Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations 19399

List of Subjects in 16 CFR Part 305

Advertising, Energy conservation,

Household appliances, Labeling,

Reporting and recordkeeping

requirements.

Accordingly, 16 CFR Part 305 is

amended as follows:

PART 305—[AMENDED]

1. The authority citation for Part 305

continues to read as follows:

Authority: 42 U.S.C. 6294.

2. Appendix F to Part 305 is revised

to read as follows:

Appendix F to Part 305—Clothes

Washers

Range Information:

‘‘Compact’’ includes all household clothes

washers with a tub capacity of less than 1.6

cu. ft. or 13 gallons of water.

‘‘Standard’’ includes all household clothes

washers with a tub capacity of 1.6 cu. ft. or

13 gallons of water or more.

Capacity

Range of estimated annual energy consumption

(kWh/yr.)

Low High

Compact:

Top Loading ...................................................................................................................................................... 592 607

Front Loading .................................................................................................................................................... (*) (*)

Standard:

Top Loading ...................................................................................................................................................... 294 1231

Front Loading .................................................................................................................................................... 241 318

(*) No data submitted.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98–10391 Filed 4–17–98; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF THE TREASURY

Customs Service

19 CFR Part 142

[T.D. 98–34]

Technical Correction Regarding Time

Limit for Filing Documentation After

Release

AGENCY: United States Customs Service,

Department of the Treasury.

ACTION: Final rule.

SUMMARY: This document makes a

technical correction to the regulation

regarding time limit for filing

documentation after release, in

accordance with Customs policy of

periodically reviewing its regulations to

ensure that they are current and

accurate.

EFFECTIVE DATE: April 20, 1998.

FOR FURTHER INFORMATION CONTACT:

Harold Singer, Chief, Regulations

Branch, (202) 927–2268.

SUPPLEMENTARY INFORMATION:

Background

In accordance with Customs policy of

periodically reviewing its regulations to

ensure that they are current and

accurate, Customs has discovered that

there is a typographical error in

§ 142.23, Customs Regulations (19 CFR

142.23). Section 142.23 was amended by

Treasury Decision 80–26, which was

published in the Federal Register (45

FR 3901) on January 21, 1980. When

that amendment was codified in Title 19

in 1980, the word ‘‘period’’ was

inadvertently omitted. The error has

been carried forward in each volume of

Title 19 since that publication. This

document corrects the error.

Inapplicability of Public Notice and

Comment and Delayed Effective Date

Requirements, the Regulatory

Flexibility Act, and Executive Order

12866

Inasmuch as this amendment merely

corrects a typographical error, pursuant

to 5 U.S.C. 553(b)(B), notice and public

procedure thereon are unnecessary, and

pursuant to 5 U.S.C. (d)(3), a delayed

effective date is not required. Since this

document is not subject to the notice

and public procedure requirements of 5

U.S.C. 553, it is not subject to the

provisions of the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.). This

amendment does not meet the criteria

for a ‘‘significant regulatory action’’ as

defined in Executive Order 12866.

Drafting Information

The principal author of this document

was Janet L. Johnson, Regulations

Branch, U.S. Customs Service. However,

personnel from other offices

participated in its development.

List of Subjects in 19 CFR Part 142

Customs duties and inspection.

Amendment to the Regulations

Part 142, Customs Regulations (19

CFR part 142), is amended as set forth

below.

PART 142—ENTRY PROCESS

1. The general authority citation for

part 142 continues to read as follows:

Authority: 19 U.S.C. 66, 1448, 1484, 1624.

§ 142.23 [Amended]

2. Section 142.23 is amended by

removing the words ‘‘for quota class

merchandise within the quota’’ and

adding in their place ‘‘for quota class

merchandise within the quota period’’.

Dated: April 15, 1998.

Harold M. Singer,

Chief, Regulations Branch.

