Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40723 

FDC date State City Airport FDC No. Subject 

07/11/09 ...... MT HELENA .......................... HELENA REGIONAL ........................... 9/8260 RNAV (RNP) Z RWY 9, ORIG. 

07/11/09 ...... AL HAMILTON ...................... MARION COUNTY–RANKIN FITE ...... 9/8352 RNAV (GPS) RWY 18, ORIG. 

07/13/09 ...... CA IMPERIAL ........................ IMPERIAL COUNTY ............................ 9/8666 TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 2. 

07/14/09 ...... WY NEWCASTLE .................. MONDELL FIELD ................................ 9/8931 TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 3. 

07/14/09 ...... OK ALTUS ............................. ALTUS/QUARTZ MOUNTAIN RGNL .. 9/8941 VOR A, AMDT 4C. 

07/15/09 ...... NV RENO .............................. RENO/TAHOE INTL ............................ 9/9101 ILS RWY 16R, AMDT 10D. 

07/17/09 ...... NY ISLIP ................................ LONG ISLAND MACARTHUR ............. 9/9568 RNAV (GPS) RWY 6, ORIG. 

07/17/09 ...... CA OROVILLE ...................... OROVILLE MUNI ................................. 9/9700 GPS RWY 1, ORIG. 

07/17/09 ...... CA OROVILLE ...................... OROVILLE MUNI ................................. 9/9701 VOR OR GPS–A, AMDT 6. 

07/21/09 ...... OR REDMOND ...................... ROBERTS FIELD ................................ 9/0045 ILS OR LOC RWY 22, AMDT 

2A. 

07/21/09 ...... OR REDMOND ...................... ROBERTS FIELD ................................ 9/0046 VOR/DME RWY 22, AMDT 3. 

07/21/09 ...... OR REDMOND ...................... ROBERTS FIELD ................................ 9/0047 VOR A, AMDT 5. 

07/21/09 ...... CA OROVILLE ...................... OROVILLE MUNI ................................. 9/0053 TAKEOFF MINIMUMS AND OBSTACLE DP, AMDT 2. 

07/21/09 ...... WV MORGANTOWN ............. MORGANTOWN MUNI–WALTER L. 

BILL HART FLD.

9/0093 ILS OR LOC RWY 18, AMDT 13. 

07/22/09 ...... OR PORTLAND ..................... PORTLAND INTL ................................. 9/0161 ILS ROR LOC RWY 28L, AMDT 

1A. 

07/22/09 ...... FL MELBOURNE .................. MELBOURNE INTL ............................. 9/0262 RNAV (GPS) RWY 27L, ORIG– 

A. 

07/22/09 ...... WY DOUGLAS ....................... CONVERSE COUNTY ......................... 9/0323 RNAV (GPS) RWY 29, ORIG. 

07/22/09 ...... WY DOUGLAS ....................... CONVERSE COUNTY ......................... 9/0324 VOR RWY 29, AMDT 1 

[FR Doc. E9–18661 Filed 8–12–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs for Use in Animal 

Feeds; Oxytetracycline; Neomycin 

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 

Pennfield Oil Co. The supplemental 

NADA provides for the use of fixedcombination Type A medicated articles 

containing oxytetracycline and 

neomycin sulfate to formulate two-way, 

fixed-combination drug Type B and 

Type C medicated feeds for chickens, 

turkeys, swine, cattle, and sheep. This 

approval reflects FDA’s effectiveness 

conclusions which relied on the 

National Academy of Sciences/National 

Research Council (NAS/NRC) Drug 

Efficacy Study Group’s evaluation of the 

effectiveness of these drugs when used 

in animal feed as single ingredients. 

DATES: This rule is effective August 13, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Harlan Howard, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8111, 

e-mail: harlan.howard@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 8, 2003 (68 

FR 47332), as corrected October 7, 2003 

(68 FR 57911), as part of the Drug 

Efficacy Study Implementation (DESI) 

program, CVM announced the effective 

conditions of use for several drug 

products and use combinations that 

were listed in § 558.15 (21 CFR 558.15). 

CVM proposed to withdraw the NADAs 

for those products or use combinations 

lacking substantial evidence of 

effectiveness following a 90-day 

opportunity to supplement the NADAs 

with labeling conforming to the relevant 

findings of effectiveness. 

In response to that notice, Pennfield 

Oil Co., (Pennfield) 14040 Industrial 

Rd., Omaha, NE 68144, filed a hearing 

request for its approved NADA 138–939 

NEO–OXY 50/50, NEO–OXY 100/100, 

and NEO–OXY 100/100 MR 

(oxytetracycline and neomycin sulfate). 

