82402 Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 

Evaluation and Quality Assurance 

• How should the HRA standards be 

evaluated and updated with respect to 

individual and population-level 

(practice-based panel management) 

health outcomes? 

Procedure: Interested persons may 

present data, information, or views 

orally or in writing, on topics listed in 

this Federal Register notice. Written 

submissions for the public comment 

period may be made to the contact 

person on or before January 18, 2011. 

Oral presentations from the public will 

be scheduled during 30-minute public 

comment periods at the end of each half 

day of proceedings, i.e., from 11:30 a.m. 

to 12 noon and 4:30 p.m. to 5 p.m. on 

Tuesday, February 1, 2011 and 

Wednesday, February 2, 2011. Those 

individuals interested in making formal 

oral comments should notify the contact 

person and submit a brief statement of 

the general nature of the comments they 

wish to present and the names and 

addresses of proposed participants on or 

before January 11, 2011. Each 

commenter will be limited to 3–5 

minutes. The CDC is not responsible for 

providing access to electrical outlets. 

Individuals who have not submitted 

comments ahead of time will have the 

opportunity to sign up to comment 

during registration on the day of the 

forum. However, if time does not allow 

for all interested parties to comment, 

individuals who have submitted their 

comments ahead of time will be given 

preference. If the number of participants 

requesting to comment is greater than 

can be reasonably accommodated, the 

CDC may conduct a lottery to determine 

the speakers for the scheduled open 

public comment sessions. The contact 

person will notify interested persons 

regarding their request to comment by 

January 18, 2011. 

Public forum participants not 

receiving an opportunity to comment 

during the open public comment period 

may submit their comments to OPTH 

mailbox at: http://www.cdc.gov/policy. 

CDC will make all comments it receives 

available to the public without change, 

including personal information you may 

provide, which includes the name of the 

person submitting the comment or 

signing the comment on behalf of an 

organization, business, or any such 

entity. If anyone does not wish to have 

this information published, then that 

information should not be included 

when submitting the comment. 

Dated: December 21, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–32963 Filed 12–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Proposed Consolidated Vaccine 

Information Materials for Multiple 

Infant Vaccines 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: Under the National 

Childhood Vaccine Injury Act (NCVIA) 

(42 U.S.C. 300aa–26), the CDC must 

develop vaccine information materials 

that all health care providers are 

required to give to patients/parents prior 

to administration of specific vaccines. 

CDC seeks written comment on a 

proposed new vaccine information 

statement that consolidates the six 

vaccine information statements for the 

following childhood vaccines: DTaP, 

Haemophilus influenzae type b, 

inactivated polio vaccine, 

pneumococcal conjugate vaccine, 

hepatitis B, and rotavirus. This 

consolidated Vaccine Information 

Statement is available to be used by 

vaccination providers as an alternative 

to providing the six individual Vaccine 

Information Statements for the same 

vaccines. 

DATES: Written comments are invited 

and must be received on or before 

February 28, 2011. 

ADDRESSES: Written comments should 

be addressed to Jennifer Hamborsky, 

National Center for Immunization and 

Respiratory Diseases, Centers for 

Disease Control and Prevention, 

Mailstop E–52, 1600 Clifton Road, NE., 

Atlanta, Georgia 30333. 

FOR FURTHER INFORMATION CONTACT: Skip 

Wolfe, National Center for 

Immunization and Respiratory Diseases, 

Mailstop E–52, 1600 Clifton Road, NE., 

Atlanta, Georgia 30333, telephone (404) 

639–8809. 

SUPPLEMENTARY INFORMATION: The 

National Childhood Vaccine Injury Act 

of 1986 (Pub. L. 99–660), as amended by 

section 708 of Public Law 103–183, 

added section 2126 to the Public Health 

Service Act. Section 2126, codified at 42 

U.S.C. 300aa–26, requires the Secretary 

of Health and Human Services to 

develop and disseminate vaccine 

information materials for distribution by 

all health care providers in the United 

States to any patient (or to the parent or 

legal representative in the case of a 

child) receiving vaccines covered under 

the National Vaccine Injury 

Compensation Program. 

