1730 Federal Register / Vol. 63, No. 6 / Friday, January 9, 1998 / Notices
DEPARTMENT OF HEALTH AND of 1986 (Pub. L. 99–660), as amended by (chicken pox) vaccines were added for
HUMAN SERVICES section 708 of Public Law 103–183, coverage under the National Vaccine Injury
added section 2126 to the Public Health Compensation Program. Development of
Centers for Disease Control and Service Act. Section 2126, codified at 42 vaccine information materials for these
Prevention vaccines is underway. As part of the process
U.S.C. § 300aa–26, requires the for developing these new materials, CDC will
Secretary of Health and Human Services publish draft materials for public comment
Revised Diphtheria, Tetanus, and to develop and disseminate vaccine and will consult with affected parties as
Pertussis (DTP/DTaP/DT) Vaccine information materials for distribution by required by the statute. Distribution of the
Information Materials health care providers to any patient (or vaccine information materials for these
AGENCY: Centers for Disease Control and to the parent or legal representative in newly covered vaccines will be required
Prevention (CDC), Department of Health the case of a child) receiving vaccines following publication of the final version of
covered under the National Vaccine each vaccine’s materials in the Federal
and Human Services.
Injury Compensation Program. Register. We anticipate that they will be
ACTION: Notice. published in the second quarter of 1998.)
Development and revision of the
SUMMARY: Under the National vaccine information materials have been Revised Diphtheria, Tetanus, and
Childhood Vaccine Injury Act (42 U.S.C. delegated by the Secretary to the Centers Pertussis (DTP, DTaP, DT) Vaccine
§ 300aa–26), the CDC must develop for Disease Control and Prevention Information Materials
vaccine information materials that (CDC). Section 2126 requires that the
materials be developed, or revised, after Prior to July 31, 1996, all combined
health care providers, either public or
notice to the public with a 60-day diphtheria and tetanus toxoids and
private, are required to distribute to
comment period, and in consultation acellular pertussis vaccines (DTaP) were
patients/parents prior to administration
with the Advisory Commission on licensed only for administration as the
of each dose of specific vaccines. On
Childhood Vaccines, appropriate health fourth or fifth doses of the DTP series.
September 13, 1996, CDC published a
care provider and parent organizations, On that date, the FDA licensed a DTaP
notice in the Federal Register (61 FR
and the Food and Drug Administration. vaccine for administration to infants as
48597) seeking public comment on
The law also requires that information young as two months of age (i.e., to
proposed revision of the diphtheria,
contained in the materials be based on include the first three doses of the DTP
tetanus, and pertussis vaccine
available data and information, be series). Since that date, the FDA has
information materials to reflect Food
presented in understandable terms, and licensed additional DTaP vaccines to
and Drug Administration (FDA)
include: cover all five doses. Licensure of these
licensure of acellular pertussis vaccine
(1) A concise description of the vaccines requires revision of the vaccine
combined with diphtheria and tetanus
benefits of the vaccine, information statement entitled,
toxoids (DTaP) for administration to
(2) A concise description of the risks ‘‘Diphtheria, Tetanus, and Pertussis
infants as young as two months of age.
associated with the vaccine, Vaccine: What you need to know before
The 60-day comment period ended on
(3) A statement of the availability of your child gets the vaccine.’’
November 12, 1996. Following review of On September 13, 1996, CDC
the National Vaccine Injury
the comments submitted and published a notice in the Federal
Compensation Program, and
consultation as required under the law, (4) Such other relevant information as Register (61 FR 48597) seeking public
CDC has finalized the revised may be determined by the Secretary. comment on proposed diphtheria,
diphtheria, tetanus, and pertussis The vaccines originally covered under tetanus, and pertussis vaccine
vaccine information materials. Those the National Vaccine Injury information materials that were revised
final materials are contained in this Compensation Program are diphtheria, to reflect the FDA licensure of acellular
notice. tetanus, pertussis, measles, mumps, pertussis vaccine combined with
DATES: Effective January 9, 1998. rubella, and poliomyelitis vaccines. diphtheria and tetanus toxoids (DTaP)
Beginning as soon as practicable, each Since April 15, 1992, any health care for administration to infants as young as
health care provider who administers provider who intends to administer one two months of age. (In addition, interim
any vaccine that contains diphtheria, of these vaccines is required to provide vaccine information materials
tetanus, or pertussis vaccine (except Td copies of the vaccine information pertaining to acellular pertussis vaccine
vaccine), shall, prior to administration materials prior to administration of any combined with diphtheria and tetanus
of each dose of the vaccine, provide a of these vaccines. The materials toxoids (DTaP) were published in the
copy of the vaccine information currently in use for measles, mumps, Federal Register on September 13, 1996,
materials contained in this notice to the and rubella vaccines and the Td tetanus (61 FR 48596) for use by health care
parent or legal representative of any diphtheria vaccine are dated June 10, providers pending completion of this
child to whom such provider intends to 1994, and were published in a Federal formal revision process.)
