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Federal Register / Vol. 71, No.

77 / Friday, April 21, 2006 / Notices 20697

and CMS document identifier, to Medicare Prescription Drug, To obtain copies of the supporting
Paperwork@cms.hhs.gov, or call the Improvement and Modernization Act statement and any related forms for the
Reports Clearance Office on (410) 786– (MMA) of 2003. The purpose of the proposed paperwork collections
1326. demonstration is to determine whether referenced above, access CMS’ Web Site
Written comments and competitive bidding can be used to address at http://www.cms.hhs.gov/
recommendations for the proposed provide quality laboratory services at PaperworkReductionActof1995, or e-
information collections must be mailed prices below current Medicare mail your request, including your
or faxed within 30 days of this notice reimbursement rates. The application is address, phone number, OMB number,
directly to the OMB desk officer: OMB to collect information from and CMS document identifier, to
Human Resources and Housing Branch, organizations that supply clinical Paperwork@cms.hhs.gov, or call the
Attention: Carolyn Lovett, New laboratory services to Medicare Reports Clearance Office on (410) 786–
Executive Office Building, Room 10235, beneficiaries in the Competitive Bidding 1326.
Washington, DC 20503, Fax Number: Area (CBA). This information will be To be assured consideration,
(202) 395–6974. used to determine bidding status, comments and recommendations for the
Dated: April 12, 2006. winners under the bidding competition, proposed information collections must
Michelle Shortt, and the competitively-determined fee be received at the address below, no
Director, Regulations Development Group, schedule for demonstration tests. The later than 5 p.m. on June 20, 2006.
Office of Strategic Operations and Regulatory winning laboratories will be selected CMS, Office of Strategic Operations
Affairs. based on multiple criteria, including and Regulatory Affairs, Division of
[FR Doc. E6–5832 Filed 4–20–06; 8:45 am] price bid, laboratory capacity, service Regulations Development—C, Attention:
BILLING CODE 4120–01–P area, and quality. Multiple winners are Bonnie L. Harkless, Room C4–26–05,
expected in each competitive 7500 Security Boulevard, Baltimore,
acquisition areas; Form Number: CMS– Maryland 21244–1850.
DEPARTMENT OF HEALTH AND 10193 (OMB#: 0938–New); Frequency: Dated: April 12, 2006.
HUMAN SERVICES Reporting—Other: Once every three Michelle Shortt,
years; Affected Public: Business or other Director, Regulations Development Group,
Centers for Medicare & Medicaid for-profit; Number of Respondents: 80; Office of Strategic Operations and Regulatory
Services Total Annual Responses: 80; Total Affairs.
[Document Identifier: CMS–10193 and CMS– Annual Hours: 7010. [FR Doc. E6–5833 Filed 4–20–06; 8:45 am]
10133] 2. Type of Information Collection BILLING CODE 4120–01–P
Request: Extension of a currently
Agency Information Collection approved collection; Title of
Activities: Proposed Collection; Information Collection: Competitive DEPARTMENT OF HEALTH AND
Comment Request Acquisition Program (CAP) for Medicare HUMAN SERVICES
AGENCY: Centers for Medicare & Part B Drugs: Vendor Application and
Medicaid Services, HHS. Bid Form; Use: The CAP Vendor Centers for Medicare & Medicaid
In compliance with the requirement Application and Bid Form is a Services
of section 3506(c)(2)(A) of the collection tool which will be used by [CMS–2235–NC]
Paperwork Reduction Act of 1995, the potential vendors to provide
Centers for Medicare & Medicaid information related to the characteristics RIN 0938–AO38
Services (CMS) is publishing the of their company and to submit their bid
prices for CAP drugs. The information State Children’s Health Insurance
following summary of proposed
collected on the CAP Vendor Program (SCHIP); Redistribution of
collections for public comment.
Application and Bid Form will be used Unexpended SCHIP Funds From the
Interested persons are invited to send
by CMS during the bidding evaluation Appropriation for Fiscal Year 2003;
comments regarding this burden
process to evaluate the vendors bid Additional Allotments To Eliminate
estimate or any other aspect of this
prices, their credentials, experience and SCHIP Fiscal Year 2006 Funding
collection of information, including any
to assess their ability to provide quality Shortfalls; and Provisions for
of the following subjects: (1) The
service to physicians and beneficiaries. Continued Authority for Qualifying
necessity and utility of the proposed
Competitive bidding is seen as a means States To Use a Portion of Certain
information collection for the proper
of using the dynamics of the SCHIP Funds for Medicaid
performance of the agency’s functions;
marketplace to provide incentives for Expenditures
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality, suppliers to provide reasonably priced AGENCY: Centers for Medicare &
utility, and clarity of the information to products and services of high quality in Medicaid Services (CMS), HHS.
be collected; and (4) the use of an efficient manner. The CAP’s ACTION: Notice with comment period.
automated collection techniques or objectives include providing an
other forms of information technology to alternative method for physicians to SUMMARY: This notice with comment
minimize the information collection obtain Part B drugs to administer to period describes the procedure for
burden. Medicare beneficiaries and reducing redistribution of States’ unexpended
1. Type of Information Collection drug acquisition and billing burdens for Federal fiscal year (FY) 2003 SCHIP
Request: New Collection; Title of physicians; Form Number: CMS–10133 allotments remaining at the end of FY
Information Collection: Medicare (OMB#: 0938–0955); Frequency: 2005 to those States that fully expended
Clinical Laboratory Services Reporting—Other, during the bidding such allotments. This notice also
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Competitive Bidding Demonstration process; Affected Public: Business or announces the application of the
Project—Bidding Form; Use: The other for-profit; Number of provisions of the Deficit Reduction Act
Medicare Clinical Laboratory Respondents: 12; Total Annual of 2005 (DRA, Pub. L. 109–171, enacted
Competitive Bidding Demonstration is Responses: 12; Total Annual Hours: on February 8, 2006) concerning the
mandated by section 302(b) of the 480. availability of additional allotments