Development and revision of the 

vaccine information materials, also 

known as Vaccine Information 

Statements (VIS), have been delegated 

by the Secretary to the Centers for 

Disease Control and Prevention (CDC). 

Section 2126 requires that the materials 

be developed, or revised, after notice to 

the public, with a 60-day comment 

period, and in consultation with the 

Advisory Commission on Childhood 

Vaccines, appropriate health care 

provider and parent organizations, and 

the Food and Drug Administration. The 

law also requires that the information 

contained in the materials be based on 

available data and information, be 

presented in understandable terms, and 

include: 

(1) A concise description of the 

benefits of the vaccine, 

(2) A concise description of the risks 

associated with the vaccine, 

(3) A statement of the availability of 

the National Vaccine Injury 

Compensation Program, and 

(4) Such other relevant information as 

may be determined by the Secretary. 

The vaccines initially covered under 

the National Vaccine Injury 

Compensation Program were diphtheria, 

tetanus, pertussis, measles, mumps, 

rubella and poliomyelitis vaccines. 

Since April 15, 1992, any health care 

provider in the United States who 

intends to administer one of these 

covered vaccines is required to provide 

copies of the relevant vaccine 

information materials prior to 

administration of any of these vaccines. 

Hepatitis B, Haemophilus influenzae 

type b (Hib), varicella (chickenpox), 

pneumococcal conjugate, hepatitis A, 

meningococcal conjugate and 

polysaccharide, rotavirus, human 

papillomavirus (HPV), and trivalent 

influenza vaccines have subsequently 

been added to the National Vaccine 

Injury Compensation Program. Use of 

the Vaccine Information Statements 

applicable to all of these vaccines, 

except meningococcal, rotavirus and 

HPV, is also required. (Interim versions 

of Vaccine Information Statements for 

meningococcal, rotavirus and HPV 

vaccines are available for discretionary 

use pending completion of the statutory 

process for finalizing VISs applicable to 

those vaccines.) Instructions for use of 

the vaccine information materials and 

copies of the materials can be found on 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 82403 

the CDC Web site at: http://www.cdc.

gov/vaccines/pubs/vis. 

Proposed Consolidated Vaccine 

Information Materials 

With six vaccines recommended for 

infants from birth through 6 months of 

age—all covered by the National 

Vaccine Injury Compensation 

Program—CDC, as required under 42 

U.S.C. 300aa–26, developed Vaccine 

Information Statements for each of those 

vaccines. In addition, CDC published, in 

2008, an alternative consolidated 

Vaccine Information Statement covering 

those six vaccines in one document, 

which providers can choose to use 

instead of the existing individual 

Vaccine Information Statements for the 

same vaccines. The attached document 

is an update of this consolidated 

Vaccine Information Statement. 

Development of Vaccine Information 

Materials 

The vaccine information materials 

referenced in this notice are being 

developed in consultation with the 

Advisory Commission on Childhood 

Vaccines, the Food and Drug 

Administration, and parent and health 

care provider groups. 

In addition, we invite written 

comment on the proposed vaccine 

information materials that follow, 

entitled ‘‘Your Baby’s First Vaccines: 

What You Need to Know.’’ Comments 

submitted will be considered in 

finalizing these materials. 

* * * * * 

Proposed Multi-Vaccine Vaccine 

Information Statement: 

Your Baby’s First Vaccines: What You 

Need to Know 

Many Vaccine Information Statements 

are available in Spanish and other 

languages. See http://www.immunize.

org/vis Hojas de Informacia ́n Sobre 

Vacunas esta ́n disponibles en Espan ̃ ol 

y en muchos otros idiomas. Visite 

http://www.immunize.org/vis 

Babies get six vaccines between birth 

and 6 months of age, with at least one 

‘‘booster’’ dose given later. 

These vaccines protect your baby 

from 8 serious diseases. 

Your baby will get these vaccines today: 

b DTaP b Polio b Hib 

b Rotavirus b Hepatitis B 

b PCV13 

(Provider: Check appropriate boxes.) 

