Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 68461 

Dated: November 4, 2005. 

Betsey S. Dunaway, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 05–22440 Filed 11–9–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Vaccine Information Statements for 

Influenza Vaccines; Revised 

Instructions for Use of Vaccine 

Information Statements 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

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. 

On July 28, 2005, CDC published a 

notice in the Federal Register (70 FR 

43694) seeking public comments on 

proposed new vaccine information 

materials for trivalent influenza 

vaccines and hepatitis A vaccines. The 

60 day comment period ended on 

September 26, 2005. Following review 

of the comments submitted and 

consultation as required under the law, 

CDC has finalized the influenza vaccine 

information materials. The final 

influenza materials, and revised 

instructions for their use and for use of 

materials for other covered vaccines, are 

contained in this notice. The final 

hepatitis A vaccine information 

materials will be published later. 

DATES: Beginning no later than January 

1, 2006, each health care provider who 

administers any trivalent influenza 

vaccine to any child or adult in the 

United States shall provide copies of the 

relevant vaccine information materials 

contained in this notice, dated October 

20, 2005, in conformance with the 

November 4, 2005 CDC Instructions for 

the Use of Vaccine Information 

Statements, also contained in this 

notice. 

FOR FURTHER INFORMATION CONTACT: 

Stephen L. Cochi, M.D., M.P.H., Acting 

Director, National Immunization 

Program, Centers for Disease Control 

and Prevention, Mailstop E–05, 1600 

Clifton Road, NE., Atlanta, Georgia 

30333, telephone (404) 639–8200. 

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. 

Since June 1, 1999, health care 

providers are also required to provide 

copies of vaccine information materials 

for the following vaccines that were 

added to the National Vaccine Injury 

Compensation Program: hepatitis B, 

haemophilus influenzae type b (Hib), 

and varicella (chickenpox) vaccines. In 

addition, use of vaccine information 

materials for pneumococcal conjugate 

vaccine has been required since 

December 15, 2002. 

Instructions for use of the vaccine 

information materials and copies of the 

materials can be downloaded in PDF 

format from the CDC Web site at: http:// 

www.cdc.gov/nip/publications/VIS. In 

addition, single camera-ready copies are 

available from State health departments. 

A list of State health department 

contacts for obtaining copies of these 

materials is included in a December 17, 

1999 Federal Register notice (64 FR 

70914). 

New Vaccine Information Materials 

Inactivated Influenza Vaccine 

Information Statement; Live, Intranasal 

Influenza Vaccine Information 

Statement; Hepatitis A Vaccine 

Information Statement 

Following the addition of hepatitis A 

and trivalent influenza vaccines to the 

National Vaccine Injury Compensation 

Program, CDC, as required under 42 

U.S.C. 300aa–26, proposed vaccine 

information materials covering those 

vaccines in a Federal Register notice 

published on July 28, 2005 (70 FR 

43694). In order to have Influenza 

Vaccine Information Statements 

available for voluntary use in the 

current influenza vaccination season, 

the proposed influenza vaccine 

materials were also issued as interim 

VISs through that notice. 

The new vaccine information 

materials referenced in this notice were 

developed in consultation with the 

Advisory Commission on Childhood 

Vaccines, the Food and Drug 

Administration, the American Academy 

of Family Physicians, American 

Academy of Pediatrics, American 

Medical Association, Emory Vaccine 

Research Center, Every Child By Two, 

Immunization Action Coalition and the 

National PTA. Also, CDC sought 

consultation with other organizations; 

however, those organizations did not 

provide comments. 

Following consultation and review of 

comments submitted, the vaccine 

information materials covering trivalent 

influenza vaccines have been finalized 

and are contained in this notice. These 

Vaccine Information Statements, dated 

October 20, 2005, are entitled: 

‘‘Inactivated Influenza Vaccine: What 

You Need to Know’’ and ‘‘Live, 

Intranasal Influenza Vaccine: What You 

Need to Know.’’ CDC has also revised 

the ‘‘Instructions for the Use of Vaccine 

Information Statements.’’ The vaccine 

information materials covering hepatitis 

A vaccine will be finalized and 

published at a later date. 

With publication of this notice, as of 

January 1, 2006, all health care 

providers will be required to provide 

68462 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 

copies of influenza vaccine information 

materials prior to immunization in 

conformance with CDC’s November 4, 

2005 ‘‘Instructions for the Use of 

Vaccine Information Statements’’ which 

are contained in this notice. 