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20698 Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices

appropriated to eliminate States’ Room 445–G, Hubert H. Humphrey A. Availability and Redistribution of
funding shortfalls under the SCHIP in Building, 200 Independence Avenue, SCHIP Fiscal Year Allotments
FY 2006. The redistributed FY 2003 SW., Washington, DC 20201; or 7500 Title XXI of the Social Security Act
allotments and the additional allotments Security Boulevard, Baltimore, MD (the Act) sets forth the State Children’s
to eliminate shortfalls in FY 2006 will 21244–1850. Health Insurance Program (SCHIP) to
be available through the end of FY 2006 (Because access to the interior of the enable States, the District of Columbia,
(September 30, 2006). HHH Building is not readily available to and specified Commonwealths and
This notice also describes the DRA persons without Federal Government Territories to initiate and expand health
amendments to the SCHIP statute identification, commenters are insurance coverage to uninsured, low-
relating to the provisions for ‘‘qualifying encouraged to leave their comments in income children. In this notice, unless
States’’ to elect to receive a portion of otherwise indicated, the terms ‘‘State’’
the CMS drop slots located in the main
their available SCHIP allotments as and ‘‘States’’ refer to any or all of the 50
lobby of the building. A stamp-in clock
increased Federal matching funds for States, the District of Columbia, and the
is available for persons wishing to retain
certain expenditures in their Medicaid Commonwealths and Territories. States
a proof of filing by stamping in and
programs. may implement the SCHIP through a
retaining an extra copy of the comments
DATES: Comment Date: To be assured being filed.) separate child health program under
consideration, comment must be title XXI of the Act, an expanded
Comments mailed to the addresses
received at one of the addresses program under title XIX of the Act, or
indicated as appropriate for hand or
provided below, no later than 5 p.m. on a combination of both.
courier delivery may be delayed and
May 22, 2006. Effective Date: April 21, Under section 2104(e) of the Act, the
received after the comment period.
2006. SCHIP allotments for a Federal fiscal
ADDRESSES: In commenting, please refer SUPPLEMENTARY INFORMATION: year are available to match expenditures
to file code CMS–2235–NC. Because of Submitting Comments: We welcome under an approved State child health
staff and resource limitations, we cannot comments from the public on all issues plan for an initial 3-fiscal year ‘‘period
accept comments by facsimile (fax) set forth in this notice with comment of availability,’’ including the fiscal year
transmission. period to assist us in fully considering for which the allotment was provided.
You may submit comments in one of issues and developing policies. You can After the initial period of availability,
four ways (no duplicates, please): assist us by referencing the file code the amount of unspent allotments is
1. Electronically. You may submit CMS–2235–NC and the specific ‘‘issue reallotted and continues to be available
electronic comments on specific issues identifier’’ that precedes the section on during a subsequent period of
in this regulation to http:// which you choose to comment. availability, specified in the SCHIP
www.cms.hhs.gov/eRulemaking. Click statute. The statute directs the Secretary
on the link ‘‘Submit electronic Inspection of Public Comments: All to redistribute allotments unexpended
comments on CMS regulations with an comments received before the close of at the end of the initial 3-year period of
open comment period.’’ (Attachments the comment period are available for availability from States that did not
should be in Microsoft Word, viewing by the public, including any fully spend the allotments to States that
WordPerfect, or Excel; however, we personally identifiable or confidential fully spent the allotments for the fiscal
prefer Microsoft Word.) business information that is included in year (with an exception for FY 1998
2. By regular mail. You may mail a comment. We post all comments through 2001 allotments that is not
written comments (one original and two received before the close of the relevant to allotments discussed in this
copies) to the following address only: comment period on the following Web notice).
Centers for Medicare & Medicaid site as soon as possible after they have
been received: http://www.cms.hhs.gov/ B. Availability and Redistribution of
Services, Department of Health and
eRulemaking. Click on the link SCHIP Fiscal Year 2003 Allotments
Human Services, Attention: CMS–2235–
NC, P.O. Box 8010, Baltimore, MD ‘‘Electronic Comments on CMS Section 2104(e) of the Act provides
21244–8010. Regulations’’ on that Web site to view that amounts allotted to a State shall
Please allow sufficient time for mailed public comments. remain available for expenditure by the
comments to be received before the Comments received timely will also State through the end of the second
close of the comment period. be available for public inspection as succeeding fiscal year, except that
3. By express or overnight mail. You they are received, generally beginning amounts reallotted to the State are
may send written comments (one approximately 3 weeks after publication available for expenditure by the State
original and two copies) to the following of a document, at the headquarters of through the end of the fiscal year in
address only: Centers for Medicare & the Centers for Medicare & Medicaid which they are reallotted. Section
Medicaid Services, Department of Services, 7500 Security Boulevard, 2104(f) of the Act requires the Secretary
Health and Human Services, Attention: Baltimore, Maryland 21244, Monday to ‘‘determine an appropriate procedure
CMS–2235–NC, Mail Stop C4–26–05, through Friday of each week from 8:30 for redistribution of allotments’’ from
7500 Security Boulevard, Baltimore, MD a.m. to 4 p.m. To schedule an States that have not expended their
21244–1850. appointment to view public comments, allotments for the fiscal year to States
4. By hand or courier. If you prefer, phone 1–800–743–3951. that have fully expended their
you may deliver (by hand or courier) allotments.
your written comments (one original FOR FURTHER INFORMATION CONTACT: Under sections 2104(e) and (f) of the
and two copies) before the close of the Richard Strauss, (410) 786–2019. Act, the Secretary is required to
comment period to one of the following I. Background establish a procedure that provides for
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addresses. If you intend to deliver your the treatment of States’ unused SCHIP
comments to the Baltimore address, [If you choose to comment on issues in allotments. Accordingly, for purposes of
please call telephone number (410) 786– this section, please include the caption this notice, in applying section 2104(f)
7195 in advance to schedule your ‘‘Background’’ at the beginning of your of the Act, following the initial 3-year
arrival with one of our staff members. comments.] period of availability referenced in

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Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices 20699