administer the vaccine. (See below, for Register notice on June 20, 1994, (59 FR The 60-day comment period ended on
information regarding the Td (tetanus, 31888). The current materials for polio November 12, 1996. Comments were
diphtheria vaccine formulated for vaccine are dated February 6, 1997, and submitted by a few individuals and
administration to individuals seven were published in a Federal Register organizations in response to the
years of age and older) vaccine notice on February 6, 1997, (62 FR September 13, 1996, notice. As required
information materials.) 5696). Single camera-ready copies of the by the statute, CDC has also consulted
FOR FURTHER INFORMATION CONTACT: Jose ´ vaccine information materials are with various groups, including the
Cordero, M.D., Acting Director, National available from State health departments. Advisory Commission on Childhood
Immunization Program, Centers for A list of contact telephone numbers for Vaccines, Food and Drug
Disease Control and Prevention, obtaining camera-ready copies is Administration, American Academy of
Mailstop E–05, 1600 Clifton Road, NE., included in this notice. Copies are Family Practitioners, American
Atlanta, Georgia 30333, telephone (404) available in English and other Academy of Pediatrics, American
639–8200. languages. College of Osteopathic Pediatricians,
SUPPLEMENTARY INFORMATION: The (Effective August 6, 1997, hepatitis B, American Nurses Association,
National Childhood Vaccine Injury Act haemophilus influenzae type b, and varicella Association of Maternal and Child
Federal Register / Vol. 63, No. 6 / Friday, January 9, 1998 / Notices 1731
Health Programs, Association of State visit for immunization, such as at the Availability of Copies
and Territorial Health Officials, Council first well baby visit. Single camera-ready copies of the
of State and Territorial Epidemiologists, vaccine information materials are
Use of Revised Diphtheria, Tetanus,
Dissatisfied Parents Together, available from State health departments.
and Pertussis (DTP/DTaP/DT) Vaccine
Immunization Education and Action Copies are available in English and in
Committee: Healthy Mothers/Healthy other languages.
Babies Coalition, National Association Beginning as soon as practicable after
of County Health Officials, National January 9, 1998, health care providers Dated: January 9, 1998.
Association of Hispanic Nurses, shall distribute copies of the August 15, * * * * *
National Black Nurses’ Association, 1997, version of the diphtheria, tetanus, List of Contact Telephone Numbers for
National Coalition of Hispanic Health and pertussis (DTP/DTaP/DT) vaccine Copies of Vaccine Information
and Human Services Organizations information materials to replace the Materials
(COSSMHO), National Council of La June 10, 1994, version or the September
Raza, National Medical Association, and 13, 1996, interim version of the Single camera-ready copies of the
Ohio Parents for Vaccine Safety. diphtheria, tetanus, and pertussis vaccine information materials are
Comments from the consultants, along materials. available by calling the telephone
with the comments submitted in number listed below for your location:
Use of Revised Polio Vaccine Alabama (334) 242–5023
response to the Federal Register notice,
Information Materials Alaska (907) 561–4406
were fully considered in revising the
vaccine information materials. Beginning as soon as practicable after American Samoa 011–684–633–4606
Following consultation and review of February 6, 1997, health care providers Arizona (602) 230–5845
comments submitted, revised shall distribute copies of the February 6, Arkansas (501) 661–2723
diphtheria, tetanus, and pertussis (DTP, 1997, version of the polio vaccine California (510) 540–2065
DTaP, DT) vaccine information information materials to replace the Chicago (312) 746–5380
materials that comply with the June 10, 1994, version of the polio Colorado (303) 692–2669
provisions of the National Childhood materials. Connecticut (860) 509–7929
Vaccine Injury Act have been finalized Delaware (302) 739–4746
and are contained in this notice. They Current Editions of Vaccine Information Detroit (313) 876–4606
are entitled ‘‘Diphtheria, Tetanus, and Materials for Other Covered Vaccines Florida (904) 487–2755
Pertussis Vaccines: What You Need to The June 10, 1994, version of the Georgia (404) 657–3158
Know.’’ following vaccine information materials Guam 011–671–734–7135
Hawaii (808) 973–9678
* * * * * shall be distributed prior to
