Animal Drug Availability Act; Medicated Feed Mill Licenses

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 225, 510, 514, 515, and 558

[Docket No. 97N-0276]

Animal Drug Availability Act; Medicated Feed Mill Licenses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the animal drug regulations to provide for feed mill licensing in

accordance with the Animal Drug Availability Act (ADAA) of 1996. The

ADAA amends the Federal Food, Drug, and Cosmetic Act (the act) to

require a single facility license for the manufacture of feeds

containing approved new animal drugs, rather than multiple medicated

feed applications (MFA's) for each feed mill, as previously required by

the act. The proposed regulation implements the requirements for feed

mill licensing set forth in the ADAA.

DATES: Submit written comments on the proposed rule by October 28,

1997. Submit written comments on the information collection provisions

by August 29, 1997. The agency proposes that any final rule that may

issue based on this proposal become effective 30 days after date of

publication of the final rule.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857. Submit written comments on information collection

requirements to the Office of Information and Regulatory Affairs, OMB,

New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC

20503, Attn: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: William D. Price, Center for

Veterinary Medicine (HFV-200), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-1724.

SUPPLEMENTARY INFORMATION:

I. Background

The ADAA (Pub. L. 104-250), which amended section 512(a) and (m) of

the act (21 U.S.C. 360b(a) and (m)), replaces the system for the

approval of specific medicated feeds with a general licensing system.

Prior to the passage of the ADAA, an approved MFA was required by

the act for the manufacture of medicated feed. The act required a feed

mill to submit a separate MFA for each medicated feed to be

manufactured by the firm. The ADAA eliminates the requirement that a

feed mill submit a separate MFA for the manufacture of each type of

medicated feed and instead provides for feed mills to be licensed and

allows a licensed facility to manufacture any feed containing an

approved new animal drug. Additionally, section 512(m)(6) of the act,

as added by the ADAA, provides the agency with the authority, to the

extent consistent with the public health, to exempt facilities that

manufacture certain types of medicated feed from the requirement of a

medicated feed mill license. The ADAA sets forth the requirements for

such licensing.

The proposed regulation will require only one facility license for

the manufacture of animal feeds containing approved new animal drugs,

instead of multiple approved MFA's. Furthermore, those medicated feeds

exempted from the MFA requirement under Sec. 558.4 (21 CFR 558.4) will

also be exempt from the requirement of a medicated feed mill license

under this proposal. Thus, the regulation, in implementing the statute,

would reduce the overall costs of regulatory compliance for industry.

Additionally, because of the reduction in the number of applications

that FDA would process annually, the proposed regulation, in

implementing the statute, would reduce costs for the Federal

Government.

The ADAA contains a transitional provision that provides that any

person currently engaged in the manufacture of a medicated feed under

an approved MFA shall be deemed to hold a medicated feed mill license

for the manufacturing site identified in the application. Such

transitional license

[[Page 40766]]

expires April 9, 1998, 18 months after the date of enactment of the

ADAA, unless the person has obtained a medicated feed mill license by

that date.

II. Description of the Proposed Rule

The proposed regulation implements the requirements of section

512(m) of the act for medicated feed mill licensing. The proposed rule

would add a new part 515 to provide the requirements for feed mill

licensing. The proposed rule would amend part 514 (21 CFR part 514) to

remove the provisions regarding MFA's.

Section 515.10 sets forth the criteria for medicated feed mill

license applications. Section 515.10(b)(1) requires the applicant to

provide the full business name and address of the feed manufacturing

facility and the facility's FDA registration number. Section

515.10(b)(2) requires the applicant to provide the name, title, and

original signature of the responsible individual or individuals for

that facility. Section 515.10(b)(3) requires the applicant to certify

that the feed manufacturing facility is manufacturing and labeling the

animal feed bearing or containing new animal drugs in accordance with

applicable regulations published under section 512(i) of the act.

Section 515.10(b)(4) requires the applicant to certify that the feed

manufacturing facility is in conformity with current good manufacturing

practice (CGMP) requirements. All of these requirements are set forth

in section 512(m)(1) of the act, as amended by the ADAA.

Section 515.10(b)(5) requires the applicant to certify that the

feed manufacturing facility will comply with applicable regulations or

orders issued under sections 512(m)(5)(A) or 504(a)(3)(A) (21 U.S.C.

354(a)(3)(A)) of the act for record and reporting requirements. This

certification requirement is based on section 512(m)(5)(A) of the act,

which sets forth the agency's authority to issue record and reporting

requirements applicable to medicated feed mill licensees, and section

512(m)(4)(B)(i) of the act, which sets forth the agency's authority to

revoke a license for the licensee's failure to comply with such

requirements.

Section 515.10(b)(6) requires the applicant to commit to the

possession of current approved Type B and/or Type C medicated feed

labeling for each animal feed containing an approved new animal drug.

The labeling is submitted in the new animal drug application (NADA)

under Sec. 514.1(b)(3)(v)(b). This commitment to possess the approved

labeling is based on section 512(a)(1)(B) of the act, which requires

that at the time of removal of the Type A medicated article from a

manufacturing, packing, or distributing establishment, such

establishment must possess an unrevoked written statement from the feed

manufacturing facility that such facility possesses a medicated feed

mill license and current approved medicated feed labeling for the use

of the Type A medicated article in animal feed. The facility can

provide such a statement to the manufacturing, packing, or distributing

establishment only if that facility is currently in possession of the

approved labeling, which is the labeling approved in the NADA for the

new animal drug in animal feed.

