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]

RIN 0910-AB18

Animal Drug Availability Act; Medicated Feed Mill Licenses

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a final

rule amending the new animal drug regulations to implement the

medicated feed mill licensing requirements of the Animal Drug

Availability Act of 1996 (ADAA). The ADAA amended the Federal Food,

Drug, and Cosmetic Act (the act) to require that each facility that

manufactures feeds containing approved new animal drugs possess a

medicated feed mill license for the facility, rather than a separate

medicated feed application

[[Page 63196]]

(MFA) for each medicated feed manufactured by the facility, as

previously required by the act. The final rule implements the feed mill

licensing provisions of the ADAA.

EFFECTIVE DATE: December 20, 1999

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

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

Standish Pl., Rockville, MD 20855, 301-827-6652.

SUPPLEMENTARY INFORMATION:

I. Background

The ADAA (Public Law 104-250), which amended sections 512(a) and

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

required the agency's approval for the manufacture of specific

medicated feeds with a site licensing system for the manufacture of

such feeds.

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 (referred to also as ``feed manufacturer,'' ``feed firm,'' or

``feed manufacturing facility'') to submit a separate MFA for each

medicated feed manufactured by the firm. The ADAA eliminates this

requirement and provides for feed mills to be licensed and allows

licensed facilities 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

obtaining a medicated feed mill license.

These final regulations implementing section 512(m) of the act as

amended by the ADAA 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

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

558.4) will also be exempt from the requirement of being manufactured

in a licensed feed mill under this regulation.

The ADAA also provided for a transitional license for any feed

manufacturing facility that, at the time of enactment of the ADAA, held

an approved MFA for the manufacture of a medicated feed . Transitional

licenses expired April 9, 1998. The Office of Management and Budget

(OMB) approved the paperwork requirements for licensing for a 3-year

period on October 31, 1997 (OMB control number 0910-0337).

II. Summary of the Proposed Rule

In the Federal Register of July 30, 1997 (62 FR 40765), FDA

published a proposed rule to implement the feed mill licensing

provisions of the ADAA. The proposed rule would add a new part 515 to

provide the requirements for medicated feed mill licensing. The

proposed rule also would amend part 514 (21 CFR part 514) to remove the

provisions regarding MFA's.

The proposed rule set forth the information to be included in

medicated feed mill license applications and supplemental applications.

The proposed rule also set forth the criteria for, among other things,

the approval and refusal to approve a medicated feed mill license

application, as well as the criteria for the revocation and/or

suspension of a license.

The proposed rule provided conforming amendments to the Code of

Federal Regulations (CFR) by removing references to ``MFA's'' and

inserting appropriate references to ``medicated feed mill licenses.''

Furthermore, the proposed rule clarified that the scope of the

exemption from the requirement of establishment registration is

identical to the scope of the exemption from the requirement of a

medicated feed mill license. Finally, the proposed rule maintained the

general scheme for categories and types of medicated feeds, and

provided that those feeds exempted from the MFA requirement now would

be exempt from being required to be manufactured in a licensed feed

mill.

III. Discussion of Comments

A total of six parties submitted comments to the proposed rule. A

discussion of the comments and FDA's responses follows:

A. Possession of Current Approved Labeling

1. Four comments objected to the requirement in proposed

Sec. 515.10(b)(6) that the license applicant commit to possess current

approved Type B and/or Type C medicated feed labeling for each animal

feed containing an approved new animal drug prior to receiving the Type

A medicated article containing such drug. Furthermore, these comments

objected to the related requirement in proposed Sec. 510.305(b) (21 CFR

510.305(b)) that the medicated feed mill licensee maintain copies of

approved labeling at the feed manufacturing facility for those Type B

and/or Type C medicated feeds being manufactured. Two comments

maintained that the possession by the feed manufacturer of labeling for

the Type A medicated article, instead of the Type B and Type C

medicated feed labeling, would satisfy the feed labeling requirements

of the statute.

These four comments argued that the two proposed provisions,

Secs. 515.10(b)(6) and 510.305(b), would impose impractical

requirements on feed mills, because the mills would be required to

possess multiple feed labels for the use of each Type A medicated

article before receipt of the Type A medicated article. These comments

explained that because many Type A medicated articles may be used in

multiple types of approved feeds, feed manufacturers typically do not

know at the time of shipment of the Type A medicated article which

feeds will be manufactured with the drug. Thus, these comments argued

that the only way to satisfy the proposed rule's labeling requirement

would be for the drug sponsor to ship in advance to the feed

manufacturer the current approved labeling for all possible feeds that

could be manufactured with each drug, and then for the feed

manufacturer to maintain all of this labeling. The comments concluded

that such a practice would pose a significant burden for both the drug

sponsor and the feed manufacturer.

FDA has evaluated the comments and has concluded that the act, as

amended by the ADAA, requires the licensed feed manufacturing facility

to possess and maintain the current approved labeling for those Type B

and/or Type C medicated feeds that will be manufactured at that

facility prior to receiving the Type A medicated article(s) for these

feeds. Section 512(a)(1) of the act, explicitly provides that at the

time of removal of a Type A medicated article from a manufacturing,

packing, or distributing establishment that the establishment have an

unrevoked written statement from the licensed feed manufacturing

facility, or a notice from the Secretary of Health and Human Services

(the Secretary), that the facility has a medicated feed mill license

and current approved labeling for the use of the Type A medicated

article in animal feed. Section 512(a)(1) of the act provides that, in

the absence of meeting these requirements, the new animal drug is

deemed unsafe. A new animal drug deemed unsafe under section 512(a)(1)

of the act is adulterated under section 501(a)(5) of the act (21 U.S.C.