[FR Doc. 98–10316 Filed 4–17–98; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. 97N–0449]

RIN 0910–ZA08

Revisions to the General Safety

Requirements for Biological Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

biologics regulations by adding ‘‘cellular

therapy products’’ to the list of products

excepted from the general safety test

(GST) and by adding an administrative

procedure for obtaining exemptions

from the GST requirements for other

biological products. FDA is taking this
19400 Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations

action because the GST may not be

relevant or necessary for biological

products, including cellular therapy

products, currently in various stages of

development. This direct final rule is

part of FDA’s continuing effort to

achieve the objectives of the President’s

‘‘Reinventing Government’’ initiative,

and is intended to reduce the burden of

unnecessary regulations on biological

products without diminishing the

protection of the public health.

Elsewhere in this Federal Register, FDA

is publishing a companion proposed

rule under FDA’s usual procedures for

notice and comment to provide a

procedural framework to finalize the

rule in the event the agency receives any

significant adverse comment and

withdraws this direct final rule.

DATES: This regulation is effective

September 2, 1998. Submit written

comments on this direct final rule on or

before July 6, 1998. Submit written

comments on the information collection

provisions by June 19, 1998.

ADDRESSES: Submit written comments

on the direct final rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–594–3074.

SUPPLEMENTARY INFORMATION:

I. Background

Under § 610.11 (21 CFR 610.11), a test

for general safety shall be performed on

biological products intended for

administration to humans. A GST is one

of several tests in part 610, General

Biological Product Standards (21 CFR

part 610), that are intended to help

ensure the safety, purity, and potency of

biological products administered to

humans. The test is used to detect

extraneous toxic contaminants that may

be present in a particular biological

product. As outlined in § 610.11, an

amount of the final container product is

injected into the peritoneum of guinea

pigs and mice. The GST is satisfactory

when: The criteria in § 610.11(d) are

met, i.e., injected animals survive the

test period, they do not exhibit an

unexpected or nonspecific response that

may indicate a difference in quality of

the product, and they weigh no less at

the end of the test period than they did

at the time of injection. Section

610.11(g) identifies the biological

products for which the GST is not

required.

The requirement for a GST test was

originally intended as a means by which

harmful extraneous toxins could be

detected (41 FR 10888, March 15, 1976).

The source of such toxins may be

bacterial toxins that persist even after

the bacteria producing the toxins had

been removed by filtration or killed by

sterilization, or formulation errors that

result in harmful levels of certain

substances, e.g., preservatives. The test

continues to serve as a safety net to

detect harmful contaminants that may

enter or be introduced into the final

container through undetected failures in

the manufacture of biological products.

In the last 15 years, technological

advances have increased the ability of

manufacturers to control and analyze

the manufacture of many biotechnology

derived biological products. After more

than a decade of experience with these

products, FDA found that it could

evaluate many aspects of a biological

product’s safety, purity, or potency with

tests other than those prescribed in part

610. In response to these developments,

FDA published in the Federal Register

on May 14, 1996 (61 FR 24227), a final

rule exempting certain biotechnology

and synthetic biological products from,

among other things, specified

regulations applicable to biological

products, including the GST (§ 601.2 (21

CFR 601.2)).

Recent scientific advances have

dramatically increased the diversity of

biological products regulated under

section 351 of the Public Health Service

Act. In particular, cellular-based

therapies intended for the diagnosis,

cure, mitigation, treatment, or

prevention of disease in man have been

the subject of much biomedical research

and are used with increasing frequency.

Typically, cellular therapies use

autologous or allogeneic cells, often

lymphocyte subpopulations, but other

cell types may be used, obtained from

a donor and manipulated ex vivo to

varying degrees before use in the

recipient patient. The ex vivo

manipulation may consist of, for

example, growing a small number of

cells to increase their number (cellular

expansion), selective enrichment of a

specific cell subpopulation, or the

addition of specific cell factors or

genetic sequences. A common

characteristic of cellular therapies is the

need for a relatively short turn-around

time between first obtaining the cells

and their final infusion as a cellular

therapy product into the patient. In

many cases, cells used in the final

cellular therapeutic are obtained only

hours before they must be used and

turn-around times of several days or less

are presently typical. A test, such as the

GST, that requires 7 days to complete is

not compatible with such products and

such a requirement would make it

impossible to use many of these

products. Furthermore, because the

procedures and materials used to

produce cellular therapy products are

stringently controlled and monitored,

the likelihood of an extraneous toxic

component contaminating a final

product is greatly reduced.

