69278 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 

Costs of Compliance 

There are about 1,063 airplanes of the 

affected design in the worldwide fleet. 

This AD will affect about 518 airplanes 

of U.S. registry. 

Replacing the bracket will take about 

1 work hour per airplane, at an average 

labor rate of $65 per work hour. 

Required parts will cost about $186 per 

airplane. Based on these figures, we 

estimate the cost of the required 

replacement on U.S. operators to be 

$130,018, or $251 per airplane. 

Inspecting the FQIS wire bundle will 

take approximately 1 work hour per 

airplane, at an average labor rate of $65 

per work hour. Based on these figures, 

we estimate the cost of the required 

inspection on U.S. operators to be 

$33,670, or $65 per airplane. 

Regulatory Findings 

We have determined that this AD will 

not have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect 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. 

For the reasons discussed above, I 

certify that this AD: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

(2) Is not a ‘‘significant rule’’ under 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and

(3) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this AD. See the ADDRESSES section for 

a location to examine the regulatory 

evaluation.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety.

Adoption of the Amendment

■ Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows:

PART 39—AIRWORTHINESS 

DIRECTIVES

■ 1. The authority citation for part 39 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD):

2004–24–07 Boeing: Amendment 39–13883. 

Docket No. FAA–2004–18562; 

Directorate Identifier 2003–NM–147–AD. 

Effective Date 

(a) This AD becomes effective January 3, 

2005. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Boeing Model 737–

600, –700, –700C, –800, and –900 series 

airplanes, as listed in Boeing Special 

Attention Service Bulletin 737–28–1190, 

Revision 1, dated March 27, 2003; 

certificated in any category. 

Unsafe Condition 

(d) This AD was prompted by a report of 

an incorrectly installed fuel quantity 

indicating system (FQIS) wire bundle. We are 

issuing this AD to prevent chafing of the 

FQIS wire(s) in the center fuel tank, which, 

when combined with a lightning strike or a 

power wire short to the FQIS wire(s), could 

result in arcing in the center fuel tank and 

consequent fuel tank explosion. 

Compliance 

(e) You are responsible for having the 

actions required by this AD performed within 

the compliance times specified, unless the 

actions have already been done. 

Replacement and Inspection 

(f) Within 24 months after the effective 

date of this AD, replace the bracket for the 

FQIS wire bundle with a new, improved 

bracket, perform a general visual inspection 

of the FQIS wire bundle for damage, and 

perform any applicable corrective actions, by 

accomplishing all of the actions specified in 

the Accomplishment Instructions of Boeing 

Special Attention Service Bulletin 737–28–

1190, Revision 1, dated March 27, 2003. Do 

any applicable corrective actions before 

further flight.

Note 1: For the purposes of this AD, a 

general visual inspection is defined as: ‘‘A 

visual examination of an interior or exterior 

area, installation, or assembly to detect 

obvious damage, failure, or irregularity. This 

level of inspection is made from within 

touching distance unless otherwise specified. 

A mirror may be necessary to enhance visual 

access to all exposed surfaces in the 

inspection area. This level of inspection is 

made under normally available lighting 

conditions such as daylight, hangar lighting, 

flashlight, or droplight and may require 

removal or opening of access panels or doors. 

Stands, ladders, or platforms may be required 

to gain proximity to the area being checked.’’

Actions Accomplished in Accordance With 

Previous Issue of Service Bulletin 

(g) Actions accomplished before the 

effective date of this AD in accordance with 

Boeing Special Attention Service Bulletin 

737–28–1190, dated January 16, 2003, are 

considered acceptable for compliance with 

the corresponding action specified in this 

AD. 

Parts Installation 

(h) As of the effective date of this AD, no 

person may install a bracket, part number 

287A9111–3, for the FQIS wire bundle, on 

any airplane. 

Alternative Methods of Compliance 

(AMOCs) 

(i) The Manager, Seattle Aircraft 

Certification Office, FAA, has the authority to 

approve AMOCs for this AD, if requested in 

accordance with the procedures found in 14 

CFR 39.19. 