351(a)(5)). Thus, the requirement in these regulations that the feed

mill possess the current approved labeling is mandated by section

512(a)(1) of the act as amended by the ADAA.

Furthermore, FDA has concluded that the ``approved labeling''

required by the

[[Page 63197]]

act and these regulations is that labeling submitted with and approved

in the new animal drug application (NADA) for use of the feed

containing the new animal drug (the ``Blue Bird'' label), not the

labeling for the Type A medicated article as maintained by some

comments.

Section 512(b)(1)(F) of the act requires an NADA for a new animal

drug intended for use in animal feed to include ``proposed labeling

appropriate for such use'' in animal feed as well as specimens of

labeling for the drug itself. The regulations at Sec. 514.1(b)(3)(v)(a)

and (b)(3)(v)(b), which implement this provision, specifically require

two sets of labels for new animal drugs for use in medicated feeds:

``labeling to be used for such new animal drug with adequate directions

for the manufacture and use of finished feeds'' and ``representative

labeling proposed to be used for Type B and Type C medicated feeds

containing the new animal drug.'' FDA refers to the representative

labeling for the Type B and Type C medicated feeds as the ``Blue Bird''

label. This labeling is approved as part of the NADA. FDA believes that

Congress intended feed mills to possess and maintain the labeling for

use of the feed approved as part of the NADA since this provides the

same level of public health protection that existed under the pre-ADAA

system under which FDA approved the feed use labeling as part of the

MFA and required such labeling to be maintained at the facility. Both

systems ensure that each facility has the pertinent information to

generate an actual feed label that is consistent with representative

medicated feed labeling already approved by the agency.

The agency has concluded that the requirement that licensed feed

manufacturers possess Blue Bird labeling for each medicated feed to be

manufactured will not add a significant regulatory burden for industry.

First, feed manufacturers have possessed and maintained feed labeling

approved by FDA since the implementation of the new animal drug

regulations in 1971 (36 FR 18375, September 14, 1971). Section

512(m)(1)(d) of the act and the regulations at Sec. 514.2(b)(11)

previously required feed manufacturers to submit for FDA's approval the

proposed feed labeling with the MFA. Section 512(a)(1) of the act and

the regulations at Sec. 510.7 (21 CFR 510.7) also required the feed

manufacturer to possess the approved MFA, with the feed labeling, prior

to shipment of the Type A medicated article for each feed. Furthermore,

the regulations at Sec. 510.305 previously required feed manufacturers

to maintain the MFA, with the approved labeling, on site at the

facility. Thus, this final rule's requirement that feed mill licensees

possess and maintain feed labeling approved by FDA in the NADA (the

Blue Bird label), as required by section 512(a) (1) of the act, is in

essence the same as the feed manufacturer's previous legal obligation

under the act to possess and maintain feed labeling approved by FDA.

Second, drug sponsors have submitted Blue Bird labels with the NADA

as required by Sec. 514.1(b)(3)(v)(b) (formerly Sec. 135.4a(b)(3)(v)(b)

(21 CFR 135.4a(b)(3)(v)(b))) since the implementation of the new animal

drug regulations in 1971 (36 FR 18375, September 14, 1971.) The

requirement for the submission and approval of such labels with the

NADA has ensured that these labels are available for distribution to

feed manufacturers. Type A manufacturers, in turn, have been supplying

approved Blue Bird labels to feed manufacturers since the development

of these labels.

Third, feed manufacturers have been using Blue Bird labels as a

model to generate actual feed labels and previously used such labels to

satisfy the requirement for the submission of representative feed

labeling with the MFA. Prior to this final rule, the new animal drug

regulations required feed manufacturers to submit an MFA for each

medicated feed with ``a copy of the final printed labeling,'' for

approval by the agency (Sec. 135.4b(d); 36 FR 18375, September 14,

1971). Initially, FDA had accepted from the feed manufacturer only the

actual feed label to satisfy this requirement. However, an FDA

medicated feed task force, after consulting with the Animal Health

Institute (AHI), the American Feed Industry Association (AFIA), and the

Association of American Feed Control Officials (AAFCO), issued a report

in December 1978 that recommended, among other things, that FDA accept

``generic'' labels with the MFA (Ref. 1). Soon after issuance of the

task force's report, FDA allowed feed manufacturers to submit the Blue

Bird label, rather than the actual feed label, with the MFA. The agency

amended Sec. 514.2(b)(11) to allow ``labeling representative of each

intended use as stated in the claim'' to be submitted with the MFA (51

FR 7382, March 3, 1986).

FDA has found that since approximately 1980, feed manufacturers

have generally relied on the Blue Bird label in submitting the required

labeling with the MFA. Feed manufacturers typically submitted with the

MFA either a copy of the Blue Bird label or a label derived from the

Blue Bird label (an equivalent Blue Bird label). An equivalent Blue

Bird label listed the same active drug(s), claim(s), caution and/or

warning statements, and mixing and feeding directions as listed in the

Blue Bird label. The facility could then generate the actual feed label

based on that labeling approved in the MFA. Since the equivalent Blue

Bird label was approved as part of the MFA, the agency was assured that

the labeling upon which the actual feed label was based correctly

reflected the approval conditions of use for the feed.

