35946 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Compliance: Required as indicated, unless

accomplished previously.

To prevent collapse of the nose landing

gear as a result of failure of the lock link bolt,

accomplish the following:

(a) Within 24 months after the effective

date of this AD, perform either a visual

inspection or a records search to determine

the serial number of the lock link bolt, part

number (P/N) ACG7079–1, installed in the

nose landing gear (NLG). If the visual

inspection is accomplished, it must be

conducted in accordance with procedures

specified in McDonnell Douglas Service

Bulletin DC10–32–242, dated November 1,

1995, for Model DC–10 series airplanes; or

McDonnell Douglas Service Bulletin MD11–

32–060, dated November 6, 1995, for Model

MD–11 series airplanes.

(b) If the serial number of the lock link bolt

is not AP001 through AP036 inclusive, or

AP200 through AP344 inclusive: No further

action is required by this AD.

(c) If the serial number of the lock link bolt

is AP001 through AP036 inclusive, or AP200

through AP344 inclusive: Within 24 months

after the effective date of this AD, replace the

lock link bolt with a bolt, P/N ACG7079–1,

that does not have one of those serial

numbers.

(d) As of the effective date of this AD, no

person shall install a lock link bolt, part

number (P/N) ACG7079–1, having a serial

number of AP001 through AP036 inclusive,

or AP200 through AP344 inclusive, on any

airplane.

(e) 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, Los

Angeles Aircraft Certification Office (ACO),

FAA, Transport Airplane Directorate.

Operators shall submit their requests through

an appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Los Angeles ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Los Angeles ACO.

(f) 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

a location where the requirements of this AD

can be accomplished.

(g) The inspection shall be done in

accordance with McDonnell Douglas Service

Bulletin DC10–32–242, dated November 1,

1995, for Model DC–10 series airplanes; and

McDonnell Douglas Service Bulletin MD11–

32–060, dated November 6, 1995, for Model

MD–11 series airplanes. This incorporation

by reference was approved by the Director of

the Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR part 51. Copies may

be obtained from McDonnell Douglas

Corporation, 3855 Lakewood Boulevard,

Long Beach, California 90846, Attention:

Technical Publications Business

Administration, Department C1–L51 (2–60).

Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

FAA, Los Angeles Aircraft Certification

Office, Transport Airplane Directorate, 3960

Paramount Boulevard, Lakewood, California;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(h) This amendment becomes effective on

August 13, 1996.

Issued in Renton, Washington, on June 27,

1996.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 96–16951 Filed 7–8–96; 8:45 am]

BILLING CODE 4910–13–P

14 CFR Part 39

[Docket No. 96–NM–133–AD; Amendment

39–9691; AD 96–14–07]

RIN 2120–AA64

Airworthiness Directives; McDonnell

Douglas Model MD–11 and MD–11F

Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment supersedes

an existing airworthiness directive (AD),

applicable to certain McDonnell

Douglas Model MD–11 and MD–11F

series airplanes, that currently requires

repetitive inspections of the tail tank

fuel pipe assembly and the associated

mounting brackets in the aft fuselage

compartment, and follow-on actions, if

necessary. That AD also provides for an

optional terminating modification for

the repetitive inspections. This

amendment deletes the optional

terminating modification, and expands

the applicability of the existing AD to

include additional airplanes. This

amendment is prompted by reports of

cracking or bending of the fuel pipe

mounting support and/or attaching

bracket in the aft fuselage compartment

due to a fuel pressure surge that caused

repetitive loading of this area. The

actions specified in this AD are

intended to prevent such cracking/

bending, which could expose the fuel

pipe coupling O-ring. An exposed Oring could lose its sealing effect and

could allow a fuel leak in the aft

fuselage compartment, which may result

in a possible in-flight or ground fire.

DATES: Effective July 24, 1996.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of July 24,

1996.

Comments for inclusion in the Rules

Docket must be received on or before

September 9, 1996.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–103,

Attention: Rules Docket No. 96–NM–

133–AD, 1601 Lind Avenue, SW.,

Renton, Washington 98055–4056.

