This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

14392

Vol. 60, No. 52

Friday, March 17, 1995

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Parts 101 and 112

[Docket No. 93–167–1]

Viruses, Serums, and Toxins and

Analogous Products; Master Labels

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Proposed rule.

SUMMARY: We are proposing to amend

the regulations regarding the packaging

and labeling of veterinary biologicals to

require the use of a master label. The

use of a master label system would:

reduce the number of copies of labels

that are required to be submitted for

review and approval, and allow labels

with certain minor revisions to be used

sooner than would be possible without

the use of a master label. A definition

of ‘‘master label’’ would be added to the

regulations. The proposed amendments

are necessary in order to improve label

approval procedures by establishing a

master label system. The effect of the

proposed amendment would be to

streamline the procedure for requesting

and receiving approval to use new or

revised labels for veterinary biologicals.

DATES: Consideration will be given only

to comments received on or before May

16, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 93–167–1, Animal and Plant

Health Inspection Service, Policy and

Program Development, Regulatory

Analysis and Development, 4700 River

Road Unit 118, Riverdale, MD 20737–

1228. Please state that your comments

refer to Docket No. 93–167–1.

Comments received may be inspected at

USDA, room 1141, South Building, 14th

Street and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead (202) 690–2817) to facilitate entry

into the comment reading room.

FOR FURTHER INFORMATION CONTACT:

Dr. David A. Espeseth, Deputy Director,

Animal and Plant Health Inspection

Service, Biotechnology, Biologics, and

Environmental Protection, Veterinary

Biologics, 4700 River Road Unit 148,

Riverdale, MD 20737–1228, telephone

number (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations pertaining to the

packaging and labeling of veterinary

biologicals are in 9 CFR part 112. The

regulations require that all labels for

veterinary biologicals be submitted and

reviewed for compliance with the

regulations and approved in writing

prior to use. APHIS has issued licenses

under the Virus-Serum-Toxin Act (21

U.S.C. 151–159) for some 2000

veterinary biological products. Each

licensed biological product is required

to have approved packaging and

labeling applicable to a variety of

container sizes, trade names, producers,

subsidiaries, and distributors.

Current regulations require each

product label to be reviewed and

approved individually prior to use.

Several nearly identical labels for one

product are often required to be

reviewed and approved by APHIS. A

minor revision in the labeling of a

product can result in the additional

review and approval of all revised labels

for that product.

Due to the large number of label

submissions and the requirement for

label review prior to the marketing of a

biological product, an inordinate

amount of program time and resources

may be expended in the review and

approval of label submissions. Many

label submissions constitute only minor

revisions.

An analysis of the time and resources

currently required to review, file, and

store label submissions involving minor

revisions, and the accompanying delay

experienced by some manufacturers in

receiving approval and written

notification suggest that the process by

which labels are approved may be

simplified. We propose to institute the

use of a master label system that would

reduce redundant review and approval

of submissions involving only minor

revisions of approved labels. Under the

proposed master label system, only the

container and carton label for the

smallest size final container that is

approved by APHIS and any insert for

the product would be required to be

submitted for review, approval, and

filing as master labels. Certain specified

revisions could be made on labels under

the Master Label system without prior

written approval, provided that such

revisions are submitted to APHIS for

review, approval, and filing within 60

days of use of the revised label.

We are proposing to amend the

definition in § 101.4 by adding a new

paragraph (h) as follows:

(h) Master label. The finished carton,

container, or enclosure label for the

smallest size final container that is

authorized for a biological product, that

serves as the master template label

applicable to all other size containers or

cartons of the same product that is

marketed by a licensee, subsidiary,

division, or distributor.

We are also proposing to revise

several paragraphs of the regulations in

§ 112.5 pertaining to the review and

approval of labels to add specific

provisions related to the use of master

labels (see introductory paragraph,

paragraphs (d)(1)(ii), (d)(1)(iv),

(d)(3)(ii)(a), (d)(4), and (g)).

Certain revised labels could be used

on products with approved master

labels prior to review and approval by

APHIS as provided under proposed

paragraph (c) of § 112.5.

