36924 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Syrup. FDA is also declaring all

identical, similar, and related drug

products, not otherwise subject to an

approved drug application, unlawful,

including Brofed Tablets and

Hydroxyzine Compound Syrup. Each of

these products contains theophylline,

ephedrine sulfate, and hydroxyzine

hydrochloride. The basis of the

withdrawals is that there is a lack of

substantial evidence that these

combination drugs are effective for the

treatment of bronchial asthma.

EFFECTIVE DATE: August 7, 1998.

ADDRESSES: Requests for applicability of

this notice to a specific product should

be identified with the Docket and DESI

numbers found in brackets in the

heading of this document and directed

to the Division of Prescription Drug

Compliance and Surveillance (HFD–

330), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: As part of

the agency’s drug efficacy program, in a

notice published in the Federal Register

of September 17, 1984 (49 FR 36443),

the Commissioner of Food and Drugs

granted an evidentiary hearing before an

administrative law judge on the

proposal to withdraw approval of NDA

11–768 for Marax Tablets and NDA 12–

879 for Marax Syrup, each containing

theophylline, ephedrine sulfate, and

hydroxyzine hydrochloride. The NDA’s

are held by J. B. Roerig, Division of

Pfizer, Inc. (Pfizer), 235 East 42d St.,

New York, NY 10017.

Other party participants were:

1. Barre-National, Inc., 4128 Haywood

Ave., Baltimore, MD 21215 (Barre);

Hydroxyzine Compound Syrup (no

NDA).

2. Cord Laboratories, Inc. (now

Geneva Pharmaceuticals, Inc.), 2555

West Midway Blvd., Broomfield, CO

80038 (Cord); Brofed Tablets (no NDA).

3. Barrows Research Group, Inc., 99

West Hawthorne Ave., Valley Stream,

NY 11580 (Barrows). Unnamed drug

product. Barrows later withdrew its

hearing request.

Subsequently, in accordance with

agreements to resolve, by other means,

the issue of their drug products’

effectiveness, Pfizer, Barre, and Cord

withdrew their hearing requests. Under

those agreements, FDA has concluded

that Marax Tablets and Marax Syrup

have not been shown to be effective, and

FDA is now withdrawing approval of

the NDA’s for these products.

This notice applies to any drug

product that is identical, related, or

similar to these products and is not the

subject of an approved NDA (21 CFR

310.6). Such products include

Hydroxyzine Compound Syrup and

Brofed Tablets, each of which contains

theophylline, ephedrine sulfate, and

hydroxyzine hydrochloride. Any person

who wishes to determine whether a

specific product is covered by this

notice should write to the Division of

Prescription Drug Compliance and

Surveillance (address above).

The Director of the Center for Drug

Evaluation and Research, under section

505 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355) and under

the authority delegated to her (21 CFR

5.82), finds that on the basis of new

information before her with respect to

Marax Tablets and Marax Syrup,

evaluated together with the evidence

available to her when the applications

were approved, there is a lack of

substantial evidence that the products

will have the effect they purport or are

represented to have under the

conditions of use prescribed,

recommended, or suggested in their

labeling.

Therefore, based on the foregoing

finding, approvals and all the

amendments and supplements thereto

of NDA 11–768 and NDA 12–879 are

withdrawn effective August 7, 1998.

Shipment in interstate commerce of the

products listed above or of any

identical, related, or similar product

that is not the subject of an approved

NDA will then be unlawful.

Dated: June 15, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–18140 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective Drugs Advisory

Committee; Notice of Meeting;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appears in the Federal

Register of June 25, 1998 (63 FR 34655).

The notice announced a meeting of the

Anti-Infective Drugs Advisory

Committee, which was scheduled for

July 29, 30, and 31, 1998. The document

was published with an error. This

document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Carolyn C. Harris, Office of Policy (HF–

27), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–2994.

In FR Doc. 98–16934 appearing on

page 34655 in the Federal Register of

Thursday, June 25, 1998, the following

correction is made:

On page 34655, under the Agenda

caption, in the 2d column, beginning in

the 1st line, ‘‘http://www.fda.gov/cder/

guidance.htm’’ is corrected to read

‘‘http://www.fda.gov/cder/guidance/

index.htm’’.

Dated: July 1, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–18144 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Notice of Hearing: Reconsideration of

Disapproval of New York Title XXI

State Plan Amendment (SPA)

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of hearing.

SUMMARY: This notice announces an

administrative hearing on July 29, 1998;

10:00 a.m., Thirty-Eighth floor, 26

Federal Plaza, New York, New York

10278 to reconsider our decision to

disapprove New York Title XXI SPA.

CLOSING DATE: Requests to participate in

the hearing as a party must be received

by the presiding officer by July 23, 1998.

FOR FURTHER INFORMATION CONTACT: Stan

Katz, Presiding Officer, HCFA, C1–09–

13, 7500 Security Boulevard, Baltimore,

Maryland 21244, Telephone: (410)–786–

2661.

SUPPLEMENTARY INFORMATION: This

notice announces an administrative

hearing to reconsider our decision to

disapprove the New York Title XXI

State Plan Amendment (SPA) submitted

March 26, 1998.

Section 1116 of the Social Security

Act (the Act) and 42 CFR Part 430

establish Department procedures that

provide an administrative hearing for

reconsideration of a disapproval of a

State plan or plan amendment. These

requirements are made applicable under
Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36925

Title XXI by section 2107(e)(2)(B). The

Health Care Financing Administration

(HCFA) is required to publish a copy of

the notice to the State that informs the

State of the time and place of the

hearing and the issues to be considered.

