Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26291 

persons who intend to market this type 

of device must submit to FDA a 

premarket notification, prior to 

marketing the device, which contains 

information about the gene expression 

profiling test system for breast cancer 

prognosis they intend to market. 

II. What Is the Environmental Impact of 

This Rule? 

The agency has determined under 21 

CFR 25.34(b) 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. 

III. What Is the Economic Impact of 

This Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 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 impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive Order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of these 

devices into class II will relieve 

manufacturers of the device of the cost 

of complying with the premarket 

approval requirements of section 515 of 

the act (21 U.S.C. 360e), and may permit 

small potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Does This Final Rule Have 

Federalism Implications? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive Order and, consequently, 

a federalism summary impact statement 

is not required. 

V. How Does This Rule Comply With 

the Paperwork Reduction Act of 1995? 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VI. What References Are on Display? 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Agendia BV, dated January 

22, 2007. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, 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 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for 21 CFR 

part 866 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2. Section 866.6040 is added to 

subpart G to read as follows: 

§ 866.6040 Gene expression profiling test 

system for breast cancer prognosis. 

(a) Identification. A gene expression 

profiling test system for breast cancer 

prognosis is a device that measures the 

ribonucleic acid (RNA) expression level 

of multiple genes and combines this 

information to yield a signature (pattern 

or classifier or index) to aid in prognosis 

of previously diagnosed breast cancer. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Gene Expression Profiling Test System 

for Breast Cancer Prognosis.’’ See 

§ 866.1(e) for the availability of this 

guidance document. 

Dated: May 1, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–8871 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 935 

[OH–251–FOR] 

Ohio Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior. 

ACTION: Final rule; approval of 

amendment. 

SUMMARY: We are approving an 

amendment to the Ohio regulatory 

program (the ‘‘Ohio program’’) under 

the Surface Mining Control and 

Reclamation Act of 1977 (SMCRA or the 

Act). This amendment is intended to 

remove certain Conflict of Interest 

provisions from the approved Ohio 

program that were previously approved 

by OSM but have not been promulgated 

by Ohio through their rulemaking 

process. 

EFFECTIVE DATE: May 9, 2007. 

FOR FURTHER INFORMATION CONTACT: Mr. 

George Rieger, Chief, Pittsburgh Field 

Division, Telephone: (717) 782–4036. 

E-mail: grieger@osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Ohio Program 

II. Submission of the Amendment 

III. OSM’s Findings 

IV. Summary and Disposition of Comments 

V. OSM’s Decision 

VI. Procedural Determinations 

I. Background on the Ohio Program 

Section 503(a) of the Act permits a 

State to assume primacy for the 

regulation of surface coal mining and 

reclamation operations on non-Federal 

and non-Indian lands within its borders 

by demonstrating that its program 

includes, among other things, ‘‘a State 


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law which provides for the regulation of 

surface coal mining and reclamation 

operations in accordance with the 

requirements of the Act * * * and rules 

and regulations consistent with 

regulations issued by the Secretary 

pursuant to the Act.’’ See 30 U.S.C. 

1253(a)(1) and (7). On the basis of these 

criteria, the Secretary of the Interior 

conditionally approved the Ohio 

program on August 16, 1982. You can 

find background information on the 

Ohio program, including the Secretary’s 

findings, the disposition of comments, 

and conditions of approval of the Ohio 

program in the August 16, 1982, Federal 

Register (47 FR 34687). You can also 

find later actions concerning Ohio’s 

program and program amendments at 30 

CFR 935.11, 935.15, and 935.16. 

II. Submission of the Amendment 

By letter dated August 30, 2006, Ohio 

sent us a proposed amendment to its 

program (Administrative Record 

Number OH–2187–00) under SMCRA 

(30 U.S.C. 1201 et seq.). In its letter, 

Ohio stated that it has reviewed 

amendments previously proposed by 

Ohio in Program Amendment #69. Ohio 

stated that those amendments of 

program amendment #69 related to 

Conflict of Interest have not been 

promulgated by Ohio and are deemed to 

be no longer necessary. Therefore, Ohio 

stated, it would like to withdraw the 

Conflict of Interest amendments from 

consideration by OSM. 