Two copies of master label sketches

would be submitted for each enclosure

and the labels for the smallest approved

size of carton and container. A master

label sketch would be held on file for

one year, or as long as a license

application was active.

For finished master labels, three

copies of each enclosure and of each

label for the smallest size carton and

final container would be submitted.

Labels for larger size containers or

cartons of the same product would not

be submitted, provided that the larger

size container or carton is approved in

the Outline of Production and the larger

size container or carton is identified on

the label mounting sheet. When the

master label enclosure is used with

more than one product, an extra copy of

the enclosure for each additional

product would have to be submitted.

Finally, the information that must be

submitted on the lower left hand corner

of each page of the label submission
Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules 14393

would include the reason for the

submission, a reference to the master

label, its replacement, and the dose

sizes for which the master label is to be

used.

We are proposing to add a provision

in § 112.5(c) to allow for specified minor

label changes without prior approval by

APHIS for products with approved

master labels. Minor label changes that

would be allowed include changes in

physical dimensions of the label or the

color of the label print that do not affect

legibility; the addition, deletion, or

change of a trademark or registered

symbol, label control number or bar

code, or logo; and the correction of

typographical errors. Such minor

changes would, of course, not be

appropriate if they cause the label to be

false or misleading. In addition, there

would be a requirement that a new

master label bearing such minor changes

be submitted to APHIS for review and

written approval within 60 days of label

use.

We are also proposing to revise

§ 112.5(d)(2)(iii)(a) to add a provision

for the labeling of individual reagent

containers included with diagnostic test

kits. Such labeling of individual reagent

containers would be mounted together

on a single sheet of paper, when

possible. Carton labels and enclosures

would be mounted on separate

individual sheets.

Finally, we are proposing to add a

provision in § 112.5(g) that provides for

inspection of labels and master labels by

authorized inspectors.

We would also correct the references

in § 112.7, paragraph (c)(2), by changing

‘‘§ 113.129’’ to read ‘‘§ 113.209’’ and in

paragraph (d)(6) by changing

‘‘§ 113.147’’ to read ‘‘§ 113.312’’. In

addition, in § 112.5(d), paragraph

(2)(iii)(b) would be redesignated

paragraph (2)(iii)(B), paragraph (3)(i)(a)

would be redesignated paragraph

(3)(i)(A), paragraph (3)(i)(b) would be

redesignated paragraph (3)(i)(B), and

paragraph (3)(ii)(b) would be

redesignated paragraph (3)(ii)(B).

This proposed amendment was

developed through the cooperative

efforts of the manufacturers of

veterinary biologicals, the Animal

Health Institute, and APHIS. The overall

effect of this regulation would be to

simplify the process whereby labels are

approved by reducing the number of

copies of labels needed to be submitted

for review.

Executive Order 12866 and Regulatory

Flexibility Act

This rule has been determined to be

not significant for purposes of Executive

Order 12866 and, therefore, has not

been reviewed by the Office of

Management and Budget.

The proposed rule would amend the

regulations for the review and approval

of biological product labels by providing

for a master label system. The current

regulations in part 112 require the

submission and approval of all labels for

each biological product to be marketed.

The approval of a prototype master label

for each product would reduce the need

for licensees producing veterinary

biologicals to submit for approval

additional copies of labels for each

product.

The approval of a master label would

apply to labels for larger containers

sizes of the same product, provided that

the labels are identical to the master

label, except for physical dimensions,

and provided that additional container

sizes are authorized in a filed Outline of

Production.

This proposed rule would also allow

certain approved labels with specified

minor revisions to be used without prior

written approval with the provision that

new master labels be submitted to

APHIS for review and approval within

60 days use of the revised label.

The proposed rule has its major effect

in reducing the number of copies of

labels that need to be submitted and

reviewed. Most products are marketed

in two or three different size containers.

Currently, each label for each container

must be submitted for approval. Under

the proposed master label concept, only

labels for the smallest size container

would need to be submitted, thus

reducing by two to three fold the

number of labels that would need to be

submitted by manufacturers and

processed by APHIS.

The proposed rule would not have

any adverse economic impact, since the

submission of product labels for

approval is already required under

§ 112.5 of the regulations, which

currently specifies that all labels shall

be reviewed and approved prior to use.