Section 515.10(b)(7) requires the applicant to commit to renew

registration with FDA every year, in accordance with Secs. 207.20 and

207.21 (21 CFR 207.20 and 207.21). Section 207.20(a) requires owners or

operators of all drug establishments, not exempt under Sec. 207.10 (21

CFR 207.10), that engage in the manufacture, preparation, propagation,

compounding, or processing of a drug or drugs to register with FDA; and

Sec. 207.21 requires the yearly renewal of such registration. Section

207.10(f) exempts domestic establishments that manufacture only certain

types of medicated feed from the registration requirement. If a feed

mill manufactures any type of medicated feed that is not exempt under

Sec. 207.10(f), then the feed mill must register the establishment with

FDA under Sec. 207.20. The types of feed that would require

registration of the establishment under Sec. 207.20 would also require

a medicated feed mill license under Sec. 558.4. Thus, under

Secs. 207.10(f) and 558.4, each medicated feed mill that must possess a

license must also register the establishment with FDA. Medicated feed

mill licensees, however, are exempt from any drug listing requirement

under Sec. 207.20(a).

Section 515.10(d) provides for the return of applications that are

``facially deficient.'' The agency would apply this provision to those

applications that fail to provide sufficient information for the agency

to make a determination regarding approvability, such as if the

application is unsigned or undated. Thus, the provision is intended to

allow the agency to respond quickly to facially deficient applications

so that the applicant may have an opportunity to correct the

deficiencies and resubmit the application.

Section 515.11 sets forth the criteria for supplemental medicated

feed mill license applications. Section 515.11(a) requires a licensee

to supplement an application for a change in ownership and/or mailing

address of the facility site. The relocation of the feed manufacturing

facility to a new site would require the submission of a new medicated

feed mill license application, because an approved license is site

specific.

Section 515.11(c) requires the agency to approve a supplemental

medicated feed mill license application within 30 days after the filing

of such an application if the Commissioner of Food and Drugs (the

Commissioner) determines that the application provides ``adequate

information'' respecting the change in ownership and/or mailing address

of the facility site. The agency views supplemental applications as a

means to ensure the accuracy of agency records regarding a licensed

site. Thus, under this provision, the supplemental application would be

approved if the application provided the agency with a complete and

accurate description of the change in ownership and/or mailing address

of the facility site.

Section 515.11(c) also requires the agency to return supplemental

applications that fail to provide adequate information respecting a

change in ownership and/or mailing address of the facility site.

Because of the limited nature of the changes requiring an approved

supplemental application, the agency believes it would be inefficient

to deny applications that do not provide adequate information regarding

such a change. Therefore, a supplemental application that does not

provide a complete and accurate description of a change would be

returned to the applicant to complete.

Section 515.20 sets forth the requirements for the approval of

medicated feed mill license applications, and Sec. 515.21 sets forth

the requirements for the refusal to approve a medicated feed mill

license application. Section 515.22 sets forth the requirements for the

suspension and/or revocation of a medicated feed mill license and

Sec. 515.23 provides for the voluntary revocation of a medicated feed

mill license. Section 515.24 provides for the notice of revocation of

medicated feed mill licenses, Sec. 515.25 provides for the revocation

of an order refusing to approve an application or suspending or

revoking a license, and Sec. 515.26 provides for the service of notices

and orders.

Section 515.30 sets forth the provisions for a notice of

opportunity for a hearing concerning a refusal to approve a medicated

feed mill license application or a revocation of approval of a

medicated feed mill license. Section 515.31 describes the procedures

for hearings, and Sec. 515.40 provides for the

[[Page 40767]]

judicial review of an order entered by the Commissioner.

The proposed regulation also provides conforming amendments to the

Code of Federal Regulations by removing references to MFA's and

inserting appropriate references to medicated feed mill licenses. In

particular, the references to ``medicated feed application'' in other

sections have been eliminated and replaced, where appropriate, with the

new term ``medicated feed mill license.''

The proposed rule would amend Sec. 207.10(f) in order to clarify

the exemption from the requirement of establishment registration, as

set forth in Sec. 207.20. Section 207.10(f), as amended, clarifies the

types of feed manufactured exclusively by a facility that would not

require the registration of that facility. This clarification would

make the scope of this exemption from the requirement of establishment

registration identical to the scope of the exemption from the

requirement of a medicated feed mill license in Sec. 558.4(b).

The general scheme for categories and types of medicated feeds set

forth in Sec. 558.3 (21 CFR 558.3) would remain under medicated feed

mill licensing. Those medicated feeds exempted from the MFA requirement

under Sec. 558.4 also would be exempt from the requirement of a

medicated feed mill license under this proposal. Thus, the manufacture

of a Type B or Type C medicated feed from a Category I Type A medicated

article or from a Category II Type B or Type C medicated feed would be

exempt from the required license, unless otherwise specified.

Section 512(m)(6) of the act, as amended by the ADAA, provides the

agency with the authority, consistent with the public health, to

establish such an exemption. Category I Type A medicated articles, as

defined in Sec. 558.3(b)(1), require no withdrawal period at the lowest

use level in each species for which they are approved. Because Category

I Type A medicated articles do not require a withdrawal period, the

agency has determined that the exemption from the licensing requirement

for facilities that manufacture only Type B and Type C medicated feed

from Category I Type A articles, with the exception of certain types of

liquid and free choice medicated feed, would be consistent with the

protection of the public health. Furthermore, because Category II, Type

B and Type C medicated feeds are much more dilute than the Type A

medicated articles, Type B and Type C medicated feeds manufactured from

Category II Type B and Type C medicated feeds are unlikely to produce

unsafe (above tolerance) residues when such feed is fed to animals.