Material Incorporated by Reference 

(j) You must use Boeing Special Attention 

Service Bulletin 737–28–1190, Revision 1, 

dated March 27, 2003, to perform the actions 

that are required by this AD, unless the AD 

specifies otherwise. The Director of the 

Federal Register approves the incorporation 

by reference of the document in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. For 

copies of the service information, contact 

Boeing Commercial Airplanes, P.O. Box 

3707, Seattle, Washington 98124–2207. For 

information on the availability of this 

material at the National Archives and 

Records Administration (NARA), call (202) 

741–6030, or go to http://www.archives.gov/

federal_register/code_of_federal_regulations/

ibr_locations.html. You may view the AD 

docket at the Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street SW., room PL–401, Nassif 

Building, Washington, DC.

Issued in Renton, Washington, on 

November 17, 2004. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service.

[FR Doc. 04–26190 Filed 11–26–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 1990N–0309]

RIN 0910–AF50

Drug Labeling; Sodium Labeling for 

Over-the-Counter Drugs

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule amending the regulations for 

sodium labeling for over-the-counter 

(OTC) drug products by extending the 

sodium content labeling requirement to 

Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 69279

rectal drug products containing sodium 

phosphate/sodium biphosphate (sodium 

phosphates). FDA is taking this action 

because people with certain medical 

conditions are at risk for an electrolyte 

imbalance to occur when using rectal 

sodium phosphates products. Serious 

adverse events and deaths have 

occurred because of the high level of 

sodium present in these products. This 

final rule is part of FDA’s ongoing 

review of OTC drug products.

DATES: This rule is effective November 

29, 2005.

FOR FURTHER INFORMATION CONTACT: Neel 

Patel, Center for Drug Evaluation and 

Research (HFD–560), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 24, 

2004 (69 FR 13765), FDA issued a 

proposed rule to amend the regulations 

for sodium labeling for OTC drug 

products to require sodium content 

labeling for rectal drug products 

containing sodium phosphates. FDA 

considers it important that consumers 

be aware of the sodium content of OTC 

rectal drug products containing sodium 

phosphates and that this information 

appear in product labeling so that it will 

be readily available to consumers, 

physicians, and other health 

professionals. Some OTC laxative drug 

products intended for rectal 

administration can contain very high 

levels of sodium from both active and 

inactive ingredients. Significant 

amounts of some of these products may 

be absorbed causing an electrolyte 

imbalance.

Section 201.64 (21 CFR 201.64) 

requires orally ingested sodium 

phosphates products to bear sodium 

content information. FDA proposed to 

add paragraph (k) to § 201.64 to require 

sodium content information to appear in 

the labeling of rectal drug products 

containing dibasic sodium phosphate 

and/or monobasic sodium phosphate.

II. Final Rule Amending Sodium 

Labeling Regulations

FDA did not receive any comments to 

its proposed new labeling requirements, 

its discussion of the statutory authority 

to require this labeling, or its discussion 

of this labeling requirement being 

constitutionally permissible under the 

first amendment. Accordingly, FDA is 

not repeating those discussions in this 

final rule, but is incorporating the 

discussions regarding statutory 

authority and the first amendment by 

reference (see 69 FR 13766 to 13767). 

FDA is finalizing its proposal by 

requiring sodium content information to 

appear in the labeling of OTC rectal 

drug products containing dibasic 

sodium phosphate and/or monobasic 

sodium phosphate.

III. Analysis of Impacts

FDA has examined the impacts of this 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1501 et 

seq.). 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). Under 

the Regulatory Flexibility Act, if a rule 

has a significant economic impact on a 

substantial number of small entities, an 

agency must analyze regulatory options 

that would minimize any significant 

impact of the rule on small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement of anticipated costs and 

benefits before proposing any rule that 

may result in an expenditure in any one 

year by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million (adjusted 

annually for inflation).

FDA concludes 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 of 

the document, the final rule will not be 

economically significant as defined by 

the Executive order. With respect to the 

Regulatory Flexibility Act, FDA 

concludes that the rule would not have 

a significant economic impact on a 

substantial number of small entities. 

