Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29233

TABLE 1.—Estimated Annual Reporting Burden1—Continued

21 CFR Section/Form No. of

Respondents

No. of

Responses per

Respondents

Total Annual

Responses

Hours per

Response Total Hours

314.98(c) (FDA 2252) 265 17.17 4,551 40 182,040

314.99(a) 46 13.04 600 2 1,200

314.110(a)(5) 55 1.13 62 8 496

314.120(a)(5) 26 1.12 29 8 232

314.420 450 1.11 500 8 4,000

Total Burden Hours 2,158,470

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: May 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14050 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0273]

Texas Vitamin Co., RSR Laboratories

Inc.; Proposal to Withdraw Approval of

New Animal Drug Applications;

Opportunity for Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing an

opportunity for hearing on a proposal to

withdraw approval of new animal drug

application (NADA) 117–688 held by

Texas Vitamin Co. and NADA 140–850

held by RSR Laboratories Inc., because

the applicants have failed to submit

required periodic reports. FDA has been

unable to locate the firms and to contact

them at their previous business

addresses.

DATES: Requests for hearing with data,

analysis, and information relied upon to

justify a request for hearing are due by

June 29, 1998.

ADDRESSES: Requests for hearing filed in

response to this notice should be

identified with Docket No. 98N–0273

and sent to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Glenn A. Peterson, Center for

Veterinary Medicine (HFV–212),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–0224; or

Mukund R. Parkhie, Center for

Veterinary Medicine (HFV–216),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–6642.

SUPPLEMENTARY INFORMATION: An

applicant is required to report

periodically to the Center for Veterinary

Medicine (CVM) concerning each

applicant’s approved NADA as provided

in § 510.300 (21 CFR 510.300). Texas

Vitamin Co., P.O. Box 18417, 10695

Aledo St., Dallas, TX 57218 (last known

address), is sponsor of NADA 117–688.

RSR Laboratories Inc., 501 Fifth St.,

Bristol, TN 37620 (last known address),

is sponsor of NADA 140–850. The

sponsors have not submitted the

required periodic reports for their

NADA’s and have not responded to

CVM requests for submission of those

reports. Letters to the firms have been

returned indicating the firms are no

longer at the above-listed addresses.

Therefore, notice is given to Texas

Vitamin Co. and RSR Laboratories Inc.,

and to all other interested persons who

may be adversely affected, that the

Director, CVM, proposes to issue an

order under section 512(e) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(e))

withdrawing approval of NADA’s 117–

688 and 140–850 and all amendments

and supplements thereto on the ground

that the applicants have failed to submit

the reports required under § 510.300.

Upon withdrawal of the NADA’s, the

applicable parts of the regulations in 21

CFR 510.600(c)(1) and (c)(2) and

520.580(b)(1) will be revoked.

In accordance with the provisions of

section 512 of the act and regulations

issued under it (parts 510 and 514 (21

CFR parts 510 and 514)), and under

authority delegated to the Director, CVM

(§ 5.84 (21 CFR 5.84)), CVM hereby

provides the applicants an opportunity

for hearing to show why approval of the

NADA’s and all amendments and

supplements thereto should not be

withdrawn (and the corresponding

regulations revoked) and an opportunity

to raise, for administrative

determination, all issues relating to the

legal status of the application and drug

products approved thereunder. Any

hearing would be subject to the

provisions of 21 CFR part 12.

An applicant who decides to seek a

hearing shall file on or before June 29,

1998, a written notice of appearance,

request for hearing, and data,

information, and analyses relied on to

justify a hearing as specified in

§ 514.200.

Procedures and requirements

governing this notice of opportunity for

hearing, notice of appearance and

request for hearing, submission of

information and analysis to justify a

hearing, other comments, and a grant or

denial of a hearing, are contained in

§ 514.200.

The failure of an applicant to file a

timely, written notice of appearance and

request for hearing as required by

§ 514.200 constitutes an election by the

applicant not to make use of the

opportunity for hearing concerning the

proposed action and constitutes a

waiver of any contentions about the

legal status of the product. In such case,

the Director, CVM, under the authority

delegated to him in § 5.84(a)(2), will,

without further notice, enter a final

order withdrawing approval of the

application. Thereafter, the product may

not be legally marketed, and FDA may

begin appropriate regulatory action to

remove it from the market. Any new

animal drug product that is not the

subject of an approved application is

subject to regulatory action at any time.

A request for hearing may not rest

upon mere allegations or denials, but

must set forth specific facts showing

that there is a genuine and substantial

issue of fact that justifies a hearing.

