Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Rules and Regulations 59131

4The reference to ‘‘cost of properties described in 

paragraph (ii) below’’ relates to the costs of 

investments in unproved properties and major 

development projects, as defined.

the adoption of Statement 143 impacts 

its accounting for oil and gas operations. 

This disclosure is expected to address 

each area of accounting that is impacted 

or expected to be impacted and should 

specifically address each way that the 

company’s application of full cost 

accounting has changed as a result of 

adoption of Statement 143. These 

disclosures and discussions should 

include, but are not limited to, how the 

company’s calculation of the ceiling test 

and depreciation, depletion, and 

amortization are affected by the 

adoption of Statement 143. 

b. Impact of Statement 143 on the 

Calculation of Depreciation, Depletion, 

and Amortization 

Facts: Regarding the base for 

depreciation, depletion, and 

amortization (DD&A) of proved reserves, 

Rule 4–10(c)(3)(i) of Regulations S–X 

states that ‘‘[c]osts to be amortized shall 

include (A) all capitalized costs, less 

accumulated amortization, other than 

the cost of properties described in 

paragraph (ii) below; 4 (B) the estimated 

future expenditures (based on current 

costs) to be incurred in developing 

proved reserves; and (C) estimated 

dismantlement and abandonment costs, 

net of estimated salvage values.’’

Statement 143 requires that upon initial 

recognition of an ARO, the associated 

asset retirement costs be included in the 

capitalized costs of the company. 

Therefore, subsequent to the adoption of 

Statement 143, the estimated 

dismantlement and abandonment costs 

described in (C) above may be included 

in the capitalized costs described in (A) 

above, at least to the extent that an ARO 

has been incurred as a result of 

acquisition, exploration and 

development activities to date. Future 

development activities on proved 

reserves may result in additional asset 

retirement obligations when such 

activities are performed and the 

associated asset retirement costs will be 

capitalized at that time.

Question: Following the adoption of 

Statement 143, should the costs to be 

amortized under Rule 4–10(c)(3) of 

Regulation S–X include an amount for 

estimated dismantlement and 

abandonment costs, net of estimated 

salvage values, that are expected to 

result from future development 

activities? 

Interpretive Response: Yes. To the 

extent that estimated dismantlement 

and abandonment costs, net of 

estimated salvage values, have not been 

included as capitalized costs in the base 

for computing DD&A because they have 

not yet been capitalized as asset 

retirement costs under Statement 143, 

compliance with Rule 4–10(c)(3) of 

Regulation S–X continues to require that 

they be included in the base for 

computing DD&A. Companies should 

estimate the amount of dismantlement 

and abandonment costs that will be 

incurred as a result of future 

development activities on proved 

reserves and include those amounts in 

the costs to be amortized. 

c. Transition 

Question: When will registrants be 

expected to comply with the accounting 

and disclosures described in this 

bulletin? 

Interpretive Response: All registrants 

are expected to apply the accounting 

and disclosures described in this 

bulletin prospectively as of the 

beginning of the first fiscal quarter 

beginning after the publication of this 

bulletin in the Federal Register. If a 

registrant files financial statements with 

the Commission before applying the 

guidance in this bulletin, disclosures 

similar to those described in Staff 

Accounting Bulletin Topic 11–M should 

be provided.

[FR Doc. 04–22186 Filed 10–1–04; 8:45 am] 

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; 

Ivermectin Paste

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Merial 

Ltd. The supplemental NADA provides 

revised labeling for ivermectin oral 

paste used in horses.

DATES: This rule is effective October 4, 

2004.

FOR FURTHER INFORMATION CONTACT:

Martine Hartogensis, Center for 

Veterinary Medicine (HFV–216), Food 

and Drug Administration, 7519 Standish 

Pl., Rockville, MD 20855, 301–827–

7815, e-mail: 

martine.hartogensis@fda.gov.

SUPPLEMENTARY INFORMATION: Merial 

Ltd., 3239 Satellite Blvd., Bldg. 500, 

Duluth, GA 30096–4640, filed a 

supplement to NADA 134–314 for 

EQVALAN (ivermectin 1.87 percent) 

Paste for Horses. The supplemental 

application provides for revisions to the 

labeled indications. Specifically, under 

the sub-heading ‘‘Small Strongyles,’’ the 

labeling has been revised to separate the 

listing of adult species from the fourthstage larvae. The supplemental NADA is 

approved as of August 9, 2004, and 21 

CFR 520.1192 is amended to reflect the 

approval. The basis of approval is 

discussed in the freedom of information 

summary.

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

a.m. and 4 p.m., Monday through 

Friday.

The agency has determined under 21 

CFR 25.33(d)(1) 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.

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808.

List of Subjects in 21 CFR Part 520

Animal drugs.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to the 

Center for Veterinary Medicine, 21 CFR 

part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

■ 2. Section 520.1192 is amended by 

revising paragraph (e)(1) to read as 

follows:

59132 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Rules and Regulations 

§ 520.1192 Ivermectin paste.

* * * * *

(e) Conditions of use—(1) Horses—(i) 

Amount. 200 micrograms per kilogram 

(91 micrograms per pound) of body 

weight.

