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<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>84406</law_id><section_number>2.2-5503</section_number><catch_line>Requirements for regulated introduction</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><referred_to_by><reference>2.2-5504</reference><reference>2.2-5505</reference><reference>2.2-5506</reference><reference>2.2-5507</reference><reference>2.2-5508</reference></referred_to_by><structure><unit label="title" level="1" order_by="1" identifier="2.2">Administration of Government</unit><unit label="subtitle" level="2" order_by="1" identifier="II">Administration of State Government</unit><unit label="part" level="3" order_by="1" identifier="B">Transaction of Public Business</unit><unit label="chapter" level="4" order_by="1" identifier="55">Virginia Biotechnology Research Act</unit></structure><text>
						<section><p>Except as provided under &#xA7;&#xA0;<a class="law" title="Exemptions from chapter to be determined by Department" href="/2.2-5502/">2.2-5502</a>, no person may commence a <span class="dictionary">regulated introduction</span> unless the person:</p></section>
						<section id="1"><p><span class="prefix-number">1.</span> Provides to the <span class="dictionary">Department</span> all of the following information within seven days after the person submits or should have submitted the information specified in subdivisions 1 a and 1 b to a <span class="dictionary">federal regulator</span>, whichever is sooner:
			a. A copy of all information that the person is required to submit to the <span class="dictionary">federal regulator</span> and that is not confidential information; and
			b. A summary of any confidential information that the person submits or is required to submit to a <span class="dictionary">federal regulator</span>. The summary shall provide sufficient information to enable the <span class="dictionary">Department</span> to exercise its notice and comment functions under &#xA7;&#xA7; <a class="law" title="Public notice of proposed regulated introduction" href="/2.2-5504/">2.2-5504</a> and <a class="law" title="Comment on proposed regulated introduction" href="/2.2-5505/">2.2-5505</a>, to provide public notice pursuant to &#xA7; <a class="law" title="Public notice of proposed regulated introduction" href="/2.2-5504/">2.2-5504</a>, and to prepare comments pursuant to &#xA7; <a class="law" title="Comment on proposed regulated introduction" href="/2.2-5505/">2.2-5505</a>, and shall have minimal extraneous and irrelevant information. The summary shall also provide sufficient information to enable the <span class="dictionary">locality</span> in which the introduction is proposed to be made to exercise its comment function under &#xA7; <a class="law" title="Comment on proposed regulated introduction" href="/2.2-5505/">2.2-5505</a>. <a id="paragraph-302533" class="section-permalink" href="https://vacode.org/2.2-5503/#1"><i class="fa fa-link"/></a></p></section>
						<section id="2"><p><span class="prefix-number">2.</span> Provides such additional information, if any, as is necessary to enable the <span class="dictionary">Department</span> to fulfill any functions it undertakes, on a case-by-case basis, under &#xA7; <a class="law" title="Comment on proposed regulated introduction" href="/2.2-5505/">2.2-5505</a>. <a id="paragraph-302534" class="section-permalink" href="https://vacode.org/2.2-5503/#2"><i class="fa fa-link"/></a></p></section></text><history>1994, c. 472, &#xA7; 2.1-772; 2001, c. 844.</history><metadata></metadata></law>