* * * * * 

Instructions for the Use of Vaccine 

Information Statements 

Required Use 

1. Provide Vaccine Information 

Statement (VIS) When Vaccination Is 

Given 

As required under the National 

Childhood Vaccine Injury Act (42 U.S.C. 

300aa–26), all health care providers in 

the United States who administer to any 

child or adult any vaccine containing 

diphtheria, tetanus, pertussis, measles, 

mumps, rubella, polio, Haemophilus 

influenzae type b (Hib), hepatitis B, 

trivalent influenza (use of influenza 

VISs required effective January 1, 2006), 

pneumococcal conjugate, or varicella 

(chickenpox) vaccine shall, prior to 

administration of each dose of the 

vaccine, provide a copy to keep of the 

relevant current edition vaccine 

information materials that have been 

produced by the Centers for Disease 

Control and Prevention (CDC): 

• To the parent or legal 

representative* of any child to whom 

the provider intends to administer such 

vaccine, and 

• To any adult to whom the provider 

intends to administer such vaccine. (In 

the case of an incompetent adult, 

relevant VISs shall be provided to the 

individual’s legal representative.* If the 

incompetent adult is living in a longterm care facility, all relevant VISs may 

be provided at the time of admission, or 

at the time of consent if later than 

admission, rather than prior to each 

immunization.) 

The materials shall be supplemented 

with visual presentations or oral 

explanations, as appropriate. 

If there is not a single VIS for a 

combination vaccine, use the VISs for 

all component vaccines. 

• A Legal representative is defined as 

a parent or other individual who is 

qualified under State law to consent to 

the immunization of a minor child or 

incompetent adult. 

2. Record information for each VIS 

provided 

Health care providers shall make a 

notation in each patient’s permanent 

medical record at the time vaccine 

information materials are provided 

indicating (1) the edition date of the 

Vaccine Information Statement 

distributed and (2) the date the VIS was 

provided. 

This recordkeeping requirement 

supplements the requirement of 42 

U.S.C. 300aa–25 that all health care 

providers administering these vaccines 

must record in the patient’s permanent 

medical record (or in a permanent office 

log): (3) The name, address and title of 

the individual who administers the 

vaccine, (4) the date of administration 

and (5) the vaccine manufacturer and lot 

number of the vaccine used. 

Applicability of State Law 

Health care providers should consult 

their legal counsel to determine 

additional State requirements pertaining 

to immunization. The Federal 

requirement to provide the vaccine 

information materials supplements any 

applicable State laws. 

Availability of Copies 

Single camera-ready copies of the 

vaccine information materials are 

available from State health departments. 

Copies are also available on the Centers 

for Disease Control and Prevention’s 

Web site at http://www.cdc.gov/nip/ 

publications/VIS. Copies are available 

in English and in other languages. 

Edition Dates of Current VISs 

Diphtheria, Tetanus, Pertussis (DTaP/ 

DT): July 30, 2001. 

Haemophilus influenzae type b (Hib): 

December 16, 1998. 

Hepatitis B: July 11, 2001. 

Inactivated Influenza: October 20, 

2005. 

Live, Intranasal Influenza: October 20, 

2005. 

Measles, Mumps, Rubella (MMR): 

January 15, 2003. 

Pneumococcal conjugate: September 

30, 2002. 

Polio: January 1, 2000. 

Tetanus Diphtheria (Td): June 10, 

1994. 

Varicella (chickenpox): December 16, 

1998. 

Reference 42 U.S.C. 300aa–26: November 4, 

2005. 

* * * * * 

Inactivated Influenza Vaccine 

Information Statement 

Inactivated Influenza Vaccine: What 

You Need To Know 

1. Why get vaccinated? 

Influenza (‘‘flu’’) is a very contagious 

disease. 

It is caused by the influenza virus, 

which spreads from infected persons to 

the nose or throat of others. 

Other illnesses can have the same 

symptoms and are often mistaken for 

influenza. But only an illness caused by 

the influenza virus is really influenza. 

Anyone can get influenza. For most 

people, it lasts only a few days. It can 

cause: 

• Fever • Sore throat • Chills 

• Fatigue • Cough • Headache 

• Muscle aches. 

Some people get much sicker. 

Influenza can lead to pneumonia and 

can be dangerous for people with heart 

or breathing conditions. It can cause 

high fever and seizures in children. 

Influenza kills about 36,000 people each 

year in the United States, mostly among 

the elderly. 

Influenza vaccine can prevent 

influenza. 