As noted previously, Type A medicated article manufacturers

frequently supplied the appropriate Blue Bird labels to the feed

manufacturer for submission with the MFA. Thus, the requirement that

the licensed feed manufacturer possess Blue Bird labeling for the feed

being manufactured is consistent with industry practice.

FDA agrees with the comments that proposed Sec. 515.10(b)(6)

appeared to require a licensed feed mill to commit to possess approved

labeling for all possible feeds that could be manufactured from the

Type A medicated article. FDA does not intend that a licensed feed

manufacturing facility must possess current approved labeling for Type

B and/or Type C medicated feeds that the facility does not actually

manufacture from the Type A medicated article. Thus, FDA is amending

proposed Sec. 515.10(b)(6) (in the final rule, Sec. 515.10(b)(7)) to

read, ``A commitment that current approved Type B and/or Type C

medicated feed labeling for each Type B and/or Type C medicated feed to

be manufactured will be in the possession of the feed manufacturing

facility prior to receiving the Type A medicated article containing

such drug.''

FDA notes that a feed manufacturer can satisfy the requirement to

possess the current approved labeling by maintaining the Blue Bird

labeling for each feed to be manufactured at the facility in either

paper or electronic format. To assist drug sponsors and feed

manufacturers in the distribution of Blue Bird labels and to allow

parties to determine more easily whether a feed mill is licensed, FDA

has created a data base of medicated feed mill licensing information,

available to the public on the Center for Veterinary Medicine's (CVM's)

web site at ``http://www.fda.gov/cvm''.

2. One comment argued that proposed Secs. 510.305(b) and

515.10(b)(6) should not apply to medicated feed mill licensees because

the majority of such licensees are firms with multiple

[[Page 63198]]

facilities, where labeling is not created at the feed facility but in

the home office. The comment claimed that these firms use the published

regulation of approval as the source of required information for the

label. Furthermore, the comment argued that the proposed regulation

would require such multiple facility firms to distribute Blue Bird

labels from the home office to all of the facilities before obtaining

the drug, which would serve no purpose. The comment noted that the

proposed rule does not apply to nonlicensed facilities and stated that

most of these facilities are single mill firms that may not have access

to the labeling information in the Federal Register, CFR, Feed Additive

Compendium, or to a computer with the capability to obtain this

information free from the various information sources on the Internet.

The comment concluded that the proposed rule's requirement for the

possession of Blue Bird labeling should be eliminated, because ``[t]he

present system of label development has worked well for the feed

industry.''

FDA has considered the previous comment and has concluded that the

requirement that licensed feed mills possess Blue Bird labels will not

add to the legal obligations with respect to feed labeling that existed

for these mills prior to the enactment of ADAA. As discussed

previously, before enactment of the ADAA, in accordance with section

512(m)(1)(D) of the act, feed firms submitted with the MFA the specimen

of labeling to be approved for that feed. To satisfy this requirement

firms typically chose to submit the Blue Bird label as the labeling

specimen. Once FDA approved the MFA, the feed mill maintained a copy of

the approved MFA, which included the approved labeling, under

Sec. 510.305. To comply with the conditions set forth in the MFA for

the manufacture of feed, the facility could then generate the actual

feed label based on the approved labeling.

Under this rule implementing medicated feed mill licensing, firms

that were previously required to have an approved MFA are now required

to have a medicated feed mill license and the approved labeling for the

manufacture of such feed. Just as the previous regulatory scheme

required firms to possess labeling approved by FDA with the MFA for

each feed to be manufactured, Sec. 515.10(b)(7) of this rule requires

firms to possess the approved labeling for such feed. The only

distinction is that instead of the firm maintaining labeling for the

feed that is approved by FDA in the medicated feed application process

in addition to the NADA approval process, the firm will maintain the

Blue Bird medicated feed labeling approved in the NADA. Additionally,

Sec. 510.305(b), as revised by this rule, requires that licensed firms

maintain the approved labeling on the premises, which is consistent

with the previous requirement for maintaining the MFA with a sample of

the approved labeling. Thus, the requirements of this rule do not

change the previous legal obligations of feed mills to possess and

maintain approved labeling for the feed. Furthermore, as also discussed

earlier in this preamble, since feed mills previously submitted the

Blue Bird label or its equivalent for approval of an MFA, the

requirements of this rule are consistent with the industry's method of

feed label development.

For those firms where labeling is created based on the CFR or other

sources, FDA has concluded that a firm must possess and maintain the

Blue Bird label to satisfy the requirements of section 512(a)(1) of the

act, and Secs. 515.10(b)(6) and 510.305(b) of this final rule. As

discussed earlier in the preamble, the statutory requirement that

licensed feed mills possess and maintain approved labeling for the feed

ensures that these facilities rely on approved labeling to develop the

actual feed labels. FDA is revising Sec. 510.305 to clarify that if the

home office of a multiple facility firm generates the actual feed

labels and maintains the Blue Bird labels for all the feed the multiple

facilities manufactures, then only the home office will be required to

maintain the Blue Bird labels.

Finally, as for nonlicensed feed mills, such firms are not the

subject of this regulation. Feed mills previously exempted from MFA's

are also exempt from the licensing requirements set forth in this

regulation. FDA previously exempted firms from the requirement that an

MFA be approved for the manufacture of Type B and/or Type C medicated

feed from Category I Type A medicated articles or from Category II Type

B and/or Type C medicated feed, unless otherwise required by

regulation. FDA exempted the manufacture of these feeds from the MFA

requirements, including the submission of the labeling specimen,

because any errors in the manufacture or labeling of such feeds would

be unlikely to produce unsafe residues (Sec. 558.4(a); 51 FR 7382,

March 3, 1986). Because nonlicensed facilities can manufacture only

exempt feeds, FDA is not proposing that the requirements of

Secs. 510.305(b) and 515.10(b)(7) in the final rule apply to

nonlicensed feed mills.