The proposed amendments would

simplify the process of label approvals

and would reduce the time and expense

necessary to get a product to market in

the case of certain minor revisions of

labels.

Under these circumstances, the

Administrator of the Animal and Plant

Health Inspection Service has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. If this proposed rule is

adopted: (1) All State and local laws and

regulations that are in conflict with this

rule will be preempted; (2) no

retroactive effect will be given to this

rule; and (3) administrative proceedings

will not be required before parties may

file suit in court challenging this rule.

Paperwork Reduction Act

The proposed rule contains no new

information collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.).

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

state and local officials (see 7 CFR part

3015, subpart V).

List of Subjects

9 CFR Part 101

Animal biologics.

9 CFR Part 112

Animal biologics, Exports, Imports,

Reporting and recordkeeping

requirements.

Accordingly, 9 CFR parts 101 and 112

would be amended as follows:

PART 101—DEFINITIONS

1. The authority citation for part 101

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

2. Section 101.4 would be amended

by adding a new paragraph (h) to read

as follows:

§ 101.4 Labeling terminology.

* * * * *

(h) Master label. The finished carton,

container, or enclosure label for the

smallest size final container that is

authorized for a biological product, that

serves as the Master template label

applicable to all other size containers or

cartons of the same product that is

marketed by a licensee, subsidiary,

division, or distributor.

PART 112—PACKAGING AND

LABELING

3. The authority citation for part 112

would continue to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.17,

2.51, and 371.2(d).

4. Section 112.5 would be amended as

follows:

a. The introductory paragraph would

be revised to read as set forth below.

b. Paragraph (c) would be revised to

read as set forth below.
14394 Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules

c. Paragraphs (d)(1)(i) and (d)(1)(ii)

would be revised to read as set forth

below.

d. Paragraphs (d)(1)(iii) and (d)(1)(iv)

would be added to read as set forth

below.

e. Paragraph (d)(2)(iii)(a) would be

revised to read as set forth below.

f. Paragraph (d)(3)(ii)(a) would be

revised to read as set forth below.

g. Paragraph (d)(4) would be revised

to read as set forth below.

h. Paragraph (g) would be added to

read as set forth below.

i. In § 112.5, paragraph (d)(2)(iii)(b)

would be redesignated paragraph

(d)(2)(iii)(B), paragraph (d)(3)(i)(a)

would be redesignated paragraph

(d)(3)(i)(A), paragraph (d)(3)(i)(b) would

be redesignated paragraph (d)(3)(i)(B),

and paragraph (d)(3)(ii)(b) would be

redesignated paragraph (d)(3)(ii)(B).

§ 112.5 Review and approval of labeling.

Labels used with biological products

prepared at licensed establishments or

imported for general distribution and

sale must be submitted to the Animal

and Plant Health Inspection Service for

review for compliance with the

regulations and approval in writing

prior to use, except under the master

label system as provided in paragraph

(c) of this section.

* * * * *

(c)(1) Labels must be submitted to the

Animal and Plant Health Inspection

Service for review and written approval.

Only labels which are approved as

provided in § 112.5 (d) may be used.

When changes are made in approved

labels, the new labels shall be subject to

review and approval before use:

Provided, That certain minor changes

may be made in labels for products with

approved master labels, and the revised

labels, may be used prior to review by

APHIS, with the provision that a new

master label bearing these changes is

submitted to APHIS for review and

written approval within 60 days of label

use, and that such minor changes do not

render the product mislabeled or the

label false and misleading in any

particular.

(2) Minor label changes that may be

made under the provision for products

with approved master labels are:

(i) Changes in the physical

dimensions of the label provided that

such change does not affect the

legibility of the label;

(ii) Change in the color of label print,

provided that such change does not

affect the legibility of the label;

(iii) The addition or deletion of a

Trade Mark (TM) or Registered (R)

symbol;

(iv) The correction of typographical

errors;

(v) Adding or changing label control

numbers or bar codes; and

(vi) Revising or updating logos.

* * * * *

(d) (1)* * *

(i) For label sketches, submit two

copies of each sketch of a final container

label, carton label, and enclosure.

