Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63271

amended in paragraph (c) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 520.2380a [Amended]

20. Section 520.2380a Thiabendazole

top dressing and mineral protein feed

block is amended in paragraph (c)(2) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.2380b [Amended]

21. Section 520.2380b Thiabendazole

drench or oral paste is amended in

paragraph (c) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 520.2380c [Amended]

22. Section 520.2380c Thiabendazole

bolus is amended in paragraph (c) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 520.2380d [Amended]

23. Section 520.2380d Thiabendazole,

piperazine citrate suspension is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 520.2380f [Amended]

24. Section 520.2380f Thiabendazole,

piperazine phosphate powder is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

25. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 522.1150 [Amended]

26. Section 522.1150

Hydrochlorothiazide injection is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 522.1192 [Amended]

27. Section 522.1192 Ivermectin

injection is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 522.1193 [Amended]

28. Section 522.1193 Ivermectin and

clorsulon injection is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 522.1452 [Amended]

29. Section 522.1452 Nalorphine

hydrochloride injection is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

§ 522.1885 [Amended]

30. Section 522.1885 Prednisolone

tertiary butylacetate suspension is

amended in paragraph (b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

31. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 524.1193 [Amended]

32. Section 524.1193 Ivermectin pouron is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 524.1484g [Amended]

33. Section 524.1484g Neomycin

sulfate-thiabendazole-dexamethasone

solution is amended in paragraph (b) by

removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 524.1883 [Amended]

34. Section 524.1883 Prednisolone

sodium phosphate-neomycin sulfate

ophthalmic ointment is amended in

paragraph (b) by removing ‘‘000006’’

and adding in its place ‘‘050604’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

35. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.55 [Amended]

36. Section 558.55 Amprolium is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.58 [Amended]

37. Section 558.58 Amprolium and

ethopabate is amended in the table in

paragraph (d)(1), in the ‘‘Limitations’’

column by removing ‘‘000006’’ each

time it appears and adding in its place

‘‘050604’’.

§ 558.95 [Amended]

38. Section 558.95 Bambermycins is

amended in paragraphs (d)(1)(ii)(b),

(d)(1)(iii)(b), (d)(1)(iv)(b), (d)(1)(v)(b),

and (d)(1)(xiii)(b)(2)(iii)(b) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.235 [Amended]

39. Section 558.235 Efrotomycin is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

§ 558.300 [Amended]

40. Section 558.300 Ivermectin is

amended in paragraphs (a)(1) and (a)(2)

by removing ‘‘000006’’ and adding in its

place ‘‘050604’’.

§ 558.615 [Amended]

41. Section 558.615 Thiabendazole is

amended in paragraph (a) by removing

‘‘000006’’ and adding in its place

‘‘050604’’.

Dated: November 10, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–31148 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 96N–0249]

RIN 0910–AB19

Exemption From Preemption of State

and Local Cigarette and Smokeless

Tobacco Requirements; Applications

for Exemption Submitted by Various

State Governments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is granting

exemptions from Federal preemption for

certain cigarette and smokeless tobacco

requirements in Alabama, Alaska, and

Utah. These exemptions will permit

those States to continue to enforce

certain restrictions on the sale and

distribution of cigarettes and smokeless

tobacco that are more stringent than

FDA counterpart restrictions under its

regulations.

EFFECTIVE DATE: December 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Anne M. Kirchner, Office of Policy (HF–

11), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–5321.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 521(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360k(a)), any State or local

requirement applicable to a device is

preempted if such requirement: (1) Is

different from, or in addition to, any

requirement applicable under the act to

the device; and (2) relates to the safety

or effectiveness of the device or any
63272 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

1RCW 26.28.080 Selling or giving tobacco to

minor—Belief of representative capacity, no

defense—Penalty.

Every person who sells or gives, or permits to be

sold or given to any person under the age of

eighteen years any cigar, cigarette, cigarette paper

or wrapper, or tobacco in any form is guilty of a

gross misdemeanor.

It shall be no defense to a prosecution for a

violation of this section that the person acted, or

was believed by the defendant to act, as agent or

representative of another.

2WAC 314-10-050 Sales to persons under 18

years of age.

(1) No person may sell or give or in any way

provide tobacco products to any person under 18

years of age.

(2) Any person attempting to purchase tobacco

products must present identification to show he/she

is at least 18 years of age upon the request of any

tobacco licensee, employee of tobacco licensee or

enforcement officer as defined by RCW 7.8.040.

