[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69853-69854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket No. CDC-2014-0015]


Request for Comment on Draft 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 of request for public comment.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), located 
within the Department of Health and Human Services (HHS), is publishing 
this notice requesting public comment on the proposed VAERS 2.0 form, 
which is intended to replace the current VAERS-1 form (https://vaers.hhs.gov/resources/vaers_form.pdf). CDC and the U.S. Food and Drug 
Administration (FDA) co-administer the Vaccines Adverse Event Reporting 
System (VAERS), a post-licensure (i.e., after vaccines have been 
licensed by the FDA and are being used in the community) reporting 
system that accepts submitted reports of adverse events that occur 
after vaccination from healthcare providers, manufacturers, and the 
public. Healthcare providers and vaccine manufacturers are required to 
submit VAERS reports. The National Childhood Vaccine Injury Act of 
1986, section 2125 of the Public Health Service Act (42 U.S.C. 300aa-
25) authorized VAERS. The current VAERS form has been used since 1990.

DATES: Written comments must be received on or before January 23, 2015.

ADDRESSES: You may submit comments, identified by docket number CDC-
2014-0015 by any of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    <bullet> Mail: You may also submit written comments to the 
following address: Centers for Disease Control and Prevention, (CDC), 
National Center for Emerging and Zoonotic Infectious Diseases, Division 
of Healthcare Quality Promotion, Immunization Safety Office, Attn: 
VAERS 2.0 form Docket No. CDC-

[[Page 69854]]

2014-0015, 1600 Clifton Rd. NE., Mailstop A-07, Atlanta, Georgia, 
30333.
    Instructions: All submissions received must include the agency name 
and docket number. All relevant comments received will be posted 
without change to http://regulations.gov, including any personal 
information provided. For access to the docket to read background 
documents or comments received, go to http://www.regulations.gov. All 
materials submitted will be available for public inspection Monday 
through Friday, except for legal holidays, from 9 a.m. until 5 p.m., 
Eastern Standard Time, at 1600 Clifton Road NE., Atlanta, Georgia 
30333. Please call ahead to (404) 639-4000 and ask for a representative 
from Immunization Safety Office to schedule your visit. You should be 
aware that this office is in a Federal government building; therefore, 
Federal security measures are applicable. For additional information, 
please see Roybal Campus Security Guidelines under SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Tiffany Suragh; Centers for Disease 
Control and Prevention, National Center for Emerging and Zoonotic 
Infectious Diseases, Division of Healthcare Quality Promotion, 
Immunization Safety Office, l600 Clifton Road NE., Mailstop D-26; 
Atlanta, Georgia, 30329-4018; Telephone: (404) 639-4000.

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 (US). 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 file 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 file VAERS reports. Although VAERS is not designed to assess 
if a vaccine caused an adverse event, VAERS provides CDC and 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 30,000 US reports annually.
    VAERS is a mandated activity for the U.S. 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 proposed VAERS 2.0 form will be 
similar to that on the current VAERS-1 form so historical comparisons 
can be made; however, the changes in the draft VAERS 2.0 form should 
improve reporting efficiency and data quality. VAERS 2.0 offers 
standardized responses, clearer instructions and guidance, and improved 
online reporting. Select questions have been updated, with questions 
added, removed, and reorganized to decrease response burden and 
maximize usability. The draft VAERS 2.0 form can be found at http://www.regulations.gov.
    During the development of the draft 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) and was tested with potential 
reporters (e.g., physicians, nurses, pharmacists, patients, and 
parents). All public comments will be reviewed and considered prior to 
finalizing the VAERS 2.0 form.
    Roybal Campus Security Guidelines: The Edward R. Roybal Campus is 
the headquarters of the U.S. Centers for Disease Control and Prevention 
and is located at 1600 Clifton Road NE., Atlanta, Georgia. The 
Immunization Safety Office is in a Federal government building; 
therefore, Federal security measures are applicable.
    In planning your arrival time, please take into account the need to 
park and clear security. All visitors must enter the Roybal Campus 
through the entrance on Clifton Road; the guard force will direct 
visitors to the designated parking area. Upon arrival at the facility, 
visitors must present government issued photo identification (e.g., a 
valid federal identification badge, state driver's license, state non-
driver's identification card, or passport). Non-United States citizens 
must complete the required security paperwork prior to the visit date 
and must present a valid passport, visa, Permanent Resident Card, or 
other type of work authorization document upon arrival at the facility. 
All persons entering the building must pass through a metal detector. 
Visitors will be issued a visitor's ID badge at the entrance to 
Building 19 and will be escorted to a room to view the available 
materials. All items brought to HHS/CDC are subject to inspection.

    Dated: November 18, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science, Centers for Disease 
Control and Prevention.
[FR Doc. 2014-27678 Filed 11-21-14; 8:45 am]
BILLING CODE 4163-18-P