The service information referenced in

this AD may be obtained from

McDonnell Douglas Corporation, 3855

Lakewood Boulevard, Long Beach,

California 90846, Attention: Technical

Publications Business Administration,

Department C1–L51 (2–60). This

information may be examined at the

FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the FAA, Los Angeles

Aircraft Certification Office, Transport

Airplane Directorate, 3960 Paramount

Boulevard, Lakewood, California; or at

the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Raymond Vakili, Aerospace Engineer,

Propulsion Branch, ANM–140L, FAA,

Los Angeles Aircraft Certification

Office, 3960 Paramount Boulevard,

Lakewood, California 90712; telephone

(310) 627–5262; fax (310) 627–5210.

SUPPLEMENTARY INFORMATION: On

November 4, 1991, the FAA issued AD

91–24–09, amendment 39–8095 (56 FR

61364, December 3, 1991), applicable to

certain McDonnell Douglas Model MD–

11 and MD–11F series airplanes. That

AD requires repetitive visual

inspections of the tail tank fuel pipe

assembly and the associated mounting

brackets located in the aft fuselage

compartment to verify the correct

position of the pipe flange and to detect

damaged brackets. It also requires

various follow-on actions, if any

discrepancy is detected. That AD also

provides for an optional terminating

modification for the repetitive

inspections. That action was prompted

by a report of an uncontained fuel leak

in the aft fuselage compartment on an

in-service airplane, which was the result

of migration of the tail tank fuel pipe

assembly, and consequent exposure of

the O-ring that provides the seal

between the pipe assembly and the

coupling shroud assembly. The actions

required by that AD are intended to

prevent a fuel leak in the aft fuselage

compartment area, and the possibility of

an in-flight or ground fire.

Actions Since Issuance of Previous Rule

Since the issuance of that AD, the

FAA has received several reports of

cracking or bending of the fuel pipe

mounting support and/or attaching

bracket at station Y=2033.750 in the aft
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35947

fuselage compartment on McDonnell

Douglas Model MD–11 series airplanes.

A section of the fuel pipe assembly and

support bracket of some of these

airplanes had been replaced in

accordance with the optional

terminating modification specified in

AD 91–24–09. Additionally, this

replacement had been accomplished

during production on certain other

airplanes on which these incidents

occurred.

Investigation revealed that a fuel

pressure surge during transfer of the tail

tank fuel caused repetitive loading of

the fuel pipe mounting support and/or

attaching bracket, which resulted in the

subject cracking/bending. Although

none of the reported events have

resulted in a fuel leak in the aft fuselage

compartment, the FAA has determined

that severe deformation of the bracket

could allow the pipe to migrate, which

could also expose the O-ring that

provides the seal between the fuel pipe

and coupling. If the O-ring is exposed,

it could lose its sealing effect, and allow

a fuel leak in the aft fuselage

compartment, which could result in a

possible in-flight or ground fire.

In light of these recent incidents,

which are similar to the incident that

prompted the issuance of AD 91–24–09,

the FAA finds that the optional and oncondition terminating modifications

(i.e., replacement of a section of the fuel

pipe assembly and support bracket, an

FAA-approved repair procedure, and

replacement of the shroud assembly)

specified in AD 91–24–09 do not

adequately preclude the addressed

unsafe condition identified as in-flight

or ground fire. Therefore, the FAA finds

that repetitive visual inspections to

detect discrepancies (i.e., cracks, or

deformation) of the fuel pipe of the fuel

transfer system of the tail tank and

associated mounting bracket located in

the aft fuselage compartment, and to

verify the correct position of the fuel

pipe flange are necessary. These actions

will ensure that the unsafe condition

presented by fuel surge during transfer

of tail tank fuel is corrected, and

provide an acceptable level of safety.