(3) All identification used to prove age must be

officially issued and contain the bearer’s age,

signature and photograph. The only forms of

identification which are acceptable as proof of age

for the purchase of tobacco products are:

(a) A liquor control authority card of

identification issued by a state of the United States

or province of Canada,

(b) A driver’s license, instruction permit or

identification card issued by a state of the United

States or a province of Canada,

(c) A United States military identification card,

(d) A passport, or

(e) A merchant marine identification card issued

by the United States Coast Guard.

other matter included in a requirement

applicable to the device under the act.

In implementing section 521 of the

act, FDA historically has interpreted

that provision narrowly and has found

it to have preemptive effect only for

those State and local requirements that,

in fact, clearly impose specific

requirements with respect to specific

devices that are manifestly in addition

to analogous Federal requirements (see

§ 808.1(d) (21 CFR 808.1(d)). In

addition, section 521 of the act ‘‘does

not preempt State or local requirements

that are equal to, or substantially

identical to, requirements imposed by or

under the act’’ (§ 808.1(d)(2)).

Section 521(b) of the act and its

implementing regulations provide that

by regulation issued after notice and an

opportunity for an oral hearing, FDA

may exempt a State or local requirement

from preemption under such conditions

as the agency may prescribe if the

requirement is: (1) More stringent than

a requirement under the act that would

be applicable to the device if an

exemption were not in effect; or (2)

required by compelling local conditions

and compliance with the State or local

requirement would not cause the device

to be in violation of any requirement

applicable under the act.

In the Federal Register of November

7, 1996 (61 FR 57685), FDA invited all

State and local governments to submit

applications for exemptions from

preemption for those State and local

requirements pertaining to cigarettes

and smokeless tobacco that are

preempted by the agency’s final rule at

part 897 (21 CFR part 897) restricting

the sale and distribution of cigarettes

and smokeless tobacco to protect

children and adolescents, and that meet

the exemption criteria. In order to

facilitate and expedite review, FDA

stated that it would consider

applications in two groups. Group 1

applications are those seeking

exemptions from Federal preemption of

State and local age and identification

requirements. Group 2 applications are

those seeking exemptions from Federal

preemption of State and local access,

labeling, and advertising requirements.

This final rule responds to Group 1

applications for exemptions from

preemption for State and local

requirements governing the sale and

distribution of cigarettes and smokeless

tobacco that are different from, or in

addition to, FDA requirements under

§ 897.14(a) and (b). Section 897.14(a)

prohibits the sale of cigarettes or

smokeless tobacco to any person under

age 18. Section 897.14(b) requires that

retailers verify, by means of

photographic identification containing

the bearer’s birth date, that the person

purchasing the product is at least 18

years of age. No such verification is

required for persons over the age of 26.

The November 1996, Federal Register

notice stated that Group 1 applications

should be submitted by December 9,

1996, and that Group 2 applications, for

exemption from preemption from any of

the requirements under part 897 other

than § 897.14(a) and (b), should be

submitted by May 6, 1997 (61 FR 57685

at 57686).

In the Federal Register of February

19, 1997 (62 FR 7390), FDA issued a

proposed rule responding to Group 1

applications submitted by the States of

Alabama, Alaska, Utah, and

Washington. The proposal gave the

public 30 days to submit written

comments. The comment period later

was reopened for an additional 2 weeks

(see 61 FR 11349, March 20, 1996).

FDA proposed to grant exemptions

from Federal preemption for

requirements in the States of Alabama,

Alaska, and Utah. Washington State

requirements were not preempted and,

therefore, no exemption needed to be

granted. The Alabama Code, the Alaska

Statutes, and the Utah Code Annotated

prohibit the sale of cigarettes or

smokeless tobacco to any person under

the age of 19. The proposed rule

explained that these requirements are

different from the age restriction

contained in the tobacco rule at

§ 897.14(a), which prohibits sales of

cigarettes or smokeless tobacco to

anyone under age 18. However, the

proposal stated FDA’s tentative

conclusion that the higher minimum age

for sale of these products will provide

increased health benefits and will not

impose significant burdens on retailers.

Therefore, to the extent that these State

requirements are preempted, FDA

proposed to grant them exemptions

from preemption.

II. Request for a Hearing

FDA received one request for a

hearing. Section 521(b) of the act

requires that FDA offer an opportunity

for an oral hearing to present evidence

that the agency should consider before

granting or denying exemptions from

preemption. The request for a hearing

submitted under this rulemaking raised

only legal and policy issues that may be

addressed adequately without holding

an oral hearing. Consequently,

consistent with FDA’s regulation at 21

CFR 12.24(b), FDA is denying the

request. The legal and policy issues

raised in the request for a hearing are

addressed in section III of this

document.

