98-525. Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT) Vaccine Information Materials

[Federal Register Volume 63, Number 6 (Friday, January 9, 1998)]
[Notices]
[Pages 1730-1733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-525]



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Part IV





Department of Health and Human Services





_______________________________________________________________________



Centers for Disease Control and Prevention



_______________________________________________________________________



Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT) Vaccine 
Information Materials; Notice

Federal Register / Vol. 63, No. 6 / Friday, January 9, 1998 / 
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT) Vaccine 
Information Materials

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C. 
Sec. 300aa-26), the CDC must develop vaccine information materials that 
health care providers, either public or private, are required to 
distribute to patients/parents prior to administration of each dose of 
specific vaccines. On September 13, 1996, CDC published a notice in the 
Federal Register (61 FR 48597) seeking public comment on proposed 
revision of the diphtheria, tetanus, and pertussis vaccine information 
materials to reflect Food and Drug Administration (FDA) licensure of 
acellular pertussis vaccine combined with diphtheria and tetanus 
toxoids (DTaP) for administration to infants as young as two months of 
age. The 60-day comment period ended on November 12, 1996. Following 
review of the comments submitted and consultation as required under the 
law, CDC has finalized the revised diphtheria, tetanus, and pertussis 
vaccine information materials. Those final materials are contained in 
this notice.

DATES: Effective January 9, 1998. Beginning as soon as practicable, 
each health care provider who administers any vaccine that contains 
diphtheria, tetanus, or pertussis vaccine (except Td vaccine), shall, 
prior to administration of each dose of the vaccine, provide a copy of 
the vaccine information materials contained in this notice to the 
parent or legal representative of any child to whom such provider 
intends to administer the vaccine. (See below, for information 
regarding the Td (tetanus, diphtheria vaccine formulated for 
administration to individuals seven years of age and older) vaccine 
information materials.)

FOR FURTHER INFORMATION CONTACT: Jose Cordero, M.D., Acting Director, 
National Immunization Program, Centers for Disease Control and 
Prevention, Mailstop E-05, 1600 Clifton Road, NE., Atlanta, Georgia 
30333, telephone [phone].

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. Sec. 300aa-26, requires the Secretary of Health 
and Human Services to develop and disseminate vaccine information 
materials for distribution by health care providers 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 
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 originally covered under the National Vaccine Injury 
Compensation Program are diphtheria, tetanus, pertussis, measles, 
mumps, rubella, and poliomyelitis vaccines. Since April 15, 1992, any 
health care provider who intends to administer one of these vaccines is 
required to provide copies of the vaccine information materials prior 
to administration of any of these vaccines. The materials currently in 
use for measles, mumps, and rubella vaccines and the Td tetanus 
diphtheria vaccine are dated June 10, 1994, and were published in a 
Federal Register notice on June 20, 1994, (59 FR 31888). The current 
materials for polio vaccine are dated February 6, 1997, and were 
published in a Federal Register notice on February 6, 1997, (62 FR 
5696). Single camera-ready copies of the vaccine information materials 
are available from State health departments. A list of contact 
telephone numbers for obtaining camera-ready copies is included in this 
notice. Copies are available in English and other languages.

    (Effective August 6, 1997, hepatitis B, haemophilus influenzae 
type b, and varicella (chicken pox) vaccines were added for coverage 
under the National Vaccine Injury Compensation Program. Development 
of vaccine information materials for these vaccines is underway. As 
part of the process for developing these new materials, CDC will 
publish draft materials for public comment and will consult with 
affected parties as required by the statute. Distribution of the 
vaccine information materials for these newly covered vaccines will 
be required following publication of the final version of each 
vaccine's materials in the Federal Register. We anticipate that they 
will be published in the second quarter of 1998.)

