Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period, 52885-52886 [E7-18221]

Download as PDF Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices applications must maintain these records. PMAs have been required since 1976, and there are 1,128 active PMAs that could be subject to these requirements, based on actual FDA data. Each study has approximately 200 subjects, and at an average of 5 minutes per subject, there is a total burden per study of 1,000 minutes, or 17 hours. The aggregate burden for all 1,128 holders of approved original PMAs, therefore, is 19,176 hours (1,127 approved PMAs with clinical data x 17 hours per PMA). The applicant determines which records should be maintained during product development to document and/ or substantiate the device’s safety and effectiveness. Records required by the current good manufacturing practices for medical devices regulation (part 820) may be relevant to a PMA review and may be submitted as part of an application. In individual instances, records may be required as conditions of approval to ensure the device’s continuing safety and effectiveness. Dated: September 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–18222 Filed 9–14–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0347] Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic Multivariate Index Assays; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment jlentini on PROD1PC65 with NOTICES period. SUMMARY: The Food and Drug Administration (FDA) is reopening until October 17, 2007, the comment period for ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays’’ published in the Federal Register of July 26, 2007 (72 FR 41081). That guidance was a revised version of the original draft, which was published on September 7, 2006, with a 90-day comment period that was extended to 180 days. In addition, FDA held a public meeting on the draft guidance in February 2006. FDA is reopening the comment period on the revised draft to allow sufficient time for stakeholder comment. VerDate Aug<31>2005 17:00 Sep 14, 2007 Jkt 211001 Submit written or electronic comments by October 17, 2007. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Draft Guidance for industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays’’ 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 draft 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 or https://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Courtney Harper, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0694. SUPPLEMENTARY INFORMATION: DATES: I. Background In the Federal Register of July 26, 2007 (72 FR 41081), FDA published a notice of availability of a revised draft guidance, ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays’’ with a 30-day comment period. The In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) guidance document has been the subject of attention, comment, and public discussion for almost a year. The original draft was published on September 7, 2006, with a 90-day comment period. In response to requests for further opportunity to comment, FDA extended the comment period to 180 days and held a public meeting on the guidance document. The second draft, which was published July 26, 2007, incorporated many of the suggested comments on the first draft. Among other things, the second draft simplified the definition of IVDMIAs, and provided a variety of specific examples to assist sponsors in understanding the definition. In light of the opportunities for comment on the first draft, we had originally set a 30-day PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 52885 period for comments on the second draft. The initial comment period closed on August 27, 2007. However, at the request of in vitro diagnostic device stakeholders, the agency has decided to reopen the comment period for an additional 30 days on the ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.’’ This draft guidance is intended to provide clarification on FDA’s approach to regulation of IVDMIAs. II. Request for Comments Following publication of the July 26, 2007, ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,’’ FDA received requests to allow interested persons additional time to comment. The requesters asserted that the time period of 30 days was insufficient to respond fully to FDA’s specific requests for comments and to allow potential respondents to thoroughly evaluate and address pertinent issues. III. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency’s current thinking on IVDMIAs. 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. IV. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To received ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,’’ 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 1610 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 E:\FR\FM\17SEN1.SGM 17SEN1 52886 Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Notices 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. Dated: September 11, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–18221 Filed 9–14–07; 8:45 am] V. How to Submit Comments Agency Information Collection Activities: Submission for OMB Review; Comment Request 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. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 0915–0184): Extension The operation of the Organ Procurement and Transplantation Network (OPTN) necessitates certain recordkeeping and reporting requirements in order to perform the functions related to organ transplantation under contract to HHS. This is a request for an extension of the current recordkeeping and reporting requirements associated with the OPTN. These data will be used by HRSA in monitoring the contracts for the OPTN and the Scientific Registry of Transplant Recipients (SRTR) and in carrying out other statutory responsibilities. Information is needed to match donor organs with recipients, to monitor compliance of member organizations with OPTN rules and requirements, to ensure that all qualified entities are accepted for membership in the OPTN, and to ensure patient safety. ESTIMATED ANNUAL REPORTING AND RECORD KEEPING BURDEN Number of respondents Section and activity 121.3(b)(2)—OPTN membership and application requirements for OPOs, hospitals, and histocompatibility laboratories ...................................... 121.3(b)(4)—Appeal for OPTN membership ................... 121.6(c) (Reporting)—Submitting criteria for organ acceptance ....................................................................... 121.6(c) (Disclosure)—Sending criteria to OPOs ............ 121.7(b)(4)—Reasons for Refusal ................................... 121.7(e) —Transplant to prevent organ wastage ............ 121.9(b)—Designated Transplant Program Requirements ............................................................................ 121.9(d)—Appeal for designation .................................... Total .......................................................................... Responses per respondents 40 2 3 1 900 900 900 260 1 1 38 1.5 10 2 1 1 954 .......................... jlentini on PROD1PC65 with NOTICES Jkt 211001 15 3 1, 800 6 900 900 34,200 390 0.5 0.5 0.5 0.5 450 450 17,100 195 10 2 5.0 6 50 12 36,524 .......................... 20,063 Agency Information Collection Activities: Submission for OMB Review; Comment Request Proposed Project: The Nurse Faculty Loan Program (NFLP): Annual Operating Report (AOR) Form—NEW Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to The Annual Operating Report (AOR) provides information on the Nurse Faculty Loan Program (NFLP) funded loan activities. Under Title VIII of the Public Health Service Act, as amended by Public Law 107–205, Section 846A, the Secretary of Health and Human Services (HHS) enters into an agreement with a school of nursing to establish and operate the NFLP fund. HHS makes an Dated: September 10, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7–18220 Filed 9–14–07; 8:45 am] 17:00 Sep 14, 2007 120 2 Total burden hours Health Resources and Services Administration DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Aug<31>2005 Hours per response OMB for review, call the HRSA Reports Clearance Office on (301) 443–1129. The following request has been submitted to the OMB for review under the Paperwork Reduction Act of 1995: Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ BILLING CODE 4165–15–P Total responses PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[Federal Register Volume 72, Number 179 (Monday, September 17, 2007)]
[Notices]
[Pages 52885-52886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18221]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0347]


