56346 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

Atomic Energy Act of 1954, as amended; 

the Energy Reorganization Act of 1974, 

as amended; and 5 U.S.C. 552 and 553; 

the NRC is adopting the following 

amendments to 10 CFR part 70. 

PART 70—DOMESTIC LICENSING OF 

SPECIAL NUCLEAR MATERIAL 

■ 1. The authority citation for part 70 

continues to read as follows: 

Authority: Secs. 51, 53, 161, 182, 183, 68 

Stat. 929, 930, 948, 953, 954, as amended, 

sec. 234, 83 Stat. 444, as amended (42 U.S.C. 

2071, 2073, 2201, 2232, 2233, 2282, 2297f); 

secs. 201, as amended, 202, 204, 206, 88 Stat. 

1242, as amended, 1244, 1245, 1246 (42 

U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 

Stat. 2835 as amended by Pub. L. 104–134, 

110 Stat. 1321, 1321–349 (42 U.S.C. 2243); 

sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 

note). 

Sections 70.1(c) and 70.20a(b) also issued 

under secs. 135, 141, Pub. L. 97–425, 96 Stat. 

2232, 2241 (42 U.S.C. 10155, 10161). Section 

70.7 also issued under Pub. L. 95–601, sec. 

10, 92 Stat. 2951 (42 U.S.C. 5851). Section 

70.21(g) also issued under sec. 122, 68 Stat. 

939 (42 U.S.C. 2152). Section 70.31 also 

issued under sec. 57d, Pub. L. 93–377, 88 

Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 

70.44 also issued under sec. 184, 68 Stat. 954, 

as amended (42 U.S.C. 2234). Section 70.81 

also issued under secs. 186, 187, 68 Stat. 955 

(42 U.S.C. 2236, 2237). Section 70.82 also 

issued under sec. 108, 68 Stat. 939, as 

amended (42 U.S.C. 2138). 

■ 2. In § 70.72, paragraph (c)(2) is 

revised to read as follows: 

§ 70.72 Facility changes and change 

process. 

* * * * * 

(c) * * * 

(2) Does not remove, without at least 

an equivalent replacement of the safety 

function, an item relied on for safety 

that is listed in the integrated safety 

analysis summary and is necessary for 

compliance with the performance 

requirements of § 70.61; 

* * * * * 

Dated at Rockville, Maryland, this 13th day 

of September 2006. 

For the Nuclear Regulatory Commission. 

Luis A. Reyes, 

Executive Director for Operations. 

[FR Doc. 06–8270 Filed 9–26–06; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

Oral Dosage Form New Animal Drugs; 

Amprolium Solution 

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 new animal drug 

application (ANADA) filed by IVX 

Animal Health, Inc. The ANADA 

provides for use of amprolium solution 

to make medicated drinking water or as 

a drench for the prevention or treatment 

of coccidiosis in calves. 

DATES: This rule is effective September 

27, 2006. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827-0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: IVX 

Animal Health, Inc., 3915 South 48th 

Street Ter., St. Joseph, MO 64503, filed 

ANADA 200–389 that provides for the 

use of Amprolium 9.6% Oral Solution 

to make medicated drinking water or as 

a drench for the prevention or treatment 

of coccidiosis in calves. IVX Animal 

Health’s Amprolium 9.6% Oral Solution 

is approved as a generic copy of Merial 

Ltd.’s CORID (amprolium) 9.6% 

Solution approved under NADA 13–

149. The ANADA is approved as of 

September 6, 2006, and the regulations 

are amended in 21 CFR 520.100 to 

reflect the approval and a current 

format. 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. 

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 Subject 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. Revise § 520.100 to read as follows: 

§ 520.100 Amprolium. 

(a) Specifications—(1) Each milliliter 

of solution contains 96 milligrams (mg) 

amprolium (9.6 percent solution). 

(2) Each gram of powder contains 200 

mg amprolium (20 percent). 

(3) Each ounce (28.4 grams) of 

crumbles contains 355 mg amprolium 

(1.25 percent). 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter. 

(1) No. 050604 for use of products 

described in paragraph (a) of this 

section as in paragraph (e) of this 

section. 

