criteria or 

the manufacturer’s criteria for 

replacement of seats after a crash. 

6.5.2.4 Interior Temperature of 

Vehicles 

The interior of vehicles used to 

transport children for field trips and 

out-of-program activities should be 

maintained at a temperature comfortable 

to children. All vehicles should be 

locked when not in use, head counts of 

children should be taken after 

transporting to prevent a child from 

being left unintentionally in a vehicle, 

and children should never be 

intentionally left in a vehicle 

unattended. 

6.5.3.1 Passenger Vans 4

Early care and education programs 

that provide transportation for any 

purpose to children, parents/guardians, 

staff, and others should not use 15- 

passenger vans whenever possible. 

Caregivers/teachers should be 

knowledgeable about the laws of the 

state(s) in which their vehicles, 

including passenger vans, will be 

registered and used. 

Infectious Disease 

7.2.0.1 Immunization Documentation 

Programs should require that all 

parents/guardians of enrolled children 

provide written documentation of 

receipt of immunizations appropriate 

for each child’s age. Infants, children, 

and adolescents should be immunized 

as specified in the ‘‘Recommended 

Immunization Schedules for Persons 

Aged 0 Through 18 Years,’’ developed 

by the Advisory Committee on 

Immunization Practices of the CDC, the 

American Academy of Pediatrics, and 

the American Academy of Family 

Physicians. Children whose 

immunizations are not up-to-date or 

have not been administered according to 

the recommended schedule should 

receive the required immunizations, 

unless contraindicated or for legal 

exemptions. 

7.2.0.2 Unimmunized Children 

If immunizations have not been or are 

not to be administered because of a 

medical condition, a statement from the 

child’s primary care provider 

documenting the reason why the child 

is temporarily or permanently medically 

exempt from the immunization 

requirements should be on file. If 

immunizations are not to be 

administered because of the parents’/

guardians’ religious or philosophical 

beliefs, a legal exemption with 

notarization, waiver, or other statespecific required documentation signed 

by the parent/guardian should be on 

file. The parent/guardian of a child who 

has not received the age-appropriate 

immunizations prior to enrollment and 

who does not have documented 

medical, religious, or philosophical 

exemptions from routine childhood 

immunizations should provide 

documentation of a scheduled 

appointment or arrangement to receive 

immunizations. An immunization plan 

and catch-up immunizations should be 

initiated upon enrollment and 

completed as soon as possible. 

If a vaccine-preventable disease to 

which children are susceptible occurs in 

the facility and potentially exposes the 

unimmunized children who are 

susceptible to that disease, the health 

department should be consulted to 

determine whether these children 

should be excluded for the duration of 

possible exposure or until the 

appropriate immunizations have been 

completed. The local or state health 

department will be able to provide 

guidelines for exclusion requirements. 

7.2.0.3 Immunization of Caregivers/

Teachers 

Caregivers/teachers should be current 

with all immunizations routinely 

recommended for adults by the 

Advisory Committee on Immunization 

Practices of the CDC as shown in the 

‘‘Recommended Adult Immunization 

Schedule’’ in the following categories: 

(a) Vaccines recommended for all 

adults who meet the age requirements 

and who lack evidence of immunity 

(i.e., lack documentation of vaccination 

or have no evidence of prior infection); 

and 

(b) Recommended if a specific risk 

factor is present. 

If a staff member is not appropriately 

immunized for medical, religious, or 

philosophical reasons, the early care 

and education facility should require 

written documentation of the reason. 

If a vaccine-preventable disease to 

which adults are susceptible occurs in 

the facility and potentially exposes the 

unimmunized adults who are 

susceptible to that disease, the health 

department should be consulted to 

determine whether these adults should 

be excluded for the duration of possible 

exposure or until the appropriate 

immunizations have been completed. 

The local or state health department 

will be able to provide guidelines for 

exclusion requirements. 

Policies 

9.2.4.1 Written Plan and Training for 

Handling Urgent Medical Care or 

Threatening Incidents 

The program should have a written 

plan for reporting and managing any 

incident or unusual occurrence that is 

threatening to the health, safety, or 

welfare of the children, staff, or 

volunteers. Staff training procedures 

should also be included. The 

management, documentation, and 

reporting of the following types of 

incidents should be addressed: 

(a) Lost or missing child; 

(b) Suspected maltreatment of a child 

(also see state’s mandates for reporting); 

(c) Suspected sexual, physical, or 

emotional abuse of staff, volunteers, or 

family members occurring while they 

are on the premises of the program; 

(d) Injuries to children requiring 

medical or dental care; 

(e) Illness or injuries requiring 

hospitalization or emergency treatment; 

(f) Mental health emergencies; 

(g) Health and safety emergencies 

involving parents/guardians and visitors 

to the program; 

(h) Death of a child or staff member, 

including a death that was the result of 

serious illness or injury that occurred on 

the premises of the early care and 

education program, even if the death 

occurred outside of early care and 

education hours; 

(i) The presence of a threatening 

individual who attempts or succeeds in 

gaining entrance to the facility. 

