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68140 Federal Register / Vol. 67, No.

217 / Friday, November 8, 2002 / Notices

Form No.: CMS–0029/0030 (OMB# Form No.: CMS–0319 (OMB# 0938– your request, including your address,
0938–0074). 0147). phone number, OMB number, and CMS
Use: The Form CMS–29 is utilized as Use: The sample selection lists document identifier, to
an application to be completed by contain identifying information on Paperwork@hcfa.gov, or call the Reports
suppliers of RHC services requesting Medicaid beneficiaries and is the basis Clearance Office on (410) 786–1326.
participation in the Medicare/Medicaid for the cases that States review to Written comments and
programs. This form initiates the determine the accuracy of the Medicaid recommendations for the proposed
process of obtaining a decision as to eligibility determinations. The Regional information collections must be mailed
whether the conditions for certification Office uses this list to monitor State within 30 days of this notice directly to
are met as a supplier of RHC services. review activity. the OMB desk officer: OMB Human
It also promotes data reduction or Frequency: Monthly. Resources and Housing Branch,
introduction to and retrieval from the Affected Public: State, Local or Tribal Attention: Brenda Aguilar, New
Online Survey and Certification and Government. Executive Office Building, Room 10235,
Reporting System (OSCAR) by the CMS Number of Respondents: 55. Washington, DC 20503.
Regional Offices (RO). The Form CMS– Total Annual Responses: 660. Dated: October 31, 2002.
30 is an instrument used by the State Total Annual Hours: 5,280.
John P. Burke, III,
survey agency to record data collected 4. Type of Information Collection
Request: Extension of a currently Paperwork Reduction Act Team Leader, CMS
in order to determine RHC compliance Reports Clearance Officer, Office of Strategic
with individual conditions of approved collection.
Operations and Regulatory Affairs, Division
participation and to report it to the Title of Information Collection: End of Regulations Development and Issuances.
Federal government. The form is Stage Renal Disease Death Notification
[FR Doc. 02–28423 Filed 11–7–02; 8:45 am]
primarily a coding worksheet designed 42 CFR 405.2133.
BILLING CODE 4120–03–P
to facilitate data reduction Form No.: CMS–2746 (OMB# 0938–
(keypunching) and retrieval into OSCAR 0448).
at the CMS ROs. The form includes Use: This form is completed by all
DEPARTMENT OF HEALTH AND
basic information on compliance (i.e., Medicare approved ESRD facilities upon
HUMAN SERVICES (HHS)
met, not met and explanatory the death of an ESRD patient. The
statements) and does not require any form’s primary purpose is to collect fact Centers for Medicare & Medicaid
descriptive information regarding the and cause of death. Reports of deaths Services
survey activity itself. are used to show cause of death and
Frequency: Annually. demographic characteristics of these Notice of Hearing: Reconsideration of
Affected Public: State, Local, or Tribal patients. Disapproval of Maryland State Plan
Government. Frequency: On occasion. Amendment 02–05
Number of Respondents: 661. Affected Public: Business or other for-
AGENCY: Centers for Medicare &
Total Annual Responses: 661; Total profit, Not-for-profit institutions,
Federal Government. Medicaid Services (CMS), HHS.
Annual Hours: 1,157.
Number of Respondents: 4,000. ACTION: Notice of hearing.
2. Type of Information Collection
Request: Extension of a currently Total Annual Responses: 56,258. SUMMARY: This notice announces an
approved collection. Total Annual Hours: 9,564. administrative hearing to be held on
Title of Information Collection: State 5. Type of Information Collection
December 19, 2002, Suite 216, The
Medicaid Eligibility Quality Control Request: Extension of a currently
Public Ledger Building, 150 S.
(MEQC) Sampling Plan and Supporting approved collection.
Independence Mall West, Philadelphia,
Regulations in 42 CFR 431.800–431.865. Title of Information Collection:
Pennsylvania 19106, at 10 a.m., to
Form No.: CMS–317 (OMB# 0938– Medicare Telephone Customer
reconsider our decision to disapprove
0146). Satisfaction Survey.
Maryland State Plan Amendment 02–05.
Use: The State MEQC sampling plan Form No.: CMS–R–293 (OMB# 0938–
0780). CLOSING DATE: Requests to participate in
is necessary for CMS to monitor the
Use: In response to the National the hearing as a party must be received
States’ operation of the MEQC system
Partnership for Reinventing Government by the presiding officer by (15 days after
for States performing the traditional
and Government Performances and publication).
sampling process. The sampling plan
Results Act (GPRA), CMS is FOR FURTHER INFORMATION CONTACT:
includes all data involved in the States’
sample selection process—population implementing a number of initiatives to Kathleen Scully-Hayes, Presiding
sizes and sample frame lists, sample measure and then improve the customer Officer, Office of Hearings, Centers for
sizes, sample selection procedures, and service that is provided by Medicare Medicare & Medicaid Services, Suite L,
claim collection procedures. Call Centers, that service over 21 2520 Lord Baltimore Drive, Baltimore,
Frequency: Semi-annually. million calls annually. Maryland 21244–2670, Telephone: (410)
Affected Public: State, Local, or Tribal Frequency: On occasion, simi- 786–2055.
Government. annually, other (single 800# survey). SUPPLEMENTARY INFORMATION: This
Number of Respondents: 55. Affected Public: Individuals or notice announces an administrative
Total Annual Responses: 110. Households; Number of Respondents: hearing to reconsider our decision to
Total Annual Hours: 2,640. 50,000. disapprove Maryland State Plan
3. Type of Information Collection Total Annual Responses: 50,000. Amendment (SPA) 02–05. This SPA was
Request: Extension of a currently Total Annual Hours: 3,500. disapproved on August 26, 2002.
approved collection; To obtain copies of the supporting In this amendment, Maryland
Title of Information Collection: State statement and any related forms for the proposes to cover targeted case
Medicaid Eligibility Quality Control proposed paperwork collections management services for abused and
(MEQC) Sample Section Lists and referenced above, access CMS Web site neglected children under foster care. At
Supporting Regulations in 42 CFR address at http://cms.hhs.gov/ issue is whether the Centers for
431.800—431.865. regulations/pra/default.asp, or e-mail Medicare & Medicaid Services properly