OSM approved the Conflict of Interest 

amendments that Ohio proposed in 

program amendment #69 (including the 

subsequent revisions) in the Federal 

Register on July 17, 1995 (60 FR 36352). 

Because we had already published our 

approval of the Conflict of Interest 

provisions that Ohio has requested be 

withdrawn from consideration, we were 

unable to merely withdraw those 

provisions. Rather, we sought public 

comment on whether the removal of the 

Conflict of Interest provisions that we 

approved in 1995 would render the 

approved Ohio program less effective 

than SMCRA and the Federal 

regulations. 

Background Information: Ohio 

program amendment #69 was originally 

submitted by Ohio by letter dated 

September 22, 1994 (Administrative 

Record Number OH–2059). Revisions to 

amendment #69 were subsequently 

submitted by letters dated March 8, 

1995, and May 3, 1995 (Administrative 

Record Numbers OH–2099 and OH–

2115, respectively). We announced 

receipt of those proposed amendments, 

and the two revisions, in the October 21, 

1994; March 17, 1995; and May 12, 

1995; Federal Register (59 FR 53122, 60 

FR 14401, and 60 FR 25660, 

respectively). We approved the 

amendments in the July 17, 1995, 

Federal Register notice. 

We announced receipt of Ohio’s 

request that we remove the Conflict of 

Interest provisions from the approved 

Ohio program in the October 19, 2006, 

Federal Register ( 71 FR 61695). In the 

same document, we opened the public 

comment period and provided an 

opportunity for a public hearing or 

meeting on the adequacy of the 

proposed amendment (Administrative 

Record Number OH–2187–01). We did 

not hold a hearing or meeting because 

no one requested one. The public 

comment period ended on November 

20, 2006. We received no comments. 

III. OSM’s Findings 

Following are the findings we made 

concerning the amendment under 

SMCRA and the Federal regulations at 

30 CFR 732.15 and 732.17. We are 

approving the amendment. Any 

revisions that we do not specifically 

discuss below concern nonsubstantive 

minor wording, editorial, or 

renumbering of sections changes, and 

are approved herein without discussion. 

Restrictions on Financial Interest of 

Employees. Ohio Administrative Code 

(OAC) Section 1501:13–1–03 

1. OAC 1501: 13–1–03(D)(2) Definition 

of ‘‘Employee’’

In its September 22, 1994, 

amendment, Ohio proposed to revise 

the definition of ‘‘Employee’’ at 

paragraph (D)(2) to provide that 

members of the Ohio Board (currently 

‘‘Council’’) on Unreclaimed Strip Mined 

Lands are included under the definition 

of ‘‘employee.’’ Ohio also proposed to 

revise this paragraph to provide that, for 

the purposes of OAC Section 1501:13–

1–03, hearing officers for the Ohio 

Reclamation Board of Review (currently 

the Reclamation Commission) shall also 

be included within the definition of 

‘‘employee.’’ Ohio also proposed to 

revise the appeal procedures at 

paragraphs (L)(1) and (2) to delete 

separate references to the Reclamation 

Commission’s hearing officers because 

those hearing officers are to be included 

under the definition of ‘‘employee’’ in 

this rule. We approved these revisions 

in our July 17, 1995, notice. 

In its August 30, 2006, letter to OSM, 

Ohio requested that the provisions that 

OSM approved on July 17, 1995, be 

withdrawn. Under this request, 

therefore, neither members of the 

Council nor hearing officers for the 

Reclamation Commission would be 

specifically identified as ‘‘employees’’

under the definition of ‘‘employee’’ at 

paragraph (D)(2). To approve these 

deletions from the Ohio provisions that 

were approved by OSM, we must 

determine whether the deletions render 

the Ohio program less effective than the 

Federal definition of ‘‘employee’’ at 30 

CFR 705.5. 

The Federal definition of ‘‘employee’’

at 30 CFR 705.5 provides as follows: 

Employee. Means (a) any person employed 

by the State Regulatory Authority who 

performs any function or duty under the Act, 

and (b) advisory board or commission 

members and consultants who perform any 

function or duty under the Act, if they 

perform decisionmaking functions for the 

State Regulatory Authority under the 

authority of State law or regulations. 

However, members of advisory boards or 

commissions established in accordance with 

State law or regulations to represent multiple 

interests are not considered to be employees. 