3. One comment argued that proposed Sec. 510.305 should be amended

so that a feed manufacturing firm with multiple establishments can

maintain each license at its home office, while the firm simply

maintains a ``single readable document with relevant licensing

information at each facility.'' Under Sec. 510.305(d), as proposed, the

home office of a multiple facility establishment can maintain the

original licenses, but each facility must maintain a copy of the

license. The license lists the requirements and commitments for the

establishment, and it is very important that the people at the

manufacturing site understand these requirements. Hence, it is very

important that a copy of the license is maintained at each

manufacturing facility. Thus, FDA has not changed Sec. 510.305 as

requested by the comment.

4. One comment requested that the agency hold a public meeting to

discuss alternatives to the proposed rule regarding medicated feed

labeling. The comment reasoned that such a meeting would give the

agency the opportunity to hear and consider current industry methods

and sources for developing labeling for medicated feeds. The comment

stated that alternatively, interested members of the public could hold

a round table for agency officials to provide the agency with input

from industry compliance directors on the development of labeling.

In response to this comment, FDA participated in a meeting with

representatives of AFIA and AHI on March 17, 1998. AFIA and AHI

presented their views, previously expressed in their written comments,

regarding the feed labeling provisions of the medicated feed mill

licensing proposed rule. The meeting helped the agency to understand

the concerns of industry. Minutes of the meeting are included in Docket

No. 97N-0276, and may be viewed at the Dockets Management Branch (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

B. Establishment Registration

5. One comment proposed that feed manufacturing facilities be

exempt from the annual establishment registration requirement set forth

in Sec. 207.20 (21 CFR 207.20), so that all feed mills would be listed

as exempt from this requirement under Sec. 207.10 (21 CFR 207.10). The

comment argued that establishment registration serves no purpose. The

comment stated that one argument for establishment registration is that

such registration is required yearly, and provides the agency with a

list of who is registered and their locations. However, according to

the comment, establishment registration has

[[Page 63199]]

not achieved this goal in practice because neither CVM nor field

enforcement offices have been provided numbers or locations of

establishment registration facilities. The comment argued that, in any

case, such information could be updated based on the agency's

inspections of firms and the requests by firms for the withdrawal of

medicated feed mill licenses.

The comment requests amendments to the registration requirements

that are beyond the scope of this rulemaking. FDA is issuing these

regulations to provide for medicated feed mill licensing in accordance

with the ADAA. Therefore, FDA is not making any substantive changes to

the scope of the registration exemption. With regard to the exemptions

in Sec. 207.10, FDA is amending the regulation merely to clarify, but

not change, the scope of the registration exemption for medicated feed

mill licensees. Furthermore, FDA is amending Secs. 207.20 and 207.21

(21 CFR 207.21) in the regulations only to replace the phrase

``medicated feed application'' with the term ``medicated feed mill

license application.''

Additionally, contrary to the comment's assertion, registration

provides beneficial information to the agency that is not available

from medicated feed mill licensing. Registration, unlike medicated feed

mill licensing, is required annually by 21 CFR 207.22. FDA has found

that firms comply with this requirement and provide annually the

numbers and locations of registered facilities. This requirement allows

FDA to determine which feed mills are still doing or intend to do

business. Therefore, the agency believes the exemptions from

registration should not be expanded.

C. Ninety-Day Approval Period

6. One comment noted that proposed Sec. 515.20 provides the agency

90 days to act upon a medicated feed mill license application. The

comment further noted that the agency did not require the 90 days set

forth by regulation to process medicated feed applications, but instead

the agency provided the industry timely approvals that ensured that

facilities were not placed at a competitive disadvantage. Thus, the

comment concluded that 30 days would better reflect the time

requirements for acting on a medicated feed mill license application,

particularly because a medicated feed mill license approval does not

involve the agency's review of the medicated feed labeling.

FDA rejects the suggestion that proposed Sec. 515.20 be changed to

allow the agency only 30 days to act on a medicated feed mill license

application. First, section 512(m)(2) of the act sets forth explicitly

the time limit of 90 days for agency action. Second, almost all feed

mills applying for a license will require a preapproval inspection by

FDA conducted after filing of the medicated feed mill license

application, and it would not be feasible for FDA, in all cases, to

conduct the preapproval inspection within 30 days of filing of the

application. Of course, as with MFA's, FDA will continue to act as

expeditiously as possible in processing license applications.

D. Requirements for Drug Sponsors

7. Three comments noted that the agency accidentally omitted a

revision of Sec. 510.7 (21 CFR 510.7) (consignees of new animal drugs

for use in the manufacture of animal feeds) in the licensing proposal.

The comments suggested that the reference in Sec. 510.7(a)(1) to

``Sec. 514.2'' should be changed to ``Sec. 515.10.'' The comments

stated that such a change would be consistent with the deletion of

Sec. 514.2 (applications for animal feeds bearing or containing new

animal drugs) and the establishment of Sec. 515.10 (applications for

licenses to manufacture animal feeds bearing or containing new animal

drugs).

