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the direct final rule is withdrawn, all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.
19404 Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations

III. Director’s Findings

Set forth below, pursuant to SMCRA

and the Federal regulations at 30 CFR

732.15 and 732.17, are the Director’s

findings concerning the proposed

amendment. Revisions not specifically

discussed below concern paragraph

notations to reflect organizational

changes resulting from this amendment.

1. COMAR 26.20.01.02B Definitions

Specifically, Maryland proposes to

delete the existing definition at (49),

‘‘keyway,’’ and add a new definition at

(49) as follows:

Lands eligible for remining means any

land that would otherwise be eligible for

expenditures under Environment

Article, Title 15, Subtitle 11, Annotated

Code of Maryland.

There are no Federal counterparts to

the term ‘‘keyway’’, nor is it used in the

Maryland Code for anything related to

the Maryland program. Therefore, the

Director finds that the proposed

deletion does not render the Maryland

program less effective than the Federal

regulations. Additionally, since subtitle

11 of the Maryland statute is the State’s

counterpart to Title IV of SMCRA

(Abandoned Mine Lands), the Director

finds that the proposed definition of

‘‘lands eligible for remining’’ is

substantively identical to and therefore

no less stringent than the Federal

definition at section 701(34) of SMCRA.

2. COMAR 26.20.14.05 Duration of

Performance Bonds

Paragraph B. is modified by adding to

the opening phrase, ‘‘except on lands

eligible for remining’’. Paragraph B.

currently specifies that the period of

liability for a bond shall continue for a

minimum period of not less than 5

years, beginning with the last year of

augmented seeding, fertilizing,

irrigation, or other work. The addition

of the phrase ‘‘except on lands eligible

for remining’’ indicates that lands

eligible for remining would therefore be

subject to a different period of time,

which is covered in new paragraph C.

below. Since the addition of this phrase

to the opening sentence in paragraph B.

simply adds a qualification to exempt

lands eligible for remining from the 5-

year period of liability, the Director

finds the change no less effective than

the corresponding federal regulations at

816/817.116(c) in view of the additional

change explained below.

New paragraph C. is added as follows:

On lands eligible for remaining

included in permits issued before

September 30, 2004, or any later date

authorized by the federal Surface

Mining Control and Reclamation Act, or

any renewal thereof, the period of

liability for a bond shall continue for a

period of not less than 2 full years,

beginning with the last year of

augmented seeding, fertilizing,

irrigation, or other work. The period of

liability shall begin again when

augmented seeding, fertilizing,

irrigation or other work is ordered by

the Bureau to correct a failure to

maintain the permanent vegetative

cover required under COMAR 08.20.29

on the site.

The federal rule at 30 CFR 816/

817.116(c) requires that on lands

eligible for remining, the operator must

assume responsibility for successful

revegetation for a period of 2 full years

after the last year of augmented seeding,

fertilizing, irrigation or other work to

comply with applicable standards.

Although Maryland’s proposed rule

includes the words ‘‘beginning with the

last year * * *’’ and the Federal rule

includes the words ‘‘after the last year.

* * *’’ the rules do not conflict because

of other regulatory sections in the

Maryland program. The preamble to the

Federal Rule at 48 FR 40155, dated

September 2, 1983 regarding

responsibility periods explained that the

responsibility period could begin from

the point at which the operator

completes seeding and fertilizing.

Maryland interprets the rule for

unmined lands in this manner, and will

interpret the proposed rule in the same

manner. See February 26, 1998 fax

(Administrative Record No. 579–04),

Maryland’s statute at § 15–513 and

Maryland’s regulations at COMAR

26.20.29.05 requires an operator to

complete a backfilling and planting

report when an affected area has been

backfilled, regraded and planted in

accordance with the statute and the

approved reclamation plan. This report

is reviewed by the on-site inspector,

approved by his/her supervisor, and

then approved by the Department. Only

when approved by the Department does

the responsibility period in Maryland

begin. This is the actual practice in

Maryland as monitored by OSM.

