13540 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices

practice of infection control and

strategies for surveillance, prevention,

and control of healthcare-associated

infections in U.S. healthcare facilities.

The committee advises CDC on

guidelines and other policy statements

regarding prevention of healthcareassociated infections and related

adverse events.

Dated: February 28, 2001.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–5376 Filed 3–5–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Proposed Vaccine Information

Materials for Pneumococcal

Conjugate, Diphtheria, Tetanus,

Acellular Pertussis (DTaP/DT) and

Hepatitis B 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 (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 proposed

new vaccine information materials for

pneumococcal conjugate vaccine, and

revised vaccine information materials

for diphtheria, tetanus, acellular

pertussis (DTaP/DT) vaccines and

hepatitis B vaccine.

DATES: Written comments are invited

and must be received on or before May

7, 2001.

ADDRESSES: Written comments should

be addressed to Walter A. Orenstein,

M.D., Director, National Immunization

Program, Centers for Disease Control

and Prevention, Mailstop E–05, 1600

Clifton Road, NE., Atlanta, Georgia

30333.

FOR FURTHER INFORMATION CONTACT:

Walter A. Orenstein, M.D., 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 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.

Instructions for use of the vaccine

information materials and copies of the

materials can be found on the CDC

website 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).

Pneumococcal Conjugate Vaccine

Information Materials

With the December 18, 1999, addition

of pneumococcal conjugate vaccine to

the National Vaccine Injury

Compensation Program, CDC, as

required under 42 U.S.C. 300aa-26, is

proposing vaccine information materials

covering that vaccine, which are

included in this notice.

Revised Vaccine Information Materials

for Diphtheria, Tetanus, Acellular

Pertussis (DTaP/DT) Vaccines and

Hepatitis B Vaccine

This notice also includes proposed

revised vaccine information materials

for diphtheria, tetanus and acellular

pertussis vaccines (other than Td

vaccine) and hepatitis B vaccine.

The DTaP/DT materials are being

revised to remove references to DTP

(whole cell pertussis-containing

vaccine) because this vaccine is no

longer used in the United States. In

addition, these proposed revised

materials reflect a new adverse event

profile for DTaP, including updated

adverse event information on acellular

pertussis vaccine.

The hepatitis B materials are being

revised to note a recently approved two

dose schedule for administration to

adolescents 11 to 15 years of age as an

alternative to the three dose schedule.

Interim revised hepatitis B vaccine

information materials were published in

a September 1, 2000 Federal Register

notice (65 FR 53316) for use pending

completion of the formal revision

process.

Development of New/Revised Vaccine

Information Materials

The proposed vaccine information

materials included in this notice were

drafted in consultation with the

Advisory Commission on Childhood

Vaccines, the Food and Drug

Administration, the American Academy

of Pediatrics, American Pharmaceutical

Association, Association of American

Indian Physicians, Every Child by Two,

Immunization Action Coalition,

Immunization, Education and Action

Committee, Infectious Disease Society of

America, National Association for

Pediatric Nurse Associates and

Practitioners and the National Vaccine

Advisory Committee. Also, CDC

provided copies of the draft materials to

other organizations and sought their

consultation; however, those

organizations did not provide

comments. Comments provided by the

consultants were considered in drafting

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices 13541

the proposed vaccine information

materials included in this notice.

We invite written comment on the

proposed vaccine information materials

that follow, entitled ‘‘Pneumococcal

Conjugate Vaccine: What You Need to

Know,’’ ‘‘Diphtheria, Tetanus &

Pertussis Vaccines: What You Need to

Know,’’ and ‘‘Hepatitis B Vaccine: What

You Need to Know.’’ Comments

submitted will be considered in

finalizing these materials. When the

final materials are published in the

Federal Register, the notice will include

an effective date for their use.

