19846 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Rules and Regulations

Capacity

Range of estimated annual

energy consumption

(kWh/yr.)

Low High

Compact:

Top Loading .................. 607 1,226

Front Loading ................ (1) (1)

Standard:

Top Loading .................. 603 1,818

Front Loading ................ 306 395

1 No data submitted.

By direction of the Commission.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 95–9930 Filed 4–20–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 206

[Docket Nos. 88P–0380 and 89P–0163]

Imprinting of Solid Oral Dosage Form

Drug Products for Human Use;

Clarification

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; clarification.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations requiring the imprinting of

solid oral dosage form drug products for

human use. This final rule clarifies

FDA’s intent regarding the effective date

for drug products introduced or

delivered for introduction into interstate

commerce.

DATES: Effective September 13, 1995;

written comments by July 20, 1995.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Deborah A. Wolf, Center for Drug

Evaluation and Research (HFD–362),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–1046.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

13, 1993 (58 FR 47948), FDA published

a final rule requiring the imprinting of

all solid oral dosage form drug products

for human use. The regulation requires

that all drugs covered by it bear an

imprint that will permit the

identification of the drug product,

including its active ingredients and

dosage strength, and its manufacturer or

distributor. The regulation was based on

a proposed rule that was published in

the Federal Register of May 15, 1991 (56

FR 22370). The preamble to the

proposed rule stated that, among other

things, any final rule based on the

proposal would become effective 1 year

after its date of publication in the

Federal Register. The preamble also

stated that any drug product subject to

the requirements of this rule that is

‘‘introduced or delivered for

introduction into interstate

commerce’’after the effective date would

be deemed to be adulterated,

misbranded, or an unapproved new

drug, unless it is imprinted in

compliance with the regulation (see 56

FR 22370 at 22375 (emphasis added)).

Under the proposed rule, FDA intended

the rule to be effective for drug products

entering interstate commerce at the

manufacturing level 1 year after the date

of publication of a final rule in the

Federal Register.

In response to the proposed rule,

many drug companies commented that

1 year was insufficient time to comply

with the requirements of the rule.

Industry comments indicated that it

would take longer than 1 year for

equipment retooling and product

imprinting.

In response to industry’s concerns,

FDA provided for an implementation

period of 2 years. The agency intended

to provide an effective date of

September 13, 1995, which is 2 years

after its date of publication in the

Federal Register.

However, in revising the final rule to

provide for a 2-year implementation

period, the agency inadvertently

replaced the reference to drug products

‘‘introduced or delivered for

introduction into interstate commerce’’

with a reference to drug products

‘‘distributed in interstate commerce’’

(see 58 FR 47948 at 47950) (emphasis

added). This change created the

misimpression that FDA intended the

rule to apply to drug products

distributed by manufacturers, repackers,

and retail distributors, thereby

increasing, rather than decreasing, the

burden on the pharmaceutical industry.

FDA has received inquires expressing

concern that FDA intended to initiate

recall actions at the retail level because

‘‘distribution’’ would include sale at

that level.

This final rule amends 21 CFR

206.10(a) by replacing the language

‘‘distributed in interstate commerce’’

with ‘‘introduced or delivered for

introduction into interstate commerce.’’

This will clarify the requirements of the

rule as it pertains to products in

interstate commerce.

Because this amendment to the

imprinting regulations makes only a

change necessary to conform the rule to

FDA’s original intention as stated in the

preamble to the proposed rule and to be

consistent with the agency’s intent to

provide a 2-year implementation period

as provided for in the final rule, notice

and public procedure are unnecessary.

FDA finds that there is good cause to

dispense with notice of proposed

rulemaking, pursuant to 5 U.S.C.

553(b)(3)(B). FDA is therefore

publishing this revision as a final rule

effective September 13, 1995. However,

the agency is giving interested persons

90 days to comment on this final rule.

II. Request for Comments

Interested persons may, on or before

July 20, 1995, submit to the Dockets

Management Branch (address above)

written comments regarding this final

rule. 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 206

Drugs.

PART 206—IMPRINTING OF SOLID

ORAL DOSAGE FORM DRUG

PRODUCTS FOR HUMAN USE

1. The authority citation for 21 CFR

part 206 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 505,

507, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

355, 357, 371); sec. 351 of the Public Health

Service Act (42 U.S.C. 262).

2. Section 206.10 is amended by

revising the first sentence of paragraph

(a) to read as follows:

§ 206.10 Code imprint required.

(a) Unless exempted under § 206.7,

no drug product in solid oral dosage

form may be introduced or delivered for

introduction into interstate commerce

unless it is clearly marked or imprinted

with a code imprint that, in conjunction

with the product’s size, shape, and

color, permits the unique identification

of the drug product and the

manufacturer or distributor of the

product. * * *

* * * * *
Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Rules and Regulations 19847

Dated: April 13, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9951 Filed 4–20–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Office of Justice Programs

Office of Juvenile Justice and

Delinquency Prevention

28 CFR Part 31

[OJP No. 1045]

RIN 1121–AA28

Formula Grants; Correction

Date: April 13, 1995.

AGENCY: Department of Justice, Office of

Justice Programs, Office of Juvenile

Justice and Delinquency Prevention.

ACTION: Correction to final regulation.

SUMMARY: This document contains

corrections to the Final Regulation,

revising 28 CFR part 31, which was

published in the Federal Register on

Friday, March 10, 1995, (60 FR 13330).

