Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 44281 

Qj = (Tj)(Pj) 

Where: 

Tj = Average time spent in failure condition 

j (in hours). 

Pj = Probability of occurrence of failure mode 

j (per hour). 

Note: If Pj is greater than 10¥3 per flight 

hour, then a 1.5 factor of safety must be 

applied to all limit-load conditions specified 

in Subpart C. 

(iii) For residual-strength 

substantiation, the airplane must be able 

to withstand two-thirds of the ultimate 

loads defined in subparagraph (c)(2)(ii). 

(iv) If the loads induced by the failure 

condition have a significant effect on 

fatigue or damage tolerance, then their 

effects must be taken into account. 

(v) Freedom from aeroelastic 

instability must be shown up to a speed 

determined from Figure 3. Flutterclearance speeds V′ and V′′ may be 

based on the speed limitation specified 

for the remainder of the flight using the 

margins defined by § 25.629(b). 

V′ = Clearance speed as defined by 

§ 25.629(b)(2). 

V′′ = Clearance speed as defined by 

§ 25.629(b)(1). 

Qj = (Tj)(Pj) 

Where: 

Tj = Average time spent in failure condition 

j (in hours). 

Pj = Probability of occurrence of failure mode 

j (per hour). 

Note: If Pj is greater than 10¥3 per flight 

hour, then the flutter clearance speed must 

not be less than V’’. 

(vi) Freedom from aeroelastic 

instability must also be shown, up to V′ 

in Figure 3 above, for any probable 

system-failure condition combined with 

any damage required or selected for 

investigation by § 25.571(b). 

(3) Consideration of certain failure 

conditions may be required by other 

subparts of part 25 regardless of 

calculated system reliability. Where 

analysis shows the probability of these 

failure conditions to be less than 10¥9, 

criteria other than those specified in this 

paragraph may be used for structural 

substantiation to show continued safe 

flight and landing. 

(d) Failure indications. For systemfailure detection and indication, the 

following apply: 

(1) The system must be checked for 

failure conditions, not extremely 

improbable, that degrade the structural 

capability below the level required by 

part 25, or that significantly reduce the 

reliability of the remaining system. To 

the extent practicable, these failures 

must be detected and annunciated to the 

flight crew before flight. Certain 

elements of the control system, such as 

mechanical and hydraulic components, 

may use special periodic inspections, 

and electronic components may use 

daily checks, in lieu of warning systems, 

to achieve the objective of this 

requirement. These certificationmaintenance requirements must be 

limited to components that are not 

readily detectable by normal warning 

systems, and where service history 

shows that inspections provide an 

adequate level of safety. 

(2) The existence of any failure 

condition, not extremely improbable, 

during flight, that could significantly 

affect the structural capability of the 

airplane and for which the associated 

reduction in airworthiness can be 

minimized by suitable flight limitations, 

must be signaled to the flight crew. 

Failure conditions that result in a factor 

of safety between the airplane strength 

and the loads of Subpart C below 1.25, 

or flutter margins below V′′, must be 

signaled to the crew during flight. 

(e) Dispatch with known failure 

conditions. If the airplane is to be 

dispatched in a known system-failure 

condition that affects structural 

performance, or affects the reliability of 

the remaining system to maintain 

structural performance, then the 

provisions of § 25.302 must be met for 

the dispatched condition and for 

subsequent failures. Flight limitations 

and expected operational limitations 

may be taken into account in 

establishing Qj as the combined 

probability of being in the dispatched 

failure condition and the subsequent 

failure condition for the safety margins 

in Figures 2 and 3. These limitations 

must be such that the probability of 

being in this combined failure state, and 

then subsequently encountering limitload conditions, is extremely 

improbable. No reduction in these safety 

margins is allowed if the subsequent 

system-failure rate is greater than 10¥3

per hour. 