Draft Guidance for Industry, Clinical Laboratories, and Food and 
Drug Administration Staff on In Vitro Diagnostic Multivariate Index 
Assays; Reopening of the Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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

SUMMARY:  The Food and Drug Administration (FDA) is reopening until 
October 17, 2007, the comment period for ``Draft Guidance for Industry, 
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic 
Multivariate Index Assays'' published in the Federal Register of July 
26, 2007 (72 FR 41081). That guidance was a revised version of the 
original draft, which was published on September 7, 2006, with a 90-day 
comment period that was extended to 180 days. In addition, FDA held a 
public meeting on the draft guidance in February 2006. FDA is reopening 
the comment period on the revised draft to allow sufficient time for 
stakeholder comment.

DATES:  Submit written or electronic comments by October 17, 2007.

ADDRESSES:  Submit written requests for single copies of the guidance 
document entitled ``Draft Guidance for industry, Clinical Laboratories, 
and FDA Staff on In Vitro Diagnostic Multivariate Index Assays'' 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 draft 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 or https://
www.regulations.gov. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Courtney Harper, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0694.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 26, 2007 (72 FR 41081), FDA 
published a notice of availability of a revised draft guidance, ``Draft 
Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro 
Diagnostic Multivariate Index Assays'' with a 30-day comment period. 
The In Vitro Diagnostic Multivariate Index Assays (IVDMIAs) guidance 
document has been the subject of attention, comment, and public 
discussion for almost a year. The original draft was published on 
September 7, 2006, with a 90-day comment period. In response to 
requests for further opportunity to comment, FDA extended the comment 
period to 180 days and held a public meeting on the guidance document. 
The second draft, which was published July 26, 2007, incorporated many 
of the suggested comments on the first draft. Among other things, the 
second draft simplified the definition of IVDMIAs, and provided a 
variety of specific examples to assist sponsors in understanding the 
definition. In light of the opportunities for comment on the first 
draft, we had originally set a 30-day period for comments on the second 
draft. The initial comment period closed on August 27, 2007. However, 
at the request of in vitro diagnostic device stakeholders, the agency 
has decided to reopen the comment period for an additional 30 days on 
the ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff 
on In Vitro Diagnostic Multivariate Index Assays.''
    This draft guidance is intended to provide clarification on FDA's 
approach to regulation of IVDMIAs.

II. Request for Comments

    Following publication of the July 26, 2007, ``Draft Guidance for 
Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic 
Multivariate Index Assays,'' FDA received requests to allow interested 
persons additional time to comment. The requesters asserted that the 
time period of 30 days was insufficient to respond fully to FDA's 
specific requests for comments and to allow potential respondents to 
thoroughly evaluate and address pertinent issues.

III. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the agency's current thinking on IVDMIAs. 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.

IV. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. To received ``Draft Guidance for Industry, 
Clinical Laboratories, and FDA Staff on In Vitro Diagnostic 
Multivariate Index Assays,'' 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 1610 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

[[Page 52886]]

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.

V. How to Submit 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: September 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18221 Filed 9-14-07; 8:45 am]
BILLING CODE 4160-01-S

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