[Federal Register Volume 66, Number 171 (Tuesday, September 4, 2001)]
[Rules and Regulations]
[Pages 46225-46227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22129]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 96


Tobacco Regulation and Maintenance of Effort Reporting 
Requirements for Substance Abuse Prevention and Treatment Block Grant 
Applicants

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Interim final rule.

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SUMMARY: This interim final rule clarifies that States may no longer 
obtain extensions to submit the maintenance of effort (MOE) information 
required under section 1930(c) of the Public Health Service (PHS) Act; 
separates the annual report required under section 1926(b)(2)(B) 
(hereinafter referred to as the Synar report), of that Act, from the 
Substance Abuse Prevention and Treatment (SAPT) Block Grant 
application; and establishes a deadline for submission of the Synar 
report of no later than December 31 of the fiscal year for which a 
State is applying for a grant.

DATES: Effective Date: September 4, 2001.
    Comment Date: The Secretary is requesting written comments which 
must be received on or before November 5, 2001.

ADDRESSES: Written comments on this interim final rule must be sent to 
David Robbins, Acting Director, Division of State and Community Systems 
Development, Center for Substance Abuse Prevention (CSAP), Rockwall II 
Building, 9th Floor, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: David Robbins, telephone no. (301) 
443-0369.

SUPPLEMENTARY INFORMATION: States are required under sections 1930(c) 
and 1932(a)(5) of the PHS Act and 45 CFR 96.122(d) to submit to the 
Secretary maintenance of effort information regarding State 
expenditures. The required MOE information must be sufficient to make a 
determination of whether the principal agency for substance abuse 
services maintained aggregate State expenditures for these activities 
at a level not less than the average level of such State expenditures 
for the two year period preceding the fiscal year for which the State 
is applying for a grant. The MOE information is required, by statute, 
to be submitted as a part of the SAPT Block Grant application.
    In SAMHSA's recent reauthorization, Pub. L. 106-310 (Oct. 17, 
2000), Congress established a receipt date for the SAPT Block Grant 
application of October 1 of the fiscal year for which a State is 
seeking Federal funds. Previously, the SAPT Block Grant application due 
date was established by regulation and the States were permitted by 
regulation to receive an extension allowing them to submit the MOE 
information no later than December 31. See former 45 CFR 96.122(d). 
However, because the statute now requires States to submit their SAPT 
Block Grant applications by October 1 and there is no authority for the 
Secretary to extend the deadline for submission of the MOE information, 
this rule clarifies that States must submit such information by October 
1 and may no longer obtain extensions of that deadline. This 
clarification is merely a technical change to make the regulation 
consistent with what is explicitly required by statute.
    With regard to the Synar report, States are required under section 
1926(b)(2)(B) of the PHS Act and 45 CFR 96.130(e) to annually submit to 
the Secretary a report describing, among other things, their efforts to 
enforce youth tobacco access laws and success during the previous 
fiscal year for which the State is applying for a grant. The Synar 
report is currently required, by regulation only, to be submitted as 
part of the SAPT Block Grant application.
    As mentioned above, in SAMHSA's recent reauthorization, Congress 
established a receipt date for the SAPT Block Grant application of 
October 1 of the fiscal year for which a State is seeking Federal 
funds. Previously, by regulation, the States were permitted to receive 
an extension allowing them to submit the Synar report by no later than 
December 31. See 45 CFR 96.122(d).
    A number of States informed SAMHSA that they required additional 
time beyond October 1 to complete their Synar reports and would not be 
able to meet the statutory due date of October 1; thus would be in 
jeopardy of losing their SAPT Block Grant funding.
    Many States need the later due date for the Synar report because 
they rely on youth to perform a central function in the work required 
for compliance with the program; that is, these youth attempt to buy, 
under adult supervision, tobacco products from tobacco outlets to 
determine retailer compliance with State laws. These youth inspectors 
are only available to many of the States during the summer school 
recess. Without a rule change, States have essentially one month to 
collate data, complete data analysis and report on the results by the 
new October 1 SAPT Block Grant application deadline. Providing States 
the opportunity to continue to submit their Synar reports as late as 
December 31 ensures that all States will have the necessary time to 
meet the Synar reporting requirements, thus enabling them to receive 
their SAPT Block Grant funds.
    Because of the burden on States, the Department is changing the 
rule to separate the Synar report from the SAPT Block Grant application 
and to require that the Synar report be submitted no later than 
December 31 of the Federal