The Unfunded Mandates Reform Act of 

1995 does not require FDA to prepare a 

statement of costs and benefits for the 

final rule, because the final rule is not 

expected to result in any 1-year 

expenditure that would exceed $100 

million adjusted for inflation. The 

current inflation adjusted statutory 

threshold is about $110 million.

The purpose of this final rule is to 

extend the requirement for sodium 

content labeling to OTC rectal drug 

products that contain sodium 

phosphates so that the information is 

available to: (1) Health professionals 

and (2) individuals who need to limit 

their sodium intake. The final rule 

would require minor relabeling of OTC 

rectal drug products containing sodium 

phosphates. There are fewer than five 

major manufacturers of these products 

in the OTC drug marketplace. One 

company manufactures a nationally 

branded product with the others 

producing private label products. One 

large manufacturer produces about onehalf to two-thirds of the products 

covered by this final rule. Three small 

manufacturers account for the 

remainder of the market. There may be 

other manufacturers/marketers not 

identified in sources FDA reviewed, but 

FDA believes there are a limited number 

and they would be small manufacturers. 

FDA concludes that this final rule 

would not have a significant economic 

impact on small entities, using the U.S. 

Small Business Administration 

designations for this industry (750 

employees). Together, fewer than 300 

stockkeeping units (SKUs) are marketed. 

The manufacturer of the nationally 

branded product and some private label 

manufacturers of these products already 

include sodium content information in 

the labeling of their products. Any 

necessary relabeling (addition of sodium 

content labeling) will impose direct onetime costs on some manufacturers. FDA 

has been informed that the cost to 

relabel these products ranges from $500 

to $3,500 per SKU. Using $3,500 per 

SKU, and assuming all SKUs would 

need to be relabeled, the total one-time 

cost to relabel these products would be 

$1,050,000. Actual costs will be lower 

because most of these products already 

include the sodium content information 

in their labeling.

Manufacturers that have not 

voluntarily included sodium content 

information may also incur one-time 

costs to test their products to determine 

the sodium content. The cost to test for 

one cation (e.g., sodium) is about $150 

for private label manufacturers. 

Assuming they repeat the testing, the 

total one-time costs for an estimated 10 

products would be $3,000.

FDA considered but rejected several 

labeling alternatives: (1) A longer 

implementation period and (2) an 

exemption from coverage for small 

entities. A longer time period would 

unnecessarily delay the benefit of the 

new labeling to consumers who selfmedicate with these products. FDA 

rejected an exemption for small entities 

because the labeling is also needed by 

consumers who purchase products 

marketed by those entities.

For the reasons stated previously and 

under the Regulatory Flexibility Act (5 

U.S.C. 605(b)), FDA certifies that this 

final rule will not have a significant 

economic impact on a substantial 

number of small entities.

69280 Federal Register / Vol. 69, No. 228 / Monday, November 29, 2004 / Rules and Regulations 

IV. Paperwork Reduction Act of 1995

FDA concludes that the labeling 

requirement in this document is not 

subject to review by the Office of 

Management and Budget because it does 

not constitute a ‘‘collection of 

information’’ under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). Rather, the labeling statements 

are a ‘‘public disclosure of information 

originally supplied by the Federal 

government to the recipient for the 

purpose of disclosure to the public’’ (5 

CFR 1320.3(c)(2)).

V. Environmental Impact

FDA has determined under 21 CFR 

25.31(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.

VI. Federalism

FDA has analyzed this final 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.

List of Subjects in 21 CFR Part 201

Drugs, Labeling, 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 201 is 

amended as follows:

PART 201—LABELING

■ 1. The authority citation for 21 CFR 

part 201 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 358, 360, 360b, 360gg–360ss, 371, 

374, 379e; 42 U.S.C. 216, 241, 262, 264.

■ 2. Section 201.64 is amended by 

adding paragraph (k) to read as follows:

§ 201.64 Sodium labeling.