State officials may through State law or 

regulations expand this definition to meet 

their program needs. 

The Ohio Revised Code (ORC) at 

section 1513.29 establishes the Council. 

Under ORC 1513.29, the Council’s 

duties involve gathering information on 

unreclaimed strip mined lands, 

studying, and making recommendations 

concerning eroded land within the 

State, including land affected by strip 

mining for which no cash is held in the 

strip mining reclamation fund. In 

addition, an Ohio Attorney General’s 

Opinion from 1978 states that the 

Council ‘‘has the authority as a matter 

of law to fund reclamation projects on 

private lands pursuant to Chapter 1513 

of the Revised Code * * *.’’ (Ohio Op. 

Atty Gen No. 78–016) That is, members 

of the Council perform a function or 

duty under Chapter 1513 of the Ohio 

Revised Code, and fall within the 

definition of ‘‘employee’’ in OAC 1501: 

13–1–03. We find that the existing Ohio 

definition of ‘‘employee’’ which does 

not specifically identify members of the 

Council as employees does not render 

the Ohio program less effective than the 

Federal definition of ‘‘employee’’ at 30 

CFR 705.5 and can be approved. 

Next, we will consider whether 

hearing officers for the Reclamation 

Commission are considered employees 

under the Federal regulations. The ORC 

at 1513.05 establishes the Reclamation 

Commission. That provision also 

provides that ‘‘The commission shall 

appoint one or more hearing officers 

who shall be attorneys at law admitted 

to practice in this state to conduct 

hearings under this chapter.’’ Therefore, 

it is clear that hearing officers for the 

Reclamation Commission are not 

members of the Reclamation 

Commission, but are appointed by the 


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Reclamation Commission to conduct 

hearings. It is our understanding that 

the hearing officer for the Reclamation 

Commission is an employee of the Ohio 

Department of Natural Resources and is 

considered by that department to be an 

‘‘employee’’ under the Ohio definition 

of ‘‘employee’’ at OAC 1501: 13–1–03 

and is required to file the appropriate 

conflict of interest forms under OAC 

1501: 13–1–03(I). Therefore, we find 

that the existing Ohio definition of 

‘‘employee’’ which does not specifically 

identify hearing officers for the 

Reclamation Commission as employees 

does not render the Ohio program less 

effective than the Federal definition of 

‘‘employee’’ at 30 CFR 705.5 and can be 

approved. Our approval is based upon 

our understanding noted above. 

2. OAC 1501: 13–1–03(I)(1) Use of 

Financial Interest Statement Form by 

Members of the Ohio Reclamation 

Commission 

In its September 22, 1994, 

amendment, Ohio proposed to revise 

paragraph (I)(1) to add that members of 

the Ohio Reclamation Board of Review 

(currently Reclamation Commission) 

shall report all required information 

concerning employment and financial 

interests on Form OSM–23. We 

approved the provisions on July 17, 

1995. On August 30, 2006, Ohio 

requested that its amendments to 

paragraph (I)(1) that we approved in 

1995 be withdrawn. In effect, the phrase 

‘‘and members of the Reclamation Board 

of Review’’ (currently the Reclamation 

Commission) will be deleted from 

provision concerning what to file at 

OAC 1501: 13–1–03(I)(1). 

The Federal regulations at 30 CFR 

705.11(a) provide that employees and 

members of advisory boards and 

commissions established in accordance 

with State laws or regulations to 

represent multiple interests, who 

perform a function or duty under 

SMCRA, must file a statement of 

employment and financial interests. The 

Ohio Reclamation Commission is such a 

multi-interest advisory board and, 

therefore, must file a statement of 

employment and financial interests. 

The current Ohio provision at OAC 

1501: 13–1–03(F)(1), concerning who 

shall file, provides that members of the 

Reclamation Commission are required 

to file a statement of employment and 

financial interests. Therefore, despite 

the fact that OAC 1501: 13–1–03(I)(1) 

concerning what to file does not 

specifically mention members of the 

Reclamation Commission, the 

Commission members are required to 

file by Ohio’s regulations. Therefore, we 

find that the existing Ohio provision at 

OAC 1501: 13–1–03(I)(1), despite the 

fact that it does not specifically mention 

members of the Reclamation 

Commission definition, does not render 

the Ohio program less effective than the 

Federal regulations at 30 CFR 705.11(a) 

and can be approved. 