Issued in Renton, Washington, on August 

20, 2009. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. E9–20697 Filed 8–27–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–329I] 

RIN 1117–AB23 

Schedules of Controlled Substances; 

Table of Excluded Nonnarcotic 

Products: Nasal Decongestant Inhalers 

Manufactured by Classic 

Pharmaceuticals LLC 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: Under this Interim Rule, the 

Drug Enforcement Administration 

(DEA) is updating the Table of Excluded 


jlentini on DSKJ8SOYB1PROD with RULESER28AU09.088</GPH>
44282 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 

Nonnarcotic Products found in 21 CFR 

1308.22 to include the Nasal 

Decongestant Inhaler/Vapor Inhaler 

(containing 50 mg Levmetamfetamine) 

manufactured by Classic 

Pharmaceuticals LLC and marketed 

under various private labels (to include 

the ‘‘Premier Value’’ and ‘‘Kroger’’ 

labels). This nonnarcotic drug product, 

which may be lawfully sold over the 

counter without a prescription under 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 301), is excluded from 

provisions of the Controlled Substances 

Act (CSA) pursuant to 21 U.S.C. 

811(g)(1). 

Any interested person may file 

comments or objections to this order on 

or before October 27, 2009. If any such 

comments or objections raise significant 

issues regarding any finding of fact or 

conclusion of law upon which this 

order is based, the Deputy Assistant 

Administrator shall immediately 

suspend the effectiveness of this order 

until he may reconsider the application 

in light of the comments or objections 

filed. Thereafter, the Deputy Assistant 

Administrator shall reinstate, revoke, or 

amend his original order as he 

determines appropriate. 

DATES: This rulemaking shall become 

effective on August 28, 2009. Written 

comments must be postmarked and 

electronic comments must be submitted 

on or before October 27, 2009. 

Commenters should be aware that the 

electronic Federal Docket Management 

System will not accept comments after 

Midnight Eastern Time on the last day 

of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–329I’’ on all written and 

electronic correspondence. Written 

comments sent via regular or express 

mail should be sent to Drug 

Enforcement Administration, Attention: 

DEA Federal Register Representative/ 

ODL, 8701 Morrissette Drive, 

Springfield, VA 22152. Comments may 

be sent to DEA by sending an electronic 

message to 

dea.diversion.policy@usdoj.gov. 

Comments may also be sent 

electronically through http:// 

www.regulations.gov using the 

electronic comment form provided on 

that site. An electronic copy of this 

document is also available at the 

http://www.regulations.gov Web site. 

DEA will accept attachments to 

electronic comments in Microsoft Word, 

WordPerfect, Adobe PDF, or Excel file 

formats only. DEA will not accept any 

file format other than those specifically 

listed here. 

Please note that DEA is requesting 

that electronic comments be submitted 

before midnight Eastern time on the day 

the comment period closes because 

http://www.regulations.gov terminates 

the public’s ability to submit comments 

at midnight Eastern time on the day the 

comment period closes. Commenters in 

time zones other than Eastern time may 

want to consider this so that their 

electronic comments are received. All 

comments sent via regular or express 

mail will be considered timely if 

postmarked on the day the comment 

period closes. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, VA 22152; telephone: (202) 

307–7183. 

SUPPLEMENTARY INFORMATION: Posting of 

public comments: Please note that all 

comments received are considered part 

of the public record and made available 

for public inspection online at http:// 

www.regulations.gov and in the Drug 

Enforcement Administration’s public 

docket. Such information includes 

personal identifying information (such 

as your name, address, etc.) voluntarily 

submitted by the commenter. 

If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘Personal Identifying 

Information’’ in the first paragraph of 

your comment. You must also place all 

the personal identifying information 

you do not want posted online or made 

available in the public docket in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be 

posted online or made available in the 

public docket, you must include the 

phrase ‘‘Confidential Business 

Information’’ in the first paragraph of 

your comment. You must also 

prominently identify confidential 

business information to be redacted 

within the comment. If a comment has 

so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be posted online or made 

available in the public docket. 

Personal identifying information and 

confidential business information 

identified and located as set forth above 

will be redacted and the comment, in 

redacted form, will be posted online and 

placed in the Drug Enforcement 

Administration’s public docket file. 

Please note that the Freedom of 

Information Act applies to all comments 

received. If you wish to inspect the 

agency’s public docket file in person by 

appointment, please see the FOR

FURTHER INFORMATION paragraph. 

