58874 Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 

(iii) Free-choice feeds—(A) Amount. 5 

mg/kg body weight (2.27 mg/lb), 

including the following formulations: 

Ingredient1 Percent International Feed No. 

(1) Free-choice, dry Type C feed: 

Salt (sodium chloride) 59.00 6–04–152 

Monosodium phosphate 31.16 6–04–288 

Dried cane molasses 3.12 4–04–695 

Zinc sulfate 0.76 6–05–556 

Copper sulfate 0.45 6–01–720 

Fenbendazole 20% Type A article 5.51 n/a 

(2) Free-choice, dry Type C feed: 

Salt (sodium chloride) 35.93 6–04–152 

Dicalcium phosphate (18.5% P) 32.44 6–00–080 

Calcium carbonate (38% Ca) 15.93 6–01–069 

Magnesium oxide (56% Mg) 10.14 6–02–756 

Zinc sulfate 1.47 6–05–556 

Mineral oil 1.00 8–03–123 

Dried cane molasses (46% sugars) 0.98 4–04–695 

Potassium iodide 0.01 6–03–759 

Fenbendazole 20% Type A article 2.10 n/a 

(3) Free-choice, liquid Type C feed: 

Cane molasses2 80.902 4–13–251 

Water 9.36 n/a 

Urea solution, 55% 7.05 5–05–707 

Phosphoric acid 75% (feed grade) 2.00 6–03–707 

Xantham gum 0.20 8–15–818 

Trace minerals 0.20 n/a 

Vitamin premix 0.01 n/a 

Fenbendazole 20% Type A article 0.278 n/a 

1The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer 

for other free-choice cattle feeds. Formulation modifications require FDA approval prior to marketing. Selenium is not approved for the freechoice formulations described in paragraph (e)(3)(iii) of this section. Free-choice cattle feeds containing selenium must comply with published 

regulations (see 21 CFR 573.920). 2The percentage of cane molasses and water in the formulation may be adjusted as needed in order to bring the brix value of the molasses to 

the industry standard of 79.5 brix. 

(B) Indications for use. As in 

paragraph (e)(3)(i) of this section. 

(C) Limitations. Feed a total of 5 mg 

of fenbendazole per kg (2.27 mg/lb) of 

body weight to cattle over a 3- to 6-day 

period. Retreatment may be needed after 

4 to 6 weeks. Cattle must not be 

slaughtered within 13 days following 

last treatment. For dairy cattle the milk 

discard time is zero hours. A 

withdrawal period has not been 

established for this product in preruminating calves. Do not use in calves 

to be processed for veal. 

* * * * * 

Dated: September 29, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–23845 Filed 10–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 801 

[Docket No. FDA–2008–N–0148] 

Medical Devices; Hearing Aids; 

Technical Data Amendments; 

Confirmation of Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule; confirmation 

of effective date. 

SUMMARY: The Food and Drug 

Administration (FDA) is confirming the 

effective date of October 15, 2008, for 

the final rule that appeared in the 

Federal Register of June 2, 2008 (73 FR 

31358). The direct final rule amends the 

hearing aid labeling to reference the 

most recent version of the consensus 

standard used to determine the 

technical data to be included in labeling 

for hearing aids. This document 

confirms the effective date of the direct 

final rule. 

DATES: Effective date confirmed: 

October 15, 2008. 

FOR FURTHER INFORMATION CONTACT: Eric 

A. Mann, Center for Devices and 

Radiological Health (HFZ–460), Food 

and Drug Administration,9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4242. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 2, 2008 (73 FR 

31358), FDA solicited comments 

concerning the direct final rule for a 75- 

day period ending August 18, 2008. 

FDA stated that the effective date of the 

direct final rule would be on October 

15, 2008, 60 days after the end of the 

comment period, unless any significant 

adverse comment was submitted to FDA 

during the comment period. FDA 

received one letter of comment on the 

direct final rule. However, this comment 

does not constitute a significant adverse 

comment. Therefore, FDA is confirming 

the effective date of the direct final rule. 

The comment received and FDA’s 

response to the comment are discussed 

as follows: 

The only comment on the direct final 

rule requested clarification regarding 

the applicability of the proposed change 

in the standard of the American 

National Standards Institute to hearing 

aid models that were tested and 

characterized prior to the effective date 


dwashington3 on PRODPC61 with RULES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Rules and Regulations 58875 

of the direct final rule on October 15, 

2008. The comment interpreted the 

proposed change as being only 

prospectively applied to new models 

undergoing test procedures on or after 

the effective date of the proposed 

change. FDA agrees that the proposed 

change applies only to new hearing aid 

models undergoing characterization on 

or after the effective date of October 15, 

2008; hearing aid models tested prior to 

this date are subject only to the 

characterization standard cited in the 

regulation at the time they were tested. 