(ii) Indications for use. For treatment 

and control of:

(A) Large Strongyles (adults): 

Strongylus vulgaris (also early forms in 

blood vessels), S. edentatus (also tissue 

stages), S. equinus, Triodontophorus

spp. including T. brevicauda and T. 

serratus, and Craterostomum 

acuticaudatum; Small Strongyles 

(adults, including those resistant to 

some benzimidazole class compounds): 

Coronocyclus spp. including C. 

coronatus, C. labiatus, and C. labratus, 

Cyathostomum spp. including C. 

catinatum and C. pateratum, 

Cylicocyclus spp. including C. insigne, 

C. leptostomum, C. nassatus, and C. 

brevicapsulatus, Cylicodontophorus

spp., Cylicostephanus spp., including C. 

calicatus, C. goldi, C. longibursatus, and 

C. minutus, and Petrovinema 

poculatum; Small Strongyles (fourthstage larvae); Pinworms (adults and 

fourth stage larvae): Oxyuris equi; 

Ascarids (adults and third- and fourthstage larvae): Parascaris equorum; 

Hairworms (adults): Trichostrongylus 

axei; Large mouth Stomach Worms 

(adults), Habronema muscae; Bots (oral 

and gastric stages): Gasterophilus spp. 

including G. intestinalis and G. nasalis; 

Lungworms (adults and fourth-stage 

larvae): Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults): 

Strongyloides westeri;Summer Sores 

caused by Habronema and Draschia

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp.

(B) Large Strongyles (adult) 

(Strongylus equinus), (adult and arterial 

larval stages) (Strongylus vulgaris), 

(adult and migrating tissue stages) 

(Strongylus edentatus), (adult) 

(Triodontophorus spp.); Small 

Strongyles, including those resistant to 

some benzimidazole class compounds 

(adult and fourth-stage larvae) 

(Cyathostomum spp., Cylicocyclus spp., 

Cylicodontophorus spp., 

Cylicostephanus spp.); Pinworms (adult 

and fourth-stage larvae) (Oxyuris equi); 

Ascarids (third- and fourth-stage larvae 

and adults) (Parascaris equorum); 

hairworms (adult) (Trichostrongylus 

axei); Large mouth Stomach Worms 

(adult) (Habronema muscae); Stomach 

Bots (oral and gastric stages) 

(Gastrophilus spp.); Lungworms (adults 

and fourth-stage larvae) (Dictyocaulus 

arnfieldi); Intestinal Threadworms 

(adults) (Strongyloides westeri); Summer 

Sores caused by Habronema and 

Draschia spp. cutaneous third-stage 

larvae; and Dermatitis caused by neck 

threadworm microfilariae (Onchocerca

sp.).

(iii) Limitations. For oral use only. Do 

not use in horses intended for human 

consumption.

* * * * *

Dated: September 14, 2004.

Daniel G. McChesney,

Director, Office of Surveillance and 

Compliance, Center for Veterinary Medicine.

[FR Doc. 04–22182 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 2003N–0561]

Orthopedic Devices; Effective Date of 

Requirement for Premarket Approval 

for Hip Joint Metal/Polymer or 

Ceramic/Polymer Semiconstrained 

Resurfacing Cemented Prosthesis

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the hip joint metal/

polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis. The agency also is 

summarizing its proposed findings 

regarding the degree of risk of illness or 

injury designed to be eliminated or 

reduced by requiring the devices to 

meet the statute’s approval requirements 

and the benefits to the public from the 

use of the devices. This action 

implements certain statutory 

requirements.

DATES: This rule is effective October 4, 

2004. Under this final rule, a PMA or a 

notice of completion of a PDP is 

required to be filed on or before January 

3, 2005, for any hip joint metal/polymer 

or ceramic/polymer semiconstrained 

resurfacing cemented prosthesis.

FOR FURTHER INFORMATION CONTACT: Pei 

Sung, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2036.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Public Law 94–

295) and the Safe Medical Devices Act 

of 1990 (Public Law 101–629), 

established a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the act (21 U.S.C. 360c) established 

three categories (classes) of devices, 

depending on the regulatory controls 

needed to provide reasonable assurance 

of their safety and effectiveness. The 

three categories of devices are class I 

(general controls), class II (special 

controls), and class III (premarket 

approval).

Section 515(b)(1) of the act (21 U.S.C. 

360e(b)(1)) established the requirement 

that a preamendments device that FDA 

has classified into class III is subject to 

premarket approval. A preamendments 

class III device may be commercially 

distributed without an approved PMA 

or a notice of completion of a PDP until 

90 days after FDA issues a final rule 

requiring premarket approval for the 

device, or 30 months after final 

classification of the device under 

section 513 of the act, whichever is 

later. Also, a preamendments device 

subject to the rulemaking procedure 

under section 515(b) of the act is not 

required to have an approved 

investigational device exemption (IDE) 

(see part 812 (21 CFR part 812)) 

contemporaneous with its interstate 

distribution until the date identified by 

FDA in the final rule requiring the 

submission of a PMA for the device. At 

that time, an IDE is required only if a 

PMA has not been submitted or a PDP 

completed.

When a rule to require premarket 

approval for a preamendments device is 

finalized, section 501(f)(2)(B) of the act 

(21 U.S.C. 351(f)(2)(B)) requires that a 

PMA or notice of completion of a PDP 

for any such device be filed within 90 

days of the date of issuance of the final 

rule or 30 months after the final 

classification of the device under 

section 513 of the act, whichever is 

later. If a PMA or notice of completion 

of a PDP is not filed by the latter of the 

two dates, commercial distribution of 

the device must cease.

The device may, however, be 

distributed for investigational use if the 

manufacturer, importer, or other 

sponsor of the device complies with the 

IDE regulations. If a PMA or notice of 

completion of a PDP is not filed by the 

latter of the two dates, and no IDE is in 

effect, the device is deemed to be 

adulterated within the meaning of