Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Notices 56539 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to Missouri announcing an 

administrative hearing to reconsider the 

disapproval of its SPA reads as follows: 

Mr. Steven E. Renne, Interim Director, 

Missouri, Department of Social Services, 

P.O. Box 1527, Broadway State Office 

Building, Jefferson City, MO 65102–1527. 

Dear Mr. Renne: I am responding to your 

request for reconsideration of the decision to 

disapprove the Missouri State plan 

amendment (SPA) 05–11, which was 

submitted on September 27, 2005, and 

disapproved on June 16, 2006. 

Under SPA 05–11, Missouri was proposing 

to alter the provider qualifications and 

payment methodology for personal care 

assistance services by transferring 

administrative responsibility for such 

providers from one State agency to another. 

At issue in this reconsideration is: (1) 

whether SPA 05–11 complied with the 

requirements of section 1902(a) of the Social 

Security Act (the Act) generally, and 

1902(a)(30) of the Act specifically, in 

providing for coverage of services for which 

the State plan did not contain a clear 

payment methodology that the State had 

shown was consistent with efficiency and 

economy; (2) whether the proposed coverage 

of personal care services in SPA 05–11 was 

consistent with the definition of personal 

care services in section 1905(a)(24) of the Act 

(which is integral to the definition of 

‘‘medical assistance’’ at sections 1905(a) and 

1902(a)(10) of the Act), and applicable 

regulations, including services of registered 

nurses. 

This amendment was disapproved because 

it did not comport with the requirements of 

section 1902(a) generally, section 

1902(a)(30)(A) specifically, and section 

1905(a)(24) of the Act and implementing 

regulations. 

Section 1902(a)(30)(A) of the Act requires 

that State plans have methods and 

procedures to assure that payments are 

consistent with economy, efficiency, and 

quality of care. While this SPA would have 

provided for coverage of personal care 

services, the methodology for paying for such 

services was not clearly set forth in the State 

plan. Moreover, Missouri provided 

information that personal care services and 

personal care assistance services are 

reimbursed based on a 15-minute service 

unit. However, the State did not provide to 

the Centers for Medicare & Medicaid Services 

(CMS) the rate for the 15-minute service unit 

or any rate derivation information to 

conclude that this payment is economic or 

efficient. In light of this, CMS cannot 

conclude that coverage of the proposed 

services would be accomplished through an 

efficient and economical payment 

methodology in compliance with the 

requirements of section 1902(a)(30)(A). 

Further, the overall requirement in section 

1902(a) for a State plan, and the specific 

requirement at section 1902(a)(30)(A) for 

methods and procedures related to payment, 

as implemented by Federal regulations at 42 

CFR §§ 430.10 and 447.252(b) require that the 

State plan include a comprehensive 

description of the methods and standards 

used to set payment rates. Payment 

methodologies should be understandable and 

auditable. In addition, since the plan is the 

basis for Federal financial participation, it is 

important that the plan language be clear and 

unambiguous. The proposed methodology 

does not provide sufficient information for 

providers to determine the payment amount 

to which they are entitled. 

Additionally, the Medicaid personal care 

services benefit does not include registered 

nurse services in the definitions at section 

1905(a)(24) of the Act and Federal 

regulations at 42 CFR 440.167, and thus such 

coverage is not within the scope of ‘‘medical 

assistance’’ defined under section 1905(a) 

and 1902(a)(10) of the Act. As CMS had 

indicated in the State Medicaid Manual Part 

4, section 4480(C), although personal care 

services may be similar to, or overlap, some 

services furnished by home health aides, 

‘‘skilled services that may be performed only 

by a health professional are not considered 

personal care services.’’ It would not be 

consistent with efficiency and economy for a 

State to pay higher rates to attract 

overqualified individuals (registered nurses) 

to provide personal care services. Registered 

nurse services may instead be furnished as a 

home health service under 42 CFR 

440.70(b)(1), or as private duty nursing 

services as defined at 42 CFR 440.80(a). 

Furthermore, there is no provision in 

Medicaid for payment for training of personal 

care providers, including the ‘‘training and 

supervision’’ of the ‘‘qualified staff licensed 

by the Department of Mental Health’’ or 

supervision visits by a registered nurse. 

For these reasons, and after consulting 

with the Secretary as required by Federal 

regulations at 42 CFR section 430.15(c)(2), I 

disapproved this SPA on June 16, 2006. 

I am scheduling a hearing on your request 

for reconsideration to be held on November 

15, 2006, at the Richard Bolling Federal 

Building, 601 E. 12th Street, Kansas City, MO 

64106–2898, the Kansas City Room, to 

reconsider the decision to disapprove SPA 

05–11. If this date is not acceptable, we 

would be glad to set another date that is 

mutually agreeable to the parties. The 

hearing will be governed by the procedures 

prescribed at 42 CFR part 430. 