Explanation of Relevant Service

Information

The FAA has reviewed and approved

McDonnell Douglas Alert Service

Bulletin MD11–28A082, dated May 14,

1996. The alert service bulletin

describes procedures for repetitive

visual inspections to detect

discrepancies (i.e., cracks, or

deformation) of the fuel pipe of the fuel

transfer system of the tail tank and

associated mounting bracket located in

the aft fuselage compartment; and to

verify the correct position of the fuel

pipe flange, and various follow-on

actions. These follow-on actions include

replacing the O-ring, repositioning the

tail tank fuel pipe, and installing a

temporary phenolic support block

assembly. Installation of a phenolic

support block assembly between the tail

tank fuel pipe and adjoining structure as

a temporary restraint will minimize the

possibility of migration of the tail tank

fuel pipe.

In addition, the visual inspections

and certain of the follow-on actions of

Alert Service Bulletin MD11–28A082

are essentially identical to those

described in McDonnell Douglas MD–11

Alert Service Bulletin A28–22, Revision

4, dated September 16, 1991 (which was

referenced in AD 91–24–09). However,

the effectivity listing of Alert Service

Bulletin MD11–28A082 includes

additional airplanes that were not

included in the effectivity listing of

Alert Service Bulletin A28–22. These

additional airplanes have been found to

be subject to the addressed unsafe

condition.

Explanation of Requirements of Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other airplanes of this same

type design, this AD supersedes AD 91–

24–09 to require repetitive visual

inspections to detect discrepancies (i.e.,

cracks or deformation) of the fuel pipe

of the fuel transfer system of the tail

tank and associated mounting bracket

located in the aft fuselage compartment

and to verify the correct position of the

fuel pipe flange, and various follow-on

actions. This AD also expands the

applicability of the existing AD to

include additional airplanes.

This is considered to be interim

action. The manufacturer has advised

that it currently is developing a

modification that will positively address

the unsafe condition addressed by this

AD. Once this modification is

developed, approved, and available, the

FAA may consider additional

rulemaking.

Determination of Rule’s Effective Date

Since a situation exists that requires

the immediate adoption of this

regulation, it is found that notice and

opportunity for prior public comment

hereon are impracticable, and that good

cause exists for making this amendment

effective in less than 30 days.

Comments Invited

Although this action is in the form of

a final rule that involves requirements

affecting flight safety and, thus, was not

preceded by notice and an opportunity

for public comment, comments are

invited on this rule. Interested persons

are invited to comment on this rule by

submitting such written data, views, or

arguments as they may desire.

Communications shall identify the

Rules Docket number and be submitted

in triplicate to the address specified

under the caption ADDRESSES. All

communications received on or before

the closing date for comments will be

considered, and this rule may be

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this AD

will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 96–NM–133–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Regulatory Impact

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory
35948 Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing amendment 39–8095 (56 FR

61364, December 3, 1991), and by

adding a new airworthiness directive

(AD), amendment 39–9691, to read as

follows:

96–14–07 McDonnell Douglas: Amendment

39–9691, Docket 96–NM–133–AD.

Supersedes AD 91–24–09, Amendment

39–8095.

Applicability: Model MD–11 and MD–11F

series airplanes, manufacturer’s fuselage

numbers 0447 through 0599 inclusive;

certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

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 (e) 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 the possibility of an in-flight or

ground fire due to fuel leaking from the fuel

pipe coupling, accomplish the following:

(a) Perform a visual inspection to detect

discrepancies (i.e., cracks or deformation) of

the fuel pipe of the fuel transfer system of the

tail tank and associated mounting bracket

located in the aft fuselage compartment; and

to verify the correct position of the fuel pipe

flange, in accordance with McDonnell

Douglas Alert Service Bulletin MD11–

28A082, dated May 14, 1996; at the time

specified in paragraph (a)(1) or (a)(2) of this

AD, as applicable.

(1) For airplanes on which the

modification specified in McDonnell Douglas

Service Bulletin 28–22, dated September 24,

1991, has been accomplished; or that have

been repaired in accordance with an FAAapproved repair procedure, as specified in

paragraph (a)(3) of AD 91–24–09, amendment

39–8095; or on which the shroud assembly

has been replaced with a serviceable part:

Prior to the accumulation of 600 flight hours,

or within 60 days after the effective date of

this AD, whichever occurs later.