Ask your doctor about ‘‘combination 

vaccines,’’ which can reduce the number 

of shots your baby needs by combining 

several vaccines in one shot. These 

combination vaccines are as safe and 

effective as these vaccines given 

separately. 

About This Vaccine Information 

Statement 

Please read this Vaccine Information 

Statement (VIS) before your baby gets 

his or her immunizations, and take it 

home with you afterward. Ask your 

doctor, nurse, or other healthcare 

professional if you have any questions. 

This VIS tells you about the benefits 

and risks of these 6 vaccines. It also 

contains information about reporting an 

adverse reaction and about the National 

Vaccine Injury Compensation Program, 

and how to get more information about 

vaccines and vaccine-preventable 

diseases. (Individual VISs are also 

available for these six vaccines.) 

How Vaccines Work 

Most medicines are designed to treat 

diseases. Vaccines are designed to 

prevent diseases, by producing 

immunity. A child who is immune to a 

disease will not get sick from it. 

Immunity from Disease: Before 

vaccines, a child had to get sick to get 

immunity. When a child gets sick with 

a disease, like measles or whooping 

cough, her immune system produces 

protective ‘‘antibodies,’’ which keep her 

from getting the same disease again. But 

getting sick the first time is unpleasant, 

and it can be dangerous or even fatal. 

Immunity from Vaccines: Vaccines 

are made with the same bacteria or 

viruses that cause disease, but they have 

been weakened or killed to make them 

safe. A child’s immune system responds 

to a vaccine by producing antibodies, 

just the same as it would if the child 

were infected with the actual disease. 

This means he will develop immunity 

in the same way * * * but without 

having to get sick first. 

Vaccine benefits: Why get vaccinated? 

Your baby’s first vaccines protect him 

from 8 serious diseases, caused by 

viruses and bacteria. These diseases 

have injured and killed millions of 

children (and adults) over the years. 

Polio killed more than 1,000 people a 

year, and paralyzed tens of thousands 

more in the early 1950s. Hib disease was 

once the leading cause of bacterial 

meningitis in children under 5 years of 

age. About 15,000 people a year died 

from diphtheria before there was a 

vaccine. Most children have at least one 

rotavirus infection before their 5th 

birthday. 

These diseases might be uncommon 

today, but if we stopped vaccinating 

they would come back. This has 

happened in the past, and even today 

disease rates go up when vaccination 

rates go down. For example in 2010 

California had more pertussis cases than 

in any year since 1947. 

8 Diseases Prevented by Childhood 

Vaccines 

1. Diphtheria 

You can get it from contact with an 

infected person. 

Signs and symptoms include a thick 

covering in the back of the throat that 

can make it hard to breathe. 

It can lead to breathing problems, 

heart failure, and death. 

2. Tetanus (Lockjaw) 

You can get it from a cut or wound. 

It does not spread from person to 

person. 

Signs and symptoms include painful 

tightening of the muscles, usually all 

over the body. 

It can lead to stiffness of the jaw that 

prevents swallowing or even opening 

the mouth. Of every 5 people who get 

tetanus, 1 dies. 

3. Pertussis (Whooping Cough) 

You can get it from contact with an 

infected person. 

Signs and symptoms include violent 

coughing spells that can make it hard 

for an infant to eat, drink, or breathe. 

These spells can last for weeks. 

It can lead to pneumonia, seizures, 

brain damage, and death. 

4. Hib (Haemophilus influenzae type b) 

You can get it from contact with an 

infected person. 

Signs and symptoms. There may not 

be any signs or symptoms in mild cases. 

It can lead to meningitis (infection of 

the brain and spinal cord coverings); 

pneumonia; infections of the blood, 

joints, bones, and covering of the heart; 

brain damage; deafness; and death. 

5. Hepatitis B 

You can get it from blood or body 

fluids of an infected person. Babies can 

get it at birth if the mother is infected, 

or through a cut or wound. 

Signs and symptoms include 

tiredness, diarrhea and vomiting, 

jaundice (yellow skin or eyes), and pain 

in muscles, joints and stomach. 

