Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Proposed Rules 19589 

identify electronically within the disk or 

CD ROM the specific information that is 

proprietary or confidential. 

Under 14 CFR 11.35(b), if the FAA is 

aware of proprietary information filed 

with a comment, the agency does not 

place it in the docket. It is held in a 

separate file to which the public does 

not have access, and the FAA places a 

note in the docket that it has received 

it. If the FAA receives a request to 

examine or copy this information, it 

treats it as any other request under the 

Freedom of Information Act (5 U.S.C. 

552). The FAA processes such a request 

under Department of Transportation 

procedures found in 49 CFR part 7. 

B. Availability of Rulemaking 

Documents 

An electronic copy of rulemaking 

documents may be obtained from the 

Internet by— 

1. Searching the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visiting the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies or 

3. Accessing the Government Printing 

Office’s Web page at http://

www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request to the Federal 

Aviation Administration, Office of 

Rulemaking, ARM–1, 800 Independence 

Avenue SW., Washington, DC 20591, or 

by calling (202) 267–9677. Commenters 

must identify the docket or notice 

number of this rulemaking. 

All documents the FAA considered in 

developing this proposed rule, 

including technical reports, may be 

accessed from the Internet through the 

Federal eRulemaking Portal referenced 

in item (1) above. 

Issued under authority provided by 49 

U.S.C. 106(f), 40103(b), and 44701(a)(5), in 

Washington, DC, on March 31, 2015. 

Abigail Smith, 

Director, Aeronautical Information Services. 

[FR Doc. 2015–08098 Filed 4–10–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1020 

[Docket No. FDA–2015–N–0828] 

Performance Standards for Ionizing 

Radiation Emitting Products; 

Fluoroscopic Equipment; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend a Federal performance standard 

for ionizing radiation to correct a 

drafting error regarding fluoroscopic 

equipment measurement. We are taking 

this action to ensure clarity and improve 

the accuracy of the regulations. 

DATES: Submit electronic or written 

comments on this proposed rule or its 

companion direct final rule by June 29, 

2015. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–0828 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Scott Gonzalez, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4641, Silver Spring, 

MD 20993–0002, 301–796–5889. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this 

Proposed Rule? 

FDA is proposing to correct a drafting 

error regarding fluoroscopic equipment 

measurement (see § 1020.32 (21 CFR 

1020.32)). Specifically, this proposed 

amendment would change the words 

‘‘any linear dimension’’ in the current 

regulation to read ‘‘every linear 

dimension’’ (see 21 CFR 

1020.32(b)(4)(ii)(A)). The alternative 

performance standard, 

§ 1020.32(b)(4)(ii)(B), currently contains 

the same phrase but would remain 

unchanged. We are proposing to amend 

the language to make the performance 

standards mutually exclusive. This will 

ensure clarity and improve the accuracy 

of the regulations. 

FDA first proposed the performance 

standards in the Federal Register of 

December 10, 2002 (67 FR 76056), to 

account for technological changes in 

fluoroscopic equipment. That proposed 

rule did not specify which measurement 

of the visible area of an image receptor 

determined the applicable performance 

standard (67 FR 76056 at 76092). When 

we addressed comments to that 

proposed rule in the Federal Register of 

June 10, 2005, we agreed with one 

comment that adding the words ‘‘any 

linear dimension’’ would clarify the 

determination of the performance 

standard (70 FR 33998 at 34007). 

FDA ultimately incorporated the 

phrase in two places, potentially 

reducing the clarity of the rule (70 FR 

33998 at 34040). Section 

1020.32(b)(4)(ii) sets performance 

standards based on a threshold, so the 

language for each standard should be 

mutually exclusive. That is, only one 

standard, and not the other, should 

apply to the image receptor in question. 

However, some image receptors may 

have linear dimensions that are both 

greater than and less than 34 cm, for 

example, receptors with a hexagonal 

shape. In such cases, the performance 

standards may not be mutually 

exclusive, so both standards may appear 

to apply. This proposed rule would 

amend § 1020.32(b)(4)(ii)(A) to read 

‘‘every linear dimension’’ to ensure the 

standards are mutually exclusive. The 

amendment will improve the clarity and 

accuracy of the regulations. 

II. Why is FDA publishing this 

companion Proposed Rule? 