Background 

The Controlled Substances Act (CSA) 

under 21 U.S.C. 811(g)(1) states that the 

Attorney General shall by regulation 

exclude any nonnarcotic drug which 

contains a controlled substance from the 

application of the CSA, if such drug 

may, under the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 301 et seq.), be 

lawfully sold over the counter without 

a prescription. This authority has been 

delegated to the Administrator of DEA 

and redelegated to the Deputy Assistant 

Administrator of the Office of Diversion 

Control pursuant to 28 CFR 0.100 and 

Title 28, Part 0, Appendix to Subpart R, 

7(g), respectively. 

Such exclusions apply only to 

nonnarcotic products and are only 

granted following suitable application to 

the DEA per the provisions of 21 CFR 

1308.21. The current Table of Excluded 

Nonnarcotic Products found in 21 CFR 

1308.22 lists those products that have 

been granted excluded status. 

Pursuant to the application process of 

21 CFR 1308.21, DEA received 

application for exclusion from Classic 

Pharmaceuticals, LLC, the manufacturer 

of a Nasal Decongestant Inhaler/Vapor 

Inhaler which contains the schedule II 

controlled substance 

Levmetamfetamine. This inhaler is sold 

over the counter under various private 

labels (such as the ‘‘Premier Value’’ 

label of the Chain Drug Consortium, 

Boca Raton, Florida, and ‘‘The Kroger’’ 

label by The Kroger Company of 

Cincinnati, OH). Based on the 

application and other information 

received, including the quantitative 

composition of the substance and 

labeling and packaging information, 

DEA has determined that this product 

(sold under various private labels) may, 

under the Federal Food, Drug, and 

Cosmetic Act, be lawfully sold over the 

counter without a prescription (21 

U.S.C. 811(g)(1)). 

The Deputy Assistant Administrator 

finds that this product meets the criteria 

for exclusion from the CSA in 

accordance with 21 U.S.C. 811(g)(1). 

Note that this exclusion only applies to 

the finished drug product in the form of 

an inhaler (in the exact formulation 

detailed in the application for 

exclusion), which is lawfully sold under 

the Federal Food, Drug, and Cosmetic 

Act. The extraction or removal of the 


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Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 44283 

active ingredient (Levmetamfetamine) 

from the inhaler shall negate this 

exclusion and result in the possession of 

a schedule II controlled substance. 

This rulemaking adds Classic 

Pharmaceuticals, LLC product 

containing 50 mg Levmetamfetamine in 

a Nasal Decongestant Inhaler/Vapor 

Inhaler and marketed under various 

private labels to the list of excluded 

nonnarcotic products contained in 21 

CFR 1308.22. Effective August 28, 2009 

this product is excluded from CSA 

regulatory provisions. Any interested 

person may file written comments or 

objections to this order on or before 

October 27, 2009. If any such comments 

or objections raise significant issues 

regarding any finding of fact or 

conclusion of law upon which this 

order is based, the Deputy Assistant 

Administrator shall immediately 

suspend the effectiveness of this order 

until he may reconsider the application 

in light of the comments or objections 

filed. Thereafter, the Deputy Assistant 

Administrator shall reinstate, revoke, or 

amend his original order as he 

determines appropriate. 

Regulatory Certifications 

Regulatory Flexibility Act 

The Deputy Assistant Administrator 

hereby certifies that this rulemaking has 

been drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612). This rule will not have a 

significant economic impact on a 

substantial number of small entities. 

This rule adds a product to the list of 

products excluded from the 

requirements of the CSA. 

Executive Order 12866 

The Deputy Assistant Administrator 

certifies that this rulemaking has been 

drafted in accordance with the 

principles in Executive Order 12866 

Section 1(b). It has been determined that 

this is not ‘‘a significant regulatory 

action.’’ As discussed previously, based 

on the information received by the 

manufacturer of the product in question, 

DEA has determined that this product 

may, under the Federal Food, Drug, and 

Cosmetic Act, be lawfully sold over the 

counter without a prescription. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988, Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law; nor 

does it impose enforcement 

responsibilities on any State; nor does it 

diminish the power of any State to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $120,000,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by Section 804 of the 

Congressional Review Act/Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act). This rule will not result in 

an annual effect on the economy of 

$100,000,000 or more; a major increase 

in cost or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. 

