Texas Vitamin Co., RSR Laboratories Inc.; Proposal to Withdraw Approval of New Animal Drug Applications; Opportunity for Hearing

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.

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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 Sec. 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

Sec. 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 (Sec. 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 Sec. 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 Sec. 514.200.

The failure of an applicant to file a timely, written notice of

appearance and request for hearing as required by Sec. 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

Sec. 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 Sec. 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

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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]

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