Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 53165 

approval of a supplemental new animal 

drug application (NADA) filed by Pfizer, 

Inc. The supplemental NADA provides 

for veterinary prescription use of 

tulathromycin injectable solution for the 

control of swine respiratory disease 

(SRD) in groups of pigs where SRD has 

been diagnosed. 

DATES: This rule is effective October 16, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Cindy L. Burnsteel, Center for 

Veterinary Medicine (HFV–130), Food 

and Drug Administration, 7500 Standish 

Pl., Rockville, MD 20855, 240–276– 

8341, e-mail: 

cindy.burnsteel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pfizer, 

Inc., 235 East 42d St., New York, NY 

10017, filed a supplement to NADA 

141–244 for DRAXXIN (tulathromycin) 

Injectable Solution. The supplemental 

NADA provides for the use of 

tulathromycin injectable solution for 

control of SRD associated with 

Actinobacillus pleuropneumoniae, 

Pasteurella multocida, and Mycoplasma 

hyopneumoniae in groups of pigs where 

SRD has been diagnosed. The 

application is approved as of September 

8, 2009, and the regulations are 

amended in § 522.2630 (21 CFR 

522.2630) to reflect the approval. 

In addition, FDA has noticed that the 

approved indications for use of this 

product in cattle (73 FR 58872, October 

8, 2008) were inaccurately codified. At 

this time, § 522.2630 is being amended 

to correctly describe these indications 

for use. 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. 

Under section 512(c)(2)(F)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(iii)), this 

supplemental approval qualifies for 3 

years of marketing exclusivity beginning 

on the date of approval. 

The agency has determined under 21 

CFR 25.33(d)(5) 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 522 

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 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

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

■ 2. In § 522.2630, revise paragraphs 

(d)(1)(ii) and (d)(2)(ii) to read as follows: 

§ 522.2630 Tulathromycin. 

* * * * * 

(d) * * * 

(1) * * * 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, 

Histophilus somni, and Mycoplasma 

bovis. For the control of respiratory 

disease in cattle at high risk of 

developing BRD associated with M. 

haemolytica, P. multocida, H. somni, 

and M. bovis. For the treatment of 

infectious bovine keratoconjunctivitis 

associated with Moraxella bovis. For the 

treatment of bovine foot rot (interdigital 

necrobacillosis) associated with 

Fusobacterium necrophorum and 

Porphyromonas levii. 

* * * * * 

(2) * * * 

(ii) Indications for use. For the 

treatment of swine respiratory disease 

(SRD) associated with Actinobacillus 

pleuropneumoniae, P. multocida, 

Bordetella bronchiseptica, Haemophilus 

parasuis, and Mycoplasma 

hyopneumoniae; and for the control of 

SRD associated with A. 

pleuropneumoniae, P. multocida, and 

M. hyopneumoniae in groups of pigs 

where SRD has been diagnosed. 

* * * * * 

Dated: September 30, 2009. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E9–24882 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 878 

[Docket No. FDA–2009–N–0333] 

Medical Devices; Plastic Surgery 

Devices; Classification of Wound 

Dressing With Poly (Diallyl Dimethyl 

Ammonium Chloride) Additive 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

wound dressing with pDADMAC 

additive into class II (special controls). 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Wound Dressing 

With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive,’’ which will serve as the 

special control for this device type. The 

agency is classifying this device type 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of these devices. 

DATES: This final rule is effective 

November 16, 2009. 

FOR FURTHER INFORMATION CONTACT: Sam 

Arepalli, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 3612, 

Silver Spring, MD 20993, 301–796– 

6434. 

SUPPLEMENTARY INFORMATION: 

I. What Is the Background of This 

Rulemaking? 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (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 the device is 

classified or reclassified into class I or 

class II, or FDA issues an order finding 

the device to be substantially 

equivalent, in accordance with section 

513(i) of the act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 


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53166 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the act 

(21 U.S.C. 360(k)) and part 807 of FDA’s 

regulations (21 CFR part 807). 

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device 

type. Within 30 days after the issuance 

of an order classifying the device, FDA 

must publish a notice in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act). 

In accordance with section 513(f)(1) of 

the act, FDA issued a written notice of 

classification on June 23, 2006, 

classifying the QMT NIMBUS Barrier 

Gauze Dressing intended for use as a 

primary dressing for exuding wounds, 

1st and 2d degree burns, and surgical 

wounds, to secure and prevent 

movement of a primary dressing, and as 

a wound packing in class III, because it 

was not substantially equivalent to a 

device that was introduced or delivered 

for introduction into interstate 

commerce for commercial distribution 

before May 28, 1976, or a device that 

was subsequently reclassified into class 

I or class II. On May 10, 2007, QuickMed Technologies, Inc., submitted a 

petition requesting classification of the 

QMT NIMBUS Barrier Gauze Dressing 

intended for use as a primary dressing 

for exuding wounds, 1st and 2d degree 

burns, and surgical wounds, to secure 

and prevent movement of a primary 

dressing, and as a wound packing under 

section 513(f)(2) of the act. The 

manufacturer recommended that the 

device be classified into class II (Ref. 1). 

In accordance with section 513(f)(2) of 

the act, FDA reviewed the petition in 

order to classify the device under the 

criteria for classification set forth in 

513(a)(1) of the act. Devices are to be 

classified into class II if general 

controls, by themselves, are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but there is 

sufficient information to establish 

special controls to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. After 

review of the information submitted in 

the petition, FDA determined that the 

wound dressing with pDADMAC 

additive can be classified into class II 

with the establishment of special 

controls. FDA believes that these special 

controls, in addition to general controls, 

are adequate to provide reasonable 

assurance of the safety and effectiveness 

of the device. The device is assigned the 

generic name ‘‘Wound Dressing with 

pDADMAC Additive.’’ A wound 

dressing with pDADMAC additive is a 

medical device that is used as a primary 

dressing for exuding wounds, 1st and 2d 

degree burns, and surgical wounds, to 

secure and prevent movement of a 

primary dressing, and as a wound 

packing. 

FDA has identified the following risks 

to health associated with this type of 

device as: 

1. Infection, 

2. Adverse tissue reactions, 

3. Leaching (of the pDADMAC into 

the wound), 

4. Degradation (of materials leading to 

device failure), and 

5. Necrosis and pain. 

FDA believes that the class II special 

controls guidance document will aid in 

mitigating the potential risks to health 

as described in Table 1 of this 

document. 

TABLE 1.—RISKS TO HEALTH AND MITIGATION MEASURES

Identified Risk Recommended Mitigation Measures 

Infection Sterility 

Biochemical testing 

Adverse tissue reaction Biocompatibility 

Leaching (of the additive pDADMAC into the wound) Non-leachability 

Degradation (of materials leading to device failure) Shelf life testing 

Necrosis or pain Labeling 

FDA believes that the special controls, 

in addition to general controls, address 

the risks to health identified previously 

and provide reasonable assurances of 

the safety and effectiveness of the 

device type. Thus, on February 25, 

2009, FDA issued an order to the 

petitioner classifying the device into 

class II. FDA is codifying this 

classification at 21 CFR 878.4015. 

Following the effective date of the 

final classification rule, manufacturers 

will need to address the issues covered 

in the special controls guidance. 

However, the manufacturer need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirement under section 510(k) of the 

act, if FDA determines that premarket 

notification is not necessary to provide 

reasonable assurance of the safety and 

effectiveness of the device. There is no 

such exemption for this type of device. 

Persons who intend to market this type 

of device must submit to FDA a 

premarket notification, prior to 

marketing the device, which contains 

information about the wound dressing 

with pDADMAC additive they intend to 

market. 

II. What Is the Environmental Impact of 

This Rule? 

The agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Thus, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

III. What Is the Economic Impact of 

This Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 104–4). 

Executive Order 12866 directs agencies 


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Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Rules and Regulations 53167 

to assess all costs and benefits of 

available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because classification of this 

device into class II will relieve 

manufacturers of the cost of complying 

with the premarket approval 

requirements of section 515 of the act 

(21 U.S.C. 360e), and may permit small 

potential competitors to enter the 

marketplace by lowering their costs, the 

agency certifies that the final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ 

The current threshold after 

adjustment for inflation is $133 million, 

using the most current (2008) Implicit 

Price Deflator for the Gross Domestic 

Product. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount. 

IV. Does This Final Rule Have 

Federalism Implications? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute 

to preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain State 

requirements ‘‘different from or in 

addition to’’ certain federal 

requirements applicable to devices (21 

U.S.C. 360k; Medtronic v. Lohr, 518 U.S. 

470 (1996); Riegel v. Medtronic, 128 S. 

Ct. 999 (2008)). 

The special controls established by 

this final rule create ‘‘requirements’’ for 

specific medical devices under 21 

U.S.C. 360k, even though product 

sponsors have some flexibility in how 

they meet those requirements (Papike v. 

Tambrands, Inc., 107 F.3d 737, 740–42 

(9th Cir. 1997)). 

V. How Does This Rule Comply With 

the Paperwork Reduction Act of 1995? 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 is not required. Elsewhere 

in this issue of the Federal Register, 

FDA is issuing a notice announcing the 

guidance for the final rule. This 

guidance, ‘‘Class II Special Controls 

Guidance Document: Wound Dressing 

With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive,’’ references previously 

approved collections of information 

found in FDA regulations. 

VI. What References Are on Display? 

The following reference has been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Petition from Quick-Med Technologies, 

Inc., May 10, 2007. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Section 878.4015 is added to 

subpart E to read as follows: 

§ 878.4015 Wound dressing with poly 

(diallyl dimethyl ammonium chloride) 

(pDADMAC) additive. 

(a) Identification. A wound dressing 

with pDADMAC additive is intended for 

use as a primary dressing for exuding 

wounds, 1st and 2d degree burns, and 

surgical wounds, to secure and prevent 

movement of a primary dressing, and as 

a wound packing. 

(b) Classification. Class II (special 

controls). The special control is: the 

FDA guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Wound Dressing With Poly (Diallyl 

Dimethyl Ammonium Chloride) 

(pDADMAC) Additive.’’ See § 878.1(e) 

for availability of this guidance 

document. 

Dated: October 2, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24963 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2009–0455(a); FRL–8969– 

9] 

Approval and Promulgation of Air 

Quality Implementation Plans; South 

Carolina; Clean Air Interstate Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve a revision to the South 

Carolina State Implementation Plan 

(SIP) submitted by the State of South 

Carolina through the South Carolina 

Department of Health and 

Environmental Control on December 4, 

2008. This revision addresses the 

requirements of EPA’s Clean Air 

Interstate Rule (CAIR) and the transition 

of the State’s Nitrogen Oxides (NOX) 

Budget Trading Program to the State’s 

CAIR NOX Ozone Season Program. 

Although the District of Columbia 

Circuit Court (D.C. Circuit Court) found 

CAIR to be flawed, the rule was 

remanded without vacatur and thus 

remains in place. Thus, EPA is 

continuing to approve CAIR provisions 

into SIPs as appropriate. CAIR, as 

promulgated, requires states to reduce 

emissions of sulfur dioxide (SO2) and 

NOX that significantly contribute to, or 

interfere with maintenance of, the 

national ambient air quality standards 

(NAAQS) for fine particulates and/or 

ozone in any downwind state. CAIR 

establishes budgets for SO2 and NOX for 

states that significantly contribute or 

interfere with maintenance and requires 

such states to submit SIP revisions that 

implement these budgets. States have 

the flexibility to choose which control 

measures to adopt to achieve the 

budgets, including participation in EPAadministered cap-and-trade programs 


CPrice-Sewell on DSKDVH8Z91PROD with RULES