Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Rules and Regulations 67353 

TETRAMED 324 HCA is approved as a 

generic copy of Boehringer Ingelheim 

Vetmedica, Inc.’s TETRASURE 324 

(tetracycline hydrochloride), approved 

under NADA 65–496. The ANADA is 

approved as of September 13, 2005, and 

the regulations are amended in 

§ 520.2345d (21 CFR 520.2345d) to 

reflect the approval. The basis of 

approval is discussed in the freedom of 

information summary. 

In addition, FDA has noticed that 

certain withdrawal times for other 

approved generic products are not 

reflected in § 520.2345d. At this time, 

the regulations are amended to reflect 

the correct withdrawal times in calves 

and swine. This action is being taken to 

improve the accuracy of the regulations. 

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. 

FDA has determined under 21 CFR 

25.33(a)(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 520.2345d is amended by 

revising the section heading, paragraphs 

(a) through (c), the heading and 

introductory text of paragraph (d), and 

paragraphs (d)(1)(iii) and (d)(2)(iii) to 

read as follows: 

§ 520.2345d Tetracycline powder. 

(a) Specifications. Each pound of 

powder contains 25, 102.4, or 324 grams 

tetracycline hydrochloride. 

(b) Sponsors. See sponsors listed in 

§ 510.600(c) of this chapter for 

conditions of use as in paragraph (d) of 

this section: 

(1) No. 000069: 25 grams per pound 

as in paragraphs (d)(3) and (d)(4) of this 

section. 

(2) Nos. 000010 and 046573: 102.4 

and 324 grams per pound as in 

paragraph (d) of this section. 

(3) No. 053501: 102.4 and 324 grams 

per pound as in paragraphs (d)(1) and 

(d)(2) of this section. 

(4) No. 046573: 102.4 and 324 grams 

per pound as in paragraph (d)(3) of this 

section. 

(5) Nos. 051259, 057561, 059130, and 

061623: 324 grams per pound as in 

paragraph (d) of this section. 

(c) Related tolerances. See § 556.720 

of this chapter. 

(d) Conditions of use. It is 

administered in drinking water as 

follows: 

(1) * * * 

(iii) Limitations. Administer for 3 to 5 

days; do not slaughter animals for food 

within 4 days of treatment for sponsor 

No. 053501 and within 5 days of 

treatment for sponsor Nos. 000010, 

046573, 051259, 057561, 059130, and 

061623; prepare a fresh solution daily; 

use as the sole source of tetracycline. A 

withdrawal period has not been 

established for this product in 

preruminating calves. Do not use in 

calves to be processed for veal. 

(2) * * * 

(iii) Limitations. Administer for 3 to 5 

days; do not slaughter animals for food 

within 7 days of treatment for sponsor 

No. 053501 and within 4 days of 

treatment for sponsor Nos. 000010, 

046573, 051259, 057561, 059130, and 

061623; prepare a fresh solution daily; 

use as the sole source of tetracycline. 

* * * * * 

Dated: October 19, 2005. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. 05–21889 Filed 11–4–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. 2005P–0366] 

Medical Devices; General and Plastic 

Surgery Devices; Classification of the 

Low Energy Ultrasound Wound 

Cleaner 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

low energy ultrasound wound cleaner 

into class II (special controls). The 

special control that will apply to the 

device is the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Low Energy 

Ultrasound Wound Cleaner.’’ The 

agency is taking this action in response 

to a petition submitted under the 

Federal Food, Drug, and Cosmetic Act 

(the act) as amended by the Medical 

Device Amendments of 1976, the Safe 

Medical Devices Act of 1990, and the 

Food and Drug Administration 

Modernization Act of 1997 (FDAMA). 

The agency is classifying this device 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance document 

that will serve as the special control for 

the class II device. 

DATES: This rule is effective December 7, 

2005. The reclassification was effective 

June 25, 2004. 