* * * * *

(k) The labeling of OTC drug products 

intended for rectal administration 

containing dibasic sodium phosphate 

and/or monobasic sodium phosphate 

shall contain the sodium content per 

delivered dose if the sodium content is 

5 milligrams or more. The sodium 

content shall be expressed in milligrams 

or grams. If less than 1 gram, milligrams 

should be used. The sodium content 

shall be rounded-off to the nearest 

whole number if expressed in 

milligrams (or nearest tenth of a gram if 

expressed in grams). The sodium 

content per delivered dose shall follow 

the heading ‘‘Other information’’ as 

stated in § 201.66(c)(7). Any product 

subject to this paragraph that contains 

dibasic sodium phosphate and/or 

monobasic sodium phosphate as an 

active ingredient intended for rectal 

administration and that is not labeled as 

required by this paragraph and that is 

initially introduced or initially 

delivered for introduction into interstate 

commerce after November 29, 2005, is 

misbranded under sections 201(n) and 

502(a) and (f) of the act.

Dated: November 18, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26269 Filed 11–26–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 914

[Docket No. IN–141–FOR] 

Indiana Regulatory Program

AGENCY: Office of Surface Mining 

Reclamation and Enforcement, Interior.

ACTION: Final rule; approval of 

amendment. 

SUMMARY: We, the Office of Surface 

Mining Reclamation and Enforcement 

(OSM), are approving, with an 

additional requirement, an amendment 

to the Indiana regulatory program 

(Indiana program) under the Surface 

Mining Control and Reclamation Act of 

1977 (SMCRA or the Act). Indiana 

proposed revisions to and additions of 

rules about definitions, identification of 

interests, topsoil, siltation structures, 

impoundments, refuse piles, prime 

farmland, lands eligible for remining, 

permitting, performance bond release, 

surface and ground water monitoring, 

roads, inspection, and civil penalties. 

Indiana intends to revise its program to 

be consistent with the corresponding 

Federal regulations, clarify ambiguities, 

and improve operational efficiency.

DATES: Effective: November 29, 2004.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Chief, Alton Field 

Division. Telephone: (317) 226–6700. Email: IFOMAIL@osmre.gov.

SUPPLEMENTARY INFORMATION:

I. Background on the Indiana Program 

II. Submission of the Amendment 

III. OSM’s Findings 

IV. Summary and Disposition of Comments 

V. OSM’s Decision 

VI. Procedural Determinations

I. Background on the Indiana Program 

Section 503(a) of the Act permits a 

State to assume primacy for the 

regulation of surface coal mining and 

reclamation operations on non-Federal 

and non-Indian lands within its borders 

by demonstrating that its State program 

includes, among other things, ‘‘a State 

law which provides for the regulation of 

surface coal mining and reclamation 

operations in accordance with the 

requirements of this Act * * *; and 

rules and regulations consistent with 

regulations issued by the Secretary 

pursuant to this Act.’’ See 30 U.S.C. 

1253(a)(1) and (7). On the basis of these 

criteria, the Secretary of the Interior 

conditionally approved the Indiana 

program effective July 29, 1982. You can 

find background information on the 

Indiana program, including the 

Secretary’s findings, the disposition of 

comments, and the conditions of 

approval, in the July 26, 1982, Federal 

Register (47 FR 32071). You can also 

find later actions concerning the Indiana 

program and program amendments at 30 

CFR 914.10, 914.15, 914.16, and 914.17. 

II. Submission of the Amendment 

By letter dated May 19, 2004 

(Administrative Record No. IND–1726), 

the Indiana Department of Natural 

Resources, Division of Reclamation 

(Indiana or IDNR) sent us an 

amendment to its program under 

SMCRA (30 U.S.C. 1201 et seq.). Indiana 

sent the amendment in response to a 

June 17, 1997, letter (Administrative 

Record No. IND–1575) that we sent to 

Indiana in accordance with 30 CFR 

732.17(c) and in response to the 

required program amendments at 30 

CFR 914.16(f), (s), and (hh) through 

(mm). The amendment also included 

changes made at Indiana’s own 

initiative. 

We announced receipt of the 

proposed amendment in the July 19, 

2004, Federal Register (69 FR 42931). In 

the same document, we opened the 

public comment period and provided an 

opportunity for a public hearing or 

meeting on the adequacy of the 

amendment. We did not hold a public 

hearing or meeting because no one 

requested one. The public comment