[Federal Register Volume 64, Number 170 (Thursday, September 2, 1999)]
[Notices]
[Pages 48238-48241]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22869]



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Part II





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Proposed Revised Vaccine Information Materials for Polio Vaccines; 
Proposed Instructions for Use of Vaccine Information Materials; Notice

  Federal Register / Vol. 64, No. 170 / Thursday, September 2, 1999 / 
Notices  

[[Page 48238]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Revised Vaccine Information Materials for Polio 
Vaccines; Proposed Instructions for Use of Vaccine Information 
Materials

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

ACTION: Notice with Comment Period.

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SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C. 
300aa-26), the Centers for Disease Control and Prevention must develop 
vaccine information materials that all health care providers, both 
public and private, are required to give to patients/parents prior to 
administration of specific vaccines. CDC seeks written comment on 
proposed revised vaccine information materials for polio vaccines. 
These materials are being revised so that they will conform with the 
CDC's revised recommendation for use of polio vaccines effective 
January 1, 2000 when the recommendation will be to use only inactivated 
poliovirus vaccine (IPV), except in very limited circumstances.
    In addition, the CDC seeks written comment on proposed instructions 
for use of these vaccine information materials and the other vaccine 
information materials mandated under 42 U.S.C. 300aa-26.

DATES: Written comments are invited and must be received on or before 
November 1, 1999.

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, N.E., 
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, N.E., 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 Pub. L. 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, both public and private, 
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 who intends to administer one of the covered 
vaccines is required to provide copies of the relevant vaccine 
information materials prior to administration of any of these vaccines. 
Effective June 1, 1999, health care providers were also required to 
provide copies of vaccine information materials for the following 
vaccines that have recently been added to the National Vaccine Injury 
Compensation Program: hepatitis B, Haemophilus influenzae type b (Hib), 
and varicella (chickenpox) vaccines.

Revised Recommendations for Use of Polio Vaccines

    Progress continues toward the goal of world-wide eradication of 
poliomyelitis by the year 2000. As the risk of polio infection has 
diminished, recommendations for use of polio vaccines in the United 
States have changed significantly during the last few years to move 
away from exclusive use of oral poliovirus vaccine (OPV) toward 
exclusive use of inactivated poliovirus vaccine (IPV) and toward an 
ultimate goal of being able to cease polio vaccination.
    In February 1997, the CDC, in accepting the advice of its Advisory 
Committee on Immunization Practices (ACIP), revised its recommendation 
from a schedule of all OPV to a recommended sequential schedule of two 
doses of inactivated IPV followed by two doses of OPV as the preferred 
polio vaccination schedule for routine childhood immunization. At that 
time schedules using either all IPV or all OPV were also considered to 
be acceptable and preferred for some children in certain circumstances.
    The CDC noted in a February 6, 1997 Federal Register notice (62 FR 
5696) that the recommended schedules for polio immunization were 
expected to change further over time:
    ``The ACIP based their revised recommendations on a determination 
that the risk-benefit ratio associated with the exclusive use of OPV 
for routine immunization has changed because of rapid progress in 
global polio eradication efforts. In particular, the relative benefits 
of OPV to the United States population have diminished because of the 
elimination of wild-virus-associated poliomyelitis in the Western 
Hemisphere and the reduced threat of poliovirus importation into the 
United States. The risk for vaccine-associated poliomyelitis caused by 
OPV is now judged less acceptable because of the diminished risk for 
wild-virus-associated disease. Consequently, the ACIP recommended a 
transition policy that will increase use of IPV and decrease use of OPV 
during the next 3-5 years. Implementation of these recommendations 
should reduce the risk for vaccine-associated paralytic poliomyelitis 
and facilitate a transition to exclusive use of IPV following further 
progress in global polio eradication.''
    Noting further progress toward global eradication of wild 
poliovirus and ongoing concern regarding the vaccine-associated 
paralytic poliomyelitis risks associated with administration of OPV 
vaccine prior to receipt of doses of IPV, the ACIP at its meeting on 
October 22, 1998, voted to further revise its recommendation for 
administration of the two polio vaccines to discourage use of OPV 
vaccine for the first two doses, except in limited circumstances. 
Interim polio vaccine information materials reflecting this revised 
recommendation were published by the CDC in the Federal Register on 
February 23, 1999 (64 FR 9040).
    At its meeting on June 16, 1999, the ACIP voted to recommend an all 
IPV schedule as of January 1, 2000, stating:
    ``An all IPV schedule is recommended for routine childhood polio 
immunization as of January 1, 2000. All children will need to receive 
four doses of IPV at 2, 4, 6-18 months and 4-6 years of age.''