In the Federal Register of June 3, 1994

(59 FR 28821 at 28822), FDA announced

that the Center for Biologics Evaluation

and Research (CBER) would review

certain biologics regulations to identify

regulations that are outdated,

burdensome, inefficient, duplicative, or

otherwise unsuitable or unnecessary.

FDA included § 610.11 in the review.

On January 26, 1995, FDA held a public

meeting to discuss the retrospective

review of regulations applicable to

biological products and to provide a

forum for the public to voice its

comments regarding the retrospective

review. At the meeting, only one

comment addressed whether § 610.11

should be retained unchanged,

modified, or deleted. The comment

acknowledged the utility of the GST for

products that have a high degree of

intrinsic variability. However, despite

its recognized value in some specific

cases, the comment questioned the

rationale for requiring the GST for all

biological products intended for

administration to humans. The

comment noted that the amount of final

container product administered to

animals for the GST may not have any

correlation with the human dose, that

some biological products possess

extensive documented histories of no

GST failure, and that each run of the test

requires the use of at least four animals.

The comment suggested that FDA revise

§ 610.11 to grant exemptions from the

GST when the test is unnecessary to

evaluate the safety of a specific product.

FDA received several comments from

the public regarding issues raised at the

January 26, 1995, meeting. Two

comments agreed with the suggestion

made at the public meeting that § 610.11

be amended to include a provision that

would allow certain products to be

exempted from the GST upon approval

of the Director, CBER. Another comment

suggested that exemptions be permitted

for appropriate biological products by

the Director, CBER, after a suitable

qualification period was met without

any failure of the GST, such as 1 year

of production or after 10 consecutive

production lots pass the GST. The

comment suggested that a demonstrated

record of GST compliance also be

supported by well-documented in-
Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations 19401

process safety controls, long-term

compliance with current good

manufacturing practices regulations (21

CFR parts 210 and 211), and the use of

sophisticated analytical techniques

capable of adequately characterizing the

final product and validating its safety.

On March 17, 1997, FDA held a

public meeting to discuss the agency’s

proposed approach to the regulation of

human cellular and tissue-based

products. The meeting was attended by

FDA, members of industry,

representatives from accrediting

organizations, and interested members

of the public. During the meeting, two

attendees addressed the use of the GST

with cellular therapy products. The

comments regarded the 7-day

incubation time of the test as an

unworkable requirement for many

cellular therapy products and suggested

that such products be exempted from

the test, including allogeneic and

autologous cell therapy products.

II. Highlights of the Direct Final Rule

FDA agrees with the comments

received that cellular therapy products

should be exempt from the GST

requirement. FDA is issuing this direct

final rule to expand the exceptions in

§ 610.11(g) to include ‘‘cellular therapy

products.’’ In addition, FDA is adding

an administrative procedure for

manufacturers of other biological

products to request and obtain

exemptions from the GST. Many

biological products are currently

manufactured, or will be manufactured

in the future, under highly controlled

and rigorously monitored conditions.

Therefore, under the amended rule,

manufacturers of biological products

that employ appropriate production

controls and quality assurance

safeguards would be permitted to apply

for an exemption from the GST

requirement. Such manufacturers will

be required to provide supporting

documentation to the Director, CBER, as

to why a product should not be subject

to the GST requirement. The request

shall include an explanation of why the

GST is unnecessary or cannot be

performed due to the mode of

administration, the method of

preparation, or the special nature of the

product and shall describe alternate

procedures, if any, to be employed. The

Director, CBER, may grant an exemption

if she finds that the manufacturer’s

submission justifies an exemption.