Maryland’s proposed regulation also

requires the restart of the liability period

when there is augmented seeding,

fertilizing, irrigation or other work to

correct a failure to maintain permanent

vegetative cover. Therefore, the Director

finds that the proposed revision at

COMAR 26.20.14.05C is no less

effective than the revegetation

provisions of 816/817.116(c) that

requires the period of extended

responsibility for remined sites to last

for two full years after the last

augmented seeding.

Existing paragraph C. is re-lettered as

D. and the 5-year reference is deleted.

This paragraph currently specifies that

if the bureau approves a long term

intensive agricultural postmining land

use, the applicable 5-year period of

liability shall commence at the date of

initial planting for such long-term

intensive agricultural land use. The

deletion of the 5-year reference from

this paragraph allows it to pertain to all

lands, i.e., lands not remined must still

meet the 5-year criteria included in

paragraph B., whereas lands remined

would be subject to the two year criteria

included in the changes outlined above

in paragraph C. Since the deletion of the

5-year reference does not change the

appropriate liability periods, the

Director finds the change no less

effective than the corresponding federal

regulations at 816/817.116(c) in view of

the additional changes explained above.

3. COMAR 26.20.14.08. Criteria and

Schedule for Release of Performance

Bond

Paragraph D. discusses the schedule

for release of performance bonds.

Existing paragraph D.(2) is deleted and

new paragraph D.(2) is added as follows:

For acreage on which Reclamation

Phase II has been completed and for

which a bond release application has

been submitted, an amount of bond not

to exceed 50 percent of the per acre rate

submitted in accordance with

Regulation .03D of this chapter may be

released;

Existing paragraph D.(3) is deleted

and new paragraph D.(3) is added as

follows:

For acreage on which Reclamation

Phase III has been completed and for

which a bond release application has

been submitted, the remaining amount

of bond equal to 50 percent of the per

acre rate submitted in accordance with

Regulation .03D of this chapter may be

released;

New paragraph D.(4) is added as

follows:

On lands eligible for remining, for

acreage on which Reclamation Phases II

and III have been completed and for

which a bond release application has

been submitted, bond in the amount of

the per acre rate submitted in

accordance with Regulation .03D of this

chapter may be released.

The primary difference in paragraphs

D.(2) and D.(3) added above from those

deleted is a reference change from 03E.

to 03D. of this regulation. Paragraph 03E

of this regulation states that the

minimum amount of the total bonds

shall be $10,000 for the entire area

under one permit, whereas 03D states

the minimum amount of revegetation
Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations 19405

bond shall be $600 per acre of affected

land. These proposed paragraphs only

change the reference from one of an

overall minimum bond amount to a per

acre minimum bond amount.

Additionally, new paragraph D.(4) has

been added to specifically address bond

release on lands eligible for remining,

which likewise requires that said release

be performed subject to the same

criteria, i.e. minimum bond amounts per

acre in the same 03D reference. Since

paragraph D.(4) requires the completion

of Phase II and III work on lands eligible

for remining before bond release, and

the changes in proposed paragraphs

D.(2) and (3) do not conflict with

corresponding federal regulations, the

Director finds that the proposed

amendments are consistent with 30 CFR

800.40(c)(2) and (3).

4. COMAR 26.20.29.07. Standards for

Success

Existing paragraph B.(8) is revised by

adding the phrase ‘‘except on lands

eligible for remining as provided in

§B.(9) of this regulation.’’ Paragraph

B.(8) currently specifies that the period

of liability for a bond shall continue for

a minimum period of not less than 5

years. The addition of the phrase

indicates that lands eligible for remining

would therefore be subject to a different

period of time, which is covered in new

paragraph B.(9) below. Since the

addition of this phrase to the opening

sentence in paragraph B.(8) simply adds

a qualification to exempt lands eligible

for remining from the 5-year period of

liability, the Director finds the change

no less effective than the corresponding

federal regulations at 816/817.116(c) in

view of the additional changes

explained above.

