Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 10587 

control number 0910–0437. The 

collections of information in the UDI 

rule have been approved under OMB 

control number 0910–0720. 

The information collection provisions 

in the eMDR rule have been submitted 

to OMB for review as required by 

section 3507(d) of the PRA (44 U.S.C. 

3507(d)). Before the effective date of the 

final rule, FDA will publish a notice in 

the Federal Register announcing OMB’s 

decision to approve, modify, or 

disapprove the information collection 

provisions in the final rule. 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. 

List of Subjects in 21 CFR Part 803 

Imports, Medical devices, Reporting 

and recordkeeping requirements. 

Therefore under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 803 as 

amended by the Medical Device 

Reporting: Electronic Submission 

Requirements final rule of February 14, 

2014, 79 FR 8832, is further amended as 

follows: 

PART 803—MEDICAL DEVICE 

REPORTING 

■ 1. The authority citation for 21 CFR 

part 803 continues to read as follows: 

Authority: 21 U.S.C. 352, 360, 360i, 360j, 

371, 374. 

■ 2. Amend § 803.3 by adding 

paragraphs (aa) and (bb) to read as 

follows: 

§ 803.3 How does FDA define the terms 

used in this part? 

* * * * * 

(aa) Human cell, tissue, or cellular or 

tissue-based product (HCT/P) regulated 

as a device means an HCT/P as defined 

in § 1271.3(d) of this chapter that does 

not meet the criteria in § 1271.10(a) and 

that is also regulated as a device. 

(bb) Unique device identifier (UDI) 

means an identifier that adequately 

identifies a device through its 

distribution and use by meeting the 

requirements of § 830.20 of this chapter. 

A unique device identifier is composed 

of: 

(1) A device identifier—a mandatory, 

fixed portion of a UDI that identifies the 

specific version or model of a device 

and the labeler of that device; and 

(2) A production identifier—a 

conditional, variable portion of a UDI 

that identifies one or more of the 

following when included on the label of 

the device: 

(i) The lot or batch within which a 

device was manufactured; 

(ii) The serial number of a specific 

device; 

(iii) The expiration date of a specific 

device; 

(iv) The date a specific device was 

manufactured. 

(v) For an HCT/P regulated as a 

device, the distinct identification code 

required by § 1271.290(c) of this 

chapter. 

* * * * * 

■ 3. Amend § 803.11 by revising 

paragraph (d) to read as follows: 

§ 803.11 What form should I use to submit 

reports of individual adverse events and 

where do I obtain these forms? 

* * * * * 

(d) Form FDA 3500A is available on 

the Internet at http://www.fda.gov/

medwatch/getforms.htm or from 

Division of International and Consumer 

Education, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4621, Silver Spring, 

MD 20993–0002, by email: DICE@

fda.hhs.gov, FAX: 301–847–8149, or 

telephone: 800–638–2041. 

■ 4. Amend § 803.32 by revising 

paragraph (c)(4) to read as follows: 

§ 803.32 If I am a user facility, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

■ 5. Amend § 803.33 by revising 

paragraphs (a)(2) and (b)(7)(iv) to read as 

follows: 

§ 803.33 If I am a user facility, what must 

I include when I submit an annual report? 

* * * * * 

(a) * * * 

(2) Division of International and 

Consumer Education, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4621, Silver Spring, 

MD 20993–0002, by email: DICE@

fda.hhs.gov, FAX: 301–847–8149, or 

telephone: 800–638–2041. 

* * * * * 

(b) * * * 

(7) * * * 

(iv) Product model, catalog, serial, 

and lot number and unique device 

identifier (UDI) that appears on the 

device label or on the device package; 

* * * * * 

■ 6. Amend § 803.42 by revising 

paragraph (c)(4) to read as follows: 

§ 803.42 If I am an importer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

■ 7. Amend § 803.52 by revising 

paragraph (c)(4) to read as follows: 

§ 803.52 If I am a manufacturer, what 

information must I submit in my individual 

adverse event reports? 