The value of the GST as a final assay

for the presence of extraneous toxins

may be diminished for certain biological

products, such as vaccines containing

recombinant or purified protein

antigens. Recombinant protein antigens

are not produced from infectious

bacteria or virus and antigens derived

from infectious pathogens may undergo

many production steps that kill or

neutralize the pathogen or inactivate

toxic materials. Therefore, for these

kinds of products, the risk is extremely

low that viable pathogenic or toxic

materials will persist through

production to the final filling. The

effectiveness of such steps can be

validated by specific in-process tests

and controls which can be used to alert

manufacturers to potential problems. To

further reduce the possibility that an

undetected extraneous toxin could

contaminate the product just before or

during the final fill stage, a

manufacturer may use production

facilities and final fill equipment that

can detect or enable the detection of any

loss in the integrity of the production

and fill processes. In addition, a method

of production and detailed product

characterization able to meet

requirements similar to those set out in

§ 601.2(c) could be used to demonstrate

the safety, purity, and potency of a

biological product without the use of

the GST. Each manufacturer will be

responsible for identifying the product

or products that are produced in such a

manner that makes the GST unnecessary

to ensure the safety, purity, and potency

of the biological product. Manufacturers

wishing to obtain an exemption to the

GST for a particular product would

contact the appropriate product division

of CBER for specific information

regarding how to apply and what

information should be included in the

application or supplemental

application.

III. Rulemaking Action

In the Federal Register of November

21, 1997 (62 FR 62466), FDA described

its procedures on when and how FDA

will employ direct final rulemaking.

FDA believes that this rule is

appropriate for direct final rulemaking

because FDA views this rule as a

noncontroversial amendment and

anticipates no significant adverse

comments. Consistent with FDA’s

procedures on direct final rulemaking,

FDA is publishing elsewhere in this

Federal Register issue, a companion

proposed rule to amend the existing

GST rule. The companion proposed rule

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of any significant adverse

comment. The comment period for the

direct final rule runs concurrently with

the companion proposed rule. Any

comments received under the

companion proposed rule will be

considered as comments regarding the

direct final rule.

FDA has provided a comment period

on the direct final rule of 75 days after

April 20, 1998. If the agency receives

any significant adverse comment, FDA

intends to withdraw this direct final

rule action by publication in the Federal

Register within 30 days after the

comment period ends. A significant

adverse comment is defined as a

comment that explains why the rule

would be inappropriate, including

challenges to the rule’s underlying

premise or approach, or would be

ineffective or unacceptable without a

change. In determining whether a

significant adverse comment is

sufficient to terminate a direct final

rulemaking, FDA will consider whether

the comment raises an issue serious

enough to warrant a substantive

response in a notice-and-comment

process. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered significant

or adverse under this procedure. For

example, a comment requesting

inclusion of additional product classes

in the exceptions paragraph of the GST

(§ 610.11(g)) will not be considered a

significant adverse comment because it

is outside the scope of this rule. A

comment recommending a rule change

in addition to the rule would not be

considered a significant adverse

comment, unless the comment states

why the rule would be ineffective

without additional change. In addition,

if a significant adverse comment applies

to part of a rule and that part can be

severed form the remainder of the rule,

FDA may adopt as final those parts of

the rule that are not subject of a

significant adverse comment.

If any significant adverse comment is

received during the comment period,

FDA will publish, within 30 days after

the comment period ends, a document

withdrawing the direct final rule. If FDA

withdraws the direct final rule, all

comments received will be applied to

the proposed rule and will be

considered in developing a final rule

using the usual Administrative

Procedure Act notice-and-comment

procedures.

If FDA receives no significant adverse

comments during the specified

comment period, FDA intends to

publish a confirmation document

within 30 days after the comment

period ends confirming that the direct

final rule will go into effect on

September 2, 1998.
19402 Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations

IV. Analysis of Impacts

A. Review Under Executive Order 12866

and the Regulatory Flexibility Act

FDA has examined the impact of the

direct final rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104–4). 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 impact; and equity). The

agency believes that this direct final rule

is consistent with the regulatory

philosophy and principles identified in

the Executive Order. The direct final

rule is a significant regulatory action as

defined by the Executive Order and is

subject to review under the Executive

Order because it deals with a novel

policy issue.