Revised Diphtheria, Tetanus, and Pertussis (DTP, DTaP, DT) Vaccine 
Information Materials

    Prior to July 31, 1996, all combined diphtheria and tetanus toxoids 
and acellular pertussis vaccines (DTaP) were licensed only for 
administration as the fourth or fifth doses of the DTP series. On that 
date, the FDA licensed a DTaP vaccine for administration to infants as 
young as two months of age (i.e., to include the first three doses of 
the DTP series). Since that date, the FDA has licensed additional DTaP 
vaccines to cover all five doses. Licensure of these vaccines requires 
revision of the vaccine information statement entitled, ``Diphtheria, 
Tetanus, and Pertussis Vaccine: What you need to know before your child 
gets the vaccine.''
    On September 13, 1996, CDC published a notice in the Federal 
Register (61 FR 48597) seeking public comment on proposed diphtheria, 
tetanus, and pertussis vaccine information materials that were revised 
to reflect the FDA licensure of acellular pertussis vaccine combined 
with diphtheria and tetanus toxoids (DTaP) for administration to 
infants as young as two months of age. (In addition, interim vaccine 
information materials pertaining to acellular pertussis vaccine 
combined with diphtheria and tetanus toxoids (DTaP) were published in 
the Federal Register on September 13, 1996, (61 FR 48596) for use by 
health care providers pending completion of this formal revision 
process.)
    The 60-day comment period ended on November 12, 1996. Comments were 
submitted by a few individuals and organizations in response to the 
September 13, 1996, notice. As required by the statute, CDC has also 
consulted with various groups, including the Advisory Commission on 
Childhood Vaccines, Food and Drug Administration, American Academy of 
Family Practitioners, American Academy of Pediatrics, American College 
of Osteopathic Pediatricians, American Nurses Association, Association 
of Maternal and Child

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Health Programs, Association of State and Territorial Health Officials, 
Council of State and Territorial Epidemiologists, Dissatisfied Parents 
Together, Immunization Education and Action Committee: Healthy Mothers/
Healthy Babies Coalition, National Association of County Health 
Officials, National Association of Hispanic Nurses, National Black 
Nurses' Association, National Coalition of Hispanic Health and Human 
Services Organizations (COSSMHO), National Council of La Raza, National 
Medical Association, and Ohio Parents for Vaccine Safety. Comments from 
the consultants, along with the comments submitted in response to the 
Federal Register notice, were fully considered in revising the vaccine 
information materials.
    Following consultation and review of comments submitted, revised 
diphtheria, tetanus, and pertussis (DTP, DTaP, DT) vaccine information 
materials that comply with the provisions of the National Childhood 
Vaccine Injury Act have been finalized and are contained in this 
notice. They are entitled ``Diphtheria, Tetanus, and Pertussis 
Vaccines: What You Need to Know.''
* * * * *

Instructions for Use of Vaccine Information Materials (Vaccine 
Information Statements)

Required Use

    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 any vaccine containing diphtheria, tetanus, pertussis, 
measles, mumps, rubella, or polio vaccine shall, prior to 
administration of each dose of the vaccine, provide a copy of the 
relevant vaccine information materials that have been produced by the 
Centers for Disease Control and Prevention (CDC):
    (a) To the parent or legal representative of any child to whom the 
provider intends to administer such vaccine, and
    (b) To any adult to whom the provider intends to administer such 
vaccine.
    The materials shall be supplemented with visual presentations or 
oral explanations, in appropriate cases.
    ``Legal representative'' is defined as a parent or other individual 
who is qualified under State law to consent to the immunization of a 
minor.

Additional Recommended Use of Materials

    Health care providers may also want to give parents copies of all 
vaccine information materials prior to the first visit for 
immunization, such as at the first well baby visit.

Use of Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT) 
Vaccine Information Materials

    Beginning as soon as practicable after January 9, 1998, health care 
providers shall distribute copies of the August 15, 1997, version of 
the diphtheria, tetanus, and pertussis (DTP/DTaP/DT) vaccine 
information materials to replace the June 10, 1994, version or the 
September 13, 1996, interim version of the diphtheria, tetanus, and 
pertussis materials.