* * * * * 

(c) * * * 

(4) Model number, catalog number, 

serial number, lot number, or other 

identifying number; expiration date; and 

unique device identifier (UDI) that 

appears on the device label or on the 

device package; 

* * * * * 

Dated: February 20, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03943 Filed 2–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9712] 

RIN 1545–BL78 

Alternative Simplified Credit Election 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and removal of 

temporary regulations. 

SUMMARY: This document contains final 

regulations relating to the election of the 

alternative simplified credit under 

section 41(c)(5) of the Internal Revenue 

Code (Code). The final regulations affect 

certain taxpayers claiming the credit 

under section 41. 

DATES: Effective Date: These regulations 

are effective on February 27, 2015. 

Applicability Date: For dates of 

applicability, see § 1.41–9(d). 


tkelley on DSK3SPTVN1PROD with RULES
10588 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: 

David Selig (202) 317–4137 (not a tollfree number). 

SUPPLEMENTARY INFORMATION: 

Background 

This document amends 26 CFR part 1 

to provide rules relating to the time and 

manner of electing the alternative 

simplified credit (ASC) under section 

41(c)(5) of the Internal Revenue Code 

(Code). 

Section 41(a) provides an incremental 

tax credit for increasing research 

activities (research credit) based on a 

percentage of a taxpayer’s qualified 

research expenses above a base amount. 

A taxpayer can apply the rules and 

credit rate percentages under section 

41(a)(1) to calculate the credit 

(commonly referred to as the regular 

credit) or a taxpayer can make an 

election to apply the ASC rules and 

credit rate percentages under section 

41(c)(5) to calculate the credit. Section 

41(c)(5)(C) provides that an ASC 

election under section 41(c)(5) applies 

to the taxable year for which it is made 

and all succeeding taxable years unless 

revoked with the consent of the 

Secretary. 

On June 10, 2011, the Treasury 

Department and the IRS published final 

regulations (TD 9528) (2011 Final 

Regulations) in the Federal Register (76 

FR 33994) relating to the election and 

calculation of the ASC. Section 1.41– 

9(b)(2) provides that a taxpayer makes 

an election under section 41(c)(5) by 

completing the portion of Form 6765, 

‘‘Credit for Increasing Research 

Activities,’’ (or successor form) relating 

to the ASC election, and attaching the 

completed form to the taxpayer’s timely 

filed (including extensions) original 

return for the taxable year to which the 

election applies. Section 1.41–9(b)(2) 

also provides that a taxpayer may not 

make an election under section 41(c)(5) 

on an amended return and that an 

extension of time to make an election 

under section 41(c)(5) will not be 

granted under § 301.9100–3. 

Following the publication of the 2011 

Final Regulations, the Treasury 

Department and the IRS received 

requests to amend the regulations to 

allow taxpayers to make an ASC 

election on an amended return. The 

requests explained that the burden of 

substantiating expenditures and costs 

for the base period under the regular 

credit can be costly, time-consuming, 

and difficult, and suggested that 

taxpayers often need additional time to 

determine whether to claim the regular 

credit or the ASC. 

On June 3, 2014, the Treasury 

Department and the IRS published a 

notice of proposed rulemaking by crossreference to temporary regulations 

(REG–133495–13) in the Federal 

Register (79 FR 31892), and final and 

temporary regulations (TD 9666) (the 

Temporary Regulations) in the Federal 

Register (79 FR 31863). The final 

regulations removed the rule in § 1.41– 

9(b)(2) that prohibited a taxpayer from 

making an ASC election for a tax year 

on an amended return. In its place, the 

Temporary Regulations provided a rule 

allowing a taxpayer to make an ASC 

election for a tax year on an amended 

return if the taxpayer had not previously 

claimed a section 41 credit for that tax 

year on an original or amended return. 