We also propose to revise the

December 17, 1999, Instructions for Use

of Vaccine Information Materials

(Vaccine Information Statements), and

interim instructions dated September 6,

2000, to add the requirement for use of

the pneumococcal conjugate vaccine

information materials and to note the

new edition dates for the revised

vaccine information materials covering

diphtheria, tetanus, pertussis (DTaP/DT)

vaccines and hepatitis B vaccine.

Pneumococcal Conjugate Vaccine:

What You Need to Know

1. Why Get Vaccinated?

Pneumococcal disease is a serious

disease that causes sickness and death.

In fact, it is the leading cause of

bacterial meningitis in the United

States. (Meningitis is a serious infection

of the covering of the brain).

Each year pneumococcal disease

causes in children under five:

• 17,000 cases of invasive disease,

including 700 cases of meningitis

• About 5 million ear infections

• About 200 deaths

It can also lead to other health

problems, including:

• Pneumonia

• Deafness

• Brain damage

Children under 2 years old are at

highest risk for serious disease.

Pneumococcus bacteria are spread

from person to person through close

contact.

Pneumococcal infections can be hard

to treat because some bacteria have

become resistant to drugs that have been

used to treat them. This makes

prevention of the disease even more

important.

Pneumococcal conjugate vaccine can

prevent serious pneumococcal disease,

such as meningitis and blood infections.

It also prevents some ear infections. But

ear infections have many causes, and

pneumococcal vaccine is effective

against only some of them.

2. Pneumococcal Conjugate Vaccine

Pneumococcal conjugate vaccine is

approved for infants and toddlers.

Protection lasts at least 3 years, so

children who are vaccinated as infants

will be protected when they are at

greatest risk for serious disease.

Some older children and adults may

get a different vaccine called

pneumococcal polysaccharide vaccine.

There is a separate Vaccine Information

Statement for people getting the

pneumococcal polysaccharide vaccine.

3. Who Should Get the Vaccine and

When?

Children under 2 years of age:

• 2 months

• 4 months

• 6 months

• 12–15 months

Children who weren’t vaccinated at

these ages can still get the vaccine. The

number of doses needed depends on the

child’s age. Ask your health care

provider for details.

• Children between 2 and 5 years of

age:

Pneumococcal conjugate vaccine is

also recommended for children between

2 and 5 years old who have not already

gotten the vaccine and are at high risk

of serious pneumococcal disease. This

includes children who:

• Have sickle cell disease,

• Have a damaged spleen or no spleen,

• Have HIV/AIDS,

• Have other diseases that affect the

immune system, such as diabetes,

cancer, or liver disease, or

• Take medications that affect the

immune system, such as

chemotherapy or steroids.

Other children who are at increased

risk of serious pneumococcal disease

include those who:

• Are under 3 years of age,

• Are of Alaska Native, American

Indian or African American descent,

or

• Attend group day care.

The number of doses needed depends

on the child’s age. Ask your health care

provider for more details.

Pneumococcal conjugate vaccine may

be given at the same time as other

routine childhood vaccines.

4. Some Children Should Not Get

Pneumococcal Conjugate Vaccine or

Should Wait

Children should not get

pneumococcal conjugate vaccine if they

had a severe (life-threatening) allergic

reaction to a previous dose of this

vaccine, or have a severe allergy to a

vaccine component. Tell your healthcare provider if your child has ever had

a severe reaction to any vaccine, or has

any severe allergies.

Children with minor illnesses, such as

a cold, may be vaccinated. But children

who are moderately or severely ill

should usually wait until they recover

before getting the vaccine.

5. What Are the Risks From

Pneumococcal Conjugate Vaccine?

In clinical trials (nearly 60,000 doses),

pneumococcal conjugate vaccine was

associated with only mild reactions:

• Up to about 1 infant out of 4 had

redness, tenderness, or swelling where

the shot was given.

• About 1 out of 3 had a fever of over

100.4 °F, and up to about 1 in 50 had

a higher fever (over 102.2 °F).

• Some children also became fussy or

drowsy, or had a loss of appetite.

So far, no moderate or severe

reactions have been associated with this

vaccine. However, a vaccine, like any

medicine, could cause serious problems,

such as a severe allergic reaction. The

risk of this vaccine causing serious

harm, or death, is extremely small.