We note that OAC 1501: 13–1–03(I)(1) 

provides that the report shall be on 

‘‘OSM Form 705–1’’ as provided by 

OSM. This form number is not correct. 

The form that OSM will provide for 

reporting financial interests is OSM 

‘‘Form 23.’’

3. OAC 1501: 13–1–03(J)(1) Acceptance 

of Gifts and Gratuities by Members of 

the Ohio Reclamation Commission 

In its September 22, 1994, 

amendment, Ohio proposed to revise 

paragraph (J)(1) to prohibit, with certain 

exceptions, the solicitation or 

acceptance of gifts and gratuities by 

members of the Ohio Reclamation Board 

of Review (currently Reclamation 

Commission) from coal companies 

which are conducting or seeking to 

conduct regulated activities or which 

have an interest that may be 

substantially affected by the 

performance of the Reclamation 

Commission members’ official duties. 

We approved the provisions on July 17, 

1995. 

On August 30, 2006, Ohio requested 

that its amendments to paragraph (J)(1) 

that we approved be withdrawn. In 

effect, the phrase ‘‘and members of the 

Reclamation Board of Review’’ will be 

deleted from the approved Ohio 

program at OAC 1501: 13–1–03(J)(1) 

concerning gifts and gratuities. Despite 

the fact that the Ohio provision at OAC 

1501: 13–1–03(J)(1) does not prohibit 

members of the Reclamation 

Commission from soliciting or accepting 

gifts or any other thing of monetary 

value, the Ohio program is not rendered 

less effective than the Federal 

regulations at 30 CFR 705.18 concerning 

gifts and gratuities. Without the 

language that we approved on July 17, 

1995, the State rule at OAC 1501: 13–

1–03(J)(1) is substantively identical to 

the counterpart Federal regulations at 30 

CFR 705.18(a) concerning the 

prohibitions against soliciting or 

receiving gifts and gratuities. That is, 

the Federal regulations do not require 

that members of multi-interest boards 

such as the Reclamation Commission 

must comply with the prohibitions 

against soliciting or receiving gifts and 

gratuities at 30 CFR 705.18. 

The Federal regulations at 30 CFR 

705.4(d) do provide, however, that 

members of multi-interest boards must 

recuse themselves from proceedings 

which may affect their direct or indirect 

financial interests. The counterpart 

State provision concerning recusal is 

OAC 1501: 13–1–03(C). Additionally, 

the Federal regulations at 30 CFR 

705.11(a) provide that members of 

multi-interest boards must file a 

statement of employment and financial 

interests. The counterpart State 

provision concerning the requirement 

for members of multi-interest boards to 

file a statement of employment and 

financial interests is OAC 1501: 13–1–

03(F)(1). Therefore, we find that the 

removal of the words ‘‘and members of 

the Reclamation Board of Review’’ from 

OAC 1501: 13–1–03(J)(1) does not 

render the Ohio provision less effective 

than the counterpart Federal regulation 

at 30 CFR 705.18(a) and can be 

approved. 

4. OAC 1501: 13–1–03(L)(1) Appeal of 

Remedial Actions 

In its September 22, 1994, 

amendment, Ohio proposed to revise 

paragraph (L)(1) to add that nothing in 

OAC Section 1501:13–1–03 modifies 

any right of appeal that any employee 

may have under State law of a decision 

by the Chief of the Division of Natural 

Resources, on an employee’s appeal of 

remedial action for prohibited financial 

interests. The State also deleted the 

words ‘‘and such board’s hearing 

officers’’ from the provision. We 

approved the provisions on July 17, 

1995. 

On August 30, 2006, Ohio requested 

that the amendment to paragraph (L)(1) 

that we approved be withdrawn. The 

existing State provision at OAC 1501: 

13–1–03(L)(1), without the language that 

the State has requested be removed from 

the approved program, provides as 

follows: 

(1) Employees other than the chief of the 

Division of Mineral Resources Management 

and members of the reclamation commission 

and such commission’s hearing officers may 

file their appeal in writing with the chief, 

who will conduct an informal hearing on the 

merits. 

