Page:United States Statutes at Large Volume 121.djvu/927

 121 STAT. 906

PUBLIC LAW 110–85—SEPT. 27, 2007

dkrause on GSDDPC44 with PUBLAW

‘‘(ii) CONTENT.—The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include— ‘‘(I) descriptive information, including— ‘‘(aa) a brief title, intended for the lay public; ‘‘(bb) a brief summary, intended for the lay public; ‘‘(cc) the primary purpose; ‘‘(dd) the study design; ‘‘(ee) for an applicable drug clinical trial, the study phase; ‘‘(ff) study type; ‘‘(gg) the primary disease or condition being studied, or the focus of the study; ‘‘(hh) the intervention name and intervention type; ‘‘(ii) the study start date; ‘‘(jj) the expected completion date; ‘‘(kk) the target number of subjects; and ‘‘(ll) outcomes, including primary and secondary outcome measures; ‘‘(II) recruitment information, including— ‘‘(aa) eligibility criteria; ‘‘(bb) gender; ‘‘(cc) age limits; ‘‘(dd) whether the trial accepts healthy volunteers; ‘‘(ee) overall recruitment status; ‘‘(ff) individual site status; and ‘‘(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act, specify whether or not there is expanded access to the drug under section 561 of the Federal Food, Drug, and Cosmetic Act for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access; ‘‘(III) location and contact information, including— ‘‘(aa) the name of the sponsor; ‘‘(bb) the responsible party, by official title; and ‘‘(cc) the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a tollfree number through which such location information may be accessed); and ‘‘(IV) administrative data (which the Secretary may make publicly available as necessary), including— ‘‘(aa) the unique protocol identification number; ‘‘(bb) other protocol identification numbers, if any; and

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00904

Fmt 6580

Sfmt 6581

M:\STATUTES\2007\59194PT1.001

APPS10

PsN: 59194PT1