6. What If There Is a Moderate or Severe

Reaction?

What Should I Look For?

Look for any unusual condition, such

as a serious allergic reaction, high fever,

or unusual behavior.

Serious allergic reactions are

extremely rare with any vaccine. If one

were to occur, it would be within a few

minutes to a few hours after the shot.

Signs can include difficulty breathing,

hoarseness or wheezing, hives, paleness,

weakness, a fast heart beat, dizziness,

and swelling of the throat.

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 health care provider to file

a Vaccine Adverse Event Reporting

System (VAERS) form, or call VAERS

yourself at 1–800–822–7967.

7. The Vaccine Injury Compensation

Program

In the rare 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 website at

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

13542 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices

8. How Can I Learn More?

• Ask your doctor or nurse. They can

give you the vaccine package insert

or suggest other sources of

information.

• Call your local or state health

department’s immunization

program.

• Contact the Centers for Disease

Control and Prevention (CDC):

—Call 1–800–232–2522 (English) or

1–800–232–0233 (Espan ̃ ol)

—Visit the National Immunization

Program’s website at http://

www.cdc.gov/nip

U.S. Department of Health & Human

Services Centers for Disease Control and

Prevention, National Immunization

Program

Vaccine Information Statement

Pneumococcal Conjugate Vaccine

(00/00/0000) (Proposed)

42 U.S.C. 300aa–26

Diphtheria, Tetanus & Pertussis

Vaccines: What You Need To Know

1. Why Get Vaccinated?

Diphtheria, tetanus, and pertussis are

serious diseases caused by bacteria.

Diphtheria and pertussis are spread

from person to person. Tetanus enters

the body through cuts or wounds.

Diphtheria causes a thick covering in

the back of the throat.

• It can lead to breathing problems,

paralysis, heart failure, and even death.

Tetanus (Lockjaw) causes painful

tightening of the muscles, usually all

over the body.

• It can lead to ‘‘locking’’ of the jaw

so the victim cannot open his mouth or

swallow. Tetanus leads to death in

about 3 out of 10 cases.

Pertussis (Whooping Cough) causes

coughing spells so bad that it is hard for

infants to eat, drink, or breathe. These

spells can last for weeks.

• It can lead to pneumonia, seizures

(jerking and staring spells), brain

damage, and death.

Diphtheria, tetanus, and pertussis

vaccine (DTaP) can prevent these

diseases. Most children who are

vaccinated with DTaP will be protected

throughout childhood. Many more

children would get these diseases if we

stopped vaccinating.

DTaP is a safer version of an older

vaccine called DTP. DTP is no longer

used in the United States.

2. Who Should Get DTaP Vaccine and

When?

Children should get 5 doses of DTaP

vaccine, one dose at each of the

following ages:

—2 months

—4 months

—6 months

—15–18 months

—4–6 years

DTaP may be given at the same time

as other vaccines.

3. Some Children Should Not Get DTaP

Vaccine or Should Wait

• Any child who has had a lifethreatening allergic reaction after a dose

of DTaP should not get any more doses.

• Any child who suffered a brain or

nervous system disease within 7 days

after a dose of DTaP should not get any

more doses.

• Talk with your doctor if your child:

—Had a seizure or collapsed after a

previous dose of DTaP,

—Cried non-stop for 3 hours or more

after a previous dose of DTaP,

—Had a high fever (over 105 °F) after a

previous dose of DTaP.

• Children who are moderately or

severely ill at the time the shot is

scheduled should usually wait until

they recover before getting DTaP

vaccine.

Ask your health care provider for

more information. Children who should

not get the pertussis part of the vaccine

can get a vaccine called DT, which

doesn’t contain pertussis.

4. Older Children and Adults

DTaP should not be given to anyone

7 years of age or older. Pertussis can still

strike older children, adolescents, and

adults, but the pertussis vaccine is

currently licensed only for children

under 7.

