[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