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Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Notices 68141

concluded as a basis for disapproving Section 1116 of the Act and 42 CFR, Because the services proposed as Medicaid
the amendment that: (1) The State had part 430 establish Department targeted case management are segments of
not demonstrated that the proposed procedures that provide an child welfare services related to the foster
care program, CMS is of the belief that they
services were within the statutory administrative hearing for
are integral components of the direct services
definition of case management services reconsideration of a disapproval of a and administrative functions of child welfare
found in section 1915(g)(2) of the Social state plan or plan amendment. The CMS services.
Security Act (the Act); (2) the proposed is required to publish a copy of the During conversations between CMS and
services are available without charge to notice to a state Medicaid agency that the State of Maryland, the State cited section
the user and thus payment under the informs the agency of the time and place 8435 of the Technical and Miscellaneous
amendment is not reasonable and of the hearing and the issues to be Revenue Act of 1988, Pub. L. 100–647. In this
necessary and would duplicate payment considered. If we subsequently notify section Congress clarified that the Secretary
under other program authorities; and (3) may not deny approval of either an SPA or
the agency of additional issues that will
a claim on the basis that the state is required
the amendment would restrict be considered at the hearing, we will to provide such services under state law, or
beneficiary freedom of choice by also publish that notice. is, or was otherwise paying for the services
limiting providers to employees of Any individual or group that wants to using non-Federal funds. However, section
public welfare agencies. participate in the hearing as a party 8435 also expressly stated that this was not
Medicaid coverage of targeted case must petition the presiding officer to be construed to require the Secretary to
management is authorized by section within 15 days after publication of this make payment for case management services
1915(g) of the Act, which defines case notice, in accordance with the that are provided without charge to the users
management as services that assist requirements contained at 42 CFR of such services. Approval of SPA 02–05
beneficiaries in gaining access to needed would be contrary to this express statutory
430.76(b)(2). Any interested person or
services and does not include the direct provision, since this SPA seeks payment
organization that wants to participate as from the Medicaid program for services that
provision of those services. Because the amicus curiae must petition the are available without charge to the users.
services proposed as Medicaid targeted presiding officer before the hearing In addition, while states are free to set
case management are segments of child begins in accordance with the qualifications for providers, a state must
welfare services related to the foster care requirements contained at 42 CFR comply with Medicaid law and regulations
program, CMS is of the belief that they 430.76(c). If the hearing is later concerning freedom of choice at section
are integral components of the direct rescheduled, the presiding officer will 1902(a)(23) of the Act and the implementing
services and administrative functions of regulations at 42 CFR 431.51. These
notify all participants. Therefore, based
child welfare services. provisions require that a state plan permit
on the reasoning set forth above, and beneficiaries to obtain services from any
During conversations between CMS after consultation with the Secretary as
and the State of Maryland, the State qualified provider that undertakes to provide
required under 42 CFR 430.15(c)(2), the services. Section 1915(g)(1) of the Act
cited section 8435 of the Technical and CMS disapproved Maryland SPA (02– states ‘‘The provision of case management
Miscellaneous Revenue Act of 1988, 05). services under this subsection shall not
Pub. L. 100–647. In this section The notice to Maryland announcing restrict the choice of the individual to receive