Houston (713) 794–9267
administration of the vaccines (whether
Instructions for Use of Vaccine Idaho (208) 334–5942
combined or single antigen vaccines are
Information Materials (Vaccine Illinois (217) 785–1455
used): measles, mumps, and rubella
Information Statements) Indian Health Service (505) 248–4226
(MMR) vaccine information materials, Indiana (317) 233–7010
Required Use and tetanus, diphtheria (Td) vaccine Iowa (515) 281–4917
As required under the National information materials. Kansas (913) 296–5593
Childhood Vaccine Injury Act (42 U.S.C. Recordkeeping Kentucky (502) 564–4478
300aa–26), all health care providers in Los Angeles (213) 580–9800
the United States who administer any Health care providers shall make a Louisiana (504) 483–1900
vaccine containing diphtheria, tetanus, notation in each patient’s permanent Maine (207) 287–3746
pertussis, measles, mumps, rubella, or medical record at the time vaccine Mariana Islands 011–670–234–8950,
polio vaccine shall, prior to information materials are provided x2001
administration of each dose of the indicating the edition (date of Marshall Islands 011–692–625–3480
vaccine, provide a copy of the relevant publication) of the materials distributed Maryland (410) 767–6679
vaccine information materials that have and the date these materials were Massachusetts (617) 983–6807
been produced by the Centers for provided. This recordkeeping Michigan (517) 335–8159
Disease Control and Prevention (CDC): requirement supplements the Micronesia 011–691–320–2619
(a) To the parent or legal requirement of 42 U.S.C. 300aa–25 that Minnesota (612) 623–5237
representative of any child to whom the all health care providers administering Mississippi (601) 960–7751
provider intends to administer such these vaccines must record in the Missouri (573) 751–6133
vaccine, and patient’s permanent medical record (or Montana (406) 444–0065
(b) To any adult to whom the provider in a permanent office log) the name, Nebraska (402) 471–2937
intends to administer such vaccine. address, and title of the individual who Nevada (702) 687–4800
The materials shall be supplemented administers the vaccine, the date of New Jersey (609) 588–7520
with visual presentations or oral administration, and the vaccine New York City (212) 676–2339
explanations, in appropriate cases. manufacturer and lot number of the New Hampshire (603) 271–4485
‘‘Legal representative’’ is defined as a vaccine used. New Mexico (505) 827–2369
parent or other individual who is Applicability of State Law New York State (518) 473–4437
qualified under State law to consent to North Carolina (919) 733–7752
the immunization of a minor. Health care providers should consult North Dakota (701) 328–2378
their legal counsel to determine Ohio (614) 466–4643
Additional Recommended Use of additional State requirements pertaining Oklahoma (405) 271–4073
Materials to immunization. The Federal Oregon (503) 731–4020
Health care providers may also want requirement to provide the vaccine Palau 011–160–680–1757
to give parents copies of all vaccine information materials supplements any Pennsylvania (717) 787–5681
information materials prior to the first applicable State law. Philadelphia (215) 685–6749
1732 Federal Register / Vol. 63, No. 6 / Friday, January 9, 1998 / Notices
Puerto Rico (787) 274–5612 The Centers for Disease Control and 4. When Should my Child get
Rhode Island (401) 277–1185, ext. 188 Prevention (CDC) recommends DTaP Vaccinated?
San Antonio (210) 207–8794 over DTP. This is because DTaP is less
Most children should get a dose at
South Carolina (803) 737–4160 likely to cause reactions than DTP.
these ages: 2 Months, 4 Months, 6
South Dakota (605) 773–3737 Related Vaccines Months, 12–18 Months, 4–6 Years.
Tennessee (615) 741–7343
Texas (512) 458–7284 • Combinations: To reduce the At 11–12 years of age and every 10
number of shots a child must get, DTP years after that you should get a booster
Utah (801) 538–9450 to prevent diphtheria and tetanus.
or DTaP may be available in
Vermont (802) 863–7638
combination with other vaccines. 5. What Can Be Done To Reduce
Virgin Islands (809) 776–8311, ext. 2148
• DT protects against diphtheria and Possible Fever and Pain After This
Virginia (804) 786–6246 or 6247 tetanus, but not pertussis. It only is
Washington, DC (202) 576–7130 Vaccine?
recommended for children who should
Washington (360) 753–3495 not get pertussis vaccine. Give your child an aspirin-free pain
West Virginia (304) 558–2188 reliever for 24 hours after the shot.
