18868 Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules 

FDA has nonetheless examined the 

economic implications of the final rule 

in accordance with the Regulatory 

Flexibility Act and determined that the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. Similarly, 

because FDA is not required to perform 

a final regulatory flexibility analysis 

under 5 U.S.C 605(b) for the final rule, 

FDA is not required to issue an SECG to 

comply with section 212 of the Small 

Business Regulatory Enforcement 

Fairness Act (Pub. L. 104–121); 

nevertheless, FDA has updated this 

SECG to state in plain language the 

requirements of 21 CFR part 1, Subpart 

J, as amended by the final rule. 

II. Paperwork Reduction Act of 1995 

This guidance refers to information 

collection provisions found in FDA 

regulations. These collections of 

information 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). 

Except for the provision regarding 

access to records, the collections of 

information in 21 CFR part 1, Subpart 

J, have been approved under OMB 

control number 0910–0560. With regard 

to access to records, we conclude that 

these information collection provisions 

are exempt from OMB review under 44 

U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 

1320.4(a)(2) as collections of 

information obtained during the 

conduct of a civil action to which the 

United States or any official or Agency 

thereof is a party, or during the conduct 

of an administrative action, 

investigation, or audit involving an 

Agency against specific individuals or 

entities. The regulations in 5 CFR 

1320.3(c) provide that the exception in 

5 CFR 1320.4(a)(2) applies during the 

entire course of the investigation, audit 

or action, but only after a case file or 

equivalent is opened with respect to a 

particular party. Such a case file would 

be opened as part of the request to 

access records. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either 

http://www.fda.gov/

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: April 1, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–07548 Filed 4–3–14; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2013–0646; FRL–9908–71– 

Region 5] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Michigan; PSD Rules for PM2.5

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

revisions to Michigan’s Prevention of 

Significant Deterioration Program rules 

and definitions, including revisions to 

Parts 1 and 18 of Michigan’s Air 

Pollution Control Rules into Michigan’s 

State Implementation Plan (SIP). The 

revised rules address the Federal 

requirements for significant emission 

levels, and definitions for fine 

particulate matter. The Michigan 

Department of Environmental Quality 

submitted these revisions to EPA on 

August 9, 2013, and September 19, 

2013. 

DATES: Comments must be received on 

or before May 5, 2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2013–0646, by one of the 

following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: damico.genevieve@epa.gov. 

3. Fax: (312) 886–0968. 

4. Mail: Genevieve Damico, Chief, Air 

Permits Section, Air Programs Branch 

(AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

5. Hand Delivery: Genevieve Damico, 

Chief, Air Permits Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Please see the direct final rule which 

is located in the Rules section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: 

Constantine Blathras, Environmental 

Engineer, Air Permits Sections, Air 

Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–0671, 

Blathras.constantine@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Rules section of this Federal Register, 

EPA is approving the State’s SIP 

submittal as a direct final rule without 

prior proposal because the Agency 

views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this rule, no 

further activity is contemplated. If EPA 

receives adverse comments, we will 

withdraw the direct final rule and will 

address all public comments in a 

subsequent final rule based on this 

proposed action. EPA will not institute 

a second comment period. Any parties 

interested in commenting on this action 

should do so at this time. Please note 

that if EPA receives adverse comment 

on an amendment, paragraph, or section 

of this rule which may be severed from 

the remainder of the rule, EPA may 

adopt as final those provisions of the 

rule that are not the subject of an 

adverse comment. For additional 

information, see the direct final rule 

which is located in the Rules section of 

this Federal Register. 

Dated: March 17, 2014. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2014–06827 Filed 4–3–14; 8:45 am] 

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