[[Page 48239]]

    ``OPV is acceptable only for the following special circumstances:
    (1) Mass immunization campaigns to control outbreaks due to wild-
type poliovirus;
    (2) Unimmunized children where travel to polio-endemic areas is 
imminent (i.e. in less than four weeks) may receive OPV for the first 
dose;
    (3) Children of parents who do not accept the recommended number of 
vaccine injections may receive OPV only for dose 3 or 4 or both. (OPV 
should be administered only after discussion of the risks of VAPP.)
    ``Limited availability of OPV is expected in the near future in the 
U.S.''
    The CDC has adopted these recommendations. In addition, CDC accepts 
use of OPV when the vaccinee has a life-threatening allergy to any 
component of IPV.
    With this notice, CDC proposes revised vaccine information 
materials to incorporate these revisions. CDC also intends to publish 
in a separate Federal Register notice proposed revised materials for 
use when OPV is being considered.
* * * * *

Proposed Instructions for Use of Vaccine Information Materials

    As noted above, under section 2126 of the Public Health Service Act 
(42 U.S.C. 300aa-26), all health care providers are required to 
distribute CDC-developed vaccine information materials to patients/
parents prior to administering any covered vaccine. This notice 
includes proposed instructions for implementing the statutory 
requirement. The proposed instructions specify the effective date for 
mandated use of each vaccine's information materials, note when the 
materials must be provided, delineate the edition dates of the current 
materials, delineate recordkeeping requirements, and include other 
related information. Under the proposed instructions, a health care 
provider would be required to note in the patient's medical record the 
date the vaccine information materials were provided and the edition 
date of the materials. The CDC considered various alternatives for 
documenting compliance with this statute, including requiring a 
patient/parent signature to acknowledge receipt of the materials. We 
concluded that a contemporaneous notation in the patient's medical 
record would be less burdensome than requiring a signature and would 
provide comparable evidence for purposes of establishing that the 
statutory mandate had been met, and as such should also meet the 
medico-legal needs of health care providers.
    We invite written comment on the proposed instructions that follow 
which delineate required use of the vaccine information materials and 
recordkeeping to verify compliance.
* * * * *

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, polio, hepatitis B, Haemophilus influenzae 
type b (Hib), or varicella (chickenpox) vaccine shall, prior to 
administration of each dose of the vaccine, provide a copy of the 
relevant current edition 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, as appropriate.
    ``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 Polio Vaccine Information Materials

    Effective January 1, 2000, health care providers shall distribute 
copies of the IPV polio vaccine information materials, dated [insert 
edition date], and/or OPV polio vaccine information materials, dated 
[insert edition date], in place of the February 1, 1999 and February 6, 
1997 versions of the polio materials.

Current Editions of Other Vaccine Information Materials

Diphtheria, Tetanus, Pertussis (DTP/DTaP/DT) Vaccine Information 
Materials, dated August 15, 1997
Tetanus, Diphtheria (Td) Vaccine Information Materials, dated June 10, 
1994
Measles, Mumps, Rubella Vaccine Information Materials, dated December 
16, 1998
Hepatitis B Vaccine Information Materials, dated December 16, 1998
Haemophilus influenzae type b (Hib) Vaccine Information Materials, 
dated December 16, 1998
Varicella (chickenpox) Vaccine Information Materials, dated December 
16, 1998

Recordkeeping

    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 materials distributed 
and (2) 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 also available on 
the Centers for Disease Control and Prevention's website at: http://
www.cdc.gov/nip/publications/VIS/. Copies are available in English and 
in other languages. 00/00/00 (Proposed) 42 U.S.C. 300aa-26
* * * * *

Proposed Revised Polio Vaccine Information Materials

    We invite written comment on the proposed revised vaccine 
information materials that follow, entitled ``Polio Vaccines: What You 
Need to Know.'' During the 60-day comment period, CDC also will consult 
with the Advisory Commission on Childhood Vaccines, appropriate health 
care provider and parent organizations, and the Food and Drug 
Administration. Comments submitted will be considered in finalizing 
these materials. We anticipate that the final version will be published

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this November, with an effective date of January 1, 2000.
    Proposed OPV polio vaccine information materials, for use when OPV 
is being considered, will be published in a separate Federal Register 
notice.
* * * * *

Polio Vaccines: What You Need to Know

1. What is polio?

    Polio is a disease caused by a virus. It can get into a child's (or 
adult's) body, usually through the mouth. Sometimes it does not cause 
serious problems. But sometimes it causes paralysis (can't move arm or 
leg), and sometimes it kills its victims.
    Polio used to be very common in the United States. It paralyzed and 
killed thousands of children a year before we had a vaccine for it.

