29462 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

Order to provide authority for Customs

to collect the assessment on all

imported, flavored honey.

A proposed rule was published in the

Federal Register on March 27, 1996, [60

FR 13463]. No comments were received

on the proposal.

This rule adds the new 2106.90.9988

HTS code for flavored honey to section

1240.115(e) of the rules and regulations

issued under the Order. Flavored honey

would be assessed at the one-cent-perpound rate. A conversion factor is not

necessary because the amount of honey

in flavored honey is estimated at 99

percent of the total product. Customs

will notify importers 60 to 90 days

before it begins collecting the

assessment on flavored honey.

Pursuant to the provisions in 5 U.S.C.

553, it is found and determined that

good cause exists for not postponing the

effective date of this action until 30 days

after publication in the Federal Register

because: (1) This action puts into effect

an HTS Code for flavored honey for the

U.S. Customs Service to use in assessing

imported flavored honey; (2) flavored

honey is currently being imported; (3) a

30-day comment period was provided

and no comments were received; and (4)

no useful purpose would be served by

a delay of the effective date.

After consideration of all relevant

material presented, it is found that this

regulation, as hereinafter set forth, will

tend to effectuate the declared policy of

the Act.

List of Subjects in 7 CFR Part 1240

Advertising, Agricultural research,

Honey, Imports, Reporting and

recordkeeping requirements.

For the reasons set forth in the

preamble, 7 CFR Part 1240 is amended

as follows:

PART 1240—HONEY RESEARCH,

PROMOTION, AND CONSUMER

INFORMATION ORDER

1. The authority citation for 7 CFR

Part 1240 continues to read as follows:

Authority: 7 U.S.C. 4601–4612.

2. In § 1240.115, paragraph (e) is

revised to read as follows:

§ 1240.115 Levy of assessments.

* * * * *

(e) The U.S. Customs Service (USCS)

will collect assessments on all honey or

honey products where honey is the

principal ingredient imported under its

tariff schedule (HTS heading numbers

0409.00.00 and 21006.90.9988) at the

time of entry or withdrawal for

consumption and forward such

assessment as per the agreement

between the USCS and USDA. Any

importer or agent who is exempt from

payment of assessments pursuant to

§ 1240.42 (a) and (b) of the Order may

apply to the Board for reimbursement of

such assessment paid.

* * * * *

Dated: June 3, 1996.

Robert C. Keeney,

Director, Fruit and Vegetable Division.

[FR Doc. 96–14758 Filed 6–10–96; 8:45 am]

BILLING CODE 3410–02–P

Animal and Plant Health Inspection

Service

9 CFR Parts 101 and 112

[Docket No. 93–167–2]

Viruses, Serums, and Toxins and

Analogous Products; Master Labels

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the

regulations regarding the packaging and

labeling of veterinary biologicals to

implement the use of a master label. The

use of a master label system will 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 under the current

regulations. A definition of ‘‘master

label’’ is added to the regulations. In the

final rule, the provision for the use of

labels with certain minor changes prior

to APHIS approval is extended to

include previously approved lebels.

The amendments are necessary in

order to improve label approval

procedures by establishing a master

label system. The effect of the

amendment will be to streamline the

procedure for requesting and receiving

approval to use new or revised labels for

veterinary biologicals.

EFFECTIVE DATE: July 11, 1996.

FOR FURTHER INFORMATION CONTACT:

Dr. David A. Espeseth, Deputy Director,

Veterinary Biologics, APHIS, BBEP,

4700 River Road, Unit 148, Riverdale,

MD 20737–1237, (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 112

pertain to the packaging and labeling of

veterinary biologicals. 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. The

Animal and Plant Health Inspection

Service (APHIS) has issued licenses

under the Virus-Serum-Toxin Act (21

U.S.C. 151–159) for some 2300

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.