It can lead to liver damage, liver 

cancer, and death. 

6. Polio 

You can get it from close contact with 

an infected person. It enters the body 

through the mouth. 

Signs and symptoms can include 

cold-like illness, or there may be no 

signs or symptoms at all. 

It can lead to paralysis (can’t move an 

arm or leg), or death (by paralyzing the 

breathing muscles). 


jlentini on DSKJ8SOYB1PROD with NOTICES
82404 Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 

7. Pneumococcal Disease 

You can get it from contact with an 

infected person. 

Signs and symptoms include fever, 

chills, cough, and chest pain. 

It can lead to meningitis (infection of 

the brain and spinal cord coverings), 

blood infections, ear infections, 

pneumonia, deafness, brain damage, 

and death. 

8. Rotavirus 

You can get it from contact with other 

children who are infected. 

Signs and symptoms include diarrhea 

(sometimes severe), vomiting and fever. 

It can lead to dehydration, 

hospitalization (up to about 70,000 a 

year), and death. 

Routine Baby Vaccines 

Vaccine Number of 

doses Recommended ages Other information 

DTaP (diphtheria, tetanus, and pertussis.5 .................. 2 months, 4 months, 6 months, 15– 

18 months, 4–6 years.

Some children should not get pertussis vaccine. 

These children should get a vaccine called DT. 

Hepatitis B .......................................... 3 .................. Birth, 1–2 months, 6–18 months ....... A child might receive a 4th dose if ‘‘combination’’ 

vaccines are used. 

Polio ................................................... 4 .................. 2 months, 4 months, 6–18 months, 

4–6 years.

A child might receive a 5th dose if ‘‘combination’’ 

vaccines are used. 

Hib (Haemophilus influenzae type b) 3 or 4 ........... 2 months, 4 months, (6 months), 12– 

15 months.

There are 2 types of Hib vaccine. With one type 

the 6-month dose is not needed. 

PCV13 (pneumococcal) ..................... 4 .................. 2 months, 4 months, 6 months, 12– 

15 months.

Older children with certain chronic diseases may 

also need this vaccine. 

Rotavirus ............................................ 2 or 3 ........... 2 months, 4 months, (6 months) ....... Rotavirus vaccine is given as drops that are 

swallowed. There are 2 types of rotavirus vaccine. With one type the 6-month dose is not 

needed. A virus called porcine circovirus is 

present in both vaccines. There is no evidence 

that it is a safety risk. For information ask your 

doctor or visit http://www.cdc.gov/vpd-vac/

rotavirus. 

An annual dose of flu vaccine is also 

recommended for children 6 months of 

age and older. 

Precautions 

Most babies can get all of these 

vaccines. But some babies should not 

get certain vaccines because of allergies 

or other health conditions. Your doctor 

can advise you. 

If your child ever had a serious 

reaction, such as a life-threatening 

allergic reaction, after a dose of vaccine, 

she should not get another dose of that 

vaccine. Tell your doctor if your child 

has any severe allergies. (Serious 

reactions to vaccines and severe 

allergies are rare.) 

If your child ever had any of these 

reactions after a dose of DTaP vaccine: 

—A brain or nervous system disease 

within 7 days, 

—Non-stop crying for 3 hours or more, 

—A seizure or collapse, 

—A fever of over 105 °F. 

Talk to your doctor before getting 

DTaP vaccine. 

If your child has: 

—A life-threatening allergy to the 

antibiotics neomycin, streptomycin, 

or polymyxin B, 

Talk to your doctor before getting 

Polio vaccine. 

If your child has: 

—A life-threatening allergy to yeast, 

Talk to your doctor before getting 

Hepatitis B or PCV13 vaccine. 

If your child has: 

—SCID (Severe Combined 

Immunodeficiency), 

— A weakened immune system for any 

other reason, 

—Ongoing digestive problems, 

—Recently gotten a blood transfusion or 

other blood product, 

—Ever had intussusception (an 

uncommon type of bowel 

obstruction), 

Talk to your doctor before getting 

Rotavirus vaccine. 