[[Page 46226]]

fiscal year for which a State is seeking funds.
    Although the annual report is not required as a matter of law to be 
part of the SAPT Block Grant application (see section 1932 of the PHS 
Act), the statute does require that the SAPT Block Grant application 
contain each funding agreement required by the law. Further, before 
making a grant to a State, the Secretary must make a determination of 
compliance with section 1926 of the PHS Act. See sections 1926(c) and 
1932(a)(2) of the PHS Act. Therefore, the rule is also being changed, 
first, to require an assurance, as part of the SAPT Block Grant 
application, that the State will submit the annual Synar report as 
required by the rule. Second, it is being changed to make it clear that 
an award will not be made without the Synar report, since the rule 
requires that retailer noncompliance rates be considered in determining 
State compliance with section 1926 of the PHS Act and its implementing 
regulations. See 45 CFR 96.130(h).
    As to issuing an interim final rule, it is the Department's view 
that good cause exists to show that notice and comment are 
impracticable, unnecessary, and contrary to the public interest, 5 
U.S.C. 553(b)(B). There is insufficient time before the SAPT Block 
Grant applications are due for fiscal year 2002 (October 1, 2001) to 
solicit public comment and to respond to such comment prior to that 
date. Not only is seeking comment prior to finalizing the rule 
impracticable in light of the time constraints, but States are in 
jeopardy of not being awarded their SAPT Block Grants if they do not 
submit by October 1 the required application which, without this rule 
change, must include the Synar report. Given that the SAPT Block Grant 
is the largest source of Federal funds for substance abuse prevention 
and treatment services, jeopardizing these funds to allow for public 
comment is contrary to the public interest.
    Further, at this time, public comment is not necessary given the 
technical nature of this rule change. As indicated above, the 
clarification regarding the MOE report simply makes the regulation 
consistent with the recent change in statute. With respect to the Synar 
report, requiring that report to be submitted by December 31 of the 
fiscal year for which the State is applying for a grant does not 
substantively change the previous requirement on the States regarding 
the due date for the Synar report. In fact, public comment was 
solicited last year when SAMHSA changed the rule to require that the 
States submit their SAPT Block Grant applications (including the Synar 
report) by October 1 and provide the States the opportunity for 
extensions to December 31 to submit the Synar reports. See 65 FR 5474 
(Feb. 4, 2000); 65 FR 45305 (July 21, 2000). Also, more recently, 
SAMHSA has received comments from the States about the impact of the 
October 1 deadline on their ability to complete and report on the Synar 
requirements through numerous sources (e.g., the annual conference of 
the National Association of State Alcohol and Drug Abuse Directors, 
June 2001). All commenters supported allowing the States additional 
time to submit their Synar reports.
    For similar reasons, this regulation is effective immediately. 
Delaying the effective date for a period of thirty days is 
impracticable, unnecessary and contrary to the public interest.
    Although the rule is being published as an interim final rule and 
is effective immediately, the Secretary is providing an opportunity for 
public comment. The Secretary will consider any comments and, after 
such consideration, make any necessary amendments in a final rule.

Economic Impact

    This rule does not have cost implications for the economy of $100 
million, nor does this interim final rule otherwise meet the criteria 
for a major rule under Executive Order 12866. Therefore, this interim 
final rule does not require a regulation impact analysis. Further, this 
regulation will not have a significant impact on substantial numbers of 
small entities, and consequently does not require regulatory 
flexibility analysis under the Regulatory Flexibility Act of 1980.

