Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53269 

Dated: October 5, 2009. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E9–24869 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0328] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Wound Dressing With Poly (Diallyl 

Dimethyl Ammonium Chloride) 

Additive; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Wound Dressing With Poly 

(Diallyl Dimethyl Ammonium Chloride) 

(pDADMAC) Additive.’’ This guidance 

document describes a means by which 

wound dressing with Poly (diallyl 

dimethyl ammonium chloride) 

(pDADMAC) additive may comply with 

the requirement of special controls for 

class II devices. Elsewhere in this issue 

of the Federal Register, FDA is 

publishing a final rule to classify wound 

dressing with pDADMAC additive into 

class II (special controls). This guidance 

document is being immediately 

implemented as the special control for 

wound dressing with pDADMAC 

additive, but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs). 

DATES: Submit written or electronic 

comments on the guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Wound Dressing 

With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, Center for 

Devices and Radiological Health 

(CDRH), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 4613, Silver Spring, MD 20850. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8502. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

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. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying into class II (special controls) 

under section 513(f)(2) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 360c(f)(2)). This guidance 

document will serve as the special 

control for wound dressing with 

pDADMAC additive. Section 513(f)(2) of 

the act provides that any person who 

submits a premarket notification under 

section 510(k) of the act (21 U.S.C. 

360(k)) 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. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Thus, FDA is issuing this 

guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

comments that are received in response 

to this notice to determine whether to 

amend the guidance document. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s GGPs regulation 

(§ 10.115). The guidance represents the 

agency’s current thinking on wound 

dressings with pDADMAC additive. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Class II Special 

Controls Guidance Document: Wound 

Dressing With Poly (Diallyl Dimethyl 

Ammonium Chloride) (pDADMAC) 

Additive,’’ you may either send an email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 240– 

276–3151 to receive a hard copy. Please 

use the document number 1684 to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (the PRA) (44 

U.S.C. 3501–3520). The collections of 

information in 21 CFR part 807, subpart 

E have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; and 

the collections of information in 21 CFR 


jlentini on DSKJ8SOYB1PROD with NOTICES
53270 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

part 801 have been approved under 

OMB control number 0910–0485. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: October 2, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24964 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–M–0299, FDA– 

2009–M–0300, FDA–2009–M–0182, FDA– 

2009–M–0244, FDA–2009–M–0243, FDA– 

2009–M–0255] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in Table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30 day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 30 

day period. Reconsideration of a denial 

or withdrawal of approval of a PMA 

may be sought only by the applicant; in 

these cases, the 30 day period will begin 

when the applicant is notified by FDA 

in writing of its decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from April 1, 2009, through 

June 30, 2009. There were no denial 

actions during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the approval date. 

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1, 

2009, THROUGH JUNE 30, 2009. 

PMA No./Docket No. Applicant TRADE NAME Approval Date 

P080014 

FDA–2009–M–0299 

Third Wave Technologies, Inc. CERVISTA HPV HR March 12, 2009 

P080015 

FDA–2009–M–0300 

Third Wave Technologies, Inc. CERVISTA HPV 16/18 March 12, 2009 

P080006 

FDA–2009–M–0182 

Medtronic Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD April 7, 2009 

P080023 

FDA–2009–M–0244 

Abbott Laboratories ARCHITECT CORE REAGENT KIT, ARCHITECT 

CORE CALIBRATOR AND ARCHITECT CORE 

CONTROLS 

April 10, 2009 

P060023 

FDA–2009–M–0243 

Medtronic Sofamor Danek BRYAN CERVICAL DISC May 12, 2009 

P060008 (S8) 

FDA–2009–M–0255 

Boston Scientific Co. TAXUS LIBERTE ATOM PACLITAXEL–ELUTING 

CORONARY STENT SYSTEM 

May 21, 2009 


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