PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 907
dkrause on GSDDPC44 with PUBLAW
‘‘(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date. ‘‘(iii) MODIFICATIONS.—The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information. ‘‘(B) FORMAT AND STRUCTURE.— ‘‘(i) SEARCHABLE CATEGORIES.—The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria: ‘‘(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors. ‘‘(II) The name of the intervention, including any drug or device being studied in the clinical trial. ‘‘(III) The location of the clinical trial. ‘‘(IV) The age group studied in the clinical trial, including pediatric subpopulations. ‘‘(V) The study phase of the clinical trial. ‘‘(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization. ‘‘(VII) The recruitment status of the clinical trial. ‘‘(VIII) The National Clinical Trial number or other study identification for the clinical trial. ‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not later than 18 months after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome. ‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis. ‘‘(iv) FORMAT.—The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared. ‘‘(C) DATA SUBMISSION.—The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, the date of the enactment of the Food and Drug Administration Amendments Act of 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of subparagraph (A)(ii) not later than the later of— ‘‘(i) 90 days after such date of enactment; ‘‘(ii) 21 days after the first patient is enrolled in such clinical trial; or
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00905
Fmt 6580
Sfmt 6581
Deadline.
Deadlines.
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