Thus, the agency has determined that the exemption from the licensing

requirement for facilities that manufacture only Type B or Type C

medicated feeds from Category II Type B or Type C medicated feeds would

be consistent with the protection of the public health.

The references to ``medicated feed application'' in the sections

for liquid medicated feed (21 CFR 558.5), and free-choice medicated

feed (21 CFR 510.455), will be amended in a future proposal that may

incorporate substantive changes to these provisions. The agency is

reviewing a citizen petition filed by the American Feed Industry

Association (AFIA) on April 30, 1993, as amended on March 3, 1994, and

December 6, 1996, concerning liquid medicated feed. Additionally, the

references to ``medicated feed application'' in 21 CFR 558.311 and

558.355 for lasalocid and monensin, respectively, will be amended in

the future proposal.

Finally, the reference to ``medicated feed application'' in the

section for records and reports (21 CFR 510.301), has been changed in

this proposal to ``medicated feed mill license.'' The agency intends to

propose other changes to this section in a future proposal in response

to a citizen petition filed by AFIA and the Animal Health Institute on

November 13, 1995, as amended on December 6, 1996, concerning the

records and reports requirements for medicated feed manufacturing

facilities.

III. Proposed Effective Date

The agency proposes that any final rule that may issue based on

this proposal become effective 30 days after date of publication of the

final rule.

IV. Environmental Impact

FDA has carefully considered the potential environmental impacts of

this proposed rule.

The agency has determined under 21 CFR 25.24(a)(8) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

Feed mill licensing is a procedure established by the ADAA as a

replacement for FDA's previous MFA system. The proposed action

substitutes a facility licensing program for a system of feed by feed

approval to manufacture feeds containing approved new animal drugs,

thereby substantially reducing the number of approval requests required

from facilities manufacturing feeds containing new animal drugs. A

medicated feed mill license authorizes a feed mill to manufacture any

feed containing an approved new animal drug. Previously, a feed mill

was required to submit a MFA for each applicable feed containing an

approved new animal drug.

This paperwork streamlining in no way reduces the responsibility of

each facility to manufacture medicated feeds in full compliance with

CGMP's regulations. Nor does the proposed action prevent the FDA from

inspecting facilities and their records or taking actions to bring

facilities into compliance.

The licensing of a feed mill by FDA does not reduce or change the

responsibilities of the mill management to comply with requirements of

other Federal, State, or local workplace waste management and emissions

laws and regulations. Consistent failure of a facility to comply with

hazard communication requirements, to provide necessary worker

protection, or to adequately manage wastes could be regarded by FDA as

an indication that the facility has a systemic problem that calls into

question the ability of the feed mill to comply with FDA CGMP's

regulations.

V. Analysis of Impacts

FDA has examined the impact of the proposed rule under Executive

Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612),

and under the Unfunded Mandates Reform Act (Pub. L. 104-4). Executive

Order 12866 directs agencies to assess all costs and benefits of

available regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages, distributive impacts and equity).

Under the Regulatory Flexibility Act, unless an agency certifies

that a rule will not have a significant impact on a substantial number

of small entities, the agency must analyze regulatory options that

would minimize any significant impact of a rule on small entities. The

Unfunded Mandates Reform Act requires (in section 202) that agencies

prepare an assessment of anticipated costs and benefits before

proposing any expenditure by State, local, and tribal governments, in

the aggregate, or by the private sector of $100 million.

The agency has reviewed this proposed rule and has determined that

the rule is consistent with the principles set forth in the Executive

Order and in these two statutes. FDA finds that the proposed rule will

not be a significant regulatory action under the Executive

[[Page 40768]]

Order. Further, the agency finds that the proposed rule will not have a

significant effect on a substantial number of small entities. Also,

because the expenditures required by the proposed rule are under $100

million, FDA is not required to perform a cost/benefit analysis

according to the Unfunded Mandates Reform Act.

As provided in this proposed rule, FDA would amend the process for

obtaining approval to manufacture medicated feeds. Instead of requiring

an approved MFA for each applicable medicated feed, this proposed

regulation requires only a single facility license per feed mill, as

appropriate. The ADAA grants a transitional license to all feed

manufacturing facilities currently holding an approved MFA. This

transitional license is valid for 18 months. During this time, the

facilities can obtain a permanent license by submitting a license

application and a copy of an approved MFA to FDA. One goal of this

proposed rule is to streamline paperwork requirements for facilities

and FDA. Despite this switch from MFA's to facility licenses, all other

existing reporting responsibilities for each drug remain unchanged.

The only costs that will be incurred are the paperwork costs

associated with applying for a facility license. FDA estimates that

approximately 2,000 feed mills will be affected by this proposed rule,

and that it will take approximately 15 minutes for each facility to

complete its application. Taking 1,995 median weekly earnings of

$684\1\ for the executives, administrators, and managers who will

complete the applications, and adding 40 percent for fringe benefits,

yields average hourly earnings of $23.94. Thus, the combined paperwork

costs for all facilities total $11,970 for the first year, and $599 for

the estimated 100 mills expected to apply for licensing or license

supplements in each subsequent year. This total cost translates into

approximately $6 per mill.

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\1\ Employment and Earnings, U.S. Department of Labor Bureau and

Labor Statistics, vol. 43, No. 1, p. 205, January 1996.