Congress clarified that the Secretary an administrative hearing to reconsider assistance in violation of section
may not deny approval of either a SPA the disapproval of its SPA reads as 1902(a)(23).’’ Therefore, based on the
or a claim on the basis that the state is reasoning set forth above, and after
follows: consultation with the Secretary as required
required to provide such services under
state law, or is, or was otherwise paying Georges C. Benjamin, M.D. under 42 CFR 430.15(c)(2), CMS disapproved
Secretary, Department of Health and Mental Maryland SPA 02–05.
for the services using non-Federal Hygiene, 201 West Preston Street, I am scheduling a hearing on your request
funds. However, section 8435 also Baltimore, MD 21201. for reconsideration to be held on December
expressly stated that this was not to be Dear Dr. Benjamin: I am responding to your 19, 2002, Suite 216, The Public Ledger
construed to require the Secretary to request for reconsideration of the decision to Building, 150 S. Independence Mall West,
make payment for case management disapprove Maryland State Plan Amendment Philadelphia, Pennsylvania 19106, at 10 a.m.
services that are provided without (SPA) 02–05. This SPA was disapproved on to reconsider our decision to disapprove
charge to the users of such services. August 26, 2002. Maryland SPA 02–05.
Approval of SPA 02–05 would be In this amendment, Maryland proposes to If this date is not acceptable, we would be
cover targeted case management services for glad to set another date that is mutually
contrary to this express statutory abused and neglected children under foster agreeable to the parties. The hearing will be
provision, since this SPA seeks payment care. At issue is whether the Centers for governed by the procedures prescribed at 42
from Medicaid program for services that Medicare & Medicaid Services (CMS) CFR, part 430.
are available without charge to the properly concluded as a basis for I am designating Ms. Kathleen Scully-
users. disapproving the amendment that: (1) The Hayes as the presiding officer. If these
In addition, while states are free to set State had not demonstrated that the proposed arrangements present any problems, please
qualifications for providers, a state must services were within the statutory definition contact the presiding officer. In order to
comply with Medicaid law and of case management services found in section facilitate any communication which may be
regulations concerning freedom of 1915(g)(2) of the Social Security Act (the necessary between the parties to the hearing,
Act); (2) the proposed services are available please notify the presiding officer to indicate
choice at section 1902(a)(23) of the Act without charge to the user and thus payment
and the implementing regulation at 42 acceptability of the hearing date that has
under the amendment is not reasonable and been scheduled and provide names of the
CFR 431.51. These provisions require necessary and would duplicate payment individuals who will represent the State at
that a state plan permit beneficiaries to under other program authorities; and (3) the the hearing. The presiding officer may be
obtain services from any qualified amendment would restrict beneficiary reached at (410) 786–2055.
provider that undertakes to provide the freedom of choice by limiting providers to Sincerely,
services. Section 1915(g)(1) of the Act employees of public welfare agencies.
Thomas A. Scully.
Medicaid coverage of targeted case
states ‘‘The provision of case management is authorized by section 1915(g) Sec. 1116 of the Social Security Act (42
management services under this of the Act, which defines case management U.S.C. section 1316); 42 CFR 430.18)
subsection shall not restrict the choice as services that assist beneficiaries in gaining (Catalog of Federal Domestic Assistance
of the individual to receive assistance in access to needed services and does not Program No. 13.714, Medicaid Assistance
violation of section 1902(a)(23).’’ include the direct provision of those services. Program)

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68142 Federal Register / Vol. 67, No. 217 / Friday, November 8, 2002 / Notices

