Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Rules and Regulations 31177 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 201 

[Docket No. FDA–1977–N–0013] (formerly 

Docket No. 1977N–0094L) 

RIN 0910–AF36 

Organ-Specific Warnings; Internal 

Analgesic, Antipyretic, and 

Antirheumatic Drug Products for Overthe-Counter Human Use; Final 

Monograph; Corrections 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule, corrections. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

final rule that appeared in the Federal 

Register of April 29, 2009. The 

document requires important new 

organ-specific warnings and related 

labeling for over-the-counter (OTC) 

internal analgesic, antipyretic, and 

antirheumatic drug products. The new 

labeling informs consumers about the 

risk of liver injury when using 

acetaminophen and the risk of stomach 

bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs). The 

document was published with an 

incorrect Analysis of Impacts section 

and omitted a reference from the 

reference section of the final rule. The 

document was also published with an 

error in the codified text regarding the 

introductory sentence to the stomach 

bleeding warning for NSAIDs. This 

document replaces the incorrect 

Analysis of Impacts section with the 

correct Analysis of Impacts section, 

adds a reference to the reference section 

of the final rule, and corrects the 

codified text. 

DATES: Effective Date: This final rule is 

effective April 29, 2010. 

Compliance Date: The compliance 

date for all products subject to this final 

rule, including products with annual 

sales less than $25,000, is April 29, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Arlene Solbeck, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993, 301–796–2090. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E9–9684, published on April 29, 2009 

(74 FR 19385), make the following 

corrections: 

1. Beginning on page 19401 and 

ending on page 19406, replace section 

VI. Analysis of Impacts with the 

following text: 

VI. Analysis of Impacts 

We have examined the impacts of the final 

rule under Executive Order 12866 and the 

Regulatory Flexibility Act (5 U.S.C. 601–612), 

and the Unfunded Mandates Reform Act of 

1995 (Public Law 104–4). Executive Order 

12866 directs 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). We believe that this final rule is not 

a significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act requires 

agencies to analyze regulatory options that 

would minimize any significant impact of a 

rule on 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 $130 million, using the most 

current (2007) Implicit Price Deflator for the 

Gross Domestic Product. We do not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed this 

amount. 

We conclude that this final rule is 

consistent with the principles set out in 

Executive Order 12866 and in these two 

statutes. As discussed in this section, we 

have determined that this final rule will not 

have a significant economic impact on a 

substantial number of small entities, but we 

lack sufficient information on the 

distribution of the burden to certify that it is 

not significant. 

The impact on industry, in terms of costs 

of compliance, are presented in section VI.B 

of this document and summarized in table 2 

of this document. The societal costs and 

benefits of this final rule are summarized in 

table 3 of section VI.B of this document. 

A. Need for the Rule 

In 2002, an FDA Advisory Committee 

recommended changes to the labeling of OTC 

acetaminophen and NSAID drug products to 

better inform consumers about the active 

ingredients and possible side effects caused 

by improper use. Current labels provide 

inadequate information about the risk of 

improper use. Although we consider 

acetaminophen to be safe and effective when 

labeled and used correctly, using too much 

can lead to liver injury and death. Similarly, 

the use of NSAIDs can lead to stomach 

bleeding and kidney damage. The number of 

cases of injury reported is a very low 

percentage of the total use of OTC 

acetaminophen and NSAID drug products. 

For many people, the risks are quite low 

because they use these products only 

occasionally. The risks may be greater for 

people who use these products more 

frequently and/or do not follow the labeling 

information on the package. The risk of 

injury may be increased for certain 

populations and under certain conditions of 

use. 

There are multiple reasons for 

unintentional acetaminophen overdoses. 

First, acetaminophen is an active ingredient 

in a wide variety of both OTC and 

prescription drug products. For prescription 

products, the immediate container may not 

state that the product contains 

acetaminophen or state the maximum daily 

dose limit. Consumers may often fail to 

recognize the presence and amount of 

acetaminophen ingredients in OTC and 

prescription drug products. This lack of 

knowledge can result in a person using two 

different products containing acetaminophen 

simultaneously. Moreover, many consumers 

are unaware that exceeding the 

recommended dosage for acetaminophen can 

lead to unintentional overdosing and cause 

potential harm. Based on the evidence 

discussed in this document, we find that 

there is sufficient incidence of liver injury 

associated with acetaminophen to warrant 

new labeling, and that without the new 

labeling, acetaminophen products would no 

longer be considered generally recognized as 

safe and effective and not misbranded for 

OTC use. 

