Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Proposed Rules 40489

1701 Columbia Avenue, College Park,

Georgia 30337, telephone (404) 305–

5586.

FOR FURTHER INFORMATION CONTACT:

Wade Carpenter, Airspace Branch, Air

Traffic Division, Federal Aviation

Administration, P.O. Box 20636,

Atlanta, Georgia 30320; telephone (404)

305–5581.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested parties are invited to

participate in this proposed rulemaking

by submitting such written data, views

or arguments as they may desire.

Comments that provide the factual basis

supporting the views and suggestions

presented are particularly helpful in

developing reasoned regulatory

decisions on the proposal. Comments

are specifically invited on the overall

regulatory, aeronautical, economic,

environmental, and energy-related

aspects of the proposal.

Communications should identify the

airspace docket number and be

submitted in triplicate to the address

listed above. Commenters wishing the

FAA to acknowledge receipt of their

comments on this notice must submit

with those comments a self-addressed,

stamped postcard on which the

following statement is made:

‘‘Comments to Airspace Docket No. 97–

ASO–10.’’ The postcard will be date/

time stamped and returned to the

commenter. All communications

received before the specified closing

date for comments will be considered

before taking action on the proposed

rule. The proposed contained in this

notice may be changed in light of

comments received. All comments

submitted will be available for

examination in the Office of the

Assistant Chief Counsel for Southern

Region, Room 550, 1701 Columbia

Avenue, College Park, Georgia 30337,

both before and after the closing date for

comments. A report summarizing each

substantive public contract with FAA

personnel concerned with this

rulemaking will be filed in the docket.

Availability of NPRMs

Any person may obtain a copy of this

Notice of Proposed Rulemaking (NPRM)

by submitting a request to the Federal

Aviation Administration, Manager,

Airspace Branch, ASO–520, Air Traffic

Division, P.O. Box 20636, Atlanta,

Georgia 30320. Communications must

identify the notice number of this

NPRM. Persons interested in being

placed on a mailing list for future

NPRMs should also request a copy of

Advisory Circular No. 11–2A, which

describes the application procedure.

The Proposal

The FAA is considering an

amendment to Part 71 of the Federal

Aviation Regulations (14 CFR part 71) to

amend the Class E airspace area at

Anniston, AL. GPS RWY 3 and RWY 15

SIAPs have been developed for

Talladega Municipal Airport, and a GPS

RWY 20 SIAP has been developed for

St. Clair County Airport. Additional

controlled airspace extending upward

from 700 feet AGL is needed to

accommodate these SIAPs, and for IFR

operations at these airports and the

Anniston Metropolitan Airport. Class E

airspace designations for airspace areas

extending upward from 700 feet or more

above the surface are published in

Paragraph 6005 of FAA Order 7400.9D

dated September 4, 1996, and effective

September 16, 1996, which is

incorporated by reference in 14 CFR

71.1. The Class E airspace designation

listed in this document would be

published subsequently in the Order.

The FAA has determined that this

proposed regulation only involves an

established body of technical

regulations for which frequent and

routine amendments are necessary to

keep them operationally current. It,

therefore, (1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11034; February

26, 1979); and (3) does not warrant

preparation of a Regulatory Evaluation

as the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule,

when promulgated, will not have a

significant economic impact on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act.

List of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (Air).

The Proposed Amendment

In consideration of the foregoing, the

Federal Aviation Administration

proposes to amend 14 CFR Part 71 as

follows:

PART 71—[AMENDED]

1. The authority citation for Part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g); 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of Federal Aviation

Administration Order 7400.9D, Airspace

Designations and Reporting Points,

dated September 4, 1996, and effective

September 16, 1996, is amended as

follows:

Paragraph 6005 Class E airspace areas

extending upward from 700 feet above the

surface of the earth.

* * * * *

ASO AL E5 Anniston, AL [Revised]

Anniston Metropolitan Airport, AL

(lat. 33°35′17′′ N, long. 85°51′29′′ W)

Talladega Municipal Airport

(lat. 33°34′12′′ N, long. 86°03′04′′ W)

St. Clair County Airport

(lat. 33°33′32′′ N, long. 86°14′57′′ W)

That airspace extending upward from 700

feet above the surface within a 12-mile radius

of Anniston Metropolitan Airport and within

a 9.5-mile radius of Talladega Municipal

Airport and within a 11.5 mile radius of St.