(2) For airplanes on which the

modification specified in McDonnell Douglas

Service Bulletin 28–22, dated September 24,

1991, has not been accomplished: Prior to the

accumulation of 600 flight hours, or within

60 days since accomplishment of the last

visual inspection in accordance with AD 91–

24–09, whichever occurs first.

(b) CONDITION 1. If no discrepancy is

detected during any visual inspection

required by paragraph (a) of this AD,

accomplish either paragraph (b)(1) or (b)(2) of

this AD.

(1) OPTION 1. Repeat the visual inspection

required by paragraph (a) of this AD

thereafter at intervals not to exceed 600 flight

hours or 60 days, whichever occurs later. Or

(2) OPTION 2. Prior to further flight, install

a temporary phenolic support block

assembly, shim, clamp, and bracket between

the tail tank fuel pipe and station

Y=2033.750 bulkhead, in accordance with

Condition 1, Option 2, of McDonnell Douglas

Alert Service Bulletin MD11–28A082, dated

May 14, 1996. Within 6 months after

accomplishment of this installation, perform

a one-time inspection to verify the correct

position of the temporary support block

assembly installation in accordance with

Figure 2 (Sheet 2 of 3) of the alert service

bulletin.

(i) If the assembly is found to be positioned

properly, repeat the verification of the correct

position of the fuel pipe flange, as specified

in paragraph (a) of this AD, thereafter at

intervals not to exceed 15 months.

(ii) If the assembly is found to be

improperly positioned, prior to further flight,

reposition the fuel pipe in accordance with

Figure 2 (Sheet 2 of 3) of the alert service

bulletin. Repeat the verification of the correct

position of the fuel pipe flange, as specified

in paragraph (a) of this AD, thereafter at

intervals not to exceed 15 months.

(c) CONDITION 2. If any discrepancy is

detected, and the fuel pipe is found to be

improperly positioned, but the O-ring is not

exposed, during any visual inspection

required by paragraph (a) of this AD, prior to

further flight, accomplish either paragraph

(c)(1) or (c)(2) of this AD.

(1) OPTION 1. Repeat the visual inspection

in paragraph (a) of this AD thereafter at

intervals not to exceed 600 flight hours or 60

days, whichever occurs later. Or

(2) OPTION 2. Prior to further flight, install

a temporary phenolic support block

assembly, shim, clamp, and bracket between

the tail tank fuel pipe and station

Y=2033.750 bulkhead; and reposition the

fuel pipe assembly, as applicable; in

accordance with Condition 2, Option 2, of

McDonnell Douglas Alert Service Bulletin

MD11–28A082, dated May 14, 1996. Within

6 months after accomplishment of this

installation, perform a one-time inspection to

verify the correct position of the temporary

support block assembly installation in

accordance with Figure 2 (Sheet 2 of 3) of the

alert service bulletin.

(i) If the assembly is found to be positioned

properly, repeat the verification of the correct

position of the fuel pipe flange, as specified

in paragraph (a) of this AD, thereafter at

intervals not to exceed 15 months.

(ii) If the assembly is found to be

improperly positioned, prior to further flight,

reposition the fuel pipe in accordance with

Figure 2 (Sheet 2 of 3) of the alert service

bulletin. Repeat the verification of the correct

position of the fuel pipe flange, as specified

in paragraph (a) of this AD, thereafter at

intervals not to exceed 15 months.

(d) CONDITION 3. If any discrepancy is

detected, and the fuel pipe is found to be

improperly positioned, and the O-ring is

exposed, during any visual inspection

required by paragraph (a) of this AD, prior to

further flight, replace the O-ring with a new

O-ring, and install a temporary phenolic

support block assembly, shim, clamp, and

bracket between the tail tank fuel pipe and

station Y=2033.750 bulkhead, in accordance

with McDonnell Douglas Alert Service

Bulletin MD11–28A082, dated May 14, 1996.