(2) No. 051311 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1) of this 

section. 

(3) No. 059130 for use of product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(2) of this 

section. 

(c) Related tolerances. See § 556.50 of 

this chapter. 

(d) Special considerations. See 

§ 500.25 of this chapter. 

(e) Conditions of use—(1) Chickens 

and turkeys. It is used in drinking water 

as follows: 

(i) Amount. Administer at the 0.012 

percent level in drinking water as soon 

as coccidiosis is diagnosed and continue 

for 3 to 5 days (in severe outbreaks, give 

amprolium at the 0.024 percent level); 

continue with 0.006 percent amproliummedicated water for an additional 1 to 

2 weeks. 

(ii)Indications for use. For the 

treatment of coccidiosis. 

(iii) Limitations. Use as the sole 

source of amprolium. 

(2) Calves. Administer crumbles topdressed on or thoroughly mixed in the 


sroberts on PROD1PC70 with RULES
Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 56347 

daily feed ration; administer concentrate 

solution or soluble powder as a drench 

or in drinking water as follows: 

(i) Indications for use and amounts—

(A) As an aid in the prevention of 

coccidiosis caused by Eimeria bovis and 

E. zuernii, administer 5 mg per kilogram 

(mg/kg) body weight in drinking water 

for 21 days during periods of exposure 

or when experience indicates that 

coccidiosis is likely to be a hazard. 

(B) As an aid in the treatment of 

coccidiosis caused by E. bovis and E. 

zuernii, administer 10 mg/kg body 

weight in drinking water for 5 days. 

(ii) Limitations. Withdraw 24 hours 

before slaughter. A withdrawal period 

has not been established for this product 

in preruminating calves. Do not use in 

calves to be processed for veal. Use as 

the sole source of amprolium. 

§ 520.100a [Removed] 

■ 3. Remove § 520.100a. 

§ 520.100b [Removed] 

■ 4. Remove § 520.100b. 

§ 520.100c [Removed] 

■ 5. Remove § 520.100c. 

Dated: September 18, 2006. 

Bernadette A. Dunham, 

Acting Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 06–8275 Filed 9–26–06; 8:45 am] 

BILLING CODE 4160–01–S 

OCCUPATIONAL SAFETY AND 

HEALTH REVIEW COMMISSION 

29 CFR Part 2201 

Regulations Implementing the 

Freedom of Information Act 

AGENCY: Occupational Safety and Health 

Review Commission. 

ACTION: Final rule. 

SUMMARY: The Occupational Safety and 

Health Review Commission (OSHRC) 

revises its regulations implementing the 

Freedom of Information Act (FOIA), 5 

U.S.C. 552, as amended. The regulations 

contain new provisions to comply with 

Executive Order 13392. In addition, the 

regulations have been updated to reflect 

changes in OSHRC’s policies and 

procedures. As a result of these 

revisions, the public will have a clearer 

understanding of OSHRC’s policies and 

procedures implementing the FOIA. 

DATES: This rule is effective on October 

27, 2006. 

FOR FURTHER INFORMATION CONTACT: Jin 

H. Kim, Attorney-Advisor, Office of the 

General Counsel, 1120 20th Street, NW., 

Ninth Floor, Washington, DC 20036–

3457. Telephone: (202) 606–5410. Fax: 

(202) 606–5417. E-mail: jkim@oshrc.gov. 

SUPPLEMENTARY INFORMATION: OSHRC is 

publishing a final rule for regulations 

implementing the FOIA. On July 21, 

2006, OSHRC published for comment a 

notice of proposed rulemaking (NPRM) 

in the Federal Register that proposed 

revisions to OSHRC’s regulations at 29 

CFR part 2201, implementing the FOIA, 

5 U.S.C. 552, as amended. 71 FR 41384, 

Jul. 21, 2006. Interested persons were 

afforded an opportunity to participate in 

the rulemaking process through 

submission of written comments on the 

NPRM. OSHRC received no public 

comments. OSHRC has reviewed the 

proposed regulations and has only 

changed the regulatory text in this final 

rule to update the contact information 

in 29 CFR 2201.3(d), correct the crossreferences in 29 CFR 2201.4(c) and (d), 

and add cross-references to Appendix A 

in 29 CFR 2201.7. All other provisions 

in the regulatory text are the same as in 

the NPRM, and OSHRC adopts them in 

this final rule. 