These products are two-way, fixedcombination Type A medicated articles 

used to make two-way combination 

drug Type C medicated feeds. Pennfield 

subsequently filed a supplement to 

NADA 138–939 to revise the labeling of 

these products to comply with these 

findings of effectiveness. The 

supplemental NADA provided for use of 

these fixed-combination Type A 

medicated articles to formulate twoway, fixed-combination drug Type B 

and Type C medicated feeds containing 

oxytetracycline and neomycin sulfate, 

in a 1:1 ratio, for several production and 

therapeutic indications in chickens, 

turkeys, swine, cattle, and sheep. The 

supplemental NADA is approved as of 

July 2, 2009, and the regulations are 

amended in 21 CFR 558.455 to reflect 

the approval. Pennfield has since 

withdrawn its hearing request for NDA 

138–939. 

Approval of this supplemental NADA 

did not require review of any new safety 

or effectiveness data. Therefore, a 

freedom of information summary was 

not prepared. 

The DESI evaluation was concerned 

only with the effectiveness of the drug 

products and use combinations. Nothing 

in this document constitutes a bar to 

further proceedings with respect to 

questions of safety of the subject drugs 

in treated animals or of the drugs or 

their metabolites in food products 

derived from treated animals. 

Products that comply with FDA’s 

findings of effectiveness are eligible for 

copying, as described in the Generic 

Animal Drug and Patent Term 

Restoration Act Policy Letter Eight, 

August 21, 1991 (56 FR 41561). 

Accordingly, sponsors may now obtain 

approval of abbreviated NADAs for this 

fixed combination Type A medicated 

article. 

The agency has determined under 21 

CFR 25.33 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 


pwalker on DSK8KYBLC1PROD with RULES
40724 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

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 558 

Animal drugs, Animal feeds. 

■ 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 558 is amended as follows: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 2. Amend § 558.455 as follows: 

■ a. Revise paragraph (b); 

■ b. Redesignate paragraph (d) as 

paragraph (e); 

■ c. Add new paragraph (d); and 

■ d. Revise newly redesignated 

paragraph (e). 

The redesignation, additions, and 

revisions read as follows: 

§ 558.455 Oxytetracycline and neomycin. 

* * * * * 

(b) Sponsors. See Nos. 048164 and 

066104 in § 510.600(c) of this chapter. 

* * * * * 

(d) Special considerations. Cattle 

feeds shall bear the following warning 

statement: ‘‘Use of more than one 

product containing neomycin or failure 

to follow withdrawal times may result 

in illegal drug residues.’’ 

(e) Indications for use—(1) Chickens. 

It is used in feed as follows: 

Oxytetracycline and neomycin sulfate 

amount in grams per ton of feed Indications for use Limitations Sponsors 

(i) 10 to 50 Chickens: For increased rate of 

weight gain and improved feed efficiency. 

Feed continuously; do not feed to 

chickens producing eggs for 

human consumption; in low calcium feeds withdraw 3 days before 

slaughter. 

048164 

066104 

(ii) 100 to 200 Chickens: For control of infectious 

synovitis caused by Mycoplasma 

synoviae; control of fowl cholera 

caused by Pasteurella multocida 

susceptible to oxytetracycline. 

Feed continuously for 7 to 14 d; do 

not feed to chickens producing 

eggs for human consumption; in 

low calcium feed, withdraw 3 d before slaughter. 

048164 

066104 

(iii) 400 Chickens: For control of chronic respiratory disease (CRD) and air sac 

infection caused by M. 

gallisepticum and Escherichia coli 

susceptible to oxytetracycline. 

Feed continuously for 7 to 14 d; do 

not feed to chickens producing 

eggs for human consumption; in 

low calcium feeds, withdraw 3 d 

before slaughter. 

048164 

066104 

(iv) 500 Chickens: For reduction of mortality 

due to air sacculitis (air-sac- infection) caused by E. coli susceptible 

to oxytetracycline. 

Feed continuously for 5 d; do not 

feed to chickens producing eggs 

for human consumption; withdraw 

24 hours before slaughter; in low 

calcium feeds withdraw 3 d before 

slaughter. 

048164 

066104 

(2) Turkeys. It is used in feed as 

follows: 

Oxytetracycline and neomycin sulfate 

amount Indications for use Limitations Sponsors 

(i) 10 to 50 grams per ton (g/ton) of 

feed 

Growing turkeys: For increased rate 

of weight gain and improved feed 

efficiency. 