section 2104(e) of the Act, the Secretary related expenditures for the 3-year available SCHIP allotments for FY 1998,
must determine an ‘‘appropriate period of availability related to FY 2002 1999, 2000, or 2001 to increase the
procedure for redistribution’’ of the (that is, FY 2002 through FY 2004) and FMAP rate for regular Medicaid
amounts of States’ FY 2003 SCHIP the State’s FY 2002 allotment. The expenditures to the enhanced FMAP
allotments from States that did not allocation basis is the percentage rate available under SCHIP. As
expend the allotments during the 3-year determined by dividing this difference described in the Federal Register
period of availability for that fiscal year for each redistribution State (including published on July 23, 2004 (69 FR
(that is, FY 2003 through FY 2005) only those redistribution States with a FY 44013), if a qualified State submits both
to States that fully expended their FY 2005 shortfall) by the total of those 20 percent allowance expenditures and
2003 allotments during the 3-year differences for all redistribution States. other ‘‘regular’’ SCHIP expenditures at
period of availability.
A final notice, published in the C. Additional Allotments To Eliminate the same time in a quarter, the 20
Federal Register on September 29, 2005 FY 2006 Funding Shortfalls percent allowance expenditures will be
(70 FR 56901), described the procedure Section 6101(a) of the DRA added a applied first against the available fiscal
for redistribution of States’ unexpended new section 2104(d) of the Act to year reallotments. However, the 20
FY 2002 SCHIP allotments, as provide for additional allotments to percent allowance expenditures may be
authorized and required under section eliminate State SCHIP funding shortfalls applied only against the specified fiscal
2104(f) of the Act. In determining the in FY 2006. The procedure for year allotment funds (upon which the
procedure for reallocating the unused redistribution of the unexpended FY 20 percent allowances were based) and
FY 2002 allotments, our primary 2003 allotments remaining at the end of which remain available. Under section
consideration was to address, to the the 3-year period of availability for that 2104(g)(1)(B)(iii) of the Act, the amounts
greatest extent possible, any projected fiscal year (that is, FY 2003 through FY of States’ FY 2001 reallotments are only
State shortfalls for each of the 2005), described in this notice below, available through the end of FY 2005;
redistribution States that would occur in incorporates a distribution procedure therefore, the FY 2001 20 percent
FY 2005, the fiscal year in which the FY for the additional allotments authorized allowances for the qualifying States are
2002 redistribution occurred. We by new section 2104(d) of the Act. only available through the end of FY
determined these State shortfalls in FY D. Expenditures, Authority for 2005.
2005 by considering for each Qualifying States To Use Available
redistribution State: (1) The projected Section 6103 of the DRA provides for
SCHIP Allotments for Medicaid continued authority for qualifying States
SCHIP-related expenditures in FY 2005, Expenditures, and Ordering of
as reflected in the State’s August 15, to use a portion of their available FY
Allotments Elections 2004 and FY 2005 SCHIP allotments to
2005 quarterly budget submission
(Forms CMS–37 and/or CMS–21B); and Under section 2105(a)(1)(A) through increase the FMAP rate for expenditures
(2) the total SCHIP allotments available (D) and (a)(2) of the Act and before made under the Medicaid program on or
in FY 2005 for the State, exclusive of enactment of Pub. L. 108–74 (Extension after October 1, 2005.
any FY 2002 redistribution. For a of Availability of SHIP Allotment Act,
redistribution State whose FY 2005 enacted on August 15, 2003), only II. Provisions of This Notice
projected SCHIP-related expenditures Federal payments for the following
Medicaid and SCHIP expenditures were [If you choose to comment on issues in
were greater than its total SCHIP this section, please include the caption
allotments available in FY 2005, the applied against States’ available SCHIP
allotments: (1) Medical assistance ‘‘Provisions of This Notice’’ at the
difference between the amounts under
provided under title XIX (Medicaid) to beginning of your comments.]
(1) and (2) for a State represents that
State’s ‘‘shortfall’’ for FY 2005. targeted low-income children in a The purpose of this notice with
In the procedure for redistributing the SCHIP-related Medicaid expansion, for comment period is to set forth our
unexpended FY 2002 allotments which the enhanced SCHIP FMAP rate procedure for redistributing FY 2003
described in the September 29, 2005 is available; (2) medical assistance unexpended allotments. In this regard,
Federal Register notice, only after provided on behalf of a child during a this notice applies solely to the
accounting for the FY 2005 shortfall period of presumptive eligibility under redistribution of FY 2003 unexpended
amounts of the redistribution States did section 1920A of the Act (these funds allotments and does not describe the
we further redistribute any remaining are matched at the regular Medicaid procedure for the redistribution of any
unexpended FY 2002 allotments to the FMAP rate); (3) child health assistance other unexpended fiscal year
redistribution States. For purposes of to targeted low income children that allotments. We anticipate publishing
consistency with previous fiscal year meets minimum benefit requirements notices on redistribution procedures for
redistribution methodologies, we based under SCHIP; and (4) expenditures in
subsequent fiscal years, unless Congress
the redistribution of the remaining the SCHIP that are subject to the 10-
otherwise amends the Act to set forth
unexpended FY 2002 allotments (that is, percent limit on non-primary
procedures for redistributing such
only after first accounting for the total expenditures (including other child
shortfalls for each redistribution State) health assistance for targeted low- unexpended fiscal year allotments. This
on the same redistribution methodology income children, health services notice also describes our distribution of
as set forth in the Medicare, Medicaid, initiatives, outreach, and administrative additional allotments in FY 2006 to
and SCHIP Benefits Improvement and costs). eliminate State SCHIP funding shortfalls
Protection Act of 2000 (BIPA), Pub. L. Section 1(b) of Pub. L. 108–74, as in FY 2006, and to implement the
106–554, enacted on December 21, amended by Pub. L. 108–127 (Social continued authority for ‘‘qualifying
2000, amending section 2104(g)(1) of the Security Act, Technical corrections, States’’ to elect to receive a portion of
rwilkins on PROD1PC63 with NOTICES

Act. Specifically, we allocated the enacted November 17, 2003), added new certain of their available FY 2004 and
remaining amounts of the unexpended section 2105(g) to the Act under which FY 2005 SCHIP allotments as increased
FY 2002 allotments based on the certain ‘‘qualifying States’’ that met Federal matching funds for certain
difference between each of the prescribed criteria may elect to use up expenditures in their Medicaid
redistribution States’ total SCHIP- to 20 percent of any of the States’ programs.