FDA agrees that in order to be consistent with Sec. 515.10 of these

regulations, the reference should be changed as noted in the comments.

Furthermore, in order to be consistent with the language of the ADAA,

FDA has concluded that Sec. 510.7 must also clarify that at the time of

a new animal drug's removal from the establishment of a manufacturer,

packer, or distributor of a Type A medicated article, such

manufacturer, packer, or distributor must possess an unrevoked written

statement from the consignee, or notice from the Secretary, that the

consignee holds a medicated feed mill license and has in its possession

current approved labeling for the drug in animal feed. Thus,

Sec. 510.7(a)(1) has been amended to read as follows: ``Holds a license

issued under Sec. 515.20''.

A drug sponsor can satisfy this requirement by receiving written

confirmation from the facility as to its feed mill license number or by

verifying the feed mill's license status on CVM's web site. The

confirmation and/or identification of a feed manufacturing facility's

license number indicates that the firm should possess current approved

labeling, because the firm must commit to the possession of such

labeling in the medicated feed mill license application. The drug

sponsor's verification from the FDA web site of an approved facility's

license number would constitute ``notice from the Secretary'' that the

feed mill possesses a license and the current approved feed labeling.

Section 510.7(a)(2) has also been amended to reference the new

Sec. 515.10 regulation. As provided in section 512(a)(1)(B)(ii) of the

act, if the consignee is not the user of the drug the shipper must

obtain an unrevoked written statement from the consignee that the

consignee will ship such drug only to a holder of an approved

application under Sec. 515.10 of this chapter.

E. Status of Related Citizen Petitions

8. One comment expressed disappointment and concern that the agency

was unable to resolve pending issues in order to publish proposed rules

for two citizen petitions on drug assays (Docket No. 95P-0373) and on

medicated liquid feeds (Docket No. 93P-0174) as part of this

rulemaking. The comment further stated that these two petitions suggest

significant and appropriate changes to the current good manufacturing

practices (CGMP's) and would have saved the agency much time and

resources if the agency had published responses concurrently or

incorporated such responses in the published proposal on medicated feed

mill licenses. The comment stated that the medicated liquid feed

petition is long overdue for rulemaking as the agency provided a letter

to AFIA on April 19, 1995, that essentially agreed with the substance

of AFIA's petition and indicated that a proposal to amend 21 CFR 558.5

was being prepared at that time. The comment urged the agency to act on

these two petitions and publish proposed rules to resolve these

impasses on serious issues related to the regulation of medicated feed.

FDA is well aware of the two citizen petitions and is actively

reviewing these petitions. In preparing this proposal, FDA concluded

that incorporating any amendments to the regulations based on these

petitions would have unduly delayed the publication of this final rule.

The agency plans to develop proposed rules related to these citizen

petitions following publication of this final rule.

FDA notes that in a March 30, 1998, amendment to the AFIA and AHI

1995 Citizen Petition (Docket No. 95P-0373) AFIA and AHI withdrew their

request to amend Sec. 510.301 (21 CFR 510.301). However, following

publication of this final rule FDA intends to develop a proposed rule

to amend Sec. 510.301 to be consistent with the requirements of the

ADAA.

[[Page 63200]]

F. Enforcement Policy

9. One comment requested that the agency take swift and positive

compliance action against those firms found to be in violation of

CGMP's. FDA recognizes that a visible and firm regulatory posture is

essential so that medicated feeds are manufactured, labeled, and

distributed in a safe manner. FDA is prepared to take the necessary

steps to ensure the safe and effective use of animal drugs in animal

feeds.

IV. Additional Changes

FDA has reordered and rewritten subpart A of part 15 to make it

more logical and consistent.

V. Environmental Impact

FDA has carefully considered the potential environmental impacts of

this rule. The agency has determined under 21 CFR 25.30(h) 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.

Medicated feed mill licensing is a procedure established by the

ADAA as a replacement for FDA's previous MFA system. The final rule

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 an MFA to manufacture each applicable feed

containing an approved new animal drug.

This streamlining does not reduce the responsibility of each

facility to manufacture medicated feeds in full compliance with CGMP's

regulations. Additionally, the final rule does not prevent 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.

VI. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive

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

and under the Unfunded Mandates Reform Act (Public Law 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 or more (adjusted

annually for inflation) million in any one year.

The agency has reviewed this final rule and has determined that the

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

and in these two statutes. FDA believes that the rule is consistent

with the regulatory philosophy and principles identified in the

Executive Order and will not have a significant effect on a substantial

number of small entities. The Office of Management and Budget has

determined that this final rule is a significant regulatory action

subject to review under the Executive Order. Also, since the

expenditures required by the rule are under $100 million, FDA is not

required to perform a cost/benefit analysis according to the Unfunded

Mandates Reform Act.

With this rule, FDA is streamlining existing paperwork requirements

by amending the process for obtaining approval to manufacture medicated

feeds. Instead of requiring an MFA for each applicable medicated feed,

this final regulation requires only a single facility license per feed

mill, as appropriate. The ADAA granted a transitional license, valid

for 18 months, to all feed manufacturing facilities that held an

approved MFA. During this time, the facilities could obtain a permanent

license by submitting a license application and a copy of an approved

MFA to FDA. All other existing reporting responsibilities for each drug

remain unchanged.

