applicable Federal, State, or local law or 
regulation; and 
‘‘(ix) assurances of compliance with 
all other requirements of this section; or 
‘‘(B) with respect to a State that intends 
to use funds under the grant as provided for in 
subsection (a)(1)(B)— 
‘‘(i) a budget cost estimate for the 
controlled substance monitoring program 
to be improved under the grant; 
‘‘(ii) a plan for ensuring that the 
State controlled substance monitoring pro-
gram is in compliance with the standards 
and penalty requirements described in 
clauses (ii) through (viii) of subparagraph 
(A); 
‘‘(iii) a plan to enable the State con-
trolled substance monitoring program to 
achieve interoperability with at least one 
other State controlled substance moni-
toring program, including— 
‘‘(I) the technical achievement of 
information sharing between the two 
programs;
‘‘(II) measures to ensure that 
interoperability activities carried out 
under this subsection are in compli-
ance with the requirements of sub-
paragraph (A); 
‘‘(III) measures to ensure that 
proposed standards for information 
access will be enforced for shared in-
formation; and 
‘‘(IV) the completion of interstate 
legal compacts necessary for such in-
formation sharing; and 
‘‘(iv) assurances of compliance with 
all other requirements of this section or a 
statement describing why such compliance 
is not feasible or is contrary to the best in-
terests of public health in such State. 
‘‘(2) APPROVAL OR DISAPPROVAL.— 
‘‘(A) IN
GENERAL.—Not later than 90 
days after the submission by a State of an ap-
plication under paragraph (1), the Secretary 
shall approve or disapprove the application, or 
request additional information as provided 
under subparagraph (C). The Secretary may 
disapprove an application that contains a state-
ment described in paragraph (1)(B)(iv), or re-
quest additional information with respect to 
such a statement, if the Secretary determines 
that the approval of such application would re-
sult in the implementation of a State program 
that substantially fails to meet the goals and 
objectives of this section. 
‘‘(B) APPROVAL.—The Secretary shall ap-
prove an application submitted under para-
graph (1) only if— 
‘‘(i) the plans contained in the appli-
cation meet the standards developed by the 
Secretary under subsection (b); and 
‘‘(ii) the State demonstrates to the 
Secretary that the State will establish and 
implement or improve a controlled sub-
stance monitoring program in accordance 
with this section. 
‘‘(C) ADDITIONAL
INFORMATION.—With 
respect to an application submitted by a State 
under paragraph (1), the Secretary may, during 
the 90-day period referred to in subparagraph 
(A), request that the State provide additional 
information with respect to the State program. 
If such a request is made after the expiration
of the 60-day period beginning on the date on 
which the application is submitted, the period 
under subparagraph (A) for approval or dis-
approval by the Secretary shall be extended for 
an additional 30 days. 
‘‘(3) WITHDRAWAL
OF
AUTHORIZATION.—Ex-
cept to the extent that a State is excused from com-
pliance with a requirement or standard as a result 
of the approval by the Secretary of a statement 
under paragraph (1)(B)(iv) or under subsection (d), 
if a State fails to implement or improve a controlled 
substance monitoring program in accordance with 
this section or fails to comply with the standards de-
veloped under this subsection— 
‘‘(A) the Secretary shall give notice of the 
failure to the State; and 
‘‘(B) if the State fails to take corrective 
action within a reasonable period of time, the 
Secretary shall withdraw any approval of the 
State’s application under this section. 
‘‘(4) VOLUNTARY DISCONTINUANCE.—A fund-
ing agreement for the receipt of a grant under this 
section is that the State involved will give a reason-
able period of notice to the Secretary before ceasing 
to implement or operate a controlled substance mon-
itoring program under this section. The Secretary 
shall determine the period of notice that is reason-
able for purposes of this paragraph. 
‘‘(5) RETURN
OF
FUNDS.—If the Secretary 
withdraws approval of a State’s application under 
this section, or the State chooses to cease to imple-
ment or improve a controlled substance monitoring 
program under this section, a funding agreement for 
the receipt of a grant under this section is that the 
State will return to the Secretary an amount which 
bears the same ratio to the overall grant as the re-
maining time period for expending the grant funds 
bears to the overall time period for expending the 
grant (as specified by the Secretary at the time of 
the grant). 
‘‘(d) REPORTING REQUIREMENTS.—In implementing 
or improving a controlled substance monitoring program 
under this section, a State shall comply, or with respect 
to a State that applies for a grant under subsection 
(a)(1)(B) submit to the Secretary for approval a state-
ment of why such compliance is not feasible or is contrary 
to the best interests of public health in such State, with 
the following: 
‘‘(1) The State shall require dispensers to re-
port to such State each dispensing in the State of