9.2.4.3 Disaster Planning, Training and 

Communication 

Early care and education programs 

should consider how to prepare for and 

respond to emergency or natural 

disaster situations that may require 

evacuation, lock-down, or shelter-inplace and have written plans, 

accordingly. The following topics 

should be addressed, including, but not 

limited to, regularly scheduled practice 

drills, procedures for notifying and 

updating parents, and the use of the 

daily class roster(s) to check attendance 

of children and staff during an 

evacuation or drill when gathered in a 

safe space after exit and upon return to 

the program. 

9.2.4.7 Sign-In/Sign-Out System 

Programs should have a sign-in/signout system to track those who enter and 

exit the facility. The system should 

include name, contact number, 

relationship to facility (e.g., parent/

guardian, vendor, guest, etc.), and 

recorded time in and out. 

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9.2.4.8 Authorized Persons To Pick Up 

Child 

Children may only be released to 

adults authorized by parents or legal 

guardians and whose identity has been 

verified by photo identification. Names, 

addresses, and telephone numbers of 

persons authorized to take a child under 

care out of the facility should be 

obtained during the enrollment process 

and regularly reviewed, along with 

clarification/documentation of any 

custody issues/court orders. The legal 

guardian(s) of the child should be 

established and documented at this 

time. 

9.4.1.12 Record of Valid License, 

Certificate, or Registration of Facility 

Every facility should hold a valid 

license, certificate, or documentation of 

registration prior to operation as 

required by the local and/or state 

statute. 

9.4.2.1 Contents of Child Records 

Programs should maintain a 

confidential file for each child in one 

central location on-site and should be 

immediately available to the child’s 

caregivers/teachers (who should have 

parental/guardian consent for access to 

records), the child’s parents/guardians, 

and the licensing authority upon 

request. The file for each child should 

include the following: 

(a) Pre-admission enrollment 

information; 

(b) Admission agreement signed by 

the parent/guardian at enrollment; 

(c) Initial and updated health care 

assessments, completed and signed by 

the child’s primary care provider, based 

on the child’s most recent well care 

visit; 

(d) Health history completed by the 

parent/guardian at admission; 

(e) Medication record; 

(f) Authorization form for emergency 

medical care; 

(g) Written informed consent forms 

signed by the parent/guardian allowing 

the facility to share the child’s health 

records with other service providers. 

10.4.2.1 Frequency of Inspections for 

Child Care Centers, Large Family Child 

Care Homes, and Small Family Child 

Care Homes 

The licensing inspector or monitoring 

staff should make an onsite inspection 

to measure compliance with licensing/ 

regulatory rules prior to issuing an 

initial license and at least two 

inspections each year to each center and 

large and small family child care home 

thereafter. At least one of the 

inspections should be unannounced, 

and more if they are needed for the 

facility to achieve satisfactory 

compliance or if the facility is closed at 

any time. Sufficient numbers of 

licensing inspectors should be hired to 

provide adequate time visiting and 

inspecting programs to ensure 

compliance with regulations. 

The number of inspections should not 

include those inspections conducted for 

the purpose of investigating complaints. 

Complaints should be investigated 

promptly, based on severity of the 

complaint. States are encouraged to post 

the results of licensing inspections, 

including complaints, on the Internet 

for parent and public review. Parents/

guardians should be provided easy 

access to the licensing rules and made 

aware of how to report complaints to the 

licensing agency. 

Dated: December 12, 2014. 

Linda K. Smith, 

Deputy Assistant Secretary for Early 

Childhood Development, Administration for 

Children and Families, U.S. Department of 

Health and Human Services. 

[FR Doc. 2014–29649 Filed 12–17–14; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0996] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application Review 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 20, 

2015. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0389. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Guidance for Industry: Fast Track Drug 

Development Programs: Designation, 

Development, and Application 

Review—(OMB Control Number 0910– 

0389)—Extension 

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) by adding 

section 506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate a 

potential to address an unmet medical 

need. Under section 112(b) of FDAMA, 

FDA issued guidance to industry on fast 

track policies and procedures outlined 

in section 506 of the FD&C Act. The 

guidance discusses collections of 

information that are specified under 

section 506 of the FD&C Act, other 

sections of the Public Health Service 

Act (the PHS Act), or implementing 

regulations. The guidance describes 

three general areas involving the 

collection of information: (1) Fast track 

designation requests, (2) premeeting 

packages, and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and 

premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

Agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it. 

Under section 506(a)(1) of the FD&C 

Act, an applicant who seeks fast track 

designation is required to submit a 

request to the Agency showing that the 

drug product: (1) Is intended for a 

serious or life-threatening condition and 

(2) has the potential to address an 

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