FOR FURTHER INFORMATION CONTACT: 

David B. Berkowitz, Center for Devices 

and Radiological Health (HFZ–410), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090, ext. 152. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the act (21 U.S.C. 360c(f)(1)), devices 

that were not in commercial distribution 

before May 28, 1976, the date of 

enactment of the Medical Device 

Amendments of 1976 (the amendments), 

generally referred to as postamendments 

devices, are classified automatically by 

statute into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

67354 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Rules and Regulations 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to previously marketed 

devices by means of premarket 

notification procedures in section 510(k) 

of the act (21 U.S.C. 360(k)) and 21 CFR 

part 807 of FDA’s regulations. 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. 

In accordance with section 513(f)(1) of 

the act, FDA issued an order on April 

8, 2004, classifying the Celleration MIST 

Therapy SystemTM in class III, because 

it was not substantially equivalent to a 

device that was introduced or delivered 

for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, or a device that 

was subsequently reclassified into class 

I or class II. On April 29, 2004, 

Celleration, Inc., submitted a petition 

requesting classification of the 

Celleration MIST Therapy SystemTM

under section 513(f)(2) of the act. The 

manufacturer recommended that the 

device be classified into class II. 

In accordance with 513(f)(2) of the 

act, FDA reviewed the petition in order 

to classify the device under the criteria 

for classification set forth in 513(a)(1) of 

the act. Devices are to be classified into 

class II if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. After review of the 

information submitted in the petition, 

FDA has determined that the low energy 

ultrasound wound cleaner intended for 

the cleaning and maintenance 

debridement of wounds can be 

classified in class II with the 

establishment of special controls. FDA 

believes that class II special controls 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name ‘‘Low energy ultrasound wound 

cleaner,’’ and it is identified as a device 

that uses ultrasound energy to vaporize 

a solution and generate a mist that is 

used for the cleaning and maintenance 

debridement of wounds. Low levels of 

ultrasound energy may be carried to the 

wound by the saline mist. 

The potential risks to health 

associated with the device are: Delayed 

wound healing, thermal damage, 

inflammation/foreign body response, 

infection, and electrical shock. The 

special control guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Low Energy 

Ultrasound Wound Cleaner’’ aids in 

mitigating the risk by recommending 

performance characteristics, safety 

testing, and appropriate labeling. 

Thus, in addition to the general 

controls of the act, a low energy 

ultrasound wound cleaner is subject to 

the special controls guidance document. 

FDA believes that following the class II 

special controls guidance document 

generally addresses the risks to health 

identified in the previous paragraph of 

this document. Therefore, on June 25, 

2004, FDA issued an order to the 

petitioner classifying the device as 

described previously into class II and is 

codifying this device by adding 

§ 878.4410. 

Following the effective date of this 

final rule classifying the device, any 

firm submitting a 510(k) premarket 

notification for the device will need to 

address the issues covered in the special 

controls guidance. However, the firm 

would need to show only that its device 

meets the recommendations of the 

guidance, or in some other way provides 

equivalent assurances of safety and 

effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirements under section 510(k) of the 

act, if FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of this type of device and, therefore, the 

type of device is not exempt from 

premarket notification requirements. 

Thus, persons who intend to market this 

type of device must submit to FDA a 

premarket notification, prior to 

marketing the device, which contains 

information about the low energy 

ultrasound wound cleaner that they 

intend to market. 

II. Environmental Impact 

The agency has determined under 21 

CFR 25.34(b) 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. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

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). The 

agency believes 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. Because reclassification of 

these devices from class III to class II 

will relieve manufacturers of the device 

of the cost of complying with the 

premarket approval requirements of 

section 515 of the act (21 U.S.C. 360e), 

and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the agency certifies 

that the final rule will not have a 

significant economic impact on a 

substantial number of 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 $115 

million, using the most current (2003) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Rules and Regulations 67355 

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. 

V. Paperwork Reduction Act of 1995 

FDA concludes that this rule contains 

no collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520) is not required. 

FDA also concludes that the special 

controls guidance document does not 

contain new information collection 

provisions that are subject to review and 

clearance by OMB under the PRA. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Low Energy Ultrasound Wound 

Cleaner.’’

List of Subjects in 21 CFR Part 878 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Section 878.4410 is added to 

subpart E to read as follows: 

§ 878.4410 Low energy ultrasound wound 

cleaner. 