In addition, the Temporary Regulations 

provided that a taxpayer that is a 

member of a controlled group in a tax 

year may not make an election under 

section 41(c)(5) for that tax year on an 

amended return if any member of the 

controlled group for that year claimed 

the research credit using a method other 

than the ASC on an original or amended 

return. 

Written and electronic comments 

responding to the proposed regulations 

were received. No requests for a public 

hearing were made and no public 

hearing was held. After consideration of 

all the comments, the proposed 

regulations are adopted as revised by 

this Treasury decision. 

Summary of Comments and 

Explanation of Provisions 

Interaction With Section 280C Elections 

A commenter requested clarification 

regarding whether a section 280C(c)(3) 

election made for a taxable year on line 

17 of Form 6765, Credit For Increasing 

Research Activities, where no amount of 

regular credit is claimed, will be viewed 

by the IRS as a claim of the section 

41(a)(1) credit and preclude an ASC 

election from being made on an 

amended return for that taxable year. 

Section 280(c)(3) allows a taxpayer to 

make an annual irrevocable election to 

claim a reduced research credit rather 

than reducing the section 174 

deduction, as required by section 

280(c)(1). A section 280C(c)(3) election 

must be made on an original return. If 

a taxpayer is undecided whether to 

claim the regular credit for a taxable 

year but wants to preserve the operative 

effect of the section 280C(c)(3) election 

for that taxable year, then the taxpayer 

will make the section 280C(c)(3) 

election on line 17 of Form 6765, but 

leave the remaining section of the form 

blank. A section 280C(c)(3) election on 

line 17 of Form 6765 made in a taxable 

year does not, in and of itself, constitute 

a credit claim under section 41(a)(1), 

and accordingly does not preclude a 

taxpayer from making an ASC election 

on an amended return for that taxable 

year. 

Section 9100 Relief 

One commenter requested that the 

final regulations allow an extension of 

time to make an election under section 

41(c)(5) under § 301.9100–3. Under 

§ 301.9100–3(c), the Commissioner will 

grant a reasonable extension of time to 

make a regulatory election only when 

the interests of the Government will not 

be prejudiced by the granting of relief. 

Under § 301.9100–3(c)(1)(ii), the 

interests of the Government are 

ordinarily prejudiced if the taxable year 

in which the regulatory election should 

have been made or any taxable years 

that would have been affected by the 

election had it been timely made are 

closed by the period of limitations on 

assessment under section 6501(a) before 

the taxpayer’s receipt of a ruling 

granting relief under this section. 

Because the final regulations allow a 

taxpayer to amend its return to make the 

ASC election in a taxable year that is not 

closed by the period of limitations for 

assessment under section 6501(a) if no 

credit under section 41(a)(1) was 

claimed in the prior taxable year on an 

original or amended return, an 

extension of time under § 301.9100–3 to 

make the ASC election is not necessary 

during this period. An extension of time 

to make an ASC election in a taxable 

year closed by the period of limitations 

on assessment under section 6501(a) 

ordinarily prejudices the interests of the 

government. See section 301.9100– 

3(c)(1)(ii). Accordingly, the final 

regulations retain the rule that an 

extension of time to make an election 

under section 41(c)(5) will not be 

granted under § 301.9100–3. 

Period for Making an ASC Election 

One commenter requested that the 

final regulations provide that a taxpayer 

may make an ASC election for an 

earlier, closed tax year on a later year’s 

return in which a research credit from 

that closed year is reported on a 

carryforward schedule, or actually used 

as a credit against tax, so long as no 

intervening amended return claiming a 

research credit for that tax year using a 

different method has been claimed. The 

Temporary Regulations only permitted a 

taxpayer to elect the ASC on an 

amended return for taxable years ending 

before June 3, 2014, (the effective/

applicability date of those regulations) if 

the taxpayer makes the election before 

the period of limitations for assessment 

of tax has expired for that year. The rule 

in the Temporary Regulations provided 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 10589 

a reasonable time period for taxpayers to 

determine whether or not to make an 

ASC election with respect to a prior, 

open tax year. To permit a taxpayer to 

make an ASC election for a tax year in 

which the period of limitations for 

assessment of tax has expired has the 

practical effect of permitting the 

taxpayer to make an ASC election on a 

return that cannot be amended. 