Reports submitted to remedy the

deficiencies must be complete in all

respects as required by § 510.300. If the

reports submitted are not complete or

there is no genuine and substantial issue

of fact that precludes the withdrawal of

approval, or the request for hearing is

not made in the required format or with

the required analysis, the Commissioner

of Food and Drugs will enter summary

judgment against the person who
29234 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

requests the hearing, making findings

and conclusions, and denying a hearing.

If a hearing is requested and is justified

by the sponsor’s response to this notice,

the issues will be defined, an

administrative law judge will be

assigned, and a written notice of the

time and place at which the hearing will

begin will be issued.

All submissions under this notice

shall be filed in two copies. Except for

information prohibited from public

disclosure under 21 U.S.C. 331(j) or 18

U.S.C. 1905, the submissions may be

seen in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 512(e) (21 U.S.C. 360b(e))) and

under authority delegated to the

Director, Center For Veterinary

Medicine (21 CFR 5.84).

Dated: May 20, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–14103 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Joint Meeting of the Pulmonary-Allergy

Drugs and Endocrinologic and

Metabolic Drugs Advisory Committees;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committees: Joint meeting of

the Pulmonary-Allergy Drugs and the

Endocrinologic and Metabolic Drugs

Advisory Committees.

General Function of the Committees:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on July 30, 1998, 8 a.m. to 5 p.m.,

and on July 31, 1998, 8 a.m. to 3:45 p.m.

Location: Bethesda Marriott Hotel,

Grand Ballroom, 5151 Pooks Hill Rd.,

Bethesda, MD.

Contact Person: Leander B. Madoo or

Kathleen R. Reedy, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), codes 12545 and

12536. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On July 30, 1998, the

committees will: (1) Discuss the impact

of orally inhaled and intranasal

corticosteroids on growth in children,

(2) hear from invited experts regarding

the process of normal growth and

development in children and how

various factors including corticosteroids

may impact on it, and (3) review

examples from industry of completed

‘‘growth studies’’ testing the various

inhaled and intranasal corticosteroid

drug products. On July 31, 1998, the

agency will: (1) Present the proposed

‘‘class labeling’’ for inhaled and

intranasal corticosteroid drug products,

(2) review the data which support it,

and (3) lead a general scientific

discussion among all meeting

participants to reach a consensus

concerning appropriate labeling for

these products and recommendations

for the design and conduct of future

clinical trials which assess growth.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 23, 1998. Oral

presentations from the public will be

scheduled between approximately 3

p.m. and 4:30 p.m., on July 30, 1998.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 23, 1998,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 20, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–14106 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Healthy Start Initiative—Phase II

Limited Competition for the

Mississippi Delta

AGENCY: Health Resources and Services

Administration (HRSA), HHS.

ACTION: Notice of availability of funds

for a limited competition for the ten

counties of Mississippi known as the

Mississippi Delta.

SUMMARY: The HRSA announces the

availability funds in fiscal year 1998 for

a single cooperative agreement for the

replication of the Healthy Start Initiative

(HSI) Phase II within the ten counties of

Mississippi known as the Mississippi

Delta. The Healthy Start Initiative is a

program of projects which, since FY

1991, has developed and implemented

community-based strategies to reduce

infant mortality in areas with a high

incidence of infant mortality. The

purpose of Healthy Start-Phase II is to

operationalize successful infant

mortality reduction strategies developed

during the demonstration phase and to

launch Healthy Start projects in new

rural and urban communities (i.e.,

communities currently without a

Healthy Start Initiative-funded project).

Within the HRSA, the Healthy Start

Initiative is administered by the

Maternal and Child Health Bureau

(MCHB). This cooperative agreement for

Healthy Start-Phase II in the Mississippi

Delta will be made under the program

authority of Section 301 of the Public

Health Service Act. Funds for this

award were appropriated under Public

Law 104–208.

To continue Healthy Start efforts to

meet critical maternal and child health

needs in the Mississippi Delta, public

and nonprofit private organizations

serving the following counties in the

Mississippi Delta—Humphries, Holmes,

Leflore, Bolivar, Quitman, Sunflower,

Tallahatchie, Washington, Cohoma, and

Tunica—are encouraged to apply.

Applicants must provide services to all

ten counties. Only one applicant

organization will be funded.

The project period is three years,

subject to continuing availability of

funds.

ADDRESSES: Interested parties may

contact the HRSA Grants Application

Center for an application package.

Requests should specify the Healthy

Start Initiative—Phase II limited

competition within the Mississippi

Delta (CFDA #93.926b). The Center may