Clair County Airport, excluding that airspace

within Restricted Area R–2101 when the

restricted area is active.

* * * * *

Issued in College Park, Georgia, on July 15,

1997.

Wade T. Carpenter,

Acting Manager, Air Traffic Division,

Southern Region.

[FR Doc. 97–19859 Filed 7–28–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 97N–0300]

Current Good Manufacturing Practice

in Manufacturing, Processing, Packing,

or Holding of Drugs; Revision of

Certain Labeling Controls

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the packaging and labeling

control provisions of the current good

manufacturing practice (CGMP)

regulations for human and veterinary

drug products by limiting the

application of special control

procedures for the use of cut labeling to

immediate container labels, individual

unit cartons, or multiunit cartons

containing immediate containers that

are not packaged in individual unit

cartons. FDA is also proposing to permit

the use of any automated technique,
40490 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Proposed Rules

including differentiation by labeling

size and shape, that physically prevents

incorrect labeling from being processed

by labeling and packaging equipment

when cut labeling is used. This action

is intended to protect consumers from

labeling errors more likely to cause

adverse health consequences, while

eliminating the regulatory burden of

applying the rule to labeling unlikely to

reach or adversely affect consumers.

This action is also intended to permit

manufacturers to use a broader range of

error prevention and labeling control

techniques.

DATES: Comments by October 27, 1997.

FDA proposes that any final rule that

may issue based on this proposal

become effective 6 months after its date

of publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville MD 20857.

FOR FURTHER INFORMATION CONTACT:

Thomas C. Kuchenberg, Center for

Drug Evaluation and Research

(HFD–7), 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

5621 (Internet electronic mail:

kuchenbergt@cder.fda.gov); or

Paul J. Motise, Center for Drug

Evaluation and Research (HFD–

325), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–

1089 (Internet electronic mail:

motise@cder.fda.gov).

SUPPLEMENTARY INFORMATION:

I. Background

Persistent problems with drug

product mislabeling and subsequent

recalls in the late 1980’s led FDA to

review labeling procedures and product

recalls. The review identified gangprinted or cut labeling as a leading

cause of labeling mixups. Gang-printed

labeling is defined in 21 CFR

210.3(b)(22) as labeling derived from a

sheet of material on which more than

one item of labeling is printed. Each

sheet includes labeling for a variety of

products and, because of this, labeling

for individual drug products must be

‘‘cut’’ or separated from the labeling for

other products. Cut labeling for

individual drug products is commonly

placed in separate stacks before being

transported to packaging and labeling

lines for application to appropriate

products. FDA found that stacks of

labeling of similar size, shape, and color

could easily be intermixed and, if the

error was not detected by the printer or

manufacturer, incorrect labeling could

be applied and a mislabeled drug

product distributed.

To reduce the frequency and

likelihood of such mislabeling, FDA, in

the Federal Register of August 3, 1993

(58 FR 41348), amended the packaging

and labeling control provisions of the

CGMP regulations in part 211 (21 CFR

part 211) to provide specific conditions

for the use of all gang-printed or cut

labeling (hereinafter referred to as the

1993 final rule). Under § 211.122(g),

packaging and labeling operations must

use one of three special control features

if cut labeling is used. Packaging and

labeling lines must be dedicated to each

different strength of each different drug

product, appropriate electronic or

electromechanical equipment must be

used to conduct a 100-percent

examination for correct labeling during

or after completion of finishing

operations, or, where labeling is handapplied, a 100-percent visual inspection

must be conducted by one person and

independently verified by a second

person. Appropriate electronic or

electromechanical equipment typically

consists of systems that scan identity

codes printed on the labeling. If the

wrong code is detected, the incorrect

labeling is ejected from the labeling line.

To further limit the potential for

mislabeling, FDA also required written

procedures for the identification and

handling of filled drug product

containers not immediately labeled

(§ 211.130(b)). FDA also amended

§ 211.125(c) to exempt manufacturers

that use automated 100-percent

examination for correct labeling from

the label reconciliation requirements.

The 1993 final rule applied to all

types of labeling including product

inserts, multiunit containers packaged

in individual containers, and shipping

containers.

