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, 26398-26399 [E7-8872]

Download as PDF 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). 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 sroberts on PROD1PC70 with NOTICES DATES: VerDate Aug<31>2005 18:12 May 08, 2007 Jkt 211001 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// 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 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://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 E:\FR\FM\09MYN1.SGM 09MYN1 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Notices 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. sroberts on PROD1PC70 with NOTICES 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 https://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 VerDate Aug<31>2005 18:12 May 08, 2007 Jkt 211001 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 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 26399 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 (https://www.fda.gov/cvm) and from the Division of Dockets Management Web site (https:// 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 E:\FR\FM\09MYN1.SGM 09MYN1

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[Federal Register Volume 72, Number 89 (Wednesday, May 9, 2007)]
[Notices]
[Pages 26398-26399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-8872]



[[Page 26398]]

-----------------------------------------------------------------------

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 https://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 
Sec.  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 
(Sec.  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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://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

[[Page 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

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