APHIS Form 2081 Adverse Event Report Follow-Up Information

Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124

APHIS 2081 SEP 2015 (SECURE)

Virus-Serum-Toxin Act and Regulations - Business

OMB: 0579-0013

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According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a valid OMB control number. The valid OMB control number for this information is 0579-0209. The time required to complete this information collection is estimated
to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information.

UNITED STATES DEPARTMENT OF AGRICULTURE
ANIMAL AND PLANT HEALTH INSPECTION SERVICE
VETERINARY SERVICES
CENTER FOR VETERINARY BIOLOGICS
1920 DAYTON AVENUE
AMES, IOWA 50010
Identify the initial report submitted using either:
•
•
•

OMB Approved
0579-0209
EXP. XX/XXXX

ADVERSE EVENT REPORT
FOLLOW-UP INFORMATION
Initial Report Identifier

the case number provided to you by USDA staff, or
the "submission reference number" allocated to your initial report by our Web site, or
your original "submitter's case number"

SUBMITTER INFORMATION
1. Information Collected By

2. Contract Number

3. Date Follow-up Information Received
(MM/DD/YYYY)

REP

SOR

4. First Name

5. Last Name

6. Submitted to Manufacturer
YES

NO

ADDITIONAL INFORMATION
Follow-up Information (narrative)

FORM SUBMITTAL
Save and submit via email to:
cvb@aphis.usda.com

APHIS Form 2081
SEP 2015

Print form and mail to:
Pharmacovigilance, USDA,
Center for Veterinary Biologics,
1920 Dayton Avenue,
Ames, IA 50010

Print and fax it to:
515-337-6120


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