I am designating Ms. Kathleen ScullyHayes as the presiding officer. If these 

arrangements present any problems, please 

contact the presiding officer at (410) 786–

2055. In order to facilitate any 

communication which may be necessary 

between the parties to the hearing, please 

notify the presiding officer to indicate 

acceptability of the hearing date that has 

been scheduled and provide names of the 

individuals who will represent the State at 

the hearing. 

Sincerely, 

Mark B. McClellan, M.D., PhD 

(Section 1116 of the Social Security Act (42 

U.S.C. section 1316); 42 CFR section 430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714, Medicaid Assistance 

Program) 

Dated: September 20, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. E6–15780 Filed 9–26–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Title IV–E Foster Care Eligibility 

Reviews; Child and Family Services 

Reviews; Anti-Discrimination 

Enforcement. 

OMB No.: 0970–0214. 

Description: The following five 

separate activities are associated with 

this information collection: 

• Foster Care Eligibility Review 

(FCER) Program Improvement Plan; 

• Child and Family Services Reviews 

(CFSR) State agency Statewide 

Assessment; 

• CFSR On-site review; 

• CFSR Program Improvement Plan; 

and 

• Anti-Discrimination Enforcement 

Corrective Action Plan. 

The collection of information for 

review of Federal payments to States for 

foster care maintenance payments (45 

CFR 1356.71(i)) is authorized by title 

IV–E of the social Security Act (the Act), 

section 474 [42 U.S.C. 674]. The Foster 

Care Eligibility Reviews (FCER) ensure 

that States claim title IV–E funds on 

behalf of title IV–E eligible children. 

The collection of informaiton for 

review of State child and family services 

programs (45 CFR 1355.33(b), 1355.33(c) 

and 1355.35(a)) to determine whether 

such programs are in substantial 

conformity with State plan requirements 

under parts B and E of the Act is 

authorized by section 1123(a) [42 U.S.C 

1320a–1a] of the Act. The CFSR looks at 

both the outcomes related to safety, 

permanency and well-being of children 

served by the child welfare system and 

at seven systemic factors that support 

the outcomes. 

Section 474(d) of the Act [42 U.S.C 

674] deploys enforcement provisions 

(45 CFR 1355.38(b) and (c)) for the 

requirements at section 4371(a)(18) [42 

U.S.C 671], which prohibit the delay or 

denial of foster and adoptive placements 

based on the race, color, or national 

origin of any of the individuals 

involved. The enforcement provisions 

include the execution and completion of 

corrective action plans when a State is 

in violation of section 471(a)(18). 


rwilkins on PROD1PC63 with NOTICES
56540 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Notices 

The information collection is needed: 

(1) To ensure compliance with title IV–

E foster care eligibility requirements; (2) 

to monitor State plan requirements 

under titles IV–B and IV–E of the Act, 

as required by Federal statute; and (3) to 

enforce the title IV–E antidiscrimination requirements through 

State corrective action plans. The 

resultant information will allow ACF to 

determine if States are in compliance 

with State plan requirements and are 

achieving desired outcomes for children 

and families, help ensure that claims by 

States for title IV–E funds are made on 

behalf of title IV–E eligible children, 

and require States to revise applicable 

statutes, rules, policies and procedures, 

and provide proper training to staff, 

through the development and 

implementation of corrective action 

plans. These reviews not only address 

compliance with eligibility 

requirements but also assist States in 

enhancing the capacities to serve 

children and families. In computing the 

number of burden hours for this 

information collection, ACF based the 

annual burden estimates on ACF’s and 

States’ experiences in conducting 

reviews and developing program 

improvement plans. 

Respondents: State Agencies. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

45 CFR 1356.7 (i) Program Improvement Plan (FCER) ................................. 7 1 90 630 

45 CFR 1366.33 (b) Statewide Assessment (CFSR) ...................................... 13 1 240 3,120 

45 CFR 1355.33 (c) On-site Review (CFSR) .................................................. 13 1 1,170 15,210 

45 CFR 1355.35 (a) Program Improvement Plan (CFSR) .............................. 13 1 240 3,120 

45 CFR 1355.38 (b) and (c) Corrective Action Plan (Anti-discrimination enforcement) .................................................................................................... 1 1 780 780 

Estimated Total Annual Burden 

Hours: 22,860. 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Attn: Desk Office for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov. 

Dated: September 20, 2006. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 06–8272 Filed 9–26–06; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0006] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; LYRICA (New Drug 

Application 21–446) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for LYRICA 

(new drug application (NDA) 21–446) 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the product. Although only a portion of 

a regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (for example, 

half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product LYRICA (NDA 

21–446) (pregabalin). LYRICA (NDA 21–

446) is indicated for management of 

neuropathic pain associated with 


rwilkins on PROD1PC63 with NOTICES