Results of several large-scale clinical 

studies performed in the United States and 

in other countries have established that the 

use of NSAIDs is an important risk factor for 

serious stomach adverse events, especially 

bleeding. The risk is higher for certain 

populations. Based on the evidence 

discussed in this document, we further find 

that NSAIDs increase the risk for stomach 

adverse events and that, without a new 

stomach bleeding warning in the labeling for 

NSAIDs, the products would no longer be 

considered generally recognized as safe and 

effective and not misbranded for OTC use. 

The purpose of this final rule is to amend 

our OTC drug labeling regulations to include 

new warnings and other labeling 

requirements to advise consumers of 

potential risks and when to consult a doctor 

(see table 1 in section II.B.2 of this 

document). We are also removing the alcohol 

warning in § 201.322 and incorporating new 

alcohol-related warnings and other labeling 

for all OTC acetaminophen and NSAID drug 

products. We are requiring certain warning 

information targeted to age-specific 

populations. In addition, we are requiring 

that the presence of acetaminophen or any 

NSAID would appear prominently on a 

product’s principal display panel (PDP). 

Without this final rule, the labeling of these 

products will not provide sufficient warnings 

of risks to consumers. 

B. Impact of the Rule 

We contracted Eastern Research Group, 

Inc. (ERG) to assess the costs and benefits of 

the proposed rule on which this final rule is 

based. The full ERG report (Ref. 56), 

including details on methods, assumptions, 

cost calculations, and findings, is on file in 

the Division of Dockets Management (71 FR 


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9Estimates of affected SKUs are 18,000 by FDA 

and 20,000 to 25,000 by industry consultant. This 

number of SKUs includes products marketed by 

manufacturers, repackers, relabelers, and 

distributors. 

10ERG conducted a sensitivity analysis using the 

same distribution of products at proposal and found 

that costs would have been about 3 percent lower. 

The former distribution was: Acetaminophen, 45 

percent; NSAIDs except ibuprofen, 38 percent; 

ibuprofen, 15 percent; and combinations of 

acetaminophen and NSAIDs, 2 percent. 

77314 at 77341). The most significant change 

from the proposal is the requirement that 

warning statements appear on both the outer 

container and on the immediate container. 

We, therefore, contracted with ERG to 

perform an updated store survey and analysis 

to assess the costs of the changes in this final 

rule. ERG’s 2008 ‘‘Addendum to the Cost 

Benefit Analysis: Final Internal Analgesic, 

Antipyretic, and Antirheumatic Drug 

Products Rulemaking’’ (Ref. 57) is also on file 

with the Division of Dockets Management. 

Most of ERG’s methods, assumptions and 

analysis used for the proposed rule remain 

unchanged for this final rule. The following 

is a summary of ERG’s findings. 

1. Cost of Compliance 

Manufacturers and marketers of OTC 

acetaminophen and NSAID drug products 

would incur one-time costs to revise affected 

product labeling to comply with this rule. We 

estimated costs for a major labeling revision 

using a pharmaceutical labeling revision cost 

model. We used an implementation period of 

12 months. The labeling model is described 

in detail in Appendix A of the ERG report 

cited in the 2006 proposed rule. 

To develop the original model, we and 

ERG interviewed pharmaceutical 

representatives from regulatory, legal, 

manufacturing controls, and labeling 

departments to collect information on 

labeling change cost components, type of 

personnel affected, and costs. The model 

incorporates data on average industry costs 

by company size, including, where 

applicable, modifications to packaging 

configurations. Industry consultants also 

provided information on model inputs 

related to the OTC acetaminophen and 

NSAID drug product industry, the labeling 

revision process, the costs of modifying 

labeling, and the frequency of packaging 

reconfiguration changes. 