Adolescents and adults still need

protection from tetanus and diphtheria.

A booster shot called Td is

recommended at 11–12 years of age. It

should be repeated every 10 years.

There is a separate Vaccine Information

Statement for Td vaccine.

5. What Are the Risks From DTaP

Vaccine?

Getting diphtheria, tetanus, or

pertussis disease is much riskier than

getting DTaP vaccine. However, a

vaccine, like any medicine, is capable of

causing serious problems, such as

severe allergic reactions. The risk of

DTaP vaccine causing serious harm, or

death, is extremely small.

Mild Problems (Common)

• Fever (up to about 1 child in 4)

• Redness or swelling where the shot

was given (up to about 1 child in 4)

• Soreness or tenderness where the shot

was given (up to about 1 child in 4)

These problems occur more often after

the 4th and 5th doses of the DTaP series

than after earlier doses.

Another mild problem is swelling of

the arm or leg in which the shot was

given, after the 4th or 5th dose (up to

about 1 child in 30).

Other mild problems include:

• Fussiness (up to about 1 child in 3)

• Tiredness or poor appetite (up to

about 1 child in 10)

• Vomiting (up to about 1 child in 50)

These problems generally occur 1–3

days after the shot.

Moderate Problems (Uncommon)

• Seizure (jerking or staring) (about 1

child out of 14,000)

• Non-stop crying, for 3 hours or more

(up to about 1 child out of 1,000)

• High fever, over 105 °F (about 1 child

out of 16,000)

Severe Problems (Very Rare)

• Serious allergic reaction (less than 1

out of a million doses)

• Several other severe problems have

been reported after DTaP vaccine.

These include:

—Long-term seizures, coma, or

lowered consciousness

—Permanent brain damage.

These are so rare it is hard to tell if

they are caused by the vaccine.

Controlling fever is especially

important for children who have had

seizures, for any reason. It is also

important if another family member has

had seizures.

You can reduce fever and pain by

giving your child an aspirin-free pain

reliever when the shot is given, and for

the next 24 hours, following the package

instructions.

6. What If There Is a Moderate or Severe

Reaction?

What Should I Look For?

Any unusual conditions, such as a

serious allergic reaction, high fever or

behavior changes. Signs of a serious

allergic reaction include difficulty

breathing, hoarseness or wheezing,

hives, paleness, weakness, a fast heart

beat or dizziness within a few minutes

to a few hours after the shot. If a high

fever or seizure occurs, it is usually

within 2 weeks after the shot.

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 file a Vaccine Adverse

Event Reporting System (VAERS) form,

or call VAERS yourself at 1–800–822–

7967.

Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices 13543

7. The National Vaccine Injury

Compensation Program

In the rare 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 the program’s

website at http://www.hrsa.gov/bhpr/

vicp

8. How Can I Learn More?

• Ask your health care provider. They

can give you the vaccine package insert

or suggest other sources of information.

• Call your local or state health

department’s immunization program.

• Contact the Centers for Disease

Control and Prevention (CDC):

—Call 1–800–232–2522 (English)

—Call 1–800–232–0233 (Espan ̃ ol)

—Visit the National Immunization

Program’s website at http://

www.cdc.gov/nip

Department of Health & Human

Services, Centers for Disease Control

and Prevention, National Immunization

Program

Vaccine Information Statement

DTaP

(00/00/0000) (Proposed)

42 U.S.C. 300aa–26

Hepatitis B Vaccine: What You Need To

Know

1. Why Get Vaccinated?

Hepatitis B Is a Serious Disease

The hepatitis B virus can cause shortterm (acute) illness that leads to:

• Loss of appetite

• Diarrhea and vomiting

• Tiredness

• Jaundice (yellow skin or eyes)

• Pain in muscles, joints, and stomach

It can also cause long-term (chronic)

illness that leads to:

• Liver damage (cirrhosis)

• Liver cancer

• Death

About 1.25 million people in the U.S.

have chronic hepatitis B virus infection.

