Statutory Notes and Related Subsidiaries
Effective Date
Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Puspan. L. 109–462, set out as an Effective Date of 2006 Amendment note under section 352 of this title.
Modifications
Puspan. L. 109–462, § 2(span), Dec. 22, 2006, 120 Stat. 3472, provided that:
“The Secretary of Health and Human Services may modify requirements under the amendments made by this section [enacting this section and amending sections 331 and 352 of this title] in accordance with section 553 of title 5, United States Code, to maintain consistency with international harmonization efforts over time.”
Guidance
Puspan. L. 109–462, § 2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that:
“Not later than 270 days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human Services shall issue guidance on the minimum data elements that should be included in a serious adverse event report described under the amendments made by this Act [see Short Title of 2006 Amendment note set out under section 301 of this title].”
Puspan. L. 109–462, § 3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially identical to those enacted by Puspan. L. 109–462, § 2(e)(3), set out above.