In May 1994, FDA received two

citizen petitions from several trade

associations requesting that the agency

extend the effective date of the rule and

reopen the administrative record to

receive additional comments on the

application of § 211.122(g) to items of

labeling other than the immediate

container label. The petitions stated that

additional time was needed to obtain,

install, or validate equipment necessary

to comply with the rule. The citizen

petitions also contended that the final

rule inappropriately expanded the scope

of § 211.122(g) from immediate

container labels to all drug product

labeling.

In the Federal Register of August 2,

1994 (59 FR 39255), FDA extended the

compliance date for § 211.122(g) as it

applies to labeling other than immediate

container labels, and opened the

administrative record through October

4, 1994, for comments on the scope of

§ 211.122(g). All other provisions of the

final rule became effective on August 3,

1994. FDA further extended the

compliance date to August 2, 1996, in

the Federal Register of April 28, 1995

(60 FR 20897), and to August 1, 1997,

in the Federal Register of July 19, 1996

(61 FR 37679).

Elsewhere in this issue of the Federal

Register, FDA is announcing a

continuation of the partial extension of

the compliance date until the effective

date of the regulation finalizing this

proposed rule.

FDA received 14 comments during

the extended comment period. Those

comments that addressed the scope of

§ 211.122(g) are discussed below:

Concerning the question of whether

§ 211.122(g) should be applied to items

of labeling other than the immediate

container label, most comments favored

restricting application of the regulation

either to immediate container labels or

to some category or subset of overall

product ‘‘labeling.’’ Several comments

requested that manual differentiation by

size, shape, and color as well as other

validated labeling control methods be

added to the list of special control

procedures listed in § 211.122(g). One

comment asserted that specifying the

use of electronic or electromechanical

methods as a special control procedure

unnecessarily limits the options of firms

packaging pharmaceuticals. A number

of comments stated that, with

appropriate controls, the use of size,

shape, or color differentiation as a

manual labeling control measure is

adequate to prevent labeling mixups. A

number of comments asked for

clarification as to which types of cut

labeling would require the use of an

automated verification system. Some

comments requested exemptions for

specific labeling. One comment

requested that hand-labeling operations

be specifically excluded from the

requirement for electronic inspection,

regardless of the volume of the

manufacturing operation, if labeling is

inspected manually. Another comment

recommended procedures to be used

when cut labeling is applied to dosageform packages assembled in stages.

In light of comments received during

the extended comment period, FDA

held a number of meetings with

representatives of the labeling industry

and others to examine control options

available through current technology.

After evaluating the comments,

reviewing the recall data, and surveying

packaging and labeling control

technology, FDA has determined that

the scope of § 211.122(g) should be
Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Proposed Rules 40491

1Unless ordered by a court, a drug recall is a

voluntary action whereby manufacturers remove

from the market drugs that are found by FDA to be

marketed in violation of laws administered by the

agency.

Under FDA’s current policy, the agency assigns

a numerical designation to each product recall to

indicate the relative degree of hazard presented by

the product being recalled. A Class I recall involves

the greatest potential health threat and a Class III

recall involves the least serious health threat.

narrowed and the permissible control

procedures expanded. FDA is proposing

to limit the scope of the cut labeling

provision to immediate container labels,

individual unit cartons, or multiunit

cartons containing immediate

containers that are not packaged in

individual unit cartons. FDA is also

proposing to expand the permissible

control procedures to include the use of

any automated technique, including

differentiation by labeling size and

shape, that physically prevents incorrect

labeling from being processed by

labeling and packaging equipment.

II. Description of the Proposed Rule

A. Scope

The first sentence of current

§ 211.122(g) states: ‘‘If cut labeling is

used, packaging and labeling operations

shall include one of the following

special control procedures’’.

FDA is proposing to limit the scope of

§ 211.122(g) by revising this sentence to

state: ‘‘If cut labeling is used for

immediate container labels, individual

unit cartons, or multiunit cartons

containing immediate containers that

are not packaged in individual unit

cartons, packaging and labeling

operations shall include one of the

following special control procedures’’.

FDA’s main concern in proposing

controls for cut labeling is to reduce the

public health and safety risk stemming

from drug product labeling mixups. The

petitions and comments on the scope of

§ 211.122(g) asserted that the economic

burden on industry would be great if the

provision applied to all labeling, and

questioned whether including such

types of labeling as shipping cartons,

that are unlikely to be read by

consumers, would provide any

significant additional protection to

public health and safety.