If you are infected as a young child, you

are much more likely to develop chronic

illness.

Each year it is estimated that:

• 200,000 people, mostly young adults,

get infected with hepatitis B virus

• More than 11,000 people have to stay

in the hospital because of hepatitis B

• 4,000 to 5,000 people die from

chronic hepatitis B

Hepatitis B vaccine can prevent

hepatitis B. It is the first anti-cancer

vaccine because it can prevent a form of

liver cancer.

2. How Is Hepatitis B Virus Spread?

Hepatitis B virus is spread through

contact with the blood and body fluids

of an infected person.

A person can get infected in several

ways, such as:

• During birth when the virus passes

from an infected mother to her baby

• By having sex with an infected person

• By injecting illegal drugs

• By being stuck with a used needle on

the job

• By sharing personal items, such as a

razor or toothbrush with an infected

person

People can get hepatitis B infection

without knowing how they got it. About

1⁄3 of hepatitis B cases in the United

States have an unknown source.

3. Who Should Get Hepatitis B Vaccine

and When?

(1) Everyone 18 years of age and

younger

(2) Adults over 18 who are at risk

Adults at risk for hepatitis B infection

include people who have more than one

sex partner, men who have sex with

other men, injection drug users, health

care workers, and others who might be

exposed to infected blood or body

fluids.

If you are not sure whether you are at

risk, ask your doctor or nurse.

People should get 3 doses of hepatitis

B vaccine according to the following

schedule. If you miss a dose or get

behind schedule, get the next dose as

soon as you can. There is no need to

start over.

HEPATITIS B VACCINATION SCHEDULE

When?

Who?

Infant whose mother is infected

with hepatitis B virus

Infant whose mother is not

infected with hepatitis B virus Older child, adolescent, or adult

First Dose ...................................... Within 12 hours of birth ................ Birth–2 months of age .................. Any time.

Second Dose ................................. 1–2 months of age ....................... 1–4 months of age (At least 1

month after first dose).

1–2 months after first dose.

Third Dose ..................................... 6 months of age ........................... 6–18 months of age ..................... 4–6 months after first dose.

The second dose must be given at least 1 month after the first dose.

The third dose must be given at least 2 months after the second dose and at least 4 months after the first.

The third dose should not be given to infants younger than 6 months of age.

Adolescents 11 to 15 years of age may

need only two doses of hepatitis B

vaccine, separated by 4–6 months. Ask

your health care provider for details.

Hepatitis B vaccine may be given at

the same time as other vaccines.

4. Some People Should Not Get

Hepatitis B Vaccine or Should Wait

People should not get hepatitis B

vaccine if they have ever had a lifethreatening allergic reaction to baker’s

yeast (the kind used for making bread)

or to a previous dose of hepatitis B

vaccine.

People who are moderately or

severely ill at the time the shot is

scheduled should usually wait until

they recover before getting hepatitis B

vaccine.

Ask your doctor or nurse for more

information.

5. What Are the Risks From Hepatitis B

Vaccine?

A vaccine, like any medicine, is

capable of causing serious problems,

such as severe allergic reactions. The

risk of a vaccine causing serious harm,

or death, is extremely small.

Getting hepatitis B vaccine is much

safer than getting hepatitis B disease.

Most people who get hepatitis B

vaccine do not have any problems with

it.

Mild Problems

• Soreness where the shot was given,

lasting a day or two (up to 1 out of

11 children and adolescents, and

about 1 out of 4 adults)

• Mild to moderate fever (up to 1 out of

14 children and adolescents and 1 out

of 100 adults)

13544 Federal Register / Vol. 66, No. 44 / Tuesday, March 6, 2001 / Notices

Severe Problems

• Serious allergic reaction (very rare)

6. What If There Is a Moderate or Severe

Reaction?

What Should I Look For?

Any unusual condition, such as a

serious allergic reaction, 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. If such a reaction were

to occur, it would be within a few

minutes to a few hours after the shot.