On March 17, 1995, we published in

the Federal Register (60 FR 14392–

14395, Docket No. 93–167–1) a proposal

to amend the regulations regarding the

packaging and labeling of veterinary

biologicals to implement the use of a

master label system. 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 would allow labels with certain

minor revisions to be used sooner than

would be possible under the current

regulations. A definition of ‘‘master

label’’ would be added to the

regulations. The amendments are

necessary in order to improve label

approval procedures by establishing a

master label system. The effect of the

amendment would be to steamline the

procedure for requesting and receiving

approval to use new or revised labels for

veterinary biologicals.

We solicited comments concerning

our proposal for 60 days ending May 16,

1995. We received six comments by that

date. They were from producers of

veterinary biologics. The comments are

discussed below.

Analysis of Comments and APHIS’

Response

Two commenters supported the

proposed rule without change. Four

commenters commended the agency for

its efforts to streamline and modernize

the labeling regulations.

Two commenters suggested that

changes to the manufacturer’s name and

address should be considered minor

label changes that would allow label use

prior to its submission to and approval

by APHIS. APHIS does not agree with

this comment. A change to the name

and address of the manufacturer is

deemed a major label change. Every

applicant for a veterinary biologics

establishment license must file an

APHIS Form 2001, Application for

United States Veterinary Biologics

Establishment License. The information

required by this form includes the name

and address of the applicant, all

subsidiaries and divisions, and

locations of all premises to be used for

preparation, testing, and initial

shipping. This information is included

in the establishment license when

issued. A change to the name and

address of the manufacturer requires a

new APHIS Form 2001 to be filed (9
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29463

CFR 102.3(a)(6)) to effect a change in the

establishment license before such label

changes would be approved.

Also, the name and address of the

manufacturer provides consumers with

one of the necessary items of

identification of a product if they wish

to file a consumer complaint about a

particular product. APHIS has issued

veterinary biologics establishment

licenses to 114 manufacturers for some

2300 veterinary biological products,

including bacterins, vaccines, and

diagnostic test kits. Consumers report

complaints of veterinary biological

products to the licensee, Veterinary

Biologics Field Operations, other units

within APHIS, and to the U.S.

Practitioners Reporting System of the

American Veterinary Medical

Association. The minimum amount of

information that these entities need to

initiate an investigation of these

complaints is the name and address of

the manufacturer and the name of the

product. For the reasons states above,

this information must first be submitted

to APHIS before such information

appears on the label.

APHIS is aware that mergers and

acquisitions often result in the need to

submit hundreds of new labels to

change the manufacturer’s name and

address. This final rule will reduce the

number of new labels that will need to

be submitted in such cases, but will not

permit the use of such labels until they

have been reviewed and filed by APHIS.

APHIS is aware of the inconvenience

that this may cause, but believes that

this is a necessary requirement. No

change to the regulations is made in

response to this comment.

The same commenter also requested

that changes to the distributor’s name,

address, and phone number be included

under minor label changes. APHIS does

not agree. Products sold through a

distributor are often traced under the

distributor’s name, address, and phone

number. Thus, APHIS should be aware

of and have on file the most current

name, address, and phone number of

distributors of biological products and

not have to wait 60 days for the

submission of this information. No

change is made in response to this

comment.

In addition, the commenter requested

that label changes to type font, font size

(so long as the size change does not

cause any element to overshadow the

true name), and trade name be included

among minor label changes. Again,

APHIS does not agree. Changes to the

type font often lead to a difference in

interpretation of the meaning of

‘‘prominence’’ in that no element on a

label may be more ‘‘prominent’’ than the

true name. Trade names often allow

consumers to recognize a specific

product. Trade names also may suggest

special qualities or ingredients about

products which may render the product

label false or misleading. Thus, APHIS

feels that a pre-review of trade names

will assure that labels are not false and

misleading. Consumer contacts or

reports about biological products are

often based on a product’s trade name.

