Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules 40765

a new airworthiness directive (AD), to

read as follows:

Raytheon Aircraft Company (Formerly

Beech, Raytheon Corporate Jets, British

Aerospace, Hawker Siddley, et al.):

Docket 97–NM–68–AD. Supersedes AD

96–17–10, Amendment 39–9719.

Applicability: The following models and

series of airplanes, certificated in any

category, equipped with AlliedSignal

outflow/safety valves, as identified in

AlliedSignal Aerospace Service Bulletin

103570–21–4012, Revision 1, dated May 30,

1995:

Model of

airplane Serial Nos.

400 ........... RJ–1 through RJ–65, inclusive.

400A ........ RK–1 through RK–42, inclusive.

400T (military).TT–4 and TT–19.

MU–300 ... S/N A001SA through A091SA.

MU–300–

10.

A1001SA through A1011SA, inclusive.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. for airplanes that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (c) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent cracking and consequent failure

of the outflow/safety valves, which could

result in rapid decompression of the airplane,

accomplish the following:

(a) Within 18 months after September 24,

1996 (the effective date of AD 96–17–10,

amendment 39–9719), replace the outflow/

safety value in accordance with AlliedSignal

Aerospace Service Bulletin 103570–21–4012,

Revision 1, dated May 30, 1995.

(b) As of September 24, 1996, no person

shall install an outflow/safety valve, having

a part number and serial number identified

in AlliedSignal Aerospace Service Bulletin

103570–21–4012, Revision 1, dated May 30,

1995, on any airplane unless that valve is

considered to be serviceable in accordance

with the applicable service bulletin.

(c) An alternative method of

compliance or adjustment of the

compliance time that provides an

acceptable level of safety may be used

if approved by the Manager, Wichita

Aircraft Certification Office (ACO),

FAA, Small Airplane Directorate.

Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then said it to the

Manager, Wichita ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Wichita ACO.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

location where the requirements of this AD

can be accomplished.

Issued in Renton, Washington, on July 24,

1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–20011 Filed 7–29–97; 8:45 am]

BILLING CODE 4910–13–M

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.

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 § 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
40766 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules

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 § 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 §§ 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 § 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 § 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

§ 207.10(f), then the feed mill must

register the establishment with FDA

under § 207.20. The types of feed that

would require registration of the

establishment under § 207.20 would

also require a medicated feed mill

license under § 558.4. Thus, under

§§ 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

§ 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 § 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 § 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, § 515.25

provides for the revocation of an order

refusing to approve an application or

suspending or revoking a license, and

§ 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 § 515.40 provides for the
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules 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

§ 207.10(f) in order to clarify the

exemption from the requirement of

establishment registration, as set forth in

§ 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 § 558.4(b).

The general scheme for categories and

types of medicated feeds set forth in

§ 558.3 (21 CFR 558.3) would remain

under medicated feed mill licensing.

Those medicated feeds exempted from

the MFA requirement under § 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

§ 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 freechoice 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
40768 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules

1Employment and Earnings, U.S. Department of

Labor Bureau and Labor Statistics, vol. 43, No. 1,

p. 205, January 1996.

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 $6841 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.

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

§ 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, § 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, § 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
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules 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

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

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

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

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

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

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:
40770 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules

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:

§ 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 freechoice feeds, as defined in § 510.455 of

this chapter, or medicated liquid feeds,

as defined in § 558.5 of this chapter,

where a medicated feed mill license is

required are not exempt.

* * * * *

§ 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,’’.

§ 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:

§ 225.1 Current good manufacturing

practice.

* * * * *

(b) * * *

(2) The regulations in §§ 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 §§ 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 § 510.301

of this chapter.

§ 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:

§ 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

§ 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:

§ 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:

§ 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).

§ 514.2 [Removed]

13. Section 514.2 Applications for

animal feeds bearing or containing new

animal drugs is removed.

§ 514.9 [Removed]

14. Section 514.9 Supplemental

applications for animal feeds bearing or

containing new animal drugs is

removed.

§ 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.

§ 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).

§ 514.112 [Removed]

17. Section 514.112 Return of

applications for animal feeds bearing or

containing new animal drugs is

removed.

§ 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.
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules 40771

19. Section 514.201 is revised to read

as follows:

§ 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

§ 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

§ 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 §§ 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.

§ 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

§ 515.20 Approval of medicated feed mill

license applications.

Within 90 days after an application

has been filed under § 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.

§ 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 § 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
40772 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules

published under section 512(i) of the

Federal Food, Drug, and Cosmetic Act.

(b) The Commissioner, as provided in

§ 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.

§ 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

§ 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.

§ 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 § 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.

§ 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.

§ 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.

§ 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

§ 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
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Proposed Rules 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 wellorganized 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.

§ 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

§ 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 § 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).

§ 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

§ 514.105(b) of this chapter’’ and adding

in their places ‘‘a medicated feed mill

license application approved under

§ 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:

§ 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 §§ 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

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 924

[SPATS No. MS–012–FOR]

Mississippi Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the

Mississippi regulatory program

(hereinafter the ‘‘Mississippi program’’)

under the Surface Mining Control and

Reclamation Act of 1977 (SMCRA). The

proposed amendment consists of

revisions to the Mississippi Surface Coal

Mining and Reclamation Law pertaining

to definitions, reorganization, adoption

of rules and regulations, small operator

assistance program, permit applications,

permit fees, reclamation plans,

performance bonds, permit issuance,

permit reissuance, permit revision,

public participation, public hearings,

formal hearings, confidentiality claims,

environmental protection performance

standards, postmining land use,

underground coal mining, mine

entrance signs, violation complaints,

civil penalties, bond release, bond

forfeiture, suspension and revocation of

permits, designating lands unsuitable

for surface coal mining, and creation of

a ‘‘Surface Coal Mining and

Reclamation Fund.’’ The amendment is

intended to revise the Mississippi

program to be consistent with SMCRA,

clarify ambiguities, and improve

operational efficiency.

This document sets forth the times

and locations that the Mississippi

program and proposed amendment to

that program are available for public

inspection, the comment period during

which interested persons may submit

written comments on the proposed

amendment, and the procedures that

will be followed regarding the public

hearing, if one is requested.

DATES: Written comments must be

received by 4:00 p.m., c.d.t., August 29,

1997. If requested, a public hearing on

the proposed amendment will be held

on August 25, 1997. Requests to speak

at the hearing must be received by 4:00

p.m., c.d.t. on August 14, 1997.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Arthur