2. Inactivated influenza vaccine. 

There are two types of influenza 

vaccine: 

An inactivated (killed) vaccine, given 

as a shot, has been used in the United 

States for many years. 

A live, weakened vaccine was 

licensed in 2003. It is sprayed into the 

nostrils. This vaccine is described in a 

separate Vaccine Information Statement. 

Influenza viruses are constantly 

changing. Therefore, influenza vaccines 

are updated every year, and an annual 

vaccination is recommended. 

For most people influenza vaccine 

prevents serious illness caused by the 

influenza virus. It will not prevent 

‘‘influenza-like’’ illnesses caused by 

other viruses. 

It takes about 2 weeks for protection 

to develop after the shot, and protection 

can last up to a year. 

Inactivated influenza vaccine may be 

given at the same time as other vaccines, 

including pneumococcal vaccine. 

Some inactivated influenza vaccine 

contains thimerosal, a preservative that 

contains mercury. Some people believe 

thimerosal may be related to 

developmental problems in children. In 

2004 the Institute of Medicine 

published a report concluding that, 

based on scientific studies, there is no 

evidence of such a relationship. If you 

are concerned about thimerosal, ask 

your doctor about thimerosal-free 

influenza vaccine. 

3. Who should get inactivated influenza 

vaccine? 

Influenza vaccine can be given to 

people 6 months of age and older. It is 

recommended for people who are at risk 

of serious influenza or its 

complications, and for people who can 

spread influenza to those at high risk 

(including all household members): 

People at high risk for complications 

from influenza: 

• All children 6–23 months of age. 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 68463 

• People 65 years of age and older. 

• Residents of long-term care 

facilities housing persons with chronic 

medical conditions. 

• People who have long-term health 

problems with: 

—Heart disease 

—Lung disease 

—Asthma 

—Kidney disease 

—Metabolic disease, such as diabetes 

—Anemia, and other blood disorders 

• People with certain muscle or nerve 

disorders (such as seizure disorders or 

severe cerebral palsy) that can lead to 

breathing or swallowing problems. 

• People with a weakened immune 

system due to: 

—HIV/AIDS or other diseases affecting 

the immune system. 

—Long-term treatment with drugs such 

as steroids. 

—Cancer treatment with x-rays or drugs. 

• People 6 months to 18 years of age 

on long-term aspirin treatment (these 

people could develop Reye Syndrome if 

they got influenza). 

• Women who will be pregnant 

during influenza season. 

People who can spread influenza to 

those at high risk: 

• Household contacts and out-ofhome caretakers of infants from 0–23 

months of age. 

• Physicians, nurses, family 

members, or anyone else in close 

contact with people at risk of serious 

influenza. 

Influenza vaccine is also 

recommended for adults 50–64 years of 

age and anyone else who wants to 

reduce their chance of catching 

influenza. 

An annual flu shot should be 

considered for: 

• People who provide essential 

community services. 

• People living in dormitories or 

under other crowded conditions, to 

prevent outbreaks. 

• People at high risk of influenza 

complications who travel to the 

Southern hemisphere between April 

and September, or to the tropics or in 

organized tourist groups at any time. 

4. When should I get influenza vaccine? 

The best time to get influenza vaccine 

is in October or November. 

Influenza season usually peaks in 

February, but it can peak any time from 

November through May. So getting the 

vaccine in December, or even later, can 

be beneficial in most years. 

Some people should get their flu shot 

in October or earlier: 

—People 50 years of age and older, 

—Younger people at high risk from 

influenza and its complications 

(including children 6 through 23 

months of age), 

—Household contacts of people at high 

risk, 

—Healthcare workers, and 

—Children younger than 9 years of age 

getting influenza vaccine for the first 

time. 

Most people need one flu shot each 

year. Children younger than 9 years of 

age getting influenza vaccine for the first 

time should get 2 doses, given at least 

one month apart. 

5. Some people should talk with a 

doctor before getting influenza vaccine. 

Some people should not get 

inactivated influenza vaccine or should 

wait before getting it. 

• Tell your doctor if you have any 

severe (life-threatening) allergies. 

Allergic reactions to influenza vaccine 

are rare. 

—Influenza vaccine virus is grown in 

eggs. People with a severe egg allergy 

should not get the vaccine. 

—A severe allergy to any vaccine 

component is also a reason to not get 

the vaccine. 

—If you have had a severe reaction after 

a previous dose of influenza vaccine, 

tell your doctor. 