In its analysis for the proposed rule, the agency had assumed that

the only costs to be incurred by industry would be the paperwork costs

associated with applying for a facility license. FDA estimated that

approximately 2,000 feed mills would be affected by this rule, and that

it would take approximately 15 minutes for each facility to complete

its application. Taking 1995 median weekly earnings of $684 (Ref. 2)

for the executives, administrators, and managers who would complete the

applications, and adding 40 percent for fringe benefits, yielded

average hourly earnings of $23.94. Thus, the agency estimated a

combined paperwork cost for all facilities totaling $11,970 for the

first year, and $600 for the estimated 100 mills expected to apply for

licensing in each subsequent year. In addition, FDA estimated annual

costs of $530 for all of those facilities completing paperwork in

reference to license supplements, the voluntary revocation of their

license, or hearing procedures. The total cost equaled approximately $6

per mill.

FDA has inflated these costs in the final rule to account for the

increase in employment costs from 1995 to 1999. Using the average

annual increase of 3.35 percent from 1995 to 1998 over the 4 years from

1995 to 1999, FDA estimates that the combined paperwork costs would

total $13,735 in the first year and about $700 in each subsequent year

(Ref. 3). Further, paperwork costs in reference to license supplements,

voluntary revocation of licenses and hearing procedures would amount to

about $600 annually.

Several comments to the proposed rule indicated that additional

costs would be incurred due to the labeling requirements of the rule.

The agency acknowledges that the costs for feed mills maintaining and

retrieving Blue Bird labels was not estimated in the proposal. In Table

3 of section VIII of this document, a total cost to the industry of 500

hours is estimated for a total of 2,000 licensees. At the inflation-

adjusted $27.47 per hour, the agency estimates that maintaining and

retrieving the labels will cost the industry an additional $13,735

annually. Total industry costs would amount to only about $14 per mill.

For the proposed rule, the agency had estimated a large savings in

the paperwork burden due to the elimination of the MFA requirements.

Over the past 5 years, the agency has received approximately 3,300

MFA's

[[Page 63201]]

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 application. Therefore, FDA estimated that the rule

would save industry over $158,000 per year, or approximately $79 per

mill per year, on average. FDA has adjusted this saving for wage

inflation to approximately $181,000 per year, or about $91 per mill

each year. The mills that have routinely submitted a larger number of

MFA's would realize a larger savings than those mills that routinely

submit few MFA's. The agency did not receive comments on this estimate

and retains the inflation-adjusted amount for the final rule.

FDA also predicted that it would experience an administrative cost

saving in response to the medicated feed mill licensing requirement.

Since 1994, the agency has spent approximately $180,000 per year for a

contractor to process the MFA's. In contrast, it would take FDA only

about 40 minutes to process each medicated feed mill license

application, at a cost of $25 per hour for a GS-13 government employee.

The first year, the agency estimated that it would cost $33,500 to

process the expected 2,000 applications, and $10,000 for starting up a

tracking and indexing computerized data base. Further, it would cost

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

thereafter.

Adjusting for wage inflation for the final rule, the agency expects

the first year cost to process the applications to be about $37,200,

and $11,500 for the tracking and indexing computerized data base.

Application processing for subsequent years is expected to cost about

$1,850 per year. The agency did not receive comments on these estimates

of government cost savings and retains the inflation-adjusted amounts

for the final rule.

The Small Business Administration (SBA) defines all manufacturers

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

employees or less as a small business. The agency previously estimated

that approximately 20 percent of the affected feed mills belong to

large conglomerates that have an overall employee count higher than

500. Therefore, the remaining 80 percent of the affected facilities

would be considered small feed mills by SBA's standards. However, as

described previously, the agency has determined that the rule will

provide a net economic savings for all facilities. Therefore, in

accordance with the Regulatory Flexibility Act, FDA certifies that this

rule will not have a significant effect on a substantial number of

small entities.

VII. Federalism

FDA has analyzed the final rule in accordance with the principles

and criteria set forth in Executive Order 13132 and has determined that

this final rule does not have sufficient federalism implications to

warrant the preparation of a federalism assessment.

VIII. Paperwork Reduction Act of 1995

This final rule contains information collection provisions that are

subject to review by OMB under the Paperwork Reduction Act of 1995 (44

U.S.C. 3501-3520). A description of these provisions is given as

follows. 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.

Title: Medicated Feed Mill License Application.

Description: This final rule implements the ADAA's medicated feed

mill licensing provisions. It requires that any medicated feed

manufacturing facility seeking a license submit an application to FDA.

In Sec. 515.10 of the final regulations, FDA proposed that medicated

feed mill license applications be submitted on FDA Form 3448,

``Medicated Feed Mill License Application.''

Section 515.11 of the final regulation specifies that supplemental

applications must be submitted for a change in ownership and/or change

in mailing address, which also would be submitted on FDA Form 3448.

Furthermore, Sec. 515.23 of the regulations provides for voluntary

revocation of a license. A medicated feed licensee would submit, in

writing to FDA, a request for voluntary revocation of a license.

Finally, Sec. 515.30 of the regulation provides procedures 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 in writing for a

hearing in response to the agency's proposal to refuse to approve a

medicated feed mill application.

Description of Respondents: Medicated Feed Manufacturing

Facilities.

In the Federal Register of July 30, 1997 (62 FR 40765), interested

persons were requested to send comments regarding this collection of

information to OMB by August 29, 1997. In response to this notice OMB

received one comment regarding the paperwork aspect of this collection

of information. The comment argued that the agency's estimate of the

burden of the proposed collection of information was inaccurate in the

following two instances: (1) In assuming that the only costs that will

be incurred are the paperwork costs associated with applying for a

facility license, and (2) in the estimate of $10,000 for tracking and

indexing a computerized data base.