Use of Revised Polio Vaccine Information Materials

    Beginning as soon as practicable after February 6, 1997, health 
care providers shall distribute copies of the February 6, 1997, version 
of the polio vaccine information materials to replace the June 10, 
1994, version of the polio materials.

Current Editions of Vaccine Information Materials for Other Covered 
Vaccines

    The June 10, 1994, version of the following vaccine information 
materials shall be distributed prior to administration of the vaccines 
(whether combined or single antigen vaccines are used): measles, mumps, 
and rubella (MMR) vaccine information materials, and tetanus, 
diphtheria (Td) vaccine information materials.

Recordkeeping

    Health care providers shall make a notation in each patient's 
permanent medical record at the time vaccine information materials are 
provided indicating the edition (date of publication) of the materials 
distributed and the date these materials were 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) the name, address, and title of the individual 
who administers the vaccine, the date of administration, and 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 law.

Availability of Copies

    Single camera-ready copies of the vaccine information materials are 
available from State health departments. Copies are available in 
English and in other languages.

    Dated: January 9, 1998.
* * * * *

List of Contact Telephone Numbers for Copies of Vaccine Information 
Materials

    Single camera-ready copies of the vaccine information materials are 
available by calling the telephone number listed below for your 
location:

Alabama [phone]
Alaska [phone]
American Samoa 011-684-633-4606
Arizona [phone]
Arkansas [phone]
California [phone]
Chicago [phone]
Colorado [phone]
Connecticut [phone]
Delaware [phone]
Detroit [phone]
Florida [phone]
Georgia [phone]
Guam 011-671-734-7135
Hawaii [phone]
Houston [phone]
Idaho [phone]
Illinois [phone]
Indian Health Service [phone]
Indiana [phone]
Iowa [phone]
Kansas [phone]
Kentucky [phone]
Los Angeles [phone]
Louisiana [phone]
Maine [phone]
Mariana Islands 011-670-234-8950, x2001
Marshall Islands 011-692-625-3480
Maryland [phone]
Massachusetts [phone]
Michigan [phone]
Micronesia 011-691-320-2619
Minnesota [phone]
Mississippi [phone]
Missouri [phone]
Montana [phone]
Nebraska [phone]
Nevada [phone]
New Jersey [phone]
New York City [phone]
New Hampshire [phone]
New Mexico [phone]
New York State [phone]
North Carolina [phone]
North Dakota [phone]
Ohio [phone]
Oklahoma [phone]
Oregon [phone]
Palau 011-160-680-1757
Pennsylvania [phone]
Philadelphia [phone]

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Puerto Rico [phone]
Rhode Island [phone], ext. 188
San Antonio [phone]
South Carolina [phone]
South Dakota [phone]
Tennessee [phone]
Texas [phone]
Utah [phone]
Vermont [phone]
Virgin Islands [phone], ext. 2148
Virginia [phone] or 6247
Washington, DC [phone]
Washington [phone]
West Virginia [phone]
Wisconsin [phone]
Wyoming [phone]

Diphtheria, Tetanus, & Pertussis Vaccines; What You Need to Know

1. Why get vaccinated?

    Diphtheria, pertussis and tetanus are serious diseases.
Diphtheria
     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)
     Tetanus causes painful tightening of the muscles, usually 
all over the body.
     It can lead to ``locking'' of the jaw so the person cannot 
open his mouth or swallow. Tetanus can lead to death.
Pertussis (Whooping Cough)
     Pertussis causes coughing spells so bad that it is hard 
for infants to eat, drink, or breathe. These can last for weeks.
     It can lead to pneumonia, seizures (jerking and staring 
spells), brain damage, and death.
    Diphtheria, tetanus, and pertussis vaccines prevent these diseases.
    Most children who get all their shots will be protected during 
childhood.
    Many more children would get these diseases if we stopped 
vaccinating.