• Tell your doctor if you ever had 

Guillain-Barre ́ Syndrome (a severe 

paralytic illness, also called GBS). You 

may be able to get the vaccine, but your 

doctor should help you make the 

decision. 

• People who are moderately or 

severely ill should usually wait until 

they recover before getting flu vaccine. 

If you are ill, talk to your doctor or 

nurse about whether to reschedule the 

vaccination. People with a mild illness 

can usually get the vaccine. 

6. What are the risks from inactivated 

influenza vaccine? 

A vaccine, like any medicine, could 

possibly cause serious problems, such 

as severe allergic reactions. The risk of 

a vaccine causing serious harm, or 

death, is extremely small. 

Serious problems from influenza 

vaccine are very rare. The viruses in 

inactivated influenza vaccine have been 

killed, so you cannot get influenza from 

the vaccine. 

Mild problems: 

• Soreness, redness, or swelling 

where the shot was given. 

• Fever. 

• Aches. 

If these problems occur, they usually 

begin soon after the shot and last 1–2 

days. 

Severe problems: 

• Life-threatening allergic reactions 

from vaccines are very rare. If they do 

occur, it is within a few minutes to a 

few hours after the shot. 

• In 1976, a certain type of influenza 

(swine flu) vaccine was associated with 

Guillain-Barre ́ Syndrome (GBS). Since 

then, flu vaccines have not been clearly 

linked to GBS. However, if there is a 

risk of GBS from current flu vaccines, it 

would be no more than 1 or 2 cases per 

million people vaccinated. This is much 

lower than the risk of severe influenza, 

which can be prevented by vaccination. 

7. What if there is a severe reaction? 

What should I look for? 

• Any unusual condition, such as a 

high fever or behavior changes. Signs of 

a serious 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 your doctor what happened, 

the date and time it happened, and 

when the vaccination was given. 

• Ask your doctor, nurse, or health 

department 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. 

8. The National Vaccine Injury 

Compensation Program 

In the event that you or your child has 

a serious reaction to a vaccine, a federal 

program has been created to help pay 

for the care of those who have been 

harmed. 

For details about the National Vaccine 

Injury Compensation Program, call 1–

800–338–2382 or visit their Web site at 

http://www.hrsa.gov/osp/vicp. 

9. How can I learn more? 

• Ask your immunization provider. 

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) 

—Visit CDC’s Web site at http:// 

www.cdc.gov/flu. 

—Vaccine Information Statement. 

—(October 20, 2005) Inactivated 

Influenza Vaccine. 

42 U.S.C. 300aa–26. 

Department of Health and Human 

Services, Centers for Disease Control 

68464 Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 

and Prevention, National Immunization 

Program. 

* * * * * 

Live, Intranasal Influenza Vaccine 

Information Statement 

Live Intranasal Influenza Vaccine: What 

You Need to Know 

1. Why get vaccinated? 

Influenza (‘‘flu’’) is a very contagious 

disease. 

It is caused by the influenza virus, 

which spreads from infected persons to 

the nose or throat of others. 

Other illnesses can have the same 

symptoms and are often mistaken for 

influenza. But only an illness caused by 

the influenza virus is really influenza. 

Anyone can get influenza, but rates of 

infection are highest among children. 

For most people, it lasts only a few 

days. It can cause: 

• Fever 

• Sore throat 

• Chills 

• Fatigue 

• Cough 

• Headache 

• Muscle aches 

Some people get much sicker. 

Influenza can lead to pneumonia and 

can be dangerous for people with heart 

or breathing conditions. It can cause 

high fever and seizures in children. 

Influenza kills about 36,000 people each 

year in the United States. 

Influenza vaccine can prevent 

influenza. 

2. Live, attenuated influenza vaccine 

(nasal spray) 

There are two types of influenza 

vaccine: 

Live, attenuated influenza vaccine 

(LAIV) was licensed in 2003. LAIV 

contains live but attenuated (weakened) 

influenza virus. It is sprayed into the 

nostrils rather than injected into the 

muscle. It is recommended for healthy 

children and adults from 5 through 49 

years of age, who are not pregnant. 

Inactivated influenza vaccine, 

sometimes called the ‘‘flu shot,’’ has 

been used for many years and is given 

by injection. This vaccine is described 

in a separate Vaccine Information 

Statement. 

Influenza viruses are constantly 

changing. Therefore, influenza vaccines 

are updated every year, and annual 

vaccination is recommended. 

