67352 Federal Register / Vol. 70, No. 214 / Monday, November 7, 2005 / Rules and Regulations 

5 5 U.S.C. 553(b). 

6 5 U.S.C. 601–612. 

7 5 U.S.C. 553(d)(3). 

8 15 U.S.C. 77f, 77g, 77h, 77j, and 77s(a). 

9 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w, and 78ll. 

10 15 U.S.C. 79t. 

11 15 U.S.C. 77sss. 

12 15 U.S.C. 80a–8, 80a–29, 80a–30, and 80a–37. 

submission form type changes. It is 

highly recommended that filers 

download, install, and use the new 

EDGARLink software and submission 

templates to ensure that submissions 

will be processed successfully. Previous 

versions of the templates may not work 

properly. Notice of the update has 

previously been provided on the 

EDGAR Filing Web site and on the 

Commission’s public Web site. The 

discrete updates are reflected on the 

EDGAR Filing Web site and in the 

updated Filer Manual Volume II. 

Along with adoption of the Filer 

Manual, we are amending Rule 301 of 

Regulation S–T to provide for the 

incorporation by reference into the Code 

of Federal Regulations of today’s 

revisions. This incorporation by 

reference was approved by the Director 

of the Federal Register in accordance 

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

You may obtain paper copies of the 

updated Filer Manual at the following 

address: Public Reference Room, U.S. 

Securities and Exchange Commission, 

100 F Street, NE., Room 1580, 

Washington, DC 20549. We will post 

electronic format copies on the 

Commission’s Web site; the address for 

the Filer Manual is http://www.sec.gov/ 

info/edgar.shtml. You may also obtain 

copies from Thomson Financial, the 

paper document contractor for the 

Commission, at (800) 638–8241. 

Since the Filer Manual relates solely 

to agency procedures or practice, 

publication for notice and comment is 

not required under the Administrative 

Procedure Act (APA).5 It follows that 

the requirements of the Regulatory 

Flexibility Act 6 do not apply. 

The effective date for the updated 

Filer Manual and the rule amendments 

is November 7, 2005. In accordance 

with the APA,7 we find that there is 

good cause to establish an effective date 

less than 30 days after publication of 

these rules. The EDGAR system upgrade 

to Release 9.2 is scheduled to become 

available on November 7, 2005. The 

Commission believes that it is necessary 

to coordinate the effectiveness of the 

updated Filer Manual with the 

scheduled system upgrade. 

Statutory Basis 

We are adopting the amendments to 

Regulation S–T under Sections 6, 7, 8, 

10, and 19(a) of the Securities Act of 

1933,8 Sections 3, 12, 13, 14, 15, 23, and 

35A of the Securities Exchange Act of 

1934,9 Section 20 of the Public Utility 

Holding Company Act of 1935,10

Section 319 of the Trust Indenture Act 

of 1939,11 and Sections 8, 30, 31, and 38 

of the Investment Company Act of 

1940.12

List of Subjects in 17 CFR Part 232 

Incorporation by reference, Reporting 

and recordkeeping requirements, 

Securities. 

Text of the Amendment 

■ In accordance with the foregoing, title 

17, chapter II of the Code of Federal 

Regulations is amended as follows: 

PART 232—REGULATION S–T—

GENERAL RULES AND REGULATIONS 

FOR ELECTRONIC FILINGS 

■ 1. The authority citation for Part 232 

continues to read in part as follows: 

Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 

77s(a), 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 

78w(a), 78ll(d), 79t(a), 80a–8, 80a–29, 80a–

30, 80a–37, and 7201 et seq.; and 18 U.S.C. 

1350. 

* * * * * 

■ 2. Section 232.301 is revised to read 

as follows: 

§ 232.301 EDGAR Filer Manual. 

Filers must prepare electronic filings 

in the manner prescribed by the EDGAR 

Filer Manual, promulgated by the 

Commission, which sets out the 

technical formatting requirements for 

electronic submissions. The 

requirements for becoming an EDGAR 

Filer and updating company data are set 

forth in the EDGAR Filer Manual, 

Volume I: ‘‘General Information,’’

Version 1 (September 2005). The 

requirements for filing on EDGAR are 

set forth in the EDGAR Filer Manual, 

Volume II: ‘‘EDGAR Filing,’’ Version 2 

(November 2005). Additional provisions 

applicable to Form N–SAR filers are set 

forth in the EDGAR Filer Manual, 

Volume III: ‘‘N–SAR Supplement,’’

Version 1 (September 2005). All of these 

provisions have been incorporated by 

reference into the Code of Federal 

Regulations, which action was approved 

by the Director of the Federal Register 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You must comply with 

these requirements in order for 

documents to be timely received and 

accepted. You can obtain paper copies 

of the EDGAR Filer Manual from the 

following address: Public Reference 

Room, U.S. Securities and Exchange 

Commission, 100 F Street, NE., Room 

1580, Washington, DC 20549 or by 

calling Thomson Financial at (800) 638–

8241. Electronic copies are available on 

the Commission’s Web site. The address 

for the Filer Manual is http:// 

www.sec.gov/info/edgar.shtml. You can 

also photocopy the document at the 

National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Dated: November 1, 2005. 

By the Commission. 

Jonathan G. Katz, 

Secretary. 

[FR Doc. 05–22085 Filed 11–4–05; 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; 

Tetracycline Hydrochloride Soluble 

Powder 

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 an abbreviated new animal 

drug application (ANADA) filed by 

Cross Vetpharm Group Ltd. The 

ANADA provides for use of tetracycline 

hydrochloride soluble powder in the 

drinking water of calves, swine, 

chickens, and turkeys for the treatment 

and control of various bacterial 

infections. 

DATES: This rule is effective November 

7, 2005. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.gov. 

SUPPLEMENTARY INFORMATION: Cross 

Vetpharm Group Ltd., Broomhill Rd., 

Tallaght, Dublin 24, Ireland, filed 

ANADA 200–374 that provides for use 

of TETRAMED 324 HCA (tetracycline 

hydrochloride), a soluble powder used 

in the drinking water of calves, swine, 

chickens, and turkeys for the treatment 

and control of various bacterial 

infections. Cross Vetpharm Group Ltd.’s 

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