Paragraph B. of COMAR 26.20.29.07

requires that the success standards for

revegetation be applied in accordance

with the approved post mining land use

and now Maryland is adding the

following condition for remined lands

as set forth in new paragraph B.(9),

which states:

On lands eligible for remining

included in permits issued before

September 30, 2004, or on any later date

authorized by the federal Surface

Mining Control and Reclamation Act, or

any renewal thereof, the period of

responsibility shall continue for a

period of not less than 2 full years.

New paragraph C. is added as follows:

On lands eligible for remining

included in any permit, the lands shall

equal or exceed the standards for

success during the growing season of

the last year of the responsibility period

in §B(9) of this regulation.

The Director finds that these revisions

are substantively identical and no less

effective than the corresponding Federal

regulations at 30 CFR 816 and

817.116(c)(2)(ii).

5. COMAR 08.20.14.14 Release of Bonds

on Remining Areas

Maryland proposed to add, and the

Office of Surface Mining approved, this

section as published in the Federal

Register (62 FR 12028) dated March 25,

1996. However, Maryland subsequently

chose not to promulgate this regulation.

Instead, Maryland now proposes the

changes enumerated in Items 1. through

4. above, which are approved by the

Director as stated. Since these revisions

are no less effective than the federal

rules, OSM finds that the nonpromulgation of this section does not

render the Maryland program less

effective, and OSM is now deleting this

section from the approved Maryland

program.

IV. Summary and Disposition of

Comments

Public Comments

The Director solicited public

comments and provided an opportunity

for a public hearing on the proposed

amendment. No comments were

received and because no one requested

an opportunity to speak at a public

hearing, no hearing was held.

Federal Agency Comments

Pursuant to 30 CFR 732.17(h)(11)(i),

the Director solicited comments on the

proposed amendment from various

Federal agencies with an actual or

potential interest in the Maryland

program. MSHA responded in its letter

dated November 19, 1997,

(Administrative Record No. 579–02),

that it anticipated no further action

regarding the proposed amendment. No

other comments were received.

Environmental Protection Agency (EPA)

Pursuant to 30 CFR 732.17(h)(11)(ii),

OSM is required to obtain the written

concurrence of the EPA with respect to

those provisions of the proposed

program amendment that relate to air or

water quality standards promulgated

under the authority of the Clean Water

Act (33 U.S.C. 1251 et seq.) or the Clean

Air Act (42 U.S.C. 7401 et seq.). The

Director has determined that this

amendment contains no such provisions

and that EPA concurrence is therefore

unnecessary. Also, EPA did not respond

to OSM’s request for comments.

V. Director’s Decision

The Federal regulations at 30 CFR

Part 920, codifying decisions concerning

the Maryland program, are being

amended to implement this decision.

This final rule is being made effective

immediately to expedite the State

program amendment process and to

encourage States to bring their programs

into conformity with the Federal

standards without undue delay.

Consistency of State and Federal

standards is required by SMCRA.

VI. Procedural Determinations

Executive Order 12866

This proposed rule is exempted from

review by the Office of Management and

Budget (OMB) under Executive Order

12866 (Regulatory Planning and

Review).

Executive Order 12998

The Department of the Interior has

conducted the reviews required by

section 3 of Executive Order 12998

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a
19406 Federal Register / Vol. 63, No. 75 / Monday, April 20, 1998 /Rules and Regulations

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon corresponding Federal regulations

for which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions in the analyses for

the corresponding Federal regulations.

Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.

List of Subjects in 30 CFR Part 920

Intergovernmental relations, Surface

mining, Underground mining.

Allen D. Klein,

Regional Director, Appalachian Regional

Coordinating Center.

For the reasons set out in the

preamble, Title 30, Chapter VII,

Subchapter T of the Code of Federal

Regulations is amended as set forth

below:

PART 920—MARYLAND

1. The authority citation for part 920

continues to read as follows:

Authority: 30 U.S.C. 1201 et seq.