Sketches must be legible, and must

include all information specified in

§ 112.2. One copy of each sketch will be

returned with applicable comments, and

one copy will be held on file by APHIS

for no more than one year after

processing, until replaced by a finished

label: Provided, That sketches submitted

in support of an application for a license

or permit shall be held as long as the

application is considered active.

(ii) For master label sketches, submit

for each product two copies of each

sketch of an enclosure, label for the

smallest size final container, and carton

label: Provided, That labels for larger

size containers and/or cartons that are

identical, except for physical

dimensions, need not be submitted. One

copy of each master label sketch will be

returned with applicable comments, and

one copy will be held on file by APHIS

for one year after processing, until

replaced by a finished master label that

is submitted according to

§ 112.5(d)(1)(iii): Provided, That master

label sketches submitted in support of

an application for license or permit

shall be held as long as the application

is considered active.

(iii) For finished labels, submit three

copies of each finished final container

label, carton label, and enclosure:

Provided, That when an enclosure is to

be used with more than one product,

one extra copy shall be submitted for

each additional product. Two copies of

each finished label will be retained by

APHIS. One copy will be stamped and

returned to the licensee. Labels to which

exceptions are taken shall be marked as

sketches and handled under

§ 112.5(d)(1)(i).

(iv) For finished master labels, submit

for each product three copies each of the

enclosure and the labels for the smallest

size final container and carton. Labels

for larger sizes of containers or cartons

of the same product that are identical,

except for physical dimensions, need

not be submitted. Such labels become

eligible for use, concurrent with the

approval of the appropriate finished

master label: Provided, That the

marketing of larger sizes of final

containers is approved in the filed

Outline of Production, and the

appropriate larger sizes of containers or

cartons are identified on the label

mounting sheet. When a master label

enclosure is to be used with more than

one product, one extra copy of each

additional product shall be submitted.

Two copies of each finished master

label will be retained by APHIS. One

copy will be stamped and returned to

the licensee. Master labels to which

exceptions are taken will be marked as

sketches and handled under

§ 112.5(d)(1)(ii).

* * * * *

(2) * * *

(iii)(A) When two final containers are

packaged together in a combination

package, the labels for each shall be

mounted on the same sheet of paper and

shall be treated as one label. For

diagnostic test kits, the labels for use on

the individual reagent containers to be

included in the kit shall be mounted

together on a single sheet of paper, if

possible; if necessary, a second sheet of

paper may be used. The carton label and

enclosure shall be mounted on separate

individual sheets.

* * * * *

(3) * * *

(ii)(A) Designation of the specimen as

a label or master label: sketch, final

container label, carton label, or

enclosure.

(B) If two final container labels or

multiple parts are on one sheet, each

shall be named, and the label or part

being revised shall be designated.

(iii) Size of package (dose, ml., cc., or

units) for which the labels or enclosures

are to be used.

(4) To appear on the bottom of each

page: The reason for and information

relevant to the submission shall be

stated in the lower left hand corner as:

(i) Master label dose sizes approved

for code lllll.

(ii) Replacement for label, master

label, and/or sketch No. lllll.

(iii) Reference to label or master label

No. lllll.

(iv) Addition to label No. lllll.

(v) License Application Pending

lllll.

(vi) Foreign Language copy of label

No.lllll.

* * * * *

(g) At the time of an inspection, or

when requested by APHIS, licensees or

permittees shall make all labels and

master labels, including labels approved

for use but exempted from filing under

the master label system, available for

review by authorized inspectors. Such

labels shall be identical to the approved

label or master label except for physical

dimensions, reference to recoverable

volume or doses and/or certain minor

differences permitted in accordance

with § 112.5(c).
Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Proposed Rules 14395

5. In § 112.7, paragraphs (c)(2) and

(d)(6) would be revised as follows:

§ 112.7 Special additional requirements.

* * * * *

(c) * * *

(2) Subsequent revaccination as

determined from the results of duration

of immunity studies conducted as

prescribed in § 113.209, paragraphs (b)

or (c), or both.

* * * * *

(d) * * *

(6) Subsequent revaccination as

determined from the results of duration

of immunity studies conducted as

prescribed in § 113.312, paragraphs (b)

or (c), or both.