Regarding instance (1), the comment stated that the agency's

assumption is inaccurate in that no consideration has been given to the

capital and operating costs for the retrieval and maintenance of

approved labeling for medicated feeds. The comment stated that this

burden applies to sponsors under section 512(a)(1)(B) of the act and to

licensed feed mills under proposed Sec. 510.305.

CVM has evaluated this part of the comment and agrees that the

agency did not address the cost for the licensed feed mill to maintain

and retrieve approved Blue Bird labels as required under Sec. 510.305.

Table 3 of this document provides an estimate of that cost at a total

of 500 hours annually for an estimated 2,000 licensees. This covers the

cost of obtaining the label from either the drug sponsor or FDA and

keeping it in a file. CVM estimates that most licensed feed

establishments would only have 1 to 10 Blue Bird labels to maintain and

retrieve. A few, primarily the multiple facilities, may have many more,

but would only maintain and retrieve these labels at their home office.

Thus the average estimate of 15 minutes per licensee takes these

factors into account.

The agency has concluded that it did not err in excluding this

burden for drug sponsors because the provision the comment cited, which

requires retrieval and maintenance of approved labeling, applies only

to feed mills, not to sponsors. The burden is on feed mills to retrieve

the approved labeling either from the sponsor or FDA.

Regarding instance (2), the comment maintained that unless access

to this data base is made available to sponsors and consignees, it

would be logical to assume that similar expenses would be incurred by

each sponsor and consignee maintaining a parallel data base in order to

ensure their compliance with section 512(a)(1)(B) of the act. The

comment argued that the most effective approach to eliminate this

unnecessary burden would be for CVM to provide public

[[Page 63202]]

access to its data base through the CVM home page. FDA has evaluated

this comment, and CVM has put a list of approved licensees on the

Internet, and public access has been granted.

FDA had estimated that 2,000 respondents would apply for feed mill

licenses under Sec. 515.10 during the first year and that a total of

500 hours would be required for them to respond. During the first 18

months (by the transition provisions, respondents had 18 months to

obtain a license), only 1,250 respondents applied for licenses. FDA

estimated that during each succeeding year, 100 new respondents would

request feed mill licenses. Based on current information, that number

appears to be a reasonable estimate of the number of respondents. The

agency has received approximately 70 requests for licenses in the year

following the first 18 months. FDA also estimated that there would be

25 respondents for supplemental applications (Sec. 515.11), 50 for

voluntary revocations (Sec. 515.23), and 0.15 for notices of

opportunity for hearing (Sec. 515.30). Those numbers also appear to

have been reasonable estimates.

This final rule contains the original provisions of part 515, as

proposed, and amends these provisions only for further clarity. As a

result of the comment(s) received, an estimate of an annual

recordkeeping burden (Table 3) has been added to the burden chart,

under Sec. 510.305. Thus, the original annual reporting burden estimate

has been changed to include annual recordkeeping requirements.

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

----------------------------------------------------------------------------------------------------------------

Annual

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

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

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

Total 522.1

----------------------------------------------------------------------------------------------------------------

\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Reporting Burden: Each Succeeding Year1

----------------------------------------------------------------------------------------------------------------

Annual

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

Respondents Response Responses Response

----------------------------------------------------------------------------------------------------------------

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

Total 47.1

----------------------------------------------------------------------------------------------------------------

\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 3.--Estimated Annual Recordkeeping Burden1

----------------------------------------------------------------------------------------------------------------

Annual

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

Recordkeepers Recordkeeping Records Recordkeeper

----------------------------------------------------------------------------------------------------------------

510.305 2,000 1 2,000 0.25 500

----------------------------------------------------------------------------------------------------------------

\1\ There are no capital cost or operating and maintenance cost associated with this collection of information.

Individuals or organizations may submit comments on this burden

estimate or any other aspect of these collection of information

provisions, including suggestions for reducing the burden, and direct

them to William Price (address above).

The information collection provisions in this final rule have been

approved under OMB control number 0910-0356. This approval expires

October 31, 2000. An agency may not conduct or sponsor, and a person is

not required to provide, a collection of information unless the

collection of information displays a currently valid OMB control

number.

IX. 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. FDA Medicated Feed Task Force, ``Medicated Feed Task Force

Report,'' December 1978.

2. Employment and Earnings, U.S. Department of Labor Bureau and

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

3. U.S. Department of Labor Bureau of Labor Statistics; ``ftp://

ftp.bls.gov/pub/special.requests/lf/aat39.txt''.

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.

[[Page 63203]]

21 CFR Parts 514 and 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, 21 CFR

Chapter I is amended to read as follows:

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: 21 U.S.C. 331, 351, 352, 355, 360, 360b, 371, 374; 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 words

``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: 21 U.S.C. 351, 352, 360b, 371, 374.

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

adding paragraph (c) to read as follows:

Sec. 225.1 Current good manufacturing practice.

* * * * *

(b)(1) * * *

(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 NADA's and a medicated feed mill license are

subject to the requirements of Sec. 510.301 of this chapter.

7. Section 225.58 is amended in paragraph (b)(1) by revising the

first sentence to read as follows:

Sec. 225.58 Laboratory controls.