Administrative Procedure Act 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act 

(5 U.S.C. 553), including notice of 

proposed rulemaking and the 

opportunity for public comment, if it is 

determined to be unnecessary, 

impracticable, or contrary to the public 

interest. DEA finds that it is 

unnecessary and impracticable to seek 

public comment prior to making the 

exclusion of this nonnarcotic product 

from the requirements of the CSA 

effective. DEA has no discretion in its 

determination of whether the product 

may, under the Federal Food, Drug, and 

Cosmetic Act, be lawfully sold over the 

counter without a prescription. 

The Administrative Procedure Act 

permits an agency to make a rule 

effective upon date of publication if it 

is ‘‘a substantive rule which grants or 

recognizes an exemption or relieves a 

restriction’’ (5 U.S.C. 553(d)(1)). Since 

this rule excludes a nonnarcotic drug 

product from the provisions of the CSA, 

DEA finds that it meets the criteria set 

forth in 5 U.S.C. 553(d)(1) for an 

exception to the effective date 

requirement. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ For the reasons set out above, 21 CFR 

Part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 2. Section 1308.22 is amended by 

adding to the table, in alphabetical 

order, the product listed below: 

§ 1308.22 Excluded substances. 

* * * * * 

EXCLUDED NONNARCOTIC PRODUCTS

Company Trade name NDC code Form Controlled substance (mg or mg/ml) 

* * * * * * * 

Classic Pharmaceuticals LLC Nasal Decongestant Inhaler/ 

Vapor Inhaler.

IN ................. Levmetamfetamine (l-Desoxyephedrine).50.00 

* * * * * * * 


jlentini on DSKJ8SOYB1PROD with RULES
44284 Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Rules and Regulations 

1 (Executive Order 13202 was signed by President 

George W. Bush on February 17, 2001 (published 

in the Federal Register on February 22, 2001 (66 

FR 11225)) and later amended by Executive Order 

13208, signed by President Bush on April 6, 2001 

(published in the Federal Register on April 11, 

2001 (66 FR 18717)). 

Dated: August 21, 2009. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Deputy Chief 

of Operations, Office of Diversion Control. 

[FR Doc. E9–20768 Filed 8–27–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

24 CFR Part 5 

[Docket No. FR–5331–F–01] 

RIN 2501–AD47 

Use of Project Labor Agreements for 

Federal Construction Projects 

AGENCY: Office of the Secretary, HUD. 

ACTION: Final rule. 

SUMMARY: This final rule removes a 

HUD regulation that prohibits the use of 

project labor agreements in HUDassisted construction contracts. 

Executive Order 13502, entitled ‘‘Use of 

Project Labor Agreements for Federal 

Construction Projects,’’ and signed by 

President Obama on February 6, 2009, 

revoked Executive Order 13202, which 

had prohibited federal agencies from 

requiring or prohibiting project labor 

agreements as a condition for award of 

any federally funded contract or 

subcontract for construction. Executive 

Order 13502, which applies to direct 

federal procurement of construction, 

encourages federal agencies to consider 

requiring the use of project labor 

agreements in connection with federally 

procured large-scale construction 

projects. The Executive Order also 

allows the use of project labor 

agreements in circumstances not 

covered by the Order, including projects 

receiving federal financial assistance. 

In a previously published Federal 

Register notice pertaining to HUD’s 

Fiscal Year 2009 (FY 2009) funding, 

participants in HUD programs and 

prospective recipients of HUD funds 

were notified of the issuance of 

Executive Order 13502, of its removal of 

the restrictions on the use of project 

labor agreements, and of the invalidity 

of the HUD regulation promulgated to 

enforce the earlier Executive Order. 

With the revocation of Executive Order 

13202, there is no longer a legal basis for 

HUD’s regulation that implemented that 

executive order with respect to HUDassisted projects. Therefore, this rule 

removes the regulation from the Code of 

Federal Regulations. 