Feed continuously; do not feed to 

turkeys producing eggs for human 

consumption. 

048164 

066104 

(ii) 100 g/ton of feed Turkeys: For control of hexamitiasis 

caused by Hexamita meleagridis 

susceptible to oxytetracycline. 

Feed continuously for 7 to 14 d; do 

not feed to turkeys producing eggs 

for human consumption. 

048164 

066104 

(iii) 200 g/ton of feed Turkeys: For control of infectious 

synovitis caused by M. synoviae 

susceptible to oxytetracycline. 

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not 

feed to turkeys producing eggs for 

human consumption. 

048164 

066104 

(iv) To provide 25 milligrams per 

pound (mg/lb) of body weight daily. 

Turkeys: For control of complicating 

bacterial organisms associated 

with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxytetracycline. 

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not 

feed to turkeys producing eggs for 

human consumption. 

048164 

066104 

(3) Swine. It is used in feed as follows: 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 40725 

Oxytetracycline and neomycin sulfate 

amount Indications for use Limitations Sponsors 

(i) 10 to 50 g/ton of feed Swine: For increased rate of weight 

gain and improved feed efficiency. 

Feed continuously. 048164 

066104 

(ii) To provide 10 mg/lb of body 

weight daily. 

1. Swine: For treatment of bacterial 

enteritis caused by E. coli and Salmonella choleraesuis and treatment of bacterial pneumonia 

caused by P. multocida susceptible 

to oxytetracycline; treatment and 

control of colibacillosis (bacterial 

enteritis) caused by E. coli susceptible to neomycin. 

Feed continuously for 7 to 14 d; withdraw 5 d before slaughter. 048164 

066104 

2. Breeding swine: For control and 

treatment of leptospirosis (reducing 

the incidence of abortion and 

shedding of leptospirae) caused by 

Leptospira pomona susceptible to 

oxytetracycline. 

Feed continuously for not more than 

14 d; withdraw 5 d before slaughter. 

048164 

066104 

(4) Cattle and sheep. It is used in feed 

as follows: 

Oxytetracycline and neomycin sulfate 

amount Indications for use Limitations Sponsors 

(i) 10 to 20 g/ton of feed Sheep: For increased rate of weight 

gain and improved feed efficiency. 

Feed continuously. 048164 

066104 

(ii) To provide 0.05 to 0.1 mg/lb of 

body weight daily. 

Calves (up to 250 lb): For increased 

rate of weight gain and improved 

feed efficiency. 

Feed continuously; in milk replacers 

or starter feed. 

048164 

066104 

(iii) To provide 10 mg/lb of body 

weight daily. 

1. Calves and beef and nonlactating 

dairy cattle: For treatment of bacterial enteritis caused by E. coli 

and bacterial pneumonia (shipping 

fever complex) caused by P. 

multocida susceptible to oxytetracycline; treatment and control of 

colibacillosis (bacterial enteritis) 

caused by E. coli susceptible to 

neomycin. 

Feed continuously for 7 to 14 d; in 

feed or milk replacers. If symptoms 

persist after using for 2 or 3 days, 

consult a veterinarian. Treatment 

should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not 

been established for use in 

preruminating calves. Do not use 

in calves to be processed for veal. 

A milk discard time has not been 

established for use in lactating 

dairy cattle. Do not use in female 

dairy cattle 20 months of age or 

older. Withdraw 5 d before slaughter. 

048164 

066104 

2. Calves (up to 250 lb): For treatment of bacterial enteritis caused 

by E. coli susceptible to oxytetracycline; treatment and control of 

colibacillosis (bacterial enteritis) 

caused by E. coli susceptible to 

neomycin. 

Feed continuously for 7 to 14 d; in 

milk replacers or starter feed. If 

symptoms persist after using for 2 

or 3 days, consult a veterinarian. 

Treatment should continue 24 to 

48 hours beyond remission of disease symptoms. A withdrawal period has not been established for 

use in preruminating calves. Do 

not use in calves to be processed 

for veal. A milk discard time has 

not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age 

or older. Withdraw 5 d before 

slaughter. 

048164 

066104 


pwalker on DSK8KYBLC1PROD with RULES
40726 Federal Register / Vol. 74, No. 155 / Thursday, August 13, 2009 / Rules and Regulations 

Oxytetracycline and neomycin sulfate 

amount Indications for use Limitations Sponsors 

3. Sheep: For treatment of bacterial 

enteritis caused by E. coli and bacterial pneumonia caused by P. 

multocida susceptible to oxytetracycline; treatment and control of 

colibacillosis (bacterial enteritis) 

caused by E. coli susceptible to 

neomycin. 