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Eliminating the MFA requirement provides industry with a large

savings in paperwork burden. Over the past 5 years, the agency has

received approximately 3,300 MFA's per year including both original

applications and MFA supplements. In the past, FDA surveyed several

feed mills and animal drug manufacturers, and determined that it took

industry about 2 hours to complete an MFA. Therefore, FDA estimates

this proposed rule will save industry over $158,000 per year, or

approximately $79 per mill per year, on average. The mills that have

routinely submitted a larger number of MFA's will realize a larger

total savings than those mills that routinely submit fewer MFA's.

FDA will also experience a cost savings in response to the feed

mill licensing requirement. Since 1994, the agency spent approximately

$180,000 per year for a contractor to process the MFA's. In contrast,

FDA estimates that it will take 40 minutes to process each feed mill

license application at a cost of $25 per hour for a GS-13 Government

employee. In the first year, it will cost the agency $33,500 to process

the expected 2,000 applications, and a startup cost of $10,000 for a

tracking and indexing computerized database. It is expected to cost

only $1,700 to process the 100 applications for each year thereafter.

The Small Business Administration (SBA) defines all manufacturers

of prepared feeds and feed ingredients for animals and fowls having 500

employees or fewer as a small business. FDA estimates that

approximately 20 percent of the affected feed mills belong to large

conglomerates that have an overall employee count of higher than 500.

Therefore, the remaining 80 percent of the affected facilities would be

considered small businesses by SBA's standards. However, the agency

concludes that these altered paperwork burdens will constitute an

insignificant percentage of gross revenue. FDA finds the proposed rule

will provide a net economic savings for all facilities, as well as the

Federal Government. Therefore, in accordance with the Regulatory

Flexibility Act, FDA certifies that this proposed rule will not have a

significant economic effect on a substantial number of small entities.

VI. Paperwork Reduction Act of 1995

This proposed rule contains information collection provisions that

are subject to review by the Office of Management and Budget (OMB)

under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The

title, description, and respondent description of the information

collection provisions are shown below with an estimate of the annual

reporting and recordkeeping burden. Included in the estimate is the

time for reviewing instructions, searching existing data sources,

gathering and maintaining the data needed, and completing and reviewing

each collection of information.

FDA invites comments on: (1) Whether the proposed collection of

information is necessary for the proper performance of FDA's functions,

including whether the information will have practical utility; (2) the

accuracy of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Title: Medicated Feed Mill License Application.

Description: This proposed rule implements the ADAA's medicated

feed mill licensing provisions. It would require that any medicated

feed manufacturing facility seeking a license submit an application to

FDA. In Sec. 515.10 of the proposed regulations, FDA is proposing that

the medicated feed mill license application form include:

(1) Manufacturing site legal business name,

(2) Address,

(3) Phone number,

(4) Fax number,

(5) Type of application,

(6) FDA registration number, and

(7) Date and signature.

The information on the form will be used to issue medicated feed

mill licenses. The information requested on the form is specifically

mandated by the ADAA, except for the phone number and fax number. These

numbers are needed so that FDA can contact the firm quickly when

necessary. The additional burden of supplying this information is

minimal.

Section 515.11 of the proposed regulations also specifies that

supplemental applications must be submitted for a change in ownership

and/or a change in mailing address. A medicated feed mill licensee

would submit such information to FDA on the medicated feed mill license

application form. Furthermore, Sec. 515.23 of the proposed regulations

also provides for voluntary revocation of the license. A medicated feed

mill licensee would submit in writing to FDA a request for voluntary

revocation of a license. Finally, Sec. 515.30 of the proposed

regulations provides procedures for refusing to approve license

applications when, among other reasons, the application is incomplete,

false, or misleading or the manufacturing, processing, and packaging of

the animal feed do not comply with applicable provisions of the act. A

medicated feed manufacturing facility would have the option to submit a

request for a hearing

[[Page 40769]]

in writing to FDA in response to the agency's proposal to refuse to

approve a medicated feed mill license application.

Description of Respondents: Medicated feed manufacturing

facilities.

Table 1.--Estimated Annual Reporting Burden: First Year

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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515.10 2,000 1 2,000 0.25 500

515.11 25 1 25 0.25 6.25

515.23 50 1 50 0.25 12.25

515.30 0.15 1 0.15 24 3.6

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There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Reporting Burden: Each Succeeding Year

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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515.10 100 1 100 0.25 25

515.11 25 1 25 0.25 6.25

515.23 50 1 50 0.25 12.25

515.30 0.15 1 0.15 24 3.6

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There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates 2,000 respondents for the submission of a medicated

feed mill license application within the first year based on the number

of current MFA holders (approximately 2,000). Furthermore, FDA

estimates 100 respondents for the submission of a medicated feed mill

license application during each succeeding year based on the average

number of new firms that began to manufacture medicated feed in past

years. FDA estimates 25 respondents per year for the submission of

supplements based on the average number of supplements that FDA

received for MFA's in past years. FDA estimates 50 respondents per year

for the submission of voluntary revocation requests based on the

average number of cancellation requests that FDA received for feed mill

registration in past years. Finally, FDA estimates 0.15 respondents per

year for the submission of hearing requests based on the fact that FDA

received only approximately five such requests for MFA's in the past 33

years.

FDA has already begun accepting and acting on feed mill license

applications in accordance with its statutory authority to do so under

the ADAA. This proposed rule would not significantly change the

application form that is now being used for such applications. To allow

FDA to begin implementing the ADAA promptly, the OMB approved this

collection of information, including the use of the application Form

FDA 3448, on a temporary basis under the emergency processing

provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(j)).

