[Federal Register Volume 63, Number 102 (Thursday, May 28, 1998)]
[Notices]
[Pages 29233-29234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14103]


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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

[[Page 29234]]

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