[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36146-36147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16335]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2014-0015]


Vaccines Adverse Event Reporting System (VAERS) 2.0 Form

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

ACTION: Notice.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS) announces the 
availability of the final Vaccines Adverse Event Reporting System 
(VAERS) 2.0 Form www.vaers.hhs.gov. The VAERS 2.0 Form replaces the 
VAERS-1 Form which had been in use since 1990.

DATES: The VAERS 2.0 Form was implemented June 30, 2017.

FOR FURTHER INFORMATION CONTACT: Tiffany Suragh, National Center for 
Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
and Prevention, 1600 Clifton Road NE., Mailstop D-26; Atlant, Georgia 
30329-4018; Telephone: (404) 498-0681.

SUPPLEMENTARY INFORMATION: VAERS is an important and critical ``early 
warning system'' in the federal vaccine safety infrastructure for 
identifying adverse events after receipt of childhood, adolescent, and 
adult vaccines licensed for use in the United States. Healthcare 
providers and vaccine manufacturers are required under section 2125(b) 
of the Public Health Service Act (42 U.S.C. 300aa-25(b)) to submit 
VAERS reports regarding the occurrence of any event set forth in the 
Vaccine Injury Table which occurs within 7 days of the administration 
of any vaccine set forth in the Table or within such longer period as 
is specified in the Table and the occurrence of any contraindicating 
reaction to a vaccine which is specified in the manufacturer's package 
insert. VAERS also accepts reports on adverse events following receipt 
of other vaccines. Patients, parents and others aware of adverse events 
can also submit VAERS reports. Although VAERS is not designed to assess 
if a vaccine caused an adverse event, VAERS provides HHS/CDC and HHS/
FDA with important early information that might signal a potential 
problem. If the VAERS data suggest a possible association between an 
adverse event and vaccination, the relationship will be further 
assessed. In recent years VAERS has received approximately 40,000 U.S. 
reports annually.
    VAERS is a mandated activity for the Department of Health and Human 
Services (HHS) and VAERS data are used by Federal agencies, State 
Health Officials, health care providers, manufacturers, and the public. 
Therefore, it is important to maximize the usefulness of this system. 
The information collected by the final VAERS 2.0 Form will be similar 
to that from the current VAERS-1 Form so historical comparisons can be 
made. However, the changes in the final VAERS 2.0 Form should improve 
reporting efficiency and data quality. VAERS 2.0 Form offers 
standardized responses, clearer instructions and guidance, and improved 
online reporting capability. Select questions

[[Page 36147]]

have been updated, with questions added, removed, and reorganized to 
decrease response burden and maximize usability. The final VAERS 2.0 
Form can be found at http://www.regulations.gov and www.vaers.hhs.gov.
    During the development of the VAERS 2.0 Form, CDC and FDA sought 
input from key stakeholders in the Federal government, State Health 
Officials involved in vaccine safety and vaccine programs, and other 
public health partners. In addition, the VAERS 2.0 Form was presented 
to three Federal advisory committees, the Advisory Commission on 
Childhood Vaccines (September 5, 2014), the National Vaccine Advisory 
Committee (September 9, 2014), and the Advisory Committee on 
Immunization Practices (October, 2014). Finally, the final VAERS form 
was tested with potential users (e.g., physicians, nurses, pharmacists, 
patients, and parents).
    On November 24, 2014 HHS/CDC published a notice in the Federal 
Register (79 FR 69853) announcing the opening of a docket to obtain 
public comment on the draft VAERS 2.0 Form. HHS/CDC received 19 
comments on the draft VAERS 2.0 Form from members of the general public 
and professional and advocacy organizations. All comments were 
carefully reviewed and considered in the preparation of the final VAERS 
form.

    Dated: July 31, 2017.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2017-16335 Filed 8-2-17; 8:45 am]
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