‘‘(ii) require periodic reports to the 
Secretary describing the progress of the re-
call; and 
‘‘(iii) provide for notice, including to 
individuals as appropriate, to persons who 
may be affected by the recall. 
In providing for such notice, the Secretary may 
allow for the assistance of health professionals, 
State or local officials, or other individuals des-
ignated by the Secretary. 
‘‘(C) 
NONDELEGATION.—An 
amended 
order under this paragraph shall be ordered by 
the Secretary or an official designated by the 
Secretary. An official may not be so designated 
unless the official is the director of the district 
under this Act in which the drug involved is lo-
cated, or is an official senior to such director. 
‘‘(d) EMERGENCY RECALL ORDER.— 
‘‘(1) IN GENERAL.—If the Secretary has cred-
ible evidence or information that a drug subject to 
an order under subsection (c)(1) presents an immi-
nent threat of serious adverse health consequences 
or death to humans or animals, the Secretary may 
issue an order requiring any person who distributes 
such drug— 
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‘‘(A) to immediately recall such drug; and 
‘‘(B) to provide for notice, including to in-
dividuals as appropriate, to persons who may be 
affected by the recall. 
‘‘(2) ACTION FOLLOWING ORDER.— 
‘‘(A) RECALL
AND
NOTIFICATION.—Any 
person who is subject to an emergency recall 
order under this subsection shall immediately 
recall such drug and provide notification as re-
quired by such order. 
‘‘(B) APPEAL.— 
‘‘(i) TIMING.—Any person who is sub-
ject to an emergency recall order under 
this subsection may appeal within 24 hours 
after issuance such order to the Secretary. 
‘‘(ii) CONTINUATION
OF
RECALL.— 
The person subject to an emergency recall 
order shall conduct the recall notwith-
standing the pendency of any appeal of 
such order. 
‘‘(C) INFORMAL
HEARING.—An informal 
hearing shall be held as soon as practicable but 
not later than 5 calendar days, or less as deter-
mined by the Secretary, after an appeal under 
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subparagraph (B) is filed, unless the parties 
jointly agree to an extension. 
‘‘(D) DETERMINATION.—After affording 
an opportunity for an informal hearing, the 
Secretary shall determine— 
‘‘(i) whether— 
‘‘(I) the order under paragraph 
(1) should be amended to require a 
recall of such drug; or 
‘‘(II) inadequate grounds exist to 
support the actions required by the 
order; or 
‘‘(ii) that the order under paragraph 
(1) was appropriate as issued. 
‘‘(E) 
AMENDMENT
OR
VACATION
OF 
ORDER.— 
‘‘(i) AMENDMENT.—In the case of a 
determination made under subparagraph 
(D)(i)(I), the Secretary shall amend the 
order made under paragraph (1) accord-
ingly. 
‘‘(ii) VACATION.—In the case of a de-
termination made under subparagraph 
(D)(i)(II), the Secretary shall vacate the 
order made under paragraph (1). 
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‘‘(3) NONDELEGATION.—An order under this 
subsection shall be issued by the Commissioner of 
Food and Drugs, the Principal Deputy Commis-
sioner, or the Associate Commissioner for Regu-
latory Affairs of the Food and Drug Administration. 
‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide notice of a recall order under this 
section to consumers to whom the drug was, or may have 
been, distributed and to appropriate State and local health 
officials. 
‘‘(f) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an 
order to cease distribution of, or to recall, a drug 
under any other provision of this Act or the Public 
Health Service Act; or 
‘‘(2) the ability of the Secretary to request any 
person to perform a voluntary activity related to any 
drug subject to this Act or the Public Health Service 
Act. 
‘‘(g) RECALL PLAN.—Any person required to register 
under section 510 shall have in effect a recall plan con-
sistent with the requirements of this section.’’. 
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(c) DELAYED
APPLICABILITY.—The amendments 
made by this section apply beginning on the date that is 
one year after the date of the enactment of this Act. 
Æ 
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