(a) Identification. A low energy 

ultrasound wound cleaner is a device 

that uses ultrasound energy to vaporize 

a solution and generate a mist that is 

used for the cleaning and maintenance 

debridement of wounds. Low levels of 

ultrasound energy may be carried to the 

wound by the saline mist. 

(b) Classification. Class II (special 

controls). The special control is FDA’s 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Low Energy Ultrasound Wound 

Cleaner.’’ See § 878.1(e) for the 

availability of this guidance document. 

Dated: September 28, 2005. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. 05–22068 Filed 11–4–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9228] 

RIN 1545–BE50 

Low-Income Housing Credit Allocation 

and Certification; Revisions 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains 

regulations that reduce the burden for 

taxpayers filing Form 8609, ‘‘LowIncome Housing Credit Allocation and 

Certification.’’ The regulations affect 

owners of low-income housing projects 

who claim the low-income housing 

credit. 

DATES: Effective Date: These regulations 

are effective November 7, 2005. 

Date of Applicability: For date of 

applicability, see § 1.42–1(j). 

FOR FURTHER INFORMATION CONTACT: Paul 

F. Handleman, (202) 622–3040 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

On January 27, 2004, the Treasury 

Department and IRS published Treasury 

Decision 9112 in the Federal Register 

(69 FR 3826), which removed 

impediments to the electronic filing of 

Form 8609, ‘‘Low-Income Housing 

Credit Allocation and Certification,’’ by 

revising former § 1.42–1T(e)(1) and 

(h)(2) and adding § 1.42–1(h). Former 

§ 1.42–1T(e)(1) and (h)(2) required an 

owner to include a third-party signature 

from an authorized State or local 

housing credit agency (Agency) official 

when filing the form with the owner’s 

Federal income tax return for each year 

of the 15-year compliance period. 

Section 1.42–1(h) contains the filing 

requirement for Form 8609 and no 

longer requires the third-party signature 

when filing the form with the owner’s 

Federal income tax return. 

Explanation of Provisions 

Section 42 provides for a low-income 

housing credit that may be claimed as 

part of the general business credit under 

section 38. In general, the credit is 

allowable only if the owner of a 

qualified low-income building receives 

a housing credit allocation from an 

Agency of the jurisdiction where the 

building is located. 

Section 1.42–1(h) provides that a 

completed Form 8586, ‘‘Low-Income 

Housing Credit,’’ must be filed with the 

owner’s Federal income tax return for 

each taxable year the owner of a 

qualified low-income building is 

claiming the low-income housing credit 

under section 42(a). A completed Form 

8609 must be filed with the owner’s 

Federal income tax return for each of 

the 15 taxable years of the compliance 

period. Failure to comply with the 

requirement of the preceding sentence 

for any taxable year after the first 

taxable year in the credit period will be 

treated as a mathematical or clerical 

error for purposes of section 6213(b)(1) 

and (g)(2). 

The IRS plans to reduce taxpayer 

burden by allowing taxpayers to file 

Form 8609 one time, instead of filing 

the form with the same information for 

15 consecutive years. Taxpayers 

currently file the form as part of their 

return with the Internal Revenue 

Service center that processes their 

return. Planned revisions to the form 

should improve administration of the 

low-income housing credit program by 

requiring taxpayers to send completed 

forms to the Philadelphia service center, 

where each Agency currently sends Part 

I of the form. The requirements for 

completing and filing Form 8609 will be 

addressed in the instructions to the 

form. 

Special Analyses 

It has been determined that this 

Treasury decision is not a significant 

regulatory action as defined in 

Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

also has been determined that section 

553(b) and (d) of the Administrative 

Procedure Act (5 U.S.C. chapter 5) does 

not apply to these regulations. Because 

no notice of proposed rulemaking is 

required, the Regulatory Flexibility Act 

(5 U.S.C. chapter 6) does not apply. 

Pursuant to section 7805(f) of the 

Internal Revenue Code, these 

regulations were 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 Paul F. Handleman, Office 

of the Associate Chief Counsel 

(Passthroughs and Special Industries),