2. Section 920.15 is amended in the

table by adding a new entry in

chronological order by ‘‘Date of Final

Publication’’ to read as follows:

§ 920.15 Approval of Maryland regulatory

program amendments.

* * * * *

Original amendment submission date Date of final publication Citation/description

* * * * * * *

October 9, 1997 ..................... April 20, 1998 ........................ COMMAR 26.20.01.02B(49), 26.20.14.05 B, C & D, 26.20.14.08.D.(2) through

(4), 26.20.29.07.B(8), B(9) and (C), deletion of 08.20.14.14.

[FR Doc. 98–10295 Filed 4–17–98; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CGD 05–98–020]

Special Local Regulations for Marine

Events; Approaches to Annapolis

Harbor, Spa Creek, and Severn River,

Annapolis, MD

AGENCY: Coast Guard, DOT.

ACTION: Notice of implementation.

SUMMARY: This notice implements the

special local regulations for the Blue

Angels Airshow, to be held May 19 and

22, 1998, over Spa Creek and the Severn

River, near the U.S. Naval Academy,

Annapolis, Maryland. These special

local regulations are necessary to

control vessel traffic in the vicinity of

the U.S. Naval Academy due to the

confined nature of the waterway and

expected vessel congestion during the

airshow. The effect will be to restrict

general navigation in the regulated area

for the safety of spectators and vessels

transiting the event area.

DATES: The regulation implemented by

this notice is effective from 11:30 a.m.

to 4 p.m. on May 19, 1998 and from

11:30 a.m. to 4:30 p.m. on May 20, 1998.

FOR FURTHER INFORMATION CONTACT:

Chief Warrant Officer R. L. Houck,

Marine Events Coordinator,

Commander, Coast Guard Activities

Baltimore, 2401 Hawkins Point Road,

Baltimore, MD 21226–1971, (410) 576–

2674.

SUPPLEMENTARY INFORMATION: The U.S.

Naval Academy will sponsor the Blue

Angels Airshow over the Severn River

near the U.S. Naval Academy,

Annapolis, Maryland. The event will

consist of 6 high performance jet aircraft

flying at low altitudes in formation over

the Severn River. Therefore, to ensure

the safety of spectators and transiting

vessels, 33 CFR 100.511 will be in effect

for the duration of the event. Under

provisions of 33 CFR 100.511, a vessel

may not enter the regulated area unless

it receives permission from the Coast

Guard Patrol Commander. Spectator

vessels may anchor outside the

regulated area but may not block a

navigable channel. Because these

restrictions will be in effect for a limited

period, they should not result in a

significant disruption of maritime

traffic.

Dated: March 25, 1998.

Roger T. Rufe, Jr.,

Vice Admiral, U.S. Coast Guard, Commander,

Fifth Coast Guard District.

[FR Doc. 98–10306 Filed 4–17–98; 8:45 am]

BILLING CODE 4910–15–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD05–98–017]

RIN 2115–AE47

Drawbridge Operation Regulations;

Anacostia River, Washington, DC

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

temporarily changing the regulations

that govern the operation of the

Frederick Douglass Memorial (South

Capitol Street) bridge across Anacostia

River at mile 1.2 in Washington, D.C.

Beginning at 8 a.m. on March 11

through 11 p.m. on August 31, 1998,

this regulation authorizes the bridge to

remain closed to navigation. This action

is necessary to facilitate extensive

mechanical and electrical rehabilitation

and maintain the bridge’s operational

integrity.

DATES: This regulation is effective from

April 2, 1998 to 11 p.m. on August 31,

1998.

ADDRESSES: Douments as indicated in

this preamble are available for

inspection or copying at the office of the

Commander (Aowb), Fifth Coast Guard

District, Federal Building, 4th Floor, 431

Crawford Street, Portsmouth, Virginia

23704–5004, between 8 a.m. and 4:30

p.m., Monday through Friday, except

Federal holidays. The telephone number

is (757) 398–6222.