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A. Redistribution of the FY 2003 SCHIP in FY 2006 under number ii. above (and percentage is the amount determined by
Allotments and Additional Allotments which would be redistributed in dividing the respective SCHIP FY 2003
To Eliminate FY 2006 Funding association with the additional amounts allotment for each Commonwealth or
Shortfalls to be allotted to States to eliminate any Territory that fully expended its FY
shortfall in FY 2006), we first 2003 allotment by the total of such
1. Current Law and Amendments
determined whether the amounts of allotments for such Commonwealths
Under section 2104(f) of the Act, the States’ available allotments under i. and and Territories.
Secretary must determine an iii. above were sufficient to meet the Furthermore, section 2104(d)(3)(B) of
appropriate procedure to redistribute States’ projected expenditures for FY the Act, as added by the DRA, requires
the entire amount of States’ unexpended 2006. A shortfall would be considered that 1.05 percent of the total
SCHIP allotments following the end of to exist for a State whose available $283,000,000 be provided to the
the related initial 3-year period of allotments would be insufficient to meet Commonwealths and Territories as
availability only to those States that its projected expenditures. We refer to additional allotments; this amount must
fully expended the allotments by the the shortfall in FY 2006 determined be allocated among the jurisdictions in
end of the initial 3-year period of without including the FY 2003 the same proportions as those specified
availability (referred to in this notice as redistribution as the ‘‘initial FY 2006 in section 2104(c) of the Act. Therefore,
the redistribution States). Furthermore, shortfall.’’ In particular, the ‘‘initial FY a total of $2,971,000 (1.05 percent of
section 2104(d) of the Act, as added by 2006 shortfall’’ for a State is equal to the $283,000,000) is available to be
section 6101(a) of the DRA, provides for difference (greater than zero) of a State’s allocated as additional allotments for
additional allotments to FY 2006 projected FY 2006 SCHIP expenditures the Commonwealths and Territories in
‘‘shortfall States.’’ As described below, and the total allotments available to the FY 2006.
the appropriate procedure for State in FY 2006 (determined as the sum b. Calculation of Additional
redistribution of States’ unexpended FY of i. and iii. above). Allotments and FY 2003 Redistributed
2003 allotments remaining at the end of The following describes the FY 2003 Allotments for Shortfall States. Based on
FY 2005 incorporates the new redistribution procedure established States’ quarterly expenditure reports as
provisions at section 2104(d) of the Act under section 2104(f) of the Act and reported and certified through
relating to the elimination of shortfalls which incorporates the FY 2006 November 30, 2005 (Forms CMS–21 and
in the SCHIP in FY 2006. shortfall provisions referenced under CMS–64), we determined the amounts
Under section 2104(d)(2) of the Act, a section 2104(d)(2) of the Act. of States’ unexpended FY 2004 and FY
shortfall State is a State with an a. FY 2003 Redistribution Amounts 2005 allotments remaining at the end of
approved child health plan under title and Additional Allotment Amounts for FY 2005; these amounts combined with
XXI of the Act, for which the Secretary the Commonwealths and Territories. States’ FY 2006 SCHIP allotments are
estimates based on the most recent data Section 2104(g)(1)(A)(ii) of the Act available in FY 2006. We then
available to the Secretary as of specifies the methodology for determined those States with FY 2006
December 16, 2005 that its projected FY determining the FY 1998 through FY initial shortfalls by comparing each
2006 expenditures under such plan will 2001 redistributed allotments for the States’ projected FY 2006 expenditures
exceed the sum of: Commonwealths and Territories that with the total of its FY 2004, FY 2005,
i. The amount of the State’s fully expended their SCHIP allotments and FY 2006 allotments available in FY
allotments for each of FYs 2004 and related to those fiscal years. We applied 2006. States for which such available
2005 that were not expended by the end the same methodology for purposes of allotments in FY 2006 would be
of FY 2005; determining an appropriate procedure insufficient to meet their projected FY
ii. The amount, if any, that is under section 2104(f) of the Act to 2006 expenditures are considered to
redistributed to the State during fiscal redistribute the unexpended FY 2003 have a shortfall equal to the difference
year 2006; and allotments remaining at the end of FY of the projected expenditures and such
iii. The amount of the State’s 2005; we had also applied this total available allotments.
allotment for FY 2006. methodology in redistributing the We then determined the total
We determined the amount of each unexpended FY 2002 allotments additional amounts available for
State’s unexpended FY 2004 and FY remaining at the end of FY 2004. Under allotment to eliminate the States’ initial
2005 allotments that were not expended this procedure, the total FY 2003 shortfalls. Under section 2104(d)(1) of
by the end of FY 2005 based on States’ allotment amount available for the Act, a total of $283,000,000 is
quarterly expenditure reports (Forms redistribution to the Commonwealths appropriated to provide for additional
CMS–21 and CMS–64) as submitted and and Territories is determined by allotments to address States’ shortfalls
certified by States through November multiplying the total amount of the in FY 2006. However, as indicated
30, 2005. The amounts of the States’ unexpended FY 2003 allotments above, under section 2104(d)(3)(B) of
allotments for FY 2006 are as published available for redistribution nationally by the Act, $2,971,500 of the $283,000,000
in the Federal Register on June 24, 2005 1.05 percent. For the FY 2003 must be allotted to the Commonwealths
(70 FR 36615). redistribution calculation, this amount and Territories. Therefore, a total of
In determining the appropriate is $1,820,404 (1.05 percent of $280,028,500 ($283,000,000 minus
procedure for reallocating the $173,371,863, the total unexpended FY $2,971,500) is available for additional
unexpended FY 2003 allotments 2003 allotments remaining at the end of allotments in FY 2006 to shortfall
remaining at the end of FY 2005, we FY 2005). Only those Commonwealths States.
incorporated the above definition of and Territories that have fully expended In determining the amounts of
shortfall State under section 2104(d)(2) their FY 2003 allotments will receive an additional allotment to eliminate the
of the Act, except that we did not allocation of this amount, equal to a shortfalls for the shortfall States, we also
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include the amount of any FY 2003 specified percentage of the $1,820,404; needed to comply with section
redistribution (number ii. above). That with respect to the FY 2003 allotments, 2104(d)(4) of the Act, as added by the
is, before we could determine the all five Commonwealths and Territories DRA, which provides that the additional
amounts of any unexpended FY 2003 fully expended those allotments by the allotments are only available for
allotments to be redistributed to States end of FY 2005. The specified amounts expended under a SCHIP State

