26398 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0137] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Gene Expression Profiling Test System 

for Breast Cancer Prognosis; 

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: Gene Expression Profiling 

Test System for Breast Cancer 

Prognosis.’’ This guidance document 

describes a means by which gene 

expression profiling test systems for 

breast cancer prognosis 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 

to classify gene expression profiling test 

systems for breast cancer prognosis into 

class II (special controls). This guidance 

document is immediately in effect as the 

special control for gene expression 

profiling test systems for breast cancer 

prognosis, but it remains subject to 

comment in accordance with the 

agency’s good guidance practices 

(GGPs). 

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: Gene Expression 

Profiling Test System for Breast Cancer 

Prognosis’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 240–276–

3151. 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.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Reena Philip, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

1286. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

classifying gene expression profiling test 

systems for breast cancer prognosis 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 gene 

expression profiling test systems for 

breast cancer prognosis devices. 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. 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 gene 

expression profiling test systems for 

breast cancer prognosis. 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: Gene 

Expression Profiling Test System for 

Breast Cancer Prognosis,’’ 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 240–276–3151 to receive 

a hard copy. Please use the document 

number 1627 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.fda.gov/ 

ohrms/dockets. 

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 No. 0910–

0120; the collections of information in 

21 CFR part 814 have been approved 

under OMB Control No. 0910–0231; the 

collections of information in 21 CFR 

part 809 have been approved under 

OMB Control No. 0910–0485; and the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB Control No. 0910–0073. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 26399 

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: May 1, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–8872 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0254] 

Guidance for Industry: Analytical 

Methods Description for Type C 

Medicated Feeds; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance for industry 

(#137) entitled ‘‘Analytical Methods 

Description for Type C Medicated 

Feeds.’’ This guidance provides our 

recommendations for describing 

methods for analyzing new animal 

drugs in Type C medicated feeds. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Comments 

should be identified with the full title 

of the guidance and the docket number 

found in brackets in the heading of this 

document. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Owen, Center for Veterinary 

Medicine (HFV–141), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–9842, email: rebecca.owen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 28, 

2006 (71 FR 36813), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Analytical Methods 

Description for Type C Medicated 

Feeds’’ giving interested persons until 

September 11, 2006, to comment on the 

draft guidance. With the exception of 

one general comment regarding 

medicated feed, FDA received no 

specific comments on the guidance. The 

final guidance has not been 

substantively changed from the draft 

version. 

Section 512 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360b) 

establishes the requirements for new 

animal drug approval. FDA regulations 

in part 514 (21 CFR part 514) specify the 

information you must submit as part of 

your new animal drug application 

(NADA) and the proper format for the 

NADA submission. As part of your 

NADA submission, you must include a 

‘‘detailed description of the collection of 

samples and the analytical procedures 

to which they are subjected’’

(§ 514.1(b)(5)(vii)). This should include 

a description of practicable methods of 

analysis which have adequate 

sensitivity to determine the amount of 

the new animal drug in the final dosage 

form (§ 514.1(b)(5)(vii)(a)). This 

guidance provides recommendations for 

describing methods for analyzing new 

animal drugs in Type C medicated 

feeds. This guidance applies to 

instrumental methods only (e.g., high 

pressure liquid chromatography, gas 

chromatography). For information on 

other methods (e.g., microbiological 

methods) you should contact the Center 

for Veterinary Medicine (CVM). 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on the topic. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate method 

may be used as long as it satisfies the 

requirements of applicable statutes and 

regulations. 

III. 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 

§ 514.1 have been approved under OMB 

control numbers 0910–0032 and 0910–

0154. 

IV. Comments 

Interested persons may, at any time, 

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 should be identified 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Electronic Access 

Copies of the guidance document 

entitled ‘‘Analytical Methods 

Description for Type C Medicated 

Feeds’’ may be obtained from the CVM 

home page (http://www.fda.gov/cvm) 

and from the Division of Dockets 

Management Web site (http:// 

www.fda.gov/ohrms/dockets/ 

default.htm). 

Dated: April 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–8808 Filed 5–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institutes of Health/National 

Institute of Environmental Health 

Sciences Proposed Collection; 

Comment Request; Program 

Assessment and Evaluations for 

NIEHS—Asthma Research 

Summary: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Environmental 

Health Sciences, the National Institutes 

of Health (NIH) will publish periodic 

summaries of proposed projects to be 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. 

Proposed Collection: Title: Program 

Assessment and Evaluations for 


sroberts on PROD1PC70 with NOTICES