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federal_register: 2014-27678

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Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2014-27678 Request for Comment on Draft Vaccines Adverse Event Reporting System (VAERS) 2.0 Form Notice 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. 2014-11-24 2014 11 https://www.federalregister.gov/documents/2014/11/24/2014-27678/request-for-comment-on-draft-vaccines-adverse-event-reporting-system-vaers-20-form https://www.govinfo.gov/content/pkg/FR-2014-11-24/pdf/2014-27678.pdf Health and Human Services Department; Centers for Disease Control and Prevention 221,44 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...  

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