If your child has: 

—Ever had a severe reaction after any 

vaccine containing diphtheria toxoid 

(such as DTaP), 

Talk to your doctor before getting 

PCV13 or DTaP vaccine. 

If your child is sick on the day her 

vaccinations are scheduled, your doctor 

might want to reschedule them after she 

recovers. A child with a mild cold or 

low fever can usually be vaccinated the 

same day, but for a more serious illness 

it might be better to wait. 

Risks 

Vaccines can cause side effects, like 

any medicine. The risk of a serious 

reaction, such as a severe allergic 

reaction, or death, is extremely low. 

Mild Reactions: Most vaccine 

reactions are mild ‘‘local’’ reactions: 

Tenderness, redness, or swelling where 

the shot was given; or a mild fever. 

These affect about 1 child in 4. They 

appear soon after the shot is given and 

go away within a day or two. 

Other Reactions: Severe allergic 

reactions to a substance in a vaccine 

happen very rarely—less than once in a 

million shots. They generally occur 

within minutes or hours after the 

vaccination. Individual vaccines have 

been associated with other mild 

problems, or with moderate or serious 

problems: 

DTaP Vaccine 

Mild Problems: Fussiness (up to 1 

child in 3); tiredness or poor appetite 

(up to 1 child in 10); vomiting (up to 1 

child in 50); swelling of the entire arm 

or leg for 1–7 days (up to 1 child in 

30)—usually after the 4th or 5th dose. 

Moderate Problems: Seizure (1 child 

in 14,000); non-stop crying for 3 hours 

or longer (up to 1 child in 1,000); fever 

over 105 °F (1 child in 16,000). 

Serious problems: Long term seizures, 

coma, lowered consciousness, and 

permanent brain damage have been 

reported. These are so rare it is hard to 

tell if they are caused by the vaccine. 

Polio Vaccine/Hepatitis B Vaccine/Hib 

Vaccine 

These vaccines have not been 

associated with mild problems other 

than local reactions. These vaccines 

have not been associated with problems 

other than mild local reactions. 

Pneumococcal Vaccine 

Mild Problems: During studies of the 

vaccine, some children became fussy or 

drowsy or lost their appetite. 

Rotavirus Vaccine 

Mild Problems: Children who get 

rotavirus vaccine are slightly more 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 250 / Thursday, December 30, 2010 / Notices 82405 

likely than other children to be irritable 

or to have mild, temporary diarrhea or 

vomiting. This happens within the first 

week after getting a dose of the vaccine. 

Serious Problems: Some studies have 

shown a small increase in cases of 

intussusception during the week after 

the first dose. Intussusception is a type 

of bowel blockage that is treated in a 

hospital. In some cases surgery might be 

required. The estimated risk is 1 case 

per 100,000 infants. 

What if my child has a severe reaction? 

What should I look for? 

Any unusual condition, such as a 

high fever or behavior changes. Signs of 

a severe allergic reaction can include 

difficulty breathing, hoarseness or 

wheezing, hives, paleness, weakness, a 

fast heart beat or dizziness. 

What should I do? 

Call a doctor, or get the person to a 

doctor right away. 

Tell the doctor what happened, the 

date and time it happened, and when 

the vaccination was given. 

Ask your doctor to report the reaction 

by filing a Vaccine Adverse Event 

Reporting System (VAERS) form. Or you 

can file this report through the VAERS 

Web site at http://www.vaers.hhs.gov, or 

by calling 1–800–822–7967. VAERS 

does not provide medical advice. 

The National Vaccine Injury 

Compensation Program 

The National Vaccine Injury 

Compensation Program (VICP) was 

created in 1986. 

People who believe they may have 

been injured by a vaccine can learn 

about the program and about filing a 

claim by calling 1–800–338–2382, or 

visiting the VICP Web site at http://

www.hrsa.gov/vaccinecompensation. 

For More Information 

• Ask your doctor. They can give you 

the vaccine package insert or suggest 

other sources of information. 

• Call your local or state health 

department. 

