Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices 54637 

epidemiology and risk factors relating to 

chronic fatigue syndrome, and 

identifying potential opportunities in 

these areas; (2) current and proposed 

diagnosis and treatment methods for 

chronic fatigue syndrome; and (3) 

development and implementation of 

programs to inform the public, health 

care professionals, and the biomedical, 

academic, and research communities 

about advances in chronic fatigue 

syndrome. 

The agenda for this meeting is being 

developed. The agenda will be posted 

on the CFSAC Web site, http:// 

www.hhs.gov/advcomcfs, when it is 

finalized. The meeting will be broadcast 

over the Internet as a real-time 

streaming video. It also will be recorded 

and archived on the CFSAC Web site for 

on demand viewing. 

CFSAC Subcommittees will convene 

scientific review sessions on Tuesday, 

October 12. The purpose of these 

sessions is to update the latest 

developments in etiology, natural 

history, clinical trials, and related areas 

for chronic fatigue syndrome. The 

public is welcome to attend these 

sessions, which are not a formal part of 

the Advisory Committee meeting. These 

sessions will be broadcast over the 

Internet as a real-time streaming video. 

It also will be recorded and archived on 

the CFSAC Web site for on demand 

viewing. An agenda will be posted on 

the CFSAC Web site when it becomes 

available. 

Public attendance at the meeting is 

limited to space available. Individuals 

must provide a government-issued 

photo ID for entry into the building 

where the meeting is scheduled to be 

held. Those attending the meeting will 

need to sign-in prior to entering the 

meeting room. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the designated contact person at 

cfsac@hhs.gov in advance. 

Members of the public will have the 

opportunity to provide comment at the 

October 13–14 meeting if pre-registered. 

Individuals who wish to address the 

Committee during the public comment 

session must pre-register by Friday, 

September 17, 2010, via e-mail at 

cfsac@hhs.gov. Time slots for public 

comment will be available on a firstcome, first-served basis. Public 

comment will be limited to five minutes 

per speaker; no exceptions will be 

made. Individuals registering for public 

comment should submit a copy of their 

testimony in advance to cfsac@hhs.gov, 

prior to the close of business on Friday, 

September 17, 2010. 

Members of the public who wish to 

have printed material distributed to 

CFSAC members for review should 

submit one copy of the material to the 

Executive Secretary, at cfsac@hhs.gov, 

prior to close of business on September 

17, 2010. Submissions are limited to 

five typewritten pages. Any written 

testimony submitted after this date will 

be available for inspection on-site and 

will be posted to the Web site after the 

meeting. 

If you do not submit your written 

testimony prior to the close of business 

Friday, September 17, 2010, you may 

bring a copy of your written testimony 

to the meeting and present it to the 

CFSAC Executive Secretary. Your 

testimony will be included in a 

notebook that will be available for 

viewing by the public on a table at the 

back of the meeting room. 

Please ensure that written testimony 

does not include any personal 

information including your personal 

mailing address and that it includes 

only your name, if you wish to be 

identified. If you wish to remain 

anonymous, please notify the CFSAC 

Executive Secretary upon submission of 

the materials to cfsac@hhs.gov. 

Dated: August 31, 2010. 

Wanda K. Jones, 

Executive Secretary, Chronic Fatigue 

Syndrome Advisory Committee. 

[FR Doc. 2010–22393 Filed 9–7–10; 8:45 am] 

BILLING CODE 4150–42–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0285] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document 

for Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters; 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 for Certain Percutaneous 

Transluminal Coronary Angioplasty 

(PTCA) Catheters.’’ The guidance was 

developed as a special control to 

support the reclassification of PTCA 

catheters, other than cutting/scoring 

PTCA catheters, from class III 

(premarket approval) into class II 

(special controls). This guidance 

describes a means by which PTCA 

catheters, other than cutting/scoring 

PTCA catheters, 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 that codifies the 

reclassification of this device type from 

class III (premarket approval) into class 

II (special controls). 

DATES: Submit written or electronic 

comments on this 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 for Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4613, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–847–8149. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Kathryn O’Callaghan, Center for Devices 

and Radiological Health (HFZ–450), 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6349. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance document was 

developed as a special control guidance 

to support the reclassification of PTCA 

catheters, other than cutting/scoring 

PTCA catheters, into class II (special 

controls). The device is intended for 

balloon dilatation of a hemodynamically 

significant coronary artery or bypass 

graft stenosis in patients evidencing 

coronary ischemia for the purpose of 

improving myocardial perfusion, 

treatment of acute myocardial 

infarction, treatment of in-stent 

restenosis and/or post-deployment stent 

expansion. Cutting/scoring PTCA 

catheters (Product Code: NWX) remain 

in class III and are subject to premarket 


jlentini on DSKJ8SOYB1PROD with NOTICES
54638 Federal Register / Vol. 75, No. 173 / Wednesday, September 8, 2010 / Notices 

approval (PMA) requirements (section 

515 of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 360e)). 

On December 4, 2000, at a public 

meeting of FDA’s Circulatory System 

Devices Panel (the Panel), the Panel 

recommended that PTCA catheters, 

other than cutting/scoring PTCA 

catheters and standard PTCA catheters 

for the treatment of in-stent restenosis 

and/or post-deployment stent 

expansion, be reclassified from class III 

to class II, when indicated for balloon 

dilatation of a hemodynamically 

significant coronary artery or bypass 

graft stenosis in patients evidencing 

coronary ischemia for the purpose of 

improving myocardial perfusion, or for 

treatment of acute myocardial 

infarction. The Panel recommended a 

guidance document, labeling, and 

postmarket surveillance as special 

controls. 

FDA considered the Panel’s 

recommendations and, on May 30, 2008, 

published a proposed rule to reclassify 

certain PTCA catheters, including 

standard PTCA catheters for the 

treatment of in-stent restenosis and/or 

post-deployment stent expansion, but 

not cutting/scoring PTCA catheters, into 

class II. In addition, FDA issued a draft 

class II special controls guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document for 

Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ to support the proposed 

reclassification. 

Following publication of the draft 

guidance, two sets of comments on the 

guidance were submitted to the FDA. 

The comments received sought minor 

clarifications on several pre-clinical 

testing recommendations, including 

biocompatibility, shelf-life and 

performance testing. We considered the 

suggestions and made appropriate 

revisions. In addition, the guidance was 

updated to include more specific 

recommendations regarding evaluation 

of coating integrity. FDA is now 

identifying the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document for Certain 

Percutaneous Transluminal Coronary 

Angioplasty (PTCA) Catheters’’ as the 

guidance document that will serve as 

the special control for this device type. 

The guidance document provides a 

means by which PTCA catheters, other 

than cutting/scoring PTCA catheters, 

may comply with the requirement of 

special controls for this class II device. 

Following the effective date of the final 

reclassification rule, any firm 

submitting a premarket notification 

(510(k)) for a PTCA catheter will need 

to address the issues covered in the 

special controls guidance document. 

However, the firm need only show that 

its device meets the recommendations 

of the guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on standard PTCA 

catheters. 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 for 

Certain Percutaneous Transluminal 

Coronary Angioplasty (PTCA) 

Catheters’’ 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 301– 

847–8149 to receive a hard copy. Please 

use the document number (1608) 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 

on the Division of Dockets Management 

Internet site 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 (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 812 have 

been approved under OMB control 

number 0910–0078; the collections of 

information under CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 820 have 

been approved under 0910–0073; and 

the collections of information in 21 CFR 

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), electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments 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: August 31, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–22303 Filed 9–7–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Selected 

Topics in Transfusion Medicine. 

Date: September 27–28, 2010. 

Time: 8 a.m. to 5 p.m. 


jlentini on DSKJ8SOYB1PROD with NOTICES