APHIS is informed of new trade names

through the label approval process. If

new trade names are used on product

labels before approval, APHIS may not

be able to identify the product if the

product becomes involved in a

complaint. No change to the regulations

is made in response to this comment.

One commenter remarked that the

master label concept will lead to the

submission of master labels for all labels

in order to take advantage of the

provision allowing label use prior to

APHIS approval. The commenter

concluded that this would lead to more

paperwork submission for the firm. This

is not the intent of the rule. The

proposed rule may have been drawn too

narrowly in its focus on master labels

and the use of certain labels prior to

approval by APHIS. There is no good

reason why the provision allowing the

use of certain labels prior to APHIS

approval should be restricted to labels

filed as master labels. In response to the

commenter, we are amending the

proposal so that it will apply to either

‘‘approved labels or master labels.’’ The

introductory paragraph in § 112.5 is also

amended to be consistent with this

change. This amendment will make

unnecessary the resubmission of

currently approved labels for reapproval

as master labels to take advantage of the

provision of allowing use prior to

approval, will avoid the additional

paperwork that could result, and is

consistent with our original intent.

One commenter requested that the

rule continue to specify that ‘‘at least’’

a certain number of copies of labels be

submitted for approval since

manufacturers sometimes need

additional approved copies of labels

when machine copies are not

acceptable. In response to this comment,

the proposed rule merely specifies the

minimum number of copies that need to

be submitted to APHIS for review and

approval. APHIS will process additional

copies if requested by a manufacturer.

No change to the regulations is made in

response to this comment.

Finally, one commenter believed that

there was a discrepancy between the

proposed rule and Veterinary Services

Memorandum 800.54, dated August 31,

1988, concerning small labels. APHIS

does not agree. APHIS’ intent in this

rule is to have the master label be based

on the smallest size label that is

identical in text to that of all other size

labels. In the case of labels that are too

small for full instructions for use, these

exceptionally small labels may differ in

text from the labels referred to under the

rule and would not qualify as master

labels. Such labels would be required to

be submitted separately for review. No

change to the regulations is made in

response to this comment.

Therefore, based on the rationale set

forth in the proposed rule and in this

document, we are adopting the

provisions of the proposal as a final

rule, with the changes discussed in this

document.

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.

Pursuant to requirements set forth in

the Regulatory Flexibility Act (5 U.S.C.

601 et seq.), APHIS has considered the

economic impact on small entities.

The rule amends the regulations for

the review and approval of veterinary

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 the smallest size

container label for the product as a

prototype master label would reduce the

need for licensees producing veterinary

biologicals to submit for approval

additional copies of labels for each size

of the product.

The approval of a master label

eliminates the need to submit labels for

larger container sizes of the same

product, provided that such 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 rule also allows certain specified

minor revisions to be made in labels for

products with approved labels or master

labels and the revised labels used

without prior written approval from

APHIS with the provision that new

labels or master labels be submitted to

APHIS for review and approval within

60 days use of the revised label.

One effect of the rule will be to reduce

the number of copies of labels that need

to be submitted and reviewed. Most

biological products are marketed in two

or three different size containers.

Currently, each label for each container
29464 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

must be submitted for approval. Under

the master label system, only labels for

the smallest size container need to be

submitted, thus reducing by two to

three-fold the number of labels that

need to be submitted by manufacturers

for review by APHIS. Another effect will

be to eliminate the delay required in

obtaining APHIS approval prior to the

use of labels with certain specified

minor changes.

The rule will not have any adverse

economic impact since the submission

of product labels for approval is already

required under § 112.5 of the

regulations. Section 112.5 currently

specifies that all labels shall be

reviewed and approved prior to use.

The amendments will simplify the

process of label approvals and reduce

the time and expense needed to get a

product to market, particularly 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 will not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12778

This final rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. It is not intended to

have retroactive effect. This rule would

not preempt any State or local laws,

regulations, or policies, unless they

present an irreconcilable conflict with

this rule. There are no administrative

procedures which must be exhausted

prior to a judicial challenge to the

provisions of this rule.

