odic-change vaccine manufactured for an applicable vac-
cine season by a producer in accordance with an agree-
ment under subsection (a), the Secretary shall purchase 
from the producer 50 percent of such doses that are 
unsold for the season. 
(c) PRICE PER DOSE.— 
(1) AVERAGE SALES PRICE.—Subject to para-
graph (2), the price per dose paid by the Secretary 
in a purchase of periodic-change vaccine under sub-
section (b) shall be the average sales price for the 
vaccine for the applicable vaccine season, as deter-
mined by the Secretary. 
(2) AUDITS; ADJUSTMENTS.—The Secretary 
may enter into an agreement under subsection (a) 
with a producer regarding a periodic-change vaccine 
only if the agreement includes a provision that per-
mits the Secretary to conduct audits of sales of such 
vaccine at wholesale by the producer. The average 
sales price determined under paragraph (1) for a 
dose of the vaccine for an applicable vaccine season 
shall be adjusted by the Secretary as determined 
necessary by the Secretary on the basis of such au-
dits and on the basis of any other information avail-
able to the Secretary on sales of the vaccine at 
wholesale.
(d) DEFINITIONS.—For purposes of this section: 
(1) The term ‘‘approved vaccine’’ means a vac-
cine for which a biologics license under section 351 
is in effect. 
(2)(A) The term ‘‘federally recommended vac-
cine’’, with respect to an adult, means an approved 
vaccine recommended by the Advisory Committee on 
Immunization Practices (an advisory committee es-
tablished by the Secretary, acting through the Direc-
tor of the Centers for Disease Control and Preven-
tion). 
(B) The term ‘‘federally recommended vaccine’’, 
with respect to a child, means a vaccine on the list 
referred to in section 1928(e) of the Social Security 
Act. 
(3) The term ‘‘periodic-change vaccine’’ means 
a federally recommended vaccine that is designed 
only for a single applicable vaccine season due to 
characteristics of the etiologic agent or agents for 
the disease involved, or due to characteristics of the 
vaccine, that adversely affect the extent to which the 
vaccine is safe and effective after such season. Such 
term includes influenza vaccine. 
(4) The term ‘‘producer’’ means a person 
who—
(A) manufactures an approved vaccine; or 
(B) who intends to manufacture such a 
vaccine and is determined by the Secretary to 
have the capacity to meet legal requirements 
applicable to such manufacturing. 
(5)(A) The term ‘‘vaccine season’’, with respect 
to a periodic-change vaccine, means a consecutive 
number of months, not exceeding 24 months, during 
which the Secretary recommends that the public in 
general, or particular populations, as the case may 
be, receive immunizations against the disease in-
volved. 
(B) The term ‘‘applicable vaccine season’’, with 
respect to a periodic-change vaccine, means the vac-
cine season that is applicable to such vaccine. 
(e) DIRECT SPENDING.—The requirement under sub-
section (b) that the Secretary make purchases of doses 
of periodic-change vaccine constitutes budget authority in 
advance of appropriations Acts, and represents the obliga-
tion of the United States to make outlays for such pur-
chases in accordance with this subsection. 
SEC. 107. SURVEILLANCE. 
(a) DOMESTIC SURVEILLANCE.— 
(1) IN GENERAL.—The Secretary, in coordina-
tion with the Secretary of Agriculture, shall establish