The counterpart Federal regulations at 

30 CFR 705.21(a) concerning appeals 

procedures provide as follows: 

(a) Employees other than the Head of the 

State Regulatory Authority, may file their 

appeal, in writing, through established 

procedures within their particular State. 

The Federal regulation at 30 CFR 

705.21(a) that is quoted above provides 

that conflict of interest appeal 

procedures for employees within a State 

should be governed by established 

procedures within the State. That is, the 

Federal conflict of interest provisions 

provide that the State has the discretion 

to establish its own appeal procedures. 


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Additionally, the Federal regulations at 

30 CFR 705.21(a) do not contain a 

counterpart to the language that Ohio 

wishes to be deleted from the approved 

program, which provides that nothing in 

the rule modifies any right of appeal of 

the Chief’s decision that any employee 

may have under State law. Therefore, 

the removal of that language does not 

render OAC 1501: 13–1–03(L)(1) less 

effective than the Federal regulations at 

30 CFR 705.21(a). Therefore, we find 

that the existing State provision at OAC 

1501: 13–1–03(L)(1) is not inconsistent 

with the Federal conflict of interest 

provisions at 30 CFR 705.21 and can be 

approved. 

5. OAC 1501: 13–1–03(L)(2) Appeal of 

Remedial Actions 

In its September 22, 1994, 

amendment, Ohio proposed to revise 

paragraph (L)(2) by deleting language so 

that paragraph (L)(2) provides that only 

the Chief of the Division of Reclamation 

(currently the Division of Mineral 

Resources Management) may appeal a 

remedial action to the Director of OSM. 

We approved the proposed deletion of 

language on July 17, 1995. 

On August 30, 2006, Ohio requested 

that the proposed deletion at paragraph 

(L)(2) that we approved be withdrawn. 

As a result, the existing State provision 

at OAC 1501: 13–1–03(L)(2) provides as 

follows: 

(2) The chief of the Division of Mineral 

Resources Management and members of the 

reclamation commission and such 

commission’s hearing officers may file their 

appeal in writing, with the director of the 

office of surface mining reclamation and 

enforcement, who will refer it to the conflict 

of interest appeals board within the United 

States Department of the Interior. 

Under paragraph (L)(2), therefore, the 

Chief of the Division of Mineral 

Resources Management, members of the 

Reclamation Commission, and the 

Commission’s hearing officers may file 

their appeals of orders for remedial 

action under paragraph (K) with OSM. 

Under the Federal regulations, appeal 

procedures for employees are specified 

at 30 CFR 705.21(a), which provides 

that employees may file their appeals 

through established procedures within 

their respective States. Under the 

Federal regulations, appeal procedures 

for the head of the regulatory authority 

are specified at 30 CFR 705.21(b), which 

provides that the head of the State 

regulatory authority may file an appeal 

with OSM who will refer it to the 

Conflict of Interest Appeals Board 

within the Department of the Interior. 

Insofar as it applies to the Chief of the 

Division of Mineral Resources 

Management, who is the head of the 

Ohio Regulatory Authority, restored 

paragraph (L)(2) is substantively 

identical to, and therefore no less 

effective than, the Federal regulations at 

30 CFR 705.21(b). With respect to 

Reclamation Commission hearing 

officers, who are ‘‘employees’’ under 

Ohio’s approved program, restored 

paragraph (L)(2) is no less effective than 

30 CFR 705.21(a), which allows States 

to establish appeal procedures for all 

employees except for the head of the 

regulatory authority. For hearing 

officers, the ‘‘established procedures’’ in 

Ohio will be those applicable to the 

United States Department of the 

Interior’s Conflict of Interest Appeals 

Board. Finally, there are no specific 

Federal provisions concerning appeals 

of conflict of interest decisions by 

members of multiple interest boards, 

such as members of Ohio’s Reclamation 

Commission. However, nothing in 

SMCRA or the Federal regulations 

prohibits Ohio from allowing these 

members to appeal these types of 

decisions. Therefore, restored paragraph 

(L)(2) is not inconsistent with SMCRA 

or the Federal regulations insofar as it 

applies to members of the Reclamation 

Commission. For all of these reasons, 

we are approving restored paragraph 

(L)(2). 