2. Diphtheria, Tetanus, and Pertussis Vaccines

DTP Vaccine
     Protects against diphtheria, tetanus, and pertussis.
     Used for many years.
DTaP Vaccine
     Protects against diphtheria, tetanus, and pertussis.
     Newer than DTP.
    The Centers for Disease Control and Prevention (CDC) recommends 
DTaP over DTP. This is because DTaP is less likely to cause reactions 
than DTP.
Related Vaccines
     Combinations: To reduce the number of shots a child must 
get, DTP or DTaP may be available in combination with other vaccines.
     DT protects against diphtheria and tetanus, but not 
pertussis. It only is recommended for children who should not get 
pertussis vaccine.

3. What Are the Risks From These Vaccines?

     As with any medicine, vaccines carry a small risk of 
serious harm, such as a severe allergic reaction or even death.
     If there are reactions, they usually start within 3 days 
and don't last long.
     Most people have no serious reactions from these vaccines.
Possible Reactions to These Vaccines
    Mild Reactions (common).
     Sore arm or leg.
     Fever.
     Fussy.
     Less appetite.
     Tired.
     Vomiting.
    Mild reactions are much less likely after DTaP than after DTP. 
Moderate to Serious Reactions (uncommon)
    Moderate to serious reactions have been uncommon with DTP vaccine:
     Non-stop crying (3 hours or more)--100 of every 10,000 
doses.
     Fever of 105 deg. or higher--30 of every 10,000 doses.
     Seizure (jerking or staring)--6 of every 10,000 doses.
     Child becomes limp, pale, less alert--6 of every 10,000 
doses.
    With DTaP vaccine, these reactions are much less likely to happen.
    Severe Reactions (very rare).
    There are two kinds of serious reactions:
     Severe allergic reaction (breathing difficulty, shock).
     Severe brain reaction (long seizure, coma or lowered 
consciousness).
    Is there lasting damage?
     Experts disagree on whether pertussis vaccines cause 
lasting brain damage.
     If they do, it is very rare.
    Most experts believe serious reactions will be more rare after DTaP 
than after DTP.

4. When Should my Child get Vaccinated?

    Most children should get a dose at these ages: 2 Months, 4 Months, 
6 Months, 12-18 Months, 4-6 Years.
    At 11-12 years of age and every 10 years after that you should get 
a booster to prevent diphtheria and tetanus.

5. What Can Be Done To Reduce Possible Fever and Pain After This 
Vaccine?

    Give your child an aspirin-free pain reliever for 24 hours after 
the shot.
    This is important if your child has had a seizure or has a parent, 
brother, or sister who has had a seizure.

6. Some Children Should Not get These Vaccines or Should Wait

    Tell your doctor or nurse if your child:
     Ever had a moderate or serious problem after getting 
vaccinated.
     Ever had a seizure.
     Has a parent, brother, or sister who has had a seizure.
     Has a brain problem that is getting worse.
     Now has a moderate or severe illness.
    Your doctor or nurse has information on what to do in this case 
(for example, give one of these vaccines, wait, give medicine to 
prevent fever).

7. What if There Is a Moderate to Severe Reaction?

    What should I look for?
     Any unusual conditions, such as those in item 3.
    What should I do?
     Call a doctor or get the child 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 Report (VAERS) form, or call VAERS yourself at: 
1-800-822-7967.

8. The National Vaccine Injury Compensation Program

    The National Vaccine Injury Compensation Program is a Federal 
program that helps pay for the care of those seriously injured by 
vaccines.
    For details, call 1-800-338-2382 or visit the program's website at 
http://www.hrsa.dhhs.gov/bhpr/vicp/new.htm

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9. 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. They can give 
you the Parents Guide to Childhood Immunization or other information.
     Contact the Centers for Disease Control and Prevention 
(CDC):

Call 1-800-232-2522 (English)
  or
Call 1-800-232-0233 (Spanish)
  or
Visit the CDC website at http://www.cdc.gov/nip.

    DTP/DTaP/DT (8/15/97), Vaccine Information Statement, 42 U.S.C. 
Sec. 300aa-26.

    Dated: January 5, 1998.
Arthur C. Jackson,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 98-525 Filed 1-8-98; 8:45 am]
BILLING CODE 4163-18-P