The baseline for this final rule is full 

compliance with the format and content 

requirements for OTC drug product labeling 

in 21 CFR 201.66 established in a 1999 final 

rule (64 FR 13254, March 17, 1999). In the 

1999 final rule, we accounted for the total 

incremental costs to comply with the format 

and content requirements, including using a 

6 point font size and related costs for 

increased package size and longer labeling 

where applicable. We note that, although 

some forms of packaging (for small 

quantities) have been granted extensions on 

compliance dates, many packaging 

alternatives now exist that can accommodate 

the format and content requirements. 

Manufacturers routinely redesign labels at 

varying intervals and have standardized 

procedures in place for complying with our 

requirements. Based on consultant input, 

manufacturers of OTC acetaminophen and 

NSAID drug products typically redesign onehalf of their labels every 2 years, the 

remainder every 3 years. The costs of labeling 

change depend on the type of labeling (e.g., 

carton and container label) and whether there 

is sufficient labeling space to accommodate 

the proposed changes. 

There are an estimated 22,500 OTC 

acetaminophen and NSAID drug product 

stock keeping units (SKUs), split evenly 

among branded and private labels, according 

to an industry consultant.9 We assume that 

branded SKUs are distributed as follows by 

firm size: 50 percent small, 17 percent 

medium, and 33 percent large. Based on 

ERG’s store survey, roughly 98 percent of 

OTC acetaminophen and NSAID drug 

products were packaged in containers within 

cartons and 2 percent in containers without 

outer cartons. About 5 percent of the 98 

percent of products packaged in cartons 

contained blister packs. For the final rule, 

ERG revised the distribution of SKUs among 

OTC acetaminophen and NSAID drug 

products as follows: Acetaminophen, 32 

percent; NSAIDs except ibuprofen, 32 

percent; ibuprofen, 34 percent; and 

combinations of acetaminophen and NSAIDs, 

2 percent.10

To assess the increase in label space and 

package size requirements, ERG purchased a 

variety of OTC IAAA packaging 

arrangements. ERG then determined the 

current baseline warning language and 

evaluated spacing constraints on packaging. 

Consistent with findings discussed in the 

proposed rule, ERG concluded that all 

current packaging except blister packs can 

accommodate the required changes in this 

final rule without altering label sizes, 

package sizes, or adding nonstandard labels. 

For blister packages, all outer cartons were 

judged to have adequate label space 

available. With respect to the immediate 

container, blister packs for OTC 

acetaminophen were judged able to 

accommodate warning statements, but the 

OTC NSAID blister packs could not. 

Therefore, ERG estimated that for OTC 

NSAIDs, both the inner blister pack container 

and the outer carton would need to be 

expanded. This assumption allows for the 

same number of unit doses per card and a 

larger carton to accommodate the larger 

cards. 

Table 2 of this document presents the 

estimated total one-time and recurring 

annual costs of compliance with this final 

rule in 2002 dollars. The total estimated firstyear one-time costs to revise labeling are 

$62.7 million. Recurring costs are $1.5 

million per year. The increases in cost from 

the proposed rule are driven by the increased 

percentage of OTC ibuprofen SKUs, the 

doubling of packaging changes needed due to 

the final regulation, and the need to change 

package sizes for OTC NSAID blister packs. 

TABLE 2.—ESTIMATED TOTAL ONE-TIME AND RECURRING ANNUAL COSTS OF COMPLIANCE WITH THIS RULE (IN 2002 

DOLLARS) 

Company Type 

Product Type 

Acetaminophen Ibuprofen NSAIDs Except 

Ibuprofen 

Combinations of 

Acetaminophen and 

NSAIDs 

Total 

Total one-time costs (expressed as millions of dollars) 

Small brand $2 .2 $4 .2 $4 .0 $0 .2 $10 .7 

Medium brand $2 .2 $3 .1 $2 .9 $0 .2 $8 .4 

Large brand $6 .1 $8 .5 $8 .0 $0 .5 $23 .0 

Private label $4 .5 $8 .0 $7 .5 $0 .5 $20 .5 

Total $15 .0 $23 .8 $22 .4 $1 .4 $62 .7 

Total recurring costs (expressed as millions of dollars) 

Small brand $0 .000 $0 .089 $0 .050 $0 .005 $0 .145 


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Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Rules and Regulations 31179 