For most people influenza vaccine 

prevents serious illness caused by the 

influenza virus. It will not prevent 

‘‘influenza-like’’ illnesses caused by 

other viruses. 

It takes about 2 weeks for protection 

to develop after vaccination, and 

protection can last up to a year. 

3. Who can get LAIV? 

Live, intranasal influenza vaccine is 

approved for healthy children and 

adults from 5 through 49 years of age, 

including those who can spread 

influenza to people at high risk, such as: 

• Household contacts and out-ofhome caretakers of infants from 0–23 

months of age. 

• Physicians and nurses, and family 

members or anyone else in close contact 

with people at risk of serious influenza. 

Influenza vaccine is also 

recommended for anyone else who 

wants to reduce their chance of catching 

influenza. 

LAIV may be considered for: 

• People who provide essential 

community services. 

• People living in dormitories or 

under other crowded conditions, to 

prevent outbreaks. 

4. Who should not get LAIV? 

LAIV is not licensed for everyone. 

The following people should check with 

their health-care provider about getting 

the inactivated vaccine: 

• Adults 50 years of age or older or 

children younger than 5. 

• People who have long-term health 

problems with: 

—Heart disease 

—Lung disease 

—Asthma 

—Kidney disease 

—Metabolic disease, such as diabetes 

—Anemia, and other blood disorders 

• People with a weakened immune 

system. 

• Children or adolescents on longterm aspirin treatment. 

• Pregnant women. 

• Anyone with a history of GuillainBarre ́ syndrome (a severe paralytic 

illness, also called GBS). 

Inactivated influenza vaccine (the flu 

shot) is the preferred vaccine for people 

(including health-care workers and 

family members) coming in close 

contact with anyone who has a severely 

weakened immune system (that is, 

anyone who requires care in a protected 

environment). 

Some people should talk with a 

doctor before getting either influenza 

vaccine: 

• Anyone who has ever had a serious 

allergic reaction to eggs or to a previous 

dose of influenza vaccine. 

• People who are moderately or 

severely ill should usually wait until 

they recover before getting flu vaccine. 

If you are ill, talk to your doctor or 

nurse about whether to reschedule the 

vaccination. People with a mild illness 

can usually get the vaccine. 

5. When should I get influenza vaccine? 

The best time to get influenza vaccine 

is in October or November, but LAIV 

may be given as soon as it is available. 

Influenza season usually peaks in 

February, but it can peak any time from 

November through May. So getting the 

vaccine in December, or even later, can 

be beneficial in most years. 

Most people need one dose of 

influenza vaccine each year. Children 

younger than 9 years of age getting 

influenza vaccine for the first time 

should get 2 doses For LAIV, these 

doses should be given 6–10 weeks apart. 

LAIV may be given at the same time 

as other vaccines. 

6. What are the risks from LAIV? 

A vaccine, like any medicine, could 

possibly cause serious problems, such 

as severe allergic reactions. However, 

the risk of a vaccine causing serious 

harm, or death, is extremely small. 

Live influenza vaccine viruses rarely 

spread from person to person. Even if 

they do, they are not likely to cause 

illness. 

LAIV is made from weakened virus 

and does not cause influenza. The 

vaccine can cause mild symptoms in 

people who get it (see below). 

Mild problems: 

Some children and adolescents 5–17 

years of age have reported mild 

reactions, including: 

• Runny nose, nasal congestion or 

cough. 

• Headache and muscle aches. 

• Fever. 

• Abdominal pain or occasional 

vomiting or diarrhea. 

Some adults 18–49 years of age have 

reported: 

• Runny nose or nasal congestion. 

• Sore throat. 

• Cough, chills, tiredness/weakness. 

• Headache. 

These symptoms did not last long and 

went away on their own. Although they 

can occur after vaccination, they may 

not have been caused by the vaccine. 

Severe problems: 

• Life-threatening allergic reactions 

from vaccines are very rare. If they do 

occur, it is within a few minutes to a 

few hours after the vaccination. 

• If rare reactions occur with any new 

product, they may not be identified 

until thousands, or millions, of people 

have used it. Over two million doses of 

LAIV have been distributed since it was 

licensed, and no serious problems have 

been identified. Like all vaccines, LAIV 

will continue to be monitored for 

unusual or severe problems. 

7. What if there is a severe reaction? 

What should I look for? 

Federal Register / Vol. 70, No. 217 / Thursday, November 10, 2005 / Notices 68465 

• Any unusual condition, such as a 

high fever or behavior changes. Signs of 

a serious 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 your doctor what happened, 

the date and time it happened, and 

when the vaccination was given. 