• Contact the Centers for Disease 

Control and Prevention (CDC): 

—Call 1–800–232–4636 (1–800–CDC– 

INFO) or 

—Visit CDC’s Web site at http://www.

cdc.gov/vaccines. 

Department of Health and Human 

Services 

Centers for Disease Control and 

Prevention 

Vaccine Information Statement 

(00/00/0000) (Proposed) 

42 U.S.C. 300aa–26 

Dated: December 21, 2010. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention 

(CDC). 

[FR Doc. 2010–32965 Filed 12–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Statement of Organization, Functions, 

and Delegations of Authority 

Part F of the Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services (CMS), (last amended 

at 75 FR 14176–14178, dated March 24, 

2010) is amended to change the title of 

the Office of Executive Operations and 

Regulatory Affairs to the Office of 

Strategic Operations and Regulatory 

Affairs, to reflect the establishment of a 

new Federal Coordinated Health Care 

Office and to update the organization for 

CMS, as follows: 

(1) Under Part F, CMS, FC. 10 

Organizations, change the title of the 

Office of Executive Operations and 

Regulatory Affairs (FCF) to the Office of 

Strategic Operations and Regulatory 

Affairs (FCF). 

(2) Under Part F, CMS, FC. 10 

Organizations, insert the following new 

Office after the Center for Medicare and 

Medicaid Innovation (FCP): ‘‘Federal 

Coordinated Health Care Office (FCQ).’’ 

(3) Under Part F, CMS, FC. 20 

Functions, change the title of the Office 

of Executive Operations and Regulatory 

Affairs (FCF) to the Office of Strategic 

Operations and Regulatory Affairs 

(FCF). 

(4) Under Part F, CMS, FC. 20 

Functions, insert the following after the 

description of the Center for Medicare 

and Medicaid Innovation (FCP): 

Federal Coordinated Health Care Office 

(FCQ) 

• Manages the implementation and 

operation of the Federal Coordinated 

Health Care Office mandated in section 

2602 of the Affordable Care Act, 

ensuring more effective integration of 

benefits under Medicare and Medicaid 

for individuals eligible for both 

programs and improving coordination 

between the Federal Government and 

States in the delivery of benefits for 

such individuals. 

• Monitors and reports on annual 

total expenditures, health outcomes and 

access to benefits for all dual eligible 

individuals, including subsets of the 

population. 

• Coordinates with the Center for 

Medicare and Medicaid Innovation to 

provide technical assistance and 

programmatic guidance related to the 

testing of various delivery system, 

payment, service and/or technology 

models to improve care coordination, 

reduce costs, and improve the 

beneficiary experience for individuals 

dually eligible for Medicare and 

Medicaid. 

• Performs policy and program 

analysis of Federal and State statutes, 

policies, rules and regulations 

impacting the dual eligible population. 

• Makes recommendations on 

eliminating administrative and 

regulatory barriers between the 

Medicare and Medicaid programs. 

• Develops tools, resources and 

educational materials to increase dual 

eligibles’ understanding of and 

satisfaction with coverage under the 

Medicare and Medicaid programs. 

• Provides technical assistance to 

States, health plans, physicians and 

other relevant entities of individuals 

with education and tools necessary for 

developing integrated programs for dual 

eligible beneficiaries. 

• Consults with the Medicare 

Payment Advisory Commission and the 

Medicaid and CHIP Payment Advisory 

Commission with respect to policies 

relating to the enrollment in and 

provision of benefits to dual eligible 

beneficiaries under Medicare and 

Medicaid. 

• Studies the provision of drug 

coverage for new full benefit dual 

eligible individuals. 

• Develops policy and program 

recommendations to eliminate cost 

shifting between the Medicare and 

Medicaid program and among related 

health care providers. 

• Develops annual report containing 

recommendations for legislation that 

would improve care coordination and 

benefits for dual eligible individuals. 

Authority: 44 U.S.C. 3101. 

Dated: December 7, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–32957 Filed 12–27–10; 4:15 pm] 

BILLING CODE 4120–01–P 


jlentini on DSKJ8SOYB1PROD with NOTICES