Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 54055 

a fax request to 301–847–8149 to receive 

a hard copy. Please use the document 

number 1697 to identify the draft 

guidance you are requesting. To receive 

‘‘Clinical Performance Assessment: 

Considerations for Computer-Assisted 

Detection Devices Applied to Radiology 

Images and Radiology Device Data— 

Premarket Approval (PMA) and 

Premarket Notification [510(k)] 

Submissions,’’ you may either send an 

e-mail 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 1698 to 

identify the draft guidance you are 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. 

V. Paperwork Reduction Act of 1995 

These draft guidances contain 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 USC 3501–3520) (the PRA). The 

collections of information addressed in 

these draft guidance documents have 

been approved by OMB in accordance 

with the PRA under the regulations 

governing premarket notification 

submissions (21 CFR part 807, subpart 

E, OMB No. 0910–0120), premarket 

approval applications (21 CFR part 814, 

OMB No. 0910–0231), investigational 

device exemptions (21 CFR part 812, 

OMB No. 0910–0078), and humanitarian 

use devices (21 CFR part 814, OMB No. 

0910–0332). The labeling provisions 

addressed in the ‘‘Computer-Assisted 

Detection Devices Applied to Radiology 

Images and Radiology Device Data— 

Premarket Notification [510(k)] 

Submissions’’ draft guidance have been 

approved by OMB under OMB No. 

0910–0485. 

VI. 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 15, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25233 Filed 10–20–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0473] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Cardiac Allograft Gene Expression 

Profiling Test Systems; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the special controls 

guidance document entitled ‘‘Class II 

Special Controls Guidance Document: 

Cardiac Allograft Gene Expression 

Profiling Test Systems.’’ This guidance 

document describes a means by which 

cardiac allograft gene expression 

profiling test systems may comply with 

the requirement of special controls for 

class II devices. It includes 

recommendations for validation of 

performance characteristics and 

recommendations for product labeling. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

codifying the classification of cardiac 

allograft gene expression profiling test 

systems into class II (special controls), 

and establishing this guidance 

document as the special control for this 

device. 

DATES: Submit electronic or written 

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: Cardiac Allograft 

Gene Expression Profiling Test 

Systems’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance, 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 self-addressed 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 to http:// 

www.regulations.gov. 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Kellie B. Kelm, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5625, Silver Spring, 

MD 20993, 301–796–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

codifying the classification of cardiac 

allograft gene expression profiling test 

systems 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)) and establishing 

this guidance document as the special 

control for cardiac allograft gene 

expression profiling test systems 

classified under that regulation. 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), request FDA to classify 

the device under the criteria set forth in 

section 513(a)(1). 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. Under 

this authority, on August 26, 2008, FDA 

by order classified into class II, subject 

to this special control guidance 

document, the XDx AlloMap Test. 


jlentini on DSKJ8SOYB1PROD with NOTICES
54056 Federal Register / Vol. 74, No. 202 / Wednesday, October 21, 2009 / Notices 

II. Significance of Special Controls 

Guidance Documents 

FDA believes that adherence to the 

recommendations described in this 

guidance document, in addition to the 

general controls, will provide 

reasonable assurance of the safety and 

effectiveness of cardiac allograft gene 

expression profiling test systems 

classified under § 862.1163 (21 CFR 

862.1163). In order to be classified as a 

class II device under § 862.1163, a 

cardiac allograft gene expression 

profiling test system must comply with 

the requirement of special controls; 

manufacturers must address the issues 

requiring special controls as identified 

in the guidance documents, either by 

following the recommendations in the 

guidance documents or by some other 

means that provides equivalent 

assurances of safety and effectiveness. 

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: Cardiac 

Allograft Gene Expression Profiling Test 

Systems,’’ 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 1686 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 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

establishing as special controls for the 

cardiac allograft gene expression 

profiling test systems the guidance 

document that is the subject of this 

notice. The preamble to that rule 

addresses the application of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520) to the information 

collection provisions referenced in this 

guidance document. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

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 9, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–25313 Filed 10–20–09; 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 Meeting 

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 meeting. 

The meeting 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; BSPH 

Member Conflict Applications. 

Date: October 23, 2009. 

Time: 3:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Mark P. Rubert, Ph.D, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5218, 

MSC 7852, Bethesda, MD 20892, 301–435– 

1775, rubertm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: October 13, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25269 Filed 10–20–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center on Minority Health and 

Health Disparities; Notice of Closed 

Meeting 

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 meeting. 

The meeting 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: National Center on 

Minority Health and Health Disparities 

Special Emphasis Panel; Conference Grant 

Review. 

Date: November 10, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Prabha L. Atreya, Ph.D, 

Chief, Office of Scientific Review, National 

Center on Minority Health and Health 

Disparities, 6707 Democracy Boulevard, 

Suite 800, Bethesda, MD 20892, (301) 594– 

8696, atreyapr@mail.nih.gov. 

Dated: October 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–25287 Filed 10–20–09; 8:45 am] 

BILLING CODE 4140–01–P 


jlentini on DSKJ8SOYB1PROD with NOTICES