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plan for child health assistance for made at the enhanced Federal medical 3. Ordering Election for FY 2003
targeted low-income children. In that assistance percentage (FMAP) (section Redistributed Amounts and Additional
regard, we established the amounts of 2105(a)(1)(A) of the Act); Allotments To Eliminate the FY 2006
the shortfall States’ projected FY 2006 (ii) Title XIX expenditures for medical Shortfall
expenditures representing child health We believe that the States eligible for
assistance provided during a
assistance for targeted low-income the FY 2003 redistribution and
presumptive eligibility period under
children. Next, we allocated the additional allotments to eliminate the
$280,028,500 among each of the section 1920A of the Act (section
2105(a)(1)(B) of the Act); FY 2006 shortfall should be afforded the
shortfall States such that the additional
flexibility to decide whether the FY
allotment for each shortfall State did not (iii) Child health assistance for
2003 redistributed funds and additional
exceed its initial shortfall amount or the targeted low-income children in the
allotments to eliminate the FY 2006
amount of its targeted low-income form of providing health benefits shortfalls would be used before or after
children expenditures. We then coverage that meets the requirements of other available allotment funds to allow
subtracted the additional allotments section 2103 (section 2105(a)(1)(C) of them to optimize the use of such funds.
from the initial shortfall to determine the Act); Therefore, we offered States that will
the amount of the remaining shortfall
(iv) Expenditures listed in section receive FY 2003 redistributed amounts
for each shortfall State.
Finally, we determined the total 2105(a)(1)(D)(i) through (iv) of the Act, and the additional allotment amounts
amount of the unexpended FY 2003 respectively: Other child health the option of choosing the order of
allotments to be redistributed to those assistance for targeted low-income when the funds would be expended
shortfall States that had fully expended children; health services initiatives during FY 2006 among the other
their FY 2003 allotments by the end of under the plan for improving the health available allotments during FY 2006. In
FY 2005 and the amount of that total, if of children (including targeted low- the previous redistributions for the
any, to be redistributed to each of the income children and other low-income unexpended FY 1998 through FY 2002
shortfall States. The total amount of the children); expenditures for outreach allotments, the redistribution States had
unexpended FY 2003 allotments activities; and administration the same ordering of allotment choice
available to be redistributed to the expenditures. for the redistributed allotment.
States is $171,551,449, calculated as An FY 2003 redistribution State (a
As discussed previously, Pub. L. 108– State that has fully expended its FY
$173,371,853 (the total unexpended FY
74, as amended by Pub. L. 108–127, also 2003 allotment by the end of FY 2005)
2003 allotments at the end of FY 2005)
minus $1,820,404 (the amount of these added new section 2105(g) to the Act, may have a maximum of four possible
funds redistributed to the under which a ‘‘qualifying State’’ choices for the order of the application
Commonwealths and Territories). Since meeting specified criteria could, at its of FY 2003 redistributed allotments and
the total remaining shortfalls at that option, elect to use up to 20 percent of the additional allotments in FY 2005,
point were $174,298,185, we any of the State’s available SCHIP depending on the other fiscal year
determined the remaining shortfall allotments for FY 1998, 1999, 2000, or allotments that are available to the
amount (if any) for each shortfall State 2001 for payments under the State’s States in FY 2006:
as a percentage of the total remaining Medicaid program, instead of (i) Before FY 2004 unexpended
shortfalls. We then multiplied the total expenditures under the State’s SCHIP. allotments;
amount available for redistribution to Furthermore, as amended by section (ii) After FY 2004 allotments and
the States ($171,551,449) by the 6103 of the DRA, qualifying States may before FY 2005 allotments;
remaining shortfall percentages to elect to use up to 20 percent of their (iii) After FY 2005 and before FY 2006
determine the amount of the available FY 2004 and FY 2005 allotments;
redistribution to each of the shortfall (iv) After FY 2006 allotments.
allotments for such purpose. As
States. As specified in section 2104(e) of the
described in the Federal Register
As indicated above, we would base Act, the FY 2003 reallotted amounts for
published on July 23, 2004 (69 FR a fiscal year will be available for
both the amounts of the additional 44013), if a qualified State submits both
allotments and the FY 2003 allowable SCHIP expenditures reported
20 percent allowance expenditures and by the redistribution States through the
redistribution on the November 2005 other ‘‘regular’’ SCHIP expenditures at
submissions of the estimates of States’ end of the fiscal year in which such
the same time in a quarter (based on the amounts are reallotted. Therefore,
FY 2006 expenditures, which we used
allotment priority order they both must amounts of the States’ FY 2003
to calculate the initial shortfall amount
for each State. For the FY 2003 apply against any available fiscal year reallotments will be available through
redistribution amounts only, however, allotments), the 20 percent allowance September 30, 2006 (the end of FY
we are reviewing further whether to use expenditures will be applied first 2006). Under section 2104(d)(5) of the
more current estimates to determine the against any remaining 20 percent Act, as added by the DRA, the
remaining shortfall as of the date of the allowance allotments amounts. We will additional allotments to eliminate the
final notice in our calculations. We apply the same approach with respect to FY 2006 shortfall are only available for
invite comments on this issue. the FY 2004 and FY 2005 20 percent expenditure by the State through
allowances determined in accordance September 30, 2006 and shall not be
2. Ordering of Expenditures with section 6103 of the DRA. subject to any further redistribution.
In applying State’s expenditures As part of the redistribution process,
In general, in accordance with the
against their available SCHIP prior to making the FY 2003
ordering of allotments and expenditures
allotments, we follow the order of redistribution funds actually available,
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provisions, the expenditures of States we contacted all of the States eligible for
expenditures as provided under section
eligible for the FY 2003 redistribution the FY 2003 redistribution in order to
2105(a)(1)(A) through (D) and (a)(2) of
the Act as follows: will be applied against the FY 2003 explain the provisions of this notice and
(i) Title XIX SCHIP-related redistribution amounts. to obtain their ordering elections for the
expenditures for which payment is FY 2003 redistributed allotment