In accordance with the principles of

Executive Order 12866, the result of the

direct final rule will be a substantial

reduction in burdens on applicants

filing for approval of certain biological

products

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

business entities. Because, as stated

previously, the overall result of the

direct final rule will be a substantial

reduction of the regulatory and

reporting burdens, the agency certifies

that the direct final rule will not have

a significant negative economic impact

on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required. This rule also does not trigger

the requirement for a written statement

under section 202(a) of the Unfunded

Mandates Reform Act because it does

not impose a mandate that results in an

expenditure of $100 million or more by

State, local, and tribal governments in

the aggregate, or by the private sector in

any one year.

B. Environmental Impact

The agency has determined under 21

CFR 25.31(j) 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.

V. The Paperwork Reduction Act of

1995

This direct final rule contains

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). The title,

description, and respondent description

of the information collection provisions

are shown below with an estimate of the

annual reporting burden. Included in

the estimate is the time for reviewing

the instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing each collection of

information.

FDA invites comments on: (1)

Whether the proposed collection of

information is necessary for the proper

performance of FDA’s functions,

including whether the information will

have practical utility; (2) the accuracy of

FDA’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Requests for Exemptions from

the General Safety Testing Requirements

for Biological Products.

Description: FDA is revising the

requirements for general safety testing

(GST) set forth in § 610.11. The test

serves as a safety net to detect harmful

contaminants that may enter or be

introduced into the final container

through undetected failures in the

manufacture of biological products. The

revision would add ‘‘cellular therapy

products’’ to the list of products

excepted from the GST, and add an

administrative procedure for obtaining

exemptions from the GST requirements

for other biological products. FDA is

proposing the new administrative

procedure because the GST may not be

feasible or appropriate for some

biological products. FDA anticipates

that manufacturers requesting

exemptions would have a demonstrated

record of GST compliance supported by

long-term compliance with CGMP’s,

well-documented in-process safety

controls, and use sophisticated

analytical techniques to adequately

characterize the final product and

validate its safety. Manufacturers would

submit their request and documentation

to the Director, CBER, who may grant

the exemption if it is determined that

the manufacturer’s submission justifies

an exemption.

Description of Respondents:

Manufacturers of biological products.

The direct final rule would require

only those manufacturers requesting an

exemption from the GST under

§ 610.11(g)(2) to submit additional

information as part of a license

application or supplement to an

approved license application.

Manufacturers of ‘‘cellular therapy

products’’ would be excepted from the

GST under § 610.11(g)(1) and thus, not

have to submit an exemption request. In

fact, manufacturers of cellular therapy

products would be relieved of

significant burdens because they would

no longer be required to perform the

GST and report the results to FDA. FDA

estimates that annually it will receive

approximately 10 requests for

administrative exemption from the GST

under § 610.11(g)(2). FDA estimates

that 40 hours will be required for an

applicant to complete and submit the

appropriate information for the

exemption request. Since that

information is ordinarily compiled and

organized by the manufacturer while

performing the GST, FDA anticipates

that the additional time needed to

submit an exemption request will be

minimal.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

610.11(g)(2) 10 1 10 40 400

Total 10 10 40 400

1There are no capital costs or operating and maintenance costs associated with this collection of information.
Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations 19403

As provided in 5 CFR 1320.5(c)(1),

collections of information in a direct

final rule are subject to the procedures

set forth in 5 CFR 1320.10. Interested

persons and organizations may submit

comments on the information collection

requirements of this direct final rule by

June 19, 1998, to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

At the close of the 60-day comment

period, FDA will review the comments

received, revise the information

collection provisions as necessary, and

submit these provisions to OMB for

review. FDA will publish a notice in the

Federal Register when the information

collection provisions are submitted to

OMB, and an opportunity for public

comment to OMB will be provided at

that time. Prior to the effective date of

the direct final rule, FDA will publish

a notice in the Federal Register of

OMB’s decision to approve, modify, or

disapprove the information collection

provisions. An agency may not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

VI. Request for Comments

Interested persons may, on or before

July 6, 1998, submit to the Docket

Management Branch (address above)

written comments regarding this

proposal. This comment period runs

concurrently with the comment period

for the companion proposed 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. All

comments received will be considered

comments regarding the proposed rule

and this direct final rule. In the event

the direct final rule is withdrawn, all

comments received regarding the

companion proposed rule and the direct

final rule will be considered comments

on the proposed rule.