2. Why get vaccinated?

    Polio vaccine can prevent polio.
    History: A 1916 polio epidemic in the Unites States killed 6,000 
people and paralyzed 27,000 more. In the early 1950's there were more 
than 20,000 cases of polio each year. Polio vaccine was introduced in 
1955. By 1960 the number of cases had dropped to about 3,000, and by 
1979 there were only about 30. This change would not have been possible 
without polio vaccine.
    Today: No wild polio has been reported in the United States for 
over 20 years. But the disease is still common in some parts of the 
world. It would only take one case of polio from another country to 
bring the disease back if we were not protected by vaccine. Until the 
disease is gone from the whole world, we should keep getting our 
children vaccinated.
    Inactivated polio vaccine (IPV) is a shot, given in the leg or arm, 
depending on age.

3. Who should get polio vaccine and when?

Children
    Most children should get 4 doses of IPV polio vaccine, at these 
ages:
     A dose at 2 months
     A dose at 4 months
     A dose at 6-18 months
     A booster dose at 4-6 years
    Polio vaccine may be given at the same time as other childhood 
vaccines.
Adults
    Most adults do not need polio vaccine because they are already 
immune. But some adults should consider polio vaccination. These adults 
include:

--People traveling to areas of the world where polio is common,
--Laboratory workers who might handle polio virus,
--Health care workers in contact with patients who could have polio.

    Adults in these groups who have never been vaccinated against polio 
should get 3 doses:
     The first dose at any time,
     The second dose 1 to 2 months later,
     The third dose 6 to 12 months after the second.
    Adults in these groups who have had 1 or 2 doses of polio vaccine 
in the past should get the remaining 1 or 2 doses. It doesn't matter 
how long it has been since the earlier dose(s).
    Adults in these groups who have received the complete series of 
polio vaccinations in the past may get a single dose of polio vaccine 
to make sure they are protected.

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                Oral Polio Vaccine: No longer recommended
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Until recently a live, oral polio vaccine (OPV) (drops that are
 swallowed) was recommended for most children in the United States. It
 was this oral vaccine that helped us rid the country of polio, and it
 is still used in many parts of the world.
The oral vaccine is very good at preventing outbreaks of polio. But
 sometimes it actually caused polio (about once for every 2.4 million
 doses). Since the risk of getting polio in the United States is now
 extremely low, experts decided that using oral vaccine is no longer
 worth the slight risk, except in very limited circumstances that can be
 described by your doctor. The polio shot (IPV) we now use can not cause
 polio.
If you or your child will be receiving oral polio vaccine (OPV), you
 should request a copy of the separate OPV vaccine information
 statement.
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4. Some People Should Not Get Polio Vaccine or Should Wait

    People should not get polio shots (IPV) if they have ever had a 
life-threatening allergic reaction to the drugs neomycin, streptomycin 
or polymyxin B. Anyone who has a severe allergic reaction to a polio 
shot should not get another one. These people can get the oral polio 
vaccine.
    People who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting polio 
vaccine.
    Ask your doctor or nurse for more information.

5. What are the risks from IPV polio vaccine?

    Some people who get IPV polio vaccine get a sore spot where the 
shot was given. The type of IPV used today has never been known to 
cause any serious problems, and most people don't have any problems at 
all with it.
    However, a vaccine, like any medicine could cause serious problems, 
such as a severe allergic reaction. The risk of a polio shot (IPV) 
causing serious harm, or death, is extremely small.

6. What if there is a serious reaction?

    What should I look for?
    Look for any unusual condition, such as a serious allergic 
reaction, high fever, or behavior changes. If a serious allergic 
reaction occurred, it would happen within a few minutes to a few hours 
after the shot. 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 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, there is a federal program that can 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 (English)
--Call 1-800-232-0233 (Espanol)

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--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, Polio--IPV (1/1/2000) (Proposed), 42 
U.S.C. Sec. 300aa-26.

    Dated: August 27, 1999.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 99-22869 Filed 9-1-99; 8:45 am]
BILLING CODE 4163-18-P