Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Rules and Regulations 42175 

Issued in Washington, DC, on August 17, 

2009. 

Pamela Hamilton-Powell, 

Director, Office of Rulemaking. 

[FR Doc. E9–20059 Filed 8–20–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 601 

[Docket No. FDA–2009–N–0100] 

Revision of the Requirements for 

Publication of License Revocation; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of September 17, 2009, for 

the direct final rule that appeared in the 

Federal Register of May 5, 2009 (74 FR 

20583). The direct final rule amends the 

biologics regulations to clarify the 

regulatory procedures for notifying the 

public about the revocation of a 

biologics license. The rule provides that 

FDA will publish a notice in the Federal 

Register following revocation of a 

biologics license under FDA regulations 

and will include a statement of the 

specific grounds for the revocation. This 

document confirms the effective date of 

the direct final rule. 

DATES: Effective date confirmed: 

September 17, 2009. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 5, 2009 (74 FR 

20583), FDA issued a direct final rule 

amending the biologics regulations for 

notifying the public about the 

revocation of a biologics license by 

clarifying that FDA will publish a notice 

of license revocation in cases where the 

Commissioner has made a finding that 

reasonable grounds for revocation exist 

under 21 CFR 601.5(b). The rule, as 

amended, does not affect other 

regulations or procedures for 

notification of license revocation. The 

rule, as amended, also does not affect 

existing FDA practices for publishing 

notices of voluntary withdrawal, 

including notices of voluntary 

withdrawal of new drug applications. 

FDA solicited comments concerning 

the direct final rule for a 75-day period 

ending July 20, 2009. FDA stated that 

the effective date of the direct final rule 

would be on September 17, 2009, 60 

days after the end of the comment 

period, unless any significant adverse 

comment was submitted to FDA during 

the comment period. FDA did not 

receive any significant adverse 

comments. 

Authority: Therefore, under the biological 

products provisions under the Federal Food, 

Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food and 

Drugs, 21 CFR part 601 is amended. 

Accordingly, the amendments issued thereby 

are effective. 

Dated: August 14, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20119 Filed 8–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 55 

[OAR–2004–0091; FRL–8941–3] 

Outer Continental Shelf Air 

Regulations; Consistency Update for 

California 

AGENCY: Environmental Protection 

Agency (‘‘EPA’’). 

ACTION: Final rule. 

SUMMARY: EPA is finalizing the update 

of the Outer Continental Shelf (‘‘OCS’’) 

Air Regulations proposed in the Federal 

Register on April 20, 2009. 

Requirements applying to OCS sources 

located within 25 miles of states’ 

seaward boundaries must be updated 

periodically to remain consistent with 

the requirements of the corresponding 

onshore area (‘‘COA’’), as mandated by 

section 328(a)(1) of the Clean Air Act 

Amendments of 1990 (‘‘the Act’’). The 

portion of the OCS air regulations that 

is being updated pertains to the 

requirements for OCS sources for which 

the Santa Barbara County Air Pollution 

Control District (Santa Barbara County 

APCD) is the designated COA. The 

intended effect of approving the 

requirements contained in the ‘‘Santa 

Barbara County Air Pollution Control 

District Requirements Applicable to 

OCS Sources’’ (June 2009) is to regulate 

emissions from OCS sources in 

accordance with the requirements 

onshore. 

DATES: Effective Date: This rule is 

effective on September 21, 2009. 

The incorporation by reference of 

certain publications listed in this rule is 

approved by the Director of the Federal 

Register as of September 21, 2009. 

ADDRESSES: EPA has established docket 

number OAR–2004–0091 for this action. 

The index to the docket is available 

electronically at http:// 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

either location (e.g., CBI). To inspect the 

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia G. Allen, Air Division, U.S. 

EPA Region IX, (415) 947–4120, 

allen.cynthia@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, the terms 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ refer to U.S. EPA. 

Organization of this document: The 

following outline is provided to aid in 

locating information in this preamble. 