If we subsequently notify the State of

additional issues that will be considered

at the hearing, we will also publish that

notice.

Any individual or group that wants to

participate in the hearing as a party

must petition the presiding officer

within 15 days after publication of this

notice, in accordance with the

requirements contained at 42 CFR

430.76(b)(2). Any interested person or

organization that wants to participate as

amicus curiae must petition the

presiding officer before the hearing

begins in accordance with the

requirements contained at 42 CFR

430.76(c). If the hearing is later

rescheduled, the presiding officer will

notify all participants.

New York submitted this SPA on

March 26, 1998 to revise its approved

Title XXI plan to change the effective

date to October 1, 1997, from the

previously approved date of April 15,

1998. This change in effective date

would permit the State to claim

enhanced matching payments for the

operation of its Child Health Plus (CHP)

program for the period from October 1,

1997 to April 14, 1998. The SPA was

disapproved on April 1, 1998.

At issue in this reconsideration is

whether the State is entitled to an

effective date for its Title XXI plan

which included a period during which

the State was not operating a program

which met the requirements of Title XXI

(or the approved State plan). HCFA

disapproved this SPA because of two

elements of the State’s CHP program, as

in effect between October 1, 1997 and

April 14, 1998, which were inconsistent

with the requirements of Title XXI.

First, premiums and cost sharing in

effect during this period were

inconsistent with the requirements of

section 2103(e)(3)(A) of the Social

Security Act. For example, the State

CHP program provided for a $35

copayment for emergency services even

if a child’s family income was less than

150 percent of the poverty level. Also

the CHP program permitted premiums

for children with family incomes

between 120 percent and 150 percent of

the federal poverty level. Both of these

charges were in amounts higher than

those authorized under section

2103(e)(3)(A), which makes applicable

the Medicaid premium and cost sharing

limitations. Moreover, the State was not

applying procedures to ensure ‘‘that

children found through * * * screening

to be eligible for medical assistance

under the State Medicaid plan under

title XIX are enrolled for such assistance

under such plan’’ as required under

section 2102(b)(3)(B) of the Social

Security Act and guidance outlined in a

letter to States on January 23, 1998.

Section 2106(c)(1) of the Act directs

the Secretary to approve plans which

‘‘substantially comply with the

requirements’’ of Title XXI. Under

section 2106(a)(2)(B), a Title XXI plan

‘‘shall be effective beginning with a

calendar quarter that is specified in the

plan, but in no case earlier than October

1, 1997.’’ However, this flexibility is

limited by the requirement in section

2106(d)(1) that ‘‘[T]he State shall

conduct the program in accordance with

the plan (and any amendments)

approved under subsection (c) and with

the requirements of this title.’’ Approval

of the October 1, 1997 effective date was

not warranted because the State was not

operating its program in substantial

compliance with the requirements of

Title XXI or with the approved State

plan during the period October 1, 1997

through April 14, 1998.

Under Section 2106(c) of the Social

Security Act, the Secretary may

approve, disapprove, or request

additional information on a proposed

Title XXI State Plan amendment within

ninety days.

The Secretary has concluded that the

State’s amendment to its Title XXI Plan,

submitted on March 26, 1998, to change

the effective date of the plan, could not

be approved because the State program

during the period in question did not

substantially comply with the

requirements of Title XXI. Therefore,

HCFA, in consultation with the

Secretary, disapproved the amendment.

The notice to New York announcing

an administrative hearing to reconsider

the disapproval of its SPA reads as

follows:

Ms. Barbara A. DeBuono, M.D.;

M.P.H., Commissioner, State of New

York, Department of Health, Corning

Tower, Empire State Plaza, Albany, New

York 12237.

Dear Ms. DeBuono: I am responding to

your request for reconsideration of the

decision to disapprove New York Title XXI

State Plan Amendment (SPA) submitted

March 26, 1998.

At issue in this reconsideration is whether

the State is entitled to an effective date for

its Title XXI plan which included a period

during which the State was not operating a

program which met the requirements of Title

XXI (or the approved State plan).

Specifically, the premiums and cost sharing

provisions for the State’s Child Health Plus

program, in effect during the period in which

the State seeks retroactive approval through

this amendment, were inconsistent with the

requirements of section 2103 (a)(3)(A) of the

Social Security Act. In addition, the State

was not applying procedures to ensure ‘‘that

children found through * * * screening to be

eligible for medical assistance under the

State Medicaid plan under title XIX are

enrolled for such assistance under such

plan’’ as required under section 2102(b)(3)(B)

of the Social Security Act and guidance

outlined in a letter to States on January 23,

1998.

I am scheduling a hearing on your request

for reconsideration to be held on July 29,

1998 on the Thirty-Eighth Floor, 26 Federal

Plaza, New York, New York 10278.

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 Mr. Stanley Katz as the

presiding officer. If these arrangements

present any problems, please contact the

presiding officer. 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. The presiding officer may be

reached at (410) 786–2661.

Sincerely,

Nancy-Ann Min DeParle,

Administrator.

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: June 29, 1998.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 98–18019 Filed 7–2–98; 10:31 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; An Evaluation of the National

Cancer Institute Science Enrichment

Program

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995,

for opportunity for public comment on

proposed data collection projects, the

National Cancer Institute (NCI), the

National Institute of Health (NIH) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: Title: An

Evaluation of the NCI Science