Within 6 months after accomplishment of the

replacement and installation, perform a onetime inspection to verify the correct position

of the temporary support block assembly

installation in accordance with Figure 2

(Sheet 2 of 3) of the alert service bulletin.

(1) If the assembly is found to be

positioned properly, repeat the verification of

the correct position of the fuel pipe flange,

as specified in paragraph (a) of this AD,

thereafter at intervals not to exceed 15

months.

(2) If the assembly is found to be

improperly positioned, prior to further flight,

reposition the fuel pipe in accordance with

Figure 2 (Sheet 2 of 3) of the alert service

bulletin. Repeat the verification of the correct

position of the fuel pipe flange, as specified

in paragraph (a) of this AD, thereafter at

intervals not to exceed 15 months.

(e) 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, Los

Angeles Aircraft Certification Office (ACO),

FAA, Transport Airplane Directorate.

Operators shall submit their requests through

an appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Los Angeles ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Los Angeles ACO.

(f) 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

a location where the requirements of this AD

can be accomplished.

(g) The actions shall be done in accordance

with McDonnell Douglas Alert Service
Federal Register / Vol. 61, No. 132 / Tuesday, July 9, 1996 / Rules and Regulations 35949

Bulletin MD11–28A082, dated May 14, 1996.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from McDonnell Douglas Corporation, 3855

Lakewood Boulevard, Long Beach, California

90846, Attention: Technical Publications

Business Administration, Department C1–

L51 (2–60). Copies may be inspected at the

FAA, Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington; or at

the FAA, Los Angeles Aircraft Certification

Office, Transport Airplane Directorate, 3960

Paramount Boulevard, Lakewood, California;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(h) This amendment becomes effective on

July 24, 1996.

Issued in Renton, Washington, on July 1,

1996.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 96–17217 Filed 7–8–96; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related

Products; Chlortetracycline

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of five supplemental new

animal drug applications (NADA’s) filed

by Hoffmann-LaRoche, Inc., Pfizer, Inc.,

ALPHARMA, Inc., ADM Animal Health

& Nutrition Div., and PennField Oil Co.

The supplemental NADA’s provide for

the safe and effective use of Type A

medicated articles containing

chlortetracycline (CTC) in the feed of

chickens, turkeys, swine, sheep, and

calves, beef and nonlactating dairy

cattle for improved production

efficiency and for control and treatment

of certain bacterial diseases susceptible

to CTC. The approvals reflect

compliance with results of the National

Academy of Sciences/National Research

Council (NAS/NRC), Drug Efficacy

Study Group’s (DESI) evaluation of the

drug’s effectiveness, and FDA’s

conclusions concerning that evaluation.

EFFECTIVE DATE: July 9, 1996.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: The

following sponsors have submitted

supplements to their approved NADA’s:

• Hoffmann-LaRoche, Inc., Nutley, NJ

07110 (formerly held by American

Cyanamid Co.), to NADA 48–761, which

covers the Type A medicated articles:

Aureomix 293 (50 grams of

chlortetracycline hydrochloride per

pound (g CTC HCl/lb)) and

Aureomycin 50, 70, 80, 90, and 100

(contain CTC calcium complex

equivalent to the indicated g/lb

concentrations of CTC HCl);

• Pfizer, Inc., 235 East 42d St., New

York, NY 10017, to NADA 92–286,

which covers the Type A medicated

articles CLTC 10, 20, 30, 50, and 70

(contain CTC calcium complex

equivalent to the indicated g/lb

concentrations of CTC HCl) and to

NADA 92–287, which covers the Type

A medicated articles CLTC 50 MR and

100 MR (contain CTC calcium complex

equivalent to the indicated g/lb

concentrations of CTC HCl);

• ALPHARMA, Inc. (formerly A. L.

Laboratories), One Executive Dr., P.O.