DATES: Effective Date: September 28, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Camille E. Acevedo, Associate General 

Counsel for Legislation and Regulations, 

Office of General Counsel, Department 

of Housing and Urban Development, 

451 7th Street, SW., Room 10282, 

Washington, DC 20410; telephone 

number 202–402–5132 (this is not a tollfree number). Persons with hearing or 

speech impairments may access this 

number through TTY by calling the tollfree Federal Information Relay Service 

at 800–877–8339. 

SUPPLEMENTARY INFORMATION: 

I. Background—Executive Order 13502, 

‘‘Use of Project Labor Agreements for 

Federal Construction Projects’’ 

Executive Order 13502, entitled ‘‘Use 

of Project Labor Agreements for Federal 

Construction Projects,’’ and signed by 

President Barack Obama on February 6, 

2009, while directed to federal agency 

procurement of construction, also 

allows federal agencies to consider 

requiring the use of project labor 

agreements in connection with largescale federally assisted construction 

projects. (Executive Order 13502 was 

subsequently published in the Federal 

Register on February 11, 2009 (74 FR 

6985).) The Executive Order revokes 

Executive Order 13202, ‘‘Preservation of 

Open Competition and Government 

Neutrality towards Government 

Contractors’ Labor Relations on Federal 

and Federally Funded Construction 

Projects,’’ which prohibited federal 

agencies from requiring or prohibiting 

project labor agreements as a condition 

for award of any federally funded 

contract or subcontract for 

construction.1 In order to bind 

participants in HUD programs to the 

provisions of Executive Order 13202, 

HUD established regulations at 24 CFR 

5.108 that barred recipients of HUD 

funds from requiring or prohibiting 

project labor agreements in their 

procurements using HUD funds. The 

HUD regulations applied to HUDassisted construction contracts. 

Construction contracts awarded directly 

by HUD were covered separately by 

provisions in the government-wide 

Federal Acquisition Regulation (FAR). 

Executive Order 13502 restores to 

federal agencies the discretion to 

determine when project labor 

agreements may be appropriate and 

beneficial in federally assisted 

construction projects, through the 

revocation of Executive Order 13202. As 

a result of the revocation, Executive 

Order 13502 also removes the 

prohibition on recipients of HUD funds 

from requiring the use of project labor 

agreements in their procurements. 

Because the foundation for HUD’s 

regulation in 24 CFR 5.108 was the prior 

Executive Order, which has been 

revoked, the rule no longer has effect. 

Accordingly, in an update of 

requirements applicable to HUD 

funding for FY 2009, published in the 

Federal Register on April 16, 2009 (74 

FR 17685), HUD notified prospective 

recipients and participants in HUD 

programs that the new Executive Order 

revoked Executive Order 13202 and that 

the regulation in 24 CFR 5.108 was no 

longer in effect. 

Executive Order 13502 was issued to 

address the challenges to efficient and 

timely procurement presented to the 

federal government by large-scale 

construction projects. Because 

construction employers often do not 

have a permanent workforce, it can be 

difficult for them to predict labor costs 

when bidding on contracts and to 

ensure a steady stream of labor on 

contracts being performed. Often, 

multiple employers are involved at a 

single location, and a labor dispute 

concerning even one employer can 

delay an entire project. A lack of 

coordination between employers or 

uncertainties about the terms and 

conditions of employment of various 

groups of workers can create friction 

and disputes in the absence of an 

agreed-upon resolution mechanism. 

Project labor agreements can present a 

means for addressing these problems by 

providing structure and stability to 

large-scale construction projects, 

thereby promoting the efficient and 

expeditious completion of federal 

construction contracts. 

Executive Order 13502 declares that it 

is the policy of the federal government 

to encourage the executive agencies to 

consider requiring the use of project 

labor agreements in connection with 

large-scale construction projects in 

order to promote economy and 

efficiency in federal procurement. The 

Executive Order, however, does not 

require an executive agency to use a 

project labor agreement on any 

construction project, nor does it 

preclude the use of a project labor 

agreement in circumstances not covered 

by the Order, including leasehold 

arrangements and projects receiving 

federal financial assistance. The 

Executive Order also does not require 

contractors or subcontractors to enter 

into a project labor agreement with any 

particular labor organization. 


jlentini on DSKJ8SOYB1PROD with RULES