III. Discussion of Comments

FDA received no comments about the

agency’s action concerning the

application submitted by the State of

Washington for exemption from Federal

preemption for: (1) Section 26.28.080 of

the Revised Code of Washington

(RCW)1, a State law prohibiting any

person from selling or giving tobacco

products to persons younger than 18

years of age, and (2) section 314–10–050

of the Washington Administrative Code

(WAC)2, a State regulation requiring that

purchasers of tobacco products provide

proof of age by providing certain

Government-issued forms of

identification. As discussed in the

proposal (62 FR 7390 at 7393), FDA

determined that portions of the State of

Washington statute and regulations are

narrower in scope than the tobacco rule

and therefore are not preempted.

Because neither RCW 26.28.080 nor

WAC 314–10–050 prohibits the

distribution of free samples of cigarettes

and smokeless tobacco to persons 18

years or older, these provisions are less

stringent than the total prohibition

against free samples in the tobacco rule

at § 897.16(d). In addition, to the extent

that the RCW 26.28.080 and WAC 314–

10–050 apply to products other than

cigarettes and smokeless tobacco, they

are not preempted by the tobacco rule

because the tobacco rule does not

establish ‘‘specific counterpart
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations 63273

regulations’’ or other requirements with

respect to products other than cigarettes

or smokeless tobacco (see § 808.1(d)).

Finally, WAC 314–10–050 requires

purchasers to present identification

establishing the purchaser’s age and

specifies requirements for the type of

identification that the purchaser must

present. Because FDA has not

established any specific counterpart

regulations that place an affirmative

duty on the purchaser to present

identification or that require a specific

type of photographic identification

containing the bearer’s birth date, WAC

314–10–050 is not preempted.

Therefore, because RCW 26.28.080 and

WAC 314–10–050 are not preempted, no

exemption is necessary.

FDA received 15 comments on the

proposed rule. Notably, none of the

comments argued that FDA should deny

the applications for exemption from

preemption submitted by Alabama,

Alaska, or Utah. In fact, several

comments specifically urged that FDA

grant these applications because active

enforcement of the higher minimum age

for sale in the three States has resulted

in a decline in illegal sales of tobacco

products to underage youths.

The remaining comments, while

supporting FDA’s proposal to grant

exemptions from preemption for the

Alabama, Alaska, and Utah

requirements, argued that FDA

misinterpreted the scope of preemption

under 521(a) of the act by failing to find

that all State and local requirements that

are less stringent than Federal

counterpart requirements are

preempted. These comments urged FDA

to reconsider its analysis of the Supreme

Court decision in Medtronic, Inc. v.

Lohr, 116 S. Ct. 2240 (1996), in light of

Papike v. Tambrands, 107 F.3d 737

(1997), and argued that the agency’s

interpretation of the narrow scope of

preemption under section 521(a) of the

act would undermine State and local

efforts to promote public health. A few

comments stated that more stringent

State or local restrictions should not be

preempted because they safeguard the

public health more than Federal

counterpart restrictions do. Several

comments argued that Medtronic is not

dispositive of the extent to which 521(a)

of the act preempts State or local

tobacco control laws because the

Medtronic Court determined whether

521(a) preempts general common law

duties, not whether 521(a) would

preempt a specific enactment of State or

local law. Comments noted that,

because State tobacco statutes are

positive enactments of State law, they

are precisely the type of requirement

that is normally preempted by specific

FDA requirements.

Comments relied on the recent Ninth

Circuit decision, Papike, to support

their interpretation of Medtronic and the

scope of preemption under 521(a) of the

act. The Papike court held that section

521(a) of the act preempts a State

common law cause of action for failure

to warn because FDA has established

specific counterpart labeling regulations

mandating the substantive content of

the warning for the particular device

and disease at issue in that case. The

Papike court distinguished the case

before it, which involved specific

Federal requirements applicable to a

specific device, from Medtronic, which

involved general Federal requirements

(good manufacturing practices and

labeling requirements). (See Papike at

740.) Applying the reasoning in Papike,

comments argued that specific Federal

tobacco requirements preempt specific,

and less stringent, State or local

counterpart requirements.