Box 1399, Fort Lee, NJ 07024, to NADA

46–699, which covers the Type A

medicated articles: CTC 100 MR (100 g

CTC HCl/lb) and CTC 10, CTC 50, CTC

65, CTC 70, and Micro CTC 100

(contains CTC calcium complex

equivalent to the indicated g/lb

concentrations of CTC HCl);

• ADM Animal Health & Nutrition

Div., P.O. Box 2508, Fort Wayne, IN

46801–2508 (formerly Feed Specialties

Co., Inc.), to NADA 48–480, which

covers the Type A medicated article

ChloratetTM 50 (contains CTC calcium

complex equivalent to 50 g CTC HCI/lb);

and

• PennField Oil Co., 14040 Industrial

Rd., Omaha, NE 68137, to NADA 138–

935, which covers the Type A

medicated articles: Chlortetracycline

Premixes 50, 60, 70, 80, 100 (all contain

CTC calcium complex equivalent to the

indicated g/lb concentrations of CTC

HCl), and 100 MR (100 g CTC HCl/lb).

The drug products were the subject of

a NAS/NRC DESI evaluation of

effectiveness (DESI 0113NV). The

findings were published in the Federal

Register of July 21, 1970 (35 FR 11646).

NAS/NRC evaluated the drug products

as probably effective for growth

promotion and feed efficiency and for

the treatment of animal diseases caused

by pathogens sensitive to

chlortetracycline. NAS/NRC stated that:

(1) Claims made regarding ‘‘for prevention

of’’ or ‘‘to prevent’’ should be replaced with

‘‘as an aid in the control of’’ or ‘‘to aid in the

control of’’’; (2) claims for growth promotion

or stimulation are disallowed and claims for

faster gains and/or feed efficiency should be

stated as ‘‘may result in faster gains and/or

improved feed efficiency under appropriate

conditions’’; (3) each disease claim should be

properly qualified as ‘‘appropriate for use in

(name of disease) caused by pathogens

sensitive to (name of drug)’’; if the disease

cannot be so qualified the claim must be

dropped; (4) claims pertaining to egg

production and hatchability should be

changed to ‘‘May aid in maintaining egg

production and hatchability, under

appropriate conditions, by controlling

pathogenic microorganisms’’; (5) the labels

should warn that treated animals must

actually be consuming enough medicated

water or medicated feed to provide a

therapeutic dosage under the conditions that

prevail and, as a precaution, state the desired

oral dose per unit of animal weight per day

for each species as a guide to effective usage

of the preparation in drinking water or feed;

and (6) effective blood levels are required for

each recommended dosage.

FDA concurred with the NAS/NRC

findings, interpreting the phrase ‘‘* * *

cannot be so qualified * * *’’ in above

item (3) to mean ‘‘* * * is not supported

by adequate data * * *’’ FDA reviewed

all available effectiveness data of

products subject to the evaluation and

concluded that the data supported

effectiveness for the control and

treatment of certain bacterial diseases

susceptible to CTC in chickens, turkeys,

swine, sheep, calves, and cattle.

The NAS/NRC DESI evaluation is

concerned only with the drugs’

effectiveness and safety to the treated

animal. It does not take into account the

safety for food use of food derived from

drug-treated animals. Nothing herein

will constitute a bar to further

proceedings with respect to questions of

safety of the drugs or their metabolites

in food products derived from treated

animals.

The five subject sponsors filed

supplements that revised the labeling of

their products to comply with the

findings of the NAS/NRC review and

FDA’s conclusions concerning those

findings. The supplemental NADA’s

were approved as of February 16, 1996.

The revisions to § 558.128 (21 CFR

558.128) list the NAS/NRC and FDAapproved conditions of use for CTCcontaining Type A medicated articles.

Products which comply with the

NAS/NRC findings and FDA’s

conclusions regarding those findings are

eligible for copying under the Generic

Animal Drug and Patent Term

Restoration Act (GADPTRA) (see the

eighth in a series of policy letters issued

to facilitate implementation of

GADPTRA that published in the Federal

Register of August 21, 1991 (56 FR

41561). Accordingly, sponsors may now