6. OAC 1501: 13–1–03(L)(3) Appeal of 

Remedial Actions 

In its September 22, 1994, 

amendment, Ohio proposed to add new 

paragraph (L)(3) to provide that 

members of the Ohio Reclamation Board 

of Review (currently the Reclamation 

Commission) may request advisory 

opinions from the Director of OSM on 

issues pertaining to an apparent 

prohibited financial interest. The 

provision also stated that resolution of 

conflicts is governed by section 1513.05 

and 1513.29 of the Ohio Revised Code. 

We approved the proposed new 

language on July 17, 1995. 

On August 30, 2006, Ohio requested 

that the proposed new language at 

paragraph (L)(3) that we approved be 

withdrawn. As noted above at Finding 

5, the existing Ohio provision at OAC 

1501: 13–1–03(L)(2) provides that 

members of the Reclamation 

Commission and such Commission’s 

hearing officers may file an appeal in 

writing, with the Director of OSM. 

Therefore, the provision that we 

approved on July 17, 1995, at OAC 

1501: 13–1–03(L)(3), which also 

provides that members of the 

Commission may request advisory 

opinions from OSM is not necessary. 

We find that the removal of paragraph 

(L)(3) from the approved Ohio program 

does not render the Ohio program less 

effective than the Federal regulations at 

30 CFR 705.21 concerning appeal 

procedures and can be approved. We 

note that the language at paragraph 

(L)(3) also provided that resolution of 

conflicts is governed by section 1513.05 

of the Ohio Revised Code. However, the 

removal of paragraph (L)(3) from the 

Ohio program does not negate the fact 

that the provisions at ORC 1513.05 and 

1513.29 continue to apply to the 

Reclamation Commission. 

IV. Summary and Disposition of 

Comments 

Public Comments 

On October 19, 2006, we published a 

Federal Register notice and asked for 

public comments of the amendment 

(Administrative Record Number OH–

OH–2187–01). No comments were 

received. 

Federal Agency Comments 

Under 30 CFR 732.17(h)(11)(i) and 

section 503(b) of SMCRA, we requested 

comments on the amendment from 

various Federal agencies with an actual 

or potential interest in the Ohio program 

(Administrative Record Number OH–

2187–02). No comments were received. 

Environmental Protection Agency (EPA) 

Concurrence and Comments 

Under 30 CFR 732.17(h)(11) (ii), we 

are required to obtain written 

concurrence from EPA for those 

provisions of the program amendment 

that relate to air or water quality 

standards issued 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.). None of the revisions that 

Ohio proposed to make in this 

amendment pertain to air or water 

quality standards. Therefore, we did not 

ask EPA to concur on the amendment. 

Under 30 CFR 732.17(h)(11)(i), we 

requested comments on the amendment 

from EPA (Administrative Record 

Number OH–2187–02). No EPA 

comments were received. 

V. OSM’s Decision 

Based on the above findings, we are 

approving, the program amendment that 

Ohio sent to us on August 30, 2006. 

To implement this decision, we are 

amending the Federal regulations at 30 

CFR part 935, which codify decisions 

concerning the Ohio program. We find 

that good cause exists under 5 U.S.C. 

553(d)(3) to make this final rule 

effective immediately. Section 503(a) of 

SMCRA requires that the State’s 

program demonstrate that the State has 

the capability of carrying out the 

provisions of the Act and meeting its 

purposes. Making this rule effective 


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immediately will expedite that process. 

SMCRA requires consistency of State 

and Federal standards. 

VI. Procedural Determinations 

Executive Order 12630—Takings 

This rule does not have takings 

implications. This determination is 

based on the analysis performed for the 

counterpart Federal regulations. 

Executive Order 12866—Regulatory 

Planning and Review 

This rule is exempted from review by 

the Office of Management and Budget 

(OMB) under Executive Order 12866. 

Executive Order 12988—Civil Justice 

Reform 

The Department of the Interior has 

conducted the reviews required by 

section 3 of Executive Order 12988 and 

has determined that, to the extent 

allowable 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 

the Federal regulations at 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. 