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amounts and the additional allotment Register on October 1, 2002 (67 FR $1,820,404 is available for redistribution
amounts. In this regard, those Shortfall/ 61632)) and other available allotments, to the five Commonwealths and
redistribution States that will receive an on Form CMS–21C, Allocation of the Territories, and $171,551,449 is
additional allotment/FY 2003 Title XIX and Title XXI Expenditures to available for redistribution to the 12 FY
redistributed allotment must provide SCHIP Fiscal Year Allotment. 2006 shortfall redistribution States. Of
their decision to us regarding their By November 30, 2005, all States the $283,000,000 available to eliminate
elections for the ordering of the reported and certified their FY 2005 States’ FY 2006 shortfalls, $2,971,500 is
additional allotments and the FY 2003 fourth quarter expenditures allocated to the Commonwealths and
redistributed allotment amounts. This is (representing the last quarter of the 3- Territories, and the remaining
essentially the same process we have year period of availability for FY 2003). $280,020,500 is available for the
used in prior years for obtaining prior Expenditures reflected in Table 2 below shortfall States. The FY 2003
fiscal year redistribution States’ were taken from our Medicaid Budget redistributed allotment amounts and the
ordering elections. and Expenditure System/State additional allotment amounts to
Consistent with past fiscal year Children’s Health Program Budget and eliminate the shortfall will remain
redistribution processes, under the FY Expenditure System (MBES/CBES) available through the end of FY 2006.
2003 redistribution methodology, once a ‘‘masterfile,’’ which represents the
State chooses the order of the FY 2003 State’s official certified SCHIP and Key to Table 1—Initial FY 2006
redistribution amounts and the Medicaid expenditure reporting system Shortfall
additional allotment amounts to records related to FY 2003 allotments. Table 1 presents the initial FY 2006
eliminate any FY 2006 shortfall, it Based on States’ expenditure reports shortfall calculation for the 50 States
cannot change that order at a later date. submitted and certified through and the District of Columbia.
We then incorporated the amounts of November 30, 2005, the total amount of
States’ FY 2003 redistributed amounts States’ FY 2002 SCHIP allotments that Column/Description
and additional allotment and such were unexpended at the end of the 3- Column A = State.
States’ ordering elections with respect to year period ending September 30, 2005, Name of State, District of Columbia,
such amounts on Form CMS–21C is $173,371,853. the Commonwealth or Territory. This is
(Allocation of Title XIX and Title XXI the only column in Table 1 that
5. Tables for Calculating the SCHIP FY includes Commonwealths and
Expenditures to the SCHIP Fiscal Year
2003 Redistributed Allotments and Territories. The initial FY 2006 shortfall
Allotment). Form CMS–21C is used for
Additional Allotments To Eliminate FY calculation in Table 1 is not applicable
tracking States’ expenditures against
2006 Shortfalls to the Commonwealths and Territories
their available SCHIP allotments. The
FY 2003 redistributed allotment The following describes Table 1 and and, therefore, the entries for the
amounts and the additional allotment Table 2, which together present the Commonwealths and Territories in the
amounts will be automatically entered calculation of the FY 2003 SCHIP rest of the Columns in Table 1 are
on this form, and the Medicaid and redistribution amounts and the ‘‘NA’’.
SCHIP expenditure system will additional allotments to eliminate FY Column B = FY 2004 Allotments
automatically apply expenditures 2006 shortfalls. Carried Over From FY 2005. This
reported on the quarterly expenditure A total of $3,175,200,000 was allotted column contains the amounts of States’
reports for the period of October 1, 2005 nationally for FY 2003, representing FY 2004 allotments carried over from
through September 30, 2006 against the $3,142,125,000 in allotments to the 50 FY 2005 and available in FY 2006.
FY 2003 redistributed amounts and States and the District of Columbia, and Column C = FY 2005 Allotments
additional allotment amounts available $33,075,000 in allotments to the Carried Over From FY 2005. This
through September 30, 2006 and the Commonwealths and Territories. Based column contains the amounts of States’
other SCHIP allotments available in FY on the quarterly expenditure reports, FY 2005 allotments carried over from
2006. submitted and certified by November FY 2005 and available in FY 2006.
30, 2005, 40 States fully expended their Column D = FY 2006 Allotments
4. Unexpended FY 2003 Allotments FY 2003 allotments, 11 States did not Initially Available Beginning FY 2006.
In Table 1 of this notice, we set forth fully expend their FY 2003 allotments, This column contains the FY 2006
the initial FY 2006 shortfall calculation and all 5 of the Commonwealths and SCHIP allotments, which are initially
for the 50 States and the District of Territories fully expended their FY 2003 available in FY 2006, and were
Columbia. In Table 2 of this final notice, allotments. Furthermore, of the 40 published in the Federal Register on
we set forth the amount of States’ States that fully expended their FY 2003 June 24, 2005 (70 FR 36615).
unexpended FY 2003 allotments, as allotments by the end of FY 2005, there Column E = Total Available
reflected by the States’ expenditure are 12 States that are projected to have Allotments In FY 2006 Not Including FY
submissions through November 30, a FY 2006 shortfall totaling 2003 Redistributions. This column
2005. These amounts are used to $454,326,685. For the 11 States that did contains the States’ total allotment
determine the States’ FY 2003 not fully expend their FY 2003 amounts (not including any FY 2003
redistributed allotment amounts. We allotments, their total FY 2003 redistribution amounts) available in FY
established the amount of States’ allotments were $586,678,632 and the 2006. This amount is the sum of
unexpended FY 2003 allotments at the total expenditures applied against their Columns B, C, and D.
end of the initial 3-year period of FY 2003 allotments were $413,306,779. Column F = Projected Expenditures
availability, based on the SCHIP-related Therefore, the total amount of FY 2006 From November 2005
expenditures, as reported and certified unexpended FY 2003 allotments at the Estimates. This column contains the
by States to us on the quarterly end of FY 2005 equaled $173,371,853 amounts of States’ projected FY 2006
rwilkins on PROD1PC63 with NOTICES

expenditure reports (Form CMS–64 and/ ($586,678,632 minus $413,306,779). SCHIP and SCHIP-related expenditures
or Form CMS–21) by November 30, In accordance with the redistribution as contained in the States’ November 15,
2005. These expenditures are applied calculation for FY 2003 described 2005 quarterly budget submission, as
and tracked against the States’ FY 2003 above, of the total $173,371,853 in available to the Secretary through
allotments (as published in the Federal unexpended FY 2003 allotments, December 16, 2005.

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Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices 20703

Column G = Initial FY 2006 Shortfall and is equal to the difference between amount was then allocated amount the
(SF) Not Including FY 2003 the amounts in Column B and Column jurisdictions in accordance with the
Redistributions. This column contains C. For States that did fully expend their percentages specified in section 2104(c)
the States’ projected initial FY 2006 FY 2003 allotments during the 3-year of the Act.
shortfall amounts, calculated as Column period of availability, the entry in this Column H = Remaining Shortfall. For
F minus Column E. column is ‘‘None.’’ $173,371,853 each shortfall State, the amount in this
represents the total amount available for column is equal to the amount in
Key to Table 2—Additional Shortfall the FY 2003 redistribution.
Allotments for FY 2006 and Column E (the initial SF) minus the
Column E = Initial FY 2006 Shortfall amount in Column G (the additional
Redistribution of the Unexpended (SF) From Column G Table 1. This
SCHIP Allotments for Fiscal Year: 2003 allotments). For the Commonwealths
column contains the amount, if any, of and Territories, the entry in Column H
Table 2 contains the calculation of the the ‘‘Initial FY 2006 Shortfall’’ for each is ‘‘NA.’’
States’ FY 2003 redistributed allotments State and the District of Columbia, taken
Column I = Percentage of Total. This
and the additional allotments to from Column G, Table 1. If there is no
column presents the remaining shortfall
eliminate the States’ FY 2006 shortfalls. projected shortfall for the State or
amount (if any) for each shortfall State
District of Columbia, the entry in this
Column/Description from Column H as a percentage of the
column is ‘‘NO SF.’’ For the
Column A = State. Name of State, total remaining shortfalls in Column H
Commonwealths and Territories, the
District of Columbia, the for all shortfall States. For the
entry in Column E is ‘‘NA.’’
Commonwealth or Territory. Column F = SF States Only FY 2006 Commonwealths and Territories, the
Column B = FY 2003 Allotments. This Targeted Low-Income Children Expend. entry in Column I is ‘‘NA.’’
column contains the FY 2003 SCHIP This column provides the Shortfall Column J = FY 2003 Redistribution.
allotments for all States, which were States’ projected targeted low-income This column contains the States’’ FY
published in the Federal Register on children (TLIC) expenditures. For the 2003 redistribution, calculated as the
October 1, 2002 (67 FR 61632). Commonwealths and Territories, the percentage in column I multiplied by
Column C = Expenditures Applied entry in Column F is ‘‘NA.’’ $171,551,449, the total amount available
Against FY 2003 Allotment. This Column G = FY 2006 Additional for redistribution to the States. For the
column contains the cumulative Allotments to Eliminate FY 2006 SF. Commonwealths and Territories, the
expenditures applied against the FY This column provides the FY 2006 entry in Column J is the jurisdiction’s
2003 allotments, as reported and additional allotments to eliminate proportionate share of a total $1,820,404
certified by all States through November shortfalls in FY 2006. For the States, (1.05 percent of $173,371,853, the total
30, 2005. this amount will not exceed the lesser unexpended FY 2003 allotments).
Column D = Unexpended FY 2003 of each shortfall State’s initial shortfall Column K = Total of FY 2006
Allotments or ‘‘None’’. This column amount in Column E or the amount of Additional Allotments + FY 2003
contains the amounts of unexpended FY the TLIC expenditures in Column F. For Redistribution. This Column shows the
2003 SCHIP allotments for States that the Commonwealths and Territories, the sum of the additional allotment
did not fully expend the allotments total of the additional allotments in amounts in Column G and the FY 2003
during the 3-year period of availability Column G is equal to $2,971,500 (1.05 redistribution amount in Column J.
for FY 2003 (FYs 2003 through 2005), percent of $283,000,000); that total BILLING CODE 4120–01–P
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EN21AP06.014</GPH>