Paperwork Reduction Act

In accordance with the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.), the information collection or

recordkeeping requirements included in

this rule have been approved by the

Office of Management and Budget

(OMB), and there are no new

requirements. The assigned OMB

control number is 0579–0013.

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

are amended as follows:

PART 101—DEFINITIONS

1. The authority citation for part 101

continues to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.22,

2.80, and 371.2(d).

2. Section 101.4 is 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—PACKING AND LABELING

3. The authority citation for part 112

continues to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.22,

2.80, and 371.2(d).

4. Section 112.5 is amended as

follows:

a. The introductory text is revised to

read as set forth below.

b. Paragraph (c) is revised to read as

set forth below.

c. Paragraphs (d)(1) is revised.

d. Paragraph (d)(2)(iii)(a) is revised to

read as set forth below.

e. Paragraph (d)(3)(ii)(a) is revised to

read as set forth below.

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

redesignated paragraph (d)(2)(iii)(B),

paragraph (d)(3)(i)(a) is redesignated

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

(d)(3)(i)(b) is redesignated paragraph

(d)(3)(i)(B), and paragraph (d)(3)(ii) is

revised to read as set forth below.

g. Paragraph (d)(3)(iii) is revised to

read as set forth below.

h. Paragraph (d)(4) is revised to read

as set forth below.

i. Paragraph (g) is added to read as set

forth below.

j. Section 112.5 is amended by adding

at the end of the section an OMB control

number as set forth below.

§ 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 as provided in

paragraph (c) of this section and under

the master label system provided in

paragraph (d) 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 labels or master labels, and

the revised labels may be used prior to

review by APHIS, with the provision

that a new label or 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 labels or 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 control

numbers of 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
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29465

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 for 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 llllll.

(ii) Replacement for label, master

label, and/or sketch No. llllll.

(iii) Reference to label or master label

No. llllll.

(iv) Addition to label No.

llllll.

(v) License Application Pending

llllll.

(vi) Foreign Language copy of Label

No. llllll.

* * * * *

(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).

(Approved by the Office of Management and

Budget under control number 0579–0013)

5. In § 112.7, paragraphs (c)(2) and

(d)(6) are revised to read 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, paragraph (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, paragraph (b) or

(c), or both.

* * * * *

§ 112.7 [Amended]

6. Section 112.7 is amended by

adding at the end of the section the

following: ‘‘(Approved by the Office of

Management and Budget under control

number 0579–0013).’’

Done in Washington, DC, this 5th day of

June 1996.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 96–14772 Filed 6–10–96; 8:45 am]

BILLING CODE 3410–34–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 96–NM–112–AD; Amendment

39–9656; AD 96–12–13]

RIN 2120–AA64

Airworthiness Directives; Dornier

Model 328 Series Airplanes Equipped

with Honeywell GP–300 Guidance and

Display Controller

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; request for

comments.

SUMMARY: This amendment adopts a

new airworthiness directive (AD) that is

applicable to certain Dornier Model 328

series airplanes. This action requires

modification of certain Honeywell GP–

300 guidance and display controllers.

This amendment is prompted by reports

of smoke and fumes, due to a defective

light bulb, emitting from the Honeywell

GP–300 guidance and display

controller; and a report of failure of the

autopilot to disconnect manually. The

actions specified in this AD are

intended to prevent a defective light

bulb from causing a short circuit that

emits smoke and fumes into the cockpit;

or causing damage to the circuit cards

and various components, which may

lock the autopilot into the engaged

mode. Locking of the autopilot into the

engaged mode could lead to the

inability of the pilot to disconnect the

autopilot, which could result in reduced

controllability of the airplane.

DATES: Effective June 26, 1996.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of June 26,

1996.

Comments for inclusion in the Rules

Docket must be received on or before

August 12, 1996.