Therefore, these final regulations do not 

adopt this suggested modification. 

One commenter requested that these 

final regulations provide that an ASC 

election can be made on an amended 

return for a tax year so long as the 

period for making a refund claim under 

section 6511 has not expired for that tax 

year, even in cases where the statute of 

limitations on assessment under section 

6501 is closed. These final regulations 

retain the rule of the Temporary 

Regulations that a taxpayer must make 

an ASC election on an amended return 

before the statute of limitations on 

assessment under section 6501(a) is 

closed. The general period under the 

statute of limitations on assessment 

under section 6501(a), which is three 

years after the tax return is filed, 

provides a reasonable time for taxpayers 

to file an ASC election on an amended 

return, and a reasonable time for the IRS 

to examine the amended return. This 

rule also preserves the integrity the of 

the rule in the final regulations 

providing that an extension of time to 

make an election under section 41(c)(5) 

will not be granted under § 301.9100–3. 

Under § 301.9100–3, the interests of the 

government are ordinarily prejudiced if 

the taxable year in which a regulatory 

election should have been made or any 

taxable years that would have been 

affected by the election had it been 

timely made are closed by the period of 

limitations on assessment under section 

6501(a) before the taxpayer’s receipt of 

a ruling granting relief under 

§ 301.9100. This requirement is 

mitigated by the fact that the period of 

limitations on assessment may be 

extended by agreement of the IRS and 

the taxpayer. For clarity, the language 

found in the effective date of the 

Temporary Regulations referencing the 

period of limitations for assessment of 

tax is added to the text of the final 

regulations under § 1.41–9(b)(2) relating 

to the time and manner of making the 

ASC election. 

Controlled Group ASC Elections 

One commenter requested that the 

final regulations modify the rules for 

controlled group ASC elections under 

§ 1.41–9(b)(4), under which only the 

designated member of a controlled 

group may make or revoke an ASC 

election. Revising those rules is beyond 

the scope of these regulations. 

Therefore, the final regulations do not 

amend § 1.41–9(b)(4). 

Modification of the Election Rule 

One commenter requested that these 

final regulations amend the rule in the 

Temporary Regulations that allows a 

taxpayer to make an ASC election for a 

tax year on an amended return only if 

the taxpayer has not previously claimed 

the section 41 credit on its original 

return or an amended return for that tax 

year to clarify that the previously 

claimed section 41 credit is determined 

under section 41(a)(1), and not under 

sections 41(a)(2) or (3). The commenter 

stated that the ASC is an alternative 

method to the regular credit under 

section 41(a)(1), and whether a taxpayer 

elects the ASC or claims the regular 

credit does not impact the 

determination of the credits allowable 

under sections 41(a)(2) and 41(a)(3). 

This approach is consistent with the 

language of section 41(c)(5)(A) and 

§ 1.41–9(a), which specifically reference 

section 41(a)(1). Accordingly, the final 

regulations provide that a taxpayer may 

make an ASC election for a tax year on 

an amended return only if the taxpayer 

has not previously claimed the section 

41(a)(1) credit on its original return or 

an amended return for that tax year. 

Effect on Other Documents 

The Temporary Regulations are 

obsolete for taxable years beginning on 

or after February 27, 2015. 