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Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices 20705

BILLING CODE 4120–01–C B. Continued Authority for Qualifying new section 2105(g) to the Act under
rwilkins on PROD1PC63 with NOTICES

States To Use Certain Funds for which certain ‘‘qualifying States’’ that
Medicaid Expenditures met prescribed criteria could elect to
use up to 20 percent of the States’
Section 1(b) of Pub. L. 108–74, as available SCHIP allotments for FY 1998,
amended by Pub. L. 108–127, added
EN21AP06.015</GPH>

1999, 2000, or 2001 as additional

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20706 Federal Register / Vol. 71, No. 77 / Friday, April 21, 2006 / Notices

Federal financial participation for amounts of those FY 2003 allotments small entities include small businesses,
expenditures under the State’s Medicaid which were unexpended at the end of nonprofit organizations, and small
program, instead of expenditures under FY 2004 (the end of the 3-year period governmental jurisdictions. Most
the State’s SCHIP. The Federal Register of availability referenced in section hospitals and most other providers and
published on July 23, 2004 (69 FR 2104(e) of the Act), and announces the suppliers are small entities, either by
44013) described the definition of amount of the FY 2003 allotments to be nonprofit status or by having revenues
qualifying State and indicated how the redistributed to the redistribution States of $6 million to $29 million in any 1
20 percent allowances for such States and the availability of the unexpended year. Individuals and States are not
would be calculated and applicable FY 2003 allotment amounts to the end included in the definition of a small
expenditures tracked against them. of 2006, in accordance with SCHIP entity. We are not preparing an analysis
Section 6103 of the DRA amended statute. for the RFA because we have
section 2105(g)(1)(A) of the Act to This notice also describes the process determined that this final notice will
provide for continued authority for for distributing additional allotments to not have a significant economic impact
qualifying States to use a portion of States that are projected to have a on a substantial number of small
their available FY 2004 and FY 2005 shortfall in FY 2006 in SCHIP funds; entities.
SCHIP allotments. The 20 percent specifically, under section 2104(d) of In addition, section 1102(b) of the Act
allowances for qualifying States the Act, as amended by section 6101(a) requires us to prepare a regulatory
associated with the FY 2004 and FY of the DRA, $283 million was impact analysis if a rule may have a
2005 allotments have been calculated in appropriated and was specifically significant impact on the operations of
the same way as we determined and authorized to eliminate FY 2006 a substantial number of small rural
tracked the 20 percent allowances shortfalls. Since the aggregate amount of hospitals. This analysis must conform to
associated with the FY 1998 through FY the additional allotments is $283 the provisions of section 604 of the
2002 fiscal years. The availability of the million, with respect to this provision RFA. For purposes of section 1102(b) of
20 percent allowances for FY 2004 and this notice is considered a major rule. In the Act, we define a small rural hospital
FY 2005, and the application of that regard, as indicated above, this as a hospital that is located outside of
expenditures against such allowances, notice describes the basis for a Core-Based Statistical Area and has
will be in accordance with the same determining the amount of the fewer than 100 beds. We are not
provisions as in the July 23, 2004 additional allotment of each State to preparing an analysis for section 1102(b)
Federal Register. eliminate the FY 2006 shortfalls in of the Act because we have determined
accordance with the provisions of this that this final notice will not have a
III. Regulatory Impact Statement legislation. In determining the significant impact on the operations of
[If you choose to comment on issues in regulatory impact analysis for this a substantial number of small rural
this section, please include the caption provision of the DRA, the primary hospitals.
‘‘Regulatory Impact Statement’’ at the considerations were to ensure that: (1) Section 202 of the Unfunded
beginning of your comments.] The calculation of the amounts of the Mandates Reform Act of 1995 also
We have examined the impact of this additional amounts was determined in requires that agencies assess anticipated
rule as required by Executive Order accordance with the legislation, and (2) costs and benefits before issuing any
12866 (September 1993, Regulatory the amounts of the additional allotments rule whose mandates require spending
Planning and Review), the Regulatory were used for the purposes specified in in any 1 year of $100 million in 1995
Flexibility Act (RFA) (September 19, the legislation. As indicated in the dollars, updated annually for inflation.
1980 Pub. L. 96–354), section 1102(b) of tables 1 and 2 in this notice, with That threshold level is currently
the Social Security Act, the Unfunded respect to the first consideration, we approximately $120 million. This final
Mandates Reform Act of 1995 (Pub. L. determined that the total shortfall in the notice will not create an unfunded
104–4), and Executive Order 13132. 12 States having such shortfalls was mandate on States, tribal, or local
Executive Order 12866 directs $454 million. With respect to the second governments. Therefore, we are not
agencies to assess all costs and benefits consideration, we considered the required to perform an assessment of the
of available regulatory alternatives and, amounts of each of these 12 States’ costs and benefits of this notice.
if regulation is necessary, to select estimated targeted low income children Executive Order 13132 establishes
regulatory approaches that maximize expenditures and the amounts of their certain requirements that an agency
net benefits (including potential FY 2006 shortfalls to ensure that the must meet when it publishes a proposed
economic, environmental, public health additional allotments did not exceed rule (and subsequent final rule) that
and safety effects, distributive impacts, these amounts. Therefore, the aggregate imposes substantial direct requirement
and equity). A regulatory impact economic impact of the additional costs on State and local governments,
analysis (RIA) must be prepared for allotments determined in this way will preempts State law, or otherwise has
major rules with economically be to provide Federal funds to the Federalism implications. We have
significant effects ($100 million or more impacted States in the aggregate amount reviewed this final notice and have
in any one year). We have determined of $283 million, and that these amounts determined that it does not significantly
that with respect to the FY 2003 may only be used by the States to pay affect States’ rights, roles, and
redistribution amounts, this notice is for the targeted low-income children responsibilities.
not a major rule. The States’ FY 2003 expenditures. Low-income children will benefit
SCHIP allotments, totaling Because State participation in the from payments under this program
$3,175,200,000 were originally SCHIP program is voluntary, any through increased opportunities for
published in a notice in the Federal payments and expenditures States make health insurance coverage. We believe
Register (67 FR 61632) and allotted to or incur on behalf of the program that this final notice will have an overall
rwilkins on PROD1PC63 with NOTICES