The approval is under OMB control number 0910-0337 and it was announced

in a notice published in the Federal Register of March 31, 1997 (62 FR

15186). The March 31, 1997, Federal Register notice solicited public

comment on the collection of information and provided 60 days for such

comments. FDA received no comments in response to this notice.

In compliance with section 3507(d) of the Paperwork Reduction Act

of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information

collection provisions of this proposed rule to OMB for review.

Interested persons are requested to send comments regarding information

collection by August 29, 1997, to (address above).

VII. Request for Comments

Interested persons may, on or before, October 28, 1997, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Two copies of any comments are to be

submitted, except that individuals may submit one copy. Comments are to

be identified with the docket number found in brackets in the heading

of this document. Received comments may be seen in the office above

between 9 a.m. and 4 p.m., Monday through Friday.

Interested persons may, on or before August 29, 1997, submit

written comments on the information collection provisions to the Office

of Information and Regulatory Affairs, OMB (address above).

List of Subjects

21 CFR Part 207

Drugs, Reporting and recordkeeping requirements.

21 CFR Part 225

Animal drugs, Animal feeds, Labeling, Packaging and containers,

Reporting and recordkeeping requirements.

21 CFR Part 510

Administrative practice and procedure, Animal drugs, Labeling,

Reporting and recordkeeping requirements.

21 CFR Part 514

Administrative practice and procedure, Animal drugs, Confidential

business information, Reporting and recordkeeping requirements.

21 CFR Part 515

Administrative practice and procedure, Animal drugs, Confidential

business information, Reporting and recordkeeping requirements.

21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that title 21 of the Code of Federal Regulations be amended as

follows:

[[Page 40770]]

PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS

IN COMMERCIAL DISTRIBUTION

1. The authority citation for 21 CFR part 207 continues to read as

follows:

Authority: Secs. 301, 501, 502, 505, 506, 507, 510, 512, 701,

704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351,

352, 355, 356, 357, 360, 360b, 371, 374); sec. 351 of the Public

Health Service Act (42 U.S.C. 262).

2. Section 207.10 is amended by revising paragraph (f) to read as

follows:

Sec. 207.10 Exemptions for domestic establishments.

* * * * *

(f) Persons who only manufacture the following:

(1) Type B or Type C medicated feed using Category I, Type A

medicated articles or Category I, Type B or Type C medicated feeds,

and/or;

(2) Type B or Type C medicated feed using Category II, Type B or

Type C medicated feeds.

(3) Persons who manufacture free-choice feeds, as defined in

Sec. 510.455 of this chapter, or medicated liquid feeds, as defined in

Sec. 558.5 of this chapter, where a medicated feed mill license is

required are not exempt.

* * * * *

Sec. 207.20 [Amended]

3. Section 207.20 Who must register and submit a drug list is

amended in paragraph (c) by removing the words ``medicated feed

application,'' and adding in its place ``medicated feed mill license

application,''.

Sec. 207.21 [Amended]

4. Section 207.21 Times for registration and drug listing is

amended in paragraph (a), in the second sentence, by removing the

phrase ``medicated feed application,'' and adding in its place

``medicated feed mill license application,''.

PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

5. The authority citation for 21 CFR part 225 continues to read as

follows:

Authority: Secs. 501, 502, 512, 701, 704 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360b, 371, 374).

6. Section 225.1 is amended by revising paragraph (b)(2) and by

adding a new paragraph (c) to read as follows:

Sec. 225.1 Current good manufacturing practice.

* * * * *

(b) * * *

(2) The regulations in Secs. 225.10 through 225.115 apply to

facilities manufacturing one or more medicated feeds for which an

approved medicated feed mill license is required. The regulations in

Secs. 225.120 through 225.202 apply to facilities manufacturing solely

medicated feeds for which an approved license is not required.

(c) In addition to the recordkeeping requirements in this part,

Type B and Type C medicated feeds made from Type A articles or Type B

feeds under approved new animal drug applications and a medicated feed

mill license are subject to the requirements of Sec. 510.301 of this

chapter.

Sec. 225.58 [Amended]

7. Section 225.58 Laboratory controls is amended in paragraph

(b)(1) by revising the first sentence to read ``For feeds requiring a

medicated feed mill license (Form FDA 3448) for their manufacture and

marketing, at least three representative samples of medicated feed

containing each drug or drug combination used in the establishment

shall be collected and assayed by approved official methods, at

periodic intervals during the calendar year, unless otherwise specified

in this chapter.''

8. Section 225.115 is amended by revising paragraph (b)(2) to read

as follow:

Sec. 225.115 Complaint files.

* * * * *

(b) * * *

(2) For medicated feeds whose manufacture require a medicated feed

mill license (Form FDA 3448), records and reports of clinical and other

experience with the drug shall be maintained and reported, under

Sec. 510.301 of this chapter.

PART 510--NEW ANIMAL DRUGS

9. The authority citation for 21 CFR part 510 continues to read as

follows:

Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 376e).

10. Section 510.301 is amended by revising the section heading to

read as follows:

Sec. 510.301 Records and reports concerning experience with animal

feeds bearing or containing new animal drugs for which an approved

medicated feed mill license application is in effect.

* * * * *

11. Section 510.305 is revised in its entirety to read as follows:

Sec. 510.305 Maintenance of copies of approved medicated feed mill

licenses to manufacture animal feed bearing or containing new animal

drugs.