FDA is not persuaded that it erred in

its determination that 521(a) of the act

preempts more restrictive, but not less

restrictive, State or local counterpart

requirements. First, FDA believes that

the Supreme Court in Medtronic has

addressed the very issue of whether less

restrictive State or local requirements

are preempted under section 521(a) of

the act. As the agency stated in the

proposed rule (62 FR 7390 at 7391), the

Medtronic Court held that State

requirements that are similar to, but

narrower than, FDA requirements are

not preempted under section 521 of the

act. The Court reasoned that, while

narrower State restrictions might be

‘‘different from’’ their more stringent

Federal counterpart restrictions, ‘‘* * *

such a difference would surely provide

a strange reason for finding a preemption of a state rule insofar as it

duplicates the federal rule’’ (Medtronic,

116 S.Ct. at 2255). Accordingly, FDA

concludes that section 521(a) of the act

does not preempt State or local

restrictions to the extent that they are

similar to, but narrower or less stringent

than, counterpart FDA restrictions.

FDA disagrees with the comments’

analysis of and reliance on Papike. The

agency agrees that a determination of

whether a State or Federal requirement

is general or specific in nature is

essential to any analysis of preemption

under section 521(a) of the act. That

determination, however, is not

dispositive as to whether a particular

State or local requirement is preempted.

Rather, if there are specific Federal and

State requirements applicable to the

specific device at issue, the next

question is whether the State

requirement is different from, or in

addition to, the Federal requirement.

The Court in Medtronic concluded that

a State or local requirement that is

narrower than, or duplicative of, a

counterpart Federal requirement, is not

‘‘different from’’ the Federal

requirement and, consequently, is not

preempted under section 521(a) of the

act.

Several comments argued that FDA

weakened the standard by which a

narrower State or local requirement is

found to be preempted. Medtronic held

that State requirements are not

preempted if they parallel Federal

requirements or insofar as they

duplicate Federal requirements (Id.). In

the proposed rule (62 FR 7390 at 7391),

FDA paraphrased this holding in stating

that State or local requirements that are

similar to, but narrower than,

counterpart Federal requirements are

not preempted. FDA believes that it has

not weakened the Medtronic standard

and that its application of the standard

articulated by the Supreme Court in

Medtronic is required by the Court’s

interpretation of the scope of

preemption under section 521 of the act.

Other comments argued that, as a

matter of policy, the finding that less

stringent State or local requirements are

not preempted weakens FDA’s tobacco

rule and undermines State and local

public health initiatives to reduce

tobacco use by children and

adolescents.

First, the act clearly requires that a

State or local enactment be ‘‘different

from,’’ or ‘‘in addition to’’ a counterpart

FDA requirement to be preempted, and

FDA regulations enumerate the types of

evidence or information that the agency

will consider in determining whether to

grant an exemption from preemption

(see 21 CFR part 808). While the agency

is always open to receiving information

regarding its decisions, including

evidence that a State or local

requirement impairs the agency’s ability

to enforce its regulations, preemption

does not occur under section 521 of the

act absent a showing that such a

requirement is ‘‘different from,’’ or ‘‘in

addition to,’’ a specific counterpart FDA

requirement. Second, as a matter of

policy, FDA believes that States and

localities are able to determine whether,

in light of the Supreme Court’s

interpretation of the scope of Federal

preemption under 521(a) of the act,

additional or new legislation is

warranted. If narrower or less stringent

State or local requirements were

preempted, as comments suggest, those

States and localities would be left with

no State or local requirements at all.

Therefore, contrary to the concern
63274 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Rules and Regulations

3To ensure that retailers are complying with the

tobacco rule and refusing to sell cigarettes or

smokeless tobacco to persons under age 18, FDA

will conduct compliance checks, wherein an

adolescent, accompanied by a State commissioned

officer, will attempt to purchase cigarettes or

smokeless tobacco.

expressed by comments, the public

health protection in those jurisdictions

would be diminished, not enhanced.

A few comments urged that, rather

than preempt more stringent State or

local requirements, FDA should leave

them intact. In that case, exemptions

from preemption would not be required.

Section 521 of the act clearly states that

State or local restrictions that are

‘‘different from’’ or ‘‘in addition to’’

FDA restrictions are preempted.

However, FDA will continue to consider

applications for exemptions from

preemption for more stringent State or

local requirements that provide greater

public health protection without

imposing significant burdens on

interstate commerce.

One comment urged FDA to refrain

from issuing general determinations

concerning whether a certain type of

State or local requirement is preempted.