Special Analyses 

It has been determined that this 

Treasury decision is not a significant 

regulatory action as defined in 

Executive Order 12866, as 

supplemented by Executive Order 

13563. Therefore, a regulatory 

assessment is not required. It also has 

been determined that section 553(b) of 

the Administrative Procedure Act (5 

U.S.C. chapter 5) does not apply to these 

regulations. It is hereby certified that the 

collection of information in these 

regulations will not have a significant 

economic impact on a substantial 

number of small entities. Although a 

substantial number of small entities may 

make an ASC election on an amended 

return pursuant to these regulations, the 

economic impact of any collection 

burden on these entities relating to this 

election is minimal because the 

regulations will result in a benefit to 

taxpayers by providing additional time 

for taxpayer to calculate and elect the 

ASC. Accordingly, a regulatory 

flexibility analysis under the Regulatory 

Flexibility Act (5 U.S.C. chapter 6) is 

not required. Pursuant to section 7805(f) 

of the Code, these regulations have been 

submitted to the Chief Counsel for 

Advocacy of the Small Business 

Administration for comment on their 

impact on small business. 

Drafting Information 

The principal author of these 

regulations is David Selig, Office of the 

Associate Chief Counsel (Passthroughs 

and Special Industries). However, other 

personnel from the IRS and the Treasury 

Department participated in their 

development. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Adoption of Amendments to the 

Regulations 

Accordingly, 26 CFR part 1 is 

amended as follows: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

Section 1.41–9 also issued under 26 

U.S.C. 41(c)(5)(C). * * * 

■ Par. 2. Section 1.41–9 is amended by: 

■ 1. Revising paragraph (b)(2). 

■ 2. Adding a third and fourth sentence 

to paragraph (d). 

The revision and addition read as 

follows: 

§ 1.41–9 Alternative simplified credit. 

* * * * * 

(b) * * * 

(2) Time and manner of election. A 

taxpayer makes an election under 

section 41(c)(5) by completing the 

portion of Form 6765, ‘‘Credit for 

Increasing Research Activities,’’ (or 

successor form) relating to the election 

of the ASC, and attaching the completed 

form to the taxpayer’s timely filed 

(including extensions) original return 

for the taxable year to which the 

election applies. A taxpayer may make 

an election under section 41(c)(5) for a 

tax year on an amended return, but only 

if the taxpayer has not previously 

claimed a section 41(a)(1) credit on its 

original return or an amended return for 

that tax year, and only if that tax year 

is not closed by the period of limitations 

on assessment under section 6501(a). 

An extension of time to make an 

election under section 41(c)(5) will not 

be granted under § 301.9100–3 of this 

chapter. A taxpayer that is a member of 

a controlled group in a tax year may not 

make an election under section 41(c)(5) 

for that tax year on an amended return 


tkelley on DSK3SPTVN1PROD with RULES
10590 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Rules and Regulations 

if any member of the controlled group 

for that tax year previously claimed the 

research credit under section 41(a)(1) 

using a method other than the ASC on 

an original or amended return for that 

tax year. See paragraph (b)(4) of this 

section for additional rules concerning 

controlled groups. See also § 1.41– 

6(b)(1) requiring that all members of the 

controlled group use the same method 

of computation. 

* * * * * 

(d) Effective/applicability date. * * * 

Paragraph (b)(2) of this section applies 

to elections with respect to taxable years 

ending on or after February 27, 2015. 

For taxable years ending before 

February 27, 2015, see § 1.41–9T as 

contained in 26 CFR part 1, revised 

April 1, 2015. 

§ 1.41–9T [Removed] 

■ Par. 3. Section 1.41–9T is removed. 

John Dalrymple, 

Deputy Commissioner for Services and 

Enforcement. 

Approved: February 3, 2015. 

Mark J. Mazur, 

Assistant Secretary of the Treasury (Tax 

Policy). 

[FR Doc. 2015–04111 Filed 2–26–15; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2014–1070] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Passaic River, Rutherford, NJ 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is removing 

the existing drawbridge operation 

regulation for the drawbridge across the 

Passaic River, mile 11.8, at Rutherford, 

New Jersey. The drawbridge was 

converted to a fixed bridge in October 

2010, and the operating regulation is no 

longer applicable or necessary. 

DATES: This rule is effective February 

27, 2015. 