States in FY 2003. This notice does not are not reimbursed by the Federal positive impact by informing States, the
revise the amount of the 2003 Government are made voluntarily. The District of Columbia, and
allotments originally made available to RFA requires agencies to analyze Commonwealths and Territories of the
the States, but rather, sets forth the options for regulatory relief of small extent to which they are permitted to
procedure for redistributing the businesses. For purposes of the RFA, expend funds under their child health

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plans using the FY 2003 allotment’s which they are redistributed/ SUMMARY: The Food and Drug
redistribution amounts. distributed, for example, until the end Administration (FDA) is soliciting gene
In accordance with the provisions of of FY 2006 (September 30, 2006). We expression datasets from
Executive Order 12866, this final notice believe it is important that we issue deoxyribonucleic acid (DNA)
was reviewed by the Office of these redistributed allotments and microarray studies, as well as proposals
Management and Budget. additional allotments as soon as to analyze these datasets in order to
IV. Waiver of Delay in Effective Date possible. Delay in States receiving those evaluate the impact of different analysis
funds could result in disruption of protocols on the selection of genes and
[If you choose to comment on issues program operations. Therefore, in the their associated signatures for biomarker
in this section, please include the interest of ensuring that the FY 2003 pattern development. This project is
caption ‘‘Waiver of Notice of Proposed redistributed allotments and the being coordinated by FDA as a followup
Rulemaking and Delayed Effective Date’’ additional allotments to eliminate the to the MicroArray Quality Control
at the beginning of your comments.] FY 2006 shortfall in SCHIP funding are (MAQC) Project. This evaluation
We ordinarily publish a proposed made available without delay to those process is open to the public.
notice in the Federal Register to provide States that need such funds, we are DATES: Datasets and proposals for
a period of public comment before the participation in the project must be
waiving notice of proposed rulemaking
provisions of a notice, such as this, are received by the National Center for
and the 30-day delay in effective date,
effective in accordance with section Toxicological Research on or before 4:30
and are publishing this issuance of the
553(b) of the Administrative Procedure p.m. c.s.t. on May 31, 2006, or be
Federal Register as a notice with
Act (APA) (5 U.S.C. 553(b)). We also postmarked on or before May 31, 2006.
comment period.
ordinarily provide a 30-day delay in the Accordingly, we provisionally will ADDRESSES: Datasets and proposals
effective date of the provisions of a make the FY 2003 redistributed funds
notice in accordance with section 553(d) should be sent to Leming Shi, National
and the additional allotments to Center for Toxicological Research, Food
of the APA (5 U.S.C. 553(d)). However,
eliminate the FY 2006 shortfall in and Drug Administration, 3900 NCTR
we can waive both the notice of
SCHIP funding available to any State Rd., Jefferson, AR 72079, 870–543–7387,
proposed rulemaking and the 30-day
that has spent all of its available SCHIP FAX: 870–543–7686; e-mail:
delay in effective date if the Secretary
allotments effective immediately upon leming.shi@fda.hhs.gov.
finds, for good cause, that it is
publication of this notice with comment SUPPLEMENTARY INFORMATION: FDA’s
impracticable, unnecessary, or contrary
period. These FY 2003 redistributed Critical Path Initiative (http://
to the public interest, and incorporates
funds are subject to final adjustment www.fda.gov/oc/initiatives/criticalpath)
a statement of the finding and the
based on comments received in identifies pharmacogenomics as a key
reasons in the notice.
We find there is good cause to waive response to this notice with comment opportunity in advancing medical
notice of proposed rulemaking and the period. Any such adjustments resulting product development and personalized
delay in the effective date of this from review and analysis of comments medicine. FDA issued the ‘‘Guidance for
issuance of the FY 2003 redistributed will be published in the Federal Industry: Pharmacogenomic Data
allotments and the additional allotments Register within 60 days of the close of Submissions’’ (http://www.fda.gov/cder/
to eliminate the FY 2006 shortfall in the comment period. (Section 1102 of guidance/6400fnl.pdf) to facilitate
SCHIP funding because such notice of the Social Security Act (42 U.S.C. scientific progress in the field of
proposed rulemaking and the delay in 1302).) pharmacogenomic data integration in
the effective date would be contrary to (Authority: Section 1102 of the Social drug development and medical
the public interest. Security Act (42 U.S.C. 1302)) diagnostics.
We determined the amounts of the FY (Catalog of Federal Domestic Assistance A microarray is a tool for analyzing
2003 redistributed allotments and Program No. 93.767, State Children’s Health gene expression. It consists of a small
additional allotments to eliminate the Insurance Program) membrane or glass slide containing
FY 2006 shortfall as expeditiously as Dated: March 17, 2006. samples of many genes arranged in a
possible in order to make them available Mark B. McClellan, regular pattern. DNA is a nucleic acid—
to the States as soon as possible. To that Administrator, Centers for Medicare & usually in the form of a double helix—
end, all States had until November 30, Medicaid Services. that contains the genetic instructions
2005 to submit their required fourth Dated: April 6, 2006. specifying the biological development of
quarter FY 2005 expenditure reports. In Michael O. Leavitt, all cellular forms of life and most
determining the FY 2003 redistributed Secretary. viruses. DNA microarray is a collection
amounts, we used State projected [FR Doc. 06–3833 Filed 4–19–06; 12 pm] of microscopic DNA spots attached to a
expenditures as contained in the most BILLING CODE 4120–01–P
solid surface, such as glass, plastic or
recent (November, 2005) States’ silicon chip forming an array. DNA
quarterly budget report submissions. microarrays represent a core technology
The redistributed FY 2003 allotments DEPARTMENT OF HEALTH AND in pharmacogenomics and
make available Federal funds to the HUMAN SERVICES toxicogenomics; however, before this
recipient redistribution States, which is technology can be reliably applied in
especially important for those Food and Drug Administration clinical practice and regulatory
redistribution States that may need such decisionmaking, further evaluation is
funds. MicroArray Quality Control Project on needed of the process for the analysis of
Furthermore, under section 2104(e) of the Evaluation of Analysis Protocols hybridization data that results in
the Act and section 2104(d)(5) of the for Deoxyribonucleic Acid Microarray predictive signatures.
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Act, the FY 2003 redistributed Data The MAQC project involves six FDA
allotments and the additional allotments AGENCY: Food and Drug Administration, centers, major providers of microarray
to eliminate the FY 2006 shortfall in HHS. platforms and ribonucleic acid (RNA)
SCHIP funding, are only available samples, government agencies,
ACTION: Notice of solicitation.
through the end of the fiscal year in academic laboratories, and other

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