Each applicant shall maintain in a single accessible location on

the premises of each establishment:

(a) A copy of the approved medicated feed mill license (Form FDA

3448); and

(b) Approved labeling for Type B and/or Type C feeds being

manufactured.

PART 514--NEW ANIMAL DRUG APPLICATIONS

12. The authority citation for 21 CFR part 514 continues to read as

follows:

Authority: Secs. 501, 502, 512, 701, 721, 801 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360b, 371, 379e,

381).

Sec. 514.2 [Removed]

13. Section 514.2 Applications for animal feeds bearing or

containing new animal drugs is removed.

Sec. 514.9 [Removed]

14. Section 514.9 Supplemental applications for animal feeds

bearing or containing new animal drugs is removed.

Sec. 514.105 [Amended]

15. Section 514.105 Approval of applications is amended by removing

paragraph (b) and by redesignating paragraphs (a)(1) and (a)(2) as

paragraphs (a) and (b) and by removing the designation ``(a)'' from the

first paragraph.

Sec. 514.111 [Amended]

16. Section 514.111 Refusal to approve an application is amended by

removing paragraph (b) and redesignating paragraph (c) as paragraph

(b).

Sec. 514.112 [Removed]

17. Section 514.112 Return of applications for animal feeds bearing

or containing new animal drugs is removed.

Sec. 514.115 [Amended]

18. Section 514.115 Withdrawal of approval of applications is

amended in paragraphs (a), (b), (c), and (d) by removing the phrase

``or (m)(2)''; in paragraph (c)(1) by removing the phrases ``or

(m)(5)(A)'' and ``or (m)(5)(B)''; in paragraph (c)(3) by removing the

phrase ``or animal feed''; and in paragraph (e) by removing the second

sentence.

[[Page 40771]]

19. Section 514.201 is revised to read as follows:

Sec. 514.201 Procedures for hearings.

Hearings relating to new animal drugs under section 512(d) and (e)

of the act shall be governed by part 12 of this chapter.

20. Part 515 is added to read as follows:

PART 515--MEDICATED FEED MILL LICENSE

Subpart A--Applications

Sec.

515.10 Applications for licenses to manufacture animal feeds

bearing or containing new animal drugs (medicated feed mill

license).

515.11 Supplemental medicated feed mill license applications.

Subpart B--Administrative Actions on Licenses

515.20 Approval of medicated feed mill license applications.

515.21 Refusal to approve a medicated feed mill license

application.

515.22 Suspension and/or revocation of approval of a medicated feed

mill license.

515.23 Voluntary revocation of medicated feed mill license.

515.24 Notice of revocation of a medicated feed mill license.

515.25 Revocation of order refusing to approve a medicated feed

mill license application or suspending or revoking a license.

515.26 Service of notices and orders.

Subpart C--Hearing Procedures

515.30 Contents of notice of opportunity for a hearing.

515.31 Procedures for hearings.

Subpart D--Judicial Review

515.40 Judicial review.

Authority: Secs. 512, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b, 371).

Subpart A--Applications

Sec. 515.10 Applications for licenses to manufacture animal feeds

bearing or containing new animal drugs (medicated feed mill license).

(a) Applications (Form FDA 3448) to be filed under section 512(m)

of the Federal Food, Drug, and Cosmetic Act (the act) shall be

completed, signed, and submitted in the form described in paragraph (b)

of this section to the Division of Animal Feeds (HFV-220), Center for

Veterinary Medicine, 7500 Standish Pl., Rockville, MD 20855.

(b) Each application for a license to manufacture animal feeds

bearing or containing new animal drugs shall include the following

information:

(1) A full statement of the business name and address of the

specific facility at which the manufacturing is to take place and the

facility's FDA registration number assigned under section 510 of the

act.

(2) The name, title, and original signature of the responsible

individual or individuals for that facility.

(3) A certification that the animal feeds bearing or containing new

animal drugs are manufactured and labeled in accordance with the

applicable regulations published under section 512(i) of the act.

(4) A certification that the methods used in, and the facilities

and controls used for, manufacturing, processing, packaging, and

holding such animal feeds are in conformity with current good

manufacturing practice as described in section 501(a)(2)(B) of the act

and part 225 of this chapter.

(5) A certification that the facility will establish and maintain

all records required by regulation or order issued under section

512(m)(5)(A) or 504(a)(3)(A) of the act, as published in Sec. 515.30,

and will permit access to, or copying or verification of such records.

(6) A commitment that current approved Type B and/or Type C

medicated feed labeling for each animal drug in animal feed will be in

the possession of the feed manufacturing facility prior to receiving

the Type A medicated article containing such drug.

(7) A commitment to renew registration every year with FDA as

required in Secs. 207.20 and 207.21 of this chapter.

(c) Upon approval, the original copy of the application will be

signed by an authorized employee of the Food and Drug Administration

designated by the Commissioner of Food and Drugs, and a copy will be

returned to the applicant.

(d) Applications that are facially deficient will be returned to

the applicant. All reasons for the return of the application will be

made known to the applicant.

(e) Applications (Form FDA 3448) may be obtained from the Public

Health Service, Consolidated Forms and Publications Distribution

Center, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD

20785.

Sec. 515.11 Supplemental medicated feed mill license applications.

(a) After approval of a medicated feed mill license application to

manufacture animal feed, a supplemental application shall be submitted

for a change in ownership and/or a change in mailing address of the

facility site.

(b) Each supplemental application should be accompanied by a fully

completed Form FDA 3448 and include an explanation of the change.