The regulation revisions provided

clarification and guidance to States in

the formulation, submission and

implementation of the State Formula

Grants Program under Part B of Title II

of the Juvenile Justice and Delinquency

Act of 1974, as amended by the Juvenile

Justice and Delinquency Prevention

Amendments of 1992 (Pub. L. 102–586,

November 18, 1992).

The 1992 Amendments reauthorize

and modify the Federal assistance

program to State, local governments,

and private not-for-profit agencies for

the prevention and control of

delinquency and improvement of the

juvenile justice system. This final

revision to the existing regulation

provides clarification and guidance to

States in the formulation, submission,

and implementation of State Formula

Grants Program plans and

determinations of State compliance with

plan requirements. It provides

additional flexibility and guidance to

participating States while strengthening

several key provisions related to the

deinstitutionalization, separation, jail

and lockup removal, and

disproportionate minority confinement

plan requirements of the JJDP Act.

EFFECTIVE DATE: This regulation is

effective March 10, 1995.

FOR FURTHER INFORMATION CONTACT:

Roberta Dorn, Director, State Relations

and Assistance Division, Office of

Juvenile Justice and Delinquency

Prevention (OJJDP), 633 Indiana Avenue

NW., Room 543, Washington, D.C.

20531; (202) 307–5924.

SUPPLEMENTARY INFORMATION: The

corrections include the requirement that

collocated juvenile detention facilities

approved by the State and concurred

with by OJJDP on or before June 30,

1995, be reviewed against the regulatory

criteria and OJJDP policies in effect at

the time of the initial approval and

concurrence. Facilities approved after

the effective date of this regulation and

prior to July 1, 1995, will be reviewed

against the regulatory criteria in effect

on the day before the effective date of

this regulation. For those collocated

juvenile detention facilities considered

after June 30, 1995, OJJDP’s concurrence

is limited to one year and, thereafter,

will be reviewed on an annual basis.

The requirement that in order to receive

OJJDP’s initial and subsequent

concurrences, a collocated juvenile

detention facility must only provide

secure custody for juvenile criminaltype offenders, status offenders accused

of violating a valid court order, and

adjudicated delinquents and valid court

order violators who are awaiting

disposition hearings or transfer to a long

term juvenile correctional facility, has

been eliminated.

Need for Correction

As published in the Federal Register

on March 10, 1995, (60 FR 13330), the

Final Regulation was an earlier draft

version that is materially different from

the final draft that was intended to be

published. These errors are in need of

correction.

Correction of Publication

Accordingly, the Final Regulation, as

published in the Federal Register on

March 10, 1995, which was the subject

of FR Doc. 95–5919, is corrected as

follows:

§ 31.301 [Corrected]

Paragraph 1. On page 13334 in

amendatory instruction 6, paragraph (e)

of § 31.301 was revised. Paragraph (e) of

§ 31.301 in the second column, line 30,

the numerals ‘‘1994’’ are corrected to

read ‘‘1995’’.

§ 31.302 [Corrected]

Paragraph 2. On page 13334 in

amendatory instruction 7, paragraph

(b)(2) of § 31.302 was revised. Paragraph

(b)(2) of § 31.302 is corrected to read as

follows:

* * * * *

(b) * * *

(2) Should consider in meeting the

statutory membership requirements and

responsibilities of section 223(a)(3) (A)–

(E), appointing at least one member who

represents each of the following: A

locally elected official representing

general purpose local government; a law

enforcement officer; representatives of

juvenile justice agencies, including a

juvenile or family court judge, a

probation officer, a prosecutor, and a

person who routinely provides legal

representation to youth in juvenile

court; a public agency representative

concerned with delinquency prevention

and treatment; a representative from a

private, non-profit organization, such as

a parents group, concerned with teenage

drug and alcohol abuse; a high school

principal; a recreation director; a

volunteer who works with delinquent or

at risk youth; a person with a special

focus on the family; a youth worker

experienced with programs that offer

alternatives to incarceration; persons

with special competence in addressing

problems of school violence and

vandalism and alternatives to expulsion

and suspension; and persons with

knowledge concerning learning

disabilities, child abuse and neglect,

and youth violence.

* * * * *

§ 31.303 [Corrected]

Paragraph 3. On page 13335, in the

second column, in amendatory

instruction 11, paragraph (d)(l)(i) of

§ 31.303 was revised. Paragraph (d)(1)(i)

of § 31.303, line ten, the word ‘‘no’’ is

corrected to read ‘‘any’’.

Paragraph 4. On page 13335 in

amendatory instruction 13, paragraph

(e)(3) of § 31.303 was revised. Paragraph

(e)(3) of § 31.303 is corrected by

removing (e)(3)(v). As corrected,

§ 31.303(e)(3) reads as follows:

* * * * *

(e) * * *

(3) Collocated facilities. (i) Determine

whether or not a facility in which

juveniles are detained or confined is an

adult jail or lockup. The JJDP Act

prohibits the secure custody of juveniles

in adult jails and lockups, except as

otherwise provided under the Act and

implementing OJJDP regulations.

Juvenile facilities collocated with these

adult facilities are considered adult jails

or lockups unless the paragraph

(e)(3)(i)(D) (1)–(4) criteria established in

this section are complied with and the

determinations and concurrences set

forth in paragraph (e)(3) (ii), (iii), and

(iv) of this section have been made.

(A) A collocated facility is a juvenile

facility that is located in the same

building as an adult jail or lockup, or is

part of a related complex of buildings

located on the same grounds as an adult

jail or lockup. A complex of buildings