Table of Contents 

I. Background 

II. Public Comment 

III. EPA Action 

IV. Statutory and Executive Order Reviews 

I. Background 

On April 20, 2009 (74 FR 17934), EPA 

proposed to approve requirements into 

the OCS Air Regulations pertaining to 

Santa Barbara County APCD. These 

requirements are being promulgated in 

response to the submittal of rules from 

this California air pollution control 

agency. EPA has evaluated the proposed 

requirements to ensure that they are 

rationally related to the attainment or 

maintenance of federal or state ambient 

air quality standards or Part C of title I 

of the Act, that they are not designed 

expressly to prevent exploration and 

development of the OCS and that they 

are applicable to OCS sources. 40 CFR 

55.1. EPA has also evaluated the rules 

to ensure that they are not arbitrary or 

capricious. 40 CFR 55.12(e). In addition, 

EPA has excluded administrative or 

procedural rules. 

Section 328(a) of the Act requires that 

EPA establish requirements to control 

air pollution from OCS sources located 

within 25 miles of states’ seaward 

boundaries that are the same as onshore 

requirements. To comply with this 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
42176 Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Rules and Regulations 

statutory mandate, EPA must 

incorporate applicable onshore rules 

into 40 CFR part 55 as they exist 

onshore. This limits EPA’s flexibility in 

deciding which requirements will be 

incorporated into part 55 and prevents 

EPA from making substantive changes 

to the requirements it incorporates. As 

a result, EPA may be incorporating rules 

into part 55 that do not conform to all 

of EPA’s state implementation plan 

(SIP) guidance or certain requirements 

of the Act. Consistency updates may 

result in the inclusion of State or local 

rules or regulations into part 55, even 

though the same rules may ultimately be 

disapproved for inclusion as part of the 

SIP. Inclusion in the OCS rule does not 

imply that a rule meets the requirements 

of the Act for SIP approval, nor does it 

imply that the rule will be approved by 

EPA for inclusion in the SIP. 

II. Public Comment 

EPA’s proposed actions provided a 

30-day public comment period. During 

this period, we received no comments 

on the proposed action. 

III. EPA Action 

In this document, EPA takes final 

action to incorporate the proposed 

changes into 40 CFR part 55. No 

changes were made to the proposed 

action. EPA is approving the proposed 

action under section 328(a)(1) of the 

Act, 42 U.S.C. 7627. Section 328(a) of 

the Act requires that EPA establish 

requirements to control air pollution 

from OCS sources located within 25 

miles of states’ seaward boundaries that 

are the same as onshore requirements. 

To comply with this statutory mandate, 

EPA must incorporate applicable 

onshore rules into Part 55 as they exist 

onshore. 

IV. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to establish 

requirements to control air pollution 

from OCS sources located within 25 

miles of States’ seaward boundaries that 

are the same as onshore air control 

requirements. To comply with this 

statutory mandate, EPA must 

incorporate applicable onshore rules 

into part 55 as they exist onshore. 42 

U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, 

in promulgating OCS consistency 

updates, EPA’s role is to maintain 

consistency between OCS regulations 

and the regulations of onshore areas, 

provided that they meet the criteria of 

the Clean Air Act. Accordingly, this 

action simply updates the existing OCS 

requirements to make them consistent 

with requirements onshore, without the 

exercise of any policy discretion by 

EPA. For that reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because it does not 

have a substantial direct effect 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, 

nor does it impose substantial direct 

compliance costs on tribal governments, 

nor preempt tribal law. 

Under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., OMB has approved the 

information collection requirements 

contained in 40 CFR part 55 and, by 

extension, this update to the rules, and 

has assigned OMB control number 

2060–0249. Notice of OMB’s approval of 

EPA Information Collection Request 

(‘‘ICR’’) No. 1601.06 was published in 

the Federal Register on March 1, 2006 

(71 FR 10499–10500). The approval 

expires January 31, 2009. As EPA 

previously indicated (70 FR 65897– 

65898 (November 1, 2005)), the annual 

public reporting and recordkeeping 

burden for collection of information 

under 40 CFR part 55 is estimated to 

average 549 hours per response. Burden 

means the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, or disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; develop, acquire, 

install, and utilize technology and 

systems for the purposes of collecting, 

validating, and verifying information, 

processing and maintaining 

information, and disclosing and 

providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements; train personnel to be able 

to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

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. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9 and are 

identified on the form and/or 

instrument, if applicable. In addition, 

the table in 40 CFR part 9 of currently 

approved OMB control numbers for 

various regulations lists the regulatory 

citations for the information 

requirements contained in 40 CFR part 

55. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this action and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by September 21, 