Executive Order 13132—Federalism 

This rule does not have Federalism 

implications. SMCRA delineates the 

roles of the Federal and State 

governments with regard to the 

regulation of surface coal mining and 

reclamation operations. One of the 

purposes of SMCRA is to ‘‘establish a 

nationwide program to protect society 

and the environment from the adverse 

effects of surface coal mining 

operations.’’ Section 503(a)(1) of 

SMCRA requires that State laws 

regulating surface coal mining and 

reclamation operations be ‘‘in 

accordance with’’ the requirements of 

SMCRA. Section 503(a)(7) requires that 

State programs contain rules and 

regulations ‘‘consistent with’’

regulations issued by the Secretary 

pursuant to SMCRA. 

Executive Order 13175—Consultation 

and Coordination With Indian Tribal 

Governments 

In accordance with Executive Order 

13175, we have evaluated the potential 

effects of this rule on Federallyrecognized Indian tribes and have 

determined that the rule does not have 

substantial direct effects on one or more 

Indian tribes, on the relationship 

between the Federal Government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

The basis for this determination is that 

our decision is on a State regulatory 

program and does not involve a Federal 

program involving Indian lands. 

Executive Order 13211—Regulations 

That Significantly Affect the Supply, 

Distribution, or Use of Energy 

On May 18, 2001, the President issued 

Executive Order 13211 which requires 

agencies to prepare a Statement of 

Energy Effects for a rule that is (1) 

considered significant under Executive 

Order 12866, and (2) likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Because 

this rule is exempt from review under 

Executive Order 12866 and is not 

expected to have a significant adverse 

effect on the supply, distribution, or use 

of energy, a Statement of Energy Effects 

is not required. 

National Environmental Policy Act 

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

1292(d)) provides that a decision on a 

proposed State regulatory program 

provision does not constitute a major 

Federal action within the meaning of 

section 102(2)(C) of the National 

Environmental Policy Act (42 U.S.C. 

4332(2)(C)). A determination has been 

made that such decisions are 

categorically excluded from the NEPA 

process (516 DM 8.4.A). 

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 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

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

that is the subject of this rule is based 

upon counterpart 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 for the 

counterpart Federal regulations. 

Small Business Regulatory Enforcement 

Fairness Act 

This rule is not a major rule under 5 

U.S.C. 804(2), the Small Business 

Regulatory Enforcement Fairness Act. 

This rule: (a) Does not have an annual 

effect on the economy of $100 million; 

(b) Will not cause a major increase in 

costs or prices for consumers, 

individual industries, geographic 

regions, or Federal, State or local 

governmental agencies; and (c) Does not 

have significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of U.S.-based enterprises to compete 

with foreign-based enterprises. This 

determination is based upon the fact 

that the State submittal, which is the 

subject of this rule, is based upon 

counterpart Federal regulations for 

which an analysis was prepared and a 

determination made that the Federal 

regulation was not considered a major 

rule. 

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 935 

Intergovernmental relations, Surface 

mining, Underground mining. 

Dated: March 15, 2007. 

H. Vann Weaver, 

Acting Regional Director, Appalachian 

Region. 

■ For the reasons set out in the 

preamble, 30 CFR part 935 is amended 

as set forth below: 

PART 935—OHIO 

■ 1. The authority citation for part 935 

continues to read as follows: 

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

■ 2. Section 935.15 is amended by 

adding a new entry to the table in 

chronological order by ‘‘Date of final 

publication’’ to read as follows: 

§ 935.15 Approval of Ohio regulatory 

program amendments. 

* * * * * 


rmajette on PROD1PC67 with RULES
26296 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

Original amendment submission date Date of final publication Citation/description 

* * * * * * * 

August 30, 2006 ................................................ May 9, 2007 ...................................................... OAC 1501:13–1–03(D)(2), (I)(1), (J)(1), (L)(1), 

(L)(2), and the deletion of (L)(3). 

[FR Doc. E7–8867 Filed 5–8–07; 8:45 am] 

BILLING CODE 4310–05–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[COTP San Francisco Bay 07–006] 

RIN 1625–AA00 

Safety Zone; KFOG ‘‘Kaboom’’

Fireworks Display, San Francisco Bay, 

CA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone in 

the navigable waters of San Francisco 

Bay for the loading, transport, inactive 

period, and launching of fireworks used 

during the KFOG ‘‘KaBoom’’ Fireworks 

Display to be held on May 12, 2007. 