* * * * *

Done in Washington, DC, this 13 day of

March 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–6650 Filed 3–16–95; 8:45 am]

BILLING CODE 3410–34–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 95–NM–02–AD]

Airworthiness Directives; Fokker

Model F28 Mark 0100 Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

adoption of a new airworthiness

directive (AD) that is applicable to

certain Fokker Model F28 Mark 0100

series airplanes. This proposal would

require repetitive checks to detect

backlash in the elevator mechanical

control system, and various follow-on

actions. The proposed AD would also

provide for an optional terminating

action for the repetitive check

requirements. This proposal is

prompted by a report indicating that

corrosion was found on the pivot bolts

and bushings of the backlash remover

lever mechanism on the elevator booster

control unit (BCU) of a Model F28 Mark

0100 series airplane. The actions

specified by the proposed AD are

intended to prevent such corrosion,

which could result in backlash in the

elevator controls and reduced elevator

control authority in the manual mode.

DATES: Comments must be received by

May 12, 1995.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–103,

Attention: Rules Docket No. 95–NM–

02–AD, 1601 Lind Avenue SW., Renton,

Washington 98055–4056. Comments

may be inspected at this location

between 9:00 a.m. and 3:00 p.m.,

Monday through Friday, except Federal

holidays.

The service information referenced in

the proposed rule may be obtained from

Fokker Aircraft USA, Inc., 1199 North

Fairfax Street, Alexandria, Virginia

22314. This information may be

examined at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue

SW., Renton, Washington.

FOR FURTHER INFORMATION CONTACT: Tim

Dulin, Aerospace Engineer,

Standardization Branch, ANM–113,

FAA, Transport Airplane Directorate,

1601 Lind Avenue SW., Renton,

Washington 98055–4056; telephone

(206) 227–2141; fax (206) 227–1100.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed 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 above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained

in this notice may be changed in light

of the comments received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed 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

summarizing each FAA-public contact

concerned with the substance of this

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 95–NM–02–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of NPRMs

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Transport Airplane Directorate,

ANM–103, Attention: Rules Docket No.

95–NM–02–AD, 1601 Lind Avenue SW.,

Renton, Washington 98055–4056.

Discussion

The Rijksluchtvaartdienst (RLD),

which is the airworthiness authority for

the Netherlands, recently notified the

FAA that an unsafe condition may exist

on all Fokker Model F28 Mark 0100

series airplanes equipped with a certain

Menasco Aerospace Elevator Booster

Control Unit (BCU). The RLD advises

that corrosion was found on the pivot

bolts and bushings of the backlash

remover lever mechanism on the

elevator BCU of Model F28 Mark 0100

series airplanes. This mechanism

prevents backlash in the elevator control

forces when the elevator BCU is not

hydraulically powered, providing the

pilot with full manual control of the

elevator system. Investigation revealed

that corrosion on the pivot bolts and

bushings causes the backlash remover

mechanism to stick, which results in

deteriorated elevator control when the

BCU is in manual mode. This condition,

if not corrected, could result in backlash

in the elevator controls and reduced

elevator control authority in the manual

mode.

Fokker has issued Service Bulletin

SBF100–27–052, Revision 1, dated

March 29, 1994, which describes

procedures for:

1. Performing repetitive operational

checks to detect backlash in the elevator

mechanical control system;

2. Performing an inspection to

determine whether certain elevator BCU

bolts rotate and slide freely, and to

detect corrosion on the bolts of the

backlash remover lever mechanism, if

any backlash is detected; and

3. Replacing the elevator BCU or bolts

with a serviceable part, if any anomaly

is detected.

The RLD classified this service

bulletin as mandatory and issued Dutch

airworthiness directive BLA 93–051/3

(A), dated April 29, 1994, in order to

assure the continued airworthiness of

these airplanes in the Netherlands.

Additionally, Fokker has issued

Service Bulletin SBF100–27–061, dated

March 2, 1994, which provides

instructions for accomplishing an

optional modification of the affected

elevator BCU, which would eliminate

the need for the repetitive operational

checks. This modification involves

replacing two bolts in the elevator BCU

with new bolts.

This airplane model is manufactured

in the Netherlands and is type

certificated for operation in the United

States under the provisions of section