[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