Authority: Therefore, under the Federal 

Food, Drug, and Cosmetic Act and the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food and 

Drugs, the amendments issued thereby 

become effective on October 15, 2008. 

Dated: October 2, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23717 Filed 10–7–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

[Docket No. MMS–2008–MRM–0021] 

30 CFR Part 210 

RIN 1010–AD20 

Reporting Amendments 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Correcting amendment. 

SUMMARY: The MMS published a final 

rule in the Federal Register on 

Wednesday, March 26, 2008 (73 FR 

15885), announcing amendments to 

existing regulations for reporting 

production and royalties on oil, gas, 

coal and other solid minerals, and 

geothermal resources produced from 

Federal and Indian leases. This 

docutment corrects the final rule, which 

contained a clerical error in the tables 

identifying OMB-approved information 

collections and their corresponding 

forms. 

DATES: Effective Date: Effective on 

October 8, 2008. 

FOR FURTHER INFORMATION CONTACT: Hyla 

Hurst, Regulatory Specialist, Minerals 

Management Service, Minerals Revenue 

Management, P.O. Box 25165, MS 

302B2, Denver, Colorado 80225; 

telephone (303) 231–3495; or e-mail 

Hyla.Hurst@mms.gov. 

SUPPLEMENTARY INFORMATION: A final 

rule was published in the Federal 

Register on March 26, 2008 (73 FR 

15885) containing a clerical error in the 

preamble and the regulatory text in the 

tables listing OMB-approved 

information collections. The forms 

approved under OMB Control Number 

1010–0139 were incorrectly identified 

on page 15889 in the preamble and page 

15893 in the regulatory text. Both tables 

contain the same error. Form MMS– 

4054 (Parts A, B, and C) and Form 

MMS–4058 are correctly identified as 

shown below in the table at § 210.10. 

List of Subjects in 30 CFR Part 210 

Coal, Solid minerals, Continental 

Shelf, Electronic funds transfers, 

Geothermal energy, Government 

contracts, Indian lands, Mineral 

royalties, Natural gas, Penalties, 

Petroleum, Oil and gas, Public lands— 

mineral resources, Reporting and 

recordkeeping requirements. 

■ Accordingly, 30 CFR Part 210 is 

corrected by making the following 

amendments: 

PART 210—FORMS AND REPORTS 

■ 1. The authority citation for part 210 

continues to read as follows: 

Authority: 5 U.S.C. 301 et. seq. ; 25 U.S.C. 

396, 2107; 30 U.S.C. 189, 190, 359, 1023, 

1751(a); 31 U.S.C. 3716, 9701; 43 U.S.C. 

1334, 1801 et. seq. ; and 44 U.S.C. 3506(a). 

■ 2. In § 210.10, the table is amended by 

revising the entry for OMB number 

1010–0139 to read as follows: 

§ 210.10 What are the OMB-approved 

information collections? 

* * * * * 

OMB Control No. and short title Form or information collected 

* * * * * * * 

1010–0139, 30 CFR Parts 210 and 216, Production Accounting.Form MMS–4054 (Parts A, B, and C), Oil and Gas Operations Report. 

Form MMS–4058, Production Allocation Schedule Report. 

* * * * * * * 

Dated: September 30, 2008. 

C. Stephen Allred, 

Assistant Secretary for Land and Minerals 

Management. 

[FR Doc. E8–23788 Filed 10–7–08; 8:45 am] 

BILLING CODE 4310–MR–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 17 

RIN 2900–AM95 

Dental Care—Provision of One-Time 

Outpatient Dental Care for Certain 

Veterans 

AGENCY: Department of Veterans Affairs. 

ACTION: Final rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) is amending its regulations 

regarding the authority to provide onetime outpatient dental treatment to 

eligible veterans following discharge or 

release from active duty. In section 1709 

of Public Law 110–181, the National 

Defense Authorization Act for Fiscal 

Year 2008, Congress amended the 

eligibility criteria for the one-time 

dental treatment benefit. This rule is 

necessary to incorporate the statutory 

amendments into VA regulations. 

DATES: Effective Date: October 8, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Tony Guagliardo, Director, Business 

Policy, Chief Business Office (163), 

Veterans Health Administration, 

Department of Veterans Affairs, 810 


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