FDA has examined these comments

and other information and agrees that

the greater the likelihood that

consumers will read incorrect labeling

information, the greater the danger that

the drug product will be used according

to the mislabeled instructions. Thus, the

immediate container label poses the

most obvious threat. In addition,

individual unit carton labeling could

pose an equal danger because it is the

outermost container in which a drug

product is commonly marketed at retail

and many consumers read this labeling

when deciding whether to purchase a

product. Moreover, because the

individual unit carton labeling may be

in a larger type or otherwise easier to

read than the immediate container label,

consumers may keep the carton and

refer to it when using the drug product.

A similar concern applies to multiunit

cartons containing immediate

containers that are not packaged in

individual unit cartons (e.g., sterile

dosage forms in tray packs in which

immediate containers lack unit cartons),

because consumers and health

professionals are more likely to rely on

labeling on the outer multiunit

container than to examine the labeling

on the individual drug product

immediate containers. In deciding

whether to limit the scope of the

labeling control provisions, FDA

reviewed recall data to determine the

danger to consumers from errors in

different types of drug product

labeling.1 This examination indicated

that there have been Class I and Class

II recalls involving immediate

containers, individual unit cartons

containing the drug product in its

immediate container, and multiunit

cartons containing immediate

containers that are not packaged in

individual unit cartons. Recalls due to

the use of the wrong inserts or outserts

(printed information about a drug

product attached to the exterior of the

product) and recalls of multiunit or

shelf-pack containers holding unit

cartons, shipping or intermediate

containers, and shipping cases have all

been designated as Class III recalls, i.e.,

situations in which the labeling error is

generally not likely to cause adverse

health consequences.

Therefore, FDA is proposing that the

control procedures specified in

§ 211.122(g) apply only to immediate

container labels, individual unit

cartons, or multiunit cartons containing

immediate containers that are not

packaged in individual unit cartons.

This action is intended to protect

consumers from labeling errors that are

more likely to cause adverse health

consequences, while eliminating the

regulatory burden of applying the rule

to labeling unlikely to reach or

adversely affect consumers. The

proposal is also intended to eliminate

any confusion about the scope of the cut

labeling control provisions and allow an

additional opportunity for public

comment.

Although a number of types of

labeling would not be subject to this

proposed rule, it is important to note

that any labeling mixup can result in a

misbranded drug product. FDA

encourages manufacturers to take steps

to protect the integrity of their labeling

operations. Although not proposed in

this rulemaking, FDA encourages firms

to: (1) Convert all articles of cut labeling

to roll labeling where possible (such as

the use of roll inserts or roll label/insert

combinations); (2) use online printing

methods; or (3) adopt 100-percent

automated verification systems for all

items of cut labeling.

B. Special Control Procedures

Under § 211.122(g)(1), (g)(2), and

(g)(3), packaging and labeling operations

must include one of the following

special control procedures when cut

labeling is used: (1) Dedication of

labeling and packaging lines to each

different strength of each different drug

product; (2) use of appropriate

electronic or electromechanical

equipment to conduct a 100-percent

examination for correct labeling during

or after completion of finishing

operations; or (3) use of visual

inspection to conduct a 100-percent

examination for correct labeling during

or after completion of finishing

operations for hand-applied labeling.

FDA is proposing to add a fourth

special control procedure at

§ 211.122(g)(4): ‘‘Use of any automated

technique, including differentiation by

labeling size and shape, that physically

prevents incorrect labeling from being

processed by labeling and packaging

equipment.’’ FDA is proposing this

additional control procedure because

the agency believes that a number of

other automated techniques will also

physically prevent incorrect labeling

from being processed by packaging and

labeling equipment, and would provide

manufacturers with the widest possible

latitude in selecting appropriate labeling

control technologies. A labeling control

method using size and shape as part of

an automated technique that prevents

incorrect labeling from being processed

by labeling and packaging lines

provides the same labeling control

protection, through prevention, as do

the other special control procedures

through surveillance or dedication of

labeling and packaging lines. An

acceptable automated technique would

allow labeling and packaging operations

to operate only if correct labeling

unique to a given product (e.g., a

specific size) is used.