• Ask your doctor, nurse, or health 

department 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. 

8. The National Vaccine Injury 

Compensation Program 

In the event that you or your child has 

a serious reaction to a vaccine, a Federal 

program has been created to help pay 

for the care of those who have been 

harmed. 

For details about the National Vaccine 

Injury Compensation Program, call 1–

800–338–2382 or visit their Web site at 

http://www.hrsa.gov/osp/vicp. 

9. How can I learn more? 

• Ask your immunization provider. 

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). 

—Visit CDC’s Web site at http:// 

www.cdc.gov/flu. 

—Vaccine Information Statement. 

—Live, Attenuated Influenza Vaccine. 

(October 20, 2005) 

42 U.S.C. 300aa–26. 

Department of Health and Human Services, 

Centers for Disease Control and Prevention, 

National Immunization Program. 

Dated: November 4, 2005. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention. 

[FR Doc. 05–22441 Filed 11–9–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2001D–0281] 

Medical Devices: A Pilot Program to 

Evaluate a Proposed Globally 

Harmonized Alternative for Premarket 

Procedures; Guidance for Industry and 

FDA Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘A 

Pilot Program to Evaluate a Proposed 

Globally Harmonized Alternative for 

Premarket Procedures; Guidance for 

Industry and FDA Staff.’’ The revised 

guidance extends the voluntary pilot 

premarket review program Summary 

Technical Documentation (STED pilot) 

until we have received an adequate 

number of submissions to evaluate the 

STED pilot. The pilot program is 

intended for evaluating the utility of an 

alternative submission procedure. 

DATES: Submit written or electronic 

comments on the guidance at any time. 

ADDRESSES: Submit written requests for 

single copies on a 3.5’’ diskette of the 

guidance document entitled ‘‘A Pilot 

Program to Evaluate a Proposed 

Globally Harmonized Alternative for 

Premarket Procedures; Guidance for 

Industry and FDA Staff’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance (HFZ–220), 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

1350 Piccard Dr., Rockville, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–443–

8818. See SUPPLEMENTARY INFORMATION

section for information on electronic 

access to the guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Harry R. Sauberman, Center for Devices 

and Radiological Health (HFZ–480), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–443–4879, or Kenneth J. Cavanaugh 

Jr., Center for Devices and Radiological 

Health (HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–443–8517. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 26, 

2003 (68 FR 38068), FDA announced the 

availability of a guidance document 

entitled ‘‘A Pilot Program to Evaluate a 

Proposed Globally Harmonized 

Alternative for Premarket Procedures; 

Guidance for Industry and FDA Staff.’’

The guidance document announced a 

pilot program for a premarket review 

program and encouraged participation 

from the medical device industry. The 

pilot program is intended to evaluate 

the utility of an alternative submission 

procedure as described in the draft 

STED document prepared by Study 

Group 1 of the Global Harmonization 

Task Force (GHTF). The document seeks 

to harmonize the different requirements 

for premarket submissions in various 

countries. 

The June 26, 2003, guidance and 

notice of availability announced that the 

pilot program would be in effect for 1 

year from the date of publication of the 

notice of availability. In the Federal 

Register of July 23, 2004 (69 FR 44040), 

the pilot program was subsequently 

extended until June 25, 2005. FDA has 

received no comments on the guidance 

issued on June 26, 2003, or the updated 

version published on July 23, 2004. In 

this revised guidance, FDA is extending 

the pilot program until we have 

received a sufficient number of 

submissions to evaluate the pilot 

program. In addition, FDA is updating 

the contact information and the 

references to the GHTF documents, 

along with other minor editorial 

changes. The FDA guidance document 

is intended to assist the medical device 

industry in making submissions to FDA 

that use a proposed internationally 

harmonized format and content for 

premarket submissions, e.g., premarket 

approval applications and 510(k) 

submissions in the United States. The 

revised guidance is a level 2 guidance 

under FDA’s good guidance practices 

(GGPs) regulation (21 CFR 10.115). FDA 

made the guidance available on its Web 

site at http://www.fda.gov/cdrh/ode/ 

guidance/1347.html. 

The GHTF is a voluntary group 

comprised of medical device regulatory 

officials and industry representatives 

from the United States, Canada, 

Australia, the European Union, and 

Japan. The goals of the GHTF include 

the following items: (1) Encourage 

convergence in regulatory practices with 

respect to ensuring the safety, 

effectiveness, performance, and quality