Federalism Impact

    The Secretary has analyzed this interim final rule in accordance 
with Executive Order 13132, which requires Federal agencies to 
carefully examine actions to determine if they contain policies that 
have federalism implications or that pre-empt State law. Because this 
interim final rule simply separates out the Synar report, while 
continuing its previous due date, it does not preempt any State law and 
there should be little, if any, impact on federalism concerns.

Regulatory Evaluation

    This interim final rule is not a significant regulatory action 
under section 3(f) of the Executive Order 12866 and does not require an 
assessment of the potential costs and benefits under section 6(a)(3) of 
that Order and thus has been exempted from review by the Office of 
Management and Budget under that Order.

Paperwork Reduction Act of 1995

    The changes to the annual ``Synar report'' and the annual Substance 
Abuse Prevention and Treatment Block Grant (SAPT BG) application for 
Fiscal Years 2002-2004 have been approved by the Office of Management 
and Budget (OMB) under control number 0930-0222 (for the Synar report) 
and 0930-0080 (for the SAPT BG application). The information collection 
language and the recordkeeping requirements associated with the 
regulations for the SAPT BG are approved by OMB under control number 
0930-0163.
    The changed forms for both the Synar report and the SAPT BG 
application for FY 2002-2004, as approved by OMB, have already been 
sent to the States prior to publication of this rule in order to allow 
sufficient time for proper reporting.

Lists of Subjects in 45 CFR Part 96

    Alcohol abuse, Alcoholism, Drug abuse, Tobacco.

    Approved: August 27, 2001.
Tommy G. Thompson,
Secretary.

    For the reasons set out in the preamble, Part 96 of Title 45 of the 
Code of Federal Regulations is amended as follows:
    1. The authority citation for Subpart L of Part 96 continues to 
read as follows:

    Authority: 42 U.S.C. 330x-21 to 330x-35 and 300x-51 to 330x-64.


    2. Section 96.122 is amended as follows:
    a. By revising paragraphs (d) and (f)(6) to read as set forth 
below; and
    b. By removing paragraph (g)(21) and redesignating paragraphs 
(g)(22) and (g)(23) as paragraphs (g)(21) and (g)(22).
    The revised text reads as follows:


Sec. 96.122  Application content and procedures.

* * * * *
    (d) The State shall submit the application for a block grant by the 
date prescribed by law. The annual report required under Sec. 96.130(e) 
is not required to be submitted as part of the application, but must be 
submitted no later than December 31 of the fiscal year for which the 
State is seeking a grant. Grant awards will not be made without the 
report required under Sec. 96.130(e).
* * * * *
    (f) * * *
    (6) For the first applicable fiscal year for which the State is 
applying for a grant, a copy of the statute enacting the

[[Page 46227]]

law as described in Sec. 96.130(b) and, for subsequent fiscal years for 
which the State is applying for a grant, any amendment to the law 
described in Sec. 96.130(b).
* * * * *

    3. Section 96.123(a)(5) is revised to read as follows:


Sec. 96.123  Assurances.

     (a) * * *
    (5) The State has a law in effect making it illegal to sell or 
distribute tobacco products to minors as provided in Sec. 96.130(b), 
will conduct annual, unannounced inspections as prescribed in 
Sec. 96.130, will enforce such law in a manner that can reasonably be 
expected to reduce the extent to which tobacco products are available 
to individuals under the age of 18, and will submit an annual report as 
required under Sec. 96.122(d) and Sec. 96.130(e);
* * * * *

    4. Section 96.130(e), introductory text is revised to read as 
follows:


Sec. 96.130(e)  State law regarding sale of tobacco products to 
individuals under age of 18.

* * * * *
    (e) As provided by Sec. 96.122(d), the State shall annually submit 
to the Secretary a report which shall include the following:
* * * * *
[FR Doc. 01-22129 Filed 8-31-01; 8:45 am]
BILLING CODE 4162-20-P