2009. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this action for the purposes of judicial 


CPrice-Sewell on DSKGBLS3C1PROD with RULES
Federal Register / Vol. 74, No. 161 / Friday, August 21, 2009 / Rules and Regulations 42177 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 55 

Environmental protection, 

Administrative practice and procedures, 

Air pollution control, Hydrocarbons, 

Incorporation by reference, 

Intergovernmental relations, Nitrogen 

dioxide, Nitrogen oxides, Outer 

Continental Shelf, Ozone, Particulate 

matter, Permits, Reporting and 

recordkeeping requirements, Sulfur 

oxides. 

Dated: June 24, 2009. 

Jane Diamond, 

Acting Regional Administrator, Region IX. 

■ Title 40, chapter I of the Code of 

Federal Regulations is amended as 

follows: 

PART 55—[AMENDED] 

■ 1. The authority citation for part 55 

continues to read as follows: 

Authority: Section 328 of the Clean Air 

Act (42 U.S.C. 7401 et seq.) as amended by 

Public Law 101–549. 

■ 2. Section 55.14 is amended by 

revising paragraph (e)(3)(ii)(F) to read as 

follows: 

§ 55.14 Requirements that apply to OCS 

sources located within 25 miles of states 

seaward boundaries, by state. 

* * * * * 

(e) * * * 

(3) * * * 

(ii) * * * 

(F) Santa Barbara County Air 

Pollution Control District Requirements 

Applicable to OCS Sources, June, 2009. 

* * * * * 

■ 3. Appendix A to CFR Part 55 is 

amended by revising paragraph (b)(6) 

under the heading ‘‘California’’ to read 

as follows: 

Appendix A to Part 55—Listing of State 

and Local Requirements Incorporated 

by Reference Into Part 55, by State 

* * * * * 

California 

(b) * * * 

* * * * * 

(6) The following requirements are 

contained in Santa Barbara County Air 

Pollution Control District Requirements 

Applicable to OCS Sources: 

Rule 102 Definitions (Adopted 01/15/09) 

Rule 103 Severability (Adopted 10/23/78) 

Rule 106 Notice to Comply for Minor 

Violations (Repealed 01/01/2001) 

Rule 107 Emergencies (Adopted 04/19/01) 

Rule 201 Permits Required (Adopted 

06/19/08) 

Rule 202 Exemptions to Rule 201 (Adopted 

06/19/08) 

Rule 203 Transfer (Adopted 04/17/97) 

Rule 204 Applications (Adopted 04/17/97) 

Rule 205 Standards for Granting Permits 

(Adopted 04/17/97) 

Rule 206 Conditional Approval of 

Authority to Construct or Permit to Operate 

(Adopted 10/15/91) 

Rule 207 Denial of Application (Adopted 

10/23/78) 

Rule 210 Fees (Adopted 03/17/05) 

Rule 212 Emission Statements 

(Adopted 10/20/92) 

Rule 301 Circumvention (Adopted 

10/23/78) 

Rule 302 Visible Emissions (Adopted 

10/23/78) 

Rule 304 Particulate Matter—Northern 

Zone (Adopted 10/23/78) 

Rule 305 Particulate Matter 

Concentration—Southern Zone (Adopted 

10/23/78) 

Rule 306 Dust and Fumes—Northern Zone 

(Adopted 10/23/78) 

Rule 307 Particulate Matter Emission 

Weight Rate—Southern Zone (Adopted 

10/23/78) 

Rule 308 Incinerator Burning (Adopted 

10/23/78) 

Rule 309 Specific Contaminants (Adopted 

10/23/78) 

Rule 310 Odorous Organic Sulfides 

(Adopted 10/23/78) 

Rule 311 Sulfur Content of Fuels (Adopted 

10/23/78) 

Rule 312 Open Fires (Adopted 10/02/90) 

Rule 316 Storage and Transfer of Gasoline 

(Adopted 01/15/09) 

Rule 317 Organic Solvents (Adopted 

10/23/78) 