This proposed rule is a companion to 

a direct final rule that corrects a drafting 

error regarding fluoroscopic equipment 

measurement. The direct final rule is 

published in the final rules section of 

this issue of the Federal Register. The 

direct final rule and this companion 

proposed rule are substantively 

identical. This companion proposed 

rule will provide the procedural 

framework to finalize a new rule in the 

event we withdraw the direct final rule 

because we receive significant adverse 

comment. We are publishing the direct 

final rule because we believe it is 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
19590 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Proposed Rules 

noncontroversial, and we do not 

anticipate any significant adverse 

comments. If we do not receive any 

significant adverse comments in 

response to the direct final rule, we will 

not take any further action on this 

proposed rule. Instead, within 30 days 

after the comment period ends, we 

intend to publish a notice that confirms 

the effective date of the direct final rule. 

If FDA receives any significant 

adverse comments regarding the direct 

final rule, we will withdraw it within 30 

days after the comment period ends. We 

will then proceed to respond to the 

comments under this companion 

proposed rule using our usual noticeand-comment rulemaking procedures 

under the Administrative Procedure Act 

(APA) (5 U.S.C. 552a, et seq.). The 

comment period for this companion 

proposed rule runs concurrently with 

the direct final rule’s comment period. 

We will consider any comments that we 

receive in response to this companion 

proposed rule to be comments also 

regarding the direct final rule and vice 

versa. We will not provide additional 

opportunity for comment. 

A significant adverse comment is one 

that explains why the rule would be 

inappropriate (including challenges to 

the rule’s underlying premise or 

approach), ineffective, or unacceptable 

without change. In determining whether 

an adverse comment is significant and 

warrants withdrawing a direct final rule, 

we consider whether the comment 

raises an issue serious enough to 

warrant a substantive response in a 

notice-and-comment process in 

accordance with section 553 of the APA 

(5 U.S.C. 553). Comments that are 

frivolous, insubstantial, or outside the 

scope of the rule will not be considered 

a significant adverse comment, unless 

the comment states why the rule would 

be ineffective without the additional 

change. In addition, if a significant 

adverse comment applies to part of a 

rule and that part can be severed from 

the remainder of the rule, we may adopt 

as final those parts of the rule that are 

not the subject of a significant adverse 

comment. 

You can find additional information 

about FDA’s direct final rulemaking 

procedures in the guidance document 

entitled ‘‘Guidance for FDA and 

Industry: Direct Final Rule Procedures,’’ 

announced in the Federal Register of 

November 21, 1997 (62 FR 62466). 

III. What is the legal authority for this 

Proposed Rule? 

This proposed rule, if finalized, 

would amend § 1020.32. FDA’s 

authority to modify § 1020.32 arises 

from the same authority under which 

FDA initially issued this regulation, the 

device and general administrative 

provisions of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 351, 352, 

360e–360j, 360hh–360ss, 371, and 381). 

IV. What is the environmental impact 

of this Proposed Rule? 

FDA has determined under 21 CFR 

25.30(h) and 25.34(a) that this action is 

of a type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

V. What is the economic analysis of 

impact of this Proposed Rule? 

FDA has examined the impacts of the 

proposed rule under Executive Order 

12866, Executive Order 13563, the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4). 

Executive Orders 12866 and 13563 

direct 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 proposed rule would 

not be a significant regulatory action as 

defined by Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this proposed rule 

does not add any additional regulatory 

burdens, the Agency has determined 

that this proposed rule would not have 

a significant economic 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 $141 

million, using the most current (2013) 

Implicit Price Deflator for the Gross 

Domestic Product. This proposed rule 

would not result in a 1-year expenditure 

that meets or exceeds this amount. 

The purpose of this proposed rule is 

to correct a drafting error regarding 

fluoroscopic equipment measurement in 

a performance standard for ionizing 

radiation. The amendment will improve 

the clarity and accuracy of the 

regulations. Because this proposed rule 

is a technical correction and would 

impose no additional regulatory 

burdens, this regulation is not 

anticipated to result in any compliance 

costs and the economic impact is 

expected to be minimal. 

VI. How does the Paperwork Reduction 

Act of 1995 apply to this Rule? 

This proposed rule contains no 

collection of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

VII. What are the Federalism 

implications of this Rule? 

FDA has analyzed this proposed 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. 

VIII. How do you submit comments on 

this Proposed Rule? 

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://

www.regulations.gov. 

List of Subjects in 21 CFR Part 1020 

Electronic products, Medical devices, 

Radiation protection, Reporting and 

recordkeeping requirements, Television, 

X-rays. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 1020 is 

proposed to be amended as follows: 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Proposed Rules 19591 

PART 1020—PERFORMANCE 

STANDARDS FOR IONIZING 

RADIATION EMITTING PRODUCTS 

■ 1. The authority citation for 21 CFR 

part 1020 continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 360e–360j, 

360hh–360ss, 371, 381. 

■ 2. Revise § 1020.32(b)(4)(ii)(A) to read 

as follows: 

§ 1020.32 Fluoroscopic equipment. 