Wisconsin (608) 266–1339 3. What Are the Risks From These
This is important if your child has
Wyoming (307) 777–7952 Vaccines?
had a seizure or has a parent, brother,
Diphtheria, Tetanus, & Pertussis • As with any medicine, vaccines or sister who has had a seizure.
Vaccines; What You Need to Know carry a small risk of serious harm, such
as a severe allergic reaction or even 6. Some Children Should Not get These
1. Why get vaccinated? death. Vaccines or Should Wait
Diphtheria, pertussis and tetanus are • If there are reactions, they usually Tell your doctor or nurse if your
serious diseases. start within 3 days and don’t last long. child:
• Most people have no serious • Ever had a moderate or serious
Diphtheria reactions from these vaccines. problem after getting vaccinated.
• Diphtheria causes a thick covering Possible Reactions to These Vaccines • Ever had a seizure.
in the back of the throat. • Has a parent, brother, or sister who
Mild Reactions (common).
• It can lead to breathing problems, has had a seizure.
• Sore arm or leg.
paralysis, heart failure, and even death. • Has a brain problem that is getting
Tetanus (Lockjaw) • Fussy. worse.
• Tetanus causes painful tightening of • Less appetite. • Now has a moderate or severe
the muscles, usually all over the body. • Tired. illness.
• Vomiting. Your doctor or nurse has information
• It can lead to ‘‘locking’’ of the jaw
Mild reactions are much less likely on what to do in this case (for example,
so the person cannot open his mouth or
after DTaP than after DTP. Moderate to give one of these vaccines, wait, give
swallow. Tetanus can lead to death.
Serious Reactions (uncommon) medicine to prevent fever).
Pertussis (Whooping Cough) Moderate to serious reactions have
been uncommon with DTP vaccine: 7. What if There Is a Moderate to Severe
• Pertussis causes coughing spells so Reaction?
bad that it is hard for infants to eat, • Non-stop crying (3 hours or more)—
drink, or breathe. These can last for 100 of every 10,000 doses. What should I look for?
weeks. • Fever of 105° or higher—30 of every • Any unusual conditions, such as
• It can lead to pneumonia, seizures those in item 3.
• Seizure (jerking or staring)—6 of
(jerking and staring spells), brain What should I do?
every 10,000 doses.
damage, and death.
• Child becomes limp, pale, less • Call a doctor or get the child to a
Diphtheria, tetanus, and pertussis doctor right away.
alert—6 of every 10,000 doses.
vaccines prevent these diseases. • Tell your doctor what happened,
With DTaP vaccine, these reactions
Most children who get all their shots the date and time it happened, and
are much less likely to happen.
will be protected during childhood. when the vaccination was given.
Severe Reactions (very rare).
Many more children would get these • Ask your doctor, nurse, or health
There are two kinds of serious
diseases if we stopped vaccinating. department to file a Vaccine Adverse
2. Diphtheria, Tetanus, and Pertussis • Severe allergic reaction (breathing Event Report (VAERS) form, or call
Vaccines difficulty, shock). VAERS yourself at: 1–800–822–7967.
• Severe brain reaction (long seizure, 8. The National Vaccine Injury
coma or lowered consciousness). Compensation Program
• Protects against diphtheria, tetanus, Is there lasting damage?
and pertussis. • Experts disagree on whether The National Vaccine Injury
• Used for many years. pertussis vaccines cause lasting brain Compensation Program is a Federal
damage. program that helps pay for the care of
• If they do, it is very rare. those seriously injured by vaccines.
• Protects against diphtheria, tetanus, Most experts believe serious reactions For details, call 1–800–338–2382 or
and pertussis. will be more rare after DTaP than after visit the program’s website at http://
• Newer than DTP. DTP. www.hrsa.dhhs.gov/bhpr/vicp/new.htm
Federal Register / Vol. 63, No. 6 / Friday, January 9, 1998 / Notices 1733
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)
Call 1–800–232–0233 (Spanish)
Visit the CDC website at http://
DTP/DTaP/DT (8/15/97), Vaccine
Information Statement, 42 U.S.C.
Dated: January 5, 1998.
Arthur C. Jackson,
Associate Director for Management and
Operations, Centers for Disease Control and
[FR Doc. 98–525 Filed 1–8–98; 8:45 am]
BILLING CODE 4163–18–P