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 file a Vaccine Adverse

Event Reporting System (VAERS) form,

or call VAERS yourself at 1–800–822–

7967.

7. The National Vaccine Injury

Compensation Program

In the rare 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 the program’s

website at http://www.hrsa.gov/bhpr/

vicp

8. How Can I Learn More?

• Ask your doctor or nurse. They can

give you the vaccine package insert or

suggest other sources of information.

• Call your local or state health

department’s immunization program.

• Contact the Centers for Disease

Control and Prevention (CDC):

—Call 1–800–232–2522 or 1–888–443–

7232 (English)

—Call 1–800–232–0233 (Espan ̃ ol)

—Visit the National Immunization

Program’s website at http://

www.cdc.gov/nip or CDC’s Hepatitis

Branch website at http://

www.cdc.gov/ncidod/diseases/

hepatitis

Department of Health & Human

Services, Centers for Disease Control

and Prevention, National Immunization

Program

Vaccine Information Statement

Hepatitis B

(00/00/0000) (Proposed)

42 U.S.C. 300aa–26

Dated: February 28, 2001.

Joseph R. Carter,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–5377 Filed 3–5–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1168]

Relative Risk to Public Health From

Foodborne Listeria Monocytogenes

Among Selected Categories of Readyto-Eat Foods; Draft Risk Assessment

Document and Risk Management

Action Plan; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

The Food and Drug Administration

(FDA), in cooperation with the Food

Safety and Inspection Service (FSIS) of

the U.S. Department of Agriculture

(USDA), and the Centers for Disease

Control and Prevention is announcing

the following public meeting: Relative

Risk to Public Health from Foodborne

Listeria Monocytogenes Among Selected

Categories of Ready-to-Eat Foods; Draft

Risk Assessment Document and Risk

Management Action Plan. The purpose

of the public meeting is to receive

comments on the technical aspects of a

draft risk assessment on the relationship

between foodborne Listeria

monocytogenes and human health, and

on a proposed risk management action

plan for L. monocytogenes. A notice of

availability of the draft risk assessment

and the action plan was published in

the Federal Register of January 19, 2001

(66 FR 5515).

Date and Time: The meeting will be

held on March 19, 2001, 8:30 a.m. to 4

p.m.

Location: The meeting will be held at

the Hilton Hotel, 2399 Jefferson Davis

Hwy., Arlington, VA 22202.

Contact: Catherine M. DeRoever,

Center for Food Safety and Applied

Nutrition (HFS–6), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4251,

FAX 202–205–4970, e-mail:

cderoeve@cfsan.fda.gov.

Registration and Requests for Oral

Presentations: Send registration

information (including name, title, firm

name, address, telephone, and fax

number), to the contact person by March

14, 2001. Interested persons may

present data, information, or views

orally or in writing, on the issues

identified above. Written submissions

must also be made to the contact person

by March 14, 2001. Time allotted for

each presentation may be limited. If you

wish to make a formal oral presentation,

you should notify the contact person

before March 14, 2001, and be prepared

to provide a brief statement of the

general nature of the evidence you wish

to present.

If you need special accommodations

due to a disability, please contact

Catherine M. DeRoever (address above)

at least 7 days in advance.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

SUPPLEMENTARY INFORMATION: The U. S.

Department of Health and Human

Services and the USDA are seeking

comments on the technical aspects of

the draft risk assessment in the

following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

All public comments will be reviewed

and evaluated, and the assessment will

be modified, as appropriate. The

agencies are also inviting comments on

the risk management strategies as

presented in the draft action plan.

Dated: February 28, 2001.

Ann M Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–5379 Filed 3–1–01; 4:23 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1075]

Public Health Impact of Vibrio

Parahaemolyticus in Raw Molluscan

Shellfish; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA) is announcing the following

meeting on: Vibrio parahaemolyticus in

raw molluscan shellfish and human

health. The purpose of the meeting is to

receive comments on the technical

aspects of the draft risk assessment on

the relationship between Vibrio

parahaemolyticus in raw molluscan