* * * * *

(b) * * *

(1) For feeds requiring a medicated feed mill licence (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 Complaint files is amended by revising paragraph

(b)(2) to read as follows:

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: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

10. Section 510.7 is amended by revising paragraphs (a)(1) and

(a)(2) to read as follows:

Sec. 510.7 Consignees of new animal drugs for use in the manufacture

of animal feed.

(a) * * *

(1) Holds a license issued under Sec. 515.20 of this chapter; or

(2) Will, if the consignee is not the user of the drug, ship such

drug only to a holder of an approved application under Sec. 515.10 of

this chapter.

* * * * *

11. Section 510.301 is amended to revise 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.

* * * * *

12. Section 510.305 is revised 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:

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

3448) on the premises of the manufacturing establishment; and

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

manufactured on the premises of the manufacturing establishment or the

facility where the feed labels are generated.

PART 514--NEW ANIMAL DRUG APPLICATIONS

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

follows:

Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.

Sec. 514.2 [Removed]

14. Section 514.2 Applications for animal feeds bearing or

containing new animal drugs is removed.

Sec. 514.9 [Removed]

15. Section 514.9 Supplemental applications for animal feeds

bearing or containing new animal drugs is removed.

Sec. 514.105 [Amended]

16. Section 514.105 Approval of applications is amended by removing

the introductory text of paragraph (a) and by removing paragraph (b),

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

(b), and by amending newly redesignated paragraph

[[Page 63204]]

(a) by removing the first word ``He'' and adding in its place ``The

Commissioner ''.

Sec. 514.111 [Amended]

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

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

(b).

Sec. 514.112 [Removed]

18. Section 514.112 Return of applications for animal feeds bearing

or containing new animal drugs is removed.

Sec. 514.115 [Amended]

19. 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.

20. 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.

21. Part 515 is added to read as follows:

PART 515--MEDICATED FEED MILL LICENSE

Subpart A--Applications

Sec.

515.10 Medicated feed mill license applications.

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 Services 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: 21 U.S.C. 360b, 371.

Subpart A--Applications

Sec. 515.10 Medicated feed mill license applications.

(a) Medicated feed mill license applications (Forms 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, or electronically from the Center for

Veterinary Medicine home page at ``http://www.fda.gov/cvm''.

(b) A completed medicated feed mill license must contain the

following information:

(1) The full business name and address of the facility at which the

manufacturing is to take place.

(2) The facility's FDA registration number as required by section

510 of the Federal Food, Drug, and Cosmetic Act (the act).

(3) The name, title, and signature of the responsible individual or

individuals for that facility.

(4) 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.

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

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

holding such animal feeds conform to current good manufacturing

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

225 of this chapter.

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

all records required by regulation or order issued under sections

512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or

copying or verification of such records.

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

medicated feed labeling for each Type B and/or Type C medicated feed to

be manufactured will be in the possession of the feed manufacturing

facility prior to receiving the Type A medicated article containing

such drug.

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

required in Secs. 207.20 and 207.21 of this chapter.

(c) Applications must be completed, signed, and submitted to the

Division of Animal Feeds (HFV-220), Center for Veterinary Medicine,

Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

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

signed by an authorized employee of FDA designated by the Commissioner

of Food and Drugs, and a copy will be returned to the applicant.

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 an

authorized employee of the Food and Drug Administration designated by

the Commissioner shall notify the applicant that it is approved 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 (the Commissioner)

determines that none of the grounds for denying approval specified in

section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act (the act)

applies, an authorized employee of the Food and Drug Administration

designated by the Commissioner 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 (the Commissioner) shall

within 90 days, or such additional period as may be agreed upon by the

Commissioner and the applicant, after

[[Page 63205]]

the filing of an application under Sec. 515.10, inform the applicant in

writing of his/her 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 animal feeds bearing or

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

conditions or indications of use that are published under section

512(i) of the 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 approval of a medicated

feed mill license.

(a) The Secretary of Health and Human Services may suspend a

medicated feed mill license approved under section 512(m)(2) of the

Federal Food, Drug, and Cosmetic Act (the act) and give the person

holding the medicated feed mill license application prompt notice of

this 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 (the Commissioner ) 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 the Commissioner

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 the Commissioner 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 sections 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 sections 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 assure 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 (the 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(b) 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 (the act) is revoked by the Commissioner of Food

and Drugs (the Commissioner), the Commissioner 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 (the Commissioner), upon his/her

own initiative or upon request of an applicant stating reasonable

grounds therefor and if the Commissioner 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 Services of notices and orders.

All notices and orders under this part 515 and section 512 of the

Federal Food, Drug, and Cosmetic Act (the 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 the applicant or respondent's last known

address in the records of the Food and Drug Administration.

[[Page 63206]]

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 (the Commissioner) 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 the Commissioner proposes to issue this order. On

request of the applicant, the Commissioner will explain the reasons for

the 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 the Commissioner 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, this 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, the applicant is required to file a written appearance

requesting the hearing 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 the

applicant 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/her 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 the Judge 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 the 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 (the 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 (the Commissioner). 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

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

follows:

Authority: U.S.C. 360b, 371.

Sec. 558.3 [Amended]

23. Section 558.3 Definitions and general considerations applicable

to this part is amended 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 its place ``a medicated feed mill license

application approved under Sec. 515.20 of this chapter''; and in

paragraphs (b)(2) and (b)(5) by removing ``Sec. 514.105(a)'' and adding

in its place ``Sec. 514.105''.

24. 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 also 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: August 12, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 99-29856 Filed 11-18-99; 8:45 am]

BILLING CODE 4160-01-F