[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Notices]
[Pages 59100-59101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96N-0279]


Agri-Tech, Inc.; Proposal To Withdraw Approval of a New Animal 
Drug Application; Opportunity for a 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 a hearing on a proposal to withdraw approval of a new 
animal drug application (NADA) for Protamone-D (iodinated casein 
tablets), held by Agri-Tech, Inc., because the applicant has failed to 
submit required periodic reports.

DATES: Requests for a hearing with data, analysis, and information 
relied upon to justify a request for a hearing are due by December 20, 
1996.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
filed in response to this notice should be identified with Docket No. 
96N-0279 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: Mohammad I. Sharar, Center for 
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0159.

SUPPLEMENTARY INFORMATION: An applicant is required to report 
periodically to the Center for Veterinary Medicine (CVM) concerning 
each of the applicant's approved NADA's as provided in Sec. 510.300 (21 
CFR 510.300). Agri-Tech, Inc., 4722 Broadway, Kansas City, MO 64112 
(last known address), is the sponsor of NADA 13-502 which provides for 
oral use of Protamone-D (iodinated casein tablets) in dogs. Agri-Tech, 
Inc., has not submitted the required periodic reports for NADA 13-502 
and has not responded to CVM's requests for submission of those 
reports. Letters to the firm have been returned indicating the firm is 
no longer at the above-listed address.

[[Page 59101]]

    Therefore, notice is given to Agri-Tech, 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 13-502 and all amendments and supplements thereto on 
the ground that the applicant has failed to submit the reports required 
under Sec. 510.300. Upon withdrawal of NADA 13-502, the corresponding 
regulation (21 CFR 520.1157) 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 applicant an opportunity for a 
hearing to show why approval of the NADA 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 
December 20, 1996, a written notice of appearance, request for a 
hearing, and the 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 a 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 a hearing as required by Sec. 514.200 
constitutes an election by the applicant not to make use of the 
opportunity for a 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 CVM may begin appropriate regulatory 
action to remove it from the market. Any new animal drug product which 
is not the subject of an approved application is subject to regulatory 
action at any time.
    A request for a 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 it is clear that the reports submitted 
are not complete or that there is no genuine and substantial issue of 
fact that precludes the withdrawal of approval, or that the request for 
a 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 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 pursuant to 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, CVM (Sec. 5.84).

    Dated: October 18, 1996.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 96-29630 Filed 11-19-96; 8:45 am]
BILLING CODE 4160-01-F