(b) * * * 

(4) * * * 

(ii) * * * 

(A) When every linear dimension of 

the visible area of the image receptor 

measured through the center of the 

visible area is less than or equal to 34 

cm in any direction, at least 80 percent 

of the area of the x-ray field overlaps the 

visible area of the image. 

* * * * * 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08361 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2014–0832; FRL–9925–34– 

Region 9] 

Revisions to the California State 

Implementation Plan, Northern Sierra 

Air Quality Management District 

AGENCY: Environmental Protection 

Agency. 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

revision to the Northern Sierra Air 

Quality Management District 

(NSAQMD) portion of the California 

State Implementation Plan (SIP). The 

submitted SIP revision contains the 

District’s demonstration regarding 

Reasonably Available Control 

Technology (RACT) requirements for 

the 1997 8-hour ozone National 

Ambient Air Quality Standards 

(NAAQS). The submitted SIP revision 

also contains negative declarations for 

volatile organic compound (VOC) 

source categories for the NSAQMD. We 

are proposing to approve the submitted 

SIP revision under the Clean Air Act as 

amended in 1990 (CAA or the Act). We 

are taking comments on this proposal 

and plan to follow with a final action. 

DATES: Any comments on this proposal 

must arrive by May 13, 2015. 

ADDRESSES: Submit comments, 

identified by docket number EPA–R09– 

OAR–2014–0832, by one of the 

following methods: 

1. Federal eRulemaking Portal: 

www.regulations.gov. Follow the on-line 

instructions. 

2. Email: steckel.andrew@epa.gov. 

3. Mail or deliver: Andrew Steckel 

(Air-4), U.S. Environmental Protection 

Agency Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901. 

Instructions: All comments will be 

included in the public docket without 

change and may be made available 

online at www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Information that 

you consider CBI or otherwise protected 

should be clearly identified as such and 

should not be submitted through 

www.regulations.gov or email. 

www.regulations.gov is an ‘‘anonymous 

access’’ system, and EPA will not know 

your identity or contact information 

unless you provide it in the body of 

your comment. If you send email 

directly to EPA, your email address will 

be automatically captured and included 

as part of the public comment. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: Generally, documents in the 

docket for this action are available 

electronically at www.regulations.gov 

and in hard copy at EPA Region IX, 75 

Hawthorne Street, San Francisco, 

California 94105–3901. While all 

documents in the docket are listed at 

www.regulations.gov, some information 

may be publicly available only at the 

hard copy location (e.g., copyrighted 

material, large maps), 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: 

James Shears, EPA Region IX, (213) 

244–1810, shears.james@epa.gov. 

SUPPLEMENTARY INFORMATION: This 

proposal addresses the revisions to the 

NSAQMD portion of the California SIP. 

In the rules and regulations section of 

the Federal Register, we are approving 

the SIP revision in a direct final action 

without prior proposal because we 

believe this SIP revision is not 

controversial. If we receive adverse 

comments, however, we will publish a 

timely withdrawal of the direct final 

rule and address the comments in 

subsequent action based on this 

proposal. Please note that if we receive 

adverse comment on a specific 

provision of this SIP revision and if that 

provision may be severed from the 

remainder of the SIP revision, we may 

adopt as final those provisions of the 

SIP revision that are not the subject of 

an adverse comment. 

We do not plan to open a second 

comment period, so anyone interested 

in commenting should do so at this 

time. If we do not receive adverse 

comments, no further activity is 

planned. For further information, please 

see the direct final action. 

Dated: February 12, 2015. 

Alexis Strauss, 

Acting Regional Administrator, Region IX. 

[FR Doc. 2015–08419 Filed 4–10–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R03–OAR–2015–0166; FRL–9926–16– 

Region 3] 

Approval and Promulgation of Air 

Quality Implementation Plans; 

Pennsylvania; Adoption of Control 

Techniques Guidelines for Offset 

Lithographic Printing and Letterpress 

Printing; Flexible Package Printing; 

and Adhesives, Sealants, Primers, and 

Solvents 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

revisions to the Pennsylvania State 

Implementation Plan (SIP) submitted by 

the Commonwealth of Pennsylvania. 

These revisions pertain to control of 

volatile organic compound (VOC) 

emissions from offset lithographic 

printing and letterpress printing, 

flexible package printing, and 

adhesives, sealants, primers, and 

solvents. These revisions also meet the 

requirement to adopt Reasonably 

Available Control Technology (RACT) 

for sources covered by EPA’s Control 

Technique Guidelines (CTG) 

recommendations for the following 

categories: Offset lithographic printing 

and letterpress printing, flexible 

package printing, and adhesives, 

sealants, primers, and solvents. This 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS