[Federal Register Volume 60, Number 80 (Wednesday, April 26, 1995)]
[Notices]
[Pages 20497-20499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10274]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0013]
Benton County Ag Center, Inc.; Proposal to Withdraw Approval of
Applications for Medicated Animal Feeds; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Center for Veterinary Medicine (CVM), Food and Drug
Administration (FDA), is providing an opportunity for a hearing on a
proposal to withdraw approval of certain medicated feed applications
(MFA's) held by Benton County Ag Center, Inc., for animal feeds bearing
or containing new animal drugs (NAD's). This action is based on new
information showing the firm's methods and controls used for
manufacturing, processing, and packing of the medicated feeds are
inadequate to assure and preserve the identity, strength, quality, and
purity of the NAD's therein, and they were not made adequate within a
reasonable time after receipt of written notice from FDA.
DATES: Requests for a hearing and data and information in support of
the hearing request are due by May 26, 1995.
ADDRESSES: Requests for a hearing in response to this notice should be
identified with Docket No. 95N-0013 and sent to the Dockets Management
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420
Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Karen A. Kandra, Center for Veterinary
Medicine (HFV-246), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1765.
SUPPLEMENTARY INFORMATION: CVM is providing an opportunity for a
hearing on a proposal to withdraw approval of 11 MFA's held by the firm
doing business as Benton County Ag Center, Inc., 312 Railroad St., P.O.
Box 308, Keystone, IA 52249-0308, for the manufacture of animal feeds
bearing or containing Category II NAD's. Benton County Ag Center, Inc.,
is a feed mill that manufactures both medicated and nonmedicated animal
feeds. The 11 MFA's, held by Benton County Ag Center, Inc., were
approved under section 512(m) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 360b(m)) and are identified as follows:
------------------------------------------------------------------------
MFA Number Drug/Combination Species
------------------------------------------------------------------------
1. F 93-642............ Carbadox............... Swine
2. F 127-333........... Tylosin/Sulfamethazine. Swine
3. F 131-878........... Carbadox............... Swine
4. F 139-280........... Levamisole Cattle and swine
Hydrochloride.
5. F 141-603........... Carbadox/Pyrantel Swine
tartrate.
6. F 141-604........... Pyrantel tartrate...... Swine
7. F 141-757........... Lincomycin/Pyrantel Swine
tartrate.
8. F 144-054........... Sulfamethazine/ Swine
Chlortetracycline
(CTC)/Penicillin.
9. F 147-607........... Sulfamethazine/CTC..... Cattle
10. F 147-617.......... Arsanilic acid......... Chickens, turkeys, and
swine
11. F 147-641.......... Oxytetracycline/ Chickens, turkeys,
Neomycin. swine, cattle, and
mink
------------------------------------------------------------------------
To manufacture a Type B or C animal feed bearing or containing a
Category II NAD (i.e., Type A medicated article) a firm must file an
MFA (Form FDA 1900) with FDA and obtain its approval. FDA does not
approve such an application unless, among other things, the firm agrees
to comply with the agency's regulations for current good manufacturing
practice (CGMP) for medicated feeds (21 CFR part 225), which are
intended to help assure that feed bearing or containing an NAD meets
the requirements of the act pertaining to identity, strength, quality,
and purity. The agency determines whether the firm's manufacture of
medicated feed is in compliance with the CGMP regulations by inspecting
the facilities and controls used for, and the methods used in, the
manufacture, processing, and packing of the feed by the firm.
On December 22, 1992, the Iowa Department of Agriculture (Medicated
Feed Bureau), under contract with FDA pursuant to section 702(a) of the
act (21 U.S.C. 372(a)), inspected Benton County Ag Center, Inc. The
inspection revealed significant deviations from the CGMP's for
medicated feeds. The investigator noted the deviations on an
inspectional observations form (Form FDA 483) (Ref. 1), issued a copy
to the firm's General Manager, and discussed in detail the deviations
with him. The deviations included the following:
1. Production records did not show when flushing of equipment was
performed or the final disposition of flush materials, as required by
21 CFR 225.102(b)(4).
2. Production records did not show the actual quantity of medicated
feed produced, as required by 21 CFR 225.102(b)(2)(iv).
3. Production records were not checked by a responsible person to
determine if all required production steps had been performed, as
required by 21 CFR 225.102(b)(4). [[Page 20498]]
4. Only two of the three required assays were performed on
medicated feeds containing monensin and melengestrol acetate, as
required by 21 CFR 225.58(b)(1).
5. Proper labeling for medicated feed manufactured containing 300
grams per ton chlortetracycline was not available, as required by 21
CFR 225.80.
6. The drug scale, ingredient scale, and the bagger scale had not
been tested for accuracy within the last year, as required by 21 CFR
225.30(b)(4).
7. No written procedures for flushing and sequencing were
available, as required by 21 CFR 225.65(b).
8. Incoming labels were not proofread, dated, or initialed by a
responsible person, as required by 21 CFR 225.80(b)(2).
9. No investigation or corrective action was taken after receipt of
failed assay result for medicated feed, as required by 21 CFR 225.58(d)
and (e).
10. No drug receipt records or daily drug inventory were maintained
for Category I, Type A medicated articles, as required by 21 CFR
225.42(b)(5) and (b)(6).