Rule 318 Vacuum Producing Devices or 

Systems—Southern Zone (Adopted 

10/23/78) 

Rule 321 Solvent Cleaning Operations 

(Adopted 09/18/97) 

Rule 322 Metal Surface Coating Thinner 

and Reducer (Adopted 10/23/78) 

Rule 323 Architectural Coatings (Adopted 

11/15/01) 

Rule 324 Disposal and Evaporation of 

Solvents (Adopted 10/23/78) 

Rule 325 Crude Oil Production and 

Separation (Adopted 07/19/01) 

Rule 326 Storage of Reactive Organic 

Compound Liquids (Adopted 01/18/01) 

Rule 327 Organic Liquid Cargo Tank Vessel 

Loading (Adopted 12/16/85) 

Rule 328 Continuous Emission Monitoring 

(Adopted 10/23/78) 

Rule 330 Surface Coating of Metal Parts and 

Products (Adopted 01/20/00) 

Rule 331 Fugitive Emissions Inspection and 

Maintenance (Adopted 12/10/91) 

Rule 332 Petroleum Refinery Vacuum 

Producing Systems, Wastewater Separators 

and Process Turnarounds (Adopted 

06/11/79) 

Rule 333 Control of Emissions from 

Reciprocating Internal Combustion Engines 

(Adopted 06/19/08) 

Rule 342 Control of Oxides of Nitrogen 

(NOx) from Boilers, Steam Generators and 

Process Heaters) (Adopted 04/17/97) 

Rule 343 Petroleum Storage Tank Degassing 

(Adopted 12/14/93) 

Rule 344 Petroleum Sumps, Pits, and Well 

Cellars (Adopted 11/10/94) 

Rule 346 Loading of Organic Liquid Cargo 

Vessels (Adopted 01/18/01) 

Rule 352 Natural Gas-Fired Fan-Type 

Central Furnaces and Residential Water 

Heaters (Adopted 09/16/99) 

Rule 353 Adhesives and Sealants (Adopted 

08/19/99) 

Rule 359 Flares and Thermal Oxidizers 

(Adopted 06/28/94) 

Rule 360 Emissions of Oxides of Nitrogen 

from Large Water Heaters and Small 

Boilers (Adopted 10/17/02) 

Rule 361 Small Boilers, Steam Generators, 

and Process Heaters (Adopted 01/17/08) 

Rule 370 Potential to Emit—Limitations for 

Part 70 Sources (Adopted 06/15/95) 

Rule 505 Breakdown Conditions Sections 

A., B.1., and D. only (Adopted 10/23/78) 

Rule 603 Emergency Episode Plans 

(Adopted 06/15/81) 

Rule 702 General Conformity (Adopted 10/ 

20/94) 

Rule 801 New Source Review (Adopted 04/ 

17/97) 

Rule 802 Nonattainment Review (Adopted 

04/17/97) 

Rule 803 Prevention of Significant 

Deterioration (Adopted 04/17/97) 

Rule 804 Emission Offsets (Adopted 

04/17/97) 

Rule 805 Air Quality Impact Analysis and 

Modeling (Adopted 04/17/97) 

Rule 808 New Source Review for Major 

Sources of Hazardous Air Pollutants 

(Adopted 05/20/99) 

Rule 1301 Part 70 Operating Permits— 

General Information (Adopted 06/19/03) 

Rule 1302 Part 70 Operating Permits— 

Permit Application (Adopted 11/09/93) 

Rule 1303 Part 70 Operating Permits— 

Permits (Adopted 11/09/93) 

Rule 1304 Part 70 Operating Permits— 

Issuance, Renewal, Modification and 

Reopening (Adopted 11/09/93) 

Rule 1305 Part 70 Operating Permits— 

Enforcement (Adopted 11/09/93) 

* * * * * 

[FR Doc. E9–20048 Filed 8–20–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2008–0252; FRL–8433–9] 

RIN 2070–AB27 

Certain Chemical Substances; 

Withdrawal of Significant New Use 

Rules 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of final rules. 

SUMMARY: EPA is withdrawing two 

significant new use rules (SNURs) 

promulgated under section 5(a)(2) of the 


CPrice-Sewell on DSKGBLS3C1PROD with RULES