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
Federal Register / Vol. 62, No. 145 / Tuesday, July 29, 1997 / Proposed Rules 40493

fiscal year. Accordingly, this would

help ensure that VA would be able to

award grants to higher priority

applicants that might otherwise reject

partial funding.

Also, it is proposed that the applicant

receiving partial funding and receiving

priority as proposed would not be

required to submit a second application

for additional funds in the subsequent

fiscal year, but could be required to

update information already submitted. It

appears that the first application would

normally be adequate because the grant

award in the second fiscal year would

be for the same project which received

the partial grant award.

Further, under the proposal, the total

amount awarded for the application

could not exceed 65 percent of the total

cost of the project as determined at the

time of the second grant award for that

grant application. This is consistent

with the statutory requirement that

limits grant awards to no more than 65

percent of the estimated cost of

construction or acquisition.

DATES: Comments must be received on

or before September 29, 1997.

ADDRESSES: Mail or hand deliver written

comments to: Director, Office of

Regulations Management (02D),

Department of Veterans Affairs, 810

Vermont Avenue, NW, Room 1154,

Washington, DC 20420. Comments

should indicate that they are submitted

in response to ‘‘RIN 2900–AI84.’’ All

written comments received will be

available for public inspection at the

above address in the Office of

Regulations Management, Room 1158,

between the hours 8:00 a.m. and 4:30

p.m., Monday through Friday (except

holidays).

FOR FURTHER INFORMATION CONTACT: Ms.

Kathleen Greve, Geriatrics and Extended

Care Strategic Healthcare Group, (202)

273–8534.

SUPPLEMENTARY INFORMATION: The

Secretary hereby certifies that the

adoption of this proposed rule would

not have a significant economic impact

on a substantial number of small entities

as they are defined in the Regulatory

Flexibility Act, 5 U.S.C. 601–612. The

rule would affect grants to States and

would not directly affect small entities.

Therefore, pursuant to 5 U.S.C. 605(b),

this rule would be exempt from the

initial and final regulatory flexibility

analyses requirements of sections 603

and 604.

The Catalog of Federal Domestic

Assistance program number for this

document is 64.005.

List of Subjects in 38 CFR Part 17

Administrative practice and

procedure, Alcohol abuse, Alcoholism,

Claims, Drug abuse, Foreign relations,

Government contracts, Grant programshealth, Grant programs-veterans, Health

care, Health facilities, Health

professions, Health records, Homeless,

Medical and dental schools, Medical

devices, Medical research, Mental

health programs, Nursing homes,

Philippines, Reporting and

recordkeeping requirements,

Scholarships and fellowships, Travel

and transportation expenses, Veterans.

Approved: July 17, 1997.

Hershel W. Gober,

Acting Secretary of Veterans Affairs.

For the reasons set forth in the

preamble, 38 CFR part 17 is proposed to

be amended as set forth below:

PART 17—MEDICAL

1. The authority citation for part 17

continues to read as follow:

Authority: 38 U.S.C. 501, 1721, unless

otherwise noted.

2. In § 17.212, paragraph (d) is added

immediately before the section authority

citation following paragraph (c) to read

as follows:

§ 17.212 Scope of grants program.

* * * * *

(d)(1) Notwithstanding paragraph (c)

of this section and the provisions for

ranking projects within a priority group

in § 17.213(c)(3)(i), the Secretary shall

give an application first priority within

the priority group to which it is

assigned on the list of projects

established under § 17.213(d) for the

next fiscal year if:

(i) the State has accepted a grant for

that application as of August 15 of the

current fiscal year that is less than the

amount that the Secretary would have

awarded if VA had had sufficient grant

funds to award the grant in such amount

in that fiscal year; and

(ii) the application is the lowest

ranking application on the priority list

for the current fiscal year for which

grant funds are available as of August 15

of that year.

(2) The Secretary shall not require a

State to submit a second grant

application for a project which receives

priority under paragraph (1) of this

section but may require the State to

update information already submitted in

the application for the project. The

Secretary shall determine the amount of

a second grant at the time of the award

of that grant. In no case shall the total

amount awarded for the application

exceed 65 percent of the total cost of the

project as determined at the time of the

second grant award for that grant

application.

* * * * *

[FR Doc. 97–19855 Filed 7–28–97; 8:45 am]

BILLING CODE 8320–01–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[TN189–1–9730(b); TN194–1–9731(b);

TN198–1–9732(b); FRL–5859–6]

Approval of Revisions to the

Tennessee SIP Regarding Prevention

of Significant Deterioration and

Volatile Organic Compounds

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is approving

miscellaneous revisions to the

Tennessee State Implementation Plan

(SIP) regarding prevention of significant

deterioration (PSD) and volatile organic

compounds (VOC). The revisions to the

PSD regulation add an additional

supplement to the EPA ‘‘Guideline on

Air Quality Models’’. The revisions to

the VOC regulation make minor changes

to the regulation for the manufacture of

high-density polyethylene,

polypropylene and polystyrene resins

and to the regulation containing test

methods and compliance procedures for

VOC sources. In the final rules section

of this Federal Register, the EPA is

approving the submitted chapter in its

entirety as a direct-final rule without

prior proposal because the EPA views

this as a noncontroversial revision and

anticipates no adverse comments. A

detailed rationale for the approval is set

forth in the direct final rule. If no

adverse comments are received in

response to this proposed rule, no

further activity is contemplated in

relation to this proposed rule. If EPA

receives adverse comments, the direct

final rule will be withdrawn and all

public comments received will be

addressed in a subsequent final rule

based on this proposed rule. The EPA

will not institute a second comment

period on this document. Any parties

interested in commenting on this

document should do so at this time.

DATES: To be considered, comments

must be received by August 28, 1997.

ADDRESSES: Written comments on this

action should be addressed to William

Denman at the Environmental

Protection Agency, Region 4 Air

Planning Branch, 61 Forsyth Street, SW,