[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:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
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]
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