FDA notes, however, that

nonautomated (i.e., manual)

differentiation of size and shape as a

labeling control does not provide

adequate protection from labeling

mixups. It is the increased opportunity
40492 Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Proposed Rules

for human error afforded by the process

of cutting, sorting, and subsequent

handling of different items of labeling

from gang-printed materials that has

caused labeling mixups and recalls. One

of the goals of this proposed rulemaking

is to reduce the likelihood for such

human error through the use of

automated labeling control systems.

III. Environmental Impact

The agency has determined under 21

CFR 25.24 (a) (10) 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.

IV. Analysis of Impacts

FDA has examined the impacts 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 (2

U.S.C. 1532). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order.

The proposed rule substantially

reduces the scope of the 1993 final rule,

which applied to all cut labeling, so that

the proposed rule only applies to cut

labeling for immediate container labels,

individual unit cartons, or multiunit

cartons containing immediate

containers that are not packaged in

individual unit cartons. This proposed

rule also increases flexibility for firms

selecting special labeling control

procedures by adding a provision for the

use of any automated technique,

including differentiation by size and

shape, that physically prevents incorrect

labeling from being processed by

labeling and packaging equipment.

Therefore this proposed rule is expected

to have a positive economic impact on

drug manufacturers that would

otherwise be subject to the more

stringent requirements under current

regulations.

Mislabeled drug products may pose a

threat to public health, lead to

extremely costly product recalls, and

create significant product liability. As a

result, FDA believes that a large number

of firms already use the labeling control

procedures proposed in this rulemaking.

The agency concludes that the proposed

rule is not a major rule as defined in

Executive Order 12866 because the

labeling control revisions significantly

reduce the scope of the current rule and

provide manufacturers with greater

flexibility in selecting special control

procedures if cut labeling is used.

Further, the agency certifies that the

proposed rule is not expected to have a

significant economic impact on a

substantial number of small entities, as

defined by the Regulatory Flexibility

Act.

The Unfunded Mandates Reform Act

requires that agencies prepare an

assessment of anticipated costs and

benefits before proposing any rule that

may result in an annual expenditure by

State, local and tribal governments, in

the aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation). Because this proposed rule

will not impose a cost of $100 million

or more on any governmental entity or

the private sector, no budgetary impact

statement is required.

V. Request for Comments

Interested persons may, on or before

October 27, 1997, submit to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, 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.

List of Subjects in 21 CFR Part 211

Drugs, Labeling, Laboratories,

Packaging and containers, Prescription

drugs, Reporting and recordkeeping

requirements, Warehouses.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 211 be amended as follows:

PART 211—CURRENT GOOD

MANUFACTURING PRACTICE FOR

FINISHED PHARMACEUTICALS

1. The authority citation for 21 CFR

part 211 continues to read as follows:

Authority: Secs. 201, 501, 502, 505, 506,

507, 512, 701, 704 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 321, 351, 352,

355, 356, 357, 360b, 371, 374).

2. Section 211.122 is amended by

revising the introductory text of

paragraph (g) and by adding new

paragraph (g)(4) to read as follows:

§ 211.122 Materials examination and usage

criteria.

* * * * *

(g) If cut labeling is used for

immediate container labels, individual

unit cartons, or multiunit cartons

containing immediate containers that

are not packaged in individual unit

cartons, packaging and labeling

operations shall include one of the

following special control procedures:

* * * * *

(4) Use of any automated technique,

including differentiation by labeling

size and shape, that physically prevents

incorrect labeling from being processed

by labeling and packaging equipment.

* * * * *

Dated: July 22, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–19817 Filed 7-28-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 17

RIN 2900–AI84

Grants to States for Construction or

Acquisition of State Home Facilities

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

SUMMARY: This document proposes to

amend the ‘‘Medical’’ regulations in 38

CFR part 17 regarding applications for

grants to States for the construction or

acquisition of State home facilities. VA

awards grants based on a priority

ranking system. Usually, the higher

priority applications deplete the

available funding to the extent that the

lowest ranking application to be offered

funding is offered only a partial grant.

It is proposed that if the lowest ranking

grant application receives only a partial

grant in a fiscal year and if such grant

award is partial solely because VA has

insufficient funds for a full grant, the

application would be placed at the top

of the list within its priority group for

the next fiscal year. Often applicants are

hesitant to accept a partial grant because

of the uncertainty of receiving an

additional grant the next fiscal year. It

appears that the adoption of the

proposal would encourage States to

accept a partial grant by creating the

likelihood that the State would receive

an additional grant in the subsequent