‘‘(v) such samples of such drug and of 
the articles used as components thereof as 
the Secretary may require; and 
‘‘(vi) specimens of the labeling pro-
posed to be used for such drug. 
‘‘(B) PATENT INFORMATION.— 
‘‘(i) REQUIREMENT.—The applicant 
shall file with the application the patent 
number and the expiration date of any pat-
ent which claims the drug for which the 
applicant submitted the application or 
which claims a method of using such drug 
and with respect to which a claim of patent 
infringement could reasonably be asserted 
if a person not licensed by the owner en-
gaged in the manufacture use, or sale of 
the drug. 
‘‘(ii) TYPES OF PATENTS.— 
‘‘(I) PATENTS SUBJECT TO RE-
QUIREMENT.—The patents for which 
information under clause (i) is re-
quired to be filed with the Secretary 
are drug substance (ingredient) pat-
ents, drug product (formulation and 
composition) patents, product by proc-
ess patents, and method of use pat-
ents. 
‘‘(II) PROHIBITION
REGARDING 
CERTAIN PATENTS.—Process patents, 
patents claiming packaging, patents 
claiming metabolites, and patents 
claiming intermediates are not patents 
described in subclause (I), and infor-
mation on such patents may not be 
filed with the Secretary. 
‘‘(III) PATENT REGARDING DRUG 
SUBSTANCE.—For patents that claim 
the drug substance, the applicant 
shall submit information only on pat-
ents that claim the drug substance 
that is the subject of the pending or 
approved application or that claim a 
drug substance that is the same as 
the active ingredient that is the sub-
ject of an approved or pending appli-
cation within the meaning of sub-
section (j)(2)(A)(ii). 
‘‘(IV) PATENT REGARDING DRUG 
PRODUCT.—For patents that claim a 
drug product, the applicant shall sub-
mit information only on those patents 
that claim a drug product that is the 
subject of a pending or approved ap-
plication. 
‘‘(V) PATENT REGARDING METH-
OD OF USE.—For patents that claim a 
method of use, the applicant shall 
submit information only on those pat-
ents that claim indications or other 
conditions of use that are the subject 
of a pending or approved application. 
For approved applications, the appli-
cant shall identify the indication or 
other condition of use in the approved 
labeling that corresponds to the listed 
patent and claim identified. 
‘‘(iii) FILING OF PATENT AFTER SUB-
MISSION OF APPLICATION.—If an applica-
tion is filed under this subsection for a 
drug and a patent which claims such drug 
or a method of using such drug is issued 
after the filing date but before approval of 
the application, the applicant shall amend 
the application to include the information 
required by clauses (i) and (ii).
‘‘(iv) PUBLICATION
OF
PATENT
IN-
FORMATION.—Upon approval of the appli-
cation, the Secretary shall publish informa-
tion submitted under clauses (i) through 
(iii). 
‘‘(C) GUIDANCE REGARDING INCLUSION OF 
WOMEN
AND
MINORITIES
IN
CLINICAL 
TRIALS.—The Secretary shall, in consultation 
with the Director of the National Institutes of 
Health and with representatives of the drug 
manufacturing industry, review and develop 
guidance, as appropriate, on the inclusion of 
women and minorities in clinical trials required 
by subparagraph (A)(i).’’. 
(2) CONFORMING AMENDMENTS.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.) is amended— 
(A) in section 201(p)— 
(i) by striking ‘‘safety and effective-
ness of’’ and inserting ‘‘safety of’’; and 
(ii) by striking ‘‘safe and effective for 
use’’ and inserting ‘‘safe for use’’; and 
(B) in section 505—