45610 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Rules and Regulations 

(vi) Payment of fees must be by check 

or money order made payable to the 

U.S. Treasury. 

(vii) Requesters may not file multiple 

requests at the same time, each seeking 

portions of a document or documents, 

solely in order to avoid payment of fees. 

When the Commission reasonably 

believes that a requester, or a group of 

requesters acting in concert, is 

attempting to break a request down into 

a series of requests for the purpose of 

evading assessment of fees, or otherwise 

reasonably believes that two or more 

requests constitute a single request, the 

Commission may aggregate any such 

requests accordingly. The Commission 

will not aggregate multiple requests on 

unrelated subjects from a requester. 

Aggregated requests may qualify for an 

extension of time under § 388.110(b). 

(3) Fees for unsuccessful search. The 

Commission may assess charges for time 

spent searching, even if it fails to locate 

the records, or if records located are 

determined to be exempt from 

disclosure. If the Commission estimates 

that search charges are likely to exceed 

$25, it will notify the requester of the 

estimated amount of search fees, unless 

the requester has indicated in advance 

willingness to to pay fees as high as 

those anticipated. The requester can 

meet with Commission personnel with 

the object of reformulating the request to 

meet his or her needs at a lower cost. 

(4) Interest—notice and rate. The 

Commission will assess interest charges 

on an unpaid bill starting on the 31st 

day following the day on which the 

billing was sent. Interest will be at the 

rate prescribed in 31 U.S.C. 3717 and 

will accrue from the date of the billing. 

(5) Advance payments. The 

Commission will require a requester to 

make an advance payment, i.e., 

payments before work is commenced or 

continued on a request, if: 

(i) The Commission estimates or 

determines that allowable charges that a 

requester may be required to pay are 

likely to exceed $250. The Commission 

will notify the requester of the estimated 

cost and either require satisfactory 

assurance of full payment where the 

requester has a history of prompt 

payment of fees, or require advance 

payment of charges if a requester has no 

history of payment; or 

(ii) A requester has previously failed 

to pay a fee charged in a timely fashion. 

The Commission will require the 

requester to pay the full amount owed 

plus any applicable interest, and to 

make an advance payment of the full 

amount of the estimated fee before the 

Commission will begin to process a new 

request or a pending request from that 

requester. When the Commission 

requires advance payment or an 

agreement to pay under this paragraph, 

or under § 388.108(a)(5), the 

administrative time limits prescribed in 

this part will begin only after the 

Commission has received the required 

payments, or agreements. 

* * * * * 

Kimberly D. Bose, 

Secretary. 

[FR Doc. E8–18040 Filed 8–5–08; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. 2008–N–0039] 

Oral Dosage Form New Animal Drugs; 

Oxfendazole Suspension 

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 Fort 

Dodge Animal Health, Division of 

Wyeth. The supplemental NADA 

provides for revised scientific 

nomenclature for an internal parasite for 

which oxfendazole suspension is used 

orally in cattle. 

DATES: This rule is effective August 6, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Donald A. Prater, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8343, email: donald.prater@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Fort 

Dodge Animal Health, Division of 

Wyeth, 800 Fifth St. NW., Fort Dodge, 

IA 50501, filed a supplement to NADA 

140–854 for SYNANTHIC (oxfendazole) 

Bovine Dewormer Suspension, 

approved for oral use in cattle for the 

removal of various internal parasites. 

The supplemental NADA provides for 

revised scientific nomenclature for a 

parasite. The supplemental application 

is approved as of July 7, 2008, and the 

regulations are amended in 21 CFR 

520.1630 to reflect the approval. 

Approval of this supplemental NADA 

did not require review of additional 

safety or effectiveness data or 

information. Therefore, a freedom of 

information summary is not required. 

The agency 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. In § 520.1630, in paragraph 

(e)(2)(ii), remove ‘‘C. mcmasteri’’ and in 

its place add ‘‘C. surnabada’’; and revise 

paragraph (e)(2)(iii) to read as follows: 

§ 520.1630 Oxfendazole suspension. 

* * * * * 

(e) * * * 

(2) * * * 

(iii) Limitations. Cattle must not be 

slaughtered until 7 days after treatment. 

Because a withdrawal time in milk has 

not been established, do not use in 

female dairy cattle of breeding age. 

Dated: July 24, 2008. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E8–18092 Filed 8–5–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2008–N–0039] 

Oral Dosage Form New Animal Drugs; 

Amprolium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 


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