List of Subjects in 21 CFR Part 610

Biologics, Labeling, Reporting and

recordkeeping requirements.

Therefore under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 610 is

amended as follows:

PART 610—GENERAL BIOLOGICAL

PRODUCTS STANDARDS

1. The authority citation for 21 CFR

part 610 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,

264.

2. Section 610.11 is amended by

revising paragraph (g) to read as follows:

§ 610.11 General safety.

* * * * *

(g) Exceptions—(1) The test

prescribed in this section need not be

performed for Whole Blood, Red Blood

Cells, Cryoprecipitated AHF, Platelets,

Plasma, or Cellular Therapy Products.

(2) For products other than those

identified in paragraph (g)(1) of this

section, a manufacturer may request

from the Director, Center for Biologics

Evaluation and Research, an exemption

from the general safety test. The

manufacturer shall submit information

as part of a license application

submission or supplement to an

approved license application

establishing that because of the mode of

administration, the method of

preparation, or the special nature of the

product a test of general safety is

unnecessary to assure the safety, purity,

and potency of the product or cannot be

performed. The request shall include

any alternate procedures, if any, to be

performed. The Director, Center for

Biologics Evaluation and Research,

upon finding that the manufacturer’s

request justifies an exemption, may

exempt the product from the general

safety test subject to any condition

necessary to assure the safety, purity,

and potency of the product.

Dated: April 10, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–10314 Filed 4–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 920

[MD–042–FOR]

Maryland Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving a proposed

amendment to the Maryland regulatory

program (hereinafter referred to as the

‘‘Maryland program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Maryland proposed

revisions to the Maryland regulations

regarding a reduced bond liability

period for lands remined. The

amendments are intended to revise the

Maryland program to be consistent with

the corresponding Federal regulations

and SMCRA.

EFFECTIVE DATE: April 20, 1998.

FOR FURTHER INFORMATION CONTACT:

George Rieger, Program Manager, OSM,

Appalachian Regional Coordinating

Center, 3 Parkway Center, Pittsburgh,

PA 15220. Telephone: (412) 937–2153.

SUPPLEMENTARY INFORMATION:

I. Background on the Maryland Program

II. Submission of the Proposed Amendment

III. Director’s Findings

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the Maryland

Program

On December 1, 1980, the Secretary of

the Interior conditionally approved the

Maryland program. Background

information on the Maryland program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the December 1, 1980, Federal Register

(45 FR 79449). Subsequent actions

concerning conditions of approval and

program amendments can be found at

30 CFR 920.12, 920.15, and 920.16.

II. Submission of the Proposed

Amendment

Maryland provided an informal

amendment to OSM regarding a reduced

bond liability period for lands remined

in a letter dated August 21, 1996. OSM

completed its review of the informal

amendment and submitted comments to

Maryland in a letter dated August 4,

1997. By letter dated October 9, 1997

(Administrative Record No. MD–579–

00), Maryland submitted its response to

OSM’s comments in the form of a

proposed amendment to its program

pursuant to SMCRA. OSM’s review of

the proposed amendment resulted in

additional questions for Maryland, to

which they responded in a fax dated

February 26, 1998 (Administrative

Record No. 579–04).

OSM announced receipt of the

proposed amendment in the November

21, 1997 Federal Register (62 FR

62273), and in the same document

opened the public comment period and

provided an opportunity for a public

hearing on the adequacy of the proposed

amendment. The public comment

period closed on December 22, 1997.