(c) Within 30 working days after a supplemental application has

been filed, if the Commissioner of Food and Drugs determines that the

application provides adequate information respecting the change in

ownership and/or postal address of the facility site, then he shall

notify the applicant that it is approvable by signing and mailing to

the applicant a copy of the Form FDA 3448. Supplemental applications

that do not provide adequate information shall be returned to the

applicant and all reasons for the return of the application shall be

made known to the applicant.

Subpart B--Administrative Actions on Licenses

Sec. 515.20 Approval of medicated feed mill license applications.

Within 90 days after an application has been filed under

Sec. 515.10, if the Commissioner of Food and Drugs determines that none

of the grounds for denying approval specified in section 512(m)(3) of

the Federal Food, Drugs, and Cosmetic Act applies, he shall notify the

applicant that it is approved by signing and mailing to the applicant a

copy of the Form FDA 3448.

Sec. 515.21 Refusal to approve a medicated feed mill license

application.

(a) The Commissioner of Food and Drugs shall within 90 days, or

such additional period as may be agreed upon by the Commissioner and

the applicant, after the filing of an application under Sec. 515.10,

inform the applicant in writing of his intention to issue a notice of

opportunity for a hearing on a proposal to refuse to approve the

application, if the Commissioner determines upon the basis of the

application, on the basis of a preapproval inspection, or upon the

basis of any other information before him that:

(1) The application is incomplete, false, or misleading in any

particular; or

(2) The methods used in and the facilities and controls used for

the manufacturing, processing, and packaging of such animal feed are

not adequate to preserve the identity, strength, quality, and purity of

the new animal drug therein; or

(3) The facility manufactures animal feeds bearing or containing

new animal drugs in a manner that does not accord with the

specifications for manufacture or labels animals feeds bearing or

containing new animal drugs in a manner that does not accord with the

conditions or indications of use that are

[[Page 40772]]

published under section 512(i) of the Federal Food, Drug, and Cosmetic

Act.

(b) The Commissioner, as provided in Sec. 515.30, shall

expeditiously notify the applicant of an opportunity for a hearing on

the question of whether such application is approvable, unless by the

30th day following the date of issuance of the letter informing the

applicant of the intention to issue a notice of opportunity for a

hearing the applicant:

(1) Withdraws the application; or

(2) Waives the opportunity for a hearing; or

(3) Agrees with the Commissioner on an additional period to precede

issuance of such notice of hearing.

Sec. 515.22 Suspension and/or revocation of a medicated feed mill

license application.

(a) The Secretary may suspend a medicated feed mill license

approved under section 512(m)(2) of the Federal Food, Drug, and

Cosmetic Act and give the person holding the medicated feed mill

license application prompt notice of his action and afford the

applicant the opportunity for an expedited hearing on a finding that

there is an imminent hazard to the health of man or of the animals for

which such animal feed is intended.

(b) The Commissioner of Food and Drugs shall notify in writing the

person holding an application approved under section 512(m)(2) of the

act and afford an opportunity for a hearing on a proposal to revoke

approval of such application if he finds:

(1) That the application contains any untrue statement of a

material fact; or

(2) That the applicant has made any changes that would cause the

application to contain any untrue statements of material fact or that

would affect the safety or effectiveness of the animal feeds

manufactured at the facility unless the applicant has supplemented the

application by filing a supplemental application under Sec. 515.11.

(c) The Commissioner may notify in writing the person holding an

application approved under section 512(m)(2) of the act and afford an

opportunity for a hearing on a proposal to revoke approval of such

application if he finds:

(1) That the applicant has failed to establish a system for

maintaining required records, or has repeatedly or deliberately failed

to maintain such records or to make required reports in accordance with

a regulation or order under section 512(m)(5)(A) or 504(a)(3)(A) of the

act, or the applicant has refused to permit access to, or copying, or

verification of, such records as required by section 512(m)(5)(B) or

504(a)(3)(B) of the act; or

(2) That on the basis of new information before him, evaluated

together with the evidence before him when such license was issued, the

methods used in, or the facilities and controls used for, the

manufacture, processing, packing, and holding of such animal feed are

inadequate to ensure and preserve the identity, strength, quality, and

purity of the new animal drug therein, and were not made adequate

within a reasonable time after receipt of written notice from the

Commissioner specifying the matter complained of; or

(3) That on the basis of new information before him, evaluated

together with the evidence before him when such license was issued, the

labeling of any animal feeds, based on a fair evaluation of all

material facts, is false or misleading in any particular and was not

corrected within a reasonable time after receipt of written notice from

the Commissioner specifying the matter complained of; or

(4) That on the basis of new information before him, evaluated

together with the evidence before him when such license was issued, the

facility has manufactured, processed, packed, or held animal feed

bearing or containing a new animal drug adulterated under section

501(a)(6) of the act, and the facility did not discontinue the

manufacture, processing, packing, or holding of such animal feed within

a reasonable time after receipt of written notice from the Commissioner

specifying the matter complained of.

Sec. 515.23 Voluntary revocation of medicated feed mill license.

A license issued under section 512(m)(2) of the Federal Food, Drug,

and Cosmetic Act will be revoked on the basis of a request for its

revocation submitted in writing by a responsible individual holding

such license on the grounds that the facility no longer manufactures

any animal feed covered under Sec. 558.4 of this chapter. A written

request for such revocation shall be construed as a waiver of the

opportunity for a hearing as otherwise provided for in this section.

Revocation of approval of a medicated feed mill license under the

provisions of this paragraph shall be without prejudice.