Feed continuously for 7 to 14 d. If 

symptoms persist after using for 2 

or 3 days, consult a veterinarian. 

Treatment should continue 24 to 

48 hours beyond remission of disease symptoms. Withdraw 5 d before slaughter. 

048164 

066104 

(iv) To provide 25 mg/head/day Calves (250 to 400 lb): For increased 

rate of weight gain and improved 

feed efficiency. 

Feed continuously. 048164 

066104 

(v) To provide 75 mg/head/day Growing cattle (over 400 lb): For increased rate of weight gain; improved feed efficiency, and reduction of liver condemnation due to 

liver abscesses. 

Feed continuously. 048164 

066104 

(vi) To provide 0.5 to 2.0 g/head/ day Cattle: For prevention and treatment 

of the early stages of shipping 

fever complex. 

Feed 3 to 5 d before and after arrival 

in feedlots. A withdrawal period 

has not been established for use in 

preruminating calves. Do not use 

in calves to be processed for veal. 

A milk discard time has not been 

established for use in lactating 

dairy cattle. Do not use in female 

dairy cattle 20 months of age or 

older. 

048164 

066104 

Dated: August 7, 2009. 

William T. Flynn, 

Acting Director, Center for Veterinary 

Medicine. 

[FR Doc. E9–19414 Filed 8–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

30 CFR Part 251 

[Docket ID: MMS–2008–OMM–0006] 

RIN 1010–AD41 

Geological and Geophysical (G&G) 

Explorations of the Outer Continental 

Shelf—Changing Proprietary Term of 

Certain Geophysical Information 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Final rule. 

SUMMARY: This final rule extends the 

proprietary term of certain reprocessed 

geophysical information submitted to 

MMS under a permit. The rule gives up 

to 5 years of additional protection to 

reprocessed vintage geophysical 

information that MMS retains and, 

without an extension, is subject to 

release by MMS 25 years after issuing 

the permit. The extension provides 

incentives to permittees and third 

parties to reprocess, market, or in other 

ways use geophysical information that 

may not otherwise be reprocessed 

without the term extension. The 

extension does not apply to geological 

data or information. 

DATES: Effective Date: This rule becomes 

effective on September 14, 2009. 

FOR FURTHER INFORMATION CONTACT: 

David Zinzer, Geophysicist, Offshore 

Energy and Minerals Management, 

Resource Evaluation Division, at (703) 

787–1628. 

SUPPLEMENTARY INFORMATION: This final 

rule implements changes put forward by 

our proposed rulemaking published 

June 18, 2007 (72 FR 33417). The 

comment period ended August 17, 2007. 

The MMS received four sets of written 

comments. One set of comments and 

recommendations was from an industry 

association; two sets were from third 

party users of geophysical data and 

information collected on the Outer 

Continental Shelf (OCS); and one set 

was from the public. 

Summary of Proposed Rulemaking 

The MMS proposed to extend, upon 

successful application to MMS, the 

proprietary term of geophysical 

information that a permittee or third 

party reprocessed 20 or more years after 

MMS issued the germane permit under 

which the originating data were 

collected. The rule proposed to give up 

to 5 years of additional protection to 

reprocessed vintage geophysical 

information that MMS retains and, 

without an extension, is subject to 

release by MMS 25 years after issuing 

the permit. The extension provides 

incentives to permittees and third 

parties to reprocess, market, or in other 

ways use geophysical information that 

may not otherwise be reprocessed 

without the term extension. 

Analysis of Comments and 

Recommendations 

The MMS has decided to proceed 

with the final rule after carefully 

considering all written comments on the 

proposed rulemaking. 

Comment: One commenter continued 

to comment about issues and changes 

put forward by our proposed 

rulemaking, published July 17, 2002 (67 

FR 46942), and the subsequent related 

final rulemaking, published March 30, 

2006 (71 FR 16033). 

Response: Changes put forth by the 

June 18, 2007, proposed rulemaking are 

directly addressed in this final 

rulemaking. However, MMS has 

clarified, where necessary, certain 

points or matters that pertain to all of 30 

CFR part 251. 

Comment: Three comments cited the 

substantial costs that can be incurred in 

reprocessing existing geophysical 

information. One estimated costs of 

reprocessing exclusive 2–D data of $5– 

10 million for a project of 5,000 sq. km 

(1,930 sq./mi.). The second comment 


pwalker on DSK8KYBLC1PROD with RULES