Dated: November 4, 2002. and Drug Administration, 7500 Standish needed, (2) existing data included in a
Thomas A. Scully, Pl., Rockville, MD 20855, 301–827– previously approved application will
Administrator, Centers for Medicare & 7577, e-mail: mmartine@cvm.fda.gov. generally suffice, or (3) the nature of the
Medicaid Services. SUPPLEMENTARY INFORMATION: supplemental application will dictate
[FR Doc. 02–28469 Filed 11–7–02; 8:45 am] whether or not new data are generally
I. Background
BILLING CODE 4165–15–P needed. A comment section follows
On November 21, 1997, the Food and each table providing explanations and
Drug Administration Modernization Act suggestions to the sponsor. The
DEPARTMENT OF HEALTH AND (FDAMA) (Public Law 105–115) was guidance also cross-references several
HUMAN SERVICES signed into law. Section 403 of FDAMA FDA documents relating to the
requires FDA to provide information processing of supplemental
Food and Drug Administration regarding approval of supplemental applications, providing further
applications for approved products.
[Docket No. 99N–2912] assistance to the sponsor.
Section 403(b)(2) of FDAMA requires
Final Guidance for Industry on the that FDA issue guidance on specific This final level 1 guidance is being
Development of Supplemental data requirements for supplemental issued consistent with FDA’s good
Applications for Approved New Animal NADAs in order to prevent duplication guidance practices regulation (21 CFR
Drugs; Availability of previously submitted data. In the 10.115). The guidance represents the
Federal Register of February 8, 2000 (65 agency’s current thinking on the
AGENCY: Food and Drug Administration, FR 6214), FDA announced the development of supplemental
HHS. availability of a draft guidance for applications for approved new animal
ACTION: Notice. industry entitled ‘‘Guidance for drugs. It does not create or confer any
Industry: Development of Supplemental rights for or on any person and does not
SUMMARY: The Food and Drug Applications for Approved New Animal operate to bind FDA or the public. An
Administration (FDA) is announcing the Drugs.’’ The draft guidance illustrated alternative approach may be used if
availability of a final guidance for the various types of supplemental
such approach satisfies the
industry (#82) entitled ‘‘Guidance for applications and their dependence on
Industry: Development of Supplemental requirements of the applicable statutes
new data. This draft guidance explained
Applications for Approved New Animal how and when drug sponsors could use and regulations.
Drugs.’’ This guidance explains how data accepted in support of an original II. Comments
and when drug sponsors may use data application to support supplemental
collected for original new animal drug applications. The draft guidance also As with all of FDA’s guidances, the
applications (NADAs) to support the explained when a sponsor should public is encouraged to submit written
technical sections of a supplemental submit a new NADA rather than a or electronic comments pertinent to this
NADA. The guidance also explains supplemental NADA. The agency guidance. FDA will periodically review
when the Center may, under existing received no comments on the draft the comments in the docket and, where
statutes or regulations, require the guidance. The content of the final appropriate, will amend the guidance.
submission of new data. Finally, the guidance is the same as the draft. The agency will notify the public of any
guidance delineates the instances in ‘‘Guidance for Industry: Development such amendments through a notice in
which a sponsor will generally need to of Supplemental Applications for the Federal Register.
file a new NADA rather than a Approved New Animal Drugs’’
supplemental application. demonstrates the agency’s dedication to Interested persons may submit to the
assisting the sponsor in creating a Dockets Management Branch (see
DATES: Submit written or electronic
project development strategy and to ADDRESSES) written or electronic
comments on agency guidances at any
time. fostering a discussion between the comments on this final guidance at any
sponsor and the agency. With this in time. Two copies of any comments are
ADDRESSES: Submit written requests for mind, the guidance is organized in a to be submitted, except that individuals
single copies of the final guidance to the user-friendly format with two may submit one copy. Comments are to
Communications Staff (HFV–12), Center distinctive sections. The first section be identified with the docket number
for Veterinary Medicine, Food and Drug separates supplemental applications found in brackets in the heading of this
Administration, 7519 Standish Pl., into two categories: Category I includes document. The final guidance and
Rockville, MD 20855. Send one self- applications that do not ordinarily received comments are available for
addressed adhesive label to assist that require additional data and category II public examination in the Dockets
office in processing your requests. includes applications that may require
Submit written comments on the final Management Branch between 9 a.m. and
additional data. The guidance then lists 4 p.m., Monday through Friday.
guidance to the Dockets Management the 14 types of supplemental
Branch (HFA–305), Food and Drug applications in each category as well as III. Electronic Access
Administration, 5630 Fishers Lane, rm. the instances in which a sponsor
1061, Rockville, MD 20852. Submit generally will need to file a new NADA Persons with access to the Internet
electronic comments to http:// rather than a supplemental NADA. may obtain the document at http://
www.fda.gov/dockets/ecomments. See The second section is dedicated to www.fda.gov/cvm.
the SUPPLEMENTARY INFORMATION section clarification of category II supplemental Dated: October 10, 2002.
for electronic access to the final applications and the data to meet the
guidance document. Margaret M. Dotzel,
technical section requirements. The data
FOR FURTHER INFORMATION CONTACT: CVM would recommend be submitted Associate Commissioner for Policy.
Marilyn N. Martinez, Office of New for each category II supplement are [FR Doc. 02–28472 Filed 11–7–02; 8:45 am]
Animal Drug Evaluation (HFV–130), provided in tables. The tables indicate BILLING CODE 4160–01–S
Center for Veterinary Medicine, Food if: (1) New data will generally be

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