Sec. 515.24 Notice of revocation of a medicated feed mill license.

When a license approved under section 512 of the Federal Food,

Drug, and Cosmetic Act is revoked by the Commissioner, he will give

appropriate public notice of such action by publication in the Federal

Register.

Sec. 515.25 Revocation of order refusing to approve a medicated feed

mill license application or suspending or revoking a license.

The Commissioner of Food and Drugs, upon his own initiative or upon

request of an applicant stating reasonable grounds therefor and if he

finds that the facts so require, may issue an order approving a

medicated feed mill license application that previously has had its

approval refused, suspended, or revoked.

Sec. 515.26 Service of notices and orders.

All notices and orders under this part and section 512 of the

Federal Food, Drug, and Cosmetic Act pertaining to medicated feed mill

licenses shall be served:

(a) In person by any officer or employee of the Department of

Health and Human Services designated by the Commissioner of Food and

Drugs; or

(b) By mailing the order by certified mail addressed to the

applicant or respondent at his last known address in the records of the

Food and Drug Administration.

Subpart C--Hearing Procedures

Sec. 515.30 Contents of notice of opportunity for a hearing.

(a) The notice to the applicant of opportunity for a hearing on a

proposal by the Commissioner of Food and Drugs to refuse to approve a

medicated feed mill license application or to revoke the approval of a

medicated feed mill license will specify the grounds upon which he

proposes to issue his order. On request of the applicant, the

Commissioner will explain the reasons for his action. The notice of

opportunity for a hearing will be published in the Federal Register and

will specify that the applicant has 30 days after issuance of the

notice within which he is required to file a written appearance

electing whether:

(1) To avail himself of the opportunity for a hearing; or

(2) Not to avail himself of the opportunity for a hearing.

(b) If the applicant fails to file a written appearance in answer

to the notice of opportunity for hearing, his failure will be construed

as an election not to avail himself of the opportunity for the hearing,

and the Commissioner without further notice may enter a final order.

(c) If the applicant elects to avail himself of the opportunity for

a hearing, he is required to file a written appearance requesting the

hearing

[[Page 40773]]

within 30 days after the publication of the notice, giving the reason

why the application should not be refused or the medicated feed mill

license should not be revoked, together with a well-organized and full-

factual analysis of the information he is prepared to prove in support

of his opposition to the Commissioner's proposal. A request for a

hearing may not rest upon mere allegations or denials, but must set

forth specific facts showing there is a genuine and substantial issue

of fact that requires a hearing. When it clearly appears from the

information in the application and from the reasons and factual

analysis in the request for the hearing that no genuine and substantial

issue of fact precludes the refusal to approve the application or the

revocation of approval of the application, the Commissioner will enter

an order on this information, stating his findings and conclusions. If

a hearing is requested and is justified by the applicant's response to

the notice of opportunity for a hearing, the issues will be defined, an

Administrative Law Judge will be named, and he shall issue a written

notice of the time and place at which the hearing will commence. In the

case of denial of approval, such time shall be not more than 90 days

after the expiration of such 30 days unless the Administrative Law

Judge and the applicant otherwise agree; and, in the case of withdrawal

of approval, such time shall be as soon as practicable.

(d) The hearing will be open to the public; however, if the

Commissioner finds that portions of the application which serve as a

basis for the hearing contain information concerning a method or

process entitled to protection as a trade secret, the part of the

hearing involving such portions will not be public, unless the

respondent so specifies in his appearance.

Sec. 515.31 Procedures for hearings.

Hearings relating to new animal drugs under section 512(m)(3) and

(m)(4) of the Federal Food, Drug, and Cosmetic Act shall be governed by

part 12 of this chapter.

Subpart D--Judicial Review

Sec. 515.40 Judicial review.

The transcript and record shall be certified by the Commissioner of

Food and Drugs. In any case in which the Commissioner enters an order

without a hearing under Sec. 314.200(g) of this chapter, the request(s)

for hearing together with the data and information submitted and the

Commissioner's findings and conclusions shall be included in the record

certified by the Commissioner.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

21. The authority citation for 21 CFR part 558 continues to read as

follows:

Authority: Secs. 512, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 360b, 371).

Sec. 558.3 [Amended]

22. Section 558.3 Definitions and general considerations applicable

to this part is amended in paragraphs (b)(2) and (b)(5) by removing the

phrase ``an application approved under 514.105(a) of this chapter'' and

in paragraphs (b)(3)and (b)(4) by removing the phrase ``an application

approved under Sec. 514.105(b) of this chapter'' and adding in their

places ``a medicated feed mill license application approved under

Sec. 515.20 of this chapter''.

23. Section 558.4 is amended by revising the section heading and

paragraphs (a), (b), and (c) to read as follows:

Sec. 558.4 Requirement of a medicated feed mill license.

(a) A feed manufacturing facility must possess a medicated feed

mill license in order to manufacture a Type B or Type C medicated feed

from a Category II, Type A medicated article.

(b) The manufacture of the following types of feed are exempt from

the required license, unless otherwise specified:

(1) Type B or Type C medicated feed using Category I, Type A

medicated articles or Category I, Type B or Type C medicated feeds; and

(2) Type B or Type C medicated feed using Category II, Type B or

Type C medicated feeds.

(c) The use of Type B and Type C medicated feeds shall conform to

the conditions of use provided for in subpart B of this part and in

Secs. 510.515 and 558.15 of this chapter.

* * * * *

Dated: July 22, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97-19820 Filed 7-29-97; 8:45 am]

BILLING CODE 4160-01-F