Specifically, the comment disagreed

with FDA’s using as an example of a

narrower restriction in the proposed

rule State or local laws that hold

retailers to a standard lower than strict

liability for selling cigarettes or

smokeless tobacco to persons under 18.

This comment argued that, while as a

general rule Medtronic holds that

narrower State or local laws are not

preempted under section 521(a) of the

act, FDA should accept evidence that a

specific State or local requirement,

although narrower, is nonetheless

‘‘different’’ from the FDA requirement

and preempted under the act.

FDA believes that it is important to

provide States and localities with

examples of how to apply the agency’s

interpretation of the scope of

preemption under section 521 of the act,

especially because the agency refined its

interpretation of Medtronic. By

providing an example FDA intends to

assist States and localities in

determining whether they need to apply

for an exemption. FDA agrees with the

comment that the agency must

determine whether a particular

requirement is preempted on a case-bycase basis considering, among other

factors, the statutory, regulatory or other

language, any judicial or administrative

interpretations, and any information

regarding implementation or

enforcement of the requirement.

Therefore, FDA remains open to

receiving specific information regarding

a particular State or local requirement

and would consider the information in

determining whether the requirement

were preempted under section 521(a) of

the act.

Several comments suggested that FDA

preempt certain types of requirements,

including State laws that hold retailers

to a standard lower than strict liability

for illegally selling tobacco products to

minors, and State laws that prohibit

using minors to aid in the inspection of

tobacco retailers3. Comments argued

that these types of requirements should

be preempted because they frustrate the

purpose of the tobacco rule by making

it difficult for FDA to enforce the

Federal requirements.

First, FDA continues to believe that

under Medtronic State or local

requirements holding retailers liable for

knowingly or negligently selling

cigarettes or smokeless tobacco to

persons under age 18 are not preempted.

As explained in the proposal (62 FR

7390 at 7391), State or local statutes that

require proving a retailer’s negligence or

knowledge in an underage sale are

similar to counterpart Federal

requirements holding retailers strictly

liable for illegally selling cigarettes or

smokeless tobacco to minors, but they

are narrower in scope than the tobacco

rule’s prohibition of sales to persons

under age 18 and therefore are not

preempted. Second, because FDA does

not have before it a positive enactment

to consider, the agency declines to issue

an opinion on the preemptive effect of

section 521 of the act on the types of

requirements that prohibit the use of

minors in inspections. Without a

specific State or local enactment before

the agency, including any legislative,

administrative, judicial or enforcement

history, the agency cannot determine

the effect of either section 521(a) of the

act or more general principles of Federal

preemption.

Therefore, in response to applications

received, FDA is granting exemptions

from Federal preemption for certain

State requirements in Alabama, Alaska,

and Utah relating to cigarettes or

smokeless tobacco.

List of Subjects in 21 CFR Part 808

Intergovernmental relations, Medical

devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 808 is

amended as follows:

PART 808—EXEMPTIONS FROM

FEDERAL PREEMPTION OF STATE

AND LOCAL MEDICAL DEVICE

REQUIREMENTS

1. The authority citation for 21 CFR

part 808 continues to read as follows:

Authority: 21 U.S.C. 360j, 360k, 371.

2. Section 808.51 is added to subpart

C to read as follows:

§ 808.51 Alabama.

To the extent that the age restriction

on the sale, barter, and exchange of

cigarettes and smokeless tobacco found

in Alabama Code, section 13A–12–3, is

preempted under section 521(a) of the

act, the Food and Drug Administration

has exempted it from preemption under

section 521(b) of the act.

3. Section 808.52 is added to subpart

C to read as follows:

§ 808.52 Alaska.

To the extent that the age restriction

on the sale and exchange of cigarettes

and smokeless tobacco found in Alaska

Statutes, sections 11.76.100(a), is

preempted under section 521(a) of the

act, the Food and Drug Administration

has exempted it from preemption under

section 521(b) of the act.

4. Section 808.94 is added to subpart

C to read as follows:

§ 808.94 Utah.

To the extent that the age restriction

on sales of cigarettes and smokeless

tobacco found in the Utah Code

Annotated, section 76–10–104, is

preempted under section 521(a) of the

act, the Food and Drug Administration

has exempted it from preemption under

section 521(b) of the act.

Dated: November 18, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–31213 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Parts 723, 724, 845, and 846

RIN 1029–AB90

Implementation of the Debt Collection

Improvement Act of 1996

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Final rule.

SUMMARY: This rule implements the

Federal Civil Monetary Penalty Inflation