I. Background 

As mentioned in the preamble to the 

proposed regulations, OSHRC is making 

several substantive and technical 

revisions to its regulations to (1) Comply 

with Executive Order 13392 (E.O. 

13392), 70 FR 75373, Dec. 19, 2005, (2) 

reflect recent changes in OSHRC’s 

policies and procedures as they relate to 

the processing of FOIA requests, and (3) 

make purely technical or clarifying 

changes in phrasing and nomenclature. 

71 FR 41384, Jul. 21, 2006. 

OSHRC’s revisions to its FOIA 

regulations, including the addition of 

new provisions and the modification of 

existing provisions, comply with the 

requirements of E.O. 13392. See 70 FR 

at 41384–85. In issuing E.O. 13392, the 

President directed each agency to 

ensure that its FOIA operations are 

‘‘citizen-centered’’ and ‘‘resultsoriented.’’ In order to achieve these 

goals, E.O. 13392 requires each agency 

head to designate a Chief FOIA Officer, 

who has agency-wide responsibility for 

the efficient and appropriate 

compliance with the FOIA. As part of 

his or her duties under E.O. 13392, the 

Chief FOIA Officer must review the 

agency’s FOIA operations and identify 

any areas for improvement. In addition, 

E.O. 13392 requires agencies to establish 

FOIA Requester Service Centers to 

enable any FOIA requester to seek 

information concerning the status of his 

or her FOIA request, as well as 

appropriate information about the 

agency’s FOIA response. E.O. 13392 

further requires agencies to designate, as 

part of the FOIA Requester Service 

Center, FOIA Public Liaisons to serve as 

the supervisory officials to whom a 

FOIA requester can raise concerns about 

the service the FOIA requester has 

received from the FOIA Requester 

Service Center, following an initial 

response to the FOIA request. Therefore, 

OSHRC revises its regulations 

implementing the FOIA to comply fully 

with E.O. 13392. 

Furthermore, based on the Chief FOIA 

Officer’s review of OSHRC’s FOIA 

operations, OSHRC also proposed 

revisions to its rule to reflect recent 

changes in OSHRC’s policies and 

procedures as they relate to the 

processing of FOIA requests. As 

mentioned in the preamble to the 

NPRM, OSHRC moved all FOIA 

processing from its Office of 

Administration to the Office of the 

General Counsel at the beginning of this 

fiscal year (FY 2006). 71 FR at 41385. 

Currently, paralegals and attorneys, who 

have received specialized FOIA 

training, are now handling all FOIA 

requests. These revised regulations 

reflect changes in OSHRC’s policies and 

procedures, which will make the 

processing of FOIA requests more 

efficient and responsive. 

Finally, as specified in the preamble 

to the NPRM, OSHRC revises its 

regulations to correct grammatical 

errors, change nomenclature, renumber 

sections and paragraphs as a result of 

deleting and adding sections and 

paragraphs to the regulations, update 

regulatory cross-references, and clarify 

sentences. 71 FR at 41384–87. 

II. Section-by-Section Analysis 

OSHRC revises § 2201.1 to correct a 

grammatical error in the section heading 

and to add abbreviations for OSHRC and 

FOIA. OSHRC has also made similar 

changes throughout the regulations and 

corrected other grammatical errors, as 

well as changed nomenclature, such as 

FOIA Disclosure Officer, and updated 

regulatory cross-references. 71 FR at 

41384–88. 

In § 2201.2, OSHRC adds a sentence 

to the end of the section to provide 

additional details about the designation 

of one of the Commissioners as the 

Chairman and his responsibilities for 

the administrative operations of the 

Commission. This is consistent with 

section 12(e) of the Occupational Safety 

and Health Act of 1970, 29 U.S.C. 

661(e). 

OSHRC revises the delegation of 

FOIA-related duties in § 2201.3 to 

reflect the changes required by E.O. 

13392. First, in paragraph (a), the 

Chairman delegates to the Chief FOIA 


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