ADDRESSES: The docket for this final 

rule, [USCG–2014–1070] is available at 

http://www.regulations.gov. Type the 

docket number in the ‘‘SEARCH’’ box 

and click ‘‘SEARCH.’’ Click on Open 

Docket Folder on the line associated 

with this final rule. You may also visit 

the Docket Management Facility in 

Room W12–140 on the ground floor of 

the Department of Transportation West 

Building, 1200 New Jersey Avenue SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Mr. Joe Arca, Project Officer, First 

Coast Guard District Bridge Program, 

telephone 212–514–4336, email 

joe.m.arca@uscg.mil. If you have 

questions on viewing the docket, call 

Cheryl Collins, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

A. Regulatory History and Information 

The Coast Guard is issuing this final 

rule without prior notice and 

opportunity to comment pursuant to 

authority under section 4(a) of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 

to the public interest.’’ Under 5 U.S.C. 

553(b), the Coast Guard finds that good 

cause exists for not publishing a notice 

of proposed rulemaking (NPRM) with 

respect to this rule because the Route 3 

Bridge, that once required draw 

operations in 33 CFR 117.739(n), was 

converted to a fixed bridge in October 

2010. Therefore, the regulation is no 

longer applicable and shall be removed 

from publication. It is unnecessary to 

publish an NPRM because this 

regulatory action does not purport to 

place any restrictions on mariners but 

rather removes a restriction that has no 

further use or value. 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds that good cause exists for 

making this rule effective in less than 30 

days after publication in the Federal 

Register. The bridge has been a fixed 

bridge for 4 years and this rule merely 

requires an administrative change to the 

Federal Register, in order to omit a 

regulatory requirement that is no longer 

applicable or necessary. 

B. Basis and Purpose 

The Route 3 Bridge across the Passaic 

River, mile 11.8, was converted to a 

fixed bridge in 2010. It has come to the 

attention of the Coast Guard that the 

governing regulation for this drawbridge 

was never removed subsequent to the 

conversion to a fixed bridge. The 

conversion of this drawbridge 

necessitates the removal of the 

drawbridge operation regulation, 33 

CFR 117.739(n), pertaining to the former 

drawbridge. 

The purpose of this rule is to remove 

paragraph 33 CFR 117.739(n), that refers 

to the Route 3 Bridge at mile 11.8, from 

the Code of Federal Regulations since it 

governs a bridge that is no longer able 

to be opened. 

C. Discussion of Rule 

The Coast Guard is changing the 

regulation in 33 CFR 117.739 by 

removing restrictions and the regulatory 

burden related to the draw operations 

for this bridge that is no longer a 

drawbridge. The change removes 

paragraph 117.739(n) of the regulation 

which governs the Route 3 Bridge and 

redesignates (o) through (t) as (n) 

through (s). This Final Rule seeks to 

update the Code of Federal Regulations 

by removing language that governs the 

operation of the Route 3 Bridge, which 

in fact no longer is a drawbridge. This 

change does not affect waterway or land 

traffic. This change does not affect nor 

does it alter the operating schedules in 

33 CFR 117.739 that govern the 

remaining active drawbridges on the 

Passaic River except to redesignate these 

bridges. 

D. Regulatory Analyses 

We developed this rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on these statutes or executive 

orders. 

1. Regulatory Planning and Review 

This rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, as supplemented 

by Executive Order 13563, Improving 

Regulation and Regulatory Review, and 

does not require an assessment of 

potential costs and benefits under 

section 6(a)(3) of Order 12866 or under 

section 1 of Executive Order 13563. The 

Office of Management and Budget has 

not reviewed it under those Orders. 

The Coast Guard does not consider 

this rule to be ‘‘significant’’ under that 

Order because it is an administrative 

change and does not affect the way 

vessels operate on the waterway. 

2. Impact on Small Entities 

The Regulatory Flexibility Act of 1980 

(RFA), 5 U.S.C. 601–612, as amended, 

requires federal agencies to consider the 

potential impact of regulations on small 

entities during rulemaking. The term 

‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 


tkelley on DSK3SPTVN1PROD with RULES