As a result of the failed CGMP inspection, FDA sent a letter dated
March 12, 1993 (Ref. 2), (with a copy of the Form FDA 483 enclosed) to
the firm's president. The letter discussed potential regulatory
consequences that could result due to facility personnel deviating from
CGMP requirements. It urged that the firm's president ``* * * ensure
complete and lasting [emphasis added] correction of all regulatory
deficiencies.'' The letter also informed the firm's president that FDA
would not approve additional MFA's until the violations were corrected
and verified. Finally, the letter closed by stating that if the
violations were not corrected, FDA might issue a notice of opportunity
for a hearing on a proposal to withdraw approval of the firm's MFA's.
In response to the FDA letter, the firm's president sent a letter
dated April 7, 1993 (Ref. 3), to FDA listing the actions that had been
taken to correct all violations listed on the Form FDA 483.
The firm was inspected again on May 3, 4, 10, and 11, 1994. That
inspection revealed continued violations of CGMP regulations for the
manufacture of medicated animal feeds including the following:
1. Failed assay results had not been investigated, and the required
corrective actions had not been instituted, as required by 21 CFR
225.58(d) and (e).
2. The three drug potency assays required per calendar year were
not performed on medicated feeds containing Aureo S 700
(chlortetracycline and sulfamethazine), as required by 21 CFR
225.58(b)(1).
3. Master Record Files did not always indicate the amount of drug
source material to be used in a batch of medicated feed, as required by
21 CFR 225.102(b)(1).
4. Liquid meters to measure molasses and white grease had not been
tested for accuracy within the last year, as required by 21 CFR
225.30(b)(4).
5. A container (bearing expiration date 10/92) with 10 pounds of
tiamulin indicated inadequate drug control, as required by 21 CFR
225.42(a).
A Form FDA 483 (Ref. 4) containing the observed violations was
presented to and discussed with the firm's president.
Consequently, FDA sent a certified letter dated August 23, 1994
(Ref. 5), to the president of Benton County Ag Center, Inc., notifying
him of FDA's intention to withdraw approval of the 11 MFA's currently
held by his firm. The firm has not submitted a formal response to the
letter.
Accordingly, FDA is now proposing to withdraw approval of the MFA's
held by Benton County Ag Center, Inc., as identified above, under
section 512(m)(4)(B)(ii) of the act and 21 CFR 514.115(c)(2).
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Form FDA 483, inspection of December 22, 1992.
2. Letter, FDA to Benton County Ag Center, Inc., dated March 12,
1993.
3. Letter, Benton County Ag Center, Inc., to FDA, dated April 7,
1993.
4. Form FDA 483, inspection of May 3, 4, 10, and 11, 1994.
5. Letter, FDA to Benton County Ag Center, Inc., dated August
23, 1994.
Therefore, notice is given to Benton County Ag Center, Inc., and to
any other interested persons who may be adversely affected, that CVM
proposes to issue an order under section 512(m)(4)(B)(ii) of the act
and 21 CFR 514.115(c)(2) withdrawing approval of MFA's F 93-642, F 127-
333, F 131-878, F 139-280, F 141-603, F 141-604, F 141-757, F 144-054,
F 147-607, F 147-617, F 147-641, and all amendments and supplements
thereto, on the grounds that new information, evaluated together with
the evidence available when the applications were approved, shows that
the methods used in, or the facilities and controls used for, the
manufacturing, processing, and packing of such animal feeds are: (1)
Inadequate to ensure and preserve the identity, strength, quality, and
purity of the NAD's therein, and (2) were not made adequate within a
reasonable time after receipt of written notice from FDA specifying the
inadequacies.
In accordance with provisions of section 512 of the act and
regulations promulgated for the efficient enforcement of it (21 CFR
part 514), and under authority delegated to the Director, Center for
Veterinary Medicine (21 CFR 5.84), CVM hereby provides an opportunity
for a hearing to show why approval of the MFA's identified in this
notice, and all amendments and supplements to the applications, should
not be withdrawn under section 512(m)(4)(B)(ii) of the act and 21 CFR
514.115(c)(2). 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
May 26, 1995, a written notice of appearance, request for a hearing,
and the data, information, and analyses relied on to justify a hearing,
as specified in 21 CFR 514.200.
Procedures and requirements governing this notice of opportunity
for a hearing, a notice of appearance and request for a hearing,
submission of information and analysis to justify a hearing, other
comments, and a grant or denial of a hearing, are contained in 21 CFR
514.200.
The failure of a sponsor to file a timely, written appearance and
request for a hearing as required by 21 CFR 514.200 shall be construed
as an election not to avail himself of the opportunity for a hearing.
In such case, the Director, Center for Veterinary Medicine, under the
authority delegated to him in 21 CFR 5.84(a)(2), without further notice
will enter a final order withdrawing approval of the applications.
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 requires a hearing. If it
clearly appears from the face of the documentation and analysis in the
request for a hearing that there is no [[Page 20499]] genuine and
substantial issue of fact that precludes the withdrawal of approval of
the MFA's, 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 as soon as practicable.
All submissions under this notice shall be filed in four copies
and, except as provided in 21 CFR 10.20(j), 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 (21 U.S.C. 360b)) and under authority delegated to the
Director, Center For Veterinary Medicine (21 CFR 5.84).
Dated: April 19, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-10274 Filed 4-25-95; 8:45 am]
BILLING CODE 4160-01-F