This safety zone is intended to prohibit 

vessels and people from entering into or 

remaining within the regulated areas in 

order to ensure the safety of participants 

and spectators. 

DATES: This rule is effective from 8 a.m. 

on May 10, 2007, to 9:30 p.m. on May 

12, 2007. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket, are part of docket COTP San 

Francisco Bay 07–006 and are available 

for inspection or copying at Coast Guard 

Sector San Francisco, 1 Yerba Buena 

Island, San Francisco, California, 94130, 

between 9 a.m. and 4 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Ensign Sheral Richardson, U.S. Coast 

Guard Sector San Francisco, at (415) 

556–2950 extension 136. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds that good cause exists 

for not publishing an NPRM. Logistical 

details surrounding the event were not 

finalized and presented to the Coast 

Guard in time to draft and publish an 

NPRM. As such, the event would occur 

before the rulemaking process was 

complete. Because of the dangers posed 

by the pyrotechnics used in this 

fireworks display, safety zones are 

necessary to provide for the safety of 

event participants, spectator craft, and 

other vessels transiting the event area. 

For the safety concerns noted, it is in 

the public interest to have these 

regulations in effect during the event. 

For the same reasons listed in the 

previous paragraph, under 5 U.S.C. 

553(d)(3), the Coast Guard finds that 

good cause exists for making this rule 

effective less than 30 days after 

publication in the Federal Register. Any 

delay in the effective date of this rule 

would expose mariners to the dangers 

posed by the pyrotechnics used in this 

fireworks display. 

Background and Purpose 

The San Francisco Radio Station 

KFOG is sponsoring a brief fireworks 

display on May 12, 2007 in the waters 

of San Francisco Bay near Piers 30 and 

32. The fireworks display is meant for 

entertainment purposes in support of 

KFOG’s annual festival in San 

Francisco. This safety zone is being 

issued to establish a temporary 

regulated area in San Francisco Bay 

around the fireworks launch barge 

during the loading of the pyrotechnics, 

during the transit of the barge to the 

display location, inactive period, and 

during the fireworks display. This 

temporary regulated area around the 

launch barge is necessary to protect 

spectators, vessels, and other property 

from the hazards associated with the 

pyrotechnics on the fireworks barge. 

The Coast Guard has granted the event 

sponsor a marine event permit for the 

fireworks display. 

Discussion of Rule 

The Coast Guard is establishing a 

temporary safety zone on specified 

waters off of the San Francisco 

waterfront. During the loading of the 

fireworks barge, while the barge is being 

towed to the display location, and until 

the start of the fireworks display, the 

safety zone will apply to the navigable 

waters around and under the fireworks 

barge within a radius of 100 feet. Fifteen 

minutes prior to and during the twentytwo minute fireworks display, the area 

to which this safety zone applies to will 

increase in size to encompass the 

navigable waters around and under the 

fireworks barge within a radius of 1,000 

feet. Loading of the pyrotechnics onto 

the fireworks barge is scheduled to 

commence at 8 a.m. on May 10, 2007, 

and will take place at Pier 50 in San 

Francisco. Towing of the barge from Pier 

50 to the display location is scheduled 

to take place on May 12, 2007. During 

the fireworks display, scheduled to 

commence at 9 p.m. on May 12, 2007, 

the fireworks barge will be located 

approximately 1,000 feet off of Pier 30 

in position 37°47.21′ N, 122°22.86′ W. 

The effect of the temporary safety 

zone will be to restrict general 

navigation in the vicinity of the 

fireworks barge while the fireworks are 

loaded at Pier 50, during the transit of 

the fireworks barge, and until the 

conclusion of the scheduled display. 

Except for persons or vessels authorized 

by the Coast Guard Patrol Commander, 

no person or vessel may enter or remain 

in the safety zone. This safety zone is 

needed to keep spectators and vessels a 

safe distance away from the fireworks 

barge to ensure the safety of 

participants, spectators, and transiting 

vessels. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. 

Although this rule restricts access to 

the waters encompassed by the safety 

zone, the effect of this rule will not be 

significant because the local waterway 

users will be notified via public 

broadcast notice to mariners to ensure 

the safety zone will result in minimum 

impact. The entities most likely to be 

affected are pleasure craft engaged in 

recreational activities. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 


rmajette on PROD1PC67 with RULES