TABLE 2.—ESTIMATED TOTAL ONE-TIME AND RECURRING ANNUAL COSTS OF COMPLIANCE WITH THIS RULE (IN 2002 

DOLLARS)—Continued 

Company Type 

Product Type 

Acetaminophen Ibuprofen NSAIDs Except 

Ibuprofen 

Combinations of 

Acetaminophen and 

NSAIDs 

Total 

Medium brand $0 .000 $0 .065 $0 .037 $0 .004 $0 .106 

Large brand $0 .000 $0 .467 $0 .264 $0 .026 $0 .756 

Private label $0 .000 $0 .290 $0 .164 $0 .016 $0 .470 

Total $0 .000 $0 .911 $0 .515 $0 .050 $1 .476 

2. Alternatives 

We considered and rejected the following 

alternatives: (1) Not adding the new 

information to OTC acetaminophen and 

NSAID drug product labeling and (2) a longer 

implementation period. We do not consider 

either of these approaches acceptable because 

they do not ensure that consumers will have 

the most current labeling information needed 

for the safe and effective use of these 

products. We consider this final rule the least 

burdensome alternative that meets the public 

health objectives of this rule. 

3. Benefits 

Our final rule requirements are intended to 

enhance consumer awareness and knowledge 

of the active ingredient in OTC 

acetaminophen and NSAID drug products. 

These new warnings include: 

• New label warnings 

• Age-specific information 

• Advising consumers of potential risks 

and when to consult a doctor 

• Prominent display of active ingredients 

on the PDP 

The revised alcohol statements are intended 

to provide clearer warnings to high-risk 

individuals about product use. The overall 

intent of these requirements is to reduce the 

liver injury and stomach bleeding episodes 

that occur due to unintentional overdosing 

with these drugs. The requirements are also 

intended to reduce the incidence of adverse 

health outcomes among high-risk 

subpopulations consuming proper doses of 

OTC acetaminophen and NSAID drug 

products (e.g., people with liver disease or 

people prone to stomach bleeding). 

Our estimate of the potential benefits of 

this final rule remains unchanged from the 

estimate discussed in the proposed rule. We 

estimated benefits assuming a reduction of 

from 1 percent to 3 percent in unintentional 

overdosing with OTC acetaminophen and 

NSAID drug products. Reducing the number 

of unintentional overdoses with OTC 

acetaminophen and NSAID drug products 

would reduce the number of emergency room 

visits, hospitalizations, and deaths 

attributable to these unintentional overdoses. 

The monetary value of these avoided adverse 

events, in 2007 dollars, is shown in table 3 

of this document. 

4. Benefit-Cost Comparison 

Table 3 of this document summarizes the 

present value over 10 years of the compliance 

costs and the benefits of a 1 percent and 3 

percent reduction in deaths and 

hospitalizations using discount rates of 7 and 

3 percent. We converted ERG’s present value 

comparison of costs and benefits to 2007 

dollars using the Gross Domestic Product 

index of 1.0948 relative to 2001. The low end 

of the benefits range uses an estimate of $5 

million as the value of a statistical life and 

includes savings from reduced 

hospitalizations. The high end of the benefits 

range uses an updated value of $7 million per 

statistical life and does not include savings 

from reduced hospitalizations. The costs of 

this final rule exceed the benefits using the 

most conservative assumption of benefits. 

The benefits exceed the costs of this rule at 

the mid to upper end of the benefits range. 

Comparing the present value of costs and 

benefits over 10 years, in 2007 dollars, costs 

would exceed benefits if this rule reduced 

deaths and hospitalizations by 2 percent or 

more. 

TABLE 3.—PRESENT VALUE AND ANNUALIZED PRESENT VALUE OF COMPLIANCE COSTS AND POTENTIAL BENEFITS OVER

10 YEARS (IN 2007 DOLLARS) 

Discount Rate 

Present Value (millions of dollars) Annualized Present Value Over 10 Years (millions 

of dollars) 

Costs1 Benefits2

Costs Benefits2

7 percent $77 .8 $45.1 - $172.8 $11 .1 $6.4 - $24.6 

3 percent $79 .8 $53.8 - $202.0 $9 .4 $6.3 - $23.7 

1The present value of compliance costs over 10 years in 2001 dollars equals $71.0 million at 7 percent and $72.9 million at 3 percent. 2Assumes that this final rule would reduce adverse events by 1 to 3 percent. 

5. Break-Even Analysis 

We note that we lack the data needed to 

confidently predict a percent reduction in 

serious cases related to unintentional 

overdosing. Because of the uncertainty in 

these estimates, we estimated an annual 

average number of adverse events that would 

need to be avoided over a 10 year period to 

reach a break-even point (i.e., the present 

value of the cost of compliance divided by 

the present value of the monetary value of 

avoiding an adverse event each year for 10 

years). The following calculations are based 

on 2001 dollars, which will not affect the 

estimated break-even values to be calculated. 

For benefits to equal costs, this final rule 

would need to prevent about 2 deaths each 

year over 10 years [1.9 deaths ($71.0 million/ 

$37.6 million at a 7 percent discount rate) 

and 1.7 deaths ($72.9 million/$43.9 million 

at a 3 percent discount rate)]. This estimate 

of deaths avoided is based on a value of $5 

million per statistical life. Alternatively, if no 

deaths are avoided, the final rule would need 

to prevent about 1,058 hospitalizations each 

year over the 10-year period at the 7 percent 

discount rate ($71.0 million/$67,156), and 

928 hospitalizations a year at the 3 percent 

discount rate ($72.9 million/$78,513). This 

estimate of hospitalizations avoided is based 

on the lowest monetized value of a poisoning 

episode requiring hospitalization: $8,936 per 

episode over 10 years at a 7 percent discount 

rate. 

Although we lack evidence to predict with 

certainty a specific level of reduction in 

adverse events, if we assume only a 2 percent 

reduction in the illnesses and deaths 

analyzed, the benefits of this final rule 


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31180 Federal Register / Vol. 74, No. 124 / Tuesday, June 30, 2009 / Rules and Regulations 

outweigh the costs. We find that this final 

rule will enhance public health and promote 

the safer use of OTC acetaminophen and 

NSAID drug products. 

6. Final Regulatory Flexibility Analysis 

This economic analysis, together with 

other relevant sections of this document, 

serves as our final regulatory flexibility 

analysis, as required under the Regulatory 

Flexibility Act. For our preliminary 

regulatory flexibility analysis, we calculated 

the average annualized compliance costs for 

firms in each size category and determined 

that the average annualized compliance costs 

totaled less than 1 percent of average receipts 

for all firm sizes. In 2007 dollars, the 

estimated annualized present value cost per 

SKU is $492 (i.e., $11.1 million divided by 

22,500 SKUs) using a 7 percent discount rate 

over 10 years, and $416 per SKU ($9.4 

million divided by 22,500 SKUs) using a 3 

percent discount rate over 10 years. For 

private label SKUs only, the annualized 

present value cost per SKU is $321 ($3.6 

million divided by 11,250 SKUs) using a 7 

percent discount rate over 10 years, or $271 

per private label SKU ($3.0 divided by 11,250 

SKUs) using a 3 percent discount rate over 

10 years. Similar to the proposed rule, the 

average annualized compliance costs of the 

final rule remain under 1 percent of average 

receipts for all firm sizes. Therefore, we 

tentatively conclude that this final rule will 

not have a significant economic impact on a 

substantial number of small entities. 

2. On page 19407, in the second 

column, add the following reference: 

57. Eastern Research Group, Inc., 

‘‘Addendum to the Cost Benefit Analysis: 

Final Internal Analgesic, Antipyretic and 

Antirheumatic Drug Products Rulemaking,’’ 

Final Report, July 30, 2008. 

§ 201.326 [Corrected] 

■ 3. On page 19408, in the third column, 

correct the first sentence in 

§ 201.326(a)(2)(iii)(A) to read as follows: 

‘‘Stomach bleeding warning [heading in 

bold type]: This product contains an 

NSAID, which may cause severe 

stomach bleeding.’’ 

■ 4. On page 19409, in the first column, 

correct the first sentence in 

§ 201.326(a)(2)(iv)(A)(1) to read as 

follows: ‘‘Stomach bleeding warning 

[heading in bold type]: This product 

contains an NSAID, which may cause 

severe stomach bleeding.’’ 

■ 5. On page 19409, in the second 

column, correct the first sentence in 

§ 201.326(a)(2)(v)(A) to read as follows: 

‘‘Stomach bleeding warning [heading in 

bold type]: This product contains an 

NSAID, which may cause severe 

stomach bleeding.’’ 

Dated: June 23, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–15403 Filed 6–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[USCG–2008–1216] 

RIN 1625–AA09 

Drawbridge Operation Regulations; 

Potomac River, Between MD and VA 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is changing 

the drawbridge operation regulations of 

the new Woodrow Wilson Memorial (I– 

95) Bridge, mile 103.8, across the 

Potomac River between Alexandria, VA 

and Oxon Hill, MD. This rule is being 

made in an effort to minimize the 

potential for major regional vehicular 

traffic impacts and consequences during 

bridge openings of the draw span while 

still providing for reasonable needs of 

marine traffic. 

DATES: This rule is effective July 30, 

2009. 

ADDRESSES: Comments and related 

materials received from the public, as 

well as documents mentioned in this 

preamble as being available in the 

docket, are part of docket USCG–2008– 

1216 and are available online at 

http://www.regulations.gov. This 

material is also available for inspection 

or copying at two locations: The Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays, and the 

Commander (dpb), Fifth Coast Guard 

District, Federal Building, 1st Floor, 431 

Crawford Street, Portsmouth, VA 

23704–5004 between 8 a.m. and 4 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call 

Waverly W. Gregory, Jr., Bridge 

Administrator, Fifth Coast Guard 

District, at 757–398–6222. If you have 

questions on viewing or submitting 

material to the docket, call Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On February 9, 2009, we published a 

notice of proposed rulemaking (NPRM) 

entitled, ‘‘Drawbridge Operation 

Regulations; Potomac River, Between 

MD and VA’’ (74 FR 6359). We received 

no comments on the published NPRM. 

No public meeting was requested, and 

none was held. 

Background and Purpose 

On July 2, 2008, we published a 

temporary regulation entitled 

‘‘Drawbridge Operation Regulations; 

Potomac River, Between MD and VA,’’ 

in the Federal Register (73 FR 37806). 

While construction continued, the 

temporary rule allowed the drawbridge 

to remain closed-to-navigation each day 

from 10 a.m. to 2 p.m. until and 

including March 1, 2009. 

The MD State Highway 

Administration and the VA Department 

of Transportation, co-owners of the 

drawbridge, requested to permanently 

maintain the Woodrow Wilson Bridge in 

the closed-to-navigation position each 

day from 10 a.m. to 2 p.m. This request 

was made in an effort to minimize the 

potential for major regional vehicular 

traffic impacts and consequences during 

bridge openings. 

In reaching our decision to implement 

this request, we balanced the large 

volume of vehicular traffic moving 

across the bridge against the lack of 

large commercial vessel traffic seeking 

to use the bridge during this period. The 

Woodrow Wilson Bridge is part of the 

Capital Beltway Interstate Highway 

System. It is a critical component of that 

system for both local and regional traffic 

moving into, around, and through the 

Washington, DC metro area. Bridge 

openings cause significant traffic delays. 

From a river-user standpoint, the 

coordinators for the construction of the 

new Woodrow Wilson Bridge Project 

have received no requests from boaters 

or mariners to open the bridge during 

the 10 a.m. to 2 p.m. timeframe since 

the first temporary deviation was issued 

in late June 2006. In fact, no requests 

have been received for an opening of the 

new bridge at all since July 3, 2006. 

Finally, the coordinators have received 

no complaints on the 10 a.m. to 2 p.m. 

restriction. This rule will affect only 

vessels with mast heights of 75 feet or 

greater. Furthermore, all operators of 

affected vessels with mast heights 

greater than 75 feet will be able to 

request an opening of the drawbridge in 

the ‘‘off-peak’’ vehicle traffic hours 

(evening and overnight) in accordance 

with 33 CFR 117.255(a). As discussed in 

the Notice of Proposed Rulemaking, 

currently, 33 CFR 117.255(a)(2)(i) states 

(paraphrasing) that the drawbridge need 

not open for the passage of a 

commercial vessel, Monday through 

Friday, 5 a.m. to 10 a.m. and 2 p.m. to 

8 p.m. This final rule connects the two 

time periods by extending the operating 


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