[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]
[[Page 1729]]
_______________________________________________________________________
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
[[Page 1730]]
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.
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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 (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. 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 (334) 242-5023
Alaska (907) 561-4406
American Samoa 011-684-633-4606
Arizona (602) 230-5845
Arkansas (501) 661-2723
California (510) 540-2065
Chicago (312) 746-5380
Colorado (303) 692-2669
Connecticut (860) 509-7929
Delaware (302) 739-4746
Detroit (313) 876-4606
Florida (904) 487-2755
Georgia (404) 657-3158
Guam 011-671-734-7135
Hawaii (808) 973-9678
Houston (713) 794-9267
Idaho (208) 334-5942
Illinois (217) 785-1455
Indian Health Service (505) 248-4226
Indiana (317) 233-7010
Iowa (515) 281-4917
Kansas (913) 296-5593
Kentucky (502) 564-4478
Los Angeles (213) 580-9800
Louisiana (504) 483-1900
Maine (207) 287-3746
Mariana Islands 011-670-234-8950, x2001
Marshall Islands 011-692-625-3480
Maryland (410) 767-6679
Massachusetts (617) 983-6807
Michigan (517) 335-8159
Micronesia 011-691-320-2619
Minnesota (612) 623-5237
Mississippi (601) 960-7751
Missouri (573) 751-6133
Montana (406) 444-0065
Nebraska (402) 471-2937
Nevada (702) 687-4800
New Jersey (609) 588-7520
New York City (212) 676-2339
New Hampshire (603) 271-4485
New Mexico (505) 827-2369
New York State (518) 473-4437
North Carolina (919) 733-7752
North Dakota (701) 328-2378
Ohio (614) 466-4643
Oklahoma (405) 271-4073
Oregon (503) 731-4020
Palau 011-160-680-1757
Pennsylvania (717) 787-5681
Philadelphia (215) 685-6749
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Puerto Rico (787) 274-5612
Rhode Island (401) 277-1185, ext. 188
San Antonio (210) 207-8794
South Carolina (803) 737-4160
South Dakota (605) 773-3737
Tennessee (615) 741-7343
Texas (512) 458-7284
Utah (801) 538-9450
Vermont (802) 863-7638
Virgin Islands (809) 776-8311, ext. 2148
Virginia (804) 786-6246 or 6247
Washington, DC (202) 576-7130
Washington (360) 753-3495
West Virginia (304) 558-2188
Wisconsin (608) 266-1339
Wyoming (307) 777-7952
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