82 FR 36146 - Vaccines Adverse Event Reporting System (VAERS) 2.0 Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 148 (August 3, 2017)

Page Range		36146-36147
FR Document		2017-16335

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.

Federal Register, Volume 82 Issue 148 (Thursday, August 3, 2017)

[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36146-36147]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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]
BILLING CODE 4163-18-P

36146 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
Number of
Number of burden per
Section Form name responses per
respondents response
respondent (in hours)

73.5 & 6 ............. Federal Law Enforcement Reporting Seizure of Select Agent or Toxin 1 1 30/60
(APHIS/CDC Form 4C).
73.5 & 6 ............. Report of Identification of a Select Agent or Toxin (APHIS/CDC Form 4) 1,030 1 30/60
Guidance.
73.5 & 73.6 ........ Request of Exemption of Select Agents and Toxins for an Investigational 1 1 30/60
Product (APHIS/CDC Form 5).
73.5 & 73.6 ........ Request of Exemption of Select Agents and Toxins for an Investigational 1 1 30/60
Product (APHIS/CDC Form 5) Guidance.
73.3 & 73.4 ........ Request for Exclusions ................................................................................ 3 1 30/60
73.3 & 73.4 ........ Request for Exclusions Guidance ............................................................... 3 1 30/60
73.9 ................... Documentation of Self-inspection ................................................................ 238 1 1
73.1 ................... Request for Expedited Review .................................................................... 1 1 15/60
73.1 ................... Request for Expedited Review Guidance .................................................... 1 1 15/60
73.11 ................. Security Plan ................................................................................................ 238 1 5
73.11 ................. Security Plan Guidance ............................................................................... 238 1 30/60
73.11 ................. Security Plan Template ................................................................................ 238 1 30/60
73.12 ................. Biosafety Plan .............................................................................................. 238 1 5
73.12 ................. Biosafety Plan Guidance ............................................................................. 238 1 30/60
73.12 ................. Biosafety Plan Template .............................................................................. 238 1 30/60
73.13 ................. Request Regarding a Restricted Experiment .............................................. 1 1 30/60
73.13 ................. Request Regarding a Restricted Experiment Guidance ............................. 1 1 30/60
73.14 ................. Incident Response Plan ............................................................................... 238 1 5
73.14 ................. Incident Response Plan Guidance .............................................................. 238 1 30/60
73.14 ................. Incident Response Plan Template ............................................................... 238 1 30/60
73.15 ................. Training ........................................................................................................ 238 1 30/60
73.15 ................. Training Guidance ........................................................................................ 238 1 30/60
73.17 ................. Records ........................................................................................................ 238 1 30/60
73.17 ................. Guidance on the Inventory of Select Agents ............................................... 238 1 30/60
73.20 ................. Administrative Review .................................................................................. 1 1 1

Leroy A. Richardson, VAERS–1 Form which had been in use vaccines. Patients, parents and others
Chief, Information Collection Review Office, since 1990. aware of adverse events can also submit
Office of Scientific Integrity, Office of the DATES: The VAERS 2.0 Form was VAERS reports. Although VAERS is not
Associate Director for Science, Office of the implemented June 30, 2017. designed to assess if a vaccine caused an
Director, Centers for Disease Control and adverse event, VAERS provides HHS/
Prevention. FOR FURTHER INFORMATION CONTACT:
Tiffany Suragh, National Center for CDC and HHS/FDA with important
[FR Doc. 2017–16333 Filed 8–2–17; 8:45 am]
Emerging and Zoonotic Infectious early information that might signal a
BILLING CODE 4163–18–P potential problem. If the VAERS data
Diseases, Centers for Disease Control
and Prevention, 1600 Clifton Road NE., suggest a possible association between
Mailstop D–26; Atlant, Georgia 30329– an adverse event and vaccination, the
DEPARTMENT OF HEALTH AND
4018; Telephone: (404) 498–0681. relationship will be further assessed. In
HUMAN SERVICES
recent years VAERS has received
SUPPLEMENTARY INFORMATION: VAERS is
Centers for Disease Control and approximately 40,000 U.S. reports
an important and critical ‘‘early warning
Prevention annually.
system’’ in the federal vaccine safety
infrastructure for identifying adverse VAERS is a mandated activity for the
[Docket No. CDC–2014–0015] events after receipt of childhood, Department of Health and Human
adolescent, and adult vaccines licensed Services (HHS) and VAERS data are
Vaccines Adverse Event Reporting for use in the United States. Healthcare used by Federal agencies, State Health
System (VAERS) 2.0 Form providers and vaccine manufacturers Officials, health care providers,
are required under section 2125(b) of manufacturers, and the public.
AGENCY: Centers for Disease Control and the Public Health Service Act (42 U.S.C. Therefore, it is important to maximize
Prevention (CDC), Department of Health 300aa–25(b)) to submit VAERS reports the usefulness of this system. The
and Human Services (HHS). regarding the occurrence of any event information collected by the final
ACTION: Notice. set forth in the Vaccine Injury Table VAERS 2.0 Form will be similar to that
which occurs within 7 days of the from the current VAERS–1 Form so
SUMMARY: The Centers for Disease administration of any vaccine set forth historical comparisons can be made.
mstockstill on DSK30JT082PROD with NOTICES

Control and Prevention (CDC), located in the Table or within such longer However, the changes in the final
within the Department of Health and period as is specified in the Table and VAERS 2.0 Form should improve
Human Services (HHS) announces the the occurrence of any contraindicating reporting efficiency and data quality.
availability of the final Vaccines reaction to a vaccine which is specified VAERS 2.0 Form offers standardized
Adverse Event Reporting System in the manufacturer’s package insert. responses, clearer instructions and
(VAERS) 2.0 Form www.vaers.hhs.gov. VAERS also accepts reports on adverse guidance, and improved online
The VAERS 2.0 Form replaces the events following receipt of other reporting capability. Select questions

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Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices 36147

have been updated, with questions comments should address any of the objectives: (1) Determine the reach and
added, removed, and reorganized to following: (a) Evaluate whether the saturation of the initiative’s messages in
decrease response burden and maximize proposed collection of information is Puerto Rico and the domestic U.S.; (2)
usability. The final VAERS 2.0 Form can necessary for the proper performance of measure the extent to which messages
be found at http://www.regulations.gov the functions of the agency, including were communicated clearly across
and www.vaers.hhs.gov. whether the information will have multiple channels to advance
During the development of the practical utility; (b) Evaluate the knowledge and counter misinformation;
VAERS 2.0 Form, CDC and FDA sought accuracy of the agencies estimate of the and (3) monitor individual and
input from key stakeholders in the burden of the proposed collection of community-level awareness, attitudes
Federal government, State Health information, including the validity of and likelihood to follow recommended
Officials involved in vaccine safety and the methodology and assumptions used; behavior. This data collection includes
vaccine programs, and other public (c) Enhance the quality, utility, and 2,400 surveys conducted in four
health partners. In addition, the VAERS clarity of the information to be geographic locations following peak
2.0 Form was presented to three Federal collected; (d) Minimize the burden of campaign activity to assess key
advisory committees, the Advisory the collection of information on those outcomes of the initiative. The
Commission on Childhood Vaccines who are to respond, including through information will be used to make
(September 5, 2014), the National the use of appropriate automated, recommendations for improving
Vaccine Advisory Committee electronic, mechanical, or other communication and education regarding
(September 9, 2014), and the Advisory technological collection techniques or the prevention and spread of the Zika
Committee on Immunization Practices other forms of information technology, virus. Information may also be used to
(October, 2014). Finally, the final e.g., permitting electronic submission of develop presentations, reports, and
VAERS form was tested with potential responses; and (e) Assess information manuscripts to document the
users (e.g., physicians, nurses, collection costs. communication effort and lessons
pharmacists, patients, and parents). To request additional information on learned in order to inform future similar
On November 24, 2014 HHS/CDC the proposed project or to obtain a copy communication efforts.
published a notice in the Federal of the information collection plan and The goal of this project is to
Register (79 FR 69853) announcing the instruments, call (404) 639–7570 or determine knowledge, attitudes, and
opening of a docket to obtain public send an email to omb@cdc.gov. Written practices related to a Domestic
comment on the draft VAERS 2.0 Form. comments and/or suggestions regarding Readiness Initiative on Zika Virus
HHS/CDC received 19 comments on the the items contained in this notice Disease being launched in the United
draft VAERS 2.0 Form from members of should be directed to the Attention: States (U.S.) mainland and Puerto Rico.
CDC Desk Officer, Office of Management CDC will seek to gain OMB approval
the general public and professional and
and Budget, Washington, DC 20503 or of this new information collection
advocacy organizations. All comments
by fax to (202) 395–5806. Written request to conduct a final survey (wave
were carefully reviewed and considered
comments should be received within 30 3) to evaluate the CDC Domestic
in the preparation of the final VAERS
days of this notice. Readiness Initiative for Zika Virus. The
form.
Zika Readiness Initiative campaign has
Dated: July 31, 2017. Proposed Project been implemented in two phases with
Sandra Cashman, Knowledge, Attitudes, and Practices peak campaign activity coinciding with
Executive Secretary, Centers for Disease related to a Domestic Readiness the height of mosquito season during
Control and Prevention. Initiative on Zika Virus Disease—New— the summer months of 2016 (phase 1)
[FR Doc. 2017–16335 Filed 8–2–17; 8:45 am] Office of the Associate Director for and 2017 (phase 2). OMB granted CDC
BILLING CODE 4163–18–P Communication, Centers for Disease an emergency review approval in 2016
Control and Prevention (CDC). (OMB Control Number 0920–1136,
expiration 3/31/2017) to conduct the
Background and Brief Description first two waves of data collection which
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Since late 2015, Zika has rapidly captured the effectiveness of the first
spread through Puerto Rico. As of phase of the campaign. The third wave
Centers for Disease Control and November 2016, there have been 35,136 of data collection will allow CDC to
Prevention confirmed cases of Zika in Puerto Rico, capture the effectiveness of the second
with 2,797 cases among pregnant phase of the campaign being
[30Day–17–17WE]
women and 67 cases of Guillain-Barré implemented through late summer/early
Agency Forms Undergoing Paperwork caused by Zika. In the continental fall 2017.
Reduction Act Review United States, there have been 4,432 While the campaign objectives and
travel-associated cases of Zika and 185 the call to action remain the same across
The Centers for Disease Control and locally-acquired Zika cases in Florida both phases, campaign materials have
Prevention (CDC) has submitted the and Texas. Due to the urgent nature of been modified between phases based
following information collection request this public health emergency, CDC is the first two waves of data collection to
to the Office of Management and Budget implementing a Zika prevention better address misinformation about
(OMB) for review and approval in communication and education Zika and promote a sense of urgency to
accordance with the Paperwork initiative. adopt preventive actions. The third and
Reduction Act of 1995. The notice for The purpose of this survey is to assess final wave of data collection is vital to
mstockstill on DSK30JT082PROD with NOTICES

the proposed information collection is a domestic U.S. and Puerto Rico-based CDC’s continued understanding of how
published to obtain comments from the communication and education initiative the campaign information is received by
public and affected agencies. aimed at encouraging at-risk target audiences and what actions are
Written comments and suggestions populations to protect themselves and being taken to prevent Zika virus
from the public and affected agencies their families from Zika virus infection. transmission Findings will be used to
concerning the proposed collection of CDC will assess the following improve planning, implementation,
information are encouraged. Your communication and education refinements and demonstrate outcomes

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Document Created: 2017-08-03 07:25:02
Document Modified: 2017-08-03 07:25:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The VAERS 2.0 Form was implemented June 30, 2017.
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.
FR Citation		82 FR 36146

82 FR 36146 - Vaccines